New Excel Sheet semifinal NHP rev1 - European Commission · 2016. 5. 27. · year. The data shows...

1

Question VI.Aa.

Question text:

VI.a) Current provisions of Directive 86/609/EEC Non-human primates are listed in the Annex I of the Directive requiring them to be purpose-bred. The current provisions state that experiments on animals taken from the wild may not be carried out unless experiments on other animals would not suffice for the aims of the experiment.

Animals listed under CITES can only be used in experiments for research aimed at preservation of the species in question, or essential biomedical purposes where the species in question exceptionally proves to be the only one suitable for those purposes.

Finally, there are specific obligations of individual identification of NHPs and reqruirement that particulars of their identity and origin must be entered in the records of each establishment.

Introduction

2

VI.b) Current situation in Member States Available data indicates that in 2002 about 9000 non-human primates were used in the 15 “old” Member States which accounted for about 0.1% of all the laboratory animals used in that year. The data shows that more non-human primates were used in the United Kingdom (UK), France and Germany than elsewhere in the Community. The total use of NHPs in the EU 25 is estimated to be close to 10,000 per year: 75-80% of these animals are Old World monkeys (mainly cynomolgus and rhesus monkeys); 20-25% are New World monkeys (mainly marmosets and some tamarins); and some Prosimians (mainly lemurs). Other species used counted for less than 3%.

The use of Great Apes is very limited, with 6 animals in 1999 and zero in 2002. The special situation of non-human primates led to a ban of the use of Great Apes in some Member States (total ban in the Netherlands, Austria and UK (no further licences issued); and a partial ban in Sweden when they can be used only for research relating to their own species.

3

VI.c) Use and trends The main biomedical research areas using primates are safety testing of pharmaceuticals, quality control of vaccines, and fundamental research. At present some scientific procedures require the use of primates e.g. for polio or Hepatitis C vaccine production, HIV research and investigations into higher cognitive function. A high proportion of NHP (> 70%) are used in applied studies and regulatory testing, therefore the development and implementation of alternative methods needs to be supported to reduce the number of animals used. Strategies are being developed in order to establish and maintain non-human primate tissue banks and primate-derived cell culture collections in order to optimise the use of this material but these are at present still inadequate to replace a substantial part of NHP in biomedical research.

There are insufficient data available to estimate whether the use of NHPs is decreasing in Europe. In the Netherlands the number of NHPs decreased from about 400 in 2000 to about 300 in 2004, but the UK there was an increase from about 3700 to 4200 in this period.

The USA, together with Japan, are the main world users of NHPs in research and testing. Most recent statistics show that 52.279 NHPs where used in research, testing and teaching in the USA in 2002. For Japan, no accurate figures are available as no mandatory reporting system is in place.

In 2002, about 60% of the NHPs used for scientific purposes were imported from outside the EU, more than 90% of them being macaques. All these macaques are F2 purpose-bred. Only a small number of the other imported animals are wild-caught or F1, these are species that are only sporadically used for specific purposes. Almost all the NHPs bred in the EU are F2.

4

The most frequently used NHPs in the EU are macaques (cynomolgus and rhesus monkeys) and marmosets; in the UK the ratio of Old to New World is about 3 : 1. The reproduction cycle for marmoset is 2 – 2.5 year (1,5 - 2 year until breeding age and, 4 months gestation ). One litter consists of 2 - 3 progeny. The reproduction cycle for macaques is longer, approx. 4-5 year (4 year until breeding age and 5 - 6 months gestation). A litter usually consists of only one progeny.

VI.d) Problem dimension Non-human primates are species with highly developed social skills and behavioural manners that are to some extent similar to those of human behaviour. Due to the similarities with human beings, the ethical justification of their use is a sensitive issue and a subject of serious debates. There is increasing (public) concern regarding their potential use in scientific procedures and their welfare is not considered sufficiently assured by the wording of the current Directive.

On the other hand, there is a clear need for NHPs in biomedical research, due to the above mentioned similarities to the human species. For example, they are used to tackle severe diseases such as diabetes, AIDS, malaria, Parkinson’s, Alzheimer’s etc. Furthermore, they are important for the development and production of new vaccines, where Europe plays a leading role (around 85% of the global supply is produced in Europe).

In their natural habitat NHPs live in complex environments and the social dimension is vital for their well-being. If the physical and social environment is inadequate the NHP is usually not a good model in research. Therefore, animal welfare and quality of science are linked. As a consequence, research on NHPs is more cost-intensive than research on other mammalian species. Special consideration is paid to experiments with Great Apes where the discussion about NHPs is the most controversial. Their use is quite rare, although some scientists are against a total ban because new emerging diseases might make it necessary to use Great Apes for the development of vaccines and treatments.

5

Statistics:

84 respondents stated that they support the preliminary analysis.

21 respondents stated that they have no opinion in relation to this question.

109 respondents stated that they do not support the preliminary analysis or components of it. To justifydisagreement, they were asked to provide arguments, facts and figures and if possible indicate the source of information. However, a number of respondents opted for the "No" reply only to supply additional arguments in support of the preliminary analysis.

Comments received:

Name of the expert or organisation

Type of organisation

Activity level of the organisation

Representative- ness

VI.Aa.

VI.e) Potential solutions The main options for the revised Directive could be to reinforce the ban on wild-caught NHPs and to allow only very limited exemptions. A gradual switch to only allowing F2 (second-generation) and following generations of purpose-bred NHPs would be most desirable regarding animal welfare and biodiversity. The use of Great Apes should be highly restricted.

Possible negative consequences have to be taken into account: If research on NHPs would be excessively restricted, private and academic research might be forced to relocate to other countries outside the EU, and loss of employment and scientific know-how might be the consequence. Also the welfare of animals might be negatively influenced by relocation of this type of research. Furthermore, the risk for human patients to be used as alternatives to NHPs in clinical studies might rise.

Do you support this overall analysis?

6

Dept. Laboratory Animal Science, Utrecht University, The Netherlands

User of animals -public sector

Worldwide chair of lab. animal sci. recognized by national authorities/responsable for national coordination education and training in lab. animal sci./ leading role in international laboratory animal science

This analysis is supportable in general terms. However, the final sentence is incorrect as stringent regulation of human patients in clinical trials would avoid this risk.

Gaertner User of animals -public sector

Regional representative for the field at the respective activity level.

at VI.e) Potential solutions and 1.1 to 1.5 No Based on the statement of a group of experts representing all stakeholders in the NHP (Non Human Primates) research field, i.e. European academia, Government institutes, pharmaceutical industry, contract research organizations (CROs), breeders and suppliers on proposals made by a Technical Expert Working Group during the revision of the Directive 86/609/EEC to exclude the use of animals from the first generation born in captivity (F1) and only allow the use of animals from the second (F2) or other subsequent generations one has to request an extended transition period to fulfil the research demand in Europe.........

Gesellschaft zur Förderung der biomedizischen Forschung


National The organisation is representative for the field at the respective activity level.

see Justuification 1.8

7

Hannover Medical School


Local; Regional; National

Hannover Medical School currently ranks highest with respect to research activities and aquired research grants

Based on the statement of a group of experts representing all stakeholders in the NHP (Non Human Primates) research field, i.e. European academia, Government institutes, pharmaceutical industry, contract research organizations (CROs), breeders and suppliers on proposals made by a Technical Expert Working Group during the revision of the Directive 86/609/EEC to exclude the use of animals from the first generation born in captivity (F1) and only allow the use of animals from the second (F2) or other subsequent generations one has to request an extended transition period to fulfil the research demand in Europe. There is a notion to transfer experiments that scientifically justify the use of NHP to either the USA or Japan; apparently other countries with less animal welfare restrictions advertise to transfer this type of experiments at less expenditure.

Hans J. Hedrich User of animals -public sector

Local; Regional; National; European

I am currently President of the European College of Laboratory Animal Medicine (ECLAM) and Vicepresident Gesellschaft zur Förderung der Biomedizinischen Forschung

No Based on the statement of a group of experts representing all stakeholders in the NHP (Non Human Primates) research field, i.e. European academia, Government institutes, pharmaceutical industry, contract research organizations (CROs), breeders and suppliers on proposals made by a Technical Expert Working Group during the revision of the Directive 86/609/EEC to exclude the use of animals from the first generation born in captivity (F1) and only allow the use of animals from the second (F2) or other subsequent generations one has to request an extended transition period to fulfil the research demand in Europe.

(Name confidential - Respondent 001)


National; European; Worldwide

yes See comment Option 1

8




Yes This section contains a number of inaccuracies. The majority of marmosets used in Europe are bred in Europe and not imported. The figure stated of 90% for the portion of macaques which are F2 purpose bred is incorrect. The estimate for the UK is 35% whilst the figure in mainland Europe is likely to be much less. The transition from F1 to F2 is a much larger undertaking than stated and there needs to be a structured exercise to determine the rate at which transition to F2 could be achieved. It is not likely to be less than 15 years. The requirement for NHPs is not expected to decrease in the short term as the number of biotech molecules increases and the evaluation of their efficacy and safety relies on such models.



National XXX are representative of our scientifi activity (basic research)

The analysis is based on wrong information: - Macaques and marmosets are referred in CITES appendix II not I. This means that their conservation status and the requirements for there use are by far not the one written above. See http://www.cites.org/fra/index.shtml - Quite no non human primates used in biomedical research in Europe are F2. They are F1 generation or wild-caught. F1 means the breeders were wild caught (F0) and the first captive-bred descendants (F1) were sold. F2 animals require F1 parents. There is no need to strengthen the present Directive as the use of purpose-bred primates is yet mandatory, as far as such animals are available. The number of purpose-bred primates is growing and this number is still far below the needs. So a support to the breeders would be more efficient than additional restriction.



Worldwide there are others To our knowledge wild caught NHPs are no more used in biomedical research. Therefore, it is difficult to answer 1.2 to 1.7 as it is asked for wild caught NHPs and not for F1 animals. The situation of animal supply has to differentiate between those in New World monkeys and those of Old World monkeys. New World monkeys (marmosets) are bred since numerous years in self sustaining colonies. Generally, animals of F2 and more generation are available. Concerning the situation in Old World monkeys, the wild caught animals are still used in breeding colonies outside EU for the production of purpose bred F1 animals. The statement is very doubtful that 90 % the imported macaques are F2 purpose-bred. The breeders in overseas mainly Asia and Mauritius sometimes declare them as F2 purpose-bred. These F1 animals are frequently used in Europe, in particular pharmaceutical industry. They are imported directly with subsequent quarantine or via commercial suppliers within the EU.

9



Worldwide One of several global pharmaceutical companies

Nobody would argue about applying highest ethical standards for using NHPs, but it is also clear to most medical and biological scientists that such experiments are needed and justified. “Increasing (public) concern regarding their potential use in scientific procedures” is used as an argument, which is not acceptable in this context, since public opinion cannot judge the value of scientific arguments. Although I am not an expert in the field of primate experiments, there seem to be flaws in this analysis, e.g. why some countries totally ban any experiment with great apes. I cannot understand the statement that a gradual switch to only allowing F2 (second-generation) and following generations of purpose-bred NHPs would be most desirable regarding animal welfare and biodiversity. I would like to see an analysis, why there is so much more primate research in the US – certainly not because applied ethical standards are lower in the US.




It represent all Cognitive Neuroscience groups working with non-human primates in our country.

We are deeply concerned that the factual information on which the amendments are based, is incorrect in many respects. For example, the report states that in the Netherlands the number of NHPs decreased from 400 in 2000 to 300 in 2004, but annual reports of the Dutch “Voedsel en Waren Autoriteit” (http://www2.vwa.nl) report other (larger) numbers. It is also claimed that a key finding of the Third Statitical Report is that “The use of non-human primates in experiments is of particular public concern” (http://ec.europa.eu/environment/chemicals/lab_animals/reports_en.htm). However, non of the Reports provide factual data to support this conclusion; these reports only include statistic regarding the number of animals used but they do not provide data on public opinions in any way. The use of wrong data is likely to result in serious, unwanted side effects. This is particularly worrisome in relation to the proposed shift towards the exclusive use of F2 purpose-bred monkeys (see 1.1)



National yes I beleive most macaques used are infact F1 generation not F2, Therefore to impose the use of F2 animals would limit research substantially. I think F1 animal should be used.

10



Local; Regional; National; European; Worldwide

No There are no significant numbers of F2 purpose bred macaques imported into the EU The vast majority of macaques are used in the EU for the development and testing of pharmaceuticals and vaccines, although a significant minority is used in academic research in the neurosciences. Since there is little prospect of a supply of F2 animals becoming available, this proposal would cause all pharmaceutical and vaccine industry primate work and much academic primate neuroscience research to be moved out of the EU. The immediate effects on these fields of EU research and development would be serious indeed.



Local yes See FELASA Primate statement. (http://www.felasa.org/Documents/Policy_statements/primstat.doc )




Yes Erroneous assumption on numbers



National no Based on the statement of a group of experts representing all stakeholders in the NHP (Non Human Primates) research field, i.e. European academia, Government institutes, pharmaceutical industry, contract research organizations (CROs), breeders and suppliers on proposals made by a Technical Expert Working Group during the revision of the Directive 86/609/EEC to exclude the use of animals from the first generation born in captivity (F1) and only allow the use of animals from the second (F2) or other subsequent generations one has to request an extended transition period to fulfil the research demand in Europe.



National yes Guidelines concerning the restriction of non-human primate research to second-generation animals will put European primate research at risk. These guidelines would have to be accompanied by establishing sufficient primate breeding facilities in Europe.

11



National yes Most NHP like macaques used for scientific purpose are listed in annex II. Scientific use of animals is not proved to be the main reason for species threatening nor extinction instead of deforestation and human activities. The ban must be decided on information on animal population and ecologic studies. The assumption that in 2002 that all macaques where F2 generation seems erroneous and need to be corroborated with CITES import permit data.




yes, we are a major EU HEI for biomedical research

No. Several research organizations have pointed out that this analysis is incorrect. Monkeys imported into the EU tend to be F1 generation, similar to those supplied to USA and Japan. Its is widely acknowledged that major suppliers outside the USA/EU/japan would supply in preference F1 animals to countries that will accept them, as opposed to the major additional costs and complications of preparing F2 animals. There are serious implications about in-breeding, for my own research area of neuroscience, if research is to be confined to F2 monkeys only.



National yes see below



National no It is as well possible that a total ban of experimentation on Great Apes encourages the scientfic community to develop procedures making use of other species

Bayer HealthCare

User of animals -private sector

Worldwide organisation is representative for the field

Some factual mistakes in the introduction: 1 Most of the NHP species used in research are listed under Appendix 2 of the CITES and are therefore not considered as being endangered. 2 As far as great apes are concerned, not all countries have facilities suitable for the use of great apes. In addition, there is a very limited number of research centres working on programmes that may justify the exceptional use of a strictly limited number of great apes. Therefore, the fact that some countries have decided to completely ban the use of these animals does not necessary mean that the need does not potentially exist in other EU countries. 3 As far as tissue banks are concerned: the problem is not that these are missing, but that these models are inadequate to replace vaccines testing on NHPs.

12

Covance Laboratories GmbH


Worldwide yes No with regard to F2 NHP generation: Supply with purpose-bred F2 NHPs is still very limited at given the current situation, it is very unlikely that a switch to purpose-bred F2 generation and even subsequent generations will be possible. Otherwise yes.

GlaxoSmithKline User of animals -private sector

Worldwide Thre are other international pharamceutical companies. We produce 25% of the worlds vaccines

Serious errors in analysis. NHP generally not used for vaccine production, some use for vaccine safety testing: http://www.gsk.com/research/about/about_animals_primates.html http://www.apgaw.org/userimages/Vaccinetesting.pdf Supplies of tissue limit do not replacement; scientific barriers the main limitation: http://www.frame.org.uk/estoniachem/testing%20strategies/EC%20criticise%20BUAV%20report.pdf NHP species listed not endangered, they are mainly not F2’s, marmosets all F2+. US used 55,000 NHP in 2004 http://www.aphis.usda.gov/ac/awreports/awreport2004.pdf of which 35% were imported http://www.nap.edu/catalog/11557.html The means than the US imports 4 times the number of macaques that the whole of the EU. There is no policy analysis of why F2 only is proposed, The main issue is that the EU imports non endangered captive born F1 animals for essential safety testing, that supplies of these animals are limited, and that a ban in F1 would seriously impair public safety.

Perini Luigi User of animals -private sector

Worldwide Yes For some "old" vaccine, as poliovirus, using African green Monkeys(Chlorocebus Aethiops) it's impossible to use F2 generations due to the short time to complete the eradication of polio in the world(see WHO project to eradicate polio by 2008). In addition F2 generation will move all research to the USA where there's no obligation to use F2 and with the globalization of industries we have to expect the opening of new cheapear markets in China and in India.

Protherics Medicines Development Ltd.


Worldwide No - ABPI and EFPIA repesent the pharmaceutical industry in UK/EU

There are several errors here: Most NHP species used are listed under Appendix 2 of CITES and are not endangered. Nowadays, most of the polio vaccine production is performed on primary monkey cells. Hepatitis C vaccines are not produced in primary monkey cells. Section VIc) statistics are not accurate. Almost all (>90%) macaques, vervets and baboons are imported but almost all marmosets are bred in EU. A requirement for F2 macaques could seriously impact primate studies in UK and mainland Europe. Most macaques and Vervets used in the EU are not F2. Switch to F2 is not beneficial to biodiversity: this has never been demonstrated. Wild caught animals are rarely used in research – just for breeding

13

sanofi pasteur R&D


Worldwide Vaccine field NHP used in Research are in the annex II. F2 is not realistic in regards with the market, internatioonal collaborations, competition, availability of resources. And Europe should explain why in some cases, we need wild-caught and why F2 are not available.



National yes There are some statemnts in the text that are not correct. The marmosets used in Europe are bred and no wild-caught. The other animals used in Europa are mostly F1 generations, bred in Europe. The import of wildcaughts is very seldom. The NHP´s are these animals that are used only for special purposes (ethical and cost reasons), so you can assume if there is a cell culture or an alternative method or model it will be used. Experiments with great apes are very seldom and a further restriction should not be done.



European Yes In short term such a possibility is available. However, the humanity should begin from a point. EU has been the gold standard of modern and morally developed human portrait and should continue with this role as the idol of world. The idea of protecting NHP in 3rd world countries should not be based on the continuation of their suffer in EU borders. The regulation will begin in EU and spread then to the whole world. This concept should be the basement of ethical regulations in EU. For human use instead of NHPs can be easyly regulated with local law and such a regulation definitely would cost a comparable amount as the well being of the animals and our responsibilites against them as the dominant mammlian of the world is considered.




Sanofi aventis is the largest pharmaceutical company in Europe and ranks third worldwide

Some factual mistakes in the introduction: 1. according to Article 4 of the Directive exceptional use relates to species listed under Appendix A of the CITES convention (not all species as stated in the Introduction). Most of the NHP species used in research are listed under Appendix 2 of the CITES and are therefore not considered as being endangered. 2. Species like Cercopithecus aetiops and Baboons account for a much greater proportion of NHP used in research than Prosimians 3. As far as great apes are concerned, not all countries have facilities suitable for the use of great apes. In addition there is a very limited number of research centres working on programmes that may justify the exceptional use of a strictly limited number of great apes. Therefore, the fact that some countries have decided to completely ban the use of these animals does not necessary mean that the need does not potentially exist in other EU countries.

14



Worldwide Yes There are a number of mistakes in the introductory paragraphs. These are addressed in the subparagraphs below.



Worldwide Research and development

Some factual mistakes in the introduction: 1 Most of the NHP species used in research are listed under Appendix 2 of the CITES and are therefore not considered as being endangered. 2 There is a very limited number of research centres working on programmes that may justify the exceptional use of a strictly limited number of great apes. 3 Large numbers of NHP are used for vaccine quality control (batch release). This is manly the case of polio vaccines but also other live viral vaccines such as measles, mumps, varicella, rotavirus, etc. vaccines, which are also to be tested on NHPs at some stage of their manufacturing process. 4 There is very limited number of wild caught animals used (the information may be obtain with national authorities since imports need to be covered by a specific authorisation). 5 Switch to F2 is not beneficial to biodiversity: this has never been demonstrated. 6 Wild caught animals are rarely used in research



Worldwide yes it's representative

It will take years and years to have F2 animals and research animals are already F1 animals and not wild-gaught !



European yes, Munich Uni is representative

As far as I know wild macaque monkeys are not used for biomedical research, but they are still needed in colonies where monkeys are bred.

15



National; Worldwide

yes -Most NHP species used in research are listed in CITES Appendix 2 and are endangered. -Prosimians are certainly not used at a level comparable to Cercopithecus aethiops or baboons - Polio vaccine production do use anymore NHP. Only the neurovirulence testing is still performed and should be replaced soon by the use of the PVR transgenic mouse. When Alternative in research are much more complex to identify - If more than 90% of cynomolgus, vervets and baboons are imported from non E.U. breeding centres, almost all marmosets are bred in Europe. - Macaques & vervets used in the E.U. are F1. The use of F2 is not a progress for animal welfare. Without any proven benefit for research and for the animals, it will mainly lead to an increase of the number of NHP kept in captivity! Due the increased animal concentration, it will also increase the complexity of colony health management and increase the risks… -



Worldwide other relevant organisations

not possible to write all our comments




representative for MD&D

Yes, relocation of research to countries outside the EU and a potential negative impact on animal welfare and control might by a negative consequence of a ban. No, switch to F2 is not beneficial to biodiversity: this has never been demonstrated. On the other hand, the requirement to produce F2 and beyond raises animal welfare concerns (increased number of animals to be kept, reduced fertility rates, increase of hunting to control the size of semi captive populations). A limited and controlled capture to replace retired breeders producing F1 animals does not raise serious animal welfare concerns in the current breeding and animal care practices. These animals show to be highly adaptable to captivity conditions when used for breeding purposes. Wild caught animals are rarely used in research – they are used for breeding purposes. Most of animals used in research are F1 animals (first generation born in captivity)

16



Worldwide There are many other such organisations in Europe

The analysis has factual inaccuracies which have great significance: species which are used in research are in no way endangered, see appropriate Appendix of CITES; there is confusion about vaccine production as opposed to vaccine batch safety testing; there is no vaccine for hepatitis C though some species are used in research into vaccines for this disease which has significant morbidity and mortality associated with it; few of the macaques used throughout the EU originate from captive breeding colonies using F1 female breeders and very few of all the macaques used are F2. This lack of availability of F2 animals means that a very protracted lead time would be required before F1 breedstock was stabilised and productive. Finally, the very strict regulations which require the use of primates in safety testing would prohibit any possible elevated risk to human patients – the work would still need to be done and would be performed elsewhere in the world.



Worldwide No It is my understanding of CITES that only EU Annex A species require the exceptional justification for use referred to above, not all primates. Very few Annex A species are used. Regarding tissue banks, it is not their non-availability which is preventing their use as a replacement, but their inadequacy as a replacement for much of the work. It is true that most primates, particularly macaques are imported into the EU, but many macaques will be F1, not F2 generation. Most marmosets are not imported. I don’t agree that it is primates’ similarity to human beings which results in increased ethical concerns, but their increased capacity to experience distress, and the difficulties with providing them with a varied and stimulating environment. I don’t agree that there is increasing public concern, although there is concern both within the scientific community and within “animal welfare/rights” community. I don’t follow the argument that switching to F2 would increase biodiversity



Worldwide YES (Safety Assessment)

The analysis is over simplified and does not reflect an understanding of the requirements of research, how it operates, what animals are used and how they are supplied. Details are provided in response to the following questions.



Worldwide Global pharmaceutical research and development

Some factual mistakes in the introduction

17



Worldwide yes Mistakes in the introduction: 1 Art. 4 Directive relates to Appendix A of CITES Most of NHPs used in research aren’t endangered. 2 Correct:use of NHP has decreased.But:increasing complexity of new medicines,more targeted approach&research in very complex disease areas(Alzheimer,immunology).We presume that nr. of NHP can again increase.An increasing nr. of biologics can only be tested in NHP with respect to safety. 3)Wild caught animals:breeding Captivity born animals:research(F1) 4)Past:NHP for polio vaccine prod. Now: primary monkey cells 5)Many NHPs= used for vaccine quality control 6)Tissue bank models can’t replace NHP vaccine testing yet 7)2002 statistics: not accurate,EU:mostly F2 used 8)Switch to F2:not beneficial to biodiversity,:has never been demonstrated.Requirement to produce F2&beyond,raises animal welfare concerns (increased number of animals to be kept,reduced fertility rates,increase of hunting to control the size of semi captive populations.




there are multiple independent Contract Research Organisations in UK and EU

In referring to NHPs imported to EU, the previous text states "All these macaques are F2 purpose-bred" . The macaques imported to this laboratory for regulatory studies are purpose-bred F1 (progeny of wild-caught animals). there is no strong evidence that there can be an adequate and sustainable supply of F2 animals in the future.



Worldwide Representative According to the Directive (Article 4), exceptional use relates to species listed under Appendix A of the CITES convention, whilst the largest majority of NHPs used in biomedical research are listed under the Appendix 2, and therefore not considered as being endangered species. As regards tissue banks, the primary issue is not that they do not yet exist, but that these models are still inadequate and not accepted by the Regulatory Authorities for safety studies, and to replace vaccines testing. The statement on the present use of F2 generation needs to be revised. Based on the present availability of NHPs at the existing EU and non-EU breeding Facilities, likely the largest number of animals used are F1.

18



Worldwide yes The analysis is over simplified and does not reflect an understanding of the requirements of research, how it operates, what animals are used and how they are supplied. Details are provided in reponse to the following questions.



Worldwide yes There is a very limited number of research centres working on programmes that may justify the exceptional use of a strictly limited number of great apes. Therefore, the fact that some countries have decided to completely ban the use of these animals does not necessary mean that the need does not potentially exist in other EU countries.Large number of NHP have been used in the past for polio vaccine production. Nowadays, most of the polio vaccine production is performed on primary monkey cells. Hepatitis C candidate vaccines are not produced in primary monkey cells. Large numbers of NHP are used for vaccine quality control.This is mainly the case of polio vaccines but also other live viral vaccines such as measles, mumps, rotavirus, etc. vaccines, which are also to be tested on NHPs at some stage of their manufacturing process. As far as tissue banks are concerned: the problem is not that these are missing, but that these models are inadequate to replace vaccines testing on NHPs.



Worldwide The bquestionaire will be completed for the German sites. Other site head in other countries will reply individually

There are several mistakes in the introduction, the most significant being the statement that ”In 2002, about 60% of the NHPs used for scientific purposes were imported from outside the EU, more than 90% of them being macaques. All these macaques are F2 purpose-bred." In fact, these animals were F1 purpose-bred primates. There are no significant numbers of F2 purpose bred macaques imported into the EU (exception is UK). In addition, the number of imported primates from outside the EU is even higher than the EU statistics state because institutes buy them from a local European supplier, not direct from an overseas breeder. Thus these primates are counted as coming from within the EU, but in reality come from China, Mauritius, Philippines.

19



Worldwide Many organisations

Based on the statement of a group of experts representing all stakeholders in the NHP (Non Human Primates) research field, i.e. European academia, Government institutes, pharmaceutical industry, contract research organizations (CROs), breeders and suppliers on proposals made by a Technical Expert Working Group during the revision of the Directive 86/609/EEC to exclude the use of animals from the first generation born in captivity (F1) and only allow the use of animals from the second (F2) or other subsequent generations one has to request an extended transition period to fulfil the research demand in Europe. There is a notion to transfer experiments that scientifically justify the use of NHP to either the USA or Japan; apparently other countries with less animal welfare restrictions advertise to transfer this type of experiments at less expenditure



Worldwide yes Due to increasing need of research in diseases like Alzheimers and immunologic disorders it appears likely that an increased demand on NHPs will result. Particularily for therapeutic human antibodies NHPs will be the only crossreacting species for pharmacodynamic and safety studies. It is not correct that the majority of animals in EU comes from F2, the rather are F1 animals and switching to F2 would require a long transition period (10 years). In addition it is questionable whether this would be an advandage for the animals kept for breeding purposes. Furthermore reproduction is likely to be reduced in these animals and biodiversity will decrease.



Worldwide Yes I doubt if the provided figures are correct.For example, data on baboons are missing.



National representative Some factual mistakes in the introduction: 1 Most of the NHP species used in research are listed under Appendix 2 of the CITES and are therefore not considered as being endangered. 2 Species like Cercopithecus aetiops and Baboons account for a much greater proportion of NHP used in research than Prosimians 3 As far as great apes are concerned, not all countries have facilities suitable for the use of great apes. In addition there is a very limited number of research centres working on programmes that may justify the exceptional use of a strictly limited number of great apes. Therefore, the fact that some countries have decided to completely ban the use of these animals does not necessary mean that the need does not potentially exist in other EU countries.

20



Worldwide YES Contrary to your statement in VI.c), the majority of macaques imported in the EU are F1 and not F2. There are no NHPs bred in the EU for private research. The validation of alternative methods for the quality control of vaccines will take at least 5-10 years. There will be a substancial increase in the of NHPs in R&D within the pharmaceutical industry. New research programmes centred on antibodies, therapeutic proteins, 'endogene ' products and biologicals require NHPs as the appropriate species for toxicology/safety/PK studies. A ban on F1 NHPs would likely mean that all our R&D work with NHPs would be trasferred to our American research sites.



Worldwide Don't understand this question

There are a number of mistakes in the introductory paragraphs.These are addressed in the subparagraphs below.

Animal Procedures Committee (APC)

Public authority National The APC provide independent advice to UK Government on the use of animals in scientific procedures. The APC consider science, industry and animal welfare. Members are from a variety of backgrounds.

We disagree with certain aspects of this analysis as the information upon which it is based it incorrect. The number of F2 animals used is wrong – the majority are F1, therefore the whole premise of this analysis is fundamentally flawed. Problems also arise from making generalisations referring to animals belonging to different species.

21

Francois Lachapelle INSERM

Public authority National BEA du CNRS, de l'INRA, du CEA

1) assuming that all macaques imported in Europe are F2 purpose bred animals is not true 2) Switch to only allowing F2 is a nonsense as this would lead to a reduction of the genetic variability in a given species which is one of the main interest of primate models . In addition foreign breeders will prefear to sell animals to the US and japan, thus animals availability will diminish and their price increase. Finally, there is no clear evidence that applying this model to all the primate species will contribute to their welfare and protection ; as these species are frequently pests in their oiginal countries and extensively destroyed by the local governments

Prof. Dr. Bernd Hoffmann, Justus-Liebig-Universität Giessen

Public authority National; European

similar to other universities

I generally support the assesment. However, a shift from F1 to F2 seems not acceptable

UK Medical Research Council

Public authority Local; Regional; National; European; Worldwide

The MRC is the UK's leading publicly funded biomedical research organisation

We disagree with that part of the Commission’s analysis which supposes that the majority of animals used are F2s.


Public authority Local yes Based on the statement of a group of experts representing all stakeholders in the NHP (Non Human Primates) research field, i.e. European academia, Government institutes, pharmaceutical industry, contract research organizations (CROs), breeders and suppliers on proposals made by a Technical Expert Working Group during the revision of the Directive 86/609/EEC to exclude the use of animals from the first generation born in captivity (F1) and only allow the use of animals from the second (F2) or other subsequent generations one has to request an extended transition period to fulfil the research demand in Europe.

22




Public authority National We are the National Competent Authority

The statement at VI.c) that almost all of the macaques recorded in 2002 were F2 purpose-bred is wrong. Old World species they are typically F1+. A proposed gradual move to requiring the acquisition and use of only F2+, even allowing for a prolonged transition period, is impractical and would in our view promote the active displacement of this and other aspects of pharmaceutical research and development to outside the EU.


Public authority National Regulatory authority in UK

Background information contains inaccuracies. Sweeping generalities are used throughout making assessment difficult. Also fails to explore the global market issues.


Public authority National; European; Worldwide

Although we are a smaller University, about half of the research groups involving animal experiments belong to leading institutions in their field.

It is widely acknowledged that the use of primates for research and testing purposes is a subject of high sensitivity, on ethical, animal welfare, conservation, animal and human health, science as well as economic grounds. NHPs are only used rationally when no other alternative exists, as also requested by law. They account for less than 0.1% of all experimental animals in Europe. Their treatment and care is continually reassessed in light of the latest knowledge and methods. Research requires stress-free animals, a fact that promotes and guarantees high standards - this is also stated VI.d), animal welfare and quality of science are linked. More restriction might not guarantee additional animal welfare. One of the most serious ethic concerns involved in more restrictive regulations is mentioned in VI.e), and should be stressed: the risk of human patients to be used as alternates to NHPs in clinical studies is rather high.

23


Public authority National representative Based on the statement of a group of experts representing all stakeholders in the NHP (Non Human Primates) research field, i.e. European academia, Government institutes, pharmaceutical industry, contract research organizations (CROs), breeders and suppliers on proposals made by a Technical Expert Working Group during the revision of the Directive 86/609/EEC to exclude the use of animals from the first generation born in captivity (F1) and only allow the use of animals from the second (F2) or other subsequent generations one has to request an extended transition period to fulfil the research demand in Europe.


Public authority National Yes - yes Research will not be forced to relocate to other countries outside the EU; in Austria it was shown that research concentrates at finding alternatives (another species or invitro methods) if experiments on a certain species are forbidden.

1.Animal Aid Other National Other organisations do exist

We challenge your presumptious and unsupported assertion in the Introduction (paragraph VI.d) Problem dimension) – which states: ‘there is a clear need for NHPs in biomedical research’. It is regarded by many in the scientific community as indefensible to conduct more research while existing research has yet to be evaluated. The applicability of animal data to human medicine is increasingly in doubt (e.g. see recent results of systematic reviews funded by National Health Service – http://www.pcpoh.bham.ac.uk/publichealth/nccrm/publications.htm

Biosciences Federation

Other National; European

There are other relevant organisations

This proposal is based on seriously inaccurate information. The Use and Trends section above states, “In 2002, about 60% of the NHPs used for scientific purposes were imported from outside the EU, more than 90% of them being macaques. All these macaques are F2 purpose-bred.” This is completely wrong. These animals are all F1. There are virtually no F2 macaques imported into the EU. In addition, the percentage of NHP’s imported from outside the EU is probably much higher. You should note that the definitions used in the EU statistics can disguise this because a significant number of NHPs are imported by EU animal suppliers who keep them on their premises for a few weeks for veterinary checks, before sending them to the end-user. In the EU statistics, these animals appear to be classed as coming from an EU supplier, when in reality they have been imported.

24

COST Action B24 “Laboratory Animal Science Welfare” - http://biomedicum.ut.ee/costb24

Other European No See FELASA Primate statement. (http://www.felasa.org/Documents/Policy_statements/primstat.doc )

Cris Iles-Wright Other Not applicable Not applicable There is no role for any primates in medical research.

Medical University of Vienna

Other Local; Regional; National; European; Worldwide

Research in Medicine

see 1.8

National Centre for the Replacement, Refinement and Reduction of Animals in Research

Other National Representative The NC3Rs disagrees with certain aspects of this analysis – we understand that the statement that most macaques used in the EU are F2 purpose-bred animals is incorrect (the majority are F1). Problems also arise from making generalisations referring to animals belonging to different species.


Other National I am the chair of the Hungarian Scientific Ethical Committeeon Animal Experimentation

The vast majority of NHPs imported to the EU are F1 and NOT F2.

