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Transcript of WP4 - Analysis of legislation, ethical issues, regulations and intellectual property ResistVir...
WP4 - Analysis of legislation, ethical issues, regulations and
intellectual property
ResistVir Meeting
6th July 2006, Helsinki, Finland
Dr Mike Adcock
SIBLE, University of Sheffield, UK
Part One – WP4
Partners WP4
University of Sheffield, UK (USFD) Central Science Laboratory, UK (CSL) Technology Codes Ltd, Ireland (Codes) University of Azores, Portugal (CBA-UA) Consejo Superior de Investigaciones Científicas,
Spain (CSIC) Universidad Politécnica de Madrid, Spain (UPM) Wageningen University and Research Centre,
Netherlands (WU)
Objectives To collate and analyse of existing standards, legislation, codes
of practice, regulations, and intellectual property (IP) issues at European and national level regarding virus/vector resistant GM and traditionally-bred crops
To produce recommendations and guidelines for future standards, legislation, codes of practice, regulations, and intellectual property issues, so as to promote the safe use of GM and traditionally-bred crops
To be informed of relevant issues by the project partners and disseminate information on legislation, regulations and IP
To address ethical issues, if and when they arise
Task 4.1: Review of standards, legislation, ethical issues, codes of practice, regulations, and intellectual property
issues at national and European level.
Collate and analyse legislation, codes of practice, regulations, and intellectual property issues controlling the testing and use of virus/vector resistant GM and traditionally-bred crops.
Encouraging the involvement of external organisations in this task when appropriate.
New developments will be added to the initial report at Months 19, 24 and 35.
Task 4.2: Produce a report on current legislation, regulations and intellectual property issues with
recommendations
Co-ordinate the legislation, technology practices, regulations and intellectual property issues workshop
Produce a report with recommendations for future standards, legislation, codes of practice, regulations, and intellectual property issues for the production and use of virus/vector resistant GM and traditionally-bred crops
Disseminate the report at the final seminar
Deliverables (months 1-18) Legislation, technology practices, regulations and
intellectual property issues report completed Month 10, Responsible partner: Codes
Legislation, technology practices, regulations and intellectual property issues workshop
Month 18, Responsible partner: CLS/USFD
Report on recent developments Legislation, technology practices, regulations and intellectual property Month 19, Responsible partner: CSL
Milestones
Completion of legislation, technology practices, regulations and intellectual property issues report
Task 4.1, Month 10, Responsible partner: Codes
Feedback from legislation, technology practices, regulations and intellectual property issues Workshop analysis and report
Task 4.2, Month 19, Responsible partner: CSL
Part Two – Progress
Activities
Identify relevant legislation at the EU level
Collect all Relevant EU legislation
Identify this legislation at Member State level
Gather this legislation from all member states
Main Legislation Directive 2001/18
the deliberate release into the environment of GMOs Directive 98/81
contained use of genetically modified micro-organisms Regulation 1829/2003
genetically modified food and feed Regulation 1830/2003
concerning the traceability and labelling Regulation 1946/2003
transboundary movements of GMOs Regulation 258/97
Novel food and feed Recommendation 2003/556
Co-existence Directive 98/44
Biotech patenting
Key LegislationKeywords EU UK
Plant health 2000/29 and 95/44 Plant Health order 2005
Deliberate release 2001/18 GMO regulations (DR) 2002 GMO
Contained use 98/81 Regulations (CU) 2000
Traceability and labelling
1830/2003
1829/2003
GMO regulations (T&L) 2004
Food and feed 258/97 GM Food regulations 2004
Cartagena 1946/2003 GMO (TM) 2004
Biotech inventions 98/44 Patent Regulations 2000
Legislation ObtainedKeywords EU Collected
Deliberate release 2001/18 Austria, Czech republic, Denmark, France, Finland, Germany, Hungary, Italy, Ireland, Lithuania, Netherlands, Poland, Portugal, Spain, Sweden, UK (16)
Contained use 98/81 Austria, Czech republic, Denmark, France, Finland, Germany, Hungary, Italy, Ireland, Lithuania, Netherlands, Poland, Portugal, Spain, Sweden, UK (16)
Legislation ObtainedKeywords EU Collected
Traceability and labelling
1830/2003
1829/2003
Czech republic, Denmark, France, Finland, Germany, Hungary, Italy, Ireland, Lithuania, Netherlands, Portugal, Spain, Sweden, UK (14)
Biotech inventions 98/44 Austria, Belgium, Czech republic, Denmark, Estonia, France, Finland, Germany, Hungary, Italy, Ireland, Lithuania, Netherlands, Poland, Portugal, Spain, Sweden, UK (18)
Other Member states
Some legislation Latvia, Slovenia, Slovakia
No legislation Cyprus, Greece, Luxembourg, Malta,
Activities
Analyse whether legislation appropriate and effective with respect to the use of virus/vector resistant GM and traditionally-bred crops
Started this analysis with EU and UK legislation
Identify Intellectual Property issues
Workshop on legislation, regulations and intellectual property issues
Workshop report
Part Three - Future
Deliverables (months 18-24) Legislation, technology practices, regulations
and intellectual property issues seminar Month 18 (?), Responsible partner: WU
Recent developments in legislation, technology practices, regulations and intellectual property issues added to the web site Month 24, Responsible partner: UPM
Activities
Analysis of member states legislation and regulations
Analysis of Intellectual Property Issues
Organisation of workshop
Addition of information on legislation to website
Deliverable (months 24-36) Recent developments in legislation, technology
practices, regulations and intellectual property issues added to the web site Month 35, Responsible partner: USFD
Suggested guidelines and recommendations report Month 35, Responsible partner: USFD
Milestones Report circulated to interested stakeholders
(Tasks 4.1/4.2, Month 36, Responsible partner: USFD)
Part Two - Regulation
Regulation Why
Scientific uncertainty Public concern Economic factors
Purpose The purpose of regulations should be to
insure safety and efficacy, to limit potential product risks while encouraging innovation and economic development.
