TITLE: Workshop on Biodiversity Conservation and Intellectual Property Rights (New Delhi, 29-31 January 1999): Statement and Recommendations AUTHOR: Workshop participants PUBLICATION: Submitted to BIO-IPR DATE: February 1999 SOURCE: Research and Information System on Non-Aligned and Developing Countries (RIS), Kalpavriksh, and IUCN - The World Conservation Union. See contact details below. WORKSHOP ON BIODIVERSITY CONSERVATION AND INTELLECTUAL PROPERTY RIGHTS New Delhi, 29-31 January, 1999 STATEMENT AND RECOMMENDATIONS PREAMBULAR STATEMENT A Workshop on Biodiversity Conservation and Intellectual Property Rights was organised in New Delhi, on 29-31 January 1999, by the Research and Information System on Non-Aligned and Developing Countries (RIS), Kalpavriksh, and IUCN - The World Conservation Union. More than 60 academics, activists, researchers, NGO representatives, government officials, and representatives of industry from India, together with a number of participants from other South Asian countries, Europe and the USA, participated in the Workshop. The major issue that was deliberated upon in the Workshop was the conflicts and complementarities between the Convention on Biological Diversity (CBD) on the one hand, and the elements of the international intellectual property regime, underlined by the World Trade Organization (WTO) in the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs), on the other. The participants identified specific action points that are required to be taken up in the multilateral forums of CBD or WTO, and in the national context within India and other developing countries, that would further the objectives of the CBD through full use of spaces within existing IPR regimes, through further development and adaptation of these using the review process in-built in the Agreement on TRIPs or, where necessary, through creation of new regimes. The statement and recommended actions below are intended to reflect the range of views expressed at the workshop and to offer a sense of the meeting. There was strong support for the three objectives of the CBD: conservation of biological diversity, sustainable use of its components, and the fair and equitable sharing of the benefits arising from such use. In addition, participants also recognised the immense contribution of traditional knowledge and practices of local and indigenous communities for conservation, and re-affirmed the need for the effective maintenance of such knowledge systems. In relation to the TRIPs Agreement, participants recognised that the objectives of the Agreement, i.e., the protection of IPRs, should provide benefits to both producers and users of technological knowledge in a manner conducive to social and economic welfare in reality. However, concern was expressed that the current IPR regimes, in particular the Agreement on TRIPs, fail to adequately address a number of concerns central to the achievement of the objectives of the CBD. They appear to pose a significant threat to conservation of biodiversity, they do not address a range of equity issues including intergenerational equity, and they render difficult both access to genetic resources and the fair sharing of benefits arising from their use. Perhaps more seriously they fail to recognise and protect traditional systems of knowledge that are needed to meet the objectives of the CBD fully, especially the local and community knowledge and the knowledge systems of indigenous peoples. There is therefore a need to achieve necessary amendments to existing regimes, and/or develop alternative regimes to address these concerns. The workshop identified the following actions as steps to address some of these concerns: RECOMMENDATIONS FOR ACTION 1. Recommendations Relating to International Regimes ------------------------------------------------------------ ---------------- Current international regimes which have relevance to IPR and biodiversity issues need to be substantially reviewed, and attempts made both to use the spaces available within them and create new spaces and alternative regimes which can help to conserve biodiversity and protect the rights of indigenous and local communities. In particular, actions are needed in the World Trade Organization (WTO), concerning specifically the Agreement on (TRIPs), the Convention on Biological Diversity (CBD), and the other relevant international processes, including those that have been initiated by the World Intellectual Property Organization (WIPO). Besides, the search for alternative international regimes is also important. A.WORLD TRADE ORGANISATION (SPECIFICALLY, TRIPs) At the level of the WTO, and specifically the TRIPs agreement, the following actions should be taken: 1.An open and transparent process, involving civil society, of reviewing article 27.3(b) in 1999 and the review in 2000 of the TRIPs Agreement overall; 2.A full consideration of the relevant provisions of the CBD, the FAO Undertaking on Plant Genetic Resources, the ILO Convention 169, the UNESCO/WIPO Guidelines for Protection of Folklore, the UN Draft Declaration on the Rights of Indigenous Peoples, international human rights declarations, and other relevant international treaties and processes, while undertaking the above-mentioned reviews; 3.An independent and transparent assessment of the environmental and equity implications of WTO in general and TRIPs in particular, with the involvement of civil society and of relevant international bodies relating to the CBD, the FAO and WIPO, and taking in particular the "precautionary principle" enshrined in Agenda 21; 4.A review of Article 31 of TRIPs to ensure its conformity with the preamble, and articles 7 and 8 of TRIPs, as well as article 16 of the CBD. The aspects of authorisation for commercial and non-commercial activity under Article 31 should be clarified during such review; 5.Expansion of, or at the very least maintenance of, the exceptions in Article 27.3(b) of TRIPs, for patenting of life forms; the expansion should ideally exclude micro-organisms, products and processes thereof, from patentability; 6.The definition of the term 'micro-organism' should not be expanded to cover tissues, cells or cell lines or DNA obtained from higher organisms, including human beings; 7.Expansion or at the very least maintenance of the sui generis clause relating to plant variety protection, in order to: (i)ensure implementation of article 8(j) of the CBD relating to indigenous and local communities; (ii)ensure that full consideration of environmental and ethical concerns about IPRs on life forms are addressed; and (iii)allow the completion of a biosafety protocol that establishes minimum international standards for the environmental safety of releases of genetically modified organisms. 8.Amending the provisions of Article 27.3(b) by either deleting the term "effective" in the context of sui generis systems of plant variety protection, or defining it such that national priority is paramount in the interpretation of the term, including the following: (i)Conservation and sustainable use of biodiversity; (ii)Promotion of traditional lifestyles; (iii)Promotion of food security and health security; (iv)Ensuring equitable benefit sharing; (v)Invoking the precautionary principle; (vi)Respect of the principles of equity and ethics; 9.Exploring ways of interpreting and implementing TRIPs that help achieve the objectives of the CBD; 10.Measures to prevent the unilateral pressure by some members to coerce other members to strengthen IPR regimes beyond the TRIPs requirements; 11.Enhancing the scope of Article 23 of TRIPs to strengthen protection of geographical indications for goods other than wine and spirits, such as Darjeeling tea; 12.The scope of Article 22 of the TRIPs should be expanded to protect denominations relating to geographic origin, and characteristics associated with a specific region; 13.Inclusion of requirements (in Article 29 of TRIPs) for disclosure of the genetic resources and the traditional knowledge used in inventions for which IPRs are claimed, the country and community of origin of these resources and knowledge, and proof of consent having been sought of the relevant community and equitable benefit-sharing arrangements having been entered into with them, as required by the CBD; 14.Steps to ensure that TRIPs implementation and elaboration fulfils all the objectives stated in Article 7. This should include striking a balance between rights and obligations, a balance that should take into account the objectives of the CBD as well as the principles enunciated at the Earth Summit; B. CONVENTION ON BIOLOGICAL DIVERSITY (CBD) The CBD process should take the following measures: 1.Assess the relationship of IPRs to access and benefit-sharing provisions, including in the development of guidelines or best practices for achieving equitable benefit-sharing from use of genetic resources. In particular, there should be consideration of mechanisms such as certificates of origin, evidence of prior consent for access to genetic resource, evidence of prior approval of indigenous and local communities for access to traditional knowledge, and disclosure of this evidence in patent applications; 2.Evaluation of the impacts of international processes relating to IPRs, including TRIPs, on the objectives of Article 8(j) of the CBD; 3.Development of a protocol on the protection of indigenous and local community knowledge and resource rights; 4.Providing inputs into the ongoing WIPO processes on "new beneficiaries" which are assessing issues relating to protection of traditional knowledge; and 5.Development of a code of conduct, or a protocol, on access and benefit-sharing, especially in relation to the resources and knowledge of indigenous and local communities, and of 'developing' countries; These steps could be taken up as concrete points for the inter-sessional process relating to the implementation of Article 8(j), which the CBD COP4 initiated; and of other processes relating to the Biosafety Protocol and the inter-sessional work on access and benefit-sharing. C. OTHER PROCESSES Other international processes relevant to IPRs and biodiversity need to take the following steps: 1.Development of the FAO Undertaking on Plant Genetic Resources, either in itself or as a protocol under the CBD, should incorporate comprehensive protection of indigenous and local community knowledge, along with provisions to conserve biodiversity and sustainably use biological resources; 2.Cooperation at the SAARC level to jointly conserve biodiversity, achieve sustainable use, and promote equitable benefit-sharing, especially through appropriate regional agreements; 3.Ensuring that any agreement on databases (e.g. the proposed Database Treaty) ensures effective control by communities of their knowledge, mechanisms that ensure effective and equitable sharing of benefits with and within communities, and space for communities define the terms by which they control access and require benefit-sharing; 4.At all international forums, setting up of "intercultural panels" to evaluate the terms of "cross-cultural transactions" by which knowledge relating to biodiversity from one knowledge system is used in another system, including in dispute-resolution processes. 2. Recommendations Relating to National Regimes ----------------------------------------------------------- ----------------- Many countries of the South Asian region are in the process of, or considering, specific legislation to bring into effect international treaties to which they are a party. In the development of such legislation, and in relevant non-legal measures, several steps need to be taken to ensure conservation, sustainable use, and equitable benefit-sharing. A. PATENT LEGISLATION 1.Countries should exclude from patentability: i.All life forms; ii.Existing traditional/indigenous knowledge (in current or translated forms), and essentially derived products and processes from such knowledge;(Use can be made of the European Patent Convention for a precedence for this, of Article 22 of the CBD for arguments relating to adverse impact on biodiversity from other international agreements, and of relevant exemptions provided in the TRIPs agreement) 2.Patent applications should include the following: i.Disclosure of all places of origin of the material/knowledge used in the application; ii.Disclosure of all communities/persons of origin; iii.Proof of consent having been obtained from the community/persons of origin; iv.Proof of benefit-sharing arrangement having been entered into with the community/persons of origin, in accordance with relevant guidelines developed by national authorities; v.Disclosure of any previous rejection of application, in the country or other jurisdictions; vi.Prior public notice in all relevant languages in the places and communities of origin. (Grounds for the above can be derived from Article 8(j), Article 15 and the clauses relating to national sovereignty under the CBD). 3.The burden of proof should be on the applicant; 4.Penalties for infringement of any of the above requirements should be severe and should include revocation of patents if already granted, or rejection of application, and appropriate compensation to the aggrieved. B.PLANT VARIETIES PROTECTION LEGISLATION 1.In view of the objectives of the CBD, UPOV 1978 or UPOV 1991 do not provide adequate models for sui generis plant variety protection legislation. Alternative regimes for providing appropriate models should contain the features elaborated below; 2.Applications for plant variety protection should include the following: i.Disclosure of all places of origin of the material/knowledge used in the application; ii.Disclosure of all communities/persons of origin; iii.Proof of consent having been obtained from the community/persons of origin; iv.Proof of benefit-sharing arrangement having been entered into with the community/persons of origin, in accordance with relevant guidelines developed by national authorities; v.Disclosure of any previous rejection of application, in the country or other jurisdictions; vi.Prior public notice in all relevant languages in the places and communities of origin; 3.The burden of proof should be on the applicant or plant variety right holder; 4.Farmers' Rights should get full treatment under the Act, and their definition should include: the right to protect farmers' varieties and knowledge, to continue having access to biological and other material which are important inputs into the farming system, to the cultural and social conditions which make continued innovation and resource use possible, and to save, propagate, use, exchange, share or sell varieties protected under the Act; and the obligation to ensure biodiversity conservation and sustainable use; 5.Farmers' Rights should further include the right to sue breeders if the latters' claims are not realised, with the burden of proving that the product complies with the claims being on the breeder; 6.The Act should contain provision for national and local level gene funds, derived from fees and other levies on plant breeding and the seed industry (other than those covered under agreements with local communities), which can be utilised for the purpose of supporting in-situ farmers' conservation measures and incentives for continued innovation by farmers; 7.The above funds and other sources should be used to provide a range of incentives for farmers to carry on conservation, use, and innovation of agricultural biodiversity, including financial, material, social, and other incentives; 8.The coverage of the Act should expand on a gradual step-by-step basis, applying the precautionary principle, following adequate environmental impact assessments, and assessing their implications for food security; 9.All new varieties being considered for protection should go through an environmental and social impact assessment to ensure that they do not threaten agro-biodiversity and community rights, using fully the precautionary principle in cases of uncertainty; the legislation coverage could expand on a gradual step-by-step basis; 10.Penalties for infringement of any of the above requirements should be severe and should include revocation of plant variety protection if already granted, or rejection of application. 11.All current ex-situ germplasm holdings in private or public sector should be required to: i.disclose the places of origin; ii.disclose the communities/persons of origin; iii.repatriate samples of the material, where relevant, to the communities/persons of origin; iv.provide full access to farmers to these holdings; and v.seek permission from the communities/persons of origin for any further use of this material; 12. Extant varieties, as identified by national inventories of biodiversity, will remain outside the purview of protection granted to industrial or formal sector breeders. C. BIODIVERSITY LEGISLATION 1.Provisions of the CBD should be given complete legal recognition and implemented effectively at a national level; 2.Article 8(j) of the CBD should be implemented under national legislation by: i.granting ownership of biogenetic material to local communities; ii. recognising and protecting of the traditional knowledge of these communities, and traditional modes of resource use regulation and dispute resolution under customary law; iii.ensuring the consent and involvement of these communities in the wider use of their knowledge and practices; iv.mandating a series of equitable benefit-sharing measures; 3.Rules should be enacted under the law laying down broad and inclusive criteria for identifying a "community". An essential criterion for such identification of a community should be direct dependence on a natural resource for subsistence; 4.The legislation should require, for both domestic and international access to biodiversity, prior informed consent, mutually agreed terms, and burden of proof on the applicant; 5.The legislation should cover not only biological taxa but also biochemicals and other parts derived from such taxa; 6.The appropriate national biodiversity agencies should scrutinize: i.market approval for products/ processes coming under the "mail-box" applications; ii.patent application for anything derived from biological resources/ knowledge of local community; and iii.other relevant commercial applications from the point of view of: iv.whether there is any threat to biological diversity, the environment, or human health (the precautionary principles should be applied in case of uncertainty); and v.whether there are any adverse implications on the rights of local communities; 7.Rules should be formulated under the legislation for equitable benefit sharing; 8.Appropriate institutions should be created or, where already existing, empowered to handle the provisions of the legislation; 9.The legislation should recognize that the appropriate local authority shall have the right of veto over any application referred to the National Authority and/or have the power to specify any special terms and conditions for regulating such access, which should be mandatory on the national Authority to incorporate into the scheme that it may formulate for the specific application; 10.All information relevant to the legislation should be available for public scrutiny; 11.The biodiversity legislation should come into force prior to the plant variety legislation; 12.Benefits derived from IPR-related legislation, and from access regulations, should be plowed back into conservation of biodiversity, and towards providing incentives for local communities to continue lifestyles and practices relevant to conservation and sustainable use. D.PROTECTION OF FOLKLORE Current laws for Copyright protection are unsuitable for protection of folklore. Measures should be therefore taken for the development of a sui generis legislation for protection of folklore based on an understanding of 'folklore' as inclusive of the following elements: folk knowledge/practices/expressions of art, craft, music, scientific belief, architecture, agriculture, medicine, and conservation of natural resources. E.GEOGRAPHIC INDICATIONS/APPELLATIONS ACT Law should be enacted to protect denominations relating to geographic origin, and characteristics associated with a specific region. The provisions of this legislation should provide additional protection as has been provided for in Article 23 of TRIPs. F. OTHER PROCESSES 1.A database (or registry) of the biodiversity and knowledge wealth of the country should be compiled, consisting of an inventory of all the biological and genetic resources, a documentation and evaluation of the uses of these resources, and clarification of their ownership (local, state/provincial, national); 2.Any effort to develop registers or databases of indigenous or local knowledge should ensure effective control by communities of their knowledge. This should include mechanisms that ensure effective and equitable sharing of benefits with and within communities. Communities should have the right to define the terms by which they control access and require benefit-sharing; these terms should be transparent; 3.The capacity of communities and citizens to deal with biodiversity and IPR issues should be enhanced, through appropriate educational and training programmes which are culturally sensitive; 4.There is a need to revitalise and strengthen local systems of governance to ensure the control of communities over their knowledge and resources; and in this context there is need to institutional capacity building at the community level (e.g. Gram Sabha) to enable their empowerment; 5.Appropriate authorities should be set up, where biodiversity and IPR issues can be continually discussed among a wide range of actors, including government officials, non-government organisations, local community members, independent scientists and academics, and others. Governments should be required to consider the deliberations of such bodies while developing policies and programmes in these fields. Such bodies could include, amongst others, a parliamentary committee on the subject; 6.Market approval (including in the case of exclusive marketing rights or product patents) should require the following: i.Environmental impact assessment of the product/process being applied for, covering impacts on environment and public health (using fully the precautionary principle in the case of uncertainties); ii.Assessment of the impacts of the product/process being applied for, on community rights as defined in relevant national legislation; and iii.Consultation of the national biodiversity agencies in the case of biological resources and related knowledge. Contact: ----------------------------------------------------------- ----------------- Biswajit Dhar/Sachin Chaturvedi Research and Information System for Non-Aligned and Other Developing Countries (RIS) Habitat Centre, Lodi Estate, New Delhi 110003, India Tel: (91-11) 461 74 03 or 461 77 09 Fax: (91-11) 462 80 68 Email: bdhar97(at)hotmail.com or chaturvedi_s(at)hotmail.com Ashish Kothari Kalpavriksh 5 Shree Dutta Krupa, 908 Deccan Gymkhana, Pune 411004, India Tel/Fax: (91-20) 35 42 39 Email: ashish(at)nda.vsnl.net.in