Science and Research
John Voumard, Inquiry Chair
© Commonwealth of Australia, 2000
ISBN 0642547157
3.1 Australia's obligation to facilitate access to, and benefit sharing arising from the use of our biological resources, is based on our responsibilities under the Convention on Biological Diversity which include:
3.2 There is also developing international recognition of Indigenous rights in biological resources and associated traditional knowledge. Relevant sections of the Convention on Biological Diversity are as follows:
3.3 Among other relevant developments are the International Labour Organisation Convention No 169 (ILO 169) and the Draft Declaration on the Rights of Indigenous Peoples. The ILO 169 (not yet ratified by Australia) contains provisions upholding Indigenous rights to lands, environments, and the biological and genetic resources on these (Articles 7, 13(1), 13(2) and 14(3)) and the Draft Declaration includes the following articles:
3.4 The United Nations Convention on the Law of the Sea includes provisions relating to marine scientific research, including where this may have commercial implications. The relevant articles are:
3.5 Australia's domestic obligations to facilitate access to and benefit sharing arising from use of our biological resources are based on:
3.6 Following Australia's signature of the Convention on Biological Diversity in 1992, the Australian and New Zealand Environment and Conservation Council submitted a report to First Ministers in February 1993 on the Implementation of and Implications of Ratification of the Convention on Biological Diversity. In addressing Article 15 of the Convention on Access to Genetic Resources, the report noted that: 'the control of access to genetic resources is an issue of national importance requiring urgent attention ... the introduction of procedures governing access ... would enable Australia to take full advantage of the opportunities provided by this article and also protect our interests. Currently, under existing legislation and guidelines it is possible to export a large range and volume of genetic resources for use in overseas research and development without appropriate returns to Australia.'
3.7 Since then there have been three national reports on access and benefit-sharing issues.
3.8 In March 1994, ANZECC released an issues paper on Access to Australia's Genetic Resources. The ANZECC report outlined relevant international agreements, described the situation governing access arrangements internationally and domestically, identified various issues relevant to Aboriginal and Torres Strait Islander peoples, and outlined collection, intellectual property and conservation issues.
3.9 Also in March 1994 the Office of the Chief Scientist in the Department of the Prime Minister and Cabinet released Access to Australia's Biological Resources -- a discussion paper, a paper prepared for the Coordination Committee on Science and Technology. The paper covered similar issues to the ANZECC paper, although in somewhat greater detail, and recommended that the following principles be adopted in further work on the issues:
3.10 In support of these principles the paper also recommended four approaches as suggested in the National Strategy for the Conservation of Australia's Biological Diversity. The approaches were:
3.11 First Ministers established the Commonwealth State Working Group in May 1994 following advice from ANZECC. The Working Group discussion paper, Managing Access to Australia's Biological Resources -- Developing a Nationally Consistent Approach, was completed in October 1996. The paper was subsequently released and submissions received in April 1998.
3.12 The principles identified by this discussion paper were that access management regimes should:
3.13 In particular, the Working Group paper expressed the belief that jurisdictions would need to give consideration to:
3.14 The Working Group's terms of reference also included the obligation to take into account 'the interests of Aboriginal and Torres Strait Islander peoples in the use and ownership of traditional knowledge, innovations and practices and biological resources on Aboriginal lands'. The discussion paper addressed the issue briefly, concluding, however, that it was not within its terms of reference to resolve this complex matter, and suggesting that it was more appropriately dealt with in other fora, because wider policy issues concerning the treatment of Indigenous people were involved.
3.15 A working group, including Environment Australia, the Department of Agriculture, Fisheries, Forestry -- Australia and representatives of State Governments, was formed to write a report to First Ministers addressing the above recommendations, based on Commonwealth and State input and the submissions to the October 1996 Commonwealth State Working Group discussion paper. This work was effectively put on hold during the Inquiry.
Commonwealth Interdepartmental Committee on Access to Australia's Biological Resources.
3.16 The working group operates in conjunction with a Commonwealth Interdepartmental Committee on Access to Australia's Biological Resources. Environment Australia and Agriculture, Fisheries, Forestry -- Australia jointly chair the Committee which includes representatives from departments and agencies with a varying range of interests in the issues. Two meetings of the Committee were held during the course of the Inquiry (December 1999 and April 2000).
3.17 Biotechnology Australia was established to coordinate and undertake non-regulatory functions to position Australia to benefit from biotechnology. This includes measures to enhance access to genetic and biological resources. The Inquiry is one of the major activities under Biotechnology Australia's Access Sork Program and is funded through this Program.
3.18 Biotechnology Australia was established in the Industry, Science and Resources portfolio but comprises five departments: Industry, Science and Resources, Environment Australia, Agriculture, Fisheries and Forestry -- Australia, Health and Aged Care and Education, Training and Youth Affairs. It is overseen by a Ministerial Council, of which the Minister for the Environment and Heritage is a member, and a Committee of departmental Secretaries.
3.19 The first Ministerial Council meeting, on 21 June 1999, endorsed the:
3.20 The second Ministerial Council meeting, on 11 August 1999, approved a Work Program for implementation of the access strategy, including expenditure for 1999--00 and 2000--01.