Trigger for Regulatory Mechanism
Europe Using modern biotechnology as defined in the
Directives that triggers the regulatory process
US The use of organisms, i.e. the product not the process
Canada The concept of novelty is used to trigger the
regulatory process
Background Series of Directives, Regulations and
Guidelines From the laboratory to field trials to
placing on the market to labelling and traceability
Case by case basis Risk assessments of its impact on
human health and the environment, food safety assessments
Directive 2001/18 Principles for the environmental risk
assessment Mandatory post-market monitoring Mandatory information to the public First approvals to be limited to a maximum
of ten years The consultation of the Scientific
Committee(s)
Environmental Risk Assessment
Identification of any characteristics of the GMO(s) which may cause adverse effects
Evaluation of the potential consequences of each adverse effect
Evaluation of the likelihood of the occurrence of each identified potential adverse effect
Estimation of the risk posed by each identified characteristic of the GMO(s)
Application of management strategies for risks from the deliberate release or placing on the market of GMO(s)
Deliberate Release (Part B)
Submit dossier to MS Regulatory Authority Consent permits GMO to be grown on
specified sites under certain conditions Releases are small scale / strict risk
management conditions Monitored for several years Subsequent releases larger All applications placed on public register
Placing on the Market (Part C) Decision at EU level Dossier submitted by one MS to European
Commission Other MS evaluate and comment No objections then Commission instructs
MS to issue marketing consent GMO can be marketed in all MS
Placing on the Market (Part C)
If MS objections raised and maintained decision taken at Community level
Scientific Committee and European Food Safety Authority
If favourable, then goes to Regulatory Committee If favourable, Committee adopts decision If not favourable a draft decision submitted to
Council of Ministers Must adopt or reject within 3 months No decision, then Commission can adopt decision
Directive 98/81 Regulates the contained use of genetically
modified micro-organisms for research and industrial purposes
Requires MS to take measures to avoid adverse effects of human health and the environment
Requires risk assessment, premises to meet certain standards and management and emergency plans
Regulation 1829/2003 To protect human life and health, animal health and
welfare, the environment and consumers' interests in relation to GM food and feed, whilst maintaining the effective functioning of the internal market;
To lay down Community procedures for the authorisation and supervision of GM food and feed
To lay down provisions for the labelling of GM food and feed.
Food containing or consisting of GMOs Food produced from or containing ingredients produced
from GMOs.
Labelling
Traces of GMOs in products, whose presence is adventitious or technically unavoidable, will continue to be exempt from the labelling requirement unless they exceed the 0.9% threshold.
The threshold fro the adventitious presence of GMOs is set at 0.5% for this type of "contamination" for GMOs which have been given scientific approval.
Regulation 1830/2003 Framework for the traceability of
products of or containing GMOs, and food and feed produced from GMOs
Facilitate accurate labelling, monitoring the effects on the environment and health
Facilitate appropriate risk management and withdrawal of products
Traceability
Producer of product consisting of or containing GMOs must inform receiver of product that that it contains or consists of GMOs; the unique identifier(s) assigned to those GMOs
Information passed on but can be if form of unique identifier(s)
Systems and standardised procedures in place to allow the holding of information for a period of five years from each transaction,
Other legislation
Regulation 258/97 Rules for authorisation and labelling of novel foods
and food ingredients Regulation 1946/2003
Sets out procedures that must be followed for the export of GMOs to third countries
Implements obligations under the Cartagena Protocol Recommendation 2003/556
Co-existence of GM and non-GM agriculture Liability and redress systems
Initial Questions
Highly regulated The purpose of regulations should be to insure
safety and efficacy, to limit potential product risks while encouraging innovation and economic development.
Are the regulations effective, appropriate and proportional with respect to virus/vector resistant GM and traditionally-bred crops?
Do we have to many Regulations in EU? If so why?