25


Other Not applicable other We have to consider that the use of NHP is scientifically necessary in very rare cases, e.g. concerning hepatitis and AIDS and sepsis research and yet undetected human diseases. Despite the small animal numbers required, such research may be of utmost importance. Catching procedures of NHPs in the wild and their use in experiments should be handled very restrictively and carefully. However, a total ban on wild-caught NHPs throughout the EU would have negative effects on breeding purposes and impede every required use in the future. Therefore we confirm the primate statement given by FELASA. (http://www.felasa.org/Documents/Policy_statements/primstat.doc)


Other National Yes There are some fundamental misunderstandings in this section. For example, species used in R&D are not threatened with extinction, and wild-caught animals are rarely used in research. If this is not addressed and the policy making on the review of Directive 86/609 continues to be based on misinformation, we are extremely concerned about the detrimental impact that this could have on the emerging bioscience sector in Europe, which the European Commission has done so much to support.


Other Worldwide The Institute of Animal Technology is the prfessional body representing animal technologists

It is our view that the questionnaire contains a serious error in its assumption that most imported NHPs are F2. The majority are in fact F1. The requirement that only at least F2 NHPs are used in the EU would probably result in the end of science requiring NHPs in the EU. Breeders will continue to supply F1 NHPs to countries outside the EU in particular the USA and Asia.

26



Most important in breeding, keeping and biomedical research of/in primates: German Primate Centre Göttingen, BPRC Rijskwijk (NL)

To our knowledge wild caught NHPs are no longer used in biomedical research. Therefore, it is difficult to answer 1.2 to 1.7 as it is asked for wild caught NHPs and not for F1 animals. The situation of animal supply has to differentiate between supply of New World monkeys and of Old World monkeys. New World monkeys (marmosets) are bred since numerous years in self-sustaining colonies. Generally, animals of F2 and more generations are available. Concerning the situation in Old World monkeys, the wild caught animals are still used in breeding colonies outside the EU for the production of purpose bred F1 animals. The statement is very doubtful that 90 % of the imported macaques are F2 purpose-bred. Breeders in overseas, mainly Asia and Mauritius, sometimes declare them as F2 purpose-bred. These F1 animals are frequently used in Europe, in particular in the pharmaceutical industry. They are imported directly with subsequent quarantine or via commercial suppliers within the EU.


Other European yes It is not the case that the majority of all NHPs used in the EU are of F2 generation. Furthermore, it is not currently clear what length the transitional period would need to be to fulfil research demand in Europe.

Eurogroup for Animal Welfare/EWLA

Non-governmental organisation

European Eurogroup/EWLA is made up of animal welfare Member Organisations and Observers in all Member States

The analysis recognises the serious ethical problem of using NHPs in research and testing, but the solutions offered are extremely limited, and do nothing to encourage the replacement of these animals with humane alternatives, which would be the most desirable option. Not only ethical, but also scientific reasons, speak against the use of NHPs. The main reason for using NHPs in scientific procedures is the expectation that due to their close relationship to humans, test results will be more relevant to the human condition. However, this fails to take into account that, regardless of the fact that their capacity to suffer is similar to humans, metabolic processes and physiological processes in NHPs and human still can differ considerably (Ruhdel & Sauer, 1998; Bhogal et al., 2005, ATLA 33, 519-527). The revised Directive should demand much more critical evaluation of the scientific validity, necessity, justification and ethical acceptability for primate use.

27

European Biomedical Research Association


European Yes This proposal is based on seriously inaccurate information. The Use and Trends section above states, “In 2002, about 60% of the NHPs used for scientific purposes were imported from outside the EU, more than 90% of them being macaques. All these macaques are F2 purpose-bred.” This is completely wrong. These animals are all F1. There are virtually no F2 macaques imported into the EU. In addition, the percentage of NHP’s imported from outside the EU is probably much higher. You should note that the definitions used in the EU statistics can disguise this because a significant number of NHPs are imported by EU animal suppliers who keep them on their premises for a few weeks for veterinary checks, before sending them to the end-user. In the EU statistics, these animals appear to be classed as coming from an EU supplier, when in reality they have been imported.

European Coalition to End Animal Experiments (ECEAE)


Worldwide Representative (the only EU coalition focusing on animal experiments)

We agree with VI.a & VI.b. We disagree with VI.d and VI.e. VI.d: Existing/emerging research non-animal techniques could replace many uses of NHPs. E.g. imaging methods now allow risk-free studies of human brain function. Molecular methods (eg MAPREC), combined with process consistency standards, could eliminate NHP use in vaccine production. 20 years of AIDS research using NHPs has failed to discover an effective human vaccine despite many vaccine candidates working in NHPs: a new human-based approach is needed. Even if non-animal alternatives are not currently available, experiments on NHPs are unethical and should stop. VI.e: potential solutions are to stop the use of NHPs and channel those research funds into R&D for non-animal replacements. The UK government states that non-animal methods are advanced in relation to animal experiments, being cheaper, quicker, more cost/effective and reliable. Thus the protection of NHPs and public health will benefit from their introduction.

28

FELASA (Federation of European Laboratory Animal Science Associations)


European FELASA represents 13 European lab animal sci associations and therefore some 3-4000 members of those associations (scientists, veterinary surgeons, technicians etc.). See www.felasa.org

This analysis is supportable in general terms. However, the final sentence is incorrect as stringent regulation of human patients in clinical trials would avoid this risk.

Gesellschaft für Versuchstierkunde - Society for Laboratory Animal Science (GV-SOLAS)


National; European

Yes See FELASA Primate statement. (http://www.felasa.org/Documents/Policy_statements/primstat.doc )

Norwegian Animal Welfare Aliance


National 2 other relevant organisations

Possible relocation of research to countries outside the EU is not an acceptable argument to be taken into account. The EU has an independent responsibility for its own ethical standards. In a longer perspective the ethical development in the EU can influence the development in other countries. If this argument was to be accepted, the EU would hardly be able to make any animal welfare improvements at all.

29

PETA Europe Ltd.


Worldwide both We oppose the use of all animals including primates in research on both ethical and scientific grounds. Until a complete ban is instituted, we support the immediate ban on the use of wild caught primates along with measures that will reduce primate use. The discussion of non-animal methods, such as micro-dosing and bio-chips, is sorely lacking. Their impact for welfare is obvious. The analysis fails to acknowledge the risks to people due to reliance on animal models. For example, 6 men nearly died in a disastrous trial of the drug TGN1412 (Science. 2006 311:1688-9). The effects of this drug were not predicted by prior animal tests, including the benign effects seen in primates who received the drug for 28 days (Ibid). Despite our overall genomic similarity, recent comparisons of humans and nonhuman primates demonstrate broad disparities in gene expression (Gene. 2005 14:215-9; Nature. 2006 440:242-5) immune responses (Science. 2006 312:672-3) among other biological functions.

Stichting EDEV - Een DIER Een VRIEND


National; European

We cooperate with animal organisations within the ECEAE

There is no need for using NHP in researsch, the assumption is incorrect.

30

The National Anti-Vivisection Society



The NAVS is the leading and oldest anti-vivisection organisation in the world. There are a number of other relevant anti-vivisection organisations around the world with expertise in this field.

NAVS does not believe there is a clear need for NHPs in biomedical research. The problems of applying data from primate experiments, as well as the alternative non-animal methods available are detailed in our reports(1,2). The remarkable differences between humans and NHPs often preclude the simple extrapolation of results from one species to the other(3). That primate research is a valuable tool for tackling illnesses such as Parkinson’s and Alzheimer’s is brought into question by its failure to deliver effective treatments. Inadequacy of animal 'models' of these diseases highlight the need for a focus on alternatives(4,5). As regards the development of vaccines, primate research is unnecessary as cell culture techniques are resulting in purer vaccines without the side effects. 1 Monkeys & Men (2002) 2 My Mate's a Primate (2005) 3 Lemon&Griffiths (2005) Muscle & Nerve 32:261 4 LDF report (2002) www.navs.org.uk/downloads/ncraeproposal.pdf 5 Bailey (2005) Biogenic Amines 19:235

The Physiological Society


Worldwide Many other Learned Societies aer also representative

See comments below.

31

The Royal Society


National Yes. The Royal Society is the independent scientific academy of the UK dedicated to promoting excellence in science. The Society plays an influential role in national and international science policy

We support the principle of moving towards the use of F2 NHPs. However, we understand that the consultation document contains a serious factual error in its assumption that most NHPs imported into the EU are F2 purpose-bred. We are therefore unable to support this proposal. The great majority of NHPs used in the EU are F1 purpose-bred. (Please see the European Commission report: ‘The welfare of non-human primates used in research’ by the Scientific Committee on Animal Health and Welfare available at http://ec.europa.eu/food/fs/sc/scah/out83_en.pdf). Furthermore, it is unlikely that there will be any incentive for breeders to move to supplying F2 stock to the EU in the near future as the USA (the largest market for NHPs) is likely to continue to accept F1 animals. This may result in the collapse of NHP use in the EU, which would be detrimental to EU competitiveness. This would also have a negative impact on animal welfare as the use of NHPs would move to less regulated countries.

UK Laboratory Animal Science Association (LASA)


National LASA represents animal user community in academic, government & industry sectors.

This section contains a number of inaccuracies. The majority of marmosets used in Europe are bred in Europe and not imported. The figure stated of 90% for the portion of macaques which are F2 purpose bred is incorrect. The estimate for the UK is 35% whilst the figure in mainland Europe is likely to be much less. The transition from F1 to F2 is a much larger undertaking than stated and there needs to be a structured exercise to determine the rate at which transition to F2 could be achieved. It is not likely to be less than 15 years. The requirement for NHPs is not expected to decrease in the short term as the number of biotech molecules increases and the evaluation of their efficacy and safety relies on such models.

32

Universities Federation for Animal Welfare


Worldwide There are others Contrary to the analysis, the majority of NHPs used currently are F1. Moving to using F2 s would result in a positive welfare impact, and likely better science. However, the US is the major importer of NHPs for science and thus has the greatest influence with breeders/suppliers.. Nonetheless, the UK has succeeded in persuading some suppliers to provide F2 animals for use in the UK. There should be a policy to move towards total F2 supply for macaques, but this may take some time. One option is to ask suppliers to provide evidence of their plans to move towards F2, see http://www.apc.gov.uk/reference/primate-sources-report.pdf



European FEPS is an umbrella organization for national Physiological societies in Europe. See further http://www.feps.org

We have been advised that the following statement is just wrong: “In 2002, about 60% of the NHPs used for scientific purposes were imported from outside the EU, more than 90% of them being macaques. All these macaques are F2 purpose-bred.” If it is indeed correct that these animals were actually F1, purpose-bred and imported to Europe it is indeed most serious and misleading – and impossible to reply to the questions. Europe’s access to purpose-bread monkeys for appropriate research must be secured, and decisions to be based on accurate facts. (see EBRA Bulletin June 2006; European Biomedical Research Association)




both Until such a time when a complete ban is instituted, we support the immediate ban on the use of wild caught primates along with other measures that will reduce primate use and minimise or mitigate suffering. Their impact for welfare is obvious. Furthermore, the overall analysis fails to acknowledge the risks to human beings due to reliance on animal models. For example, 6 men nearly died in a disastrous trial of the drug TGN1412 (Science. 2006 311:1688-9). The effects of this drug were not predicted by prior animal tests, including the benign effects seen in primates who received the drug for 28 days (Ibid). Despite our overall genomic similarity, recent comparisons of humans and nonhuman primates demonstrate broad disparities in gene expression (Gene. 2005 14:215-9; Nature. 2006 440:242-5) immune responses (Science. 2006 312:672-3) among other biological functions.

33



National yes The MUV performs no experiments on NHP at this time and plans no experiments in the near future. Experiments on Great Apes have recently been banned in Austria. Nevertheless, we have to consider that the use of NHP is scientifically necessary in very rare cases, e.g. in hepatitis and AIDS research. Such research may be of utmost importance. A total ban on wild-caught NHPs throughout the EU would have negative effects on breeding purposes and impede every required use in the future. We endorse the primate by FELASA. (http://www.felasa.org/Documents/Policy_statements/primstat.doc)



Worldwide Yes In regards to the section entitled “potential solutions”, the statement that great ape research (which is assumed to mean nonhuman great apes) “should be highly restricted” should indicate that only non-invasive research that is beneficial to the great ape is allowed. The proposed standards for the national chimpanzee sanctuary system in the US at http://www.ncrr.nih.gov/compmed/cm_chimp.asp explains what research is acceptable within the sanctuary system—this could be used to provide guidance on acceptable great ape research in the EU



National NO OTHER RELEVANT ORGANISATION

The analysis is based on wrong information: - Macaques and marmosets are referred in CITES appendix II not I. This means that their conservation status and the requirements for there use are by far not the one written above. See http://www.cites.org/fra/index.shtml - Quite no non human primates used in biomedical research in Europe are F2. They are F1 generation or wild-caught. F1 means the breeders were wild caught (F0) and the first captive-bred descendants (F1) were sold. F2 animals require F1 parents. Refer also to Felasa statement: http://www.felasa.org/Documents/Policy_statements/primstat.doc



National YES Depending on the species, the availability of F2 captive-born animals is currently non-existent or very scarce compared to the requirements, and considerable time is needed before sufficient numbers might be available.

34



Worldwide No other organisations

It would be erroneous for the Trust to support a proposal that is based on information that is factually incorrect. Your background information states that all the macaques that were imported into Europe “are F2 purpose-bred”. This is not the situation; in reality the majority of imported macaques were (and still are) F1 purpose-bred. (We refer you to the European Commission report: “The welfare of non-human primates used in research” by the Scientific Committee on Animal Health and Welfare - http://ec.europa.eu/food/fs/sc/scah/out83_en.pdf)




One other While supporting the main option of utmost reduction it is of paramount necessity to attain complete eradication of experiments on NHPs



National yes This proposal to only permit the use of F2 purpose-bred primates is based upon a serious factual error in the background information, which states, “In 2002, about 60% of the NHPs used for scientific purposes were imported from outside the EU, more than 90% of them being macaques. All these macaques are F2 purpose-bred.” In fact, these animals were, and continue to be, first generation, or F1, purpose-bred. There are no significant numbers of F2 purpose bred macaques imported into the EU. It is estimated that between 90% and 95% of all macaques used in the EU are imported from outside the EU. This is a higher figure than recorded in the EU statistics on animal experimentation, but that is because some animals are imported by a supplier and then sold on to the final user. In the EU statistics these primates are counted as coming from within the EU, simply because the laboratory buys them from the local supplier, not direct from the overseas breeder.



Worldwide yes Ethical evaluation based on harm-benefit analysis is not only a matter of animal ethics, but is equally to be applied to medical ethics and scientific ethic. Until now the latter two are not represented in an equitable form during ethical evaluation. There is a lack how to do that evaluation in a way that is in accordance with discursive ethics. Until this is corrected the proposed compulsory publications will be misleading.



Worldwide yes From an German and company point of view we do not work with NHPs. From an global point of view, people working with NHP are concerned about the availability if only F2 breed NHPs could be used.

35


Breeder of animals

Worldwide yes The present assessment and statistics concerning the use of F2 generation of macaques does not reflect reality. In 2002, XXX exported to Europe 522 of wild caught and 2295 of F1 cynomolgus, which would represent 37.5 % of the total imports for the same year (7,500 to 8,000 as given in the text).


Breeder of animals

Worldwide Yes Background info stating that most of macaques used in Europe are currently F2 is completely erroneous. The vast majority are F1.


Local; National Yes To create a supply of F2 animals the breeders would either have to substantially reduce their sales of F1 animals so they can breed them or substantially increase the number of animals taken from the wild, neither of which they want to do. There is a high world demand for purpose-bred macaques, particularly from the USA. Since these breeders can sell all the F1 animals they breed to buyers in the USA, they have not shown any particular interest in breeding F2 animals. The size of the EU market for purpose-bred macaques is not large enough to make it likely that the breeders could be persuaded to create an F2 supply.


National; European

There are other organisations

Most imported NHP are actually F1 rather than F2. It will not be economically attractive for breeders to supply F2, who will instead focus on supplying F1 to other countries such as the USA. Animals captured in the wild are not used for research, but for breeding, which currently, requires justification.


National There are other relevant organisations

The premise the all all NHP are F2 is false, as the generation of NHP caputured would not necessarily be known.


Local representative This proposal to only permit the use of F2 purpose-bred primates is based upon a serious factual error in the background information, which states, “In 2002, about 60% of the NHPs used for scientific purposes were imported from outside the EU, more than 90% of them being macaques. All these macaques are F2 purpose-bred.” In fact, these animals were, and continue to be, first generation, or F1, purpose-bred.

36



Yes, we are representarive for the field

This proposal to only permit the use of F2 purpose-bred primates is based upon a serious factual error in the background information, which states, “In 2002, about 60% of the NHPs used for scientific purposes were imported from outside the EU, more than 90% of them being macaques. All these macaques are F2 purpose-bred.” In fact, these animals were, and continue to be, first generation, or F1, purpose-bred. There are no significant numbers of F2 purpose bred macaques imported into the EU. It is estimated that between 90% and 95% of all macaques used in the EU are imported from outside the EU. This is a higher figure than recorded in the EU statistics on animal experimentation, but that is because some animals are imported by a supplier and then sold on to the final user. In the EU statistics these primates are counted as coming from within the EU, simply because the laboratory buys them from the local supplier, not direct from the overseas breeder.


European all universities are relevant

The use of Great Apes should be absolutely forbidden. Their similarities to humans are so strong that there is no morally relevant difference between using an ape in a scientific procedure and using a human being. See The Great Ape Project.

37

Question VI.1.1.

Question text:

Statistics:




Comments received:

An amendment of the current Directive could be a requirement to use F2 animals (and subsequent generations) without exemptions, instead of the requirement of using only purpose-bred animals. This restriction may lead to supply problems and increasing costs, depending on the transitional period. Preliminary assessment shows an overall slightly negative impact of this option in case the implementation would take place at short notice but changes to a slightly positive impact if an acceptable transitional period would be taken into account. Also the positive impact on the welfare of NHPs used in experiments is recognized. Available data indicates that already today more than 90% of all NHPs used in the EU are of F2 generation. Overall preliminary assessment: neutral Do you support this overall analysis? Yes/No/No opinion

38





VI.1.1a.




Although in principle a shift towards use only of F2 and subsequent generations can be supported, there would be a very serious negative impact on research and costs in the medium to long term. The statements above also do not take account of the considerable variation between species. For example, 90% of all NHPs already being F2 may be a correct estimate as applied to marmosets or even as an average, but most certainly does not apply to F2 macaques, where the percentage will be considerably lower.



at VI.e) Potential solutions and 1.1 to 1.5 No ..........There is a notion to transfer experiments that scientifically justify the use of NHP to either the USA or Japan; apparently other countries with less animal welfare restrictions advertise to transfer this type of experiments at less expenditure. It is widely acknowledged that the use of primates for research and testing purposes is a subject of high sensitivity, on ethical, animal welfare, conservation, animal and human health, science as well as economic grounds. NHPs are only used rationally when no other alternative exists, as also requested by law. They account for less than 0.1% of all experimental animals in Europe. They are used efficiently in a manner that promotes rapid progress in science and medicine, and their treatment and care is continually reassessed in light of the latest knowledge and methods.

39









Based on the statement of a group of experts representing all stakeholders in the NHP (Non Human Primates) research field, i.e. European academia, Government institutes, pharmaceutical industry, contract research organizations (CROs), breeders and suppliers on proposals made by a Technical Expert Working Group during the revision of the Directive 86/609/EEC to exclude the use of animals from the first generation born in captivity (F1) and only allow the use of animals from the second (F2) or other subsequent generations one has to request an extended transition period to fulfil the research demand in Europe. There is a notion to transfer experiments that scientifically justify the use of NHP to either the USA or Japan; apparently other countries with less animal welfare restrictions advertise to transfer this type of experiments at less expenditure.

Prof Alan Palmer


Worldwide Yes NHPs is a very sensitive area that needs special consideration. However, there are real justifications for their use in some areas. The negative impact will in this case be somewhat greater if the use of F2s is imposed with no exemptions as at present the majority of macaques used are F1.





40




XXX It is our clear understanding that the questionnaire contains a serious factual error in its assumption that most imported NHPs are at least F2. In fact the great majority are F1. Since the USA, which is the largest market by far, is most likely to continue to accept F1 animals, it is not likely that in the foreseeable future there will be any incentive for overseas breeders to move to supplying only F2 stock. Insistence on use of only F2 stock would therefore probably result in unsustainable increased costs and/or the collapse of NHP use in the EU, which would be detrimental to EU competitiveness and could only be bad for animal welfare because it would trigger the move of NHP use to less regulated countries.




Yes This proposal is based on seriously inaccurate information. The Use and Trends section above states, “In 2002, about 60% of the NHPs used for scientific purposes were imported from outside the EU, more than 90% of them being macaques. All these macaques are F2 purpose-bred.” This is completely wrong. These animals are all F1. There are virtually no F2 macaques imported into the EU. In addition, the percentage of NHP’s imported from outside the EU is probably much higher. You should note that the definitions used in the EU statistics can disguise this because a significant number of NHPs are imported by EU animal suppliers who keep them on their premises for a few weeks for veterinary checks, before sending them to the end-user. In the EU statistics, these animals appear to be classed as coming from an EU supplier, when in reality they have been imported.




The proposal is based on wrong information as no F2 animal is available today for biomedical research.



Worldwide there are others The proposal that only F2 bred primates should be used in biomedical research is contrary to the present situation in Europe. Most of the animals used in various fields of research are F1 purpose bred. If Europe wants only to permit biomedical research in F2 macaques, existing European breeding colonies have to be substantially enlarged to create a sufficient supply of F2 purpose-bred macaques. This means high financial support and a transition period of ten years and more.

41



Local; National; European; Worldwide

representative of a research university

It should also be possible to use surplus F1s. I am not sure whether the figure of 90% already being F2s is correct?




Other organisations in Austria: Karl-Franzens-University; Medical University Vienna; Medical University Innsbruck

See 1.8




Yes see 1.8

42





The proposal is based on the assumption that 90% of the imported NHPs in the EU are already F2 generations. However, statistics supporting this assumption are missing. And we ourselves have received conflicting information: The European Biomedical Research Association (June 2006) reports there are actually no significant numbers of F2 macaques imported. The size of the EU market (~ 9000 NHPs) for purpose-bred macaques is not large enough compared to the US-market (~60000 NHPs) to make it likely that the breeders will shift toward more expensive F2 supplies. If true, major supply problems will arise to the extent that it will force primate research outside the EU. The reason being that the USA does not impose restrictions on F1 macaques. On the other hand, information from a supplier in our country indicates that their entire supply of macaques is F2 and higher. Since we are unable to check these numbers, we urge the EU to disclose the sources on which their information is based.




Yes I am not sure that F2 primates are in fact used



National yes Incorrect information on current usage



Regional yes see 1.8



Local; National There are several central laboratory animal facilities at Austrian universities

Using only F2 animals without exemptions may cause problems if new models (using other primate species) should be developed or existing breeding groups show inbreeding effects.

43



National; Worldwide

There are other universities at the respective activity level

In fact, these animals are first generation, or F1, purpose-bred. There are no significant numbers of F2 purpose bred macaques imported into the EU. The main macaque breeders are outside EU. These breeders take animals captured from the wild and breed them, selling the offspring (the F1 captive bred generation). To create a supply of F2 animals the breeders would either have to reduce their sales of F1 animals so they can breed them or increase the number of animals taken from the wild, neither of which they want to do. There is a high world demand for purpose-bred macaques, particularly from the USA. Since these breeders can sell all the F1 animals they breed to buyers in the USA, they have not shown any particular interest in breeding F2 animals. Since there is little prospect of a supply of F2 animals becoming available, this proposal would cause all pharmaceutical and vaccine industry primate work and much academic primate neuroscience research to be moved out of the EU.




No This proposal to only permit the use of F2 purpose-bred primates is based upon a serious factual error in the background information, which states, "In 2002, about 60% of the NHPs used for scientific purposes were imported from outside the EU, more than 90% of them being macaques. All these macaques are F2 purpose-bred." In fact, these animals were, and continue to be, first generation, or F1, purpose-bred.







Yes Based on flawed premise and inaccurate numbers




YES There is no obvious reason to ban experiments on F1 animals. On the other hand this ban will increase the cost of experiments draining important resources away from research.

44



National yes Most NHP like macaques used for scientific purpose are listed in annex II. Scientific use of animals is not proved to be the main reason for species threatening nor extinction instead of deforestation and human activities. The ban must be decided on information on animal population and ecologic studies. The assumption that in 2002 that all macaques where F2 generation seems erroneous and need to be corroborated with CITES import permit data.





No. The use of F1 animals is sufficient to meet this expectation.



National yes see propositions of FELASA, BCLAS and AFSTAL at http://www.felasa.org/Documents/Policy_statements/primstat.doc



National yes Based on the statement of a group of experts representing all stakeholders in the NHP (Non Human Primates) research field, i.e. European academia, Government institutes, pharmaceutical industry, contract research organizations (CROs), breeders and suppliers on proposals made by a Technical Expert Working Group during the revision of the Directive 86/609/EEC to exclude the use of animals from the first generation born in captivity (F1) and only allow the use of animals from the second (F2) or other subsequent generations one has to request an extended transition period to fulfil the research demand in Europe.

Bayer HealthCare



1.1 The positive trend in long run described above cannot be confirmed at this stage. Research shows rather that switch will have a negative impact on welfare.



Worldwide yes In our experience the majority of NHP used are F1 animals and not F2 animals. It appears that F1 and F2 might have been confused.

45



Analysis completely flawed, most animals are not F2


Worldwide Yes To switch to F2 means to have in the future not enough animals to use in the research and to push industries to invest 10 years in advance in supporting colonies located in countries at high risk(political, natural as hurricane, typhoon, tsusami). No European industries will do it. It's no true that 90% of NHP used in Europe are F2 (where are coming from these data?)




The positive trend in long run described above cannot be confirmed at this stage. Research shows rather that switch will have a negative impact on welfare. It is not true that majority of all NHPs used in the EU are F2. It is not clear how long the transitional period should be in order to fulfil research demand in Europe. The figure of 90% is heavily overstated. UK sources report 35% with a switch programme running for a long time already. In other European countries this figure will be even lower. FELASA suggest a 15 year transition period to avoid interruption to primate research programmes in the EU: http://www.felasa.org/Documents/Policy_statements/primstat.doc

sanofi pasteur R&D


Worldwide Vaccine field F2 animals of the most used species are not available on the market. Figures about F2 is not true. But maybe 90% of animals are purpose-bred. There is no demonstration of positive impacts of F2. Negative impacts are: increase number of animals in captivity, increase inbreeding, increase the length of the life in cages, new pathologies occurred (diabetes, behaviour…), the first babies are most of the time lost… There is a risk for Research not to get old animals, unusual species, genetic diversity close to humans…

46



National yes The number 90% F2 animals used in research is oversized. Advantages and disadvantages musted checked before such an option will be fixed. May be that the prolongation of breeding to F2 generation demands the housing of more NHP in Europe to fulfil the needs. Some species, like marmosets, are mostly bred in Europe they will not need this requirements. There are no data about the duration of the transitional period.





90% of NHP's are NOT F2. Where does this figure come form To my knowledge the UK reports 35% F2 and this is probably the highest F2 usage in Europe. See overall analysis



Worldwide Yes Sweden accountabilities are already clear. It is not possible to assess costs across EU when the requirements are not known.




The positive trend in long run described above cannot be confirmed at this stage. Research shows rather that switch will have a negative impact on welfare. It is not true that majority of all NHPs used in the EU are F2. It is not clear how long the transitional period should be in order to fulfil research demand in Europe. The figure of 90% is heavily overstated. UK sources report 35% with a switch programme running for a long time already. In other European countries this figure will be even lower.



Worldwide Yes The assessment of 90% of all NHPs used in EU being F2 generation seems strange, since experts estimated that supply of UK with only F2 monkeys will not be possible before 2010. The estimate of the experts was, that to fulfil the requirement that all monkeys used could be F2, the total number of animals kept in captivity for breeding purposes would have to be at least doubled. This means that there will be an serious shortage of monkeys for research for several years to increase the number of F1 breeders. In addition, the advantage for animal welfare is doubtful since keeping significantly more monkeys in captivity cannot be in the interest of animal welfare

47




This requirement is the best way to stop research and vaccine and biomedical progress !!!




At present the supply of F2 bred macaques is not sufficient for Europe



National; Worldwide

yes See VI.E. The majority of all NHPs used in the EU are F1 and NOT F2! As explained already, moving to F2 animals would have very negative animal welfare impact creating a useless burden on European research and an important loss of performance, encouraging new delocalisation!









It is not true that majority of all NHPs used in the EU are F2. It is not clear how long the transitional period should be in order to fulfil research demand in Europe.




The overall analysis is flawed as it does not differentiate between macaques and marmosets. Marmosets breed very successfully in captivity with self-sustaining breedstock. There are some F1 macaque breedstocks in the UK but the development of these colonies has been a very slow and expensive process. Not all the macaques supplied from within the UK are F2 and given the sources of macaques for other Member States is non-UK it is impossible to conclude that 90% could be F2.

48



Worldwide No I can agree with the ultimate goal of establishing and using only those animals which are F2 plus, but a number of practical difficulties mean that it is not currently realistic. Disagree completely with the statement that 90% of primates used in EU are F2. Most commonly used animals are macaques, most are imported, and most imported animals (macaques) are F1. In Mauritius, a programme to increase production of F2 animals has resulted in problems with health and productivity of the animals, which has then resulted in a much more pessimistic forecast of when only F2 animals may be available for export to the UK – at least 10 years – not counting the rest of the EU!. Use of Mauritian animals is desirable for health and safety reasons as they do not carry the Herpes virus simiae, which can be fatal to humans. F2 and above animals are available from Asia (eg China, Vietnam), but these animals do have this virus in the population, and it is very difficult to eradicate.




We believe that 90% is heavily overstated. UK sources report 35% with other European countries having an even lower figure. Over time there will be a positive impact (to prevent health issues due to inbreeding) if wild caught animals continue to be introduced into established colonies. The description in the proposal is over simplistic.




It is not true that majority of all NHPs used in the EU are F2. It is not clear how long the transitional period should be in order to fulfil research demand in Europe.



Worldwide yes The positive trend in long run described above cannot be confirmed at this stage. Research shows rather that switch will have a negative impact on welfare. It is not true that majority of all NHPs used in the EU are F2. It is not clear how long the transitional period should be in order to fulfil research demand in Europe. The figure of 90% is heavily overstated. European sources report 20 to 30% as a maximum





As response to Aa. The premise is based on a misunderstanding. Present availability of F2 macaques is very limited. This laboratory is dependent on supply of F1 macaques

49



Worldwide Representative Welfare issues related to the use of F2 vs F1 need a more accurate revision and should be properly balanced against concerns related to lower fertility, longer term of captivity for the F1 generation, capture and killing of wild animals considered "pests" in some Country (ie sugar-can damaged by macaques in Mauritius), etc. Figures should also be revised, considering that in some Countries (ie Italy, France and UK) most of the imported animals are F1 (not F2).



Worldwide yes The positive trend in long run described above cannot be confirmed at this stage. Research shows rather that switch will have a negative impact on welfare. It is not true that majority of all NHPs used in the EU are F2. It is not clear how long the transitional period should be in order to fulfil research demand in Europe. The figure of 90% is heavily overstated. UK sources report 35% with a switch programme running for a long time already. In other European countries this figure will be even lower.




As stated above the 90 % figure is wrong and the impact will not be neutral but highly negative. It will impede research with primates in Europe in the short run and force pharmaceutical companies to do their primate research in the US. Overseas breeders will be pleased to sell their F1 animals to buyers in the USA. They will get good money there and in addition and do not have to worry about breeding F2 animals which is difficult, very expensive and takes a long time. No one can say how long an “acceptable transitional period” must be. Experts claim it to be at least 10 – 15 years (see EFPIA Round Table position paper)





50



Worldwide yes This statement is not correct for Cynomolgus monkeys



Worldwide Yes This requires decades of transition time for the long reproduction periods in some species.



National representative The positive trend in long run described above cannot be confirmed at this stage. Research shows rather that switch will have a negative impact on welfare. We import NHP from China where they are breeded and we get the F1 generation.



Worldwide YES False - The majority of NHPs used in the EU are still F1.




The assertion that 90% of primates used in the EU are F2 is erroneous. Estimates from the UK suggest the figure may be nearer 35%. The scale of supply problems is not yet clear but may be considerable as decreases in fertility are reported in pure captive breeding of macaques.

51



We agree for reasons of good welfare and good science that the use of F2 animals is nearly always the preferred option. However, as stated under VIe above, the information about the numbers of F2 animals used is wrong – the majority of macaques are F1 specimens. For species other than rhesus and cynomolgus macaques and marmosets, the small numbers required means that breeding to produce F2 animals may be impractical.



assuming that all macaques imported in Europe are F2 purpose bred animals is not true? Very feww breeding centers have the experience of F2 generation and their ability to breed, and their physiological performances




see comment above

52




This is based on flawed assumptions about the extent of use of F2 NHPs.




Public authority Local yes There is a notion to transfer experiments that scientifically justify the use of NHP to either the USA or Japan; apparently other countries with less animal welfare restrictions advertise to transfer this type of experiments at less expenditure.



Yes I agree Yes - but there should be movement to allow for F2s derived from hybridisation of different F1 colonies for situations where an increase in genetic diversity is an advantage.



The statement at VI.c) that all of the macaques recorded in 2002 were F2 purpose-bred is wrong. Old World species they are typically F1+. A proposed gradual move to requiring the acquisition and use of only F2+, even allowing for a prolonged transition period, is impractical and in our view would promote the active displacement of this and other aspects of pharmaceutical research and development to outside the EU.

53



Impact always likley to be negative. See comments in 1.8


Public authority National representative There is a notion to transfer experiments that scientifically justify the use of NHP to either the USA or Japan; apparently other countries with less animal welfare restrictions advertise to transfer this type of experiments at less expenditure.


The use of such highly sentient creatures is morally indefensible - the main reason for the desire to use them, their similarity to ourselves, is also a most compelling reason for not doing so.




As noted above, this proposal is based on seriously inaccurate information (e.g. the statement above that “today more than 90% of all NHPs used in the EU are of F2 generation.”). The breeders outside the EU do not supply F2 NHPs and, since the world demand for F1 NHPs outstrips their production, these breeders have little or no motivation to undertake an F2 breeding programme. The impact of this proposal would be very large indeed. Even if the breeders could be persuaded to set up F2 breeding programmes, the substantial costs involved would be passed on the users in the EU. The costs are likely to be so high that it would result in most primate research leaving the EU, with disastrous effects on basic research in many fields as well as pharmaceutical and biotechnology research and development.



54




see 1.8


Other National Representative We agree that for the reasons of good welfare and good science the use of F2 animals is nearly always the best option. However, as stated previously, it is unlikely that more than 90% of all NHPs used in the EU are of F2 generation (most are F1).



The impact is highly negative (---), since the vast majority of NHPs imported to the EU are F1 and NOT F2



55


Other National Yes It is not correct that the majority of NHPs used in the EU are of F2 generation. In addition, it is not currently clear what length the transitional period would be needed to fulfil European research demand.



See above.