3.21 Biotechnology Australia released a Discussion Paper, Developing Australia's Biotechnology Future, in September 1999 which, among other things, invited public comment on a wide range of matters relating to development of a biotechnology strategy, including access to biological resources. The Discussion Paper also referred to the Inquiry into Access to Biological Resources.
3.22 In the May 2000 budget, the Commonwealth Government announced the allocation of an additional $30.5 million over four years to Australian biotechnology, for targeted initiatives under the Commonwealth's National Biotechnology Strategy.
3.23 The Minister for Industry, Science and Resources, Senator Nick Minchin, announced the National Biotechnology Strategy on 3 July 2000 at the Australian Biotechnology Association conference in Brisbane.
3.24 The work of the Inquiry is reflected in the Strategy as it includes, as an objective, 'The development of measures to enhance access to Australian biological resources' and includes among the strategies to meet that objective the need to:
3.25 The major outcome proposed from Biotechnology Australia's Access Work Program is a streamlined path for the biotechnology industry to access Australia's biological resources. Current access mechanisms are slow and cumbersome and hamper industry development. The establishment of a streamlined Commonwealth access regime is anticipated to act as an incentive to State and Territory participation in a nationally consistent approach to access, in accordance with the recommendations of the October 1996 Working Group report.
3.26 I have prepared this report with the Working Group recommendations in mind and made recommendations about developing a nationally consistent system.
3.27 The Aboriginal and Torres Strait Islander Commission established this Taskforce to address the protection of Indigenous cultures, in particular through protecting Indigenous intellectual property.
3.28 The focus of the Taskforce was an ATSIC commissioned report called Our Culture, Our Future: Report on Australian Indigenous Cultural and Intellectual Property Rights which was released in September 1999. The report's major concern was Indigenous intellectual property issues relating to arts and cultural expression. However, in relation to the issue of the appropriation of Indigenous biodiversity knowledge, the report stated that:
A major concern of Indigenous people is that their cultural knowledge of plants, animals and the environment is being used by scientists, medical researchers, nutritionists and pharmaceutical companies without any benefits flowing back to them.2
3.29 An Interdepartmental Committee convened by the Department of Communications, Information Technology and the Arts has considered these issues further, particularly in relation to copyright, trademarks and designs. The Committee is finalising a Cabinet Submission regarding measures to enhance protection for Indigenous intellectual property relating to arts and cultural expression.
3.30 The Fourth Conference of the Parties (COP4) to the Convention on Biological Diversity, held in May 1998 in Bratislava, in the Slovak Republic, addressed 'Access and Benefit sharing'.
3.31 As part of Decision IV/8, COP4 decided to establish a regionally balanced Panel of Experts on Access and Benefit Sharing. The Panel's mandate was to draw on all relevant sources, including legislative, policy, administrative measures, best practices and case studies on access to genetic and biological resources and benefit sharing arising from the use of those resources (including biotechnology) to develop a common understanding of basic concepts. In addition the Panel was to explore all options for access and benefit sharing on mutually agreed terms, including guiding principles, guidelines and codes of best practice for access and benefit-sharing arrangements.
3.32 The Convention Secretariat selected Ms Elizabeth Evans-Illidge, a research scientist at the Australian Institute of Marine Science, to attend the meeting of the Panel in Costa Rica on 4--8 October 1999. The Panel reported to COP5 in Nairobi, Kenya in May 2000.
3.33 The Costa Rica meeting brought together individuals to represent their own views and experiences rather than any particular sectoral or institutional position. While discussions were at times lively and controversial, all Panel members were committed to finding areas of consensus and common understanding as a point from which to move forward.
3.34 The Panel observed that the issues of access and benefit sharing are controversial. They involve a wide range of sectors including industry, research, Indigenous communities, non government organisations and governments. The key conclusions for COP5 consideration included the Panel's view that individual contracts were currently the main mechanism for achieving access and benefit sharing.
3.35 The Panel went on to say that, while effective legislative, administrative and policy measures set in sound national strategies were the ideal way in which parties to the Convention should implement access and benefit sharing, no country had yet achieved this (although some were in the developmental stages). Accordingly, the Panel saw the need for interim measures. To provide legal certainty and clarity, it suggested measures which included adopting voluntary guidelines and government involvement in, or endorsement of, individual contracts.
3.36 The Panel further suggested that legislation for access and benefit sharing should not be overly prescriptive, and needed to ensure low transaction costs and allow for flexibility in the negotiation of mutually-agreed terms in individual contracts. Intellectual property rights could influence implementation of access and benefit sharing arrangements, and needed to be taken into account. Prior informed consent was a core requirement, which must be based on comprehensive information about all issues, and might be required at a number of levels from governments to communities. Improved capacity is required in many countries in all aspects of access and benefit sharing.
3.37 The Panel saw a national focal point and competent authorities as essential facilitators of access and benefit sharing, and proposed to ask COP5 to encourage parties to establish such mechanisms.
3.38 The Panel saw the Costa Rica meeting as successful in tackling the ambitious mandate set by the COP. It developed a common understanding of basