Genetic Resources & Traditional Knowledge at International Fora

Brief approach to some related issues by Teodora Zamudio

Relevant terms..................................................................................................................................1A. Genetic Resources.....................................................................................................................1B. Traditional Knowledge..............................................................................................................2

C.B.D..................................................................................................................................................3Genetic resources..........................................................................................................................3Traditional knowledge...................................................................................................................5

F.A.O. Genetic Resources for Food & Agricultural.............................................................................6W.I.P.O. Intellectual Property Rights.................................................................................................9

The Committee on GR, TK & F.....................................................................................................10W.T.O./ T.R.I.P.s Agreement & the Doha Round.............................................................................14At the present, some main issues …................................................................................................18

Relevant termsHere a glossary of the prevalent use of relevant terms, according to the international treaties and documents1

A. Genetic ResourcesIn the context of discussions on genetic resources, relevant terms have been defined by international fora working on this theme. In keeping with that prevalent use of terms, for the purposes of WIPO documents and unless expressly otherwise stated:

(i) ‘genetic resources’ means “genetic material of actual or potential value”2 (ii) ‘genetic material’ means “any material of plant, animal, microbial or other origin containing

functional units of heredity.” “Functional units of heredity” are considered to include whole organisms, parts of organisms, and biochemical extracts from tissue samples that contain deoxyribonucleic acid (DNA) or, in some cases, ribonucleic acid (RNA), such as genes, plasmids, etc. The ‘functionality’ of a ‘unit of heredity’ is a matter of interpretation which is highly dependent on the evolution of modern biotechnology3

(iii) ‘biological resources’ means “genetic resources, organisms or parts thereof, populations, or any other biotic component of ecosystems with actual or potential use or value for humanity”4

Genetic resources form one category of biological resources.(iv) ‘plant genetic resources’ means “germplasm or genetic material of actual or potential value” in

the context of international rules for the exploration and collection of plant genetic resources5

The terms “genetic material” or “plant germplasm” in this context mean “reproductive or vegetative propagating material of plants”6

1 Extracted from WIPO/GRTKF/IC/1/3 2 Article 2, CBD.3 Article 2, CBD. While it is not specified which actual or potential value of the resource is meant, a range of qualities are listed which confer value to the components of biodiversity, including genetic resources: the Contracting Parties adopted the CBD conscious of “the ecological, genetic, social, economic, scientific, educational, cultural, recreational and aesthetic values of biological diversity and its components.” (Preamble, CBD, first recital). The implied distinction between genetic material and genetic resource maybe therefore of a merely theoretical nature…4Article 2, CBD. Whereas genetic resources are defined as being “of actual or potential value,” “biological resources” are defined as resources “with actual or potential use or value for humanity.”5 FAO International Code of Conduct for Plant Germplasm Collecting and Transfer (1993), Article 2.86 Ibid., Article 2.9

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(v) in the area of “plant genetic resources for food and agriculture” (PGRFA), the term “plant genetic resources”7 means “the reproductive or vegetative propagating material of the following categories of plants:(a) cultivated varieties (cultivars)8 in current use and newly developed varieties;(b) obsolete cultivars;9

(c) primitive cultivars (landraces);10

(d) wild and weed species,11 near relatives of cultivated varieties; and(e) special genetic stocks (including elite and current breeders’ lines12 and mutants13).”

B. Traditional KnowledgeIn the context of discussions on traditional knowledge, relevant terms have been defined by international fora working on this theme. In keeping with that prevalent use of terms, for the purposes of WIPO documents and unless expressly otherwise stated:

(i) “indigenous knowledge” refers to the knowledge held by “indigenous peoples.”14 (ii) “indigenous communities, peoples and nations” means “those which, having a historical

continuity with ‘pre-invasion’ and pre-colonial societies that developed on their territories, consider themselves distinct from other sectors of the societies now prevailing in those countries, or parts of them. They form at present non-dominant sectors of society and are determined to preserve, develop and transmit to future generations their ancestral territories, and their ethnic identities, as the basis of their continued existence as peoples, in accordance with their own cultural patterns, social institutions and legal systems.”15

(iii) “traditional medicine” means “the sum total of the knowledge, skills and practices based on the theories, beliefs and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health, as well as in the prevention, diagnosis, improvement or treatment of physical and mental illnesses. The terms complementary/alternative/non-conventional medicine are used interchangeably with traditional medicine in some countries.”16

7 International Undertaking on Plant Genetic Resources (1983), Article 2.1(a)8‘Cultivars,’ or ‘cultivated varieties,’ are varieties of a plant produced by selective breeding, which has been specifically improved for agricultural or horticultural purposes and is grown in cultivated conditions.9‘Obsolete cultivars’ refers to formal and informal cultivated varieties which have fallen into disuse and are no longer on the list of traded varieties in those countries which maintain such lists. This does not necessarily correspond to the formal lists for seed certification. 10 Primitive cultivars, or landraces, are crops grown under traditional agricultural systems, which have not undergone much improvement and which, in many cases, have developed from landraces selected by farmers. They are often associated with a specific region or indigenous or local communities and are identifiable by vernacular names.11 Weeds are plant species which are adapted to grow in disturbed or open habitats.12 The terms “current breeders’ line” and “elite lines” are overlapping, since, in plant breeding, a “line” refer to a group of genetically uniform individuals formed from the selfing of a common homozygote parent and an “elite” refers to germplasm which has been manipulated for use in breeding programs, including advanced, inbred and pure lines.13 “Mutants,” i.e. plants which have acquired a heritable variation as a result of mutation, are created by mutation breeding through the use of mutagenic genetics and are used to create variability within a species and alter characteristics. Some of the altered characteristics may be agriculturally useful and can be further selected by the breeder. 14 United Nations Declaration on the Rights of Indigenous Peoples. Preamble, XI° paragraph15 Document E/CN.4/Sub.2/1986/7 and Add. 1-4, “Study of the Problem of Discrimination Against Indigenous Populations,” prepared by Jose Martínez Cobos, Special Rapporteur of the United Nations Sub-Commission on Prevention of Discrimination and Protection of Minorities, Mr. J. Martínez Cobo. Further definitions of the terms “indigenous peoples” and “tribal peoples” are contained in Article 1 of the Indigenous and Tribal Peoples Convention of the International Labor Organization (ILO) (“ILO Convention 169). As in document E/CN.4/Sub.2/1986/7 and Add. 1-4, self-identification as indigenous or tribal is regarded as a fundamental criterion for determining the groups to which the provisions of the term apply (ILO Convention 169, Article 2).16 See WHO General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine. Document WHO/EDM/TRM/2000.

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(iv) “knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity” or abbreviations of this term generally refer to Articles 8(j), 10(c), 17.2 and 18.4 of the Convention on Biological Diversity (CBD), but are not defined in Article 2, CBD. However, in this context “traditional knowledge” has been noted by the Executive Secretary of the CBD as “a term used to describe a body of knowledge built by a group of people through generations living in close contact with nature. It includes a system of classification, a set of empirical observations about the local environment, and a system of self-management that governs resource use. […] In the context of knowledge, innovation is a feature of indigenous and local communities whereby tradition acts as a filter through which innovation occurs. In this context, it is traditional methods of research and application and not always particular pieces of knowledge that persist. Practices should therefore be seen as the manifestations of knowledge and innovation.”17

(v) “local and traditional knowledge”18 and “traditional and local technology, knowledge, know-how and practices”19 generally refer to Articles 16(g), 17.1(c), 18.2(a)-(d) of the United Nations Convention to Combat Desertification in Those Countries Experiencing Serious Drought and/or Desertification, Particularly in Africa. In this context, “traditional knowledge” means subject matter which “consists of practical (instrumental) and normative (enabling) knowledge about the ecological, socio-economic and cultural environment. Traditional knowledge is people-centered (generated and transmitted by people as knowledgeable, competent and entitled actors), systemic (inter-sectorial and holistic), experimental (empirical and practical), transmitted from one generation to the next and culturally valorized. This type of knowledge promotes diversity; it valorizes and reproduces the local (internal) resources.”20

(vi) “traditional knowledge, innovations and creativity,” refers to the creative and innovative aspect of traditional knowledge systems and a preliminary working definition of this term has been used by WIPO for the purposes of its own work from an intellectual property point of view.21

C.B.D. The Convention on Biological Diversity (CBD)22 entered into force on 29 December 1993. It has 3 main objectives: (a) To conserve biological diversity; (b) The use biological diversity in a sustainable fashion; and (c) To share the benefits of biological diversity fairly and equitably. Parties commit themselves to a more effective and coherent implementation of the three objectives of the Convention, to achieve by 2010

The Convention Bodies are: Conference of the Parties; Scientific Body (SBSTTA); Working Group on the Review of Implementation (WGRI); Working Group on ABS; Working Group on Article 8(j); Working Group on Protected Areas. Two of these bodies: (Working Group on ABS and Working Group on Article 8(j)) work, mainly, with two clauses of the Convention: Article 15 and Article 8 (j)

17 See, UNEP/CBD/TKBD/1/2: paragraphs 84 and 86, emphasis added.18 Article 16(g), United Nations Convention to Combat Desertification in Those Countries Experiencing Serious Drought and/or Desertification, Particularly in Africa (1994) (“the UNCCD”).19 Articles 17.1(c), 18.2(a) and (b), UNCCD.20 See ‘Common Understanding of the Term Traditional Knowledge.’ Document ICCD/COP(4)/CST/2, paragraph 30. 21 See, Chapter 5 on ‘Terminology’ of the FFM Report. 22 For the history of this convention see http://www.cbd.int/convention/history.shtml

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Genetic resourcesArticle 1523 (referred to Access to Genetic Resources24) recognizes the sovereign rights of States over their natural resources25, what means that:

the authority to determine access to genetic resources rests with the national governments and is subject to national legislation; but

the States shall attempt to create conditions to facilitate access to genetic resources for environmentally uses by other Contracting Parties26 and not to impose restrictions that run counter to the objectives27 of the Convention28

Getting into the access issues… For this Convention, the genetic resources are those ones that are provided by:

1. the countries that are countries of origin29 of such resources; or,2. the Parties that have acquired 30the genetic resources in accordance with this Convention.

23 Article 15. Access to Genetic Resources: 1. Recognizing the sovereign rights of States over their natural resources, the authority to determine access to genetic resources rests with the national governments and is subject to national legislation. 2. Each Contracting Party shall endeavor to create conditions to facilitate access to genetic resources for environmentally sound uses by other Contracting Parties and not to impose restrictions that run counter to the objectives of this Convention. 3. For the purpose of this Convention, the genetic resources being provided by a Contracting Party, as referred to in this Article and Articles 16 and 19, are only those that are provided by Contracting Parties that are countries of origin of such resources or by the Parties that have acquired the genetic resources in accordance with this Convention. 4. Access, where granted, shall be on mutually agreed terms and subject to the provisions of this Article. 5. Access to genetic resources shall be subject to prior informed consent of the Contracting Party providing such resources, unless otherwise determined by that Party. 6. Each Contracting Party shall endeavor to develop and carry out scientific research based on genetic resources provided by other Contracting Parties with the full participation of, and where possible in, such Contracting Parties. 7. Each Contracting Party shall take legislative, administrative or policy measures, as appropriate, and in accordance with Articles 16 and 19 and, where necessary, through the financial mechanism established by Articles 20 and 21 with the aim of sharing in a fair and equitable way the results of research and development and the benefits arising from the commercial and other utilization of genetic resources with the Contracting Party providing such resources. Such sharing shall be upon mutually agreed terms.24 Titles are always of importance (relative or fundamental…) for interpretation, so keep them in mind such in case you need to fix the limit of the scope…25 Before this Convention, nature was a mankind’s common patrimony, because that it was understood that it and its compounds (like genetic resources) where in free disposition for whoever wanted to access them… (think that the richest countries in biodiversity assets are the poorest in others; so, what the richest took from the nature of the poorest became more wealth for the first ones without any compensation for the second ones…, read below The Committee on GR, TK & F’s starting points)26 Two points here: one it is never going to be a Party (a State) who ask for access but a private company or university (so, was it a type mistake or and the unpredictable development of business?…) and second, USA is not Party but most of the accesses has been asked by American companies (so, they would not have the right to get a facilitate access… or companies do not have nationality (it is a legal doctrine also in some countries)?27 Article 1. Objectives. The objectives of this Convention, to be pursued in accordance with its relevant provisions, are the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding.28 This condition will not apply for indigenous and local communities’ approval!!, just for Parties, and they (the Member-Parties) shall, as far as possible and as appropriate promote their (Traditional Knowledge) wider application with the approval and involvement of the holders [from Article 8 (j)]. So, the Party shall create the legal conditions, the rules but the communities may say “NO”… 29 Because that, many people think about a “certification of origin” (what might be confused with another issue of the Intellectual Property Right, in accordance with TRIPs… or some Free Trade Agreements; so, I do not advice to keep that denomination for the CBD certificate) 30 But it never will be a Party but an institution addressed in that Party… i.e. think in the Kew Garden or in any Zoo… Did they acquire the genetic resource within the plants/animals they got? What about the fito/zoo collection scientists like so mucho to share and even to gift each others, especially when they retire and/or die? Do those acts include the genetically active properties of those individuals? Another situation could show up if the

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What means according to the next requirements…

The requirements for this kind of access (in accordance with CBD) are two:

a. subject to prior informed consent [PIC] of the Contracting Party providing such resources, unless otherwise determined by that Party31

b. share in a fair and equitable way the results of research and development and the benefits arising from the commercial and other utilization of genetic resources with the Contracting Party providing such resources. Such sharing shall be upon mutually agreed terms [MAT]

Traditional knowledgeBesides, the CBD rules in Article 8. Conservation in situ32, section (j) as a “new” asset: the traditional knowledge of the local and indigenous communities. Actually the text imposes to the Parties that, subject to their national legislation:

respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity 33

promote their wider application34 with the approval35 and involvement of the holders of such knowledge, innovations and practices and

access is made through the ex situ collections of plant genetic resources for food and agriculture held by the International Agricultural Research Centers of the Consultative Group on International Agricultural Research administered by F.A.O.31 So, it is pretty dangerous for a Party that does not rule this Access because could it be understood that that country gives up its sovereign rights? or that in use of its sovereign rights decides to leave its resource for free to anybody?32 Some experts want to include the TK collected in libraries or data bases… that is not in situ but ex situ… and scope seems to be ruled differently for genetic resources than for traditional knowledge 33 To get within the CBD, the knowledge shall be related to biodiversity, if it is not associated it will not be protected by its statements34 Which means that only the knowledge in commerce would considered under this section. The sacred, secret knowledge is out of the question, and might be protected by other kind of treaties such as the UNESCO’s treaties: Protection and Promotion of the Diversity of Cultural Expressions (2005); Safeguarding of the Intangible Cultural Heritage (2003); Protection of the Underwater Cultural Heritage (2001); Protection of the World Cultural and Natural Heritage (1972); Prohibiting and Preventing the Illicit Import, Export and Transfer of Cultural Property (1970); Protection of Cultural Property in the Event of Armed Conflict (1954). See http://portal.unesco.org/culture/en/ev.php-URL_ID=34328&URL_DO=DO_TOPIC&URL_SECTION=201.html 35 After all these years experts, negotiators and others arrived to the (for me, wrong) point to consider that it was going to be stronger if it would be understood that “approval” include PIC. I will try to explain my point: APPROVAL is a unilateral manifestation of will, and then it does not endure any other person’s action/decision/manifestation/feeling/ whatsoever… but PIC is another thing… (this concept is not just the result of the simple addition of the concepts of the three words). PIC is a bioethical concept that was built up within the doctor-patient’s relationship… it includes a strong presence of the concept of competence (ability, skills…) to understand the matters to structure a vital decision, then if the person is not considered to have this competence shall be substitute by another one that represents his/her interests; so, i.e., the isolated indigenous communities (of Brazil or Peru) will be substitute –in their PIC- by the State, in that case it would be necessary to find out if they (the States) are under the compromising condition “to facilitate” of Article 15…. Anyway PIC is installed so we have to go on with this concept and build up a new content/essence for it to do not get invaded by the bioethical one

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encourage the equitable36 sharing of the benefits37 arising from the utilization38 of such knowledge, innovations and practices

[GR & TK are also relevant for Climate Change. So, natural and cultural heritages are debated at that Forum because their potential positive roles for disaster reduction as part of sustainable development]39

F.A.O. Genetic Resources for Food & AgriculturalAt present, under the provisions of Article XIV of the FAO Constitution, 16 approved conventions or agreements are in force40. Among these, The FAO Conference, at its Thirty-first Session (November 2001), through Resolution 3/2001, approved the International Treaty on Plant Genetic Resources for Food and Agriculture41; having reached the required number of instruments in order for the Treaty to enter in force on the 29th of June 200442

36 What is EQUITABLE? It is too hard and vane to try to choose a definition, so see by your own at http://en.wikipedia.org/wiki/Equity_theory 37 The same with BENEFIT (see http://en.wiktionary.org/wiki/benefit). Once, I was talking to my students about this issue and I asked “What a shaman will do with 2 millions dollars in the middle of the jungle?” (to show them the ridiculous it was to share money) and one of my students replied: “He could quit being a shaman and go to live in Miami Beach”. After you stop laughing, just think again it is stupid to think that money is something equitable to share, which is my point of view; then again it is necessary a lot of creativeness to imagine “benefits” to share between the people involved in this kind of deal. Business people do not have imagination or what is worse they do not have anything else to share but money; sad, isn’t it? And… do not think that giving them back their own lands, granting them education and/or health could be an answer, because beyond their indigenous or local identity they already have those rights because their citizenships or residencies (at least in Latin America), so if they already have those rights you cannot pay them back for their TK with those “benefits”… the floor is open to suggestions…38 ACCESS and USE are not similar. For example, maybe you will need access first to know if the resource (genetic and/or cultural) is useful for you. So, I propose two instances (if it is necessary), especially for the certificate expedition. The first one for access will allow just that and it won’t give you rights to build on it any further rights such as IP, commercial exploitation, etc.; the second one (for industrial/commercial uses) will give “full use” and will contain not only PIC but benefic-sharing agreement (whatsoever it is understood by benefit). Some “access” will be asked just for academic reasons (i.e. a PhD research) then it could be difficult to share the benefits coming out of that work… 39 World Heritage Decision 31 COM 7.2, 4 and WHC-07/31,COM/7.2 Strategy for Risk Reduction at World Heritage Properties http://whc.unesco.org/download.cfm?id_document=8864 40 Conventions and Agreements concluded under Article XIV of the FAO Constitution: Agreement for the Establishment of the Asia-Pacific Fishery Commission (1948) Constitution of the International Rice Commission (1948) Agreement for the Establishment of a General Fisheries Commission for the Mediterranean (1949) Amended text approved by FAO Council at its 113th Session (November 1997) International Plant Protection Convention (1951) Constitution of the European Commission for the Control of Foot-and-Mouth Disease (1953) Plant Protection Agreement for the Asia and Pacific Region (1955) Convention Placing the International Poplar Commission within the framework of FAO (1959) Agreement for the Establishment of an FAO Commission for Controlling the Desert Locust in South-West Asia (1963) Agreement for the Establishment of a Commission for Controlling the Desert Locust in the Central Region (1965) Agreement for the Establishment of a Commission for Controlling the Desert Locust in North-West Africa (1970) Agreement for the Establishment of a Regional Animal Production and Health Commission for Asia and the Pacific (1973) Agreement to Promote Compliance with International Conservation and Management Measures by Fishing Vessels on the High Seas (1993) Agreement for the Establishment of the Indian Ocean Tuna Commission (1993) Agreement for the Establishment of the Regional Commission for Fisheries (RECOFI) (1999) Agreement for the Establishment of a Commission for Controlling the Desert Locust in the Western Region (2000) International Treaty on Plant Genetic Resources for Food and Agriculture (2001)41 See the text of the Treaty at http://www.fao.org/Legal/treaties/033t-e.htm42 Member who ratified it so far: (56): Angola Australia Austria Bangladesh Belgium Bhutan Brazil Burkina Faso Burundi Cameroon Canada Central African Republic Costa Rica Côte d'Ivoire Cuba Cyprus Denmark Egypt El Salvador Eritrea Ethiopia Finland Gabon Ghana Germany Greece Guatemala India Iran, Islamic Republic of Ireland Italy Jordan Lebanon Luxembourg Madagascar Malawi Mali Morocco Namibia Niger Norway Peru Senegal Spain Sudan Sweden Switzerland Syrian Arab Republic Togo Tunisia Turkey United Kingdom Uruguay Venezuela Zambia Zimbabwe

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This legally-binding Treaty covers all plant genetic resources relevant for food and agriculture, it provides in its Article 15 that the Contracting Parties:

(i) recognize the importance of the ex situ collections of plant genetic resources for food and agriculture held by the International Agricultural Research Centers of the Consultative Group on International Agricultural Research, and other International Institutions; and

(ii) call upon the International Agricultural Research Centers to sign agreements with the Governing Body of the Treaty with regard to such ex situ collections. At present, 15 agreements have been signed43.

(iii) also recognizes the contribution that farmers and their communities have made and continue to make to the conservation and development of plant genetic resources. This is the basis for Farmers' Rights, which include the protection of traditional knowledge, and the right to participate equitably in benefit-sharing and in national decision-making about plant genetic resources.

However, in my opinion this treaty fails somehow to be realistic in terms of the implementation of its proposed measures related with CBD’s statements, for instance and just as examples:

Inventory and collections: Article 6.2 (b) refers to ‘strengthening research which enhances and conserves biological diversity by maximizing intra- and inter-specific variation for the benefit of farmers…’ Before this can happen, there needs to be greater knowledge of what diversity currently exists and why farmers may or may not continue to use it, particularly if they have sustained loss of diversity.

Farmers can only be introduced to Farmer Participatory Breeding (see Article 6.2 (c)) 44, which has proved so successful in other regions of the world if knowledge exists about landraces to be utilized.

43 Agreements concluded under Article 15 of the International Treaty on Plant Genetic Resources for Food and Agriculture subscribed in 2006: Tropical Agricultural Research and Higher Education Center Africa Rice Center |Bioversity International |International Centre for Tropical Agriculture |International Maize and Wheat Improvement Center |International Centre for Agricultural Research in the Dry Areas |International Crops Research Institute for the Semi-Arid Tropics |International Institute of Tropical Agriculture |International Livestock Research Institute |International Potato Center |International Rice Research Institute |World Agroforestry Centre; and in 2007: International Coconut Genetic Resources Network | International Coconut Genebank for the South Pacific | Division mixte FAO/AIEA des techniques nucléaires44 International Treaty on Plant Genetic Resources for Food and Agriculture Article 6 – Sustainable Use of Plant Genetic Resources. 6.1 The Contracting Parties shall develop and maintain appropriate policy and legal measures that promote the sustainable use of plant genetic resources for food and agriculture. 6.2 The sustainable use of plant genetic resources for food and agriculture may include such measures as: (a) pursuing fair agricultural policies that promote, as appropriate, the development and maintenance of diverse farming systems that enhance the sustainable use of agricultural biological diversity and other natural resources; (b) strengthening research which enhances and conserves biological diversity by maximizing intra- and inter-specific variation for the benefit of farmers, especially those who generate and use their own varieties and apply ecological principles in maintaining soil fertility and in combating diseases, weeds and pests; (c) promoting, as appropriate, plant breeding efforts which, with the participation of farmers, particularly in developing countries, strengthen the capacity to develop varieties particularly adapted to social, economic and ecological conditions, including in marginal areas; (d) broadening the genetic base of crops and increasing the range of genetic diversity available to farmers; (e) promoting, as appropriate, the expanded use of local and locally adapted crops, varieties and underutilized species; (f) supporting, as appropriate, the wider use of diversity of varieties and species in on-farm management, conservation and sustainable use of crops and creating strong links to plant breeding and agricultural development in order to reduce crop vulnerability and genetic erosion, and promote increased world food production compatible with sustainable development; and (g) reviewing, and, as appropriate, adjusting breeding strategies and regulations concerning variety release and seed distribution

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While agreement of the Parties has been reached over farmers’ rights45, access to PGRFA46 and benefit sharing47, it is apparent that the consequences of these agreements do not easily filter down to individual farmers [see below, next paragraphs].

The questions also deal with farmer incentives for keeping and sustainably using diverse PGRFA. For this question to be addressed with any chance of a positive outcome for local farmers, a dialogue between scientists and farmers needs to take place.

The Governing Body adopted, in particular, the Standard Material Transfer Agreement48, that is the legal instrument by which plant genetic resources for food and agriculture under the Treaty’s Multilateral System of Access and Benefit-Sharing can be accessed, and which makes provision for the fair and equitable sharing of the commercial benefits resulting from the use of such resources.

45 International Treaty on Plant Genetic Resources for Food and Agriculture. Article 9 – Farmers’ Rights 9.1 The Contracting Parties recognize the enormous contribution that the local and indigenous communities and farmers of all regions of the world, particularly those in the centres of origin and crop diversity, have made and will continue to make for the conservation and development of plant genetic resources which constitute the basis of food and agriculture production throughout the world. 9.2 The Contracting Parties agree that the responsibility for realizing Farmers’ Rights, as they relate to plant genetic resources for food and agriculture, rests with national governments. In accordance with their needs and priorities, each Contracting Party should, as appropriate, and subject to its national legislation, take measures to protect and promote Farmers’ Rights, including: (a) protection of traditional knowledge relevant to plant genetic resources for food and agriculture; (b) the right to equitably participate in sharing benefits arising from the utilization of plant genetic resources for food and agriculture; and (c) the right to participate in making decisions, at the national level, on matters related to the conservation and sustainable use of plant genetic resources for food and agriculture. 9.3 Nothing in this Article shall be interpreted to limit any rights that farmers have to save, use, exchange and sell farm-saved seed/propagating material, subject to national law and as appropriate46 International Treaty on Plant Genetic Resources for Food and Agriculture Article 12 – Facilitated access to plant genetic resources for food and agriculture within the Multilateral System […] 12.3 Such access shall be provided in accordance with the conditions below: (a) Access shall be provided solely for the purpose of utilization and conservation for research, breeding and training for food and agriculture, provided that such purpose does not include chemical, pharmaceutical and/or other non-food/feed industrial uses. In the case of multiple-use crops (food and non-food), their importance for food security should be the determinant for their inclusion in the Multilateral System and availability for facilitated access. (b) Access shall be accorded expeditiously, without the need to track individual accessions and free of charge, or, when a fee is charged, it shall not exceed the minimal cost involved; (c) All available passport data and, subject to applicable law, any other associated available non-confidential descriptive information, shall be made available with the plant genetic resources for food and agriculture provided; (d) Recipients shall not claim any intellectual property or other rights that limit the facilitated access to the plant genetic resources for food and agriculture, or their genetic parts or components, in the form received from the Multilateral System; (e) Access to plant genetic resources for food and agriculture under development, including material being developed by farmers, shall be at the discretion of its developer, during the period of its development; (f) Access to plant genetic resources for food and agriculture protected by intellectual and other property rights shall be consistent with relevant international agreements, and with relevant national laws; (g) Plant genetic resources for food and agriculture accessed under the Multilateral System and conserved shall continue to be made available to the Multilateral System by the recipients of those plant genetic resources for food and agriculture, under the terms of this Treaty; and (h) Without prejudice to the other provisions under this Article, the Contracting Parties agree that access to plant genetic resources for food and agriculture found in in situ conditions will be provided according to national legislation or, in the absence of such legislation, in accordance with such standards as may be set by the Governing Body. […]47 International Treaty on Plant Genetic Resources for Food and Agriculture Article 13 - Benefit-sharing in the Multilateral System […] 13.2 The Contracting Parties agree that benefits arising from the use, including commercial, of plant genetic resources for food and agriculture under the Multilateral System shall be shared fairly and equitably through the following mechanisms: the exchange of information, access to and transfer of technology, capacity-building, and the sharing of the benefits arising from commercialization, taking into account the priority activity areas in the rolling Global Plan of Action, under the guidance of the Governing Body: […] (d) Sharing of monetary and other benefits of commercialization: (i) The Contracting Parties agree, under the Multilateral System, to take measures in order to achieve commercial benefit-sharing, through the involvement of the private and public sectors in activities identified under this Article, through partnerships and collaboration, including with the private sector in developing countries and countries with economies in transition, in research