The proposal that only F2 bred primates should be used in biomedical research is contrary to the present situation in Europe. Most of the animals used in various fields of research are F1 purpose bred. If Europe only wants to permit biomedical research in F2 macaques, existing European breeding colonies have to be substantially enlarged to create a sufficient supply of F2 purpose-bred macaques. This means high financial support and a transition period of ten years and more.


Other National Yes The concern is that many F1 animals are in use and have the potential for further use.

56


Other European yes It is not the case that the majority of all NHPs used in the EU are of F2 generation. Furthermore, it is not currently clear what length the transitional period would need to be to fulfil research demand in Europe.




The figure of 90% of all NHPs used in the EU being of F2 generation cannot be verified from the data presented, but if this is correct then the impact of moving to F2 animals would be very low. Increased financial costs should be irrelevant when considering the very serious animal welfare concerns associated with capture of wild NHPs to produce F1 animals for subsequent use in laboratories. While it is important to ensure that wild-caught NHPs and F1 generation animals are no longer used, this should not be the only special provision regarding the use of these animals for scientific purposes in the revised Directive. Additional justification should be required in the authorisation process; there should be no possibility of ‘group authorisations’; and specific provisions should be laid down to aim at reducing and replacing the use of these animals.



European Yes As noted above, this proposal is based on seriously inaccurate information (eg the statement above that “today more than 90% of all NHPs used in the EU are of F2 generation.”) The breeders outside the EU do not supply F2 NHPs and, since the world demand for F1 NHPs outstrips their production, these breeders have little or no motivation to undertake an F2 breeding programme. The impact of this proposal would be very large indeed. Even if the breeders could be persuaded to set up F” breeding programmes, the substantial costs involved would be passed on the users in the EU. The costs are likely to be so high that it would result in most primate research leaving the EU, with disastrous effects on basic research in many fields as well as pharmaceutical and biotechnology research and development.




As explained, we support the end of all experiments on NHPs. Only if this does not occur would we consider a shift to F2 and subsequent generations to be beneficial for NHPs. If such a shift took place we would want to see it happen immediately, without a transition period.

57




Although FELASA supports in principle a shift towards use only of F2 and subsequent generations, there would be a very serious negative impact on research and costs in the medium to long term. The statements above also do not take account of the considerable variation between species. For example, 90% of all NHPs already being F2 may be a correct estimate as applied to marmosets or even as an average, but most certainly does not apply to F2 macaques, where the percentage will be considerably lower. FELASA has issued a statement relating to the use of NHPs and which details issues regarding the use only of F2 animals (see http://www.felasa.org).



National; European


58

PETA Europe Ltd.


Worldwide both The most significant negative costs, which are exacted both in terms of ethics and science, are through the perpetuation of vivisection in general and primate vivisection per se. If primate experimentation is to continue, however, we favour the ban on the use of wild caught primates without exception, with immediate implementation. We find three primary justifications for an immediate ban: ) Capture and transport pose extraordinary risks for morbidity, mortality and psycho-social trauma, both for those who are captured and the family members and friends who are left behind. 2) Many factors, including the superiority and cost-effectiveness of non-animal methods, harmonization, and growing public disfavour of vivisection, portend decreased demand for primates in testing and experimentation. 3) Data on the supply of primates internationally do not support the assumptions made per Section 2.4 indicating a “bottleneck”. Thus, any transitional period would be unacceptable.



National; European


Animal welfare has nothing to do with the sources all animals suffer.

59





The benefits, in terms of welfare and conservation, of using only ≥F2 primates are such that, in our view, they would outweigh any problems relating to primate supply, however short the transitional period. A consequence of using F1 primates is that the breeding centres that supply them often resort to trapping wild animals to replenish their stocks. Primates caught from the wild are subjected to high levels of stress, brought on not just by the trapping process but by subsequent transport, and by the need to adjust to a restrictive and unfamiliar environment (1). Avoiding F1 primate use would also improve safety by reducing the exposure of humans to microbiological agents, known to be less common among ≥F2 animals (2). 1 Prescott M. et al. (2004) Ethical and Welfare Implications of the Acquisition and Transport of Non-human Primates for Use in Research and Testing, ATLA 32, Supplement 1, 323–327. 2 AHAW Report. December 2002.




It is our clear understanding that the questionnaire contains a serious factual error in its assumption that most imported NHPs are at least F2. In fact the great majority are F1. Since the USA, which is the largest market by far, is most likely to continue to accept F1 animals, it is not likely that in the foreseeable future there will be any incentive for overseas breeders to move to supplying only F2 stock. Insistence on use of only F2 stock would therefore probably result in unsustainable increased costs and/or the collapse of NHP use in the EU, which would be detrimental to EU competitiveness and could only be bad for animal welfare because it would trigger the move of NHP use to less regulated countries.

60

The Royal Society



We support the principle of moving towards the use of F2 NHPs. However, we understand that the consultation document contains a serious factual error in its assumption that most NHPs imported into the EU are F2 purpose-bred. We are therefore unable to support this proposal. The great majority of NHPs used in the EU are F1 purpose-bred. (Please see the European Commission report: ‘The welfare of non-human primates used in research’ by the Scientific Committee on Animal Health and Welfare available at http://ec.europa.eu/food/fs/sc/scah/out83_en.pdf). Furthermore, it is unlikely that there will be any incentive for breeders to move to supplying F2 stock to the EU in the near future as the USA (the largest market for NHPs) is likely to continue to accept F1 animals. This may result in the collapse of NHP use in the EU, which would be detrimental to EU competitiveness. This would also have a negative impact on animal welfare as the use of NHPs would move to less regulated countries.




As stated in the overall analysis this figure of 90% is incorrect.

61








both If primate experimentation is to continue, however, we favour the ban on the use of wild caught primates without exception and with immediate implementation. We find three primary justifications for an immediate ban, which are explored in greater detail in sections below: 1) Capture and transport pose extraordinary risks for morbidity, mortality and psycho-social trauma, both for those who are captured and the family members and friends who are left behind. 2) Many factors, including the superiority and cost-effectiveness of non-animal methods, harmonization, and growing public disfavour of vivisection, portend decreased demand for primates in testing and experimentation. 3) Data on the supply of primates internationally do not support the assumptions made per Section 2.4 indicating a “bottleneck”. Thus, any transitional period would be strictly for the convenience of the biomedical enterprise and thus completely unacceptable in terms of the welfare costs.




62







National YES The proposal that only F2 bred primates should be used in biomedical research is unrealistic in the present situation in Europe. Most of the animals used in various fields of research are F1 purpose bred. If the aim is to permit biomedical research in F2 macaques, existing European breeding colonies have to be substantially enlarged to create a sufficient supply of F2 purpose-bred macaques. This means high financial support and an adequate transitional period. See FELASA Primate statement. (http://www.felasa.org/Documents/Policy_statements/primstat.doc )




It would be erroneous for the Trust to support a proposal that is based on information that is factually incorrect. Your background information states that all the macaques that were imported into Europe “are F2 purpose-bred”. This is not the situation; in reality the majority of imported macaques were (and still are) F1 purpose-bred. (We refer you to the European Commission report: “The welfare of non-human primates used in research” by the Scientific Committee on Animal Health and Welfare - http://ec.europa.eu/food/fs/sc/scah/out83_en.pdf)



Regional Yes see 1.8





63



National yes It is estimated that between 90% and 95% of all macaques used in the EU are imported from outside the EU. This is a higher figure than recorded in the EU statistics on animal experimentation, but that is because some animals are imported by a supplier and then sold on to the final user. In the EU statistics these primates are counted as coming from within the EU, simply because the laboratory buys them from the local supplier, not direct from the overseas breeder.



Worldwide yes There is a notion to transfer experiments that scientifically justify the use of NHP to either the USA or Japan; apparently other countries with less animal welfare restrictions advertise to transfer this type of experiments at less expenditure.



Worldwide Representative Our information is that the statement that most NHPs are F2 is flawed. Our understanding is that most are F1 and that breeders currently supply all they can breed.


Breeder of animals

Worldwide yes The present assessment and statistics concerning the use of F2 generation of macaques does not reflect reality. In 2002, XXX exported to Europe 522 of wild caught and 2295 of F1 cynomolgus, which would represent 37.5 % of the total imports for the same year (7,500 to 8,000 as given in the text).


Breeder of animals

Worldwide Yes Breeding F2 macaques is very problematic. We have such colonies established in Mauritius since 1995 and have significant data on this matter. Contact me if more info is required on this.

giacomo Ri(olatti


it is represntative

There is no obvious scientific reason to ban experiments on F1 animals. On the other hand this ban will increase the cost of experiments draining important resources away from research.


Local; National Yes see above

64


National; European


F2 are not the majority of NHPs used in the EU, and a switch will therefore have significant impact.


Regional; Worldwide

also others see 1.8


Local representative of national pharmacological research institutions

Guidelines concerning the restriction of non-human primate research to F2 animals will put primate research at risk. If put to effect the implementation of the guidelines has to be accompanied by establishing sufficient primate breeding facilities in Europe.



Whole argument is based on a False premise


Local representative It is estimated that between 90% and 95% of all macaques used in the EU are imported from outside the EU. This is a higher figure than recorded in the EU statistics on animal experimentation, but that is because some animals are imported by a supplier and then sold on to the final user. In the EU statistics these primates are counted as coming from within the EU, simply because the laboratory buys them from the local supplier, not direct from the overseas breeder.




It is estimated that between 90% and 95% of all macaques used in the EU are imported from outside the EU. This is a higher figure than recorded in the EU statistics on animal experimentation, but that is because some animals are imported by a supplier and then sold on to the final user. In the EU statistics these primates are counted as coming from within the EU, simply because the laboratory buys them from the local supplier, not direct from the overseas breeder.

65

Question VI.1.2.

Question text:

Statistics:




Comments received:





VI.1.2a.

Animal welfare: The increase in animal welfare would be high as no more wildlife NHPs would be caught and transferred to an unnatural environment. Do you support the preliminary findings? Yes/No/ No opinion

66



at VI.e) Potential solutions and 1.1 to 1.5 No ........The use of non-human primates for experimental purposes should be strictly limited to cases where the use of in vitro methods and other animal models are of insufficient value. In view of the slow progress in transplantation research towards bio-artificial development of organs, the prospect of an earlier verifiable approach to temporarily transplant xenogeneic organs to humans, makes further use of NHPs indispensable. In this limited number of cases, only animals bred in captivity should be used except in cases where no valid alternative is available for essential research programmes.









It is widely acknowledged that the use of primates for research and testing purposes is a subject of high sensitivity, on ethical, animal welfare, conservation, animal and human health, science as well as economic grounds. NHPs are only used rationally when no other alternative exists, as also requested by law. They account for less than 0.1% of all experimental animals in Europe. They are used efficiently in a manner that promotes rapid progress in science and medicine, and their treatment and care is continually reassessed in light of the latest knowledge and methods.

67




There is a notion to transfer experiments that scientifically justify the use of NHP to either the USA or Japan; apparently other countries with less animal welfare restrictions advertise to transfer this type of experiments at less expenditure.

Marta Saloña User of animals -public sector

Regional there are more That will affect only to NHP but not to other animal species. This may have statistical significance but has no ethical basis for non primate species








XXX See 1.1




Yes Wild-caught primates are very rarely used for experiments and no suppliers will produce F2 for research thus any welfare benefit must be balanced again the loss of research from the EU (thus no global welfare benefit)

68







Worldwide there are others This question covers only the situation in Old World monkeys. There are only a few animals which may be wild caught and used for breeding purposes. Most of the important breeding colonies overseas are controlled by local veterinarians and by audits of European primate experts. This involves animal welfare and veterinary care.





The presumed positive impact on welfare is not based on scientific evidence. The proposal is full of statements that are not backed up by the relevant references. E.g., where are the data which indicate that more than 90% of all NHPs used in the EU are of F2 generation?! And, which studies show the positive impact on the welfare of NHPs?!



National; Worldwide


No, because NHPs used in the EU are usually F1 offspring bred by overseas breeders from wild captured NHPs. Furthermore, the demand for F1/purpose-bred NHPs is higher in particularly the USA, which would not change the situation at overseas breeders.




Yes As above (1.1)



National yes The increase in animal welfare is not scientifically proved whereas management of animals in captivity is improving however catching wild animal is a stressor.

69



National yes not possible yet (see above reference)



National yes There is a notion to transfer experiments that scientifically justify the use of NHP to either the USA or Japan; apparently other countries with less animal welfare restrictions advertise to transfer this type of experiments at less expenditure.




It is a University, the question is meaningless

The underlying assumption form point 1.2 is that, once caught and contained, the overall quality of life for a NHP is lower than that of living in the wild. This is not necessarily true, given high standards of care and appropriate conditions, NHP's may flourish in the "restricted" environment. I think it is wrong to over-generalise in this way - life in the "wild" may not be particularly pleasant for many animals! The statistics on the life span of young male macaques in the wild should be looked at carefully - it is likely to be hard and short. (eg see Rosenblum/Andrews in Nonhuman Primates in Biomedical Research eds Bennet et al, Academic Press 1995, ISBN 0-12-088661-8.

Bayer HealthCare



1.2 The impact on welfare will most likely be negative since these animals that would not be caught would be shot or destroyed by other more cruel means to control population size. In addition, since in most of the cases experimental protocols require to use both genders in equal proportions, and since a significant proportion of females of each generation need to set apart to replace retired breeding females, there will be a surplus of males that will not be absorbed by research needs and may need to be culled. Vervets are also seen as a pest and capture is alternative to extermination. This must be weight against welfare and judicious capture and use may be better alternative to indiscriminate extermination.

70



This assumes that capture programmes and hosing conditions cannot be implements adequately. There is no evidence provided that is is universally the case, and the high quality supply from many countries. A different perspective of the impact of these animals as agricultural pests, how they are actually kept, and the ecological and financial aspects can be seen at: http://www.accutravel.net/guide/content/view/27/66/ There should be consultation with 3rd country governments to understand there perspective and control, not just assumptions made


Worldwide Yes These NHP are seen in the wild as a pest because they destroy the agricultural farming industries eating cereals and fruit. In the same time they are in competition with the tourism industry(see Barbados, St Kitts Nevis, the Philippines). In the 50' of the last century in Barbados the law allowed people to shoot the NHP with a reward in money. Actually small amount of wild caught NHP are used by industries and instead are killed in their country as a pest.




The impact on welfare will most likely be negative as these animals that would not be caught would be shot or destroyed by other more cruel means to control population size. In addition, since in most of the cases experimental protocols require to use both genders in equal proportions, and since a significant proportion of females of each generation need to set apart to replace retired breeding females, there will be a surplus of males that will not be absorbed by research needs and may need to be culled. Vervets are also seen as a pest and capture is alternative to extermination. This must be weight against welfare and judicious capture and use may be a better alternative to indiscriminate extermination.

sanofi pasteur R&D


Worldwide Vaccine field Not all species could be concerned. New emerging disease or new models could lead to the use of other species. In addition to avoid inbreeding, wild-caught animals should be re-introduced into the colony on a regular basis.

71



National yes The expansion of breeding in Europe could lead to greater numbers of NHP in Europe as now. Demands for research purposes can vary, the reproduction time of the NHP`s is long and not easy to handle. So there is the tendency to breed more animals. A second problem could arise with sexes, females are often used for breeding and so there could develop a disproportion between sexes. Experiments demands equal sexes mostly. The living conditions of the macaques in their country of origin should also take into consideration.





The impact on welfare will most likely be negative since these animals that would not be caught would be shot or destroyed by other more cruel means to control population size. In addition, since in most of the cases experimental protocols require to use both genders in equal proportions, and since a significant proportion of females of each generation need to set apart to replace retired breeding females, there will be a surplus of males that will not be absorbed by research needs and may need to be culled. Vervets are also seen as a pest and capture is alternative to extermination. This must be weighed against welfare and judicious capture and use may a be better alternative to indiscriminate extermination.



Worldwide Yes We cannot support finding when requirement are not known.




The impact on welfare will most likely be negative since these animals that would not be caught would be shot or destroyed by other more cruel means to control population size. In addition, since in most of the cases experimental protocols require to use both genders in equal proportions, and since a significant proportion of females of each generation need to set apart to replace retired breeding females, there will be a surplus of males that will not be absorbed by research needs and may need to be culled. Vervets are also seen as a pest and capture is alternative to extermination. This must be weight against welfare and judicious capture and use may a be better alternative to indiscriminate extermination.

72



Worldwide Yes The most important increase in animal welfare would result from optimized housing conditions in the breeding colonies. If the number of animals to be housed would have to be significantly increased to have enough F1 breeders, this would possibly result in more restrictive housing conditions for cost control. Therefore, restricting NHP in research to F2 could result in a negative impact on animal welfare, both short-term and long-term




Take in account the following: in Mauritius, NHP destroys agricultural places, they are considered like vermin and they are hunted for that. NHP caught for F1 production are accepted.




Very few wild animals are used for breeding and the important breeding stations are supervised by local and European experts.



National; Worldwide

yes This statement is non-sense as hunting would immediately replace capture for breeding. In the countries of origin, the authorities have to control the population growth. It is especially true on islands, with the extreme situation of vervets that are hunted as a pest. As breeding requires more females and as most experimental applications require equivalent groups of males and females, it would generate a surplus of males that cannot used for research and may need to be euthanized.



European Representitive I do not see this increases animal welfare

73













The preliminary finding does not take account of the fate of animals in some geographic locations where they are unfortunately regarded as agricultural pests.

74




It is not as simple as stated. The impact on welfare will most likely be negative since many of these animals are regarded as pests and, if not be caught, they would be shot or destroyed by other more cruel means to control population size. In addition, since in most of the cases experimental protocols require to use both genders in equal proportions, and since a significant proportion of females of each generation need to set apart to replace retired breeding females, there will be a surplus of males that will not be absorbed by research needs and may need to be culled. Also, forcing colonies to be closed to the introduction of wild caught animals too quickly would result over time in health issues due to inbreeding.



Worldwide yes The impact on welfare will most likely be negative since these animals that would not be caught would be shot or destroyed by other more cruel means to control population size. In addition, since in most of the cases experimental protocols require to use both genders in equal proportions, and since a significant proportion of females of each generation need to set apart to replace retired breeding females, there will be a surplus of males that will not be absorbed by research needs and may need to be culled. Vervets are also seen as a pest and capture is alternative to extermination. This must be weight against welfare and judicious capture and use may a be better alternative to indiscriminate extermination.



Worldwide Representative See the above comments on capture and killing of wild animals.



Worldwide yes It is not as simple as stated. The impact on welfare will most likely be negative since many of these animals are regarded as pests and, if not be caught, they would be shot or destroyed by other more cruel means to control population size. In addition, since in most of the cases experimental protocols require to use both genders in equal proportions, and since a significant proportion of females of each generation need to set apart to replace retired breeding females, there will be a surplus of males that will not be absorbed by research needs and may need to be culled. Also, forcing colonies to be closed to the introduction of wild caught animals too quickly would result over time in health issues due to inbreeding.

75



National; Worldwide

yes Not necessarily increasing animal welfare if captive NHP's originate from areas where they are hunted as "pests".



Worldwide yes The impact on welfare will most likely be negative since these animals that would not be caught would be shot or destroyed by other more cruel means to control population size. In addition, since in most of the cases experimental protocols require to use both genders in equal proportions, and since a significant proportion of females of each generation need to set apart to replace retired breeding females, there will be a surplus of males that will not be absorbed by research needs and may need to be culled. Vervets are also seen as a pest and capture is alternative to extermination. This must be weight against welfare and judicious capture and use may a be better alternative to indiscriminate extermination.




In the countries where the animals come from they are in all cases not respected and in many cases even regarded and exterminated as a pest. It is questionable if being killed as a pest in the natural environment means an improved welfare in comparison with being caught for breeding purposes in an environment which is as close as possible to the natural environment.

76







Worldwide yes The wildlife population will be controlled by hunting instead, which is a questionable advantage with respect to animal welfare.



National representative The impact on welfare will most likely be negative since these animals that would not be caught would be shot or destroyed by other more cruel means to control population size. In addition, since in most of the cases experimental protocols require to use both genders in equal proportions, and since a significant proportion of females of each generation need to set apart to replace retired breeding females, there will be a surplus of males that will not be absorbed by research needs and may need to be culled. Vervets are also seen as a pest and capture is alternative to extermination. This must be weight against welfare and judicious capture and use may be better alternative to indiscriminate extermination.



Worldwide YES This would lead to more wildlife NHPs, which would be eventually shot and considered as "pests".




The overall impact on welfare may be negative, as remaining wild primates may be killed to control their populations. Several of the NHP species used in research are considered pests in their local environments.

77



everyone really working with primates knows that wild caught animals better bred that purpose bred animals so what?????




This is based on flawed assumptions about the extent of use of F2 NHPs.


Public authority Local yes There is a notion to transfer experiments that scientifically justify the use of NHP to either the USA or Japan; apparently other countries with less animal welfare restrictions advertise to transfer this type of experiments at less expenditure.


Public authority Local yes It is widely acknowledged that the use of primates for research and testing purposes is a subject of high sensitivity, on ethical, animal welfare, conservation, animal and human health, science as well as economic grounds. NHPs are only used rationally when no other alternative exists, as also requested by law. They account for less than 0.1% of all experimental animals in Europe. They are used efficiently in a manner that promotes rapid progress in science and medicine, and their treatment and care is continually reassessed in light of the latest knowledge and methods.



The provision of non-human primates for EU laboratories is not the primary driver behind the taking and trapping of feral animals.



Some of these species are considered to be vermin in their native areas. Welfare in the wild may be much poorer than in captivity. Need to look at the overall ethical issues in there true context

78




As long as there is any economic benefit of catching and selling NHPs, these animals will be caught. A ban in the EU will not stop this miserable practice.


Public authority National representative It is widely acknowledged that the use of primates for research and testing purposes is a subject of high sensitivity, on ethical, animal welfare, conservation, animal and human health, science as well as economic grounds. NHPs are only used rationally when no other alternative exists, as also requested by law. They account for less than 0.1% of all experimental animals in Europe. They are used efficiently in a manner that promotes rapid progress in science and medicine, and their treatment and care is continually reassessed in light of the latest knowledge and methods.


The higher primates, by their very nature, cannot be institutionalised and remain healthy.




Wild-caught NHP’s are hardly ever used in the EU, so this welfare benefit has already been achieved.

Cris Iles-Wright Other Not applicable Not applicable Primates labelled captive bred have been filmed living free on islands. The definition of captivity is ill-defined. Primates bred in captivity undergo suffering due to the breeding process.

79




see 1.8




Other National Yes There would in likelihood still be a negative impact on welfare. Those wild NHPs not caught could still be killed to control population size or because they are considered to be pests (as is the case with vervets, for example).



Very few wild caught NHPs are used in the EU and so would have little impact.

80




This question only covers the situation in Old World monkeys. There are only a few animals which may be wild-caught and used for breeding purposes. Most of the important breeding colonies overseas are controled by local veterinarians and by audits of European primate experts. This involves animal welfare and veterinary care.


Other National Yes The concern is that many F1 animals are in use and have the potential for further use.


Other National representative Just because Europe moves towards using only F2 animals would not automatically mean that breeders would stop catching animals from the wild. Europe is not the only market. Already it would seem that 90% of the NHP used in Europe are F2 or beyond. The remaining 10% represents about 740 animals, compared with an annual usage of 52,279 in the US. A change in the EU requirement would have a minimal impact on the demographics of the animals in the breeding centres.

81


Other Worldwide These comments originate from a large academic institution in Belgium with a large tradition in biomedical research and were formulated by mutual agreement

This questionnaire is totally unclear about what constitutes F1 and F2 animals. This makes it impossible to respond to these questions. In general, F1 animals are not wild-caught, but captivity-bred from animals that were caught in the wild (these are F0). F2 generation animals are bred from F1 animals, so they constitute second generation captivity-bred animals. According to the current text of the Directive (article 21) non-human primates to be used in experiments shall be bred animals unless a general or special exemption has been obtained under arrangements determined by the authority. Moreover, the requirement to use exclusively animals from the second or more generation would cause a dramatic increase (more than 100%) in the number of primates to be kept in captivity for breeding purposes and is therefore not acceptable from an animal welfare point of view. Therefore, the use of captivity-bred F1 generation animals should remain allowed.


Other European yes In fact, there would likely be a negative impact on welfare. Those not caught may still be killed to control population size or because they are seen as pests (as in the case of vervets).



European Yes Wild-caught NHP’s are hardly ever used in the EU, so this welfare benefit has already been achieved and the proposal will not produce further welfare benefit.

82

PETA Europe Ltd.


Worldwide both A ban on the use of wild caught primates would not improve conditions for those primates already in captivity or who will be born into captivity, i.e. a large proportion of primates used under the existing provisions of 86/609. The most important improvements will come through reductions in overall demand.Capture and transport can lead to acute injury, stress and death The destruction of familial and other close bonds in animal social networks traumatize both those captured and wild survivors (Biol. Lett. In Press: DOI:10.1098/rsbl.2006.0510). A ban would have a positive effect on the welfare of wild primates, who would be protected from exploitation and harm as a result. Given the figures presented in VIb, the ban would affect approximately 1000 primates (i.e. those ≤ F2). In addition, the ban would be positive for the remaining resident members of their communities who would also be protected from the trauma caused during capture operations and the resultant social separation.



National; European


Not high a slight improvement but others animals have to suffer in different ways for this. Stop using NHP is a better solution




It is our clear understanding that the questionnaire contains a serious factual error in its assumption that most imported NHPs are at least F2. In fact the great majority are F1. Since the USA, which is the largest market by far, is most likely to continue to accept F1 animals, it is not likely that in the foreseeable future there will be any incentive for overseas breeders to move to supplying only F2 stock. Insistence on use of only F2 stock would therefore probably result in unsustainable increased costs and/or the collapse of NHP use in the EU, which would be detrimental to EU competitiveness and could only be bad for animal welfare because it would trigger the move of NHP use to less regulated countries.

83




Wild caught primates are not used in the UK. They are however used to provide a source of breeding animals for those colonies which are not self-sufficient ie. the majority. The evidence that animals used in this way are subjected to lower welfare is unclear. In many cases these animals are pests eg. Cynomolgus in Mauritius and are controlled by hunting.



Worldwide There are others see previous answer




both Notably, a ban on the use of wild caught primates would not improve conditions for those primates who are already in captivity or who will be born into captivity, i.e. a large proportion of primates used under the existing provisions of 86/609. The most important improvements to welfare of primates in the wild and in captivity will necessarily come through the abolition of vivisection and reductions in overall demand. Capture and transport can lead to acute injury, stress and death (http://www.worldcongress.net/2002/proceedings/C2Prescott.pdf). A ban would have a positive effect on the welfare of wild primates, who would be protected from exploitation and harm as a result. In addition, the ban would be positive for the remaining resident members of their communities who would also be protected from the trauma caused during capture operations and the resultant social separation.




84




See 1.1



National YES The impact will not be so high considering that the situation regards only Old World monkeys and only a few wild caught animals are used for breeding purposes. Most of the important breeding colonies overseas are controlled by local veterinarians and by audits of European primate experts. This involves animal welfare and veterinary care.







Worldwide - -



National yes The impact on welfare will most likely be negative since these animals that would not be caught would be shot or destroyed by other more cruel means to control population size.



Worldwide yes It is widely acknowledged that the use of primates for research and testing purposes is a subject of high sensitivity, on ethical, animal welfare, conservation, animal and human health, science as well as economic grounds. NHPs are only used rationally when no other alternative exists, as also requested by law. They account for less than 0.1% of all experimental animals in Europe. They are used efficiently in a manner that promotes rapid progress in science and medicine, and their treatment and care is continually reassessed in light of the latest knowledge and methods.

85


Breeder of animals

Worldwide We are representative for the field and constitute about 50 percent of the activity

The reproductive information for Macaques is incorrect from a biological standpoint. In Item 1.2 it must be appreciated that with native-country captive-breeding operations infusions of wild caught and conditioned animals into the breeding program does, in fact, occur albeit on an infrequent basis. Hence, this statement is not totally true.


Breeder of animals

Worldwide Yes In the Mauritian context, if feral animals were not used for breeding, they would go back to being shot in the wild as they are an introduced feral pest to indigenous fauna and flora.


National; European


There will be a negative impact on welfare as animals no longer caught in the wild are likely to be destroyed to control population sizes.



Whole argument is based on a False premise


Local representative The impact on welfare will most likely be negative since these animals that would not be caught would be shot or destroyed by other more cruel means to control population size.




The impact on welfare will most likely be negative since these animals that would not be caught would be shot or destroyed by other more cruel means to control population size.

86

Question V.1.3.

Question text:

Statistics:




Comments received:





VI.1.3a.



see above

Public concern: High benefit in public concern as there is considerable opposition to the use of wild-caught NHPs in scientific research. Do you support the preliminary findings? Yes/No/ No opinion

87









The use of non-human primates for experimental purposes should be strictly limited to cases where the use of in vitro methods and other animal models are of insufficient value.




There is a notion to transfer experiments that scientifically justify the use of NHP to either the USA or Japan; apparently other countries with less animal welfare restrictions advertise to transfer this type of experiments at less expenditure. The use of non-human primates for experimental purposes should be strictly limited to cases where the use of in vitro methods and other animal models are of insufficient value.

88

Prof. Dr. R. Nobiling, University of Heidelberg


Regional; National; European; Worldwide

Biomed research at Univ. Heidelberg is Top - ranked

Central facilities as such carry the inherent problem of self-running administration costs and lack of flexbility to respond to scientific demands. A hope of positive public acceptance seems to be unrealistic: the discussion most probably would focus on “total ban” irrespective where the animals come from.








XXX The public is not likely to be concerned over the distinction between F1 and F2.




Yes Pulic concern focuses more on the use of primates and less on the source. Most members of the public are unlikely to see any significant difference between F1 and F2 primates.




The finding does not deserve comments as no F2 animal is available for biomedical research.



Worldwide there are others There are only a few animals which may be wild caught and used for breeding purposes. Wild caught animals are not used in scientific research with exception of primatological field studies in the countries of origin.




Concern of a public often mislead and not being able judge the benefit of such experiments for science and human benefit is hardly a valuable argument. Would the public be aware of consequences for vaccine research and development?

89





Much of the opposition raised against primate research is generated by a small group of animal rights organizations, rather than by the general public. If properly informed, the general public is not opposed to biomedical research involving nonhuman primates. Compared with patient organizations, which successfully raise Millions and Millions of Euros to fund biomedical research, animal rightists represent a very small portion of the public. In their campaigns, they often misinform the general public and politicians using outdated photographs and filmed material. Recent reports from the police and the national security agency in the Netherlands (available at http://www.informatiedierproeven.nl/) indicate that some of these groups (but certainly not all) could be regarded as part of a criminal network.



National; Worldwide


No, as said, nearly all used NHPs are F1/purpose bred and not wild caught





No. Since even allegedly expert bodies cannot tell the difference between f1 and f2 animals, the general public is unlikely to appreciate this distinction.






National yes It is widely acknowledged that the use of primates for research and testing purposes is a subject of high sensitivity, on ethical, animal welfare, conservation, animal and human health, science as well as economic grounds. NHPs are only used rationally when no other alternative exists, as also requested by law. They account for less than 0.1% of all experimental animals in Europe. They are used efficiently in a manner that promotes rapid progress in science and medicine, and their treatment and care is continually reassessed in light of the latest knowledge and methods.

90

Bayer HealthCare



1.3 The directive regulates these aspects. Regulating further might address public concern but at the same time cause serious shortage of primates for research in Europe since most of world vaccines research, development and production are done in Europe.



There is no evidence that the public oppose specifically wild caught animal use. There is more concern on primate versus rodent use


Worldwide Yes This issue has been regulated by the directive and there's no need to reinforce the organized opposition of the public against the use of all animals in scientific research(not only NHP).




The directive regulates these aspects. Regulating further might address public concern but at the same time cause serious shortage of primates for research in Europe – please note that e.g. most of world vaccines research, development and production are done in Europe.



National yes The overregulation of use of NHP in experiment will regulated and handicap research in Europe. The general requirements in the directive are adequate.

91








Worldwide Yes Short term, there might be a benefit to public concern, but once the longer ter m impacts became apparent, this could turn to a negative effect







Worldwide Yes F1 generation monkeys are not wild-caught, but purpose-bred. And use of wild-caught NHPs in research in EU is even now restricted to exceptional cases without alternative, and in these cases, wild-caught animals might even be used, if in general, only F2 would be used. Thus, for the well informed public, it should not make much difference with regard to opposition to the use of wild-caught NHPs in scientific research. We also do not really see such a differentiated public discussion about NHP




Wild-caught NHP are not used in research ! They are used for reproduction and only F1 are used for research: purpose-bred !




In contrast to public belief wild macaques are not used for biomedical research

92



National; Worldwide

yes We should never forget public health issues and make sure that the pubic is aware of the stakes. Creating q shortage of primates for research in Europe would first jeopardize vaccine research and pharmaceutical R&D in Europe, leading to a delocalization of these activities that are critical. It would be a huge loss for the E.U. (most vaccine research, development and production is done in Europe!)



European Representitive I am not aware of this oposition to wild caught animals, if the reasons are explained, then it may be more justified. Also, could I fence off an entire island, wait XXX years and then say I have F2 animals if I only 'harvest' the youngsters?













The preliminary finding is biased by not considering the benefits derived from non-human primate use as several vaccines which are key to public health and childhood illnesses require safety testing using macaques which currently may have been bred from wild-caught macaques.



Worldwide No Wild-caught primates are rarely used in the EU as you noted above. I do not believe that there is high public concern on this issue, but concern expressed by scientists and animal welfare/rights groups.




Regulating further might address public concern but at the same time would cause serious shortage of primates for research in Europe where most vaccines research, development and production are done.

93




Regulating further might address public concern but at the same time cause serious shortage of primates for research in Europe – please note that e.g. most of world vaccines research, development and production are done in Europe.



Worldwide yes The directive regulates these aspects. Regulating further might address public concern but at the same time cause serious shortage of primates for research in Europe (academic, government, EU&industrial research programs) – please note that e.g. most of world vaccines research, development and production are done in Europe.



Worldwide Representative Although regulating the use of purpose-bred (and possibly F2) animals might in some instances address public concern, this proposal would not solve the general concern of those who are opposed to the use of NHPs and at the same time cause dangerous shortage of NHP required for the ongoing research in Europe and outsourcing scientific competence to non-EU Countries.



Worldwide yes The directive regulates these aspects. Regulating further might address public concern but at the same time cause serious shortage of primates for research in Europe where most vaccines research, development and production are done.




The wild caughts are nearly excusively used for breeding purposes. We believe that the public would accept that if people knew about it.

94







Worldwide yes Such regulations would satisfy populistic trend and opinions but not really contribute to animal welfare.



Worldwide Yes Yes at first sight, but the public view may change very quickly once development of prevention/treatment for newly emerging diseases requires NHP research.



National representative The directive regulates these aspects. Regulating further might address public concern but at the same time cause serious shortage of primates for research in Europe since most of world vaccines research, development and production are done in Europe.




Short term, there might be a benefit to public concern, but once the longer term impacts became apparent, this could turn to a negative effect.


Public authority Local yes It is widely acknowledged that the use of primates for research and testing purposes is a subject of high sensitivity, on ethical, animal welfare, conservation, animal and human health, science as well as economic grounds. NHPs are only used rationally when no other alternative exists, as also requested by law. They account for less than 0.1% of all experimental animals in Europe. They are used efficiently in a manner that promotes rapid progress in science and medicine, and their treatment and care is continually reassessed in light of the latest knowledge and meth


Public authority Local yes The use of non-human primates for experimental purposes should be strictly limited to cases where the use of in vitro methods and other animal models are of insufficient value.

95



Current use is mainly F1s which are not wild caught so public opinion unlikely to change.


Public authority National representative The use of non-human primates for experimental purposes should be strictly limited to cases where the use of in vitro methods and other animal models are of insufficient value.


The use of such highly sentient creatures is morally indefensible - the main reason for the desire to use them, their similarity to ourselves, is also a most compelling reason for not doing so.




There would be no real benefit because the public are not aware of or interested in the difference between F1 and F2.




see 1.8




Other National Yes The use of wild-caught primates is already regulated by the Directive. Further regulation could address public concern, but it is essential to note that it would also severely hamper vital medical research taking place in the EU. We believe that this would also be a cause for significant public concern.

96


Other Not applicable not applicable It is already regulated



Very few wild caught NHPs are used in the EU and so would have little impact.




There are only a few animals which may be wild caught and used for breeding purposes. Wild-caught animals are not used in scientific research with exception of primatological field studies in the countries of origin.


Other National representative Since few if any wild caught animals are used at present the impact on public concern would be minimal.

97


Other European yes The use of wild-caught primates is already regulated by the Directive. Further regulation could address public concern, but it would also severely hamper the production of important medical research in Europe, which would also be a cause for public concern.




High public concern about the use of all primates will not be diminished by a partial ban of only a small number.



European Yes There would be no real benefit to public concern because the public are concerned about wild-caught primates being used and they are not aware of or interested in the difference between F1 and F2.




The public is not likely to be concerned over the distinction between F1 and F2.




Wild caught primates are not used in scientific research in the UK. The public concern relates to the use of NHPs in general and it is important that all users and authorities explain the value of these animal models to the serious diseases which we still face.

98







The finding does not deserve comments as no F2 animal is available for biomedical research.



National YES Wild caught animals are not used in scientific research with exception of primatological field studies in the countries of origin. A limited number of wild caught animals are used for breeding purposes.







National yes People opposed to the use of primates in research do not care whether they are wild-caught or bred in captivity.



Worldwide yes The use of non-human primates for experimental purposes should be strictly limited to cases where the use of in vitro methods and other animal models are of insufficient value.

99


National; European


The public is not concerned about differentiating between F1 and F2.




People oppossed to the use of primates do not care whether they are wild caught or bred in captivity.

100

Question VI.1.4.

Question text:

Statistics:




Comments received:





VI.1.4a.



see above

Biodiversity: A ban on wild-caught NHPs would contribute to the protection of biodiversity as all NHPs are listed either in Annex I or II of CITES and therefore (vulnerable to being) threatened with extinction. Do you support the preliminary findings? Yes/No/ No opinion

101









In view of the slow progress in transplantation research towards bio-artificial development of organs, the prospect of an earlier verifiable approach to temporarily transplant xenogeneic organs to humans, makes further use of NHPs indispensable.




In view of the slow progress in transplantation research towards bio-artificial development of organs, the prospect of an earlier verifiable approach to temporarily transplant xenogeneic organs to humans, makes further use of NHPs indispensable. In this limited number of cases, only animals bred in captivity should be used except in cases where no valid alternative is available for essential research programmes.

102


Regional there are more Only for NHP but not for other wild species that may be collected for research if no restrictive regulation is performed








XXX This is not feasible since a ban on catching wild NHPs in third world countries cannot be monitored or regulated by EU authorities. Moreover there could be occasional situations in which species that are not bred in captivity are required for some specific high-need projects such as the cure for AIDS or some future European pandemic.




Yes The species used for research in the EU are not endangered.




Only Appendix I NHP are threatened with extinction. Quite all NHP used for biomedical research are referred to in appendix II.



Worldwide there are others Wild caught rhesus and cynomolgus macaques are only used for breeding purposes. The number of required animals is relatively low. Both species are not endangered (neither vulnerable nor threatened) and listed in CITES II with a lower risk.




The majority of species used in research seem not to be endangered.

103





It is questionable whether the requirement to use only F2 animals (and subsequent generations) will yield any significant contribution to the solution of the biodiversity problem. Reports from organizations like the World Wildlife Fund indicate that biodiversity of NHP-species is primarily threatened by the destruction of the animals’ habitat and illegal poaching. If the EU truly means to protect biodiversity, it should take actions against logging of tropical rainforests and other environmental threats. Moreover, it is misleading and dangerous to suggest that all NHP-species used in experiments are threatened with extinction. For example, information published by the National Primate Research Center at the Univ. of Wisconsin (http://pin.primate.wisc.edu/) shows that rhesus monkeys are found ubiquitously throughout mainland Asia (Rowe 1996; Smith & McDonough 2005). Indeed, rhesus macaques as well as several marmoset species have a Low-Risk status on the CITES species database.




As wild caught NHPs would be primarily used for breeding they even can contribute to biodiversity conservation programs!



Local yes If wild-caught NHPs are necessary, then in very low numbers for breeding purposes to prevent inbreeding or for starting breeding stocks. Therefore, it is unlikely that this will influence wildlife stocks. Even if these are very rare cases, depending also on the species, it is important to have this possibility.



National yes The ban must be decided on information on animal population and ecologic studies which differs between locations. There is great differences between kind of primates (apes versus primates). The main reason for species disparition is not scientific use but humane activities like deforestation or bush meat.

104





No. For the main species concerned (marmoset, macaca fascicularis & mulatta), scientific use of these species is nugatory compared with destruction of habitat. This is a clear example of a false attack on biomedical science.






National yes The use of non-human primates for experimental purposes should be strictly limited to cases where the use of in vitro methods and other animal models are of insufficient value.





Animals used in research, as outlined above, are CITES II, not CITES I listed. This difference should be explained!

Bayer HealthCare



1.4 Species used in R&D are not threatened with extinction. The use of wild-caught NHP for breeding purposes does not necessitate huge numbers of animals and is therefore not likely to raise any conservation issues.



The species commonly used in Europe are not endangered, indeed are culled as pests http://www.issg.org/database/species/management_info.asp?si=139&fr=1&sts= http://darwin.nap.edu/books/030908945X/html/11.html

105


Worldwide Yes All species of NHP used in the research are coming from Breeding Center that are under the control of strict international regulations and there's no threat of extinction (some species are a pest -see answer 1.2)




Species used in R&D are not threatened with extinction. The use of wild caught NHP for breeding purposes does not necessitate huge numbers of animals and is therefore not likely to raise any conservation issues.

sanofi pasteur R&D


Worldwide Vaccine field Macaques and vervets, the most used species are not endangered although they are in the Annex II. In some countries, there are even considered as pests. And hunting is done to control wild population. Trapping of wild-caught is done by profesionals with the minimum distress.



National yes Species, used in research are not threatened with extinction. As mentioned above most wild-caught NHP are used for breeding purposes, and the number of animals they need is low. A wild-caught for experimental use is the exemption.








Worldwide Yes Most of the species used in research are listed in appendix 2 of the CITES convention, and are thus not considered as endangered. Continued capture of small numbers of wild NHPs to top-up breeding colonies would not be expected to have a significant effect on conservation

106







Worldwide Yes The extinction of NHPs is not primarily caused by capture of these animals as breeders for experimental purposes, but by destruction of their natural habitat, by killing them for meat. The use of the monkeys as breeders may even offer some change to protect them, as it is done for other species in zoos and breeding programs




NHP used for research are not threatened with extinction




Wild macaques are only used for breeding, and are not endangered species.



National; Worldwide

yes - Species used in R&D are not endangered. - The level of NHP caught I the wild for breeding is not a danger for the biodiversity.










107



Worldwide yes The numbers required are too small to endanger biodiversity




The preliminary finding appears not to consider the situation in certain parts of the world where the relevant species of non-human primate are regarded as agricultural pests. It would be reasonable that the Directive specified that use of non-human primate species in biomedical research would be regulated to avoid compromises to biodiversity through extinction. The specification of highly detailed aspects of breeding and management is not desirable in a Directive when the intentions may be delivered by means other than total bans.



Worldwide No Centres which do trap macaques for breeding, principally in Mauritius do so under government licence to trap a quota of animals which are not an indigenous species to the island, are a threat to the sugar industry, and are considered a pest. If animals are not caught for breeding they will be hunted and killed to protect crops. There is no evidence that I am aware of that the species is threatened in Mauritius or elsewhere




Yes Cette affirmation n’est pas vraie pour les macaques couramment utilisés en études de sécurité, dont l’espèce n’est pas en voie d’extinction.




Species used in R&D are not threatened with extinction and many are treated locally as pests. The use of wild caught NHP for breeding purposes does not necessitate huge numbers of animals and is therefore not likely to raise any conservation issues.




Species used in R&D are not threatened with extinction.

108



Worldwide yes Species used in R&D are not threatened with extinction. The use of wild caught NHP for breeding purposes does not necessitate huge numbers of animals and is therefore not likely to raise any conservation issues.





The proposal fails to recognise the efforts of some breeder establishments to contribute to biodiversity in their local area and beyond.



Worldwide Representative The largest majority of NHPs used in biomedical research is not threatened with extinction. Wild NHPs are actually captured mainly for breeding purposes.



Worldwide yes Species used in R&D are not threatened with extinction, many are treated locally as pests. The use of wild caught NHP for breeding purposes does not necessitate huge numbers of animals and is therefore not likely to raise any conservation issues.



National; Worldwide

yes Loss of habitat in native countries may be more threatening to biodiversity.



Worldwide yes Species used in R&D are not threatened with extinction. The use of wild caught NHP for breeding purposes does not necessitate huge numbers of animals and is therefore not likely to raise any conservation issues.

109




The species used are not threatened with extinction.







Worldwide yes There is no proof that biodiversity will increase rather decrease.



National representative Species used in R&D are not threatened with extinction. The use of wild caught NHP for breeding purposes does not necessitate huge numbers of animals and is therefore not likely to raise any conservation issues.



Worldwide YES These wild-caught NHPs are not threatened with extinction




Most of the species used in research are listed in appendix 2 of the CITES convention, and are thus not considered as endangered. Continued capture of small numbers of wild NHPs to top-up breeding colonies would not be expected to have a significant effect on conservation.

110



Most of the species used in research are frequently pests in their oiginal countries and extensively destroyed by local governments. A reasonable agreement would diminish the number of uneusefully killed wild animals if a part could contribute to the renwal of breeders in breeding centers




The use of wild caught NHP for breeding purposes requres only few animals and has no impact on the wild population. On the contrary, it might help preserve a given species.


Public authority Local yes he use of non-human primates for experimental purposes should be strictly limited to cases where the use of in vitro methods and other animal models are of insufficient value.


Public authority Local yes In view of the slow progress in transplantation research towards bio-artificial development of organs, the prospect of an earlier verifiable approach to temporarily transplant xenogeneic organs to humans, makes further use of NHPs indispensable.



The provision of non-human primates for EU laboratories is not the primary driver behind the trapping of feral primates.



Many are pests/vermin in their native countries


Public authority National representative In view of the slow progress in transplantation research towards bio-artificial development of organs, the prospect of an earlier verifiable approach to temporarily transplant xenogeneic organs to humans, makes further use of NHPs indispensable.

111




This is not feasible since a ban on catching wild NHPs in third world countries cannot be monitored or regulated by EU authorities. Moreover there could be situations in which species that are not bred in captivity are required for some specific high-need projects.


Other European No If wild-caught NHPs are necessary, then in very low numbers for breeding purposes to prevent inbreeding or for starting breeding stocks. Therefore, it is unlikely that this will influence wildlife stocks. Even if these are very rare cases, depending also on the species, it is important to have this possibility.




see 1.8



This is a created problem. NHPs used in research are currently not threatened with extinction and catching them in the wild happens in such a low number that it does not carry this risk.

112




Other National Yes Species used in R&D are not threatened with extinction.


Other Not applicable not applicable Species used in R&D are not threatened with extinction. The use of wild caught NHP for breeding purposes does not necessitate huge numbers of animals and is therefore not likely to raise any conservation issues.




Wild-caught rhesus and cynomolgus macaques are only used for breeding purposes. The number of required animals is relatively low. Both species are not endangered (neither vulnerable nor threatened) and are listed in CITES II with a lower risk.

113


Other National representative For the reasons given above an EU ban on wild caught primates woudl have little impact.


Other European yes Species used in R&D are not threatened with extinction.



National; European

Yes If wild-caught NHPs are necessary, then in very low numbers for breeding purposes only to prevent inbreeding or for starting breeding stocks. Therefore, it is unlikely that this will influence wildlife stocks. Even if these are very rare cases, depending also on the species, it is important to have this possibility.




1.4 is not feasible since a ban on catching wild NHPs in third world countries cannot be monitored or regulated by EU authorities. Moreover there could be occasional situations in which species that are not bred in captivity are required for some specific high-need projects.




The species used in research and development in Europe are not endangered species.

114







Only Appendix I NHP are threatened with extinction. Quite all NHP used for biomedical research are referred to in appendix II.



National YES Wild caught rhesus and cynomolgus macaques are only used for breeding purposes. The number of required animals is relatively low. Both species are not endangered (neither vulnerable nor threatened) and listed in CITES II with a lower risk. It has to be considered that only the few most commonly used species are bred in captivity while for the less commonly used species the captive breeding is very scarce or even non-existent. These species, for their particular characteristics, might represent unique models for specific pathologies.



National yes The use of wild caught NHP for breeding purposes does not necessitate huge numbers of animals and is therefore not likely to raise any conservation issues.



Worldwide yes Based on the statement of a group of experts representing all stakeholders in the NHP (Non Human Primates) research field, i.e. European academia, Government institutes, pharmaceutical industry, contract research organizations (CROs), breeders and suppliers on proposals made by a Technical Expert Working Group during the revision of the Directive 86/609/EEC to exclude the use of animals from the first generation born in captivity (F1) and only allow the use of animals from the second (F2) or other subsequent generations one has to request an extended transition period to fulfil the research demand in Europe.

115


Breeder of animals

Worldwide yes In Mauritius, the trapping of monkeys contributes to the protection of the biodiversity, by preventing the destruction of endemic species. The maintenance captive bred NHP’s is not a factor contributing to extinction of the macaques but rather helps the preservation of the species.


Breeder of animals

Worldwide Yes Mauritius is an exception as wild NHP's are an introduced feral pest and are themselves a well recognised threat to native biodiversity. Conservationists want them out of the forests.


National; European


Those species used for R&D are not endangered. Only small numbers are caught in the wild for breeding purposes and these are often animals that would be killed anyway to for biodiversity or agriculture reasons, and so do not impact significantly on conservation.


Local representative The use of wild caught NHP for breeding purposes does not necessitate huge numbers of animals and is therefore not likely to raise any conservation issues.




The use of wild caught NHP for breeding purposes does not necessitate huge numbers of animals and is therefore not likely to raise any conservation issues.

116

Question VI.1.5.

Question text:

Statistics:




Comments received:





VI.1.5a.

Costs for user establishments: A total ban on wild-caught NHPs for experimental use without transitional period would lead to high negative impacts on research in the period before alternative/additional sources are developed, e.g. through self-sustaining primate breeding centres in the EU or in the origin countries. Therefore, the costs of supply would increase. The supply would have great difficulties in meeting the current demand parallel to reserving a part of the stock for reproduction. Do you support the preliminary findings? Yes/No/ No opinion

117



see above









In this limited number of cases, only animals bred in captivity should be used except in cases where no valid alternative is available for essential research programmes.








There would be a minor impact, since wild-caught NHPs are only used in exceptional cases.

118



National yes In view of the slow progress in transplantation research towards bio-artificial development of organs, the prospect of an earlier verifiable approach to temporarily transplant xenogeneic organs to humans, makes further use of NHPs indispensable. In this limited number of cases, only animals bred in captivity should be used except in cases where no valid alternative is available for essential research programmes.



Local organisation is representative

this question was not in the questionnaire when I printed it out



Wild caught animals are very rarely used, F1, (born in captivity), are used . A ban on the latter would be disastrous for public health


Worldwide Yes The wild caught NHP are used in very small amount and all NHP are coming from Breeding center and the Companies have just invested in facilities in the origin country in order to have a high quality NHP (a cost for 1 monkey F1 is actually about 10.000 euro.




The question mixes up the use of wild caught primates for research and for breeding purposes. Wild caught animals are rarely used in research – there are used for breeding purposes. Most of animals used in research are F1 animals (first generation born in captivity). At this stage it is difficult to assess how long a transitional period should be. Impact on cost will in any case remain even after expiry of the transitional period due to: loss of fertility, increased number of animals in captivity, etc.



National yes As mentioned before there are very small numbers of wild caught NHP used in experiments. Wild-caught animals will be used in very specialized experiments, so total ban can restrict research.

119



European Yes In short term an unbalance in supply-demand is predictable.However, in medium and long term, both the enviroment and the scientific research will benefit more than loss. For the continuation of the funds in research, public confidence is crucial. In this decade where enviromental problems became main concern, public confidence is highly affected from all type of damage against nature which can lead to immense decrease in funds in long term. protecting wild born animals and keeping them out of lab will only benefit the science community.













Wild caught animals are used for breeding purposes. There is no need of creating other alternative source.



National; Worldwide

yes Only a limited and ever decreasing number of wild caught animals are now used in research. They are exclusively used for breeding purposes in order to generate F1 animals. The main impact would be on breeding as explained already. .

120













This preliminary finding cannot be supported as it appears to confuse the use of wild caught primates with their F1 offspring. Very few wild caught primates are used in Europe though very many F1 primates are.



Worldwide No This question appears to confuse use of wild caught animals for breeding with use in experiments – it is not clear what is being asked. As noted above, few wild caught animals are used in experiments in the EU, so impact of a ban would be small. If the assertion is that a ban on use of wild caught animals for breeding would have a serious impact, this is of course correct.





121



Worldwide yes The question mixes up the use of wild caught primates for research and for breeding purposes. Wild caught animals are rarely used in research – they are used for breeding purposes. Most of animals used in research are F1 animals (first generation born in captivity). At this stage it is difficult to assess how long a transitional period should be. Impact on cost will in any case remain even after expiry of the transitional period due to: loss of fertility, increased number of animals in captivity, etc.





Wild-caught primates are not used for regulatory studies at this laboratory.



Worldwide yes The question mixes up the use of wild caught primates for research and for breeding purposes. Wild caught animals are rarely used in research – there are used for breeding purposes. Most of animals used in research are F1 animals (first generation born in captivity). At this stage it is difficult to assess how long a transitional period should be. Impact on cost will in any case remain even after expiry of the transitional period due to: loss of fertility, increased number of animals in captivity, etc.







Worldwide yes Not only costs would increase but research would be jeopardized in the EU and consequently lead to a transition of such research in countries which less strict regulations and less animal welfare.

122



Worldwide yes no response



Worldwide YES You forget that the major problem is that there are no self-sustaining private primate breeding centres in the EU and none planned in the future. We cannot purchase NHPs from the public research breeding centres.

MA 60-Veterinäramt, Wien/Vienna

Public authority Local; Regional yes Because it was mentioned before that today more than 90% of all NHPs used in the EU are of F2 generation.




Public authority Local yes In view of the slow progress in transplantation research towards bio-artificial development of organs, the prospect of an earlier verifiable approach to temporarily transplant xenogeneic organs to humans, makes further use of NHPs indispensable.


Public authority Local yes In this limited number of cases, only animals bred in captivity should be used except in cases where no valid alternative is available for essential research programmes.



Yes Larger colonies should be generated so that demand does not exceed supply.



There may always be an exceptional justification for such use. But it needs to be borne in mind that at present the vast majority of the wild-caught animals are used for overseas breeding programmes or are sold to non-EU research labs.

123


Public authority National representative In this limited number of cases, only animals bred in captivity should be used except in cases where no valid alternative is available for essential research programmes.


There is little evidence that primates provide effective models for human disease, especially since insufficient is usually known either of the human disease, or of its purported relation in primates, for a rational judgement to be made about how useful the primate model is likely to be.




Since there are hardly any wild-caught NHP’s used in the EU, such a ban would have little negative impact on research.

Cris Iles-Wright Other Not applicable Not applicable Primates have no value in medical research for human benefit.




see 1.8


Other National Yes It is very important to note that wild-caught animals are rarely used in research. They are used for breeding purposes. Most NHPs used in research are of F1 generation. In addition, it is not currently clear what length the transitional period would be needed to fulfil European research demand.



Although there are very few wild caught NHPs used in the EU, a total ban would limit scientific endeavour where there is a justifiable and unavoidable requirement for a particular species of NHP not available from captive bred populations.

124




Wild-caught NHPs are not used in biomedical experiments but a ban on them for breeding purposes have a high negative impact on the supply of F1 animals. The aim of self-sustaining breeding colonies for rhesus and cynomolgus macaques needs a high financial support in order to increase the breeding abilities of existing centres in EU during the next ten and more years.


Other National representative For the reasons given above an EU ban on wild caught primates would have little impact.


Other European yes This question is misleading. Wild caught animals are rarely used in research; they are used for breeding purposes. Most of the NHPs used in research are of F1 generation. It is not currently clear what length the transitional period would need to be to fulfil research demand in Europe.

125




The costs for user establishments cannot be quantified from the information presented. If 90% of all NHPs used in the EU are F2 generation animals, then there should be little cost increase. The implications of using wild-caught NHPs are of paramount importance because of the welfare of the individual animals and also because of the need to conserve the species in the wild. Therefore, any increase in costs of supply that does occur is considered justifiable. Additionally, a ban on the use of wild-caught or F1 generation animals can act as an incentive to increase efforts to develop and use more non-animal test methods in those areas of research in which NHPs are currently used. Industry, scientists and regulators should be sufficiently innovative and flexible to accommodate these requirements. There are human health and safety hazards associated with wild caught NHPs; and the effects of stress imposed on these animals can further compromise the validity of data collected from them.



European Yes Since there are hardly any wild-caught NHP’s used in the EU, such a ban would have little negative impact on research. However it will be important to permit very limited exceptions as there are some rare cases where a particular species of NHP is essential for a particular research project and the animals are not bred in captivity.




These impacts are over-estimated. The UK’s Home Office Inspectors report that some overseas breeding centres are already changing or have already changed their policy in this direction. These companies have set target dates by which they will stop taking feral animals and/or will retain more F1 animals as breeding stock. This change will happen much faster if the EU requests it, rather than just the UK. Thus impacts would be more like “- - “.

126

PETA Europe Ltd.


Worldwide both The presumption that the ban on experimentation with wild caught primates would lead to negative impacts on research and increases in cost rests on two assumptions: 1) that current primate experimentation has high positive impacts, and 2) that there would be a period before alternative sources would be available. The potential for positive effects of the ban have been ignored or at least not articulated in Section 1.5. A sudden change could lead to innovation that would advance science, allow for much needed investment in the development of additional non-animal methods, or encourage further thoughtful data mining of extant genomic data. The extraordinary ethical costs in terms of trauma and suffering for the capture and transport of wild caught primates, the traumatized primate social groups that such practices leave behind and the suffering of animals in breeding and testing centres far outweigh the perceived market costs named above in 1.5.



National; European


This would create new innovative ways without using animals. If there are no more NHPs' animal testers will be forced to think a bit further then normal.





This issue isn’t new- primate suppliers have addressed captive breeding from at least the early 1990s, as reflected in the pricing (captive bred have cost more than wildcaught primates for some time (1). There seems no evidence that breeders would meet demand if they had longer. Rather, this would perpetuate acknowledged animal suffering (1,2) The UK, the EU's largest user of laboratory NHPs, already has a "ban" on the use of wildcaught primates and in 1999 accounted for 44% of EU NHP use. So in effect there has already been a lengthy transitional period (3) Under a wildcaught primate ban, the difficulties of captive breeding macaques would perhaps naturally restrict numbers used. 1 My Mate's a Primate (2005) www.ad-international.org/admin/downloads/mmap_report_-_complete.pdf 2 Monkeys & Men (2002) 3 3rd Report from the Commission to the Council & the European Parliament on the statistics on no. animals used for experimental & other scientific purposes in the MS of the EU 2003

127




both The presumption that the ban on experimentation with wild caught primates would lead to negative impacts on research and increases in cost rests on two assumptions: 1) that current primate experimentation has high positive impacts, and 2) that there would be a period before alternative sources would be available. We reject both assumptions, as detailed in our responses to sections VIe and 2.4 respectively.A sudden change could lead to innovation that would advance science, allow for much needed investment in the development of additional non-animal methods, or encourage further thoughtful data mining of extant genomic data.The extraordinary ethical costs in terms of trauma and suffering for the capture and transport of wild caught primates, the traumatized primate social groups that such practices leave behind and the suffering of animals in breeding and testing centres far outweigh the perceived market costs named above in 1.5.






Worldwide Yes If over 90% of NHPs currently used in the EU are F2, the lack of a transition period should not have the negative impact indicated here. One could argue that if there is no transition period, the research community will more carefully scrutinize NHP use and perhaps recognize that some research currently being done is not needed. Government and industry should make ending biomedical research and testing on NHPs a priority, and this could be a small step in that direction.



Worldwide yes In view of the slow progress in transplantation research towards bio-artificial development of organs, the prospect of an earlier verifiable approach to temporarily transplant xenogeneic organs to humans, makes further use of NHPs indispensable.

128


National; European


F1 bred in captivity are used for research, not NHP caught in the wild (these are used for breeding).

129

Question VI.1.6.

Question text:

Statistics:




Comments received:





VI.1.6a.

Scientific need A ban on wild-caught NHPs would have a high negative impact on specific biomedical research programmes (see 1.3) due to supply problems if the transitional period is too short. Do you support the preliminary findings? Yes/No/ No opinion (If yes please specify current demand and supply, expected needs in the next future)

130


Regional there are more more information referred to alternative methods are needed for a correct analysis of this assumption



Not applicable equivalent to other large medical universities

with 10% of NHP not being F2 purpose bred, the impact of a ban will be small. The laboratory is no place for wild-caught NHP because it does not fulfil its behavioural needs.







National no A ban on NHP-experiments would presumably encourage scientists to develop procedures using other species



Wild caught animals are very rarely used, F1, born in captivity are used. A ban on the latter would be disastrous for public health. For the medium term, until alternatives area implemented over several decades, we see no decline in use of primates for safety testing. At the same time we see increasing demand internationally that will not allow the F2 only option. There should be a systemic EU analysis such as done in the US: http://www.nap.edu/catalog/10774.html



European Yes Too short is a very relative term: A huntsman would probably prefer a 30 year of transitional period which is only due to profit. And negative is again relative in the manner of time. Short term negative is always expected but what important is long term results which will be definitely positive.

131




Actually yes 1 Future needs cannot be easily predicted now – see emerging diseases 2 Wild caught primates are used very exceptionally when biomedical research needs justify it. 3 Breeding is not always possible and establishment of a colony is a long process. 4 Use of wild caught primates should remain exceptional as provided today by the directives.



Worldwide Yes Actually Yes: the Use of NHP will stay more or less constant or may even slightly increase because of the increase in development of biologics and human receptor-specific targets in drug research and development




YES !!! Wild caught animals are used for breeding purposes. There is no need of creating other alternative source. So no transitional period is needed.




yes but, 1 Future needs cannot be easily predicted now – see emerging diseases 2 Wild caught primates are used very exceptionally when biomedical research needs justify it. 3 Breeding is not always possible and establishment of a colony is a long process. 4 Use of wild caught primates should remain exceptional as provided today by the directives.




Future needs cannot be easily predicted now – see emerging diseases Wild caught primates are used very exceptionally when biomedical research needs justify it. Breeding is not always possible and establishment of a colony is a long process. Use of wild caught primates should remain exceptional as provided today by the directives.



Worldwide yes Actually yes, but: 1 Future needs cannot be easily predicted now – see emerging diseases and research in more complex substances, e.g.. proteins. 2 primates are used only when no other possibility) 3 Breeding is not always possible and establishment of a colony is a long process. 4 Use of wild caught primates should remain exceptional as provided today by the directive.

132





Wild-caught macaques are not used for regulatory work at this laboratory




Actually yes, but 1 Future needs cannot be easily predicted now – see emerging diseases 2 Wild caught primates are used very exceptionally when biomedical research needs justify it. 3 Breeding is not always possible and establishment of a colony is a long process. 4 Use of wild caught primates should remain exceptional as provided today by the directives.








Yes Despite gestational and litter-size limitations, an increase to the size of breeding colonies would alleviate supply problems.



There may always be an exceptional justification for such use. But it needs to be borne in mind that at present the vast majority of the wild-caught animals are used for overseas breeding programmes or are sold to non-EU research labs.


Trying to reproduce animal models of human disease is an outdated approach, especially since there are now many non-invasive ways of working with human patients.

133





Cris Iles-Wright Other Not applicable Not applicable Primates have no value in medical research for human benefit.

John Mellerio Other National no Yes I provide no data – see 1.8 below Note: had to tick no as there is no box for YES so even if I had data I would have no YES space into whioch to place them.


Other National Representative VI.c states that only a small number of the wild-caught non-human primates are used in the EU and that these are species used only sporadically – the negative impact would thus appear to be overstated. If the question refers to limiting use of non-human priamtes to F2 or later generations (rather than a ban on use of wild-caught primates for experiments) then YES – there would be supply problems for macaques (particularly M. fascicularis) which would impact on specific biomedical research programmes.

TNO Quality of Life (The Netherlands)

Other National; Worldwide

Yes To our knowledge most NHPs used in research are already obtained from breeders.


Other National Yes NB we do agree, but the Word version of this questionnaire asks for further information on current demand and supply if you select yes, but this online version does not seem to have been designed to allow this. So, our answer is yes, and our comments are: New diseases emerge, and as a result it is difficult to predict future needs. Wild-caught primates are only used where this is exceptionally necessary. This should continue to be the case, as currently provided for by the Directive.



See 1.5 above.

134




A ban on wild-caught NHPs would have a negative impact on breeding abilities of macaques in the non EU breeding colonies. Therefore, a negative impact on biomedical research using F1 macaques will result. At present about 10.000 NHPs are needed in Europe. Most of them are macaques of F1 generation.


Other National representative A total ban on wild caught animals would impact mainly on those using animal species which cannot be bred in captivity.


Other European yes Do you support the preliminary findings? Yes/No/ No opinion Yes (If yes please specify current demand and supply, expected needs in the next future) As new diseases emerge, it is difficult to predict future needs. It should be noted that wild-caught primates are only used where exceptionally needed, and this should remain the case, as currently provided by the Directive.

135

Antidote Europe Non-governmental organisation

European; Worldwide

Equivita (http://www.equivita.it), Europeans for Medical Progress (http://www.curedisease.net)

In our view, a ban in the use of NHPs, whether wild-caught or captive-bred, would have a positive effect on the progress of medical research projects. Discrepancies between the symptoms and progression of a human disease, or its artificially-induced nearest equivalent, in NHPs seriously complicates any attempt to derive useful data from these models (e.g.: Bailey, J., 2005; Bocan, TM., 1998). Similarly, species differences in the response to treatments limits the accuracy with which NHP data can be extrapolated to humans: the trials of TGN1412 tragically proved this. Fundamental differences between the immune systems of the humans and NHPs rendered it impossible to safely extrapolate data obtained in one to the other. Research projects currently reliant on the use of NHPs may rather be better served by the application of human material-based methods. Bocan, TM. Curr Pharm Des, 4 (1) pp37-52 (1998). Bailey, J. Biogenic Amines, (4-6) pp. 235-255 (2005).




The impact on specific biomedical research programmes cannot be quantified from the information presented. If, as stated, 90 % of all NHPs used in the EU are F2 generation animals, then there should be little effect on supply and thus on specific biomedical research programmes. Additionally, a ban on the use of wild-caught or F1 generation animals can act as an incentive to increase the efforts to discontinue specific procedures with NHPs and to develop and use more non-animal test methods in those areas of research in which NHPs are currently used. Industry, scientists and regulators should be sufficiently innovative and flexible to accommodate these requirements.



European Yes See comment at 1.5 above.




Again, these impacts are over-estimated. The UK’s Home Office Inspectors report that some overseas breeding centres are already changing or have already changed their policy in this direction. These companies have set target dates by which they will stop taking feral animals and/or will retain more F1 animals as breeding stock. This change will happen much faster if the EU requests it, rather than just the UK. Thus impacts would be more like “- - “.

136

Europeans for Medical Progress


National; European

Other relevant organisations: Antidote Europe (www.antidote-europe.org), Equivita (http://www.equivita.it), the Association for the Abolition of Animal Experiments (http://www.animalexperiments.ch).

In our view, a ban in the use of NHPs, whether wild-caught or captive-bred, would have a positive effect on the progress of medical research projects. Discrepancies between the symptoms and progression of a human disease, or its artificially-induced nearest equivalent, in NHPs seriously complicates any attempt to derive useful data from these models (e.g.: Bailey, J., 2005; Bocan, TM., 1998). Similarly, species differences in the response to treatments limits the accuracy with which NHP data can be extrapolated to humans: the trials of TGN1412 tragically proved this. Fundamental differences between the immune systems of the humans and NHPs rendered it impossible to safely extrapolate data obtained in one to the other. Research projects currently reliant on the use of NHPs may rather be better served by the application of human material-based methods. Bocan, TM. Curr Pharm Des, 4 (1) pp37-52 (1998). Bailey, J. Biogenic Amines, (4-6) pp. 235-255 (2005).

PETA Europe Ltd.


Worldwide both Please refer to responses to sections 1.5 and 1.7.

PROFESSOR RD COMBES - FRAME


Worldwide THERE ARE OTHERS

Where is the evidence for this? I do not believe that sufficient ongoing research programmes use wild caught primates for this to be a big effect.



National; European


Wild caught animals bring in all sorts of diseases and health risks for the public

137





The above analysis fails to take into account the long-term benefits to which any initial supply-related problems are likely to give way. Any measure, including this one, which makes it less easy for researchers to acquire the animals they want is likely to encourage the development and adoption of alternative models for biomedical research. Since non-animal techniques tend to be faster, cheaper and more rigorous, such as by allowing for larger sample sizes and greater reproducibility (1), this will have a positive impact on science as a whole – a point which appears to have been overlooked. A natural restriction on supply NHPs might also help ensure that the cost benefit assessment for these species is more effective. (1) Coecke S et al. 2006. The value of alternative testing for neurotoxicity in the context of regulatory needs. Environmental Toxicology and Pharmacology 21: 153-167.




both Please refer to responses to sections 1.5 and 1.7.



Worldwide Yes Current reliance on wild caught NHPs is low enough that a prompt end to this practice should not have a “high” negative impact and would perhaps lead to greater attention to justification of current uses. In the US, history has shown resistance by the research community to policy changes but, in each case, the research community has adjusted without the negative impact often argued—resulting in better animal welfare and, thus, better research results. As one example, when regulations regarding the psychological well-being of NHPs were adopted in the US, the research community argued that costs would shut down the ability to conduct research, but the US continues to be perhaps the largest user of NHPs in research in the world. There should be careful scrutiny of comments provided by those who otherwise argue that there will be a high negative impact on the conduct of NHP research in the EU.

138







Worldwide - -



Worldwide yes In view of the slow progress in transplantation research towards bio-artificial development of organs, the prospect of an earlier verifiable approach to temporarily transplant xenogeneic organs to humans, makes further use of NHPs indispensable.


