1999 Genetics, Law and Society Conference, Saint Paul, Minnesota

Related Documents

Union for the Protection of New Varieties of Plants, Issues:
Non-UPOV Plant Protection Schemes

Beyond UPOV: Examples of developing countries preparing non-UPOV "sui generis" plant variety protection schemes for compliance with TRIPS

GRAIN
July 1999

Background

The World Trade Organisation's agreement on intellectual property, known as TRIPS, sets out minimal standards for patent and other forms of intellectual property protection in the 134 WTO member states. If countries do not provide these standards, they can be punished through trade sanctions. TRIPS Article 27.3(b) requires all countries to protect intellectual property over plant varieties, the basis of food security. According to the agreement, this can be done by patent law or by "effective 'sui generis' system". Developing countries must implement this rule by 1 January 2000 and least developed countries by 1 January 2006. However, the article is being formally reviewed by the WTO members right now and could possibly be changed before the implementation deadline.

The review of Article 27.3(b), which has been going on in Geneva over the 1999 series of TRIPS Council meetings, has revealed that the WTO membership is unclear as to what an "effective 'sui generis' system" is or should be. "Sui generis" simply means special or unique, leaving the matter completely open to interpretation.

Industrialised nations argue that the model provided by the Union for the Protection of New Varieties of Plants (UPOV), to which 44 mainly industrialised countries subscribe, is the best "sui generis" system for now. Most developing countries do not agree, because that model is highly biased toward the commercial interests of industrial breeders in the North and it helps promote genetic uniformity in agriculture.

In the longer term, however, industrialised nations would like TRIPS to be strengthened so that it either names UPOV as the only "sui generis" system recognised by WTO or deletes the "sui generis" option altogether (meaning full-fledged patents must be provided). Yet developing countries increasingly question whether the patenting of life forms is ethical and should be permitted, as a matter of WTO policy, at all.

At stake in this debate is control over the world's food supply, among other things. North America, Europe and Japan host the global $30 billion seed industry which aims to conquer markets in the developing world once intellectual property, which guarantees royalty and licensing payments to exclusive owners, over plant genetic research is secured through implementation of TRIPS. Developing countries, on the other hand, want to promote their own plant breeding and protect not only their plant genetic diversity but the rights and interests of local communities who nurture that diversity and who contest its privatisation by the North.

Substantive Debate Opens

At the last meeting of the WTO TRIPS Council, on 7-8 July, governments discussed the substance of these issues and what to do about them. Governments are also starting to officially advocate amendments to TRIPS as part of the preparatory process for the WTO Ministerial Conference in Seattle, 29 November - 4 December 1999.

Kenya's position is that the differences of interpretation of Article 27.3(b), plus the controversy surrounding the "sui generis" option itself, merit a five-year extension of the implementation deadline for developing countries. The group of least developed countries at WTO has called for an extension of the deadline for their group, plus maximum flexibility in the interpretation of "sui generis" regimes for both developing and least developed countries. Malaysia has formally summoned the WTO to clarify exactly what are the "sui generis" options available to the member states beyond the oft mentioned UPOV system. India argues, in the meantime, that the TRIPS agreement conflicts with the Convention on Biological Diversity (CBD) and that the two must be reconciled before they can be properly implemented at the national level. India's position is widely supported by governments across the South. The Africa Group, for its part, is also finalising a common position on the TRIPS Review of Article 27.3(b). While the policy issues get thrashed about in Geneva, many governments back home in the developing world are well into drafting "sui generis" laws on protection of plant varieties which clearly move away from UPOV and towards the protection and implementation of farmers' rights, community rights and other provisions stemming from or related to the internationally binding Convention on Biological Diversity. In most countries, these laws are not yet adopted -- they are under debate, increasingly involving more and more stakeholders at the local and national levels.

To help give a picture of the situation, GRAIN has compiled a set of examples of some of these "non-UPOV 'sui generis' initiatives" in the South. We merely point out those provisions where national "sui generis" bills are deviating from the restrictive UPOV regime. Any errors of interpretation are our own.

Latin America and the Caribbean

Of the 40 or so countries in the region, 11 are members of UPOV (all bound to the 1978 Convention): Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Mexico, Panama, Paraguay, Trinidad & Tobago and Uruguay.

Nicaragua

The Nicaraguan government sent a draft plant variety protection (PVP) bill marked "urgent" to Parliament in May 1999. It basically followed UPOV 1991. A modified draft was subsequently developed in the Parliament's Environment Committee containing a number of substantial demarcations from the UPOV model, which we highlight below. By mid-July, a form of compromise draft had been adopted in general, but not specific, terms. Parliament will reconvene in August and continue its deliberations.

1. Discoveries may not be protected.

2. A plant variety shall be eligible for protection if it differs from another variety in several characteristics (not just one).

3. Transgenic material shall be subject to separate biosafety legislation.

4. The definition of breeder and breeding is wider in scope: it covers anyone making use of techniques of crop improvement.

5. It recognises that priority rights based on reciprocity under UPOV conflict with the WTO-TRIPS regime of national treatment and it therefore does not include them.

6. It sets PVP apart from industrial property and therefore seeks to comply with UPOV 1978 which expressly prohibits double protection.

