31. At the invitation of the Chair, the Secretariat introduced document WIPO/GRTKF/IC/3/4 (Possible Format for an Electronic Database of National and Regional Clauses and Practices Concerning Access to Genetic resources and Benefit-Sharing) and the activities it proposed. The Chair recalled that at its previous session, the Committee had agreed to a two-step approach - discussion of the structure of the database to be followed by work on its contents - and invited the Committee to decide on the database structure and on the distribution of the questionnaire proposed in the document.
General issues on the contracts database
32. The Delegation of Spain, on behalf of the European Union, voiced general support for the approach set out in document WIPO/GRTKF/IC/3/4 but noted that there were several technical problems, such as responsibility for channeling information from Members to the database; issues regarding languages; and inclusion of detailed legal documents in summary form.
33. The Delegation of Venezuela emphasized that the database should contain information based on the experience of all Members, especially developing countries, and that its structure should reflect the requirements and needs of developing countries. It encouraged developing countries to send their remarks and comments, so as to achieve this balance. The Delegation supported the general structure of the database, and said it should be flexible enough to accommodate emerging needs. The Delegation stressed the importance of including the origin of the genetic resources and/or associated TK within the contract checklist (item 4.4 of document WIPO/GRTKF/IC/3/3). Information should cover whether the resources came from an in situ or ex situ origin, and also whether there had been prior informed consent. The Delegation stressed the need for any mechanism aimed at resolving disputes to be compatible with national law. It welcomed references to both monetary and non-monetary benefit-sharing, farmers' rights and confidentiality clauses, and stressed that definitions of terms for the purposes of the questionnaire should be as contained in the Convention on Biological Diversity (CBD) and not interpreted in a way that could prejudice agreements previously reached in other fora. The Delegation called for account to be taken of work in other WIPO Committees which were addressing issues related to the work of the present Committee, particularly on substantive patent law.
34. The Delegation of India, on behalf of the Asian Group, expressed appreciation for the work on collecting and compiling existing contractual clauses, but noted the need to focus on IP related aspects in contractual agreements concerning genetic resources and benefit sharing. The proposed questionnaire would benefit from the range of views and experience within the Committee. At the previous session, the Group had underlined the importance of prior art in its consideration of the protection of TK and the need to integrate TK documentation into the databases available to patent offices worldwide.
35. The Delegation of India appreciated the Secretariat's efforts to extend the coverage of periodicals, gazettes and newsletters in the minimum documentation list of TK for international and international type searches. It recognized that such an inventory could not fully reflect the scope and diversity of TK or the documentation available. It was a useful starting point, but this exercise could not be in isolation. An effective classification system for such disclosed prior art documentation was necessary, such as TK Digital Libraries with search tools for the retrieval of relevant information. The Delegation noted that this was presently being addressed by the WIPO Task Force on Classification of Traditional Knowledge, as part of the Committee of Experts of the Special Union for the International Patent Classification (IPC). The Delegation of India endorsed cooperation between the IPC Committee of Experts and the Committee. In the Delegation's view, the Committee also needed to address the more complex issue of "defensive protection" of TK and the "positive legal protection" through existing IP or contractual agreements or the development of sui generis rights. A review of national systems and existing IP mechanisms was crucial in this exercise.
end-users to look for contract parties that signed the contract on behalf of other organizations or stakeholders, such as when a governmental bodies signs on behalf of a community which holds TK. On (b)(iv) `contract scope,' the Delegation proposed the addition of "know-how," since much know-how was distinct from TK, even though the two were related. On item (j), concerning dispute resolution, the Delegation said that the questionnaire should cover how parties had agreed to resolve disputes but also the effectiveness of alternative dispute resolutions. This would help illustrate what forms of dispute resolution are most beneficial. The Delegation agreed, in principle, that the questionnaire could be disseminated with some adjustments. In many countries there were several governmental bodies, organizations, or institutions responsible for the provision of access to genetic resources and benefit sharing (in Thailand, the Department of Agriculture, the Forestry Department, and the National Institute on Traditional Medical Practices were all involved). All responsible parties should be encouraged to cooperate on responses to the questionnaire, including consultation with stakeholders such as holders of TK. Where different approaches were evident in a particular country, the database should include this diverse information so as to ensure a full picture of the various options.