National; European


Future demand is difficult to predict due to uncertainty over new or emerging diseases. The ability to use wild NHP is valuable where there is scientific justification, and only in exceptional cases.



It would provide a breathing space for these research programmes to review their direction and portfolio of research in light of knowledge that research on NHPs is of deep concern.

139

Question VI.1.7.

Question text:

Statistics:




Comments received:





VI.1.7a.


Regional there are more Research results should be published to be useful and is responsibility of the editorial boards to check the procedures previous the decision of accepting a mansucritpt. In the same way EU has to assume the responsibility and may ban the comercial distribution of any product that has not been developed under our regultaory processes

Outsourcing of research/competitiveness A total ban, without a transitional period, on wild-caught NHPs would lead to a transfer of research to countries outside the EU. Do you support the preliminary findings? Yes/No/ No opinion (If yes please give an estimate on the extend of this transfer)

140







National no A ban on NHP-experiments would presumably encourage scientists to develop procedures using other species



As most animals are not F2 and most imported in excess of 50% would stop immediately. However due to the difficulty many companies would simply transfer all work to 3rd countries. Thus the work will continue, just elsewhere.




Actually yes Approximately 50% of current research efforts using NHP will have to be discountinued or delocalised



Worldwide Yes Actually Yes: A significant shortage of NHP in EU, while available in other parts fo the world might result in a shift of NHP research sites to countries outside EU, which would not be reversible after resolution of the shortage and might even result in an almost total loss of regulatory testing in monkeys in EU and major loss of private institutions’ research in EU. There is anyway a tendency to transfer NHP research to countries outside of EU because of public opinion and because of lower costs in other regions. This may impact further areas of preclinical research as a consequence.

141




YES !!!!!! Europe is one of the greatest users of NHP, and strategic project of vaccine or biomedical progress for human medecine uses NHP in Europe




Yes but, Approximately 50% of current research efforts using NHP will have to be discountinued or delocalised




If the non-human primate F1s are banned then all the research currently conducted in these non-human primates would be transferred to third countries. In some circumstances the toxicological expertise may transfer too meaning that in time, work involving rat and dog might also transfer.



Worldwide yes Actually yes, but: F2 requirement would be much more demanding for breeders&much more expensive to raise&buy F2 NHPs. Between 50% and 60% of current research efforts using NHP will have to be discountinued or delocalised indeed, it is probable that part of the research will just be moved to other countries with a lower animal welfare protection level.





Wild-caught macaques are not used for regualtory work at this laboratory




142







Yes The increase in challenges associated with obtaining authorisation and animals for NHP work in our institution has not resulted in transfer of research outside the country despite ample opportunity for this to happen.



The impact might not be great in the short term but there may always be an exceptional justification for such use. But it needs to be borne in mind that at present the vast majority of the wild-caught animals are used for overseas breeding programmes or are sold to non-EU research labs.


Whether NHP research is undertaken in the UK, the EU or in China, the results will be equally irrelevant and misleading in terms of human health





Cris Iles-Wright Other Not applicable Not applicable This implies that other countries will be encouraged to do the experiments. The EU should use its influence to show the reality of the limitations of experimental primate use and the superiority of other technical methods.

John Mellerio Other National no Yes and my reply is that I cannot supply the data you seek - see 1.8 below.


Other National Yes As with the above question, we do agree, but the Word version of this questionnaire asks for further information on the extent of the transfer if you select yes, but this online version does not seem to have been designed to allow this. So, our answer is yes, and our comments are: Feedback from companies indicates that around 50% of current research using NHPs would have to be either discontinued or moved out of Europe.

143



See 1.5 above




Wild-caught NHPs are not used in biomedical research. Nevertheless, a ban of F1 generation without a transitional period will stop research in Europe. This raises severe problems in particular in the pharmaceutical industry but also in neurosciences and infectious disease research. As it is difficult to transfer the specific knowledge (animal care takers, veterinarians, scientists) of primate keeping under experiments, a total ban of F1 macaques will lead to an extensive and substantial transfer outside the EU countries.


Other National representative As above. The impact would be minimal as the numbers are very small.


Other European yes YES but Feedback from companies indicates that around 50% of current research using NHPs would have to be either discontinued or moved out of Europe.

144




The argument put forward in 1.7. is unobjective. There are numerous reasons why scientists transfer their research to other countries. A ban on the use of wild-caught animals is indispensable for the reasons mentioned in 1.5., 1.6. and 1.8. If scientists do consider transferring their research in order to avoid fulfilling provisions that are of paramount importance to improve animal welfare and protect the species this should not prevent the European Commission from pursuing their objectives.



European Yes See comment at 1.5 above.




This impact is unlikely. Even if a total ban without transition did temporarily delay a small fraction of primate work, breeders may be in a position to supply F2 NHPs sooner than the time it would take to transfer primate work outside the EU (see above).

PETA Europe Ltd.


Worldwide both Animal experimentation is indeed a global endeavour. The practice of primate vivisection is morally repugnant regardless of where it occurs. Furthermore, we reject the notion that access to wild caught primates for experimentation per se is now or would be in the future a driving force for outsourcing to non-EU countries. Any such shift would result from the economic factors that affect the globalization of enterprise more generally. Section 2.4 addresses the fallacy of a supply bottleneck overall. Claims of a scientific exodus due to supply are misleading. To the contrary, the enterprise of experimentation has remained stable or increased in the developed world, including the UK (http://news.bbc.co.uk/2/hi/science/nature/5209718.stm). Gross inadequacies of off-shore facilities (http://www.apc.gov.uk/reference/primate-sources-report.pdf) are a countervailing force for outsourcing that are stronger than any perceived lack of access to monkeys per se.

145



National; European


Not if the funds now available are earmarked and cannot be used for NHP research.





There is no indication that this would be the case. There are a considerable number of factors influencing the location of research above and beyond animal welfare and the source of animals. It has been stated in the past that increased animal protection in the UK would drive research abroad, but this has not been borne out. With regard to the UK's wild caught primate ban, there was no immediate drop in research, nor an international shift in research. Indeed research on NHPs is rising in the UK.




both Animal experimentation is indeed a global endeavour with many multinational corporate conglomerates engaged in the for-profit enterprise of primate experimentation. we reject the notion that access to wild caught primates for experimentation per se is now or would be in the future a driving force for outsourcing to non-EU countries. Rather, as with other enterprise, any such shift would result from the economic factors that affect the globalization of enterprise more generally. Section 2.4 addresses the fallacy of a supply bottleneck overall.Claims of a scientific exodus due to supply are misleading. To the contrary, the enterprise of experimentation has remained stable or increased in the developed world, including the UK (http://news.bbc.co.uk/2/hi/science/nature/5209718.stm).

146



It is more likely to lead to researchers thinking again about the objectives of their research and better ways of obtaining biomedical information. There are great costs (cultural, practical) in transferring research programmes elsewhere. In addition, other countries outside the EU are also tightening their policies on use of NHPs

147

Question VI.1.8.

Question text:Justification (open text box)

Statistics:(no numbers registered as this was not a closed question)

Comments received:





VI.1.8. Justification




at VI.e) Potential solutions and 1.1 to 1.5 No Based on the statement of a group of experts representing all stakeholders in the NHP (Non Human Primates) research field, i.e. European academia, Government institutes, pharmaceutical industry, contract research organizations (CROs), breeders and suppliers on proposals made by a Technical Expert Working Group during the revision of the Directive 86/609/EEC to exclude the use of animals from the first generation born in captivity (F1) and only allow the use of animals from the second (F2) or other subsequent generations one has to request an extended transition period to fulfil the research demand in Europe. In this limited number of cases, only animals bred in captivity should be used except in cases where no valid alternative is available for essential research programmes.

Prof Alan Palmer


Worldwide Yes NHPs is a very sensitive area that needs special consideration. However, there are real justifications for their use in some areas. The negative impact will in this case be somewhat greater if the use of F2s is imposed with no exemptions as at present the majority of macaques used are F1.

148





Most probably, the public in its majority will not distinguish between wild caught and F2 NHP.

Timo Nevalainen User of animals -public sector

Local Yes 1.2. Yet more NHP will be housed in breeding units.




yes Our University performs no experiments on NHP and plans no experiments in the near future. Experiments on Great Apes have recently been banned in Austria. Nevertheless, we have to consider that the use of NHP is scientifically necessary in very rare cases, e.g. concerning hepatitis and AIDS research and yet undetected human diseases. Despite the small animal numbers required, such research may be of utmost importance. Catching procedures of NHPs in the wild and their use in experiments should be handled very restrictively and carefully. However, a total ban on wild-caught NHPs throughout the EU would have negative effects on breeding purposes and impede every required use in the future. Therefore we confirm the primate statement given by FELASA.




A total ban, without a transitional period, on wild-caught NHPs would lead to a 100% transfer of research to countries outside the EU.



Worldwide there are others to 1.7. Wild-caught NHPs are not used in biomedical research. Nevertheless, a ban of F1 generation without transitional period will stop research in Europe. This raises severe problems in particular in pharmaceutical industry but also in neurosciences and infectious disease research. Although it is difficult to transfer the specific knowledge (animal care takers, veterinarians, scientists) of primate keeping under experiments, a total ban of F1 macaques will lead to an extensive and substantial transfer outside EU countries.

149



National representative ad 1.7. There is already transfer of primate research to China (see in the section “News” about this topic in the journal Science this year)





Please check on the number of F2s already being supplied and note that surplus F1s would be equally usable. An exception should be made for research on endangered species and the great apes when the population itself is threatened because of some indigenous problem i.e. research for the sake of the species. 1.4 I agree but an exception should be made when the population itself is threatened because of some indigenous problem i.e. for the sake of the species




Special care should taken to the opinion of primate researchers and experts from pharmaceutical industry concerning the impact on basic primate research and impact on vaccine development and research on substance abuse to mention only a few important topics. It should be avoided to be unduly guided by a poorly informed public opinion.





The restriction of non-human primate research to second-generation animals will put European primate research at risk. If put into effect, the guidelines has to be accompanied by establishing sufficient primate breeding facilities in Europe.

150




Yes Any guidelines aiming at a restriction of non-human primate research to second-generation animals will put European primate research at risk. The limitation to the use of F2 primates is in some way cynical as these have to be derived from F1 primates caught or kept outside Europe. Any ban on non-human primate research in some member states of the EU is likewise cynical as long as clinical studies on human primates are not put under the same regulations. In other terms, clinical studies that can be done on humans should also be feasible on non-human primates. If the proposed guideline is implemented, it will have to be accompanied by the establishment and funding of sufficient primate breeding facilities in Europe.





ad 1.6 Cognitive neuroscience research groups in Holland currently house a total of about 30 rhesus monkeys. Because each trained animal participates in experiments for several years, supply demands are low; on average we only require about 6 new animals per year. Our current supply consists mostly of F2 and higher. However, we anticipate a high negative impact on our research if it becomes virtually impossible to obtain second-generation macaques due, e.g., to increased demands from other laboratories around the EU ad 1.7 In recent years, our groups have acquired >10 MEuros from National and International funding agencies to invest in primate neuroscience research. Most, if not all us will move our research to countries outside the EU (USA/Canada) if it proves very difficult to obtain F2+ macaques. This would mean that all Cognitive Neuroscience research that requires non-human primates would disappear from our country. We expect a very similar situation in other EU countries.



Regional yes The restriction of non-human primate research to second-generation animals will put European primate research at risk. If put into effect, the guidelines has to be accompanied by establishing sufficient primate breeding facilities in Europe.

151




New emerging diseases may need new animal models, which may need wild caught NHP - if not possible in Europe, research activities will move elsewhere. But we agree that primarily breeding colonies should be established.



National yes. There are other academic medical centres

It should be realised that the general statement that already 90% of NHP are of F2 generation, is certainly not true for macaques.




Yes The majority of macaques currently used are F1s, not F2s.



Local yes At 1.6 If there are new upcoming diseases where only a certain species can be used for research for which no breeding colony is established at that time. There should be always a possibility to start research in such cases. Of course the use of wild-caught NHPS should remain exceptional and has to be justified in these single cases. At 1.7 Yes, on a long term, if there are no self-sustaining breeding colonies for certain species. While industry has in principle the chance relocate to other countries, academic institutions do not have this opportunity. Scientists working in that field, especially the younger once, will be tempted to go to universities in other continents. Therefore, there is a risk that Europe looses competence in research areas, where non-human primates are necessary.




Yes Most of the macagues used are F1 animals, not F2 as supposed.

152



National yes A ban of wild-caught animal will conduct to delay or arrest research program using adult animal. Captive bred are very light (weighting around 3kg) subadult 3 years old animal. For example, it is impossible to conduct studies on passage of HIV virus into sperm on subadult animals; blood sample volumes are limited by the weight of animals, drastically restricting access to circulating cells in bone marrow aplasia studies. Older and heavier animals are irreplaceable. Most of these studies will be outsourced.





The extent of out-sourcing is hard to estimate, but the more significant areas of fundamental research will be hardest-hit by this transition. There will be a significant loss of expertise within the EU, perhaps comparable to the drain in scientists from the USA owing to their position on stem-cell research.




Why should the research be transferred outside the EU when already today more than 90 % of all NHPs used in the EU are of F2 generation?

Bayer HealthCare



Reference document: EFPIA briefing paper on use of NHP in pharmaceutical research http://www.efpia.org/2_indust/useofprimates2004.pdf



See http://www.efpia.org/2_indust/useofprimates2004.pdf http://europa.eu.int/comm/food/fs/sc/scah/out83_en.pdf


Worldwide Yes Please refer to EFPIA briefing paper on use of NHP in pharmaceutical research.

153





sanofi pasteur R&D


Worldwide Vaccine field Section 1.6, scientific need: For infectious disease: polio eradication plan, Malaria and Dengue as tropical disease. Section 1.7 outsourcing of research: A plan exists within my company to transfer 100% of research in NHP to other non-European sites.



National yes Yes, there will be negative impact on research, especially in supplying new animals for further research demands, which you cannot imagine now. If there is no ban of wild-caught no transition period occur. Research will be outsourced, I can only he estimate the extend of this transfer – to at least 50%.





Seen EFPIA Briefing paper http://www.efpia.org/2_indust/useofprimates2004.pdf And FELASA report: http://www.felasa.org/Documents/primstat.rtf



Worldwide Yes This section needs clarification of the facts and figures before a proper impact assessment can be made. The assertion that 90% of NHPs used in the EU are already F2 seems to be a significant overestimate. We support the view that use of wild-caught primates should not be the norm, and should be specifically justified, but we consider that a blanket ban could have some undesirable consequences. Where species are already mainly supplied from breeding colonies, we emphasise that moving to a strict requirement for F2 animals may be difficult to achieve in a short period, and that there may be some as yet unquantified effects on breeding that will need to be taken into consideration. Up to approx 50% might need to be relocated outside the EU if a total ban is introduced.

154








If F1 animals are banned without a longer transitional period research on Macaques in Europe would have to stop.



National; Worldwide

yes Even is used in small numbers, some specific research programs may critically rely on the use of specific animal models including NHP, especially in the field of infectious diseases (including future emerging diseases) and new strategies to fight drug resistance. Research on neurodegenerative diseases and related therapeutic approaches could also require specific models. We can assume that all vaccine research and drug preclinical development wiil be transferred outside the E.U. This is representing the majority of NHP used (> 60 %) and the loss of a critical activity in Europe both scientifically, economically and socially. Please, refer to the EFPIA paper on use of NHP in pharmaceutical research http://www.efpia.org/2_indust/useofprimates2004.pdf



European Representitive Due to the indecision on the chnge to ETS 123 this company has already made provision to move this work to other countries.









1. Future needs cannot be easily predicted now – see emerging diseases 2. Wild caught primates are used very exceptionally when biomedical research needs justify it. 3. Breeding is not always possible and establishment of a colony is a long process. 4. Use of wild caught primates should remain exceptional as provided today by the directives. Approximately 50% of current research efforts using NHP will have to be discountinued or relocated

155



Worldwide yes 1.6 expected needs in the next future depend on progress of science



Worldwide No 1.6 is answered on the understanding that the ban refers to use for breeding, as noted above. Current demand is at least that shown in annual statistical returns of animal use. Future demand is likely to increase due to the suitability of primates for testing biotechnologically-derived test items, which is an ever increasing ercentage of the pharmaceutical market. Re 1.7 The majority of primate work would cease in the UK, not sure of other countries.



Worldwide pharmaceutical I have no expertise in the use of NHP




Yes 1.6/ Le marché est déjà tendu à l’heure actuelle et l’util. des primates pourrait augmenter sensiblement dans l’avenir en raison du dévlpmnt des médic. macromoléculaires. 1.7/ Les élevages de macaques chinois, déjà très sollicités en raison de la pénurie mondiale, amélioreront encore la qualité de leurs animaux. Une mesure d’application immédiate qui rigidifierait encore les règles d’approvisionnement encouragerait un développement encore plus rapide du marché chinois. En corollaire, les instituts de toxicologie spécialisés en primates se développeraient et proposeraient des services à coût inférieur, ce qui pourrait induire une délocalisation d’emplois et de compétences au détriment des centres européens. De plus, une baisse significative des coûts pourrait entraîner, de façon non spécifique, une augmentation de l’utilisation des primates, ce qui irait contre l’effet recherché.

156




For 1.6 : 1 Future needs cannot be easily predicted because of emerging diseases and the difficulty of predicting species requirements for future research. 2 Wild caught primates are rarely used - only when an experiment needs them for some scientific reason. 3 Establishment of a colony is a long process, so when a species not currently bred is need for a specific reason, wild caught animals need to be used. 4 Use of wild caught primates should continue only to be done by exception as required already. For 1.7 : Approximately 50% of current research efforts using NHP will have to be conducted elsewhere







Worldwide yes Reference document: EFPIA briefing paper on use of NHP in pharmaceutical research http://www.efpia.org/2_indust/useofprimates2004.pdf





Those interpreting the EU questionnaire should seek to confirm the availability of second generation macaques.



Worldwide Representative See the position paper issued by EFPIA: http://www.efpia.org/2_indust/useofprimates2004.pdf

157



Worldwide yes 1 Future needs cannot be easily predicted because of emerging diseases and the difficulty of predicting species requirements for future research. 2 Wild caught primates are rarely used - only when an experiment needs them for some scientific reason. 3 Establishment of a colony is a long process, so when a species not currently bred is need for a specific reason , wild caught animals need to be used if a colony does not exist already. 4 Use of wild caught primates should continue only t be done by exception as required already.




Re 1.7: The transfer would comprise all primate research and testing done at our European sites which would mean a transfer of two major core disease groups incl. discharging/ exchanging of staff which for personal reasons can not be relocated. It is difficult to say, but this could involve 200 jobs. As a relocation of one part of research is usually followed by the relocation of others, it would probably be much more.




Approximately 50% of current research efforts using NHP will have to be discountinued or delocalised . Reference document: EFPIA briefing paper on use of NHP in pharmaceutical research http://www.efpia.org/2_indust/useofprimates2004.pdf



Worldwide Yes conc. 1.6.: There sould be exemptions for specific demans, e.g. highly dangerous infectious diseases conc. 1.7.: Approx. 50 % will be outsourced to low standard countries



National representative Reference document: EFPIA briefing paper on use of NHP in pharmaceutical research http://www.efpia.org/2_indust/useofprimates2004.pdf

158



Worldwide YES Use of wild-caught NHPs would always be exceptional and should require authorisation. Some research may have to be relocated but it is difficult to quantify.




This section needs clarification of the facts and figures before a proper impact assessment can be made. The assertion that 90% of NHPs used in the EU are already F2 seems to be a significant overestimate. We support the view that use of wild-caught primates should not be the norm, and should be specifically justified, but we consider that a blanket ban could have some undesirable consequences. Where species are already mainly supplied from breeding colonies, we emphasise that moving to a strict requirement for F2 animals may be difficult to achieve in a short period, and that there may be some as yet unquantified effects on breeding that will need to be taken into consideration.

Coordination group for laboratory animal activities

Public authority National Yes 1.2. Yet more NHP will be housed in breeding units.

Swedish Animal Welfare Agency

Public authority National yes The Swedish Animal Welfare Agency supports the overall analysis; however, according to the information available to SAWA, most of the macaques used in Sweden are of F1 generation.



yes There are some grave misconceptions which makes answering these questions impossible.

159



The proposals set out above is based on misinformation. F2+ animals are in short supply and within Europe the animals used are typically F1+. Overseas centres tend to use wild-caught animals as breeding stock or for sale to non-EU labs.. The provision of non-human primates to EU research labs is not a significant driver behind the capture of feral primates. The EU is a small part of the world market for laboratory primates – a commodity for which world wide demand exceeds supply, and where there are some pressures that might further increase demand in the foreseeable future. To set a target or requirement that cannot be achieved would inevitably lead to non-human primate research, and other aspects of pharmaceutical research and development, being done outside the EU.


Public authority National yes Why not reduce the use of NHPs in Europe?



Information in background is not accurate and contains fundamental errors on work using NHPs in Europe. As the majority of animas are supplied from countries outwith Europe it is very difficult to exert control over this. In many countries that supply NHPs these animals are considered as pests and capture and use for breeding may be an improvement on general abuse and culling. Use of F1s from the breeding programme is not an issue for suppliers. The main focus should be on the care, housing, socialisation of the animals and not on which generation. For some studies there could be the argument that use of outbred animals (not possible if confine to F2s) gives greater genetic diversity and may be a better predictor for potential toxicity in regulatory toxicology work. Most of those using NHPs operate in a global market and these restrictions would impose a major commercial disadvantage

160


Public authority Local; Regional This is the only representative organisation for the Federal Government of Styria.

The use for both (Great Apes and NHPs) in animal testing is not allowed in Austria.


Public authority Worldwide yes I support a switch to F2 generation in non-human primates and a reduction of the use of wild caught animals. There are, however, to few breedin facilities in Europe. These had to be buildt up


Some of the strongest scientific arguments against using non-human primates in medical research have been voiced by individual scientists who themselves performed animal experiments in the past. A recent example can be found in a powerful editorial written by Michael Balls (M Balls. Editorial in ATLA 2003; 31, 545-547.)

Arun Kumar, UCC, Cork

Other National; European; Worldwide

yes not now


Other European No At 1.6 If there are new upcoming diseases where only a certain species can be used for research for which no breeding colony is established at that time. There should be always a possibility to start research in such cases. Of course the use of wild-caught NHPS should remain exceptional and has to be justified in these single cases. At 1.7 Yes, on a long term, if there are no self-sustaining breeding colonies for certain species. While industry has in principle the chance relocate to other countries, academic institutions do not have this opportunity. Scientists working in that field, especially the younger once, will be tempted to go to universities in other continents. Therefore, there is a risk that Europe looses competence in research areas, where non-human primates are necessary.

161

John Mellerio Other National no You have preliminary findings that you quote above and you ask if I support them. If I agree with your interpretation of them, you ask me to give data about demand and supply, etc. The outcome of this approach will be, if strictly followed, that only those who work directly with NHP’s or supply them will have the data you request. The numbers responding to this question will therefore, as you argue earlier, be small so might be disregarded as you seem to believe throughout this questionnaire that only points, effects and so on that affect many are worthy of consideration. If the effect is small overall, it seems it can be ignored. But here, the small number of replies should carry immense weight.




The Medical University of Vienna performs no experiments on NHP at this time and plans no experiments in the near future. Experiments on Great Apes have recently been banned in Austria. Nevertheless, we have to consider that the use of NHP is scientifically necessary in very rare cases, e.g. concerning hepatitis and AIDS research and yet undetected human diseases. Despite the small animal numbers required, such research may be of utmost importance. Catching procedures of NHPs in the wild and their use in experiments should be handled very restrictively and carefully. However, a total ban on wild-caught NHPs throughout the EU would have negative effects on breeding purposes and impede every required use in the future. Therefore we confirm the primate statement given by FELASA. (http://www.felasa.org/Documents/Policy_statements/primstat.doc)

Royal Netherlands Akademie of Arts and Sciences

Other National Yes, representative of the scientific community

Comment to 1.1: Yes, but only a few dedicated European primate centers are able to produce enough animals for their own research programs and to support academic research programs to a rather limited extent. Most Academia and commercial enterprises are heavily dependent on import animals (most of which come however from breeding centers). With regard to numbers, this need is not easily restored. Comment to 1.5: Yes. Without a transition period only a handful of dedicated primate centers will survive. Moreover they will only be able to support their own research programs to a limited extent. Noteworthy: the USA is stepping up its breeding programs to support the scientific research programs. Comment to 1.7: Yes. The breeding centers in the EU are not capable of producing enough animals to meet the current demand.

162

The Association for the Study of Animal Behaviour

Other Worldwide yes The risk of unintended consequences for important fundamental research is a key concern here – for example, as it might affect captive breeding programmes for endangered species and much-needed basic behavioural research


Other Not applicable not applicable Don’t mix up use in research and for breeding purposes ! 1. Future needs cannot be easily predicted now – see emerging diseases 2. Wild caught primates are used very exceptionally when biomedical research needs justify it. 3. Breeding is not always possible and establishment of a colony is a long process. 4. Use of wild caught primates should remain exceptional as provided today by the directives. Approximately 50% of current research efforts using NHP will have to be discountinued or relocated Reference document: EFPIA briefing paper on use of NHP in pharmaceutical research http://www.efpia.org/2_indust/useofprimates2004.pdf



Although there are very few wild caught NHPs used in the EU, a total ban would limit scientific endeavour where there is a justifiable and unavoidable requirement for a particular species of NHP not available from captive bred populations.


Other National Yes As we now obtain maacques only from breeding establishments in the UK THIS IS NOT A MAJOR ISSUE IN THE uk.


Other National representative The statement in the introductory text ‘Animals listed under CITES can only be used in experiments for research aimed at preservation of the species in question, or essential biomedical purposes where the species in question exceptionally proves to be the only one suitable for those purposes’ is inaccurate. This only applies to animals listed in Appendix I of CITES as endangered. The majority of primates used are CITES list II.

163




Despite the ethical dimension of using NHPs in scientific procedures, a reduction in their use is not discernible. Consequently the revision of the Directive should: a) contain provisions to discontinue the use of wild-caught NHPs; b) implement concrete measures to require more stringent justifications for using these animals in any scientific procedures and c) require specific research programmes dedicated to the replacement of experiments with NHPs by non-animal test methods. With such provisions, a ban on their use should not have a negative effect on biomedical research or on economic issues, even if currently still less than 90% of the NHPs used in the EU were F2 generation animals.




1.1: We strongly support a ban on wild-caught NHPs, but think the negative impacts are over-estimated. 1.5, 1.6: These impacts are over-estimated. The UK’s Home Office Inspectors report that some overseas breeding centres are already changing or have already changed their policy in this direction. These companies have set target dates by which they will stop taking feral animals and/or will retain more F1 animals as breeding stock. This change will happen much faster if the EU requests it, rather than just the UK. Thus impacts would be more like “- - “. 1.7: This impact is unlikely. Even if a total ban without transition did temporarily delay a small fraction of primate work, breeders may be in a position to supply F2 NHPs sooner than the time it would take to transfer primate work outside the EU (see above).



National; European

Yes At 1.6 If there are new upcoming diseases where only a certain species can be used for research for which no breeding colony is established at that time. There should be always a possibility to start research in such cases. Of course the use of wild-caught NHPS should remain exceptional and has to be justified in these single cases. At 1.7 Yes, on a long term, if there are no self-sustaining breeding colonies for certain species. While industry has in principle the chance relocate to other countries, academic institutions do not have this opportunity. Scientists working in that field, especially the younger once, will be tempted to go to universities in other continents. Therefore, there is a risk that Europe looses competence in research areas, where non-human primates are necessary.

164

Nuffield Council on Bioethics


National; Worldwide

There any other relevant organisations

See paras 4.34-4.35 for discussion of the welfare implications for wild-caught animals, in Nuffield Council on Bioethics (2005) The ethics of research involving animals (London: Nuffield Council on Bioethics) Available at: http://www.nuffieldbioethics.org/go/ourwork/animalresearch/publication_178.html 4.35 Capture from the wild imposes significant psychological stress on animals that are not habituated to humans or to captivity. It usually presents a number of risks to the animal and can result in physical injury, shock or even death. In addition to the impact on the target animal, effects on other animals also need to be considered as they may experience stress leading to behavioural disturbances that could leave them open to predation or cause them to abandon their young. This could affect not only other members of the colony in social species, but also animals of other species that are disturbed during the capture process.

PETA Europe Ltd.


Worldwide both Approximately 90% of primates kept in biomedical colonies suffer from behavioural pathology; 25% or more engage in self-mutilation (Am J Primatol. 2003 59:3-19; Am J Primatol. 2002 58:57-69). The incidence of abnormal behaviours in breeding centres is similar to that in biomedical colonies (Biol Psych. 2002 52:1047-56), suggesting that overall incidence ranges between 89-99% of individuals. Thus, moving wild caught animals to breeding centres could cause similar levels of distress and trauma and thus would be unacceptable also. Separation from the mother before the natural age of weaning, a practice condemned by the International Primatological Society (www.pin.primate.wisc.edu/ips/IPSGuidelinesRevisedDRAFT.DOC), is the primary risk factor for the development of behavioural pathologies (Am J Primatol. 2003 59:3-19). Regardless of generation or centre location, infant primates must not be separated from their mothers before the natural weaning age.




In recognition of the level of concern about the acquisition and use of primates, there must be a more detailed authorisation process for these animals. We cannot see any reason why, with careful planning, any wild caught primates need to be allowed to be used within the EU, and urge that any transition period deemed necessary be for the minimum time necessary. The EU should be working toward a phasing out of the use of all NHPs in conjunction with a strategy for developing alternative methods.

165





The NAVS is concerned that breeding primates continue to be wild caught. In 2000, 99.5% of the macaques supplied to the UK from Mauritius were first generation captive bred (1). This means that the majority of primates being f1 (first generation) and not f2 the offspring of captive bred NHPs. The figure of 90% of EU NHPs being F2 appears to be incorrect. 1.4: A ban on wild caught NHPs could eradicate a significant area of stress and suffering from the animals and could help conserve the species (if also applied to breeding stock). However, it should be noted that most macaque breeding centres would still require long journeys to reach EU laboratories, and that these remain wild animals. Caution would need to be taken so as not to mislead the public about the suffering of f2 NHPs. Reference: 1. My Mate's a Primate (2005) http://www.ad-international.org/admin/downloads/mmap_report_-_complete.pdf

The Royal Society



The Royal Society, together with the UK’s Academy of Medical Sciences, Wellcome Trust and Medical Research Council are undertaking a study ‘to examine the scientific basis for recent, current and future use of non-human primates within biological and medical research’. The study is expected to be published later in 2006 and further information can be found at www.nhpstudy.com.

166




1.6 - Wild caught primates are not used in the UK but are still required for essential vaccine production in mainland Europe. 1.7 - There is no direct impact in the UK and the impact in mainland Europe would need to be determined following careful review.








both Approximately 90% of primates kept in biomedical colonies suffer from behavioural pathology; 25% or more engage in self-mutilation (Am J Primatol. 2003 59:3-19; Am J Primatol. 2002 58:57-69). The incidence of abnormal behaviours in breeding centres is similar to that in biomedical colonies (Biol Psych. 2002 52:1047-56), suggesting that overall incidence ranges between 89-99% of individuals. Thus, moving wild caught animals to breeding centres could cause similar levels of distress and trauma and thus would be unacceptable also. Regardless of generation or centre location, infant primates must not be separated from their mothers before the natural weaning age. Reform of husbandry practices must be instituted with the ban on wild caught primates to ensure that suffering and the development of pathologies in breeding and testing centres are minimized.

167



Worldwide Yes any shift away from wild-caught and F1 would have a positive impact on animal welfare. If more than 90% of NHPs used in the EU are of F2 generation at this time, the negative impact should not be overstated and also should not require a long transition period, as is being indirectly suggested.




100%



National YES At the moment, about of 10.000 NHPs are needed and used in Europe. The vast majority of them are macaques of F1 generation. There will be a negative impact in case of emerging diseases where only a certain species can be used for research and for which no breeding colony is established. There should be always a possibility to perform research in wild-caught NHPs as an exception to be justified case by case. A ban of F1 generation without transitional period will stop research in Europe. This raises severe problems in pharmaceutical industry and in public, academic research. There is a serious risk that Europe looses competence in many important research areas. Although we supports in principle a shift towards use only of F2 and subsequent generations, there would be a very serious negative impact on research and costs in the medium to long term.



National Represents all Finnish pharmacologists

No members of our society are working with great apes

168



National The Danish Society of Pharmacology and Toxicology represents Danish pharmacologists and toxicologists.

No further comments,



Regional Yes The restriction of non-human primate research to second-generation animals will put European primate research at risk. If put into effect, the guidelines has to be accompanied by establishing sufficient primate breeding facilities in Europe.



Worldwide - -



National yes Since there is little prospect of a supply of F2 animals becoming available, this proposal would cause all pharmaceutical and vaccine industry primate work and much academic primate neuroscience research to be moved out of the EU. The immediate effects on these fields of EU research and development would be serious indeed.


Breeder of animals


The reproductive information for Macaques is incorrect from a biological standpoint. In Item 1.2 it must be appreciated that with native-country captive-breeding operations infusions of wild caught and conditioned animals into the breeding program does, in fact, occur albeit on an infrequent basis. Hence, this statement is not totally true.

169

Biotechnology and Biological Sciences Research Council

National Representative This proposal is based on a factual error in the background information (section VI.c. Use and trends) where it states, “In 2002, about 60% of the NHPs ... these macaques are F2 purpose-bred.” In fact, these animals were, and continue to be, F1 purpose-bred. There are no significant numbers of F2 purpose bred macaques imported into the EU.

giacomo Ri(olatti


it is represntative

This is a further proposal whose aim is not the welfare of animals but to render experiemnts on animals more costly and, at the end, impossible. It is not clear why primate research shoule be left to USA and Japan.


National; European


Given the above, and that welfare does not suffer under the current Directive, there is no reason for the Directive to be changed.


Regional; Worldwide

also others Any guidelines aiming at a restriction of non-human primate research to second-generation animals will put European primate research at risk. The limitation to the use of F2 primates is in some way hypocritical as these have to be derived from F1 primates caught or kept outside Europe. Any ban on non-human primate research in some member states of the EU is likewise hypocritical as long as clinical studies on human primates are not put under the same regulations. In other terms, procedures that can be performed on humans in the course of clinical studies should also be feasible on non-human primates. If the proposed guideline is implemented, it will have to be accompanied by the establishment and funding of sufficient primate breeding facilities in Europe.


Local representative Since there is little prospect of a supply of F2 animals becoming available, this proposal would cause all pharmaceutical and vaccine industry primate work and much academic primate neuroscience research to be moved out of the EU. The immediate effects on these fields of EU research and development would be serious indeed.




Since there is little prospect of a supply of F2 animals becoming available, this proposal would cause all pharmaceutical and vaccine industry primate work and much academic primate neuroscience research to be moved out of the EU. The immediate effects on these fields of EU research and development would be serious indeed.

170

Question VI.2.1.

Question text:

Statistics:




Comments received:





VI.2.1a.

Prof Alan Palmer


Worldwide Yes It is not correct that currently only 10% of Macaques are F1 and a longer transition is necessary to prevent a severely negative impact of a shorter transition.

Transitional period of 0 years Preliminary assessment: No transitional period would jeopardize a continuous supply with the subsequent consequences as described above. Do you support the preliminary findings? Yes/No/ No opinion

171




XXX See 2.4




Yes The figure of 10% is incorrect. No transition will be possible.




Yes Flawed premise





The premise is false








yes The transfer of research outside the EU is unlikley as resources to do the research are not in place.



National yes The number 10% of the used animals is not a F2 NHP is not realistic.

172





Significantly more than 10% of NHP's are not F2 Bred. I do support the preliminary findings.




Actually yes but the figure of 10% above is underestimated.



Worldwide Yes Actually yes but The figure of 10% of not F2 purpose bred does not seem correct




yes but, The figure of 10% above is underestimated.



Worldwide yes Actually yes, but: The figure of 10% above is highly underestimated.





The length of the transitional period should be governed by reported progress in establishing a supply of F2 NHPs.

173




Actually yes, but The figure of 10% above is underestimated.


Public authority Local; Regional yes only 10%….


Public authority Local; Regional yes only 10%….




This position is taken owing to flawed assumptions e.g. that most Macaques are F2s.



An immediate prohibition would end the majority of work in the EU using Old World species. The statement at VI.c) that almost all of the macaques recorded in 2002 were F2 purpose-bred is wrong. In the EU F1+ are typically used. There is insufficient supply of F2+ to meet current needs. A proposed gradual move to requiring the acquisition and use of only F2+, even allowing for a prolonged transition period, is impractical and would promote the active displacement of this and other aspects of pharmaceutical research and development to outside the EU.




No transition is realistically possible

174



The information regarding the use of F2 NHPs in the EU is inaccurate.


Other National Yes The concern is that at this time a significant number of F1s are being used.


Other National representative The number of animals being discussed is small. Applying the F2 rule immediately is unlikely to cause major issues.




Eurogroup would like to see an immediate end to all use of wild caught NHPs whether to supplement breeding colonies or for use in research. Whilst primate use continues, an immediate switch to F2 animals for research purposes is essential. Continuity in supply mainly depends upon the number of animals requested. Provided that specific measures are implemented that require special justification for using NHPs in scientific procedures and that aim to develop non-animal test methods designed to replace procedures with these animals, the demand for NHPs should diminish. This will not therefore be a problem.



European Yes No transition is realistically possible.

175




Our preference is for an immediate ban and we do not believe the negative impact of this would be as high as indicated. The UK’s Home Office Inspectors report that some overseas breeding centres are already changing or have already changed their policy in this direction. These centres have set target dates by which they will stop taking feral animals and/or will retain more F1 animals as breeding stock. This change will happen much faster if the EU as a whole requests it, rather than just the UK.

PETA Europe Ltd.


Worldwide both Commercial suppliers from across Asia sell tens of thousands of monkeys per year to corporate and institutional buyers in the USA (e.g. 2005 Annual Report available from www.usda.gov/APHIS). In 2005, 28135 monkeys were imported into the USA; a single consumer, Covance, accounted for 12681 of those (Ibid.). Records indicate that Covance received a single shipment of 900 monkeys, and several others in the hundreds. The proposition that EU facilities would not be able to obtain monkeys upon an immediate ban on the use of wild caught monkeys is not consistent with the data about the global market. Breeding centres for Rhesus macaques have already been established in Nepal (e.g. www.sfbr.org/pdf/ROUND-UP-4-1.pdf). Similarly, several Chinese suppliers sold rhesus monkeys to biomedical consumers in the USA in 2005 (www.usda.gov/APHIS). Innovations such as biochips (J Neurophysiol. 2006 96:1638-45



National; European



176





The NAVS believes that a requirement to use only ≥F2 primates should be introduced immediately, with no transitional period. While aware this will cause supply problems for some, we feel that the overall effect will be positive, owing to the considerable welfare and biodiversity benefits that would arise. A ban on wild caught NHPs could eradicate a significant area of stress and suffering from the animals and could help conserve the species (if also applied to breeding stock). However, it should be noted that most macaque breeding centres would still require long journeys to reach EU laboratories, and that these remain wild animals. Caution would need to be taken so as not to mislead the public about the suffering of f2 NHPs.




See 1.8 for challenge to the assumption that 90% of NHPs are F2 purpose bred. Even with a 10 year transition period, it is unlikely that overseas breeders would bother to adapt to supplying the EU with only F2 NHPs. Unless there is a definite resolution to this situation, implementing the F2 regulation would have very serious detrimental effects, however desirable it may be to minimise the catching of wild NHPs. Further, it is our understanding that many wild NHPs of non-threatened species used in research are anyway caught or culled to protect local agriculture.

177

The Royal Society



Again, we are unable to support a proposal based on serious factual errors in its assumption that most NHPs imported into the EU are F2 purpose-bred.




both Commercial suppliers from across Asia sell tens of thousands of monkeys per year to corporate and institutional buyers in the USA (e.g. 2005 Annual Report available from www.usda.gov/APHIS). In 2005, 28135 monkeys were imported into the USA; a single consumer, Covance, accounted for 12681 of those (Ibid.). Records indicate that Covance received a single shipment of 900 monkeys, and several others in the hundreds. The proposition that EU facilities would not be able to obtain monkeys upon an immediate ban on the use of wild caught monkeys is not consistent with the data about the global market. Breeding centres for Rhesus macaques have already been established in Nepal (e.g. www.sfbr.org/pdf/ROUND-UP-4-1.pdf).



Worldwide Yes While the “continuous supply” would be impacted, short-term decreased supply doesn’t necessarily lead to a negative impact and could, again, lead to greater scrutiny of primate use

178




Once again, it would be erroneous for the Trust to support a proposal that is based on information that is factually incorrect.







Worldwide The field at the respective activity level

In this moment is impossible to have all NHP to F-2


National; European


10% is an underestimate.



A transitional period is necessary

179

Question VI.2.2.

Question text:

Statistics:




Comments received:





VI.2.2a.

Transitional period of 5 years Preliminary assessment: Taking into account the current demand, type of species and their breeding patterns, a transitional period of 5 years should allow most breeding facilities to rise their production and provide enough F2 animals to users. Therefore, the supply should be guaranteed and additional costs should not be significantly high. Do you support the preliminary findings? Yes/No/ No opinion

180




This figure is unrealistic and does not take account of the physiology of breeding. Even where F1 breeding animals are available, a minimum time of 8 years is required, 13 years if starting with F0 (5 years to sexual maturity + 0.5 years for gestation + 5 years for sexual maturity of F1 + 0.5 years for gestation + 2 years to age of usage). Taking into account the need for enlargement and construction of new facilities, 15 years would be the absolute minimum. It should also be stressed that demand for certain species is so low as to make purpose-breeding non-viable, and specific exemptions to any requirement for F2 use would be essential.



Neither five nor ten years is sufficient to establish enough breeding colonies and breed enough F2 animals. One has to keep in mind that only a few EU Member States host a Primate Centre.





181











Regional there are more Alternatives should be urgently supply

Prof Alan Palmer



182

Torgny Jeneskog, Umeå University, Sweden



Yes, guess so ... I think that a 5 yr period would be far to short in reality, and thus "vote" for the 10 yr period in 2.3








XXX See 2.4




Yes For reasons given earlier a transition to F2 does not at present appear possible.




No F2 animal is available today. Fifteen years are needed for transition. During that time, there will be a decrease in the availability of F1 animals.



Worldwide there are others Most of the NHPs in biomedical research are F1 purpose-bred. To improve the situation (F2 macaques) and to be independent from imported macaques, the European Union should support existing breeding colonies which are keeping laboratory animals under controlled conditions with well documented history, health status and defined genetic background. The increase of a sufficient animal provision within the EU needs more than ten years and is accompanied by high costs for necessary facilities with adequate infrastructure.

183



National representative Supply would not be guaranteed within this to short transitional period




Five years are not sufficient to establish breeding colonies.



Local Yes It is possible that 5 years is to short to set up sufficient breeding capacity.





see 1.1




Yes I am not aware that F2 animals are provided – do you not mean F1 animals




As reproduction rates of NHP are low 5 years may be too short.

184




Given the generation time of macaques and the numbers needed to be bred which are in access of the 10% of all NHPs used in the EU, a transition time in access of 10 years is more realistic. Already more than 8 years are required when sufficient numbers of F1 animals are available for breeding. This does not include time needed for the adaptation of existing facilities and expansion of breeding and housing capacity.




No The main macaque breeders are in Mauritius, Philippines. China and Israel. These breeders take animals captured from the wild and breed them, selling the offspring (the F1 captive bred generation). To create a supply of F2 animals the breeders would either have to substantially reduce their sales of F1 animals so they can breed them or substantially increase the number of animals taken from the wild, neither of which they want to do. There is a high world demand for purpose-bred macaques, particularly from the USA. Since these breeders can sell all the F1 animals they breed to buyers in the USA, they have not shown any particular interest in breeding F2 animals. The size of the EU market for purpose-bred macaques is not large enough to make it likely that the breeders could be persuaded to create an F2 supply.







Yes As for 2.1





The premise is false

185



National yes see above reference



National yes Neither five nor ten years is sufficient to establish enough breeding colonies and breed enough F2 animals. One has to keep in mind that only a few EU Member States host a Primate Centre.









The examples of USA and the UK both indicate that supplies will be affected and costs will significantly rise. The time to eastablish a breeding colony of, say, macaques, to provide adult animals of 3-4 years of age may exceed the 5 years allowed.

Bayer HealthCare



2.2 Five years is not enough to establish enough breeding colonies and breed enough F2 animals. This assessment does not take account of - difficulty to establish breeding facilities - difficulty to produce enough animals of given quality Reference document: http://www.felasa.org/Documents/primstat.rtf.



Worldwide yes This assumption is not realistic. We already experience shortage in the supply of F1 animals.

186



Without an effective analysis this timescale should not be just a guess. There should be a systemic EU analysis such as done in the US: http://www.nap.edu/catalog/10774.html


Worldwide Yes 5 years are not enough because the breeding facilities need more time and space to assess colonies. Please note that the Breeding Center are now requiring Industries to make a reservations 1 year in advance and sometimes they are not able to supply the planned number. In addition as you have F1 parents bred, you have to imagine the spread of behavioural changes and the increase of some diseases as enteric problems link to the fighting in a stress condition. The breeding Center, as large they are, take the NHP in different conditions from the wild.




Five years is not enough to establish enough breeding colonies and breed enough F2 animals. This assessment does not take account of - difficulty to establish breeding facilities - difficulty to produce enough animals of given quality Reference document: NHP users briefing paper on F2

sanofi pasteur R&D


Worldwide Vaccine field See section 2.3 for details; 5 years is the time needed for a baby to be mature. And no reproducers are available on the market.



National yes The time period is to short for building up breeding colonies, check the biological data in the introduction part before.

187





5 years is totally inadequate. It will be necessary to set up breeding facilities and then have enough time for build up of sexually mature stock in sufficient numbers to supply research demands.



Worldwide Yes With reference to the issues in the section above, 5 years would be too short a period to be confident that all the issues can be resolved.




Five years is not enough to establish enough breeding colonies and breed enough F2 animals. This assessment does not take account of - difficulty to establish breeding facilities - difficulty to produce enough animals of given quality Reference document: NHP users briefing paper on F2.



Worldwide Yes Even today, supply situation for monkeys is sometimes difficult with a transient shortage of monkey supply. Since research activities in the Asian region are increasing (e.g. China) and more monkeys are consumed there, a rise in production will even be necessary to fulfil the demand for monkeys in research. Having to increase production of breeders may result in a significant shortage of animals and a significant increase in costs. As the breeding colonies will have to be extended to allow production of enough F2 generation NHP for EU, the costs of monkeys in EU should anyway increase, as production costs will increase.




The management of such a system will take more than 5 years: need growing of animals, new facilities, financial support, …




A period of 5 years is too short

188



National; Worldwide

yes If we ever find a benefit to the exclusive use of F2 animals, for the reasons commented above, 5 years is NOT enough to establish breeding colonies that could breed enough F2 animals. It is a very long, complex expensive process with major administrative issues. The creation of F2 breeding stations will create a short-term shortage with no benefit both for animal welfare and for research…



European Representitive additional animals would need to be set aside for future breeders, making a short term shortage, and so a 10 year transition may be more realistic. The costs of these animals will also escalate, as I expect the housing guidlines will be revised in the future anyway, reuiring larger pens for improved welfare.












Worldwide yes Five years ist too short




The five year period is unrealistic given the generation time in the macaque species and that management of F1 breeders has been difficult. The experience in the UK with F1 breeders and the long transition time appears to have not been considered. The preliminary finding does not appear to have consulted with the relevant experts.

189



Worldwide No Currently available information from one of the most commonly used suppliers of macaques have indicated their results to date show that a period of at least 10 years will be required to supply the UK alone, not counting the rest of the EU. There will be additional costs in setting aside and housing additional animals for breeding which would normally be sold. Also costs to the breeder from lost sales of animals retained for breeding. These would need to be passed on to users in more expensive F2 animals. There may also be a shortage of supply to users, as animals are retained by the breeder.




Yes En raison du cycle de vie des primates non humains et de la lourdeur des investissements requis par les établissements d’élevage, une période de transition de 5 ans apparaît clairement insuffisante pour permettre au marché de se structurer.




Five years is not long enough to establish enough breeding colonies and breed enough F2 animals. The proposal does not reflect the difficulties of establishing breeding facilities and of producing enough animals of given quality. To hurry these processes would have serious immediate consequences to research and to animal welfare (eg inbreeding) in the future




5 years might be too short



Worldwide yes Five years is not enough to establish enough breeding colonies and breed enough F2 animals. This assessment does not take account of - difficulty to establish breeding facilities - difficulty to produce enough animals of given quality Reference document: NHP users briefing paper on F2.



Worldwide Yes 10 yeras seems more realistic, depending on the numbers of F1 used by the US. Limited available F1 generation would hamper the breeding of sufficient F2.

190








Worldwide Representative Five years is a too optimisic and unrealisti period, considering the time necessary to establish new breeding facilities in EU, and the reduced productivity in captivity.



Worldwide yes Five years is not long enough to establish enough breeding colonies and breed enough F2 animals. The proposal does not reflect the difficulties of establishing breeding facilities and of producing enough animals of given quality. To hurry these processes would have serious immediate consequences to research and to animal welfare ( eg inbreeding) in the future.



Worldwide yes Five years is not enough to establish enough breeding colonies and breed enough F2 animals. This assessment does not take account of - difficulty to establish breeding facilities - difficulty to produce enough animals of given quality




This is for sure much too short!

191







Worldwide yes This period does not consider planning and investments and the need to establish productive colonies



National representative Five years is not enough to establish enough breeding colonies and breed enough F2 animals. This assessment does not take account of - difficulty to establish breeding facilities - difficulty to produce enough animals of given quality Reference document: http://www.felasa.org/Documents/primstat.rtf.



Worldwide YES Unrealistic - the transitional period should be 15 years.




With reference to the issues in the section above, 5 years would be too short a period to be confident that all the issues can be resolved.

Coenraad F.M.Hendriksen

Public authority National at the national level: yes

Transition period is too short considering the gestation period of the animals and the time needed for up-scaling of the breeding colony.




see comment above concerning the sole use of F2. In addition, 5 years are too short.

192






Public authority Local yes Neither five nor ten years is sufficient to establish enough breeding colonies and breed enough F2 animals. One has to keep in mind that only a few EU Member States host a Primate Centre.


Public authority Local yes Neither five nor ten years is sufficient to establish enough breeding colonies and breed enough F2 animals. One has to keep in mind that only a few EU Member States host a Primate Centre.


Public authority Local; Regional no given the long reproduction period, time should be 10 years or more.



The statement at VI.c) that almost all of the macaques recorded in 2002 were F2 purpose-bred is wrong. They are typically F1+. A proposed gradual move to requiring the acquisition and use of only F2+, even allowing for a prolonged transition period, is impractical and would promote the active displacement of this and other aspects of pharmaceutical research and development to outside the EU.



see 2.4

193


Public authority National Ministry of VWS is also involved

might be a bit short F2 often needs to be mature before being introduced into experiments




See comment 2.3


Public authority National representative Neither five nor ten years is sufficient to establish enough breeding colonies and breed enough F2 animals. One has to keep in mind that only a few EU Member States host a Primate Centre.





194



John Mellerio Other National no No: I feel this time would be too short in comparison to the breeding cycle and time for maturity of individual animals.




see Option 1: 1.8


Other National Representative The question is predicated on erroneous information about the number of F2 animals. The NC3Rs would support a gradual move to use of only second or later generation purpose-bred non-human primates, but is disappointed that the data on which to decide a realistic transitional period has not been provided here.



The proposed transitional period will not allow most breeding facilities to meet the demands. Generation times of NHP are slow. If the EU wishes to rely totally on the use of purpose bred F2 animals, the breeding centers have to expand.

195



Since F1 NHPs can be sold easily to other countries outside the EU breeding facilities will not produce F2 animals for the sake of EU. Therefore the EU should establish its own NHP breeding center which surely will take a longer period.


Other Not applicable other see comment 1.1.


Other National Yes Feedback from companies indicates that five years would not be sufficient to establish breeding colonies and breed a sufficient number of F2 NHPs.


Other Not applicable not applicable Five years is not enough to establish enough breeding colonies and breed enough F2 animals. This assessment does not take account of - difficulty to establish breeding facilities - difficulty to produce enough animals of a given quality Reference document: NHP users briefing paper on F2.




196




Due to biological reasons it needs more than five years to rise production on NHPs (macaques) to the level which is required in Europe.


Other National Yes The concern is that at this time a significant number of F1s are being used and 5 years would be too short a time period to phase out valuable animals.



A transition period of 10 years will be the minimum to meet the current demands. Even more preferable would be no obligation to use F2 animals. F1 animals bred in captivity should continue to be used in research. A small number of new animals caught in the wild will be necessary to keep an optimal genetic diversity in the colonies. This will not jeopardize the species at all, since macaque monkeys are abundant in many countries.

197


Other European yes Feedback from companies makes clear that five years is insufficient to establish breeding colonies and breed enough F2 NHPs.




see points in 2.1 above







The preliminary assessment is accurate but we do not support a transition period of 5 years. Some overseas breeding centres are already changing, or have already changed, their policy in this direction. These centres have set target dates by which they will stop taking feral animals and/or will retain more F1 animals as breeding stock. This change will happen much faster if the EU as a whole requests it, rather than just the UK. The need to improve the welfare of MHPs is very urgent and should over-ride perceived negative impacts, which we think are over-estimated.

198




This figure is unrealistic and does not take account of the physiology of breeding. Even where F1 breeding animals are available, a minimum time of 8 years is required, 13 years if starting with F0 (5 years to sexual maturity + 0.5 years for gestation + 5 years for sexual maturity of F1 + 0.5 years for gestation + 2 years to age of usage). Taking into account the need for enlargement and construction of new facilities, 15 years would be the absolute minimum. It should also be stressed that demand for certain species is so low as to make purpose-breeding non-viable, and specific exemptions to any requirement for F2 use would be essential. See FELASA statement on use of NHPs on http://www.felasa.org.



National; European


PETA Europe Ltd.


Worldwide both Please see response to 2.1 above.

199



National; European







The NAVS believes that the suppliers of NHPs (in particular macaques) have had a very long period to address this issue. India banned the export of wild caught primates in 1978 because of the immense suffering and devastation of local populations. Since then there have been continuous calls to end the use of wild caught primates. The UK ban has been in place since 1995. A transitional period will merely delay rather than drive a change.





200

The Royal Society







Since the estimate of current use of F2 animals is incorrect it would be impossible to move to a total sourcing of second generation within 5 years.

201








both Please see response to 2.1 above







No F2 animal is available today. Fifteen years are needed for transition. During that period, there will be a decrease in the availability of F1 animals.



National YES 5 years will not be enough.

202











National yes Five years is not enough to establish enough breeding colonies and breed enough F2 animals.



Worldwide The field at the respective activity level

No, is not possible in the period, 5 years,to have all NHP F-2


Breeder of animals

Worldwide yes Statistical data regarding F2 are incorrect. The number of F2 currently available is negligible. To attain the same level of supply with F2 instead of F1, a transitional period of 15 years is required to XXX


Breeder of animals


Given the reproductive information and the small number of progeny produced per year, simple breeding calculations would suggest that the stated goal cannot be achieved in five years but rather would take ten years or more.


Breeder of animals

Worldwide Yes Background info above is totally erroneous concerning % of F2 in use to-day in the EU.See above about problems re breeding with F1 macaques.

203


National Representative The main macaque breeders take animals captured from the wild and breed them, selling the offspring. These breeders can sell all the F1 animals they breed to buyers in the USA. The size of the EU market for purpose-bred macaques is comparatively small and it may be difficult to persuade breeders to create an F2 supply. It is important that there is a supply of NHPs to allow work to research to continue within the EU, and this must be balanced with the significant welfare arguments for moving to F2s. BBSRC supports the principle of encouraging the use of captive bred rather than wild caught primates. Any new regulation must balance the welfare advantages of mandatory use of F2s against the research need for a supply. We recommend a 10 year transition period.


National; European


5 years is inadequate for the establishment of breeding colonies to produce sufficient F2.



this position is taken owing to the flawed premise (namely that most Macaques are F2s)


Local representative Five years is not enough to establish enough breeding colonies and breed enough F2 animals.




Five years is not enough to establish enough breeding colonies and breed enough F2 animals.

204

Question VI.2.3.

Question text:

Statistics:




Comments received:





VI.2.3a.

Transitional period of 10 years Preliminary assessment: 0 A transitional period of 10 years should allow all breeding facilities to rise their production and provide enough F2 animals to users even if demand rises significantly during this period. Additional costs should not occur. Do you support the preliminary findings? Yes/No/ No opinion

205




See comments on 2.2 above. A transitional period of 10 years is insufficient for the same reasons.





206














207




XXX See 2.4




Yes For reasons given earlier a transition to F2 does not at present appear possible.




No F2 animal is available today. Fifteen years are needed for transition. During that time, there will be a decrease in the availability of F1 animals.



Worldwide there are others Most of the NHPs in biomedical research are F1 purpose-bred. To improve the situation (F2 macaques) and to be independent from imported macaques, the European Union should support existing breeding colonies which are keeping laboratory animals under controlled conditions with well documented history, health status and defined genetic background. The increase of a sufficient animal provision within the EU needs more than ten years and is accompanied by high costs for necessary facilities with adequate infrastructure.



National representative The guidelines have to be accompanied by establishing sufficient primate breeding facilities in Europe




There is considerable doubt whether this would be appropriate. The judgement of those researchers affected should be taken serious.

208





see 1.1




Yes If F1 animals are currently supplied, then additional breeding stocks from F1 progeny will be required to produce the desired F2 animals




See 2.2




No The main macaque breeders are in Mauritius, Philippines. China and Israel. These breeders take animals captured from the wild and breed them, selling the offspring (the F1 captive bred generation). To create a supply of F2 animals the breeders would either have to substantially reduce their sales of F1 animals so they can breed them or substantially increase the number of animals taken from the wild, neither of which they want to do. There is a high world demand for purpose-bred macaques, particularly from the USA. Since these breeders can sell all the F1 animals they breed to buyers in the USA, they have not shown any particular interest in breeding F2 animals. The size of the EU market for purpose-bred macaques is not large enough to make it likely that the breeders could be persuaded to create an F2 supply.




209



National yes See precedent observation on F2 macaques. Around 5000 macaques are used per year. Assuming 0,8 new-born per female, sexual maturity around 4 years old and 10% of these animals dedicated to self-renewal of breeders, the genitors population must be around 7000 F1 female breeder usable at the start of transitional period. In all other case, this decision conducts to a shortage and an increase of the cost of animals. Wild-caught animals are commercialized around 1800 €, captive bred are at 2500 €, the additional cost is 700 € per animal (40% increase).





The premise is false.



National yes see above reference











yes Ten years is a long period of time in the context os setting up a captive breeding program for primates and would alloe to much feet dragging by member states. The welfare considerations of primate research requires urgent attention not a delay of several years.

Bayer HealthCare



2.3 The need to set a significant part of the current F1 animals for breeding purposes will immediately worsen the current shortage in supply. Cost will increase in any case.

210



Worldwide yes This assumption is not realistic either. For macaques, reproductive age may start as late as 4-6 years of age plus a 6 months pregnancy time plus again 4-6 years for next round or reproduction. It is hard to envisage how a self-sustaining number of F” animals can be produced within 10 years.



Without an effective analysis this timescale should not be just a guess. There should be a systemic EU analysis such as done in the US: http://www.nap.edu/catalog/10774.html


Worldwide Yes See 2.2. In addition nothe that both(Industries or Breeding center) can invest for a long time in this unusual business. Only States o EC could invest a project like this to help the European research.




See above. The need to set a significant part of the current F1 animals for breeding purposes will immediately worsen the current shortage in supply. Costs will increase in any case.

211

sanofi pasteur R&D


Worldwide Vaccine field It is very long to create a breeding colony; 10 years is not enough. In the FELASA statement, primate experts estimated not less than 15 years are required. To get mature F1 reproducers (not available on the market) is estimated to minimum 5 to 10 years for macaques cynomolgus. Much longer for other species. First litters are usually lost. Animals could be used not before the age of 2 years old. To supply macaque needs for Europe, an estimate of 15,000 females was done. When adding the males and the young primates before being available, the colony size should be around 40,000 macaques. No breeding facilities are available in Europe. For less used species, the proposal will obliged to maintain large colonies for a small market. The price of the primates will not be competitive in comparison with US or Japan.



National yes Could be that the period of 10 years will be long enough to built up the needed breeding capacity. But there is the danger that the number of animals kept in captivity will arise and additional will arise the number of animals who cannot used in experiments (retired breeders, wrong sex..) so I decline the ban of wild-caught of NHP.



European Yes 5 years is enough time for both public and private scintific spheres to arrange the continuity of ongoing projects and next steps in planned project. After crucial 5 year, an additional 5 or 15 years would not make huge difference since all the main steps would have been already taken and the system has been rearranged accordingly.





Se 2.2



Worldwide Yes Ten years is a more realistic transitional period, but we still believe there are too many uncertainties to be sure it is achievable.

212




See above. The need to set a significant part of the current F1 animals for breeding purposes will immediately worsen the current shortage in supply. Cost will increase in any case.



Worldwide Yes actually yes but costs yill increase substantially




Same problems occurs and F1 generation already works well today: no need to change




A period of 10 years is too short



National; Worldwide

yes If we ever find a benefit to the exclusive use of F2 animals, for the reasons commented above, 10 years is a more reasonable timing to start breeding F2 animals… BUT it is still a very long, complex expensive process with major administrative issues… AND the creation of F2 breeding stations will create a short-term shortage with no benefit both for animal welfare and for research…



European Representitive additional costs will occur due to the reduced competition.





213





The need to set a significant part of the current F1 animals for breeding purposes will immediately worsen the current shortage in supply. Cost will increase in any case.




There are many technical and management questions which must be answered before even a 10 year period could be properly assessed as reasonable. The generation time in macaque species means that at least a 10 year period would be required and there would be little time to adapt if expansion of the F1 breedstock was not successful.



Worldwide No Same answers as for 2.2 above




Ten years is not long enough to establish enough breeding colonies and breed enough F2 animals. The proposal does not reflect the difficulties of establishing breeding facilities and of producing enough animals of given quality. To hurry these processes would have serious immediate consequences to research and to animal welfare (eg inbreeding) in the future. The need to set a significant part of the current F1 animals for breeding purposes will immediately worsen the current shortage in supply. Cost will increase in any case.



Worldwide yes See above. The need to set a significant part of the current F1 animals for breeding purposes will immediately worsen the current shortage in supply. Cost will increase in any case.






214



Worldwide Representative Although a period of ten year would allow the generation of a quite large number of F1 (and F2 ??) animals, the prediction does not consider possible needs for new emerging diseases.










See 2.4







Worldwide yes But this would still not solve the questionable biodiversity and decrease in reproductivity

215



Worldwide Yes With respect to long reproduction cycles of some species, transition time should be longer.



National representative The need to set a significant part of the current F1 animals for breeding purposes will immediately worsen the current shortage in supply. Cost will increase in any case.



Worldwide YES Still unrealistic - the transitional period should be 15years.




Ten years is a more realistic transitional period, but we still believe there are too many uncertainties to be sure it is achievable.

216



This may be a fair reflection for some breeding facilities and not for others. The evidence provided is not sufficient to make a judgment.





217



The statement at VI.c) that almost all of the macaques recorded in 2002 were F2 purpose-bred is wrong. The majority are F1+. A proposed gradual move to requiring the acquisition and use of only F2+, even allowing for a prolonged transition period, is impractical and would promote the active displacement of this and other aspects of pharmaceutical research and development to outside the EU.



see 2.4



This might also be a bit short. This needs to be addressed by the users and breeders.




Neither five nor ten years is sufficient to establish enough breeding colonies and breed enough F2 animals. One has to keep in mind that only few Member States host a Primate Centre. There may be serious limits for breeders to fulfil delivery demands due to animal rights extremists.


Public authority National representative Neither five nor ten years is sufficient to establish enough breeding colonies and breed enough F2 animals. One has to keep in mind that only a few EU Member States host a Primate Centre.

218










see Option 1: 1.8



See above. Ten years may be enough but the costs are quite large(establishing the NHP breeding center).


Other Not applicable other see comment 1.1

219


Other National Yes A significant proportion of current F1 NHPs would need to be allocated for breeding purposes, with the result that the current shortage would immediately be made worse. Costs would undoubtedly occur.


Other Worldwide - 5 years should be sufficient as most countries are already along this road.







Most of the macaques in biomedical research are F1 purpose-bred. In order to improve the situation (F2 macaques) and to be independent from imported macaques, the European Union should support existing breeding colonies which are keeping laboratory animals under controled conditions with well documented history, health status and defined genetic background. The increase of a sufficient animal provision within the EU needs more than ten years and is accompanied by high costs for necessary facilities with adequate infrastructure.

220


Other National There are other similar organisations

The welfare of primates is an important issue and definitely the F2 generation should be the goal. Most probably there is a need for a transitional period, which should not, however, be too long. Thus, 5 years period should be reasonable long.


Other European yes A significant part of the current F1 NHPs would need to be set aside for breeding purposes, so the current shortage would immediately be made worse. Costs would certainly occur.




see points in 2.1 above







The preliminary assessment is accurate but we do not support a transition period of 10 years. Some overseas breeding centres are already changing, or have already changed, their policy in this direction. These centres have set target dates by which they will stop taking feral animals and/or will retain more F1 animals as breeding stock. This change will happen much faster if the EU as a whole requests it, rather than just the UK. The need to improve the welfare of MHPs is very urgent and should over-ride perceived negative impacts, which we think are over-estimated.

221




See comments on 2.2 above. A transitional period of 10 years is insufficient for the same reasons.



National; European


PETA Europe Ltd.


Worldwide both Please see response to 2.1 above.




There should be no reason for such a long transitional period.

222



National; European







The NAVS believes that the suppliers of NHPs (in particular macaques) have had a very long period to address this issue. India banned the export of wild caught primates in 1978 because of the immense suffering and devastation of local populations. Since then there have been continuous calls to end the use of wild caught primates. The UK ban has been in place since 1995. A transitional period will merely delay rather than drive a change.





223

The Royal Society







See 2.2 above.

224








both Please see response to 2.1 above






Worldwide Yes Government and industry should be working aggressively to end the use of NHPs for biomedical research and testing—thus, an argument of increasing demand should not be used, especially to drive policy decisions




See 2.2

225



National YES 10 years will not be enough.











National yes Ten years is not enough to establish enough breeding colonies and breed enough F2 animals. One has to keep in mind that only a few EU Member States host a Primate Centre. Feasibility, usefulness and impact in the long term of a requirement for using only F2 animals from the welfare, science, health, conservation and environmental perspective is still to be assessed. This will take 10 – 15 years.


Breeder of animals



Breeder of animals

Worldwide Yes 10 years is more realistic but would still be a difficult target given the problems encountered so far in breeding with F1 macaques.


National; European


Increased numbers of F1 required for breeding to produce F2 will exacerbate a shortage of animals.

226


Local representative Ten years is not enough to establish enough breeding colonies and breed enough F2 animals. One has to keep in mind that only a few EU Member States host a Primate Centre. Feasibility, usefulness and impact in the long term of a requirement for using only F2 animals from the welfare, science, health, conservation and environmental perspective is still to be assessed. This will take 10 – 15 years




Ten years is not enough to establish enough breeding colonies and breed enough F2 animals. One has to keep in mind that only a few EU Member States host a Primate Centre. Feasibility, usefulness and impact in the long term of a requirement for using only F2 animals from the welfare, science, health, conservation and environmental perspective is still to be assessed. This will take 10 – 15 years

227

Question VI.2.4.



Comments received:





VI.2.4. Justificattion




Prof Alan Palmer







Not enough special knowledge for this topic

228








XXX See 1.8 for challenge to the assumption that 90% of NHPs are F2 purpose bred. Even with a 10 year transition period, it is unlikely that overseas breeders would bother to adapt to supplying the EU with only F2 NHPs. Unless there is a definite resolution to this situation, implementing the F2 regulation would have very serious detrimental effects, however desirable it may be to minimise the catching of wild NHPs. Further, it is our understanding that many wild NHPs of non-threatened species used in research are anyway caught or culled to protect local agriculture.





The EU should consider setting up a primate supplying organisation, that could be run commercially as is done privately now. But they would be able to regulate supply and provide a centre of excellence in the same way that the regional primate centres in the USA do today




Nobody would argue about applying highest ethical standards for using NHPs, but it is also clear to virtually all medical and biological scientists that such experiments are needed and justified. “Public opinion” is of limited value in this context, since public opinion cannot entirely judge the value of the scientific situation requiring such experiment.





Do not have sufficient knowledge of this area. However, our information is that the statement that most NHPs are F2 is flawed. Our understanding is that most are F1 and that breeders currently supply all they can breed. If a restriction of non-human primate research to second-generation animals is indeed taken into consideration it is essential that the EU must also help to etsblish enough breeding facilities in order not to jeopardise European primate research

229



Regional yes If a restriction of non-human primate research to F2 animals is indeed taken into consideration it is essential that the EU must also help to etsblish enough breeding facilities in order not to jeopardise European primate research.




Yes The majority of macaques curretnly used are F1s, not F2s.




Yes This position is taken because macaque use is largely of F2 animals.





The premise is false. The EU is misinformed about the position on F2 animals.




Bayer HealthCare



Reference documents: 1) http://www.efpia.org/2_indust/useofprimates2004.pdf 2) http://ec.europa.eu/food/fs/sc/ssc/out253_en.pdf 3) http://portail.unice.fr/jahia/webdav/site/myjahiasite/users/guy_n/public/Reglementation/Directive%2086-609-CEE%20Revision%202005.pdf

230



Proposals in this area are based on serious factual errors and poor policy analysis. This is a serious deficiency for what is an issue with major public health implications. Most such animals are F1 and they are not from endangered species. F1 animals are often from parents that would either be captured or killed to protect agriculture or biodiversity. There is no evidence that welfare is not assured by the current Directive. Use of wild caught primates, as opposed to breeding, already requires special justification. There is no need to change current controls.




A transition period of 15 years will probably be needed: http://www.felasa.org/Documents/Policy_statements/primstat.doc



National yes Before taking into account the total ban of wild-caught NHP an objective cost-benefit analysis should be done, the number of caught wildlife in opposition to expected number of animals kept in breeding facilities, the costs of implementation, the research handicap in combination with possible transfers outside EU countries.





The proposition has been made without taking into account the breeding logistics of acquiring a breeding population, breeding s F1 stock and then start producing animals for research. I estimate that this could take as long 15 to 20 years. In the interim European Research would be severely hampered!. Taking into account the current global breeding and supply situation and the very limited number of F2 generation primates (except Marmosets which have been bred in closed colonies for several generations and for which much more experience is available), a potential requirement for using only F2 animals would have a dramatic impact in the short term on the availability of such animals for academic, government, EU and industrial research programmes in Europe.

231




Reference documents: 1) EFPIA briefing paper on NHP in biomedical research 2) NHP users roundtable paper on shortage of supply 3) NHP users roundtable document on F2




Sufficient provision of F2 monkeys in Eurpe needs more than 10 years, and the necessary facilities would cause very high costs. Instead existing breeding colonies for F1 macaques with a high standard outside the EU should be supported.



National; Worldwide

yes Please, refer to the EFPIA paper on use of NHP in pharmaceutical research http://www.efpia.org/2_indust/useofprimates2004.pdf




- In this limited number of cases, only animals bred in captivity should be used except in cases where no valid alternative is available for essential research programmes. - The capture of animals from the wild for breeding purposes should be strictly controlled by local authorities and be limited to cases where it does not put the concerned species into danger. The current European legislation already provides sufficient provisions to ensure such limitations. - Short or medium term ban of F1 would be very disadvantageous and unwise for all the reasons/ facts mentioned in this paper. - Feasibility, usefulness and impact in the long term of a requirement for using only F2 animals from the welfare, science, health, conservation and environmental perspective is still to be assessed. This will take 10 – 15 years. Any immediate unilateral legislation to exclude the use of the F1 generation would interfere with these initiated projects and do more harm than good.

232





Offspring of the newly born F1 generation would not be available for research purpose before 8 to 10 years. The use of non-human primates for experimental purposes should be strictly limited to cases where the use of in vitro methods and other animal models are of insufficient value. In this limited number of cases, only animals bred in captivity should be used except in cases where no valid alternative is available for essential research programmes. The capture of animals from the wild for breeding purposes should be strictly controlled by local authorities and be limited to cases where it does not put the concerned species into danger. The current European legislation already provides sufficient provisions to ensure such limitations. Feasibility, usefulness and impact in the long term of a requirement for using only F2 animals from the welfare, science, health, conservation and environmental perspective is still to be assessed. This will take 10 – 15 years.



Worldwide No The initial sentence in option re 10% figure of non-F2 animals is inaccurate – should be much higher. -Primates should be used where scientifically justified. Wild caught animals should not be used in experiments without specific and exceptional justification as approved by the national authority. -The capture of animals from the wild for breeding purposes remains necessary for the time being, but should be controlled by authorities in the source countries, with an appropriate training programme and guiadance for those involved in the capture process. -Short or medium term ban on use of F1 would cause a massive loss of primate work from the EU, and transfer to other countires where husbandry and housing conditions will be no better and may well be considerably worse. For example the US requirements for primate housing (NRC Guide for the Care and Use of Laboratory Animals) are considerably poorer than EU requirements as will be required according to the new Council of Europe ETS 123.




233




Requiring the use of F2 generations for research should be a long term aim. The legislation must provide a framework that facilititates the development of colonies to produce animals of F2 and subsequent generations for research, but without imposing a specified time – this must be flexible to accommodate individual difficulties as colonies are set up. Over time the need for the exceptions to be used will diminish




The use of non-human primates for experimental purposes should be strictly limited to cases where the use of in vitro methods and other animal models are of insufficient value. In this limited number of cases, only animals bred in captivity should be used except in cases where no valid alternative is available for essential research programmes. Strict control of capture by local authorities. Feasibility, usefulness and impact in the long term of a requirement for using only F2 animals from the welfare, science, health, conservation and environmental perspective is still to be assessed. This will take 10 – 15 years.



Worldwide yes Reference document: 1) EFPIA briefing paper on NHP http://www.efpia.org/2_indust/useofprimates2004.pdf Statement of expert group representing all stakeholders in NHP research field, i.e. European academia, Government institutes, pharmaceutical industry, contract research organizations (CROs), breeders & suppliers on proposals made by Technical Expert Working Group during the revision of the Directive 86/609/EEC to exclude the use of animals from the first generation born in captivity (F1) and only allow the use of animals from the second (F2) or other subsequent generations: -sufficient F1” animals not available before 8-10 years. -Use of primates=highly sensitive;only used when no other alternative:less than 0.1% of all experimental animals in EU. -if large part of the newborn F1 generation=set apart for breeding purposes,their offspring not available for research in less than 8-10 years (generation interval&time needed before young animals can be used in research programs).





No further comment

234



Worldwide Representative See the position paper issued by EFPIA: http://www.efpia.org/2_indust/useofprimates2004.pdf



Worldwide yes - We support the long term aim of requiring the use of F2 generations for research. Other animals ( wild caught, F!) should only be used by exception, The legislation must provide for this with a framework that facilititates the development of colonies to produce animals of F2 and subsequent generations for research , but without imposing a specified time – this must be flexible to accommodate individual difficulties as colonies are set up. Over time the need for the exceptions to be used will diminish.




For details please see the Round Table Position paper (already conveyed to Commission and Prognos before).




Statement of a group of experts representing all stakeholders in the NHP (Non Human Primates) research field, i.e. European academia, Government institutes, pharmaceutical industry, contract research organizations (CROs), breeders and suppliers on proposals made by a Technical Expert Working Group during the revision of the Directive 86/609/EEC to exclude the use of animals from the first generation born in captivity (F1) and only allow the use of animals from the second (F2) or other subsequent generations.



National representative Reference documents: 1) http://www.efpia.org/2_indust/useofprimates2004.pdf 2) http://ec.europa.eu/food/fs/sc/ssc/out253_en.pdf 3) http://portail.unice.fr/jahia/webdav/site/myjahiasite/users/guy_n/public/Reglementation/Directive%2086-609-CEE%20Revision%202005.pdf

235



Worldwide YES You forget that the majority of NHPs used in the EU today are F1, which explains that if F2 NHPs become mandatory, there will be a need for 15 year transitional period.



Worldwide There are any other relevant organisations but we are making research with rodents

I'm not enouhgt knowledge about non humats primats



Option 2: Transitional period: The Animal Procedures Committee supports a gradual move to use of only second (F2) or later generation purpose-bred non-human primates. See para. 6.1.3 in the document: Animal Procedures Committee (2006) Acceptance of overseas centres supplying non-human primates to UK laboratories - A report by the Primates Sub-Committee of the Animal Procedures Committee http://www.apc.gov.uk/reference/primate-sources-report.pdf

236



F2 purpose bred objective is a scientific and environmental nonsense (see before)


Public authority National XXX is central conpetent authority for approvel for the experiments and inspections animal protection

The Slovak republik does not used primates for experiment and in the SR is not breeding and supplying establishments for primates



yes Grave misconceptions - impossible to answer questions.



The statement at VI.c) that almost all of the macaques recorded in 2002 were F2 purpose-bred is wrong – they are typically F1+. Thus the analysis and options that follow are wrong. A proposed gradual move to requiring the acquisition and use of only F2+, even allowing for a prolonged transition period, is impractical and would promote the active displacement of this and other aspects of pharmaceutical research and development to outside the EU.



The figures quoted in the background are not accurate and assumptions that there is a desire to use macaques of F2 generation is wrong. The supply of NHPs is to a global market that generally does not have a restriction to F2s. Work will continue using the current supplies and may be driven to countries outwith Europe where housing and care standards are poorer. Must address the ethical issues within the correct context. Is establishment of closed colonies and captive breeding more welfare friendly and acceptable than capture and housing for breeding of animals considered vermin that could be starved, culled etc in the wild in their country of origin .

237



Yes, together with the National Food and Product safety Authority

2.3 With a reservation about if this transitional period will alow ALL breeding facilities to ries eteh rpoduction and provide enough F2 animals







Comment to 2.1: Yes. An immediate importation ban will kill 90% of the academic and industrial research programs in Europe. The existing breeding centers cannot breed the numbers of animals that are needed. Comment to 2.3: Yes. This is possible if the EU and/or the national governments support and allow expansion of the breeding centers.


Other Worldwide yes not in a position to provide a meaningful assessment of this]

TNO Quality of Life (The Netherlands)

Other National; Worldwide

Yes We have no experience with wild-caught NHPs, but we assume tha a transitional period of at least 5 years is necessary to obtain enough animals from supplier/breeders

238




As stated above, the financial and scientific impact of a ban on the use of wild-caught NHPs does not justify the implementation of a general transitional period. Additionally, any transitional period would reduce incentives to develop new non-animal test methods and to replace research with NHPs with such methods.




Our preference is for an immediate ban and we do not believe the negative impact of this would be as high as suggested. If an immediate ban is not enacted, we agree that 5 years for transition would guarantee supply, but it would have negative impacts on animal welfare and public concern. A 10-year transition is totally unacceptable: it would incur very heavy negative costs for animal welfare and public concern. In the UK, successive opinion polls consistently show more people opposed to primate experiments than in favour. A 10-year transition would inflame public opinion. Public campaigns against primate experiments would escalate and would possibly lead to otherwise unnecessary user expenditure on public relations measures and extra security arrangements. Such a delay might therefore increase public disquiet to the point that users might consider transferring their research to third countries.

PETA Europe Ltd.


Worldwide both In the absence of evidence for a present supply bottleneck, and given factors predicting future negative growth in demand as indicated above, we reject claims that any transitional period is warranted. There is an ethical imperative to end the use of primates in experimentation immediately. Barring that, the ban on the use of wild caught primates should be implemented immediately while measures to reduce (e.g. harmonisation) and replace the use of primates and other animals are promoted vigorously.

239




Many primate breeding centres in 3rd world countries are not self-sustaining and continue to draw heavily upon wild populations for replenishment and augmentation of breeding stock. This is totally irresponsible and unnecessary with proper planning so that sufficient F1 animals are retained for breeding to produce F2 offspring – if the EU Directive were to ban the use of wild-caught animals then such breeders would merely have to plan more carefully.





We would like to reiterate our position that irrespective of how short the transitional period, the welfare and biodiversity benefits of using ≥F2 primates are such that they would outweigh supply-related problems. We therefore call for this requirement to be made with the shortest possible transitional period, preferably with immediate effect.




Please refer to FELASA document on supply of F2 animals which provides a sound basis for understanding the introduction of purpose bred, F2 animals.

240




both In the absence of evidence for a present supply bottleneck, and given factors predicting future negative growth in demand as indicated above, we reject claims that any transitional period is warranted. There is an ethical imperative to end the use of primates in experimentation immediately. Barring that, the ban on the use of wild caught primates should be implemented immediately while measures to reduce (e.g. harmonisation) and replace the use of primates and other animals are promoted vigorously.



National YES The proposed transitional periods are unrealistic and do not take account of the physiology of breeding. In addition, taking into account the need for enlargement and construction of new facilities, 15 years would be the absolute minimum. It should also be stressed that demand for certain species is so low as to make purpose-breeding non-viable, and specific exemptions to any requirement for F2 use would be essential. To improve the situation (F2 macaques) and to be independent from imported macaques, the European Union should support existing breeding colonies which are keeping laboratory animals under controlled conditions with well documented history, health status and defined genetic background. The increase of a sufficient animal provision within the EU needs more than ten years and is accompanied by high costs for necessary facilities with adequate infrastructure.




Important that a sufficiently long transitional period be used consistent with the life-span of the animals involved. This could be as long as 15 years.



Regional Yes If a restriction of non-human primate research to second-generation animals is indeed taken into consideration it is essential that the EU must also help to etsblish enough breeding facilities in order not to jeopardise European primate research.

241



Worldwide - -



Worldwide yes Neither five nor ten years is sufficient to establish enough breeding colonies and breed enough F2 animals. One has to keep in mind that only a few EU Member States host a Primate Centre.


Breeder of animals



Breeder of animals


Given the reproductive information and the small number of progeny produced per year, simple breeding calculations would suggest that the stated goal cannot be achieved in five years but rather would take ten years or more.


National Representative BBSRC supports the view that member states should be encouraged to move towards using only F2 NHPs for research, as long as any new regulation takes into account the difficulties outlined above and recognises the time that achieving this goal might take. Interim measures, such as encouraging member states to only use breeding centres that have a clearly defined strategy to decrease reliance upon wild populations and move to the supply of F2 animals, may be helpful in achieving this goal. All BBSRC-funded researchers using rhesus macaques are required to obtain their animals from a breeding colony in the UK called the Centre for Macaques.

242

Question VI.3.1.

Question text:

Statistics:




Comments received:





VI.3.1a.

Elwin Rombouts User of animals -public sector

National; Worldwide

More relavant organisations, University, Biomedical Research

There are still some, though few, animal models without alternatives requiring great-apes. However due to the ever increasing concern about the use of these apes for animal experiments these models are getting fewer and fewer. Yet, for the models with out replacement might necessitate a transition period.

Preliminary assessment shows an overall positive impact of this element: The only real necessity for experiments with Great Apes is the development of treatments for new diseases that might occur. For this purpose, limited but well equipped centralised possibilities of research would be sufficient. Do you support this overall analysis? Yes/No/No opinion

243



at 3.1 to 3.5 No There is no need for a central facility. In case of a total ban such research will not be carried out at all.




There is no need for a central facility. In case of a total ban such research will not be carried out at all.






244




No. There is no need for a central facility. In case of a total ban such research will not be carried out at all.

KTL (National Public Health Institute)


National yes, in occupational health there is the Finnish Institute of Occupational Health

So you do not consider e.g psychological research important? This does not cause any harm to the animal.


Regional there are more Alternatives should be checked previous assuming this principle





Central facilities as such carry the inherent problem of self-running administration costs and lack of flexbility to respond to scientific demands.

245




Yes, guess so ... My opinion - as of today - is that Great Apes are not at all needed for ANY scientific purposes than those related to their own health and wellbeing.








A ban on the use of Great Apes limited to mandatory need for new disease does not add anything to Cites regulation. It is useless.



Worldwide there are others Detailed impacts




The current directive is already sufficient. Thus a further positive effect is doubtful.




This is a highly speculative statement.

246



Local yes Chimpanzees are also necessary for hepatitis C research. Because there are no animals available in Europe, this research can not be performed in the EU.





There is still important fundamental research to be conducted with Great Apes. For example, we will soon have a complete genome for several of the Great Apes, with the consequence that we will wish to probe for the associations of human language and seek the Great Ape phenotype associated with language-related genes in humans. These experiments are fundamental to understanding the nature of the human condition, but with this ban EU scientists would be prevented from taking part in this grand enterprise. The experiments are purely observational and behavioural in nature, requiring only the maintenance of groups of great apes in captivity in quasi-naturalistic conditions.



National yes There is no need for a central facility. In case of a total ban such research will not be carried out at all.

Bayer HealthCare



3.1 Current directive already provides for such a ban with exceptions. The very low number of great apes used in Europe proves that this provision is particularly well followed.


Worldwide Yes The number of Great Apes used in europe is very low and close to 0.




Current directive already provides for such a ban with exceptions. The very low number of great apes used in Europe proves that this provision is particularly well followed

247

sanofi pasteur R&D


Worldwide Vaccine field Great Apes are not anymore used in Europe. Regulations are already in place to limit and control the use of Great Apes if strictly required. No additional regulation is needed. A formal ban could lead to a lack of competitiveness and obliged European research to contract out (US) some sensitive research.



National yes There is no need for such a determination. It is just part of the current directive and the number of great apes used in Europe is extremely low.





The current directive already has a ban with exceptions. There is no need to reaffirm this.



Worldwide Yes Our understanding is that the Directive already allows for this position, so no change is actually required.




Current directive already provides for such a ban with exceptions. The very low number of great apes used in Europe proves that this provision is particularly well followed.



Worldwide Yes the number of great apes used in research in Europe is very little already and procedures on great apes are highly regulated



National; Worldwide

yes The Directive is already addressing this issue. Only a VERY few great apes are used in Europe. The use of great apes should be strictly regulated, not the facilities that could potentially use them in the future.

248












Worldwide yes Carrying out good science is not a matter of centralisation provided this will be done in compliance with all necessary conditions







Worldwide No With development of new diseases and new types of treatments, specific and exceptional justification to use great apes should continue to be possible to seek




The existing Directive provides for such a ban with exceptions and the provision is well followed.




Current directive already provides a ban with exceptions. Very low number of great apes used in Europe shows that this provision is well followed.

249



Worldwide yes Current directive already provides for such a ban with exceptions. The very low number of great apes used in Europe proves that this provision is particularly well followed.



Worldwide yes The existing Directive provides for such a ban with exceptions and the provision is well followed.



Worldwide yes Current directive already provides for such a ban with exceptions. The very low number of great apes used in Europe proves that this provision is particularly well followed.







Worldwide Yes The level of regulation on Great Apes is very high already and the numbers of animals used are extremely low.



National representative Current directive already provides for such a ban with exceptions. The very low number of great apes used in Europe proves that this provision is particularly well followed.




Our understanding is that the Directive already allows for this position, so no change is actually required.



using these animals in cognitive research without immediate applications and based on non invasive methods is also necessary

250




replace centralized by authorized

Swedish Animal Welfare Agency

Public authority National yes Using the EU definition of animals used for scientific purposes, Sweden has a total ban on the use of Great Apes. The Swedish Animal Welfare Agency therefore does not believe there is a need for limited exceptions from the ban. The unquestionable sentience of Great Apes makes justification of such research very difficult.


Public authority Local yes There is no need for a central facility. In case of a total ban such research will not be carried out at all.




Public authority Local; Regional no fundamental testing as, e.g., of cognitive abilities will further be necessary. But a limited number of well equipped facilities will be sufficient.



1. Research to conserve the species in question could also be considered a legitimate and justifiable use. 2. We would agree that only a very small number of specialist centres will ever be in a position to undertake this work.



For research on Hepatitis C the Chimp is the only animal model (when efficacy tests are performed) other diseases might be the same?

251


Public authority National representative There is no need for a central facility. In case of a total ban such research will not be carried out at all.


There is little evidence that primates provide effective models for human disease, especially since insufficient is usually known either of the human disease, or of its purported relation in primates, for a rational judgement to be made about how useful the primate model is likely to be.


Other European No Chimpanzees are also necessary for hepatitis C research. Because there are no animals available in Europe, this research can not be performed in the EU.

Cris Iles-Wright Other Not applicable Not applicable The use of Great Apes is not relevant to the study of human illness.




see Option 1: 1.8


Other Worldwide yes see 3.6 below

252


Other Not applicable other there are also current diseases, which need NHP e.g. spinal cord injury


Other National Yes The Directive already provides for such a ban with limited exceptions.


Other Not applicable not applicable Current directive already provides for such a ban with exceptions. The very low number of great apes used in Europe proves that this provision is particularly well followed.




Biomedical research is done only in chimpanzees. At the moment there are only a few research areas in which it is mandatory to use them in particular in hepatitis C research. This research is exclusively performed in the USA. The assumption that chimpanzees are necessary only for new diseases that might occur therefore is wrong. In current research the negative impact is high as no animals are available at the moment. It is difficult to estimate the impact for future research on unknown fields.


Other European yes The Directive already provides for such a ban with limited exceptions.

253




Eurogroup believes that for ethical, animal welfare and scientific reasons there should be a ban on the use of Great Apes, and we therefore agree that this option would have a positive impact. However, we strongly disagree that any exceptions should be allowed and that centralised facilities would be necessary. There is strong scientific evidence that the Great Apes have complex mental abilities similar in important ways to those of humans. This enhances their capacity for suffering to such an extent that it is unethical to confine them in laboratories and use them in research and testing no matter what the perceived benefit (Smith and Boyd, 2002). In our view, and that of the public we represent, there is no justification for performing procedures on Great Apes that would not be considered ethically acceptable on humans.




We cannot support this overall assessment because we believe it unethical to allow exceptions to a ban on great ape experiments. We support a total ban without exception & we believe this is true of EU citizens too (the European Coalition to End Animal Experiments has more than 1.1 million EU citizens as members). However, we do agree with the assessment of a ban having overall a very positive impact.

254




Research into conservation of the species (on which research is being conducted) should also be permissible.



National; European

Yes Chimpanzees are also necessary for hepatitis C research. Because there are no animals available in Europe, this research can not be performed in the EU.

255

PETA Europe Ltd.


Worldwide both We are fundamentally opposed to all animal experimentation on ethical grounds, including experiments on great apes. Many polls indicate that the majority of the public shares our sentiment. Given that chimpanzees from The Netherlands have been “retired” and that ape experimentation has been abandoned or is formally banned in EU countries, we find the suggestion that a centralized supply of great apes must be established for unknown future needs ethically disturbing. As noted in Section VIe, there are many biological and physiological differences between humans and chimpanzees despite their overall genomic similarity. Because of the risks inherent in using one species as a surrogate for another, as with the TGN1412 trial mentioned above, we advocate for the use of non-animal methods.




I see no necessity for using Great Apes, under any circumstances.



National; European


A total ban is the only way to go. And there are no such facilities in the EU and we shouldn't create those any more.

256





NAVS disagrees that research on GAs may be necessary for new human diseases as there are significant species differences(1). The cognitive & behavioural characteristics of GAs are such that it’s unethical to use them for research(2). The UK, Austria, the Netherlands and Sweden have all banned the use of Great Apes in research. Given the extremely small usage of GAs in the EU (none in 2002), the effect of an EU ban would be negligible, yet would send a powerful message to countries where it remains common, notably the US. The EU would be ill-equipped to house & care for GAs and the lack of scientific data and experience for comparison would further limit any possible value of the research. In the 1980s the US began large scale chimpanzee research to combat AIDS, but when the research took a different course were left with huge animal welfare and financial problems. 1 Nielsen&Bustamante (2005) PLOS Biology 3:976 2 Angela Eagle, House of Commons written answers, 5/2/2002




both We are fundamentally opposed to all animal experimentation on ethical grounds, including experiments on great apes. Many polls indicate that the majority of the public shares our sentiment. Given that chimpanzees from The Netherlands have been “retired” and that ape experimentation has been abandoned or is formally banned in EU countries, we find the suggestion that a centralized supply of great apes must be established for unknown future needs ethically disturbing. As noted in Section VIe, there are many biological and physiological differences between humans and chimpanzees despite their overall genomic similarity. Because of the risks inherent in using one species as a surrogate for another, as with the TGN1412 trial mentioned above, we advocate for the use of non-animal methods

257






Worldwide Yes Great apes should not be maintained in laboratories simply in an attempt to address an imagined future need. The use of great apes for HIV and Ebola research, for example, has largely failed—and these fall into the category of “new diseases” discussed here. Historical arguments regarding new diseases haven’t led to research breakthroughs that justify their use in laboratories and, further, do not justify maintaining a colony for future use. The costs (financial and ethical) far outweigh any benefits.







National YES Chimpanzees are also used for hepatitis C research, but not in Europe where they are unavailable.



National; European

zet is the national platform of Austria

Exceptions to a ban of the use of Great Apes for experiments are not acceptable. As under VI. b) it has been mentioned, there are already members of the EU which have a total ban and do not see the necessity of exceptions.




One other Why exceptions when Great Apes are especially sensitive to pain and suffering..

258



National yes Current directive already provides for such a ban with exceptions. The very low number of great apes used in Europe proves that this provision is particularly well followed.



Worldwide yes There is no need for a central facility. In case of a total ban such research will not be carried out at all.


National Representative BBSRC supports a ban on the use of great apes in research, and does not endorse the recommendation to set up a central facility for their use. Such a facility may lead to great apes being held for long periods in case they are needed, which is very undesirable. In addition, the costs of establishing a central facility would be high.


Local; National Yes Current directive already provides for such a ban with exceptions. The very low number of great apes used in Europe proves that this provision is particularly well followed.


National; European


The use of great apes is already banned under the current directive, unless in exceptional cases. There is therefore a very low number of animals used and a change to the directive is not needed.


Local representative Current directive already provides for such a ban with exceptions. The very low number of great apes used in Europe proves that this provision is particularly well followed.





259



There should be a total ban on the use of Great Apes. Even if a new disease arose it would be no more ethical to use Great Apes than to use humans.

260

Question VI.3.2.

Question text:

Statistics:




Comments received:





VI.3.2a.

Animal welfare: A ban on the use of Great Apes would have a positive effect on animal welfare as Great Apes are animals especially sensitive to pain and suffering. However the impact would be moderate since only a very limited number of Great Apes is used within the EU (see 1.c). Do you support the preliminary findings? Yes/No/ No opinion

261

Elwin Rombouts User of animals -public sector

National; Worldwide

More relavant organisations, University, Biomedical Research

Though I do support the aims of a ban and agree with an increase in welfare the statement that these animals are especially sensitive to pain and suffering is not correct. As we humans are a more closely related species it is easier for us to recognise their suffering and as such we tend to interpret this as the fact they are more sensitive to pain and suffer more.













262






Regional there are more That not question of how many apes suffer but if we are allowed to act in that way or not. Once again the principle of Responsibility towards sentient beings is forgotten in this assumption




Yes, guess so ... Please, see my response to 3.1a. The "positive effect on animal welfare", as stated, would be a kind of collective welfare more related the Animal Kingdom than to single animals (regardless of species), and I perfer to think of welfare (including absence of suffering) in relation to single animals.








XXX See justification.

263







Worldwide there are others To our knowledge, there are no experiments using chimpanzees in Europe. Therefore, no impact on animal welfare will result in a ban.




The number is already very limited and great apes are only being used in exceptional cases.



Not applicable yes There will be no positive effect on animal welfare. The idea that Great Apes are especially sensitive to pain and suffering has no scientific basis and seems to be based on anthropomorphic and emotional reasoning




Legislation on use of Great Apes is already restrictive. There is no need for a ban, which will cause problems if the necessity for research in new emerging diseases arrives.



Local yes There is an impact concerning new upcoming diseases. See also 3.1.

264




Bayer HealthCare



3.2 The impact will not be significant since very limited numbers of animals are concerned and procedures on great apes are highly regulated in order to reduce the suffering of the animals. Exceptional character of such research could be strengthened.


Worldwide Yes The public opinion requires ONLY to stop all experiments and doesn't care care about animals more or less sensitivie. What is the difference between a Rhesus and a Great Ape?




The impact will not be significant since very limited numbers of animals are concerned and procedures on Great Apes are highly regulated in order to reduce the suffering of the animals. Exceptional character of such research could be strengthened

sanofi pasteur R&D


Worldwide Vaccine field No great apes are used. Even if the number is very limited, the importance of these research programs for Europe is obvious and strategic.



National yes See 3.1 there is no further positive effect to expect, the use is regulated.





This is a value judgement. There is no difference between Great Apes and other apes in terms of pain and suffering. The issue here may be more of a cognitive ability of foresee and interpret pain and suffering. The current Directive is adequate.

265



Worldwide Yes The number of Great Apes used in the EU is very small, so any impact would also be small




The impact will not be significant since very limited number of animals are concerned and procedures on great apes are highly regulated in order to reduce the suffering of the animals. Exceptional character of such research could be strengthened.



Worldwide Yes the impact will not be significant as there is a limited number of animals concerned.



National; Worldwide

yes The impact will NOT be significant: the number is already very limited and is already very strictly controlled. A separate document could specifically address the use of great apes, showing that their use is already exceptional.












Worldwide yes The kind of science, which depends on Great Apes would be made impossible in EU, this is not a problem of quantity

266




If no animals are used currently, then there will be no welfare impact resulting from a ban.




Yes La Directive actuelle comporte déjà cette mesure, et le nombre de grands singes utilises dans la recherché étant déjà extrêmement réduit, l’impact serait négligeable.




The possibility of using Great Apes by exception must be maintained. The current position works well.



Worldwide yes The impact will not be significant since very limited number of animals are concerned and procedures on great apes are highly regulated in order to reduce the suffering of the animals. Exceptional character of such research could be strengthened.



Worldwide yes The possibility of using Great Apes by exception must be maintained. The current position works well.



Worldwide yes The impact will not be significant since very limited number of animals are concerned and procedures on great apes are highly regulated in order to reduce the suffering of the animals. Exceptional character of such research could be strengthened.





267



Worldwide Yes The level of regulation on Great Apes is very high already.



National representative The impact will not be significant since very limited numbers of animals are concerned and procedures on great apes are highly regulated in order to reduce the suffering of the animals. Exceptional character of such research could be strengthened.




The number of Great Apes used in the EU is very small, so any impact would also be small.




Wrong wording; not a ban should be passed but a very restricted authorization.







They are seldom used and never and never, under terms of the current Directive, without exceptional justification.

268




Other European No There is an impact concerning new upcoming diseases. See also 3.1.




see Option 1: 1.8






Other National Yes There would be an insignificant impact as a very limited number of great apes are used in Europe and such research is very highly regulated.

269


Other Not applicable not applicable The impact will not be significant since very limited number of animals are concerned and procedures on great apes are highly regulated in order to reduce the suffering of the animals. Exceptional character of such research could be strengthened




To our knowledge, there are no experiments using chimpanzees in Europe. Therefore, a ban has no impact on animal welfare. It can be only proposed and will have negative impacts on research.


Other European yes There would not be a significant impact as a very limited number of great apes are used in Europe and such research is very highly regulated.



National; European

Yes There is an impact concerning new upcoming diseases. See also 3.1.

270



National; European


All animals are sensitive to pain and suffering not only great apes





The NAVS strongly supports the suggested ban on the use of Great Apes, and would like to argue for a +++ grading here, in recognition of the particular sensitivity of GAs to pain and suffering. That only a few GAs are used in research each year does not mitigate the distress inflicted on those unfortunate few, which, owing to their complex cognitive and behavioural characteristics, may be more severe than for less advanced animals. It is morally unacceptable to subject beings at this level of sentience and sapience to the treatments involved in invasive research. The benefits of protecting them from it should thus be recognised accordingly. The limited use of great apes in EU facilities means now is a good time for such a move, not merely for welfare reasons but for the practical reasons outlined in 3.1. It also means that the use of other NHPs can be addressed with greater clarity and urgency and that such a welfare measure would be a positive influence elsewhere in the world.




271




See 3.1



National YES There are no experiments using chimpanzees in Europe. Therefore, no impact on animal welfare will result in a ban.







National yes For the past 15 years great apes have not been used for experimental purposes in Germany. In the EU the use of them is highly regulated in order to reduce the suffering of the animals.





Breeder of animals


The statement on Item 3.2 suggesting Great Apes are especially sensitive to pain and suffering—presumably more than other nonhuman primates or for that matter other species—is not supported by scientific evidence. Given their great physical similarly and behavioral similarity in many respects to humans, it is easier to anthropomorphize/relate to these species as compared to others.


Local; National Yes For the past 15 years great apes have not been used for experimental purposes in Germany. In the EU the use of them is highly regulated in order to reduce the suffering of the animals.

272


National; European


There will be little impact as low numbers of animals are used and procedures are already highly regulated.


Local representative Since 15 years great apes are not used for experimental purposes in Germany. In the EU the use of them is highly regulated in order to reduce the suffering of the animals.




For the past 15 years great apes have not been used for experimental purposes in Germany. In the EU the use of them is highly regulated in order to reduce the suffering of the animals.

273

Question VI.3.3.

Question text:

Statistics:




Comments received:





VI.3.3a

Augusto Vitale User of animals -public sector

National There are other relevant organisation

In general, the general public does not distinguish between different species of NHP. The ban on the use of Great Apes would not have an impact on the public, if not accompanied by information on the scientific and ethical reasons to do so.

Public concern: A ban on the use of Great Apes with only very limited exemptions would lead to a high improvement of the public opinion on ethical aspects in scientific research and improve the image of the industry as a whole. Do you support the preliminary findings? Yes/No/ No opinion

274












t is widely acknowledged that the use of primates for research and testing purposes is a subject of high sensitivity, on ethical, animal welfare, conservation, animal and human health, science as well as economic grounds. NHPs are only used rationally when no other alternative exists, as also requested by law. They account for less than 0.1% of all experimental animals in Europe.

275









the discussion most probably would focus on “total ban” irrespective where the animals come from.




Yes, guess so ... I just don´t think so!





276







National representative The improvement of the public opinion on ethical aspects in scientific research and of the image of the industry as a whole will be minor.




The general public, when informed appropriately, does not have a poor image of research and industry. This is only true for parts of the public in some, probably not all member states.




Animal activists will stick on the exemptions anyway.




Bayer HealthCare



3.3 Current directive is already doing it. The measure is not widely promoted or understood. This existing measure did not improve industry image so far.


Worldwide Yes The public opinion link to the Animal Right Movement can't change the idea that the idustries are trying to save ONLY their own image.

277




Current directive is already doing it. The measure is not widely promoted or understood. This existing measure did not improve industry image so far.

sanofi pasteur R&D


Worldwide Vaccine field Speaking about ban, but contracting out Europe (outsourcing) some research could be worse.



National yes see point 3.1





The current Directive is adequate. I question the word high. I am not sure that public fully understands the issues. The current ban has not done anything to improve industry image as it is.



Worldwide Yes There would be no real change over the existing situation, so there is no real expectation that public opinion would change





278



Worldwide Yes Existing measures did not improve the image of the industry so far.



National; Worldwide

yes The impact will NOT be significant: the number is already very limited and is already very strictly controlled. A separate document could specifically address the use of great apes, showing that their use is already exceptional.









Current directive is already banning it. The dimension is not widely promoted or understood and hasn’t improved industry image so far.



Worldwide yes Since only small numbers are used it is clear to the public that these animals are used only when there is no other option




The preliminary finding does not acknowledge the current situation with the Directive regarding the use of these species and a revised Directive is unlikely to influence public opinion more than the current one.



Worldwide No Not if the specific and exceptional need to use great apes were indicated. Announcing a ban with no real scientific justification does not (or should not) lead people to have a better opinion about anything.

279




This already happens. No change needed.




Current directive is already doing it.



Worldwide yes Current directive is already doing it. The measure is not widely promoted or understood. This existing measure did not improve industry image so far.



Worldwide yes This already happens. No change needed.



National; Worldwide

yes Likely that any holding of captive great apes will be opposed by the public.



Worldwide yes Current directive is already doing it. The measure is not widely promoted or understood. This existing measure did not improve industry image so far.

280




Industry is already now not using Great Apes!. A ban would thus not improve the image.







National representative Current directive is already doing it. The measure is not widely promoted or understood. This existing measure did not improve industry image so far.




There would be no real change over the existing situation, so there is no real expectation that public opinion would change.



It would be more convincing to explain that great apes can be used, in exceptionnal conditions of survey for non invasive research and that they are uncomparable models for cognitive processing

281




Their use is already very restricted and good controlled. I expect no further changes and hence no changes in public opinion.






Public authority Local; Regional no acceptance of scientific research does not depend specifically on how great apes are treated.



A ban with exceptions is not a ban. A ban is an absolute prohibition.






see Option 1: 1.8

282



Most people are against any type of animal experimentation. Their attitude is often based on emotion. However, if they learn more about the necessity and results that have been achieved, about 70% approve animal research.




Other National Yes The Directive already provides for such a ban. We do not believe that there is evidence that this has had an impact on image.


Other Not applicable not applicable Current directive is already doing it. The measure is not widely promoted or understood. This existing measure did not improve industry image so far.


Other National representative The use of great apes is so small that the impact would be minimal.


Other European yes The Directive already provides for such a ban; we do not believe that there is evidence that this has had an impact on image to date.

283




High public concern about the use of Great Apes will not be diminished by a partial ban of only a small number i.e.: 6 in 1999.



National; European


only if there would be a total ban





A ban with limited exemptions would likely be seen as merely sustaining the current position whilst claiming to advance laboratory animal protection. A clear ban would be decisive and reassuring to the public and would be in line with laboratory practice over the past 20 years.

284




Great Apes are not used in the UK and there use in mainland Europe has been for specific purposes which has been authorised within the Directive. As stated previously the concern is with the use of all NHPs.







See 3.1




One other Public opinion is dead set against the use of Great Apes.



Worldwide - -

285



National yes Current directive is already doing it.






Worldwide yes Industry do not use great Apes, so it would be no Improvement at all.


National; European


It is questionable whether the public is aware of current controls that are already in place.


Local representative Current directive is already doing it.




Current directive is already doing it.

286

Question VI.3.4.

Question text:

Statistics:




Comments received:





VI.3.4a.




Research: The negative impact on research would be low as already at this stage the number of Great Apes used is extremely low. Do you support the preliminary findings? Yes/No/ No opinion

287














288




The argument is false. Negative impact is in no way related to number of apes. A single study may change the world.





But this research wuold be negatively influenced

Timo Nevalainen User of animals -public sector

Local Yes Low numbers do not mean low impact.











Worldwide there are others Chimpanzees are actually used in the USA not in Europe. There is already a negative impact.

289



National representative The impact might be high in specific areas of research and development




Research is already largely restricted to issues that cannot be solved otherwise. A ban of such experiments had a clear impact on research.





It is in the nature of scientific research that future impacts are hard to predict. Potentially, the impact could be enormous if Great Apes would be essential for the development and testing of drugs and vaccines against new life-threatening diseases. Thus, to assess future impact, the CURRENT number of animals is immaterial.




Yes We cannot predict if research will require Great Apes in the future to answer questions of fundamental importance for the survival of man kind




Even low numbers means high importance, otherwise these research would not be performed in Greta Apes.

290




Although limited numbers of Great Apes are used, they are used in experiments for which no alternative is available. The impact on research dependent on these experiments will be significant. These include investigations into (viral) diseases that could lead to pandemics to name one category



Local yes Low numbers does not mean that it is not important. See also 3.1 and 3.2..



National yes The negative impact could not see as extremely low. The scientific need for Great Apes is putative. In case of need, they will be irreplaceable conducting to an outsourcing of the research program. Without ban, there is no more Great Apes used for scientific purpose. The proposition will have no effect




Bayer HealthCare



3.4 Even if the numbers are low, the significance of research is very high – current research into an unmet medical need causing thousands of cancers per year is certainly justified.


Worldwide Yes The current research is actually requiring to use these NHP for very important reserach as cancer, HIV, Hepatitis.




Even if the numbers are low, the significance of research is very high – current research into an unmet medical need causing thousands of cancers per year is certainly justified.

291

sanofi pasteur R&D


Worldwide Vaccine field See above section 3.2



National yes Great apes are used in Europe for specialized questions only, so a further regulation will not bring an effect.





The extremely low numbers are used in research that has significant impact. The fact that the use of these animals is based on a very care cost benefit analysis and are limited to projects that can only be done with these species, a ban would have a significant impact and could lead to avenues of research with significant impacts on human health not being carried out. It could lead to research on emerging diseases not being done in Europe.







Worldwide Yes Since Great Apes are mainly used for development of treatments of new diseases a ban would mean that such highly innovative research will not longer be possible in EU. Even if the actual impact currently is low, it may be significant in the future and it may be a signal that EU is not promoting, but hindering innovation and thus lead to a shift of research sites to outside of EU and may hinder important cooperation for public institutions.



National; Worldwide

yes A low number does not mean a low importance! Their use could still be very limited but critical in the future.





292





Even if the numbers are low, the significance of this model is very high.



Worldwide yes Low numbers can not be taken as evidence for low imortance



Worldwide No In terms of total numbers the impact is low, but assuming the need to do the very occasional work is real and important, then banning it could potentially have a very large impact.




The number may be low, but it is done by exception to meet exceptional medical need. A ban would remove the facility to meet this need and this could be very major.




what about unmet medical needs ?



Worldwide yes Even if the numbers are low, the significance of research is very high – current research into an unmet medical need causing thousands of cancers per year is certainly justified.



Worldwide Representative Possible impact on the research should not be based on the number of animals used, whilst on the results obtained and their final impact on the whole society.

293



Worldwide yes The number may be low, but it is done by exception to meet exceptional medical need. A ban would remove the facility to meet this need and this could be very major.



Worldwide yes Even if the numbers are low, the significance of research is very high – current research into an unmet medical need causing thousands of cancers per year is certainly justified.




Already now research with Great Apes is only done in very, very important cases following a decent case-by-case decision and in extremely research relevant cases. Thus the impact would be considerable.







Worldwide Yes this statement is too general. In some very special cases impact could be extremely high.



National representative Even if the numbers are low, the significance of research is very high – current research into an unmet medical need causing thousands of cancers per year is certainly justified.

294

Coordination group for laboratory animal activities

Public authority National Yes Low numbers do not mean low impact



new tools for cognitive neurosciences are now developed which could allow new important developments in that field








Trying to reproduce animal models of human disease is an outdated approach, especially since there are now many non-invasive ways of working with human patients.

295


Other European No Low numbers does not mean that it is not important. See also 3.1 and 3.2..

Cris Iles-Wright Other Not applicable Not applicable There would be no impact as the use of Great Apes is not relevant to the study of human illness.




see Option 1: 1.8



Even if the number of Great Apes used is low, negative impact on research can be high.




Other National Yes Although the number of great apes used is extremely low, the research for which they are used is of extremely high importance.

296


Other Not applicable not applicable Even if the numbers are low, the significance of research may be extremely high




Chimpanzees are actually used in the USA not in Europe. A negative impact is already existing in particular in hepatitis C pathogenesis research and corresponding subjects.



The use of great apes should be restricted to research on diseases for which there is no cure and for which there is no other animal model. New diseases can and will appear in the future, and the economic and humanitarian effects of new and rapidly spreading diseases cannot be foreseen. Therefore, research on great apes should in principle be possible because it can potentially save millions of lives.

297


Other European yes Although the number of great apes used is extremely low, the research for which they are used is extremely high.




We estimate the overall impact on research should be “0” not “-“. Experiments on chimpanzees can (and must) be replaced. The recent breakthrough in propagating hepatitis C virus in cultured human cells rather than in chimpanzees is an example of replacing chimpanzee experiments while also advancing medical progress more rapidly (Zhong J et al (2005). Robust hepatitis C virus infection in vitro. Proc. Natl. Acad. Sci. 28:9294-9299; Lindenbach BD et al (2005). Complete replication of hepatitis C virus in cell culture. Science 309:623-626).




Regarding 3.4, the POTENTIAL impact on future research must be taken into account. The need to carry out research into, e.g., future pandemics and for which the only suitable species is a Great Ape, must be allowed for.

298



National; European

Yes Low numbers does not mean that it is not important. See also 3.1 and 3.2..





We believe that any negative impact a ban might have on research currently dependent on Great Apes would be negligible (0). In any case, such an impact would be offset by the benefits of obliging researchers to adopt alternative techniques, which, as outlined under Ethical Evaluation of projects (III.A: 1.7), tend to be cheaper, faster and more rigorous (1,2). (1) Coecke S et al. (2006) The value of alternative testing for neurotoxicity in the context of regulatory needs. Environmental Toxicology and Pharmacology 21:153-167. (2) Animal Experimentation in India (2003) NAVS/ADI report http://www.navs.org.uk/downloads/animalexperimentsinindia.pdf




299




See 3.1



National YES Chimpanzees are not used in Europe. The potential impact on future research must be taken into account. The need to carry out research into, e.g., future pandemics and for which the only suitable species is a Great Ape, must be allowed for.



National yes Current directive is already doing it.






Worldwide yes Low impact due to the fact that even now research is very restricted.


National; European


The impact on research will be high, as medical research is only conducted in great apes where answers that have an impact on human health cannot be obtained by other animal systems.




A situation might arise in the future where a particular, perhaps lethal, disease could only be countered by research on great apes. In such a - now qeemingly quite hypothecial case - the negative impact would be great.

300

Question VI.3.5.

Question text:

Statistics:




Comments received:





VI.3.5a.

Central facility to cope with future demand: In case of a total ban on the use of Great Apes, a centralised facility for these animals would be required in order to anticipate on future needs. The cost of running such facility with the given uncertainty of future demands would be high. Do you support the preliminary findings? Yes/No/ No opinion

301













302









Central facilities as such carry the inherent problem of self-running administration costs and lack of flexbility to respond to scientific demands





303



Worldwide there are others Biomedical research in Great Apes is done only in chimpanzees. In the moment there are only a few research areas where it is mandatory to use them in particular in hepatitis C research. This research is exclusively performed in the USA. The assumption that chimpanzees are necessary only for new diseases that might occur is therefore wrong. In current research the negative impact is high as there are no animals available in the moment. The existing facility in The Netherlands is not allowed to do research with the animals. It is difficult to estimate the impact for future research on unknown fields. The term “total ban” is inappropriate. A centralised facility should keep animals for very limited research of high scientific value with high impact on human health. The animals of a centralised facility should be made available to all European scientists.




Why would a centralised facility be required in case of a total ban?





It is naïve to assume that, after years of a total ban on the use of Great Apes, this expertise will be available in case of immediate emergency. Either you run a Great Apes facility and allow (under very strict conditions) scientific experiments, thus preserving the necessary expertise and mediate scientific progress, or you ban it all together and face the consequences of that decision.




Why a ban, if we agree on the possible need for research in future?

304



Local yes Why a centralised facility is necessary in case of a total ban? If there is no total ban then a centralised facility would make sense.







yes A total ban is just that theere should be no future needs that can reverse such a decision.





Provided that future needs may be accommodated by an immediate lifting of the ban, if extreme circumstances arise (epidemic etc) then a problem does not exist. The UK system of a "hold" on licences seems a sensible approach. Under these extrem conditions, taking animals from the wild may be justified, as the lesser of two evils - to maintain stocks in captivity cannot be jutified unless they also contribute to captive breeding programmes for CITES purposes etc.

Bayer HealthCare



3.5 There is no need for a central facility. In case of a total ban – such research will not be carried out at all – or will be relocated. An EU body is not necessary. In case exceptions are allowed – this should be justified after a thorough ethical review and stringent protocol authorisation as it is the case today.


Worldwide Yes A central facility or a network of facilities has just failed in the past as EUPREN started to have an independent project to allow EU to use only NHP bred in EU. The main risk is that if one problem(for example disease) will happen in this facility you'll have 0 facilities in europe. In the USA the NOH has several facilities in different location in order to afford hurricanes, flooding and unexpected diseases.

305




There is no need for a central facility. In case of a total ban – such research will not be carried out at all – or will be relocated. An EU body is not necessary. In case exceptions are allowed – this should be justified after a thorough ethical review and stringent protocol authorisation as it is the case today



National yes The facility is not necessarily, the exceptional use of great apes in low numbers will avoid such facility. Otherwise there is the question who will finance such a facility. It is easier to go away from Europe.





There is no need for a central facility. Current facilities are adequate and allow for the very limited numbers of projects that are currently done in Europe. The proposition is misleading. In the event fo a total ban there would be no possibility to set up a centralised facility.



Worldwide Yes This analysis seems contradictory - in case of a total ban, why would a central EU facility be needed? If the work were required, presumably it would go ahead outside the EU?




There is no need for a central facility. In case of a total ban – such research will not be carried out at all – or will be relocated. An EU body is not necessary. In case exceptions are allowed – this should be justified after a thorough ethical review and stringent protocol authorisation as it is the case today.



Worldwide Yes There is no need for a central facility in case of total ban

306



National; Worldwide

yes Why should we create a "central facility" in case of a total ban? If their use is strictly controlled and limited, the facility would have to be selected according to expertise both for the quality of animal care and welfare AND for the scientific resources available.












Worldwide yes In case of a total ban a centralised facility is not possible - since there is a total ban




It is difficult to understand the proposal for a centralised facility when there is no evidence presented for the use of this species.



Worldwide No No need or justification for such a facility. Who would be responsible for it, pay for it, decide when/how it were used and run. Simply not feasible to support pharmaceutcial development.




In case exceptions are allowed – this should be justified after a thorough ethical review and stringent protocol authorisation as it is the case today. The work should then be conducted where the scientific expertise exists. It is not possible to establish this kind of expertise for all potential needs at a central facililty. This proposal would be unworkable.

307




in case of a total ban such research might be relocated in other countries. In case of exceptions the ethical review and protocol authorisation is already established.



Worldwide yes There is no need for a central facility. In case of a total ban – such research will not be carried out at all – or will be relocated. An EU body is not necessary. In case exceptions are allowed – this should be justified after a thorough ethical review and stringent protocol authorisation as it is the case today.



Worldwide Representative Although a centralized facility would be a partial solution, the costs to establish and maintained such a facility would be higher than relocating the activities outside the EU.



Worldwide yes In case exceptions are allowed – this should be justified after a thorough ethical review and stringent protocol authorisation as it is the case today. The work should then be conducted where the scientific expertise exists. It is not possible to establish this kind of expertise for all potential needs at a central facililty. This proposal would be unworkable.



Worldwide yes There is no need for a central facility. In case of a total ban – such research will not be carried out at all – or will be relocated. An EU body is not necessary. In case exceptions are allowed – this should be justified after a thorough ethical review and stringent protocol authorisation as it is the case today.







National representative There is no need for a central facility. In case of a total ban – such research will not be carried out at all – or will be relocated. An EU body is not necessary. In case exceptions are allowed – this should be justified after a thorough ethical review and stringent protocol authorisation as it is the case today.

308




This analysis seems contradictory - in case of a total ban, why would a central EU facilty be needed? If the work were required, presumably it would go ahead outside the EU?



Given the difficulties in meeting the physical, behavioural, psychological and social needs of these highly intelligent animals in the captive environment, they should not be kept and maintained in a centralised facility for the eventuality of a future human disease outbreak for which their use might be justified.




A central facility for work on Great Apes would not only be expensive to run but should be opposed given the undesirability of holding Great Apes for long periods ‘in case’ they are needed.

309







A ban is an absolute prohibition. In the case of a ban no facility would be necessary. In the absence of an exceptionally justified and sustainable programme for the use of these animals it is not clear what the justification would be for breeding and keeping such animals in captivity.



see 3.6




Such a facility would not be necessary if our research was focused on human-based studies and not on misleading animal research.

310


Other European No Why a centralised facility is necessary in case of a total ban? If there is no total ban then a centralised facility would make sense.




see Option 1: 1.8


Other National Representative Given the difficulties in meeting the physical, behavioural, psychological and social needs of these highly intelligent animals in the captive environment, they should not be kept/bred and maintained in a centralised facility for the eventuality of a future human disease outbreak for which their use might be justified.





311


Other National Yes A central facility is not necessary. Where exceptions are allowed under the Directive, such research is very highly regulated. If a total ban were introduced, the research would in all likelihood move out of Europe, where it could be less well regulated.


Other Not applicable not applicable There is no need for a central facility. In case of a total ban – such research will not be carried out at all – or will be relocated. An EU body is not necessary. In case exceptions are allowed – this should be justified after a thorough ethical review and stringent protocol authorisation as it is the case today.




The term “total ban” is inappropriate. A centralised facility should keep animals for very limited experiments of high scientific value with high impact on human health. The animals of a centralised facility should be made available to all European scientists.


Other National Yes Such a move would be very expensive and be criticised on the basis of potenial under use. The scientific expertise and the incentive to work on these aniamls is low in Europe.


Other European yes A central facility is not required. Where exceptions are allowed under the Directive, this research is very highly regulated. In the case of a total ban, the research would in any case move out of Europe, where it may be less well regulated.

312




Given the reasons set out in this document and elsewhere as to why Great Apes should no longer be used in research (Smith & Boyd, 2002), it is inconceivable that a civilised society would plan to set up a facility to accommodate these animals, in order to ‘anticipate’ future research needs. Such a facility would inevitably breed animals which would then be available to be “used”. This would send the message to scientists that these animals were acceptable and readily available ‘research tools’ and this would encourage scientific reasons to use these animals to be “made up” just because the supply would exist. Eurogroup strongly opposes the establishment of any facility for the breeding, supply or use of Great Apes in experiments.




We agree that a centralised facility would indeed be very costly. We disagree that a centralised facility for great apes should be maintained just in case of the emergence of a hypothetical new human disease. A ban should be an in-principle ethical decision based on the intrinsic moral value of apes as individuals (see open text below). Moreover, maintaing apes in such a facility would risk an oversupply, which would lead to research projects being conducted just to use the available animals. This would be deeply unethical and strongly opposed by EU citizens.



National; European

Yes Why a centralised facility is necessary in case of a total ban? If there is no total ban then a centralised facility would make sense.

313

PETA Europe Ltd.


Worldwide both On ethical grounds, we reject the claim that establishment of a centralized facility would be required. Captivity deprives great apes of agency and exacts profound trauma and suffering and thus is Fwholly unacceptable. Furhtermore, given that great apes are not currently used, such a centre would require the transfer of individuals from sanctuary or from the wild and neither is acceptable. Data from the USA provide compelling evidence regarding economic costs of such a centre. For example, projected one-year costs (fiscal 2006) for maintaining chimpanzees held in “research reserve” are $11 million USD (www.releasechimps.org/pdfs/Senate Appropriations Testimony.pdf). Because of their long life span (~60 years), lifetime maintenance is projected at $1.85 billion USD (Ibid).




Since I do not see the need for using Great Apes, I see no need for a centralised facility.



National; European


There is no such facility and we do not want one.

314





We agree that a central facility for Great Apes would have a strong negative impact. The situation over the past 20 years in the EU clearly has not warranted a centralised great ape experimentation facility. With more non-animal methods of research both fundamental and applied becoming available to scientists each year, there does not seem a logical reason to anticipate demand for research on great apes. To build such a facility would increase the opportunity for such research and more likely lock the EU into a certain level of great ape research in perpetuity.




both Captivity deprives great apes of agency and exacts profound trauma and suffering and thus is Fwholly unacceptable. Furhtermore, given that great apes are not currently used, such a centre would require the transfer of individuals from sanctuary or from the wild and neither is acceptable. Data from the USA provide compelling evidence regarding economic costs of such a centre. For example, projected one-year costs (fiscal 2006) for maintaining chimpanzees held in “research reserve” are $11 million USD (www.releasechimps.org/pdfs/Senate Appropriations Testimony.pdf). Because of their long life span (~60 years), lifetime maintenance is projected at $1.85 billion USD (Ibid). Breeding programmes in the US have been suspended until at least 12/2007 for economic and scientific reasons (Ibid). Along with the ethical opposition to testing on great apes, the economic costs associated with such a facility would be a source of contention with the public.

315






Worldwide Yes as explained above, the ethical and financial costs of great ape research far outweigh any benefits (which could likely be nonexistent)—therefore a centralised facility is largely inappropriate. It is agreed that the costs of running such a facility would be high. It is estimated that it costs over $30 (US) per day per chimpanzee to maintain them in research laboratories.



National YES The term “total ban” is inappropriate. A centralised facility should keep animals for very limited research of high scientific value with high impact on human health. The animals of a centralised facility should be made available to all European scientists.









National Representative BBSRC supports a ban on the use of great apes in research, and does not endorse the recommendation to set up a central facility for their use. Such a facility may lead to great apes being held for long periods in case they are needed, which is very undesirable. In addition, the costs of establishing a central facility would be high.

316


National; European


It is not clear what the role of this facility would be, as a ban on great apes would likely result in shifting of such research outside the EU.



Will be expensive and undesirable



There should be no centralised facility as this leaves open an avenue which is morally completely unacceptable.

317

Question VI.3.6.



Comments received:





VI.3.6. Justification

318




The statement in 3.5 is illogical. If there is a “total” ban on the use of Great Apes, it is not possible to plan against any future need. The word “ban” should be avoided and reference only made to the very limited strict conditions under which use would be allowed.








IThey are used efficiently in a manner that promotes rapid progress in science and medicine, and their treatment and care is continually reassessed in light of the latest knowledge and methods. The use of non-human primates for experimental purposes should be strictly limited to cases where the use of in vitro methods and other animal models are of insufficient value. In view of the slow progress in transplantation research towards bio-artificial development of organs, the prospect of an earlier verifiable approach to temporarily transplant xenogeneic organs to humans, makes further use of NHPs indispensable. In this limited number of cases, only animals bred in captivity should be used except in cases where no valid alternative is available for essential research programmes.

319








This treatise shows a somewhat simplistic ideas of the use and necessity of research. Again, it shows the underlying assumption that animal use always means suffering. This is simply not true, and it makes answering very difficult in many cases.

Prof Alan Palmer


Worldwide Yes The cost of a central facility would be untenable and given the public opinion at least in the UK would be difficult if not impossible to establish.





Central facilities as such carry the inherent problem of self-running administration costs and lack of flexbility to respond to scientific demands. A hope of positive public acceptance seems to be unrealistic: the discussion most probably would focus on “total ban” irrespective where the animals come from.

320








XXX As indicated, there are two areas in which great apes are potentially needed. One would be investigation (including protection) of the animals themselves (such as if a serious disease epidemic (eg H5N1 or HIV) were to afflict the wild population) and the other is the emergence of new critical human disease. In either case a total ban would delay appropriate action, and cannot therefore be advisable. It seems most likely that all would agree that stringent controls should be exerted on any such use.



Worldwide there are others Biomedical research in Great Apes is done only in chimpanzees. In the moment there are only a few research areas where it is mandatory to use them in particular in hepatitis C research. This research is exclusively performed in the USA. The assumption that chimpanzees are necessary only for new diseases that might occur is therefore wrong. In current research the negative impact is high as there are no animals available in the moment. The existing facility in The Netherlands is not allowed to do research with the animals. It is difficult to estimate the impact for future research on unknown fields. The term “total ban” is inappropriate. A centralised facility should keep animals for very limited research of high scientific value with high impact on human health. The animals of a centralised facility should be made available to all European scientists.





Despite the cost it may have to be done, but perhaps on a global scale (worldwide, EU, US etc) rather than in each member state.




Research with great apes is already restricted. There may be scientific questions which cannot be anwered otherwise and are ethically justified. Public concern is used as argument, which is not entirely appropriate in this context.

321





It is essential that at least a limited number of Great Apes can still be used since this is the only real option to model certain severe diseases where current treatment possibilities are insufficient. We must keep the opportunity to use great apes in exceptional circumstances e.g. where a great ape is the only species in which a disease can be modelled and where that disease provides a threat to man, not only in numerical terms but in the severity of its consequences




Yes A centralized institution is desirable, also in terms of cost and standardization. A ban on great apes, however, is cynical as long as clinical studies on human primates are not put under the same regulations. In other terms, clinical studies that can be done on humans should also be feasible on great apes. It is essential that at least a limited number of Great Apes can still be used since this is the only real option to model certain severe diseases where current treatment possibilities are insufficient. We must keep the opportunity to use great apes in exceptional circumstances e.g. where a great ape is the only species in which a disease can be modelled and where that disease provides a threat to man, not only in numerical terms but in the severity of its consequences .



European Yes Whilst not relevant to this establishment because we do not use non human primates, this section seems to be based on flawed information concerning the use of F2 rather than F2 animals. If implemented as suggested it could force all non human primate work out of the EU and into countries with less rigorous welfare standards (eg USA).



National yes The option of using great apes should not be ruled out forever in case anew disease emerges requiring there use.

322



Regional yes It is essential that at least a limited number of Great Apes can still be used since this is the only real option to model certain severe diseases where current treatment possibilities are insufficient.




Yes It is most undesirable to hold grant apes for long periods for possible use.



National; Worldwide

yes, major UK research organisation for aquatic organisms and environment

Not within our expertise



National yes Populations of captive apes exists (usally orphans who could not be reintroduce). These populations useless for conservation could be dedicated if necessary to scientific use




yes Current scientific evidence shows that a chimpanzee has the cognative abbilities of a three year old child. No experiments are justifiable on children and the science forces the conclusion that none are justuifiable on chimpanzees either.



In reality this work has been exported already to 3rd countries, where it continues to be done as required by the European Safety Authorities. http://www.who.int/vaccines-documents/DocsPDF03/www780.pdf

323





This section has significant and major errors. The numbers of NHP's, the numbers of F2 etc are all incorrect. The current situation in Europe is already restricted and there is a real possibility that research will be done outside the European Union area if many of the propositions are implemented.



Worldwide Yes The low number of Great Apes used in the EU suggests that the current provision in the Directive is adequate, and any change would be symbolic rather than genuine progress




no comment







There is no need to change from the existing situation where Great Apes may only be used in exceptional circumstances where other kinds of research/ species cannot provide the scientific answers required and where there is an exceptional medical need.



Worldwide yes -

324





No comment



National Yes Species like Cercopithecus aetiops and Baboons account for a much greater proportion of NHP used in research than Prosimians As far as great apes are concerned, not all countries have facilities suitable for the use of great apes. In addition there is a very limited number of research centres working on programmes that may justify the exceptional use of a strictly limited number of great apes. Large numbers of NHP are used for vaccine quality control (batch release). This is manly the case of polio vaccines. Macaques and Vervets used in the EU are not F2. Switch to F2 is not beneficial to biodiversity. A limited and controlled capture to replace retire breeders that produce F1 animals to be used in research does not raise serious animal welfare concerns in the current breeding and animal care practices. These animals show to be highly adaptable to captivity conditions when used for breeding purposes.



Worldwide yes There is no need to change from the existing situation where Great Apes may only be used in exceptional circumstances where other kinds of research/ species cannot provide the scientific answers required and where there is an exceptional medical need.




The low number of Great Apes used in the EU suggests that the current provision in the Directive is adequate, and any change would be symbolic rather than genuine progress.

325



In addition to the need for use of these animals in relation to a future human disease outbreak, some research may need to be carried out in the interests of preservation of the species. In November 1997, the UK Government announced that it could not see any circumstances under which it would be prepared to issue project licences for programmes of work involving the use of great apes (gorillas, chimpanzees, pygmy chimpanzees and orang-utans).

Coenraad F.M.Hendriksen

Public authority National at the national level: yes

ad. 3.4: In general yes, but the answer might be different for specific diseases.




The answer to 3.1 should be viewed in the context of the answer to 3.5 and the additional justification given. With regard to 3.3: The effect on UK public opinion will be small as an effective ban already exists in the UK.

326



yes These questions are very badly worded and the concepts are not well presented. It appears as though they are not well understood by tgose constructing the questionaire. I have opinions but there is no opportunity to air them adeqautely here.



Very low numbers of these are likely to be used. Holding animals as a potential resource in a central facility for any period is not necessary and would not be good for the welfare of the animals.



Yes, together with the National Food and Product safety Authority

3.1. and 3.5, there i sexplanation needed regarding to the central facility named in these 2 questions, is this a national or an European facility?


Although NHP are often considered as a special category, based on their evolutionary proximity to human beings, we would argue that any animal with a central nervous system, or even a decentralized nervous system, and pain receptors, which is capable of feeling the effects of pain, should not be experimented upon.




As indicated, there are two areas in which great apes are potentially needed. One would be investigation (including protection) of the animals themselves (such as if a serious disease epidemic (e.g. H5N1 or HIV) were to afflict the wild population) and the other is the emergence of new critical human disease. In either case a total ban would delay appropriate action, and cannot therefore be advisable. It seems most likely that all would agree that stringent controls should be exerted on any such use.



Comment to 3.1: Yes. However, such a place and relevant resources (great apes) are not available anymore in Europe. Setting up such a center will attract the attention of animal welfare groups and will result in serious starting up problems.

327


Other Worldwide yes This seems to have only exploitative research in mind. Again, there need to be safeguards on fundamental research in whatever regulations are drawn up. Point 3.5 implies equivocation on any ban, anticipating that it may be only temporary; it also begs the question of the welfare standards that will operate here and what information they will be based on. The Great Apes also highlight particularly starkly the need for fundamental research on welfare per se, with the paradoxical consequence that it may require deliberately impairing welfare in order to study it


Other Not applicable Not applicable There is no need of using NHP in research.... The past experiences give us the knowledge that is true! Many disastres after experiments with this kind of animals happen due to errors in final conclusions. In that case, the use of primates can give us worng conclusion and that means different conclusions to be replaced into the human healht! The use of NHP in research should be banned!




Eurogroup believes that for ethical, animal welfare and scientific reasons there should be a ban on the use of Great Apes, and we therefore agree that this option would have a positive impact. We strongly disagree that any exceptions should be allowed and that centralised facilities would be necessary. There is strong scientific evidence that the Great Apes have complex mental abilities similar in important ways to those of humans. This enhances their capacity for suffering to such an extent that it is unethical to confine them in laboratories and use them in research and testing no matter what the perceived benefit for humans (e.g. Smith and Boyd, 2002). In our view, and that of the public we represent, there is no justification for performing procedures on Great Apes that would not be considered ethically acceptable on humans. Some countries already ban the use of Great Apes and this ban should be extended worldwide.

328




We support the assessment of a ban as very positive but disagree with any exceptions or facility for apes. A ban must be an ethical decision based on the intrinsic moral value of apes. New evidence - post-dating the SCAHAW primate report (see Langley G (2006) Next of Kin: A Report on the Use of Primates in Experiments, www.buav.org/campaigns/primates/report.html) - of the complexity of apes’ minds & their social/cognitive skills, strongly supports a total ban. It should not be contingent on an imagined future medical need. 3.2 Few apes would be saved, but the level of suffering avoided would be high (see comments on 3.4, 3.5, below). We suggest increasing impact to “+ + +”. 3.4, 3.5 Primates (partic great apes) cannot be confined in lab conditions without damage to their physical/mental health. Scientific reports show how NHPs develop physiological/pharmacological abnormalities, which seriously jeopardise the validity of research data (see SCAHAW (2002); & Langley G (2006) ibid.).




The statement in 3.5 is illogical. If there is a “total” ban on the use of Great Apes, it is not possible to plan against any future need. The word “ban” should be avoided and reference only made to the very limited strict conditions under which use would be allowed.

329

Nuffield Council on Bioethics


National; Worldwide

There any other relevant organisations

See paras 4.42, 4.46, 4.47, 4.53, 4.59 and 15.80 for discussion of the welfare implications and scientific validity of using non-human primates in research, in Nuffield Council on Bioethics (2005) The ethics of research involving animals (London: Nuffield Council on Bioethics) Available at: http://www.nuffieldbioethics.org/go/ourwork/animalresearch/publication_178.html

PETA Europe Ltd.


Worldwide both Repeated surveys of the public, expert statements, and national bans adopted or pending in several countries demonstrate overwhelming support for a total ban on ape experiments. The risk of extinction for great apes is so high (http://www.unep.org/grasp/) that all formal and informal markets for great apes and their parts must be closed. Biomedical markets are no exception. The existence of a centralized supply would prompt exemption requests and perpetuate demand. With growing maintenance costs and public opposition, sustaining a population for uncertain future needs would exact unacceptable costs not just economically, but for physical and psychosocial suffering of the great apes. Given the grave risk of extinction for the great apes, any practice that serves to perpetuate demand for great apes or their parts is wholly unacceptable from the standpoint of biodiversity conservation as well.




The Directive must seek to harmonise what occurs within the EU with regard to the use of Great Apes and non-human primates. Why not suggest a compromise in which: a) those MS wishing to ban their use can continue to do so, while b) those wishing to use them, have to supply a stringent justification before a special expert committee of the EC for each specific licence granted? However, the latter should be within the context of a transitional period during at the end of which a ban on the use of Great Apes will be applied.

330





Great Apes are creatures whose particularly advanced cognitive and behavioural characteristics make them thoroughly unsuitable as models in research. We ask the Commission to recognise this, and to introduce an unconditional ban on their use. If such a ban is not introduced, a ban with exceptions can be the only, albeit inferior, alternative. The failure to introduce any EU-wide ban would be totally unacceptable. Recent research has in addition shown that Great Apes are more different from humans than previously assumed, making them unsuitable as research models (1). 3.5: The NAVS does not recognise the need for a facility of this type, as we are opposed to the use of great apes regardless of the circumstances. Yet in the absence of an option to bar their use unconditionally, it is imperative that the cost of this facility does not stand in the way of a ban with limited exceptions. 1 Nielsen & Bustamante (2005) PLOS Biology 3:976




As indicated, there are two areas in which great apes are potentially needed. One would be investigation (including protection) of the animals themselves (such as if a serious disease epidemic (eg H5N1 or HIV) were to afflict the wild population) and the other is the emergence of new critical human disease. In either case a total ban would delay appropriate action, and cannot therefore be advisable. It seems most likely that all would agree that stringent controls should be exerted on any such use.



Worldwide There are others We do not agree with the concept of maintaining colonies of Great Apes at centres as potential research subjects, because of the likely impact on their welfare, and because there might be increased pressure to carry out research on them to justify the expense of keeping them. However, a complete ban on experimentation on Great Apes could have the unintended consequence that research aimed at improving Great Ape Welfare or conservation might also be banned

331




both Repeated surveys of the public, expert statements, and national bans adopted or pending in several countries demonstrate overwhelming support for a total ban on ape experiments. The risk of extinction for great apes is so high (http://www.unep.org/grasp/) that all formal and informal markets for great apes and their parts must be closed. Biomedical markets are no exception. The existence of a centralized supply would prompt exemption requests and perpetuate demand. With growing maintenance costs and public opposition, sustaining a population for uncertain future needs would exact unacceptable costs not just economically, but for physical and psychosocial suffering of the great apes. Given the grave risk of extinction for the great apes, any practice that serves to perpetuate demand for great apes or their parts is wholly unacceptable from the standpoint of biodiversity conservation as well.



National YES Biomedical research in Great Apes is done only in chimpanzees. At the moment there are only a few research areas where it is mandatory to use them, in particular, in hepatitis C research. This research is exclusively performed in the USA. The assumption that chimpanzees are necessary only for new diseases that might occur is therefore wrong. In current research the negative impact is high as there are no animals available in Europe.




There may be situations where the only way of developing a treatment of a disease which is a major threat to man is by the performance of experiments on great apes.



Regional Yes It is essential that at least a limited number of Great Apes can still be used since this is the only real option to model certain severe diseases where current treatment possibilities are insufficient.

332



Worldwide - -



Worldwide Representative We must keep the opportunity to use great apes in exceptional circumstances e.g. where a great ape is the only species in which a disease can be modelled and where that disease provides a threat to man, not only in numerical terms but in the severity of its consequences.


Breeder of animals


The statement on Item 3.2 suggesting Great Apes are especially sensitive to pain and suffering—presumably more than other nonhuman primates or for that matter other species—is not supported by scientific evidence. Given their great physical similarly and behavioral similarity in many respects to humans, it is easier to anthropomorphize/relate to these species as compared to others.


Regional; Worldwide

also others A centralized institution is desirable, also in terms of cost and standardization. A ban on great apes, however, is hypocritical as long as clinical studies on human primates are not put under the same regulations. In other terms, clinical studies that can be done on humans should also be feasible on great apes.

New Excel Sheet semifinal NHP rev1 - European Commission · 2016. 5. 27. · year. The data shows...

Documents

Transcript of New Excel Sheet semifinal NHP rev1 - European Commission · 2016. 5. 27. · year. The data shows...