7. Protection extends to the following acts: direct sowing, preparation for reproduction or multiplication as certified seed, repetitive use for the production of another variety. It does not offer protection for marketing, import or export.

8. The provision regarding essential derivation shall be applied in cases whether the "new" variety is at least 20% dependent on an earlier variety.

9. Plant breeders' rights shall not extend to the variety when it is used for consumption or sowing directly by farmers or when it is used by tenants, cooperatives or other non landholding entities.

10. Criteria for protection are: novelty, distinction, uniformity or variability, stability or evolutionary capacity, plus the variety must carry a denomination.

11. A variety shall be deemed distinct if it bears at least ten characteristics that set it apart from commonly known varieties.

12. A variety shall be deemed variable if its characteristics are adapted to different climatic and soil conditions of the country.

13. A variety shall be deemed to have evolutionary capacity if it contains genes or genetic complexes which are expressed under environmental change.

14. Registration requires: proof of compliance with CBD Art 8j and 15 (especially compensation to countries and communities of origin) and scientific proof of the variety's superiority to cultivars grown in the country through at least two production cycles of comparative tests.

15. Wider compulsory licensing.

16. This law is subordinate to the rights and obligations acquired through the Convention on Biological Diversity.

Costa Rica

Costa Rica does not have a PVP law yet but plans to adopt one by the end of the year for the purpose of compliance with TRIPS. It is established that Costa Rica's PVP law will be subordinate to the country's compliance with the CBD, which was formalised through the enactment of Law No. 7788 entitled "Biodiversity Law" in May 1998. The Biodiversity Law decrees (Article 82) that communities are the holders of "sui generis" community intellectual rights which exist and are henceforth recognised and protected by the State owing to the mere existence of cultural practices or knowledge related to genetic resources and biochemicals. These rights, which cover "the knowledge, practices and innovations of the indigenous peoples and the local communities, related to the use of the components of biodiversity and associated knowledge," shall not be affected by Plant Breeders' Rights(PBR), patents or any other form of intellectual property applied to biodiversity and associated knowledge.

Any application for PBR in Costa Rica must receive clearance from the Technical Office of the Commission administering the Biodiversity Law to ensure that the application does not contravene community intellectual rights, even though these need not be formally registered. The recognition of community intellectual rights in Costa Rica "oblige[s] the Technical Office to answer negatively any consultation related to the recognition of intellectual or industrial rights over the same component [of biodiversity] or knowledge" (Article 84).

Africa

Only Kenya and South Africa are members of UPOV (the 1978 Convention in both cases). However, in February 1999, the 15 francophone member states of the Organisation Africaine de la Propriete Intellectuelle (African Organisation of Intellectual Property) revised the Bangui Agreement which governs their common intellectual property regime. The new Agreement establishes, in Annex X, a common PVP system and foresees that the OAPI member states will join UPOV by depositing an instrument of accession to the 1991 Act. The Bangui Agreement must be ratified at the national level for it to come into effect for the individual countries. Cameroon, Gabon, Ivory Coast and Senegal are allegedly expected to ratify by the end of this year.

SADC

The Southern African Development Community, with the support of the International Plant Genetic Resources Institute, has examined whether alignment with UPOV would be appropriate for compliance with the "sui generis" principle of TRIPS. The conclusion was that UPOV is mainly appropriate to protect the interests of exporters of horticultural and ornamental varieties, but not for southern Africa. As a result, SADC is currently drafting a common legislative framework for "sui generis" rights that protects the gamut of plant biodiversity as well as traditional knowledge of the local communities, in cooperation with the OAU (see below).

Zambia

The Zambian government has made it clear that in order to fulfill its rights and obligations under CBD, its "sui generis" PVP system must recognise and reward the innovation of indigenous peoples and local communities. For this, their law, which is being drawn up with full stakeholder participation, defines innovation to include "any inventive input done collectively, accretionally, inter-generationally and over a period of time, in relation to genetic resources." UPOV has already commented extensively on Zambia's draft.

Public consultation on the draft law in Zambia has resulted in a number of observations:

1. that the Act did not comprehensively protect farmers' varieties and other plants of various uses

2. that the Act was biased toward cultivated plants

3. that the Act placed too much emphasis on protecting the rights of individuals, mainly breeders and seed companies, and remained silent on collective community knowledge and intellect

4. that the Act is disconnected from the government's policy to promote the informal seed system and achieve its integration with the formal seed system

Therefore, the draft was recently put on hold so that the government can pursue wider stakeholder consultations to address these concerns. The government remains intent on protecting community intellectual rights appropriately under this Act.

Zimbabwe

Zimbabwe has a plant breeders' rights system in place since 1975 but it is partial and non-compliant with UPOV. Zimbabwe has been revising its law to comply with UPOV 1978 but missed the deadline for joining (24 April 1999). Zimbabwe also fears, like Zambia and the whole of the SADC community, that the UPOV model compromises the country's need to fulfil its rights and obligations towards Convention on Biodiversity.

OAU

The Organisation of African Unity is currently developing an "African Model Legislation for the Recognition and Protection of the Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Genetic Resources", which expands on the 1998 model law. A draft-in-progress, the document is not yet public. A final version is expected to be available in October or November 1999. As regards the Plant Breeders' Rights component, the current version of the model legislation demarcates itself from UPOV in various ways:

1. Protection shall be available to any variety that is distinct, stable, sufficiently homogenous or a well-defined multiline.