37. The Delegation of Peru accepted the proposals in principle, yet emphasized that the database should be flexible so as to allow for the compatibility of the different interests involved. The Delegation of Bolivia supported the position of the Delegation of Venezuela, noting that the checklist should contain the origin of genetic resources and TK, and definitions should correspond with the CBD.
38. The Delegation of Australia welcomed the database as a useful step towards clearly identifying the issues and addressing the concerns raised before the Committee. The database would provide a practical tool to aid contract negotiators when considering protection and commercialization of IP related to genetic resources, and would increase understanding about existing practices. It would therefore contribute to assessments of the need for and the nature of any changes to national or international regimes. Noting that the database would serve immediate and ongoing objectives, the Delegation informed the Committee of the "Intellectual Property & Biotechnology: Training Handbook," produced by Australia under the auspices of Asia-Pacific Economic Cooperation (APEC) as a practical introduction to the management of IPRs in relation to biotechnology for the use of developing countries in the Asia and Pacific region. The database, once ready, would give actual operational examples of contractual terms; the Handbook gives practical insight on how to negotiate those terms. In order to encourage contributions to the database, the Australian Government had conducted wide consultations with State Governments, research institutes, professional and industry organizations, indigenous groups and companies, and many stakeholders had agreed to contribute - once aware of the purpose of the database, they saw value in contributing to it. Other delegations were invited to discuss how Australia had engaged key stakeholders. The Delegation flagged the need for technical co-operation on consultation mechanisms, and recommended that the Secretariat direct technical assistance towards ensuring developing countries had ample opportunity to contribute to the database. The Delegation noted the need to examine how confidential information could be handled, and whether such information should be collected at all.
39. The Delegation of the United States of America reaffirmed its support for this exercise, as it sought to even the playing field by providing capacity building to suppliers of genetic resources and also provided guidelines for researchers and users of the resources. It agreed with other delegations that the final product must be user-friendly to make the greatest impact, and expressed support for many of the items in document WIPO/GRTKF/IC/3/4, including the confidentiality provision, as it was often the practice to keep price and terms of agreements confidential, while at the same time making the existence of the agreement known. It suggested that the database include information on whether any patents had been granted on the research relevant activities as a result of the partnerships (and, in the case of commercialization of a pharmaceutical product, any marketing approval), and information on whether the research had been subject to approval by the national authorities (as distinct from the holders of the knowledge). The Delegation supported dissemination of the questionnaire to Committee Members and stakeholders and looked forward to a compilation of responses which would assist the Committee in its work.
40. The Delegation of Brazil advised that Brazil had carried out thorough consultations with relevant national stakeholders in preparation for this session of the Committee. This involved representatives from different governmental policy areas such as trade, IP, indigenous affairs, environment, culture, research and science and technology, together with non-governmental representatives of indigenous communities, such as the Coordination of Organizations of the Brazilian Amazon (COAIB) and the Council for Articulation of the Indigenous Peoples and Organizations of Brazil (CAPOIB). These consultations had been very useful in identifying its interests in the Committee's work. The Delegation referred to recent developments in other IGOs which were dealing with the issues of genetic resources, TK and folklore, and commented that WIPO could have a significant role in contributing to the international debate on the protection of TK and folklore, as well as on access to genetic resources as far as IPRs were concerned. This task was not exclusive to WIPO and could not be carried out in isolation from the work of other relevant IGOs that also had their respective mandates to address genetic resources, TK and folklore. Particularly relevant were the Food and Agricultural Organization (FAO), the World Trade Organization (WTO) and the CBD. The FAO International Treaty on Plant Genetic Resources for Food and Agriculture (FAO Treaty) contained provisions related to IPRs which must be taken into account in discussions regarding access to genetic resources. The WTO Doha Ministerial Declaration (adopted 14 November, 2001) instructed the Council for TRIPS to examine the relationship between the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the CBD, the protection of TK and folklore. Integrally with the single undertaking of the Doha Development Agenda, the TRIPS Council would address these outstanding implementation issues. The Committee would have to take account of developments in the World Trade Organization (WTO). The Decisions adopted by the Sixth Conference of the Parties of the CBD were also important inputs for the Committee. The "Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization" (Bonn Guidelines) clearly supported disclosure of the source of the genetic material in IP legislation, matter that should be considered in the Committee's discussions on access to genetic resources. Discussions on issues related to genetic resources, TK and folklore in WIPO did not and should not duplicate discussions in other organizations. Progress in the Committee that was not clearly compatible with developments in the CBD and FAO would not be meaningful or acceptable. Likewise, progress in WIPO would be extremely limited if the TRIPS Agreement remained unchanged in matters related to genetic resources and TK. Therefore, in light of its expertise and resources on IPRs, WIPO could contribute to a synergy among the relevant international fora. Cooperation between the WIPO Secretariat and the Secretariats of other relevant organizations had been very positive in this respect. At the national level, Governments should ensure that the relevant stakeholders would also contribute to this synergy. Finally, the Delegation referred to the ongoing discussions on the Substantive Patent Law Treaty (SPLT) in the WIPO Standing Committee on the Law of Patents (SCP). The Delegation was seriously concerned with the fact that the developments in the SPLT could actually represent a step backwards in relation to important provisions of the CBD, FAO and over the flexibilities contained in the TRIPS Agreement. Ultimately, developments on patent harmonization in the SCP could be in serious contradiction with possible developments in the Committee, and the Delegation invited other Members to reflect on the urgent need for coherence between those two exercises. The Delegation noted that the proposed database of contractual practices and clauses was in accord with the spirit of the Bonn Guidelines. The proposed definitions (Part III of Annex II) should include the term "derivatives" related to biological resources, as it was not adequately covered in the questionnaire. "Products thereof" can be both natural, such as the resin of a tree - which does not contain the original genetic material, but has been synthesized from the original biological material of a tree - or it may have been artificially synthesized from the genetic material in a laboratory. Annex I did not mention derivatives, but Question 6 of Annex II did.
41. The Delegation of Japan supported development of the proposed database, as a useful and practical means for parties involved in contract negotiations. It queried whether it would be feasible to collect sufficient actual contractual information. An initial survey of the Japanese private sector had revealed hesitations about contributing commercially sensitive information. Some measures may be necessary to encourage various kinds of stakeholders to contribute to the database. It may also be useful to pursue the additional approach of developing a guide of contractual practices, guidelines and model IP clauses, as originally proposed by the Secretariat, a guide which would be beneficial to stakeholders. The Delegation accordingly favored a dual approach, combining development of the database with the elaboration of a guide to contractual practices.
42. The Delegation of Norway generally supported the proposed database and questionnaire but raised a specific comment on the term "contract purposes" which, it felt, needed a different approach, since the categories given needed to reflect relevant uses. Material falling under the FAO Treaty, was to be used for research, breeding and training in food and agriculture, uses which seemed to fall between the categories as currently proposed. The Delegation supported Brazil's reference to the relevance of developments in fora such as the FAO, the CBD and the WTO.
43. The Delegation of France suggested an extension of the deadline for the collection of information on practices. The samples of contracts attached should be distributed in their original languages and that the database should reflect the regional diversity and diversity of legal systems. The questionnaire and database should include an indication of the conditions of scientific publication and communication. Finally, the explanatory parts of the questionnaire could be corrected in two ways: first, there was no automatic correspondence between commercial and industrial application and bioprospecting, on the one hand, and scientific applications and ex situ exchanges, on the other; second, the explanatory document should not mention definitions contained in the CBD nor should it propose additional definitions not yet agreed upon.
44. The Delegation of New Zealand expressed its support for the proposed database as set out in the Secretariat's document, which it considered to be comprehensive and user-friendly, and for the questionnaire. The request, in the questionnaire, for confidential or commercially sensitive information to be deleted from any contracts or comments would reassure those asked to participate in the process and would ultimately enhance the number of responses received. The Delegation recommended that work on the database proposal be advanced as soon as possible and as a matter of priority. The Committee could expect to make relatively fast progress through the provision of a practical tool to aid those entering into negotiations concerning the use, protection and commercialization of genetic resources and associated TK.
45. The Delegation of Zambia said that there was a need to identify the source of genetic material, whether obtained in situ or ex situ. The original source should be identified of material obtained ex situ. The Delegation proposed that no patents be applied for information obtained from the database.
46. The Delegation of Switzerland supported the proposed structure as meeting the needs of potential users and providing a concise and user-friendly source of information for use in drafting and negotiating relevant agreements. The Delegation supported the dissemination of the proposed questionnaire to Committee Members and a wide range of stakeholders with practical experience in the area of contractual practices and agreements relating to IP and access and benefit sharing. The Delegation hoped that many stakeholders would send in a reply so that the database would be as complete and comprehensive as possible. The next meeting of the Committee should review progress made.
47. The Delegation of India supported the two proposals, in principle. It had always supported WIPO as the most appropriate and neutral forum to harmonize and resolve the interests of different stakeholders. It shared the views of the Delegation of Brazil on the need to complement and coordinate with the activities of other bodies, and to establish an equitable and enforceable legal framework. This would be important if the approval of the two current proposals were to lead to salutary consequences for developing countries, especially those where awareness levels were low or where awareness was just increasing or where the holders of such resources were yet to be fully empowered.
48. The representative of the FAO advised that the FAO Treaty had already obtained seven ratifications and 47 signatures. The Treaty dealt with a specific kind of genetic resource, namely plant genetic resources for food and agriculture. Synergies across the various sectors concerned with those resources, such as WIPO, CBD and the WTO, was of utmost importance. He stressed the difference between the multilateral system, established by the FAO Treaty, and the contractual or bilateral systems of access. The multilateral system was based on the understanding that plant genetic resources belong to the international community and therefore it followed rules established multilaterally, examples of which could be found already under the Consultative Group on International Agricultural Research (CGIAR), which held hundreds of thousands of plant genetic resources in trust for the international community. Agreements that gave access to resources under the control of the CGIAR were not bilateral contracts, but agreements entered into in the framework of internationally approved rules. The question, then, was whether those rules should be reflected in the database, and yet taking into account that they had not been individually negotiated. The representative suggested that this question should be reflected in the database, or at least the existence of internationally established rules could be mentioned.
49. The Delegation of Argentina called for further consideration of some questions raised by the representative of the FAO and expressed full support for synergy and cooperation between the work of the FAO and WIPO. The exact linkages and interactions between the proposed electronic database and the FAO Treaty should be clarified, particularly how plant genetic resources for food and agriculture were to be covered in the database.
50. The Delegation of Egypt referred to the difficulty faced by developing countries in dealing with such complex and multi-faceted issues in a short time, and referred to the need for coordination between WIPO and other IGOs, notably under Article 19 of the WTO Doha Ministerial Declaration and certain work of the World Health Organization (WHO). The Delegation voiced concern of the impact of the SCP's activities on the Committee's work. The Committee's work would not be effective unless it resulted in a binding international instrument.
51. The representative of the Indian Movement Tupaj Amaru stated that there was no IP system that protected genetic resources and TK of indigenous peoples. He rejected any debate on human genetic resources and any contract involving the transfer of human genes.
Scope of subject matter
52. The Secretariat outlined the comment process that had been undertaken. One amendment that was introduced as a result of a Member's proposal at the comment phase was to include a reference under subject matter to human genetic resources, derivatives, modifications and progeny, and non-biological natural resources. Many delegations expressed views on this amendment.
53. The delegations of Bolivia, Brazil, Egypt, France, the Holy See, Peru, Spain (on behalf of the European Union), Venezuela, and Zambia objected to the reference to human genetic resources, on the basis of a range of ethical, cultural and religious grounds. The Delegation of Brazil pointed out that such resources are not covered by the same legislation as genetic resources of plants, animals and microorganisms. The Delegation of the Holy See added that a prudent approach to matters concerning human genetics was called for and that the reference to human genetic material is inappropriate in a contractual context. The delegations of Algeria (on behalf of the African Group), France, Peru, Spain (on behalf of the European Community and its Member States), Venezuela and Zambia opposed the inclusion of
non-biological natural resources. The delegations of Algeria (on behalf of the African Group), France, Spain (on behalf of the European Community and its Member States), and Zambia raised concerns about the references to derivatives.
54. The Delegation of Thailand noted that the inclusion of a reference to human genetic resources was sensitive and that the Committee must ensure that such inclusion would not lead to the belief that they were supporting the bio-prospecting of human genes or other human genetic entities and understood that much research was undertaken in this area, i.e. the search for human genes or genetic entities It clarified that it was not taking a position as to the inclusion or exclusion of human genetic material in the document, but that it was concerned that the Committee should not be seen as accepting the bioprospecting of human genes. With regard to (j), Dispute Resolution, the Delegation stated that not only that the provision of information should be on how the parties have agreed to resolve any disputes but also on the effective alternative dispute resolutions used so far in the contracting party countries, if any, with details of how it was utilized and why it was a success. The Delegation stated that this was to provide an idea of what sort of dispute resolution should be incorporated in the contract in order for the parties to effectively resolve the problems without delay. The Delegation recommended the dissemination of the questionnaire of contractual practices and clauses relating to intellectual property, access to genetic resources and benefit sharing provided in Annex II, with the following suggestions, namely that since in many countries there are several governmental bodies, organizations, or institutions responsible for the provision of access to genetic resources and benefit sharing. The Delegation stated that in answering the questionnaire all responsible parties should be encouraged to cooperate on the preparation of the information given together with the consultation with stakeholders to obtain the uniform and harmonized information relating to intellectual property related clauses and contractual practices in individual contracts concerning access to genetic resources and benefit sharing of each country. It added that if the uniformity and harmonization of such information cannot be met among responsible parties of the country, differences in each version of the information should be provided so that the Secretariat could compile a complete data of practices in that country.
55. The Delegation of Australia indicated it did not share other delegations' concerns regarding the listing of human genetic resources. Since the prospecting of human genetic resources was actually taking place, it may be useful for further information to be available on these activities. On the other hand, it acknowledged that the interface between IP and human genetic resources was a sensitive issue.
56. The Delegation of Norway noted that this was not a normative document but a database that reflected realities. If human genetic resources were actually the subject matter of contracts, they should be included. The Delegation of New Zealand called for the retention of references to human genetic resources and non-biological natural substances, as collection of contractual terms concerning those matters must surely be of assistance to indigenous peoples and communities being asked to participate in such arrangements.
57. The Secretariat clarified that the proposed database was intended solely to gather information. It would assist research into contractual practices and IP clauses relating to access to genetic resources and benefit-sharing; provide guidance on how other parties had dealt with IP issues of access and benefit-sharing contracts and on lessons learned; and enable those who were unfamiliar with the field of IP and genetic resources to learn about contracting practices. Since the database would potentially deal with any contracts concerning genetic resources, the proposed structure divided genetic resources into several categories solely to assist information retrieval. As the Delegation of Norway had pointed out, the database would not have a normative nature, and would merely reflect existing practices. Nonetheless, a statement could be added to the relevant part of the database explaining that the reference to human genetic resources should not be seen as an endorsement of any practices in that area. The Secretariat clarified that the reference to `human genetic resources' and other terms which had been discussed by the Committee had not been included at the initiative of the Secretariat, but was included following the receipt of comments by Members on the proposal in document WIPO/GRTKF/IC/3/3. On confidentiality, the Secretariat did not expect to receive any information that was of a confidential nature, nor would it cater for it. The FAO Treaty covered material which would overlap with "plant genetic resources" in the questionnaire. Yet in contrast to the proposed database, the FAO Treaty was not an information collection exercise but a binding international treaty establishing a multilateral system of access to plant genetic resources for food and agriculture. Some information in the proposed database might relate to contracts on such resources, both outside and within the multilateral system. Hence the exercises undertaken by the FAO and WIPO were complementary rather than contradictory, and the database would include suitable references to the multilateral system under the FAO Treaty.
58. The representative of the FAO concurred, observing that there was no problem between the exercises undertaken by the FAO and WIPO. The Governing Body of the FAO Treaty, was establishing a work program in which it would define the Material Transfer Agreement for the multilateral system. He stated that the interest of the FAO was to ensure that nothing was done in the context of the present exercise which would prejudice the further work of the Treaty, and supported the approach set out by the Secretariat.
59. The Chair noted that there was a broad support both for the structure of the proposed database and the dissemination of the questionnaire. On the structure, the general comments concerned the eventual grant of patents on research based on genetic resources and whether the research had been approved by national authorities. The structure should also take account of specific remarks on IP aspects; know-how and confidentiality; the reference to prior informed consent; the concept of derivatives; and publication of scientific research. The Committee had noted the need to encourage a wide range of recipients of the questionnaire to submit information, and the need for technical assistance for developing countries to use the questionnaire. The matter of confidentiality had been raised, but had already been clarified by the Secretariat. A further common topic had been the need for synergy and cooperation between intergovernmental organizations.
60. Noting that there were two distinct views on maintaining the reference to human genetic resources, as well as to non-biological natural resources, the Chair observed that the questionnaire was clearly not a norm-setting exercise and the Committee was not endorsing anything by means of the questionnaire; the questionnaire only sought to collect data for the potential use of people interested in precedents of various contractual practices; and the Committee was at present only establishing the database, which would have to be revised over the years to come. There were ethical concerns relating to human genetic resources, and a distinct concern about the scope of WIPO's competence since the questionnaire was aimed at elucidating practices in
benefit-sharing and the CBD did not cover human genetic resources. The Chair's proposal to replace the reference to human genetic resources by a reference to medical research was not accepted by several delegations.
61. The Chair therefore proposed, and the Committee agreed, that the questionnaire be circulated without the reference to human genetic resources. The Chair proposed, and the Committee decided, that given the lack of consensus on references to derivatives and non-biological natural resources, the questionnaire should be circulated without them.
Certain Decisions by the Conference of the Parties to the Convention on Biological Diversity (WIPO/GRTKF/IC/3/12)
62. At the invitation of the Chair, the Secretariat introduced document WIPO/GRTKF/IC/3/12. The representative of the Secretariat of the CBD reported on the outcomes of the sixth meeting of the Conference of the Parties (COP) to the CBD, reporting that the COP had noted the work of the Committee with appreciation. She described several COP decisions of particular interest to the Committee, namely the decisions on:
- Article 8(j) and related provisions (Decision VI/10);
- access and benefit-sharing as related to genetic resources (Decision VI/24);
- cooperation with other organizations, initiatives and conventions (Decision VI/20);
- agricultural biological diversity (Decision VI/5); and
- scientific and technical cooperation and the clearing house mechanism (Decision VI/18).
63. The representative recalled that COP Decision VI/10 ("Article 8(j) and Related Provisions") had invited the Committee:
- to continue to promote the more effective participation of indigenous and local communities in its work;
- to examine and consider mechanisms to protect TK, such as the disclosure of origin of relevant TK in applications for IPRs; and
- to forward to the Executive Secretary all documents considered relevant with respect to advances made by the Committee.
The COP had also requested the Working Group on Article 8(j) and Related Provisions to address the issue of sui generis systems for the protection of TK, taking into account the work of the Committee. The CBD therefore welcomed document WIPO/GRTKF/IC/3/8 ("Elements of a sui generis System for the Protection of Traditional Knowledge"). The COP had urged CBD Parties and Governments, with the approval and involvement of indigenous and local communities, and with the support of WIPO, to develop and implement strategies to protect TK based on a combination of appropriate approaches. To this effect, the COP had identified a number of additional measures to assist the protection of TK which included improving operational links between national IP bodies and indigenous and local communities, as well as inviting Governments, with the assistance of WIPO, to take into account TK in the examination of novelty and inventive step in patent applications. The COP, at its seventh meeting, would examine the feasibility of establishing appropriate dispute-settlement or arbitration procedures and mechanisms to address disputes between CBD Contracting Parties concerning the interpretation or application of the CBD relating to TK, innovations and practices. Decision VI/20, entitled "Cooperation with other organizations, initiatives and conventions," addressed matters of cooperation with WIPO, recognized the role of WIPO as the lead specialized agency to address IPRs, and emphasized continued cooperation between the CBD and WIPO. The COP had invited WIPO to address, as a matter of priority, the role of IPRs in the implementation of access and benefit-sharing arrangements. With reference to Decision VI/24, entitled "Access and benefit-sharing," one of the main achievements of the sixth meeting of the COP had been the adoption of the Bonn Guidelines, which were to assist Parties and relevant stakeholders in implementing the access and benefit-sharing provisions of the CBD. The Guidelines were to be "...applied in a manner that is coherent and mutually supportive of the work of relevant international agreements and institutions. ..[and that] the work of [WIPO] on issues of relevance to access and benefit-sharing should be taken into account." The COP addressed the role of IPRs in access and benefit-sharing arrangements, inviting Governments to encourage the disclosure of (i) the country of origin of genetic resources in IPR applications as a possible contribution to tracking compliance with prior informed consent and mutually agreed terms on which access to those resources was granted; and (ii) relevant TK in applications for IPRs. The COP had recognized that further work was needed on these issues and, in relation to the role of IPRs, sought the help of WIPO to undertake further information gathering and analysis. The COP had invited WIPO to prepare a technical study and report its findings to the COP at its seventh meeting, on methods consistent with obligations in treaties administered by WIPO for requiring the disclosure within patent applications of, inter alia (a) genetic resources utilized in the development of the claimed inventions; (b) the country of origin of genetic resources utilized in the claimed inventions; (c) associated TK utilized in the development of the claimed inventions; (d) the source of the associated TK; and (e) evidence of prior informed consent. COP Decision VI/24 had also encouraged WIPO to make rapid progress in the development of model IP clauses which may be included in contractual agreements when mutually agreed terms were under negotiation.
64. The representative noted that in Decision VI/5, entitled "Agricultural Biological Diversity," on the impacts of genetic use restriction technologies (GURTS), the COP had invited the Committee and other relevant organizations to undertake several activities, including (1) to examine the specific IP implications of GURTS, particularly in respect of indigenous and local communities; (2) to further study their potential impacts on smallholder farmers, indigenous and local communities and on Farmers' Rights; and (3) to study the applicability of existing, or the need to develop new, legal mechanisms to address the application of GURTS. In the context of Decision VI/18, "Scientific and technical cooperation and the clearing-house mechanism," she welcomed the WIPO Portal of TK Databases. If WIPO should decide to implement Options 2, 3 or 4 (Section IV of document WIPO/GRTKF/IC/3/6), the CBD Secretariat would be willing to discuss areas of collaboration and potential support. This support could be based upon the experience of the SCBD with common formats, protocols and standard-issues that would be of central concern in the development of the WIPO Portal of TK Databases. The representative referred to many areas of mutual interest under the CBD and WIPO, particularly with regard to the work of the Committee, and expressed confidence that the outcomes of the Committee's third session would contribute significantly to progress in the CBD's current work.
65. The Secretariat reported that a Memorandum of Understanding between WIPO and the SCBD was in the process of being signed by the Executive Secretary of the CBD and the Director General of WIPO, responding to COP decisions in this regard. This would reinforce and confirm the positive cooperation that existed between the two Secretariats. It would set out the main areas of collaboration along the existing lines of cooperation between the WIPO and CBD Secretariats and help clarify the distinct roles of the two agencies, while ensuring that they continue to work cooperatively.
66. The representative of the United Nations Environment Programme (UNEP) reported on the working relationship UNEP had with WIPO on IPRs, access to genetic resources and benefit-sharing, noting that the WIPO and UNEP had jointly launched a CD-ROM, with a full WIPO-UNEP Study to follow in the course of 2002. The Executive Secretary of UNEP had announced at the recent COP the UNEP's new initiative on Access to Genetic Resources and Benefit-sharing. UNEP had recently put together a Partnership Proposal for the World Summit on Sustainable Development.
67. The representative of United Nations Conference on Trade and Development (UNCTAD) reported that UNCTAD's work on TK protection focused on exchanging national experiences with TK protection and on identifying policies to harness TK for trade and development, adding that UNCTAD would include capacity building on TK in its work on post-Doha capacity building. She reported on an International Seminar on Systems for the Protection and Commercialization of Traditional Knowledge, which had been convened by UNCTAD and the Government of India in New Delhi. UNCTAD also planned to organize a meeting in Geneva on the FAO Treaty in the fall of 2002. She offered the full support of UNCTAD to the work of the Committee.
68. The Chair invited comments from Committee Members on the work schedule proposed in paragraph 3 of document WIPO/GRTKF/IC/3/12 in carrying out a technical study on certain IP issues related to genetic resources and TK, noting that it fell within the Committee's mandate.
69. The Delegation of Spain, on behalf of the European Union, stated that it supported the proposal made by the Secretariat and that it considered that the suggested timetable was well coordinated with the CBD work program. Other delegations voicing general support for the proposal included those of India, Norway, Switzerland and Thailand.
70. The Delegation of the Dominican Republic recalled that it already had taken a specific position on the issue of the disclosure of origin of genetic resources, and, in particular, on the issue of whether such disclosure should be a condition of patentability, and that this position had already been put before the Standing Committee on Patent Law (SCPL). The Delegation requested that the list of questions prepared by the Secretariat to answer these technical questions should first be made available for comment by its capital. The Delegations of Venezuela, of Peru, of Bolivia and of Sri Lanka supported this request. The Delegations of Peru, of Ecuador and of Bolivia also raised questions concerning the overlap with work of the SCPL and the need for sensitivity in this regard.
71. The Delegation of the United States of America recognized that the identification of the origin of genetic resources was a part of the disclosure for some patent applications, but noted that, in keeping with the TRIPS Agreement, such identification could not be a substantive legal requirement for patentability. It voiced support for the CBD and for a cooperative relationship with WIPO.
72. The Delegation of Zambia noted that it was very important for IGOs to work together and that it was also very important for the source of genetic material to be disclosed. This was one way to enable the fair and equitable sharing of benefits.
73. The Delegation of Thailand expressed support for the proposed timeframe for conduct of the technical study. It further invited the Secretariat to consider specifically Section C of Decision VI/24, paragraph 4 by emphasizing on paragraph 8 to invite other organizations to study paragraph 3 and 4 of such decision, as set out in document WIPO/GRTKF/IC/3/12. The Delegation in particular requested the Secretariat to invite the WTO to consider the addition of such disclosure proposed in paragraph 4 of Decision VI/24 into the TRIPS Agreement, Section 5 on Patent, particularly Article 27.
74. The Delegation of Switzerland supported the work schedule as laid out in document WIPO/GRTKF/IC/3/12 and noted that it was important that WIPO, as the expert organization in the field of IP, should give consideration to these issues.
75. The Delegation of Sri Lanka said that it accepted the outline program, but would like to see the structure of the proposed questionnaire. The Delegation indicated that it took a different view on compatibility with TRIPS from that of the Delegation of the United States of America.
76. The Delegation of Egypt welcomed the cooperation between the CBD and WIPO, and supported the Delegation of the Dominican Republic, in particular its position regarding declaration of origin as a condition of patentability. The Delegation of Sudan expressed its support for this position.
77. The Delegation of Norway noted that the Committee should not reedit the mandate of CBD. If the Committee were to adhere to the proposed timetable, there would not be sufficient time to comment upon the proposed questionnaire. The Delegation stated that it would be very unfortunate to delay the process and asked for advice on the best way forward.
78. The representative of the Saami Council recalled that his organization and other indigenous organizations had repeatedly stressed the need for the Committee to consider aspects other than IP if its work were to be relevant to indigenous peoples. This entailed sustainable development and other environmental issues, as were raised in document WIPO/GRTKF/IC/3/12. He noted that paragraph 38 of decision VI/20 encourages WIPO to take account of the objectives and principles of the CBD and urged the Committee to seek information from the CBD on the relevance of sustainable development aspects to genetic resources and TK. The representative urged the Committee to cooperate fully with the newly formed United Nations Permanent Forum on Indigenous Issues.
79. The Chair concluded that:
- the Committee welcomed the proposed cooperation with the CBD;
- the Committee in essence, agreed with the timescale set out by the Secretariat; and
- a number of delegations wished to comment upon the draft questionnaire upon which the requested technical study would be based.
80. The Secretariat noted that document WIPO/GRTKF/IC/3/12 had necessarily been subject to a very tight timetable, due to factors beyond the control of the Secretariats of both the CBD and WIPO. The sixth CBD COP was held in April 2002; the letter of invitation from the Secretariat of the CBD to WIPO was dated May 21, 2002; and the current date was
June 13, 2002. While Members could comment on the questionnaire, they would need to accept that this would radically alter the timetable set out in document WIPO/GRTKF/IC/3/12. In particular, the process of commenting on the questionnaire would give Committee Members relatively little time to consider the first draft of the technical study in December 2002 at the fourth session of the Committee, and still less time for translated versions of the study. The draft technical study had to be available for consideration by the Committee at its fourth session, to allow time for it to by revised for the fifth session and then considered by the WIPO Assemblies prior to transmission to the CBD Secretariat in time for the seventh COP. The issues set out in paragraph 4 of document WIPO/GRTKF/IC/3/12 would shape the proposed questionnaire.
81. The Chair noted that several Members had expressed strong interest in receiving the draft questionnaire for comment. He stated that, if this request was acceded to, Committee Members had to be aware that it would result in a very short timetable. In particular, the draft technical study may not be complete, may not be translated into all the working languages of the Committee and may be disseminated only a short time in advance of the fourth session. The Chair also noted that, in any event, the main discussion about the technical study would take place in June 2003. The draft questionnaire would be made available for comments in the language in which it had been written at the end of June 2002 and in the other two working languages of WIPO as soon as possible thereafter.