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The Standard Material Transfer Agreement provides for payment to the Treaty’s Funding Strategy of 1.1% of the sales of a commercialized product, such as a new crop variety, which incorporates material accessed from the Multilateral System, when there are restrictions such as patent protection, that result in the product not being freely available to others for research and breeding.

Users of the Multilateral System can also opt for a crop-based payment system, whereby they pay at a lower rate (0.5%), on all their commercialized products of a particular crop, regardless of whether material from the Multilateral System is incorporated in those products, and whether or not they are freely available to others for research and breeding.

At its ninth session, the Commission on Genetic Resources for Food and Agriculture CGRFA requested that WIPO cooperate with FAO in preparing a study on how intellectual property rights might affect the availability and use of material from the International Network and the International Treaty. In response to this request, WIPO and FAO have cooperated to analyze how IP rights might affect the availability and use of plant genetic resources for food and agriculture49

(i) The first report from WIPO only considered patents, rather than intellectual property more generally. One initial pathway to gaining insights on this question was to build up an information base on relevant patents and patent applications50.

(ii) In 2006, WIPO provided a second progress report on the follow-up work identified in its first findings to the first session of the Governing Body of the International Treaty 51 This Progress Report contained a factual description of the international patent landscape surrounding gene promoters relevant to rice52. The Report noted that similar searches would be conducted for maize, potato and soybean, and would subsequently be added to the Report.

W.I.P.O. Intellectual Property Rights

The need for international protection of intellectual property became evident when foreign exhibitors refused to attend the International Exhibition of Inventions in Vienna in 1873 because they were afraid

and technology development; (ii) The Contracting Parties agree that the standard Material Transfer Agreement referred to in Article 12.4 shall include a requirement that a recipient who commercializes a product that is a plant genetic resource for food and agriculture and that incorporates material accessed from the Multilateral System, shall pay to the mechanism referred to in Article 19.3f, an equitable share of the benefits arising from the commercialization of that product, except whenever such a product is available without restriction to others for further research and breeding, in which case the recipient who commercializes shall be encouraged to make such payment. The Governing Body shall, at its first meeting, determine the level, form and manner of the payment, in line with commercial practice. The Governing Body may decide to establish different levels of payment for various categories of recipients who commercialize such products; it may also decide on the need to exempt from such payments small farmers in developing countries and in countries with economies in transition. The Governing Body may, from time to time, review the levels of payment with a view to achieving fair and equitable sharing of benefits, and it may also assess, within a period of five years from the entry into force of this Treaty, whether the mandatory payment requirement in the MTA shall apply also in cases where such commercialized products are available without restriction to others for further research and breeding. […]48 See complete text at ftp://ftp.fao.org/ag/cgrfa/gb1/SMTAe.pdf 49 CGRFA/MIC-2/04/Inf.5, ftp://ftp.fao.org/ag/cgrfa/mic2/m2i5e.pdf 50 The main insight from these preliminary sample searches was to illustrate the choices involved in developing a search method, and the type of data that might be obtained through its use51 Progress Report on Work Towards the Assessment of Patent Data Relevant to Agricultural Biotechnology and the Availability and Use of Material from the International Network of ex-situ Collections Under the Auspices of FAO and the International Treaty: A Draft Patent Landscape Surrounding Gene Promoters Relevant to Rice IT/GB-1/06/Inf.17.52 Rice had been selected by FAO and WIPO for the draft patent landscape because of its crucial importance for food security. FAO selected gene promoters as an illustrative technology for the initial set of patent searches and analysis. Gene promoters regulate the transcription of genetic information from DNA (gene expression), and are therefore key tools in agricultural biotechnology and in the use of plant genetic resources for food and agriculture in research and development

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their ideas would be stolen and exploited commercially in other countries53. The negotiations that followed determined that in 1883, 14 countries54 gave birth to the Paris Convention for the Protection of Industrial Property, the first major international treaty designed to help the people of one country obtain protection in other countries for their intellectual creations in the form of industrial property rights, known as: inventions (patents) trademarks industrial designs. In 1886, copyright entered the international arena with the Berne Convention for the Protection of Literary and Artistic Works55.

WIPO was established by the WIPO Convention in 1967. In 1974, WIPO became a specialized agency of the United Nations system, with a mandate to administer intellectual property matters recognized by the member States of the UN. Nowadays, WIPO administers 24 treaties.

The rationale of the IP system is quite simple: if something –an immaterial “thing”- is useful, it has to have an owner (that person who developed the “something”) with property rights to exploit it exclusively and exclude others to do so without his/her permission and paying him/her for that use. There are several “categories” within the IP system for each kind of immaterial, useful “something”… they had started as exceptions, as sui generis56 rights, and then they consolidated their legal and economical existence as they got used: innovation, trademark, model of utility, design and industrial model, software, integrated circuit, new plant varieties, etc. each category has its own requirements according with the subject each one protects. These rights are not absolute and endure just for certain amount of time; also, they are not easy to obtain (the “something” has to responds to specific requirements57 and proceedings of evaluation) and each country has its own registering, interpretative and enforcement rules… here is the main importance of international treaties: try to put together all those national regulations without hurt the nationals sovereignties, about this point WTO/TRIPs went further and deeper than WIPO’s treaties58…

WIPO’s treaties have two characteristics that make them soft:

Parties may declare “reserves” to some rules of the treaties they sign and ratify; so, not all their clauses might be binding for every Party in the same scale.

The WIPO’s treaties do not have a Dispute Settlement Body for the Resolution of Conflicts and Differences. If a Party does not accomplish the compromises they assumed, the legal proceedings shall take place at the International Court of Justice of La Hague.

Those characteristics59 finally convinced developed countries to include IP in the Uruguay Round of the GATT Negotiations60… and in 1996 WIPO entered into a cooperation agreement with the World Trade Organization (WTO).

But the challenges for WIPO were far to end… At the beginning of the IXX century, intellectual property issues related to genetic resources, traditional knowledge and folklore have emerged in a wide range of policy areas, including food and agriculture, biological diversity and the environment, human rights, cultural policy, trade and economic development. Discussions about such uses of genetic resources,

53 An old film A Breath of Scandal (1960) with Maurice Chevalier, Sophia Loren and John Gavin (it was not a good performance from any of them) placed a romance in the middle of that historical battle. 54 Belgium, Brazil, France, Italy, Netherlands, Portugal, Spain, Switzerland, Tunisia & United Kingdom55 See more about WIPO’s history at http://www.wipo.int/treaties/en/general/ 56 Sui generis is a neo-latin expression, literally meaning of its own kind/genus or unique in its characteristics. The expression was effectively created by scholastic philosophy to indicate an idea, an entity or a reality that cannot be included in a wider concept57 To obtain a Patent the product or process (the “something”) shall have: novelty – non obviousness – industrial application. Apparently quite simple, but… For instance, what is new? something unknown (or unregistered) till the moment the inventor vindicate it?, or something that did not exist before?... when you have to demonstrate that you invention is “new” the difference matters a lot…58 WIPO had the brain… WTO put the muscles!!! 59 And for some experts there was a third ideological circumstance: since the 60’ till the 80’, WIPO’s meeting and assemblies were the “third position” countries -they were called the “Group of the 70s”- showed to be a hard floor to deal with, and other scenario was necessary…60 Where TRIPs is a binding agreement for Members -without any possibility to make “reserves”- and it has structured an Dispute Settlement Body, I will come back over this Agreement, later

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traditional knowledge and folklore have linked the protection of intellectual property to policy objectives as diverse as the promotion of free trade, environmental conservation, food security, cultural diversity, etc. These linkages, established by discussions in other international fora (such as CBD first and right after in WTO, FAO and others) have significant technical, administrative and policy implications for the intellectual property system. So, the WIPO General Assembly, at its Twenty-Sixth Session, held in Geneva from September 26 to October 3, 2000, established an Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (“the Committee”). Three primary themes were identified:

(i) access to genetic resources and benefit-sharing, (ii) the protection of traditional knowledge, innovations and creativity, and (iii) the protection of expressions of folklore, including handicrafts

As you may notice the scope is much broader since the considered issues which include not only the TK related to genetic (or biological) resources but all TK’s expressions …

The Committee on GR, TK & FThe document prepared by the Secretariat61 for the first meeting of the Committee gave certain basis of why the three themes [genetic resources, traditional knowledge and folklore] should be treated altogether. From the intellectual property point of view, these themes share –according to WIPO- certain common characteristics62.

I. The first common characteristic of the three themes before the Committee is that the concept of “common heritage” has been applied to genetic resources63, traditional knowledge64, and folklore65. The intangible elements of this common heritage were available for use and, from the intellectual property point of view, were considered to be in the public domain66. The primary international policy objective was the preservation of the common heritage. Other creators and innovators could freely utilize elements of this heritage from the public domain in their creations and innovations, which might then give rise to intellectual property rights.

In recent years, new technologies and scientific discoveries have generated unprecedented ways for creators and innovators to utilize certain elements of this common heritage, and consequently attention has shifted from the preservation towards the utilization of such heritage. Certain elements of the common heritage are now seen as resources (i.e., material of actual or potential value) which are provided to the innovator or creator, rather than being freely available to him in the public domain. Hence the public domain [as “in free disposition”] status of the material has been called into question.

61 See document WIPO/GRTKF/IC/1/3, from where I transcribe the next concepts in the text, with my comments in footnotes or into brackets. 62 See document WO/GA/26/10, paragraphs 50, 54, 59. See also ‘A Policy and Action Agenda for the Future.’ Meeting Statement. WIPO Inter-Regional Meeting on Intellectual Property and Traditional Knowledge, Chiang Rai, Thailand, November 9 to 11, 2000 (“the Chiang Rai Statement”).63Genetic resource policy was based on “the universally accepted principle that plant genetic resources are a heritage of mankind and consequently should be available without restriction” (Article 1, International Undertaking on Plant Genetic Resources (1983))64For example, “[m]ovable cultural property representing the different cultures forms part of the common heritage of mankind.” (Preamble, Recommendation for the Protection of Movable Cultural Property (1964))65For example, “folklore forms part of the universal heritage of humanity” (Recommendation on the Safeguarding of Traditional Culture and Folklore (1989), Preamble); “folklore represents an important part of the living cultural heritage of the nation” (UNESCO-WIPO Model Provisions for National Laws on the Protection of Expressions of Folklore for Illicit Exploitation and Other Prejudicial Actions (1982), Preamble)66 That’s why I rejected to use that concept: if we keep using concepts from the old times of the IP and scientific freedom to research with any purposes… we could never be in condition to establish an adequate scope to protect economic rights for the TK’s holders which allow some balance between providers and users… anyway it is a task within restrictively economic considerations and I am afraid they would not be enough (or the right ones) … Trying to be clearer: I do not think these economic equations would be enough (or the right ones) to preserve TK and/or its holders and I do not think those equations would be enough (or the right ones) to compensate them

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The equity of intellectual property rights is discussed not only in the balance between the rights of the creator and society as the user of his creation, but also in the balance of rights between the creator and society as the provider of heritage resources which he utilizes in his creation. This is the case especially where the provider has conserved the common heritage for generations under in-situ conditions, i.e. in the surroundings where the resource developed its distinctive properties. This principle concerning the equity of intellectual property is now applied in the discussions on genetic resources, traditional knowledge and folklore.

II. The second common characteristic of genetic resources, traditional knowledge and folklore is that they constitute subject matter which transforms and evolves beyond the logic of individualized human intellectual activity. Genetic resources complicate the boundaries of human innovation, because they are self-replicating, living resources. Similarly, the traditions which underlie traditional knowledge and folklore evolve across individuals and generations. In both contexts, human creativity and innovation create considerable value. However, in both cases the resource reproduces and transforms itself in a logic that lies beyond, and is independent of, the individualized creativity and innovation from which existing intellectual property rights result. Because of this distinctive quality, there have been discussions under each theme about a possible need to establish new and specific intellectual property standards, which address their unique nature.

III. The third common characteristic is that each theme cuts across a spectrum between formal and informal innovation and creativity. Informal innovators and creators have raised new claims for intellectual property protection67. The cross-cutting nature of the subject matter has increasingly introduced a new quid-pro-quo68 rationale into the discussion on intellectual property in these areas. According to this reasoning, the creation of new intellectual property rights for formal innovations in a certain subject matter is seen as contingent upon the creation of cognate rights for informal innovations relating to the same or similar subject matter. An early expression of this rationale occurred in 1989 in the field of plant genetic resources for food and agriculture, in the form of two simultaneously adopted resolutions, one recognizing farmers’ rights and the other recognizing plant breeders’ rights69. Since then, this rationale has been extended to the three themes of genetic resources, traditional knowledge and folklore in a variety of international fora and processes70.

67 ‘Informal innovators’ have been defined as “countries, communities and individuals, generally working at the local level, that have through generations developed and conserved local technologies and products including plant genetic resources without having obtained formal recognition of their innovative labor or right related to it.” The complementary definition of ‘formal innovators’ includes a reference to intellectual property rights: “each physical or juridical person developing new technologies and products, that could be a private or a researcher working in formally recognized governmental or non-governmental institutions whose inventions may be formally recognized through the intellectual property rights system.” See, Article 3, draft FAO International Code of Conduct on Plant Biotechnology as it affects the Conservation and Utilization of Plant Genetic Resources (“the FAO Code of Conduct on Plant Biotechnology”).68 A Latin phrase meaning "something for something". This term is typically used in financial circles to describe a mutual agreement between two parties in which each party provides a good or service in return for a good or service. Quid pro quo agreements are sometimes viewed negatively. For example, in a quid pro quo agreement between a large financial house and a company, the financial house might alter poor stock ratings in exchange for company business. A positive example of a quid pro quo agreement is a soft money agreement. In a soft money agreement, one firm A uses another firm B’s research. In exchange, Firm B executes all of Firm A's trades. This exchange of services is used as payment in lieu of a traditional, hard money payment69See, Resolutions 4/89 and 5/89, adopted by the Twenty-fifth Session of the FAO Conference, Rome, November 11 to 29, 1989, and incorporated into the International Undertaking as Annexes I and II, respectively.70 The FAO Code of Conduct on Plant Biotechnology has as one of its objectives “to balance the rights of formal and informal innovators” (Article 1.5). The revision of the International Undertaking recognizes modern intellectual property rights as well as “the enormous contribution which farmers of all regions of the world, particularly those in the centers of origin and crop diversity, have made and will continue to make for the … development of plant genetic resources” (Chairman’s Elements Derived from the Monteux Meeting, 19-22 January 1999, element 5).

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Nowadays, Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore -fourteenth Session in Geneva, June 29 to July 3, 2009 71- has covered three main areas:

(i) defensive protection of genetic resources; (ii) IP aspects of access to genetic resources and equitable benefit-sharing arrangements that

govern use of genetic resources;(iii) disclosure requirements in patent applications for information related to genetic resources and

traditional knowledge used in the claimed invention and alternative proposals for dealing with the relationship between IP and genetic resources.

71 The pre-documents coming out of this meeting are on-line at http://www.wipo.int/meetings/es/details.jsp?meeting_id=17452 (the conclusions will be on-line soon, I guess) and also if you want to follow up the whole process since 2001 see http://www.wipo.int/meetings/es/topic.jsp?group_id=110. In a very brief extraction it could be told that the objectives and principles built on the Committee’s work on the elements of protection of TK that commenced in 2001: (a) Second session (December 2001): Delegations of the African Group, Venezuela, supported by the Delegations of Brazil, Ecuador and Egypt, request the preparation of a document with “elements for a possible sui generis system” [WIPO/GRTKF/IC/2/16, paragraphs 188, 189, 190, 191; recorded in Chairman’s Conclusions, paragraph 194] (b) Third session (June 2002): the Committee considered “Elements of a Sui Generis System for the Protection of Traditional Knowledge”, which set out eight core elements. [WIPO/GRTKF/IC/3/8, paragraphs 29 to 57 (“V. Elements of a Sui Generis System for the Protection of Traditional Knowledge”)] Based on these elements, the Delegation of Norway proposed “to provide protection for TK … using Article 10bis [of the Paris Convention] as a model when considering the framework of a sui generis system for TK” and “to have a general international norm that obliged the States to offer protection against unfair exploitation of TK … supplied with internationally agreed guidelines on how to apply the norm”. [WIPO/GRTKF/IC/3/17, paragraph 227] The Committee decided to “prepare an amended … version of the document … taking into account the suggestion made by the Delegation of Norway” [WIPO/GRTKF/IC/3/17, paragraph 249, item 3] and to “discuss whether it would be possible to provide protection for TK along similar lines as in article 10bis of the Paris Convention concerning unfair competition”. [WIPO/GRTKF/IC/3/17, paragraph 249, item 3] The Committee invited written comments on the contents of sui generis TK systems and, based on the comments, requested a revised draft text on the core elements of TK protection; [WIPO/GRTKF/IC/3/17, paragraph 249, items 2 and 4] (c) Fourth session (December 2002): the Committee considered a revised version of the core elements [WIPO/GRTKF/IC/4/8], which incorporated the Norwegian proposal and the comments and observations of Committee members. It decided to incorporate the core elements of sui generis systems for TK into a composite study, aiming for “a more concrete analysis of specific options” [WIPO/GRTKF/IC/4/15, paragraph 163(i)]; (d) Fifth session (July 2003): the Committee conducted a comparative analysis of ten existing sui generis TK laws, [Including those of the African Union, Brazil, China, Costa Rica, India, Peru, Philippines, Portugal, Thailand and the United States of America: see WIPO/GRTKF/IC/5/INF/4, WIPO/GRTKF/IC/5/INF/6 and WIPO/GRTKF/IC/5/INF/7]. It also heard a Panel on national experiences with these laws, which became the basis for the development of the draft objectives and principles; (e) Sixth session (December 2003): the Committee welcomed an African Group proposal on “Objectives, Principles and Elements of an International Instrument, or Instruments”. [WIPO/GRTKF/IC/6/12] Support was expressed for ten “key principles and objectives of TK protection”. [For the ten key principles of TK protection see WIPO/GRTKF/IC/6/4, paragraphs 17 to 28; and WIPO/GRTKF/IC/6/14, paragraph 109] The Committee agreed to develop “first drafts of an overview of policy objectives and core principles” of TK protection; [WIPO/GRTKF/IC/6/4, paragraph 104, and WIPO/GRTKF/IC/6/14, paragraph 109] (f) Seventh session (November 2004): the Committee considered draft objectives and principles on the protection of TK, based on proposals, discussion and documented approaches from the previous five sessions. [WIPO/GRTKF/IC/7/5] (maybe you would like to read the proposals made by Kyrgyz Republic |Brazil |Ghana |Belize |Colombia |European Community and its Member States |African Group |Switzerland |United States of America |Australia |Turkey |Japan |Russian Federation |Peru on behalf of Andean Community |Islamic Republic of Iran, available at http://www.wipo.int/tk/en/genetic/proposals/index.html) The Committee agreed that the draft should provide a basis for preparing further drafts of the objectives and principles [WIPO/GRTKF/IC/7/15, paragraph 149] and called for “comments on the draft … including specific suggestions for wording” within an agreed timeframe, which would provide the basis for the preparation of the next draft. [WIPO/GRTKF/IC/7/15, paragraph 150] Extensive comments were provided, [WIPO/ GRTKF/IC/8/INF/4] including specific suggestions for wording, on the draft Objectives and Principles on the protection of TK and TCEs. As noted, these comments were integrated into the revised draft provisions for consideration at the eighth session. (g) Eighth session (June 2005): after reviewing this revised draft (WIPO/GRTKF/IC/8/5), the Committee concluded that there was broad support for the process

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Also the Committee was considering -at this meeting- the protection of traditional knowledge (“TK”) through three related and complementary processes:

(i) consideration of an agreed List of Issues concerning the protection of TK; (ii) consideration of a draft set of “Revised Objectives and Principles for the Protection of

Traditional Knowledge” (“Objectives and Principles”)72; and(iii) a draft gap analysis on the protection of TK.

In final words; the recurring issues –in this Forum- include the following:

a) nature of the subject matter of TK, and possible descriptions or definitions;b) criteria for protection of subject matter;c) identity of owners, bearers or custodians of TK, or other beneficiaries of protection;d) nature of protection, including the possible need for formalities and the possible role of

registration and other forms of official notice;e) scope of rights and exceptions;f) duration of protection;g) role of government agencies or other authorities;h) relationship with conventional IP protection, and international and national legal measures

concerning the recognition of farmer’s rights and the in-situ conservation of biodiversity, including the preservation, promotion and protection of biodiversity-related TK, and legal frameworks regulating access to genetic resources and benefit-sharing;

i) transitional measures, retroactivity of protection and the role and status of the public domain;j) international and regional protection;k) recognition of foreign right holders and other foreign beneficiaries of protection.

W.T.O./ T.R.I.P.s Agreement & the Doha RoundThe World Trade Organizations was created by the Uruguay Round (1986-1994) of GATT (General Agreements on Trade and Taxes) and it launched on January 1st of 1995. WTO is the world multilateral trading system, based on several agreements73, negotiated and signed by a large majority of the world’s trading nations74, and ratified in their parliaments. These agreements are the legal ground-rules for international commerce.

and work it was undertaking on TK [WIPO/ GRTKF/IC/8/15 Prov, paragraph 162] but “noted the diverse views expressed” on this issue. [WIPO/ GRTKF/IC/8/15 Prov, paragraph 163] The WIPO General Assembly subsequently agreed in October 2005 to renew the mandate of the Committee to continue its current mandate for the 2006 2007 biennium. (h) Ninth session (April 2006): on taking up its renewed mandate, the Committee continued its review of the draft objectives and principles (reissued unaltered as the annex to WIPO/GRTKF/IC/9/5), and commissioned a further intersessional commentary process.72 The draft objectives and principles comprise: (i) policy objectives, which could set common general directions for protection and provide a consistent policy framework; (ii) general guiding principles, which could ensure consistency, balance and effectiveness of substantive principles; and (iii) specific substantive principles, which could define the legal essence of protection. These principles should be respected to ensure that the specific substantive provisions concerning protection are equitable, balanced, effective and consistent, and appropriately promote the objectives of protection: (a) Principle of responsiveness to the needs and expectations of traditional knowledge holders (b) Principle of recognition of rights (c) Principle of effectiveness and accessibility of protection (d) Principle of flexibility and comprehensiveness (e) Principle of equity and benefit sharing (f) Principle of consistency with existing legal systems governing access to associated genetic resources (g) Principle of respect for and cooperation with other international and regional instruments and processes (h) Principle of respect for customary use and transmission of traditional knowledge (i) Principle of recognition of the specific characteristics of traditional knowledge (j) Principle of providing assistance to address the needs of traditional knowledge holders73 The Legal Texts is a daunting list of about 60 agreements, annexes, decisions and understandings. In fact, the agreements fall into a simple structure with six main parts: an umbrella agreement (the Agreement Establishing the WTO); agreements for each of the three broad areas of trade that the WTO covers (goods, services and intellectual property, the reasons for including an Agreement about IP has been told above in the paragraph dedicated to W.I.P.O. Intellectual Property Rights); dispute settlement; and reviews of governments’ trade policies. The agreements for the two largest areas — goods and services — share a common three-part outline, even though the detail is sometimes quite different. See more at http://www.wto.org/english/thewto_e/whatis_e/tif_e/agrm1_e.htm

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The agreements were negotiated and signed by governments. But their purpose is to help producers of goods and services, exporters, and importers conduct their business. Virtually all decisions in the WTO are taken by consensus among all member countries and they are ratified by members' parliaments. Essentially, the system:

binds governments to keep their trade policies within agreed limits to everybody’s benefit. routes trade friction into the WTO's dispute settlement process where the focus is on

interpreting agreements and commitments, and how to ensure that countries' trade policies conform to them.

In 2001, the Declaration of the Fourth Ministerial Conference in Doha75, Qatar, provides the mandate for negotiations on a range of subjects which include those on agriculture and services, which began in early 2000. In Doha, Ministers also approved a linked decision on implementation problems of the developing countries. The original mandate has now been refined by work at Cancún in 2003, Geneva in 2004, and Hong Kong in 200576. The Paragraph 1977 has broadened the discussion about the PIC&ABS/CBD and TRIPs:

T.R.I.P.s Council should also look at the relationship between the T.R.I.P.s Agreement and the UN Convention on Biological Diversity, the protection of traditional knowledge and folklore (this last issue is not include in CBD since it is not related to biodiversity, but to WIPO’s approach).

T.R.I.P.s Council’s work on these topics has to be guided by the T.R.I.P.s Agreement’s objectives78 and principles79, and must take development issues fully into account.