2. PBR is subject to the law's provisions on Farmers' Rights.

3. Broad compulsory licensing provisions are included.

4. The plant breeder's right is limited to the production and sale of the propagating material of the variety and does not impinge on the rights of farmers to reproduce seed or on the rights of innovators to conduct research.

Asia

Of the developing countries in Asia, only China is member of UPOV (1978 Act).

India

The final version of India's draft PVP Act, now before Parliament, demarcates itself from UPOV in several ways:

1. It formalises Farmers' Rights in the following terms: "Nothing contained in this Act shall affect a farmer's traditional right to save, use, exchange, share or sell his farm produce of a variety protected under this Act except where a sale is for the purpose of reproduction under a commercial marketing arrangement."

2. It makes specific and detailed provision for communities to register collective rights.

Thailand

Thailand's draft PVP Act, also before Parliament at this moment, distances itself even more from UPOV:

1. It define various classes of plant varieties with specific rights and responsibilities attached to each: local domestic plant varieties, new plant varieties, general domestic plant varieties and wild plant varieties.

2. Transgenic varieties are subject to special biosafety reviews.

3. Duration of protection is 12, 17 or 27 years depending on the type of plant.

4. Exhaustion of the plant breeder's right in terms of farmers' cultivation practices is more ample (farmers get broad rights to use protected material).

5. It creates a Plant Variety Protection Fund aimed at supporting research or conservation and development of plant varieties.

6. It requires profit-sharing agreements in the case of general domestic and wild plant varieties, the revenue from which shall accrue to the Fund.

Bangladesh

The Plant Varieties Act of Bangladesh, drawn up and approved by the National Committee on Plant Genetic Resources, is now under public debate. It takes substantial distance from UPOV:

1. To be eligible for protection a variety must be new, have consistent specific traits, be stable and have distinctive specific traits.

2. Breeding alone is not sufficient to justify commercial privileges. The variety must have "immediate, direct and substantial benefit to the people of Bangladesh."

3. Hybrids may only be protected if the parents are available as community varieties in the public domain.

4. Any variety which made lead to genetic or cultural erosion shall not be protected

5. Transgenics are subject to further legislation.

6. All varieties which are developed in any national public research institute (universities, national agricultural research centres, etc) shall be considered the property of the people of Bangladesh, i.e. common property. The same holds for farmer- or NGO-developed varieties which were created through the use of public funding (development cooperation funds). In these cases, Citation of Award shall replace a PVP certificate.

7. PVP is not available to nationals or juristic persons of countries which are not party to CBD.

8. County of origin of the material used to develop the variety shall be disclosed.

9. Where a community variety, indigenous plant variety or wild plant variety has been used in the development of a protected variety, 25% of the revenue accruing from its commercialisation shall be shared

10. Periods of protection are 7 years for annuals, 10 years for bi-annuals, 15 years for perennials and 25 years for woody species.

11. There is a Citation of Recognition system to award innovators who wish to register their innovations without claiming commercial privilege or protection for personal gain.

12. Community rights are substantively provided for.

13. Farmers rights are substantively provided for.

14. A Plant Variety Development Fund shall be established to support communities in the conservation and development of plant varieties.

Pakistan

In April 1999, the Government of Pakistan confirmed its intention of joining UPOV as compliance with TRIPS Art 27.3(b) on the basis of draft national legislation modelled tightly from UPOV 1991. National civil society organisations protested against both the lack of consultation with prime stakeholders and the biases ingrained in the draft bill. Following several months of open debate, the Government announced in July that it will no longer seek accession to UPOV and invited NGOs to participate in redrafting the bill "in line with national interests".

Sources

Plant Varieties Act of Bangladesh, text proposed by the National Committee on Plant Genetic Resources, Dhaka, 29 September 1998

Ministry of Agriculture & Cooperation, Government of India, "The Plant Varieties and Farmers' Rights Protection Bill, 1998", No. 18-136/97/SD-IV, New Delhi, circa November 1998

"(Draft) Plant Varieties Protection Act, Thailand", translation by Dr Pinai Nanakorn for the Department of Agriculture, Ministry of Agriculture and Cooperatives, for its presentation to UPOV.

Papers presented at the UPOV-WIPO-WTO Joint Regional Workshops on "The Protection of Plant Varieties under Article 27.3(b) of the TRIPS Agreement" held in Bangkok on 18-19 March 1999 and in Nairobi on 6-7 May 1999.

African Model Legislation for the Recognition and Protection of the Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Genetic Resources", draft of June 1999 for OAU, Addis Ababa.

Ley de Proteccion para la Obtenciones Vegetales, working document of 21 May 1999, Managua.

"Press Statement on the Regional Workshop in Southern Africa on the Implementation of Article 27.3(b) of WTO/TRIPS", co-organised by the Biotechnology Research Institute, Community Technology Development Trust and the International Plant Genetic Resources Institute in Harare on 22-24 March 1999. (See BIO-IPR of 12 April 1999.)

Edward D. Zulu, Rosemary M. Makano and Anessie Banda, National Experiences and Plans to Implement a Sui generis System of Protection in Zambia, paper presented at the UPOV-WIPO-WTO Joint Regional Workshop on "The Protection of Plant Varieties under Article 27.3(b) of the TRIPS Agreement", Nairobi, 6-7 May 1999. (See BIO-IPR of 25 May 1999.)

UPOV, "Aide Memoire pour la Ratification du Nouvel Accord de Bangui et l'Adhesion y l'Union Internationale pour la Protection des Obtentions Vegetales (UPOV)", Geneve, Juin 1999.

"The Africa Group Position on TRIPS Agreement, IPRs and CBD", Intervention delivered by H.E. Ambassador Pilemon Yang of Cameroon on the behalf of the African States during the Inter-Sessional Meeting on the Operations of the Convention on Biological Diversity, Montreal, 28-30 June 1999.

Permanent Mission of Kenya to the United Nations, "Preparations for the 1999 Ministerial Conference, Contribution to the Preparatory Process, Communication from Kenya", World Trade Organisation, WT/GC/W/23, Geneva, 5 July 1999. Accessible through http://www.wto.org/wto/ddf/ep/public.html

Peter Ungphakorn, Information and Media Services, World Trade Organisation, Geneva, 13 July 1999, personal communication.

Dr Shahid Zia, Research Fellow, Sustainable Development Policy Institute, Islamabad, 16 July 1999, personal communication.

"The Challenge of Integrating LDCs into the Multilateral Trading System", Coordinating Workshop for Senior Advisers to Ministers of Trade in LDCs in Preparation for the Third WTO Ministerial Conference, Sun City, South Africa, 21-25 June 1999, Communication from Bangladesh, World Trade Organization, WT/GC/W/251, 13 July 1999. Accessible through http://www.wto.org/wto/ddf/ep/public.html

Reconciling Trips with CBD, Development

Geneva, 21 July (Chakravarthi Raghavan) -- Proposals to review and change some of the provisions of the Agreement on Trade- Related Intellectual Property Rights (TRIPS) are now before the World Trade Organization -- both in the context of the preparatory process at the General Council for the Seattle Ministerial Conference and the review exercise in the TRIPS Council itself.

In terms of the Seattle ministerial, and the preparations, developing countries have been formulating and presenting a range of proposals under individual agreements in terms of 'implementation' problems and issues. As one of them put it: "At the moment, we are all presenting proposals and issues, and explaining them at the informal meetings. But so far we have only been talking past each other, and not having any genuine exchange of views, leave aside serious negotiations or pre-negotiations. We may return to these after September. But it is not so clear."

In terms of the TRIPS Council, Art. 27.3 (b) provides for review of the provisions of that sub-paragraph. The TRIPS Agreement, in para 27.3 (b) enables Members to exclude from patentability plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and micro-biological processes.

However, Members who exercise this non-patentability option are nevertheless required to provide for protection of plant varieties either by patents or an effective sui generis system or by a combination thereof.

"The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement."

In terms of this provision, the review has been mandated to be taken up in 1999.

But within the TRIPS Council, in two or three meetings this year, there has been some debate and discussions, with the US, EU and others taking the position that what is required is not "review of the provisions" but "review of the implementation of the provisions."

Developing countries rejected this view -- with a range of them pointing out that where the WTO and TRIPS have called for "review of implementation" they have specifically said so (as in Art 71 of TRIPS), whereas 27.3 (b) calls for review of the provisions of that sub-paragraph.

The industrialized countries also argued that the paramount consideration for TRIPS review should be the commercial motivation and this would be the deciding factor for countries to take a decision on patenting of life forms. But India and others argued that not all countries and civilizations would agree that commercial motivation was a deciding element in life patenting. Governments everywhere have also to look at other elements in taking their decisions.

In the light of the discussions, the developed countries appear to have come around to the view that what is contemplated is the review of the provisions, and not implementation (which for developing countries kicks in only on 1 Jan 2000).

At the July meeting of the TRIPS Council, India took the issue further and has tabled a document calling for specific review of the provisions of Art. 27.3 (b). The Indian proposal was supported by a number of developing countries including the Philippines, Malaysia, Indonesia, Pakistan, Singapore, Egypt, Kenya, Brazil, Costa Rica, the Dominican Republic, and Honduras.

Among the industrialized countries, the European Union said the Indian proposal for review was new, but that they contained some 'interesting ideas' and the EU was looking forward to a discussion. Switzerland was willing to look at the issues. Canada and Japan said they needed more time to react. In addition, Canada said that there was internal discussion going on within Canada on the whole issue of patenting higher life forms, and Canada would not shy away from looking at the Indian proposals. Australia noted that Art.27.3.(b) was a negotiated compromise and its position on the review was flexible. The United States has said that it would need time to reflect on it.

The next meeting of the TRIPS Council is tentatively set for October. Several of the key developing countries appear to be still in the process of formulating their stands and tabling proposals in this area -- banning patenting of life-forms. Some more recent positions of scientists, with expertise in molecular biology and genetics, have challenged the idea of patenting itself -- arguing that there is no invention, and at best a mere discovery.

In parallel, in the General Council's Seattle preparatory process, India has formulated proposals focusing on the issues of transfer of technology on fair and equitable terms and for operationalising Articles 7 and 8 of the TRIPS.

It has also called for reconciling the provisions of the Convention on Biological Diversity and TRIPS, and incorporating provisions in TRIPS so that patents inconsistent with Art. 15 of the CBD may not be granted by any Member.

Another provision in the Indian proposal calls for modifying Art 64 paragraph 2 of TRIPS, so that non-violation complaints are excluded in the dispute settlement of TRIPS.

In its latest communication in July 1999 to the General Council, where it has formulated the proposals in terms of paragraph 9(a)(i) of the Geneva Ministerial Declaration (on implementation issues), India has said that its proposals are aimed at making TRIPS more compatible with Multilateral Environmental Agreements such as the Convention on Biological Diversity and make TRIPS more balanced between the task of promoting intellectual property rights and promoting developmental objectives.

TRIPS, India has pointed out in a communication, is not about harmonization of standards, but minimum standards of IPRs. And unlike GATT and GATS, TRIPS is not about regulating competitive relationships.

At any rate, comparisons between GATT and TRIPS, especially in the non-violation context are not correct.

The Indian position formulated on the non-violation complaints issue is shared by a large number of developed countries too, like Canada. In the communication of July for the Ministerial preparatory process, India has said that, in terms of Art 23 and 24 of TRIPS (protection for geographical indications of origin), additional protection for geographical indications should be extended for products other than wines and spirits. Article 22 of TRIPS requires countries to make provisions to provide legal means for interested parties to prevent the use of any means in the designation or presentation of a good that indicates its origin in a geographical area other than true place of origin, thus misleading the public, and prevent any use constituting an act of unfair competition. Article 23 goes on to provide for additional protection for geographical indications for wines and spirits, for negotiations within the TRIPS Council for a multilateral system of notification and registration of geographical indications for wines eligible for protection.

While the EU has been pushing for strengthening of the geographical indications (appellations of origin) for wines and spirits, several developing countries have now called for similar protection for other products which are specific in terms of origin -- such as basmati varieties of rice (long-grained varieties with a fragrance), specific to some regions of India and Pakistan, tea and similar products.

Some of the non-European countries (including the US, Australia and some Latin Americans), producing and marketing their own wines (from varieties taken from Europe, but called by their original geographical names) have been resisting enhanced protection.

The Indian proposal also calls for incorporating a provision in TRIPS so that patents inconsistent with Art 15 of the CBD are not granted. In an earlier communication, India has said that the issues to be addressed -- apart from the built-in agenda of review of Art.27.3 (b) and Art.71 or issues about patenting of plants and animals or benefit-sharing in commercial exploitation of ex situ materials -- are for harmonisation of approaches to utilisation of living resources found in TRIPS on the one hand and CBD on the other.

It has however noted that the preamble to TRIPS recognizes IPRs to be private rights. In this light, Art. 27.3 incorporates specific obligations on patenting of life forms, requiring members to provide product patents for micro-organisms and for non-biological and micro-biological processes, and for protection of plant varieties, either by patents or an effective sui generis system or combination.

The CBD on the other hand, in its preamble, categorically reaffirms that nation states have sovereign rights over their own biological resources, recognizes the desirability of sharing equitably benefits arising from the use of these resources as well as traditional knowledge, innovations and practices relevant to the conservation of biological diversity and its sustainable use, and acknowledges that special provisions are required to meet needs of developing countries.

The Indian communication also noted that the CBD has unambiguously stated that the authority to determine access to genetic resources rests with national governments and subject to national legislation. The CBD also specifies that access, where granted, shall be on mutually agreed terms and subject to prior informed consent of the resource provider. The international community is also enjoined to respect, preserve and maintain knowledge innovations and practices of indigenous and local communities and encourages equitable sharing of benefits arising from their utilisation. India's February communication called for an obligation to be incorporated via provisions in Art 29 of the TRIPS requiring a clear mention of biological source material and country of origin in patent applications, making this part of the patent application open to full public scrutiny on filing of the application to permit countries with possible opposition claims to examine the application and state their claims well in time. Domestic laws on biodiversity would be required to ensure prior informed consent of the country of origin and knowledge holder of the biological raw material meant for use in a patentable invention -- which would enable signing of material transfer agreements or transfer of information agreements. Such a provision in the domestic law should be considered compatible with TRIPS.

In its latest (2 July) communication to the General Council process, India has also called for operationalizing Articles 7 and 8 of the TRIPS agreement by providing for transfer of technology on fair and mutually advantageous terms.

SUNS #4482 - 22 July 1999

Costa Rics's Biodivesity Law: Sharing the Process
by Vivienne Solis Rivera* and Patricia Madrigal Cordero**

Paper prepared for the workshop on "Biodiversity Conservation and Intellectual Property Regime" organised by the Research and Information System for the Non-Aligned and Other Developing Countries (RIS) with the World Conservation Union (IUCN) in New Delhi, India, 29-31 January 1999

The aim of this paper is to share the process of drawing up, approving and starting to implement the Biodiversity Law of Costa Rica. Approved on 23 April 1998, this Law is the result of a long process to elaborate a legal framework in response to the ethical and social mandate for a more just and fairer distribution of benefits deriving from the commercial use of components of biological diversity in accordance with the principles of the Convention on Biological Diversity (CBD). The Costa Rican experience gives one example of how the Convention can be put into practice at the national level. The process has forced us to face important lessons in trying to promote a legal initiative which aims to regulate economic interests. This paper does not deal in depth with the Convention, nor defend its precepts. Each country should seek its own legal means to regulate biodiversity according to its specific social, economic and political context.

1. History of the Law

First, some context. When the initial draft Biodiversity Law was presented in June of 1996, six contracts allowing transnational corporations to conduct biodiversity prospecting had already been signed in Costa Rica. These contracts were drawn up in a regulatory vacuum. Laws which regulate specific natural resources -- such as the Law for Wildlife Conservation (1992), the Forest Law (1996), the Constitutive Law for the National Parks Service (1972), and the Organic Law on the Environment (1995) -- were in effect at that time. But a legal gap existed in the regulation of genetic and biochemical resources, as well as regards access to biodiversity and the fair distribution of benefits derived from it. Prior to the Biodiversity Law, there were two agencies active in administering biological resources: the Advisory Council to the Minister of the Environment and Energy (COABIO) and the National Biodiversity Institute (INBio), a non-government non-profit association at the forefront of bioprospecting for commercial use.

The promoter of the Law initiative was Luis Martinez Ramirez, ex-congressman and former president of the Environmental Commission of the Legislative Assembly, who officially requested the technical support of the World Conservation Union=92s Regional Office for Mesoamerica (IUCN-ORMA), located in Costa Rica, in the drawing up of the draft Biodiversity Law. The aim of this legal initiative was to comply with the mandate of the Convention on Biological Diversity which challenged its signatories to legislate on the themes covered by the Convention. Costa Rica ratified the Convention in August 1994.

ORMA responded positively to the request and charged the Wildlife Thematic Area with responsibility for the project. Prior to the drawing up of the draft law, its philosophical framework was defined jointly with the Environmental Commission of the Legislative Assembly. Through this process, the following were established as guiding priniples:

• equal access to and distribution of the benefits from the use of biodiversity components
• respect for human rights, principally those groups which are marginalised due to cultural or economic conditions
• sustainable use of biodiversity components respecting development options for future generations
• that democracy guarantees a greater participation of all citizens in decision making, within an environment of peace, and in development options.

With this conceptual base, a consultation process was initiated with specific groups: indigenous peoples, people living close to protected areas, small farmer groups, legal experts, scientists, civil servants and private companies. The objective of the consultation was to learn what the basic content of the draft law should be.

With this input, the preparation of the draft law started. The Law was meant to be general and comprehensive, regulating all aspects of the Convention on Biological Diversity in an integral manner. This deliberately left open the possibility of developing discrete regulations in the future for specific issues such as biosafety, biotechnology, access to genetic resources and intellectual property.

The draft was published on 18 June 1996 and became subject to wide debates and mixed reactions, both for and against. Three thousand copies of the draft were distributed throughout the country for comment. It was also made available on Internet in order to facilitate discussion processes. Based on the comments, observations and suggestions sent to the Environmental Commission, a substantive draft law was drawn up half a year later in December 1996. However, the discussion process got bogged down due to the polarisation of different positions.

A proposal for a reconciliation forum made by Jorge Mora, Rector of the National University, was accepted by the Environmental Commission. The latter delegated the task of drawing up the draft law to a special mixed sub-commission, made up of representatives of the National Indigenous Forum, the Costa Rican Federation for Environmental Conservation, the National Small Farmers Forum, the University of Costa Rica and the National University, the Union of Chambers for Private Business, INBio, COABIO, and the National Liberation and Christian Socialist Unity parties.

The objective of this sub-commission was to draft a consensual draft within a period of five months. Debate focused, among other things, on: the role of the state as guardian of biodiversity; the concepts of public and private ownership; the administrative organisation; biosafety; access to genetic and biochemical components; the protection of associated knowledge; and the intellectual rights of communities.

The sub-commission submitted its consensual text in November 1997, and five months later, on the 23rd of April 1998, during the last days of the Figueres Olsen administration, the draft Biodiversity Law was approved by a conditional majority vote in the legislative assembly to be subsequently signed and converted into Law of the Republic No. 7788 on 6 May 1998.

2. Highlight of the Law

2.1 Basic Concepts

The following concepts are defined in Article 7:

• Biodiversity: The variability of living organisms from any source, existing within terrestrial, aerial, marine or aquatic ecosystems or in other ecological complexes. It includes the diversity within each species, as well as between species and the ecosystems of which they are part. For the purpose of this law, the term biodiversity is understood to include those intangible components being: individual or collective knowledge,innovation and traditional practice, of real or potential value associated with biochemical and genetic resources, protected or not by intellectual property systems or sui generis registry systems.
• Biodiversity prospecting: The systematic search for, classification and research for commercial ends of new sources of chemical compounds, genes, proteins, micro-organisms and other products of current or potential economic use, that are to be found in biodiversity.
• Genetic resources: Any material from of plant, animal, fungal or micro-organism sources which contain units with a hereditary function
• Knowledge: A dynamic product generated by society over time and by different mechanisms, and includes that which is produced by traditional means or generated by scientific practice.
• Prior informed consent (PIC): Procedure by which the state, private owners or local and indigenous communities, having been previously supplied with all requested information, agree to permit access to biological resources or to the intangible component associated with them, under mutually agreed conditions.

2.2. Administration

The Administrative structure, which we will not explain in detail, hinges on the National Commission for Biodiversity Management (CONAGEBIO). This Commission defines policy, provides advice to the government and grants permits for the collection of biological resources. It is composed of:

• Eleven representatives of the following ministries: Environment and Energy which presides the Commission, Agriculture and Livestock, Health and Trade
• A representative from the Costa Rican Institute for Fisheries and Aquaculture, as the body charged with overseeing marine resources.
• The Executive Director of the National System of Conservation Areas.
• Representatives of: Association of the National Small Farmers' Board, Association of the National Indigenous Board, Costa Rican Federation for Environmental Conservation, Costa Rican Union of Chambers of Commerce and the National Council of Rectors

CONAGEBIO has an Office for Technical Support which takes care of the processing, coordination and granting of permits.

2.3 Access

Access to genetic and biochemical components of biodiversity is regulated under Article 62. Any research programme or biodiversity prospecting on genetic or biochemical material from biodiversity to be carried out on Costa Rican territory requires an access permit. However, one of the exclusions established in Article 4 of the law is that it does not apply to the exchange of biochemical and genetic resources between indigenous peoples and local communities.

The basic requirements for access are:

a) prior informed consent of representatives of the place where access is to take place, these being the regional councils of the Conservation Areas, farm owners or indigenous authorities, when this lies within their territory;

b) authorisation of this prior informed consent on the part of the CONAGEBIO's Technical Office;

c) terms of technology transfer and the fair distribution of benefits, when these exist, agreed in the permits, agreements and concessions, as well as the type of protection of associated knowledge called for by the representatives of the place where access takes place;

d) definition of the means by which such activities will contribute towards the conservation of species and ecosystems; and

e) designation of a legal representative, resident in the country, in the case of an individual or corporate entity resident overseas. Access permits for research or bioprospecting only allow for the carrying out of prospecting activities on explicitly identified biodiversity components. The permits clearly stipulate: the certification of origin, the possibility or prohibition to extract or export samples or, failing which, the duplication or deposit of materials; periodic reports, monitoring and control, publicity and ownership of rights, as well as any other condition which, given the applicable scientific and technical rules, are necessary according to the Commission's Technical Office.

These requirements are established in a different manner for commercial and non-commercial research. In the case of non-commercial research, it must be established beyond any shadow of a doubt that no economic interests exist. For duly registered ex situ collections, there is a special procedure for authorising permits. These permits are granted to a researcher or research centre on a personal and non-transferable basis. Further, they are limited to the material containing the authorised genetic or biochemical components and can only be used in the area or territory which is clearly indicated in the permit.

As a direct consequence and corollary of the principle of prior informed consent, the law recognises the right to cultural objection. This means that local communities and indigenous peoples have the right to deny access to their resources and associated knowledge for cultural, spiritual, social, economic or other reasons. Since this right is embedded in the Biodiversity Law only since its enactment in 1998, it does not automatically apply to materials that were collected earlier in time and may be stored at present in ex situ conditions. However, the concept of public domain as defined in Article 6 of the law does grant power to the State to access materials, whether found in ex situ or in situ conditions, irrespective of when they were collected.

2.4 Intellectual Property

Intellectual property is regulated under Articles 62-67 of the Biodiversity Law. CONAGEBIO is the obligatory consulting body in procedures soliciting protection of any intellectual rights on biodiversity. The following aspects should be highlighted.

• The State recognises the existence and validity of all forms of knowledge and innovation, and the need to protect them through appropriate legal means for each specific case.
• The State will grant protection through patents, trade secrets, plant breeders rights, sui generis community intellectual rights, copyright, farmers' rights, and other forms.
• The following are excluded from any form of intellectual property protection in Costa Rica: deoxyribonucleic acid sequences per se; plants and animals; micro-organisms which have not been genetically modified; essential biological procedures for the production of plants and animals; natural processes and cycles themselves; inventions which are essentially derived from knowledge associated with publicly-owned traditional or cultural biological practices; inventions which, on being commercially exploited in a monopolistic manner, could affect agricultural processes or products considered basic for food and health of the country's inhabitants
• Both the National Seed Office and the Intellectual Property Office are obliged to consult with CONAGEBIO on innovations which involve biodiversity components prior to granting protection of intellectual or industrial property. Any such protection granted by these offices must always be accompanied by a certificate of origin issued by the Commission's Technical Office and a certificate of prior informed consent. Opposition raised by the Technical Office will effectively prevent registration of any patent or plant breeder's right certificate.
• Individuals benefiting from protection of intellectual or industrial property related to biodiversity will cede, in favour of the State, a compulsory license in cases of national emergency for the benefit of the collectivity.

2.5 Sui Generis Community Intellectual Rights

The state recognises and expressly protects, under the basket denomination "sui generis community intellectual rights", the practices and innovations of indigenous peoples and local communities, related to the use of biodiversity components, and their associated knowledge. This right exists and is legally recognised by the simple existence of the cultural practice or knowledge related to genetic and biochemical resources. It requires no previous declaration, formal recognition or official registration. However, it may cover practices which do acquire formal status in the future. The recognition implies that none of the forms of protection of intellectual and industrial rights regulated in this law, in any special laws and in international law will affect such historical practices.

The law states that within 18 months following its coming into force, the Commission, through its Technical Office, together with the Indigenous Board and the Small Farmers' Board, are required to carry out a participatory process with indigenous and small farmer communities to determine the nature, scope and requirements of these rights for their definitive regulation. This process is not over yet, so we must wait for its finalisation to appreciate more fully the attributes and form of these rights. An inventory will be made of specific and unique community intellectual rights for which communities request protection. However, the possibility will remain open in the future for the registration or recognition of other communities' rights with the same characteristics. Any registration of community intellectual rights with the Commission's Technical Office shall be voluntary and free of charge.

The existence of community rights in the Registry will oblige the Commission's Technical Office to reject any request for recognition of intellectual or industrial property rights over the same component or knowledge. Such refusal, always being duly well-founded, can be made for the same motive even when the sui generis right is not officially registered.  

3. Polemical Issues

The most polemical issues raised by this Law and how they were resolved were the following:

Criticism

The law established too many obstacles to access.

Conciliation

It was clarified that the law governs access to genetic and biochemical resources, not biological resources. Access conditions were simplified.

Criticism

University autonomy will suffer.

Conciliation

The law does not affect university autonomy as far as teaching and research in the field of biodiversity is concerned, except when the research has commercial ends.

Criticism

Protected areas are not covered by the law.

Conciliation

A chapter was included for the legal establishment of the National System of Conservation Areas (SINAC).

Criticism

Indigenous and small farmer groups are not organised, so they cannot be parties to this public legal process

Conciliation

The Indigenous Board and the Small Farmers=92 Board shall participate in the National Commission for Biodiversity Management.

Criticism

Human genetic material is governed by the law.

Conciliation

Access to human biochemical and genetic material is excluded from the law.

4. Current Situation and Follow-up: National Incidence Network

With the aim of ensuring the regulation and enforcement of the Biodiversity Law and strengthening the participation of civil society in debates relating to trade and environment, the National Small Farmers' Board, the National Indigenous Board, the Costa Rican Federation for Environmental Conservation and the National University's CAMBIOS programme have formed a National Incidence Network with the following objectives:

a) Ensure the direct participation of farmers, indigenous populations, academia and the environmental movement in the regulation of the law.

b) Strengthen civil society participation through the National Commission for Biodiversity Management (CONAGEBIO), the body which was created to draw up national policy in the conservation, sustainable use and restoration of biodiversity. CONAGEBIO is the body which will propose policies relating to access to the genetic and biochemical components of biodiversity and will act as the obligatory consultative body as far as procedures relating to requests for protection of intellectual rights over biodiversity are concerned.

c) Strengthen civil society participation through its effective incorporation into the Regional Councils of the Conservation Areas, created within the framework of the National System of Conservation Areas.

d) Support the participatory process with communities so as to achieve the means, the scope and requirements for the regulation of sui generis community intellectual rights (rights of local communities to collectively benefit from their knowledge, practices and innovations relating to the conservation and sustainable use of biodiversity).

e) Support education in biodiversity conservation and sustainable use.

f) Strengthen international relations with organisations which work in this area so as to share experiences and support proposals which benefit local communities.

On the legal level, the Ministry of the Environment and Energy has presented to the constitutional chamber a charge of unconstitutionality against articles 14 and 22 of the Biodiversity Law. These articles create the National Commission for Biodiversity Management (CONAGEBIO) and the National System of Conservation Areas (SINAC). The justification for this action is to recover state jurisdiction over the definition of environmental and natural resources policies, and its exclusive jurisdiction and responsibility in the use of public funds. The National Incidence Network together with other sectors, is analysing the possible consequences of this charge and is attempting to ensure that it does not become an insurmountable problem for the enforcement of the law.

5. Lessons Learned

The main lessons we have drawn from this long process are the following:

a) The regulation of activities which are underway and un-regulated is a process which generates strong opposition and considerable political and economic pressure.

b) There are no systematised experiences or practices which help analyse how these issues can be resolved in the South. We have to take a path which is both empirical and innovative.

c) Information available to the general public on biodiversity and its economic, ethical and social interests has been very limited. As a result, only an academic/scientific elite is informed.

d) There is no adequate or continuous participation of Central America, as a region, in meetings on issues prioritised by developing countries as regards follow-up to the Biodiversity Convention.

e) The transcendental points should appear in the Law and not in its regulations.

f) The State does not yet want to share decision-making power with civil society sectors, especially the small farmers and indigenous peoples.

But the best lesson we have learned in the legislative and advisory processes we have undertaken in Central America is that the drafting of the law can open a space for learning and for strengthening capacities. This allows for a real change in management of power and resources, even if the law, in the end, is not approved.

* Co-ordinator, Wildlife Thematic Area, World Conservation Union (IUCN) Regional Office for Mesoamerica.

** Environmental Law Consultant, Wildlife Thematic Area, World Conservation Union (IUCN) Regional Office for Mesoamerica.

For further information or copies of the original paper presented in New Delhi, please contact the authors at World Conservation Union.

Regional Office for Mesoamerica (IUCN-Mesoamerica)
PO Box 1161-2150
Moravia, Costa Rica
Tel: (506) 236 27 33
Fax: (506) 240 99 34
Email: vsolis@orma.iucn.org or patmadri@sol.racsa.co.cr

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