74 Members (153): Albania Angola Antigua and Barbuda Argentina Armenia Australia Austria Bahrain, Kingdom of Bangladesh Barbados Belgium Belize Benin Bolivia Botswana Brazil Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Central African Republic Chad Chile China Colombia Congo Costa Rica Côte d'Ivoire Croatia Cuba Cyprus Czech Republic Democratic Republic of the Congo Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Estonia European Communities Fiji Finland Former Yugoslav Republic of Macedonia (FYROM) France Gabon Gambia Georgia Germany Ghana Greece Grenada Guatemala Guinea Guinea-Bissau Guyana Haiti Honduras Hong Kong, China Hungary Iceland India Indonesia Ireland Israel Italy Jamaica Japan Jordan Kenya Korea, Republic of Kuwait Kyrgyz Republic Latvia Lesotho Liechtenstein Lithuania Luxembourg Macao, China Madagascar Malawi Malaysia Maldives Mali Malta Mauritania Mauritius Mexico Moldova Mongolia Morocco Mozambique Myanmar Namibia Nepal Netherlands — For the Kingdom in Europe and for the Netherlands Antilles New Zealand Nicaragua Niger Nigeria Norway Oman Pakistan Panama Papua New Guinea Paraguay Peru Philippines Poland Portugal Qatar Romania Rwanda Saint Kitts and Nevis Saint Lucia Saint Vincent & the Grenadines Saudi Arabia Senegal Sierra Leone Singapore Slovak Republic Slovenia Solomon Islands South Africa Spain Sri Lanka Suriname Swaziland Sweden Switzerland Chinese Taipei Tanzania Thailand Togo Tonga Trinidad and Tobago Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom United States of America Uruguay Venezuela (Bolivarian Republic of) Viet Nam Zambia Zimbabwe. And observers (30): Afghanistan Algeria Andorra Azerbaijan Bahamas Belarus Bhutan Bosnia and Herzegovina Comoros Equatorial Guinea Ethiopia Holy See (Vatican) Iran Iraq Kazakhstan Lao People's Democratic Republic Lebanese Republic Liberia, Republic of Libya Montenegro Russian Federation Samoa Sao Tomé and Principe Serbia Seychelles Sudan Tajikistan Uzbekistan Vanuatu Yemen. 75 See it at http://www.wto.org/english/thewto_e/minist_e/min03_e/min03_e.htm 76 See brief summaries about these Declarations at http://www.wto.org/english/tratop_e/dda_e/dda_e.htm 77 Ministrial Declaration of Doha. Paragraph 19. We instruct the Council for TRIPs, in pursuing its work program including under the review of Article 27.3(b), the review of the implementation of the TRIPs Agreement under Article 71.1 and the work foreseen pursuant to paragraph 12 of this declaration, to examine, inter alia, the relationship between the TRIPs Agreement and the Convention on Biological Diversity , the protection of traditional knowledge and folklore, and other relevant new developments raised by members pursuant to Article 71.1. In undertaking this work, the TRIPs Council shall be guided by the objectives and principles set out in Articles 7 and 8 of the TRIPS Agreement and shall take fully into account the development dimension.78 TRIPs. Article 7 Objectives. The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations79 TRIPs. Article 8 Principles. 1. Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent

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Different views have been expressed about linkages between the issues of Geographical Indicators extension & Register and T.R.I.P.s/CBD80 “disclosure” (required for patents) and also between these issues and work elsewhere81.

This “disclosure” -when claiming for a patent- would be a new clause (Article 29 bis) for the TRIPs which would require “evidence” of the PIC/BS and MAT82 to consider any claim of patent on biotechnological inventions83.

The debate focuses on how the TRIPS Agreement relates to the Convention on Biological Diversity84. The ideas put forward include:

1. Disclosure as a TRIPS obligation: A group represented by Brazil and India and including Bolivia, Colombia, Cuba, Dominican Republic, Ecuador, Peru, Thailand, and supported by the

with the provisions of this Agreement. 2. Appropriate measures, provided that they are consistent with the provisions of this Agreement, may be needed to prevent the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology.80 Draft modalities for TRIPs related issues submitted on 17th July 2008 by Albania, Brazil, China, Colombia, Ecuador, the European Communities, Iceland, India, Indonesia, the Kyrgyz Republic, Liechtenstein, the Former Yugoslav Republic of Macedonia, Pakistan, Peru, Sri Lanka, Switzerland, Thailand, Turkey, the ACP Group and the African Group + Croatia + Georgia + Moldova. GI-Register: draft Modality text: Members agree to establish a register open to geographical indications for wines and spirits protected by any of the WTO Members as per TRIPS. Following receipt of a notification of a geographical indication, the WTO Secretariat shall register the notified geographical indication on the register. The elements of the notification will be agreed. Each WTO Member shall provide that domestic authorities will consult the Register and take its information into account when making decisions regarding registration and protection of trademarks and geographical indications in accordance with its domestic procedures. In the framework of these procedures and in the absence of proof to the contrary in the course of these, the Register shall be considered as a prima facie evidence that, in that Member, the registered geographical indication meets the definition of "geographical indication" laid down in TRIPS Article 22.1. In the framework of these procedures, domestic authorities shall consider assertions on the generalness exception laid down in TRIPS Article 24.6 only if these are substantiated. Text based negotiations shall be intensified, in Special Sessions of the TRIPS Council and as an integral part of the Single Undertaking, to amend the TRIPS Agreement in order to establish the Register accordingly. TRIPS/CBD disclosure: draft Modality text: Members agree to amend the TRIPS Agreement to include a mandatory requirement for the disclosure of the country providing/source of genetic resources, and/or associated traditional knowledge for which a definition will be agreed, in patent applications. Patent applications will not be processed without completion of the disclosure requirement. Members agree to define the nature and extent of a reference to Prior Informed Consent and Access and Benefit Sharing. Text based negotiations shall be undertaken, in Special Sessions of the TRIPS Council, and as an integral part of the Single Undertaking, to implement the above. Additional elements contained in members' proposals, such as PIC and ABS as an integral part of the disclosure requirement and post grant sanctions, may also be raised and shall be considered in these negotiations. GI-Extension: draft Modality text: Members agree to the extension of the protection of Article 23 of the TRIPS Agreement to geographical indications for all products, including the extension of the Register. Text based negotiations shall be undertaken, in Special Sessions of the TRIPS Council and as an integral part of the Single Undertaking, to amend the TRIPS Agreement in order to extend the protection of Article 23 of the TRIPS Agreement to geographical indications for all products as well as to apply to these the exceptions provided in Article 24 of the TRIPS Agreement mutatis mutandis. Special and Differential treatment shall be an integral part of negotiations in the three areas above, as well as special measures in favor of developing countries and in particular least-developed countries.81 Geographical indications. Extending the “higher level of protection” to other products. The TRIPs Agreement provides a higher level of protection to geographical indications for wines and spirits. This means they should be protected even if there is no risk of misleading consumers or unfair competition. However, in some cases, geographical indications do not have to be protected or the protection can be limited. Among the exceptions that the agreement allows are: when a name has become the common (or “generic”) term (for example, “cheddar” now refers to a particular type of cheese not necessarily made in Cheddar, in the UK), and when a term has already been registered as a trademark. A number of countries want to negotiate extending this higher level to other products. Others oppose the move, and the debate in the TRIPs Council has included the question of whether the relevant provisions of the TRIPs Agreement provide a mandate for extending coverage beyond wines and spirits. The Doha Declaration notes that the TRIPs Council will handle this under the declaration’s paragraph 12 (which deals with implementation issues). Paragraph 12 offers two tracks: “(a) where we provide a specific negotiating mandate in this Declaration, the relevant implementation issues shall be addressed under that

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African group and some other developing countries, wants to amend the TRIPS Agreement so that patent applicants are required to disclose the country of origin of genetic resources and traditional knowledge used in the inventions, evidence that they received “prior informed consent” (a term used in the Biological Diversity Convention), and evidence of “fair and equitable” benefit sharing.

2. Disclosure through WIPO: Switzerland has proposed an amendment to the regulations of WIPO’s Patent Cooperation Treaty (and, by reference, WIPO’s Patent Law Treaty) so that domestic laws may ask inventors to disclose the source of genetic resources and traditional knowledge when they apply for patents. Failure to meet the requirement could hold up a patent being granted or, when done with fraudulent intent, could entail a granted patent being invalidated.

3. Disclosure, but outside patent law: The EU’s position includes a proposal to examine a requirement that all patent applicants disclose the source or origin of genetic material, with legal consequences of not meeting this requirement lying outside the scope of patent law.

4. Use of national legislation, including contracts rather than a disclosure obligation: The United States has argued that the Convention on Biological Diversity’s objectives on access to genetic resources, and on benefit sharing, could best be achieved through national legislation and contractual arrangements based on the legislation, which could include commitments on disclosing of any commercial application of genetic resources or traditional knowledge.

For the States supporting the first position of the listed above, the nature of the legal effect of not providing evidence of prior informed consent and the benefit sharing according with mutually agreed terms will depend on whether it is at the pre- or post-grant stage:

Where it is determined that genetic resource and/or traditional knowledge was used in an invention but no evidence of prior informed consent has been furnished as required before the examination or grant of a patent, the legal effect could be that the application would not be processed any further until the submission of the necessary declaration and evidence.

Where the failure to provide evidence of prior informed consent is discovered after the grant of a patent, the legal effect could include: (1) Revocation of the patent. In addition to revocation, criminal and/or administrative sanctions may also follow, though outside the patent system, in particular, to ensure adequate compensation where it is eventually determined that no prior informed consent was obtained; (2) Criminal and/or civil sanctions, including the

mandate; (b) the other outstanding implementation issues shall be addressed as a matter of priority by the relevant WTO bodies, which shall report to the Trade Negotiations Committee [TNC], established under paragraph 46 below, by the end of 2002 for appropriate action.” In papers circulated at the Ministerial Conference, member governments expressed different interpretations of this mandate82 That evidence should perfectly be satisfied by the CBD Certificate that would be include in the International Regime to be discussed in the COP1083 Till now, a States or an indigenous or local community who understand that their rights under the CBD were violated, shall go to the courts to ask for the revocation of the patent –see the judicial decision at http://www.tk.bioetica.org/biblioteca/neem.pdf -. If the TRIPs is modified no more patent without the “evidence” of a regular access according with Articles 15 and 8 (j) of CBD should be attended. Moved the horse before the cart … (what I want to say is put the things in the right place and at the right time!)84 (a) How to deal with the commercial use of traditional knowledge and genetic material by those other than the communities or countries where these originate, especially when these are the subject of patent applications; and, (b) how to ensure that the TRIPS Agreement and the UN Convention on Biological Diversity (CBD) support each other

WTO-Joint Proposal FTA-USA MegadiverseArgentina üAustralia Canada Chile üCosta Rica üDominican Republic ü Ecuador üEl Salvador ü Guatemala üHonduras üJapan Republic of Korea Mexico üNew Zealand Nicaragua üParaguay üChinese Taipei South Africa USA

üGRULAC

Australia Bahrain Canada Chile Dominican Republic El Salvador Guatemala Honduras Israel Jordan Mexico Morocco Nicaragua SingaporeUSA

Australia Brazil China Colombia Costa Rica Congo Ecuador India Indonesia Madagascar Malaysia Mexico

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possibility of punitive damages, could follow, again outside the patent system, where it is determined that the patent holder in fact obtained prior informed consent but did not provide the evidence in the application.

On July 2008, a group of WTO members called for a “procedural decision” to negotiate three intellectual property issues in “parallel”: two Geographical Indications issues (register and extension) and the “disclosure” proposal

A large number of Members85 who are proponents of Geographical Indicators extension and a new T.R.I.P.s disclosure requirement have proposed that these issues, together with that of the Geographical Indicators register86, should be part of the horizontal process in order to have modality texts that reflect Ministerial agreement on the key parameters for negotiating final draft legal texts with respect to each of these issues as part of the Single Undertaking87.

A number of other Members have expressed their strong opposition to this proposal and their conviction that it would substantially set back efforts to arrive at a viable way forward for the Doha negotiations. They reject what they consider to be an artificial parallelism being made in the proposal between the T.R.I.P.s issues cited, saying that each has its own terms of reference and subject-matter, many technical issues remain, and the interest of Members in each varies considerably

At the present, some main issues …Among others also important issues:

What is a genetic resource? The answer will set the matter under the Convention for ABS/PIC since the States’ rights under CBD are just over “genetic resources” some countries -moved by the interests of researchers and business88, and also by theirs local rules89- reject to include/make extensive the concept to “natural” and/or “biological” resources as well. Others want not only to

85 By November 2008, they were already 110 members out of 153 supporting it86 Geographical Indicators (GI) register negotiations are not part of the mandate relating to outstanding implementation issues in paragraph 39 of the Hong Kong Ministerial Declaration and therefore not a subject of this report. 87 TN/C/W/52 19 July 2008 Communication from Albania, Brazil, China, Colombia, Ecuador, the European Communities, Iceland, India, Indonesia, the Kyrgyz Republic, Liechtenstein, the Former Yugoslav Republic of Macedonia, Pakistan, Peru, Sri Lanka, Switzerland, Thailand, Turkey, the ACP Group and the African Group The following communication is being circulated at the request of the Delegations of Brazil, the European Communities, India and Switzerland. Proponents of the TRIPS related issues under the Doha Work Program (GI Register, TRIPS disclosure requirement and GI Extension) agree to include these issues as part of the horizontal process in order to have modality texts that reflect Ministerial agreement on the key parameters for negotiating final draft legal texts with respect to each of these issues as part of the single undertaking. The central objective of the proponents remains the adoption of a procedural decision that would open up the way for negotiations on the three issues88 In those cases the difference would make it possible to push the feeble line to go beyond the CBD Convention and to avoid the PIC/ABS requirements even if there would be others imposed by national laws… and what could be more important: if WTO finally adds the Article 29 bis to TRIPs will take the language and interpretation from CBD imposing the formal requirement of the certificate in the terms and cases rule by CBD; so, is it going to be asked when the invention comes out from a biological resource or just from a genetic resource?89 For instance, Argentina’s Constitution Law recognizes the original domain of its Provinces over their “natural resources” so the extension of the concept will put the issue under their jurisdiction rather than the national

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reach the “biological”90 resources but also the "concerns", "derived from" and "developed with"91

those biological resources and/or associated traditional knowledge.

What relationship has to have the traditional knowledge to be considered as traditional knowledge related to the biological resource92 and, then, under the rule of PIC/ABS? The question is if the use the local/indigenous people give to a biological resource is not the same for what the resource will be collected, but that use is an indicator of some property that at the view (or further investigation) of the researcher could be pointing some other appliance93 shall it be compensated to and approved for… ILC [indigenous and local communities]?

Which is going to be the text of the PIC/ABS Certificate for it be internationally legally binding? That Certificate shall be the “EVIDENCE” to accomplish the requirement asks by several national legislations94 (and that the proposed Article 29 bis for TRIPs would extent –as a formal requirement- to the 153 Member’s legislations). It could essentially be the written decision of a national competent authority granting the providers’ PIC/ABS were accomplished according with the national laws; this certificate shall be internationally binding through the Apostille Convention95

procedure96 or other to be created under the CBD. Also, how certificates would be applied to genetic resources that are located in ex situ collections or in F.A.O.’s International Agricultural Research Centers of the Consultative Group shall be decided.

90 The CBD recognizes that "States have, in accordance with the Charter of the United Nations and the principles of international law, the sovereign right to exploit their own resources...". Thus, the power enjoyed by the States is not limited to regulation of genetic resources. Accordingly, the fact that Article 15 of the CBD addresses "access to genetic resources" should not be interpreted as preventing States from regulating access and benefit-sharing relating to biological resources. IP/C/W/475. Communication from Brazil to the Council for Trade-Related Aspects of Intellectual Property Rights 26 July 2006.91 These three triggers seek to encompass the relevant situations in which biological resources and/or associated traditional knowledge contributed to reaching an invention, while providing a margin of flexibility for the national competent authorities of the country where the patent is sought to define whether the applicant has effectively complied with the rule or not. Two of the triggers – "concerns" and "derived from" – have meanings that are already known to Members who have used them in their legislation. IP/C/W/475. Communication from Brazil to the Council for Trade-Related Aspects of Intellectual Property Rights 26 July 200692 I full agree with what you said about that indigenous and local people get related with the biological resource and most of the times they even ignore there is a genetic resource involved!! 93 What is to be understood by the term associated traditional knowledge? The proponents intend to give its ordinary meaning to the term traditional knowledge (TK). The word "associated" is prefixed to TK in order to restrict the disclosure to TK that has some relevance to the biological resources used in developing or concerning the subject matter of the invention. Therefore, not all forms of traditional knowledge are covered IP/C/W/475. Communication from Brazil to the Council for Trade-Related Aspects of Intellectual Property Rights 26 July 200694 Among others: Brazil. Resolution 23 (10/11/2006). The Andean Community’ Members (Peru, Bolivia, Ecuador, Colombia) Decision 456. Denmark. Act 412 (31/5/2000) amending the Patent Act (consolidated Patent Act 926 22/9 2000). Egypt Law No. 82 on the Protection of Intellectual Property Rights March 6, 2002. Norway. Patents Act (Act No. 9 of Dec. 15, 1967) as last amended by Act No. 20 of May 7, 2004 Added by Act No. 127 of December 19, 2003. South Africa. The Patents Amendment Act No. 20 of 200595 The Apóstille Convention. Abolishing the requirement of legalization for foreign public documents. The Hague, 5 October 1961 Entry into force: 24-I-1965. Facilitates the circulation of public documents executed in one State party to the Convention and to be produced in another State party to the Convention. It does so by replacing the cumbersome and often costly formalities of a full legalization process with the mere issuance of an Apostille (also called Apostille Certificate or Certificate). The Hague Apostille Convention only applies between States parties Members-States (69 so-far): Albania Argentina Australia Austria Belarus Belgium Bosnia and Herzegovina Bulgaria China, People's Republic of Croatia Cyprus Czech Republic Denmark Ecuador Estonia Finland France Georgia Germany Greece Hungary Iceland India Ireland Israel Italy Japan Korea, Republic of Latvia Lithuania Luxembourg Malta Mexico Monaco Montenegro Netherlands New Zealand Norway Panama Poland Portugal Romania Russian Federation Serbia Slovakia Slovenia South Africa Spain Suriname Sweden Switzerland The former Yugoslav Republic of Macedonia Turkey Ukraine United Kingdom of Great Britain and Northern Ireland United States of America Venezuela96 For the “legalization of foreign documents” and the Apóstille Convention Article 2 says that the legalization produced on the document certify the authenticity of the signature, the capacity in which the person signing the document has acted and, where appropriate, the identity of the seal or stamp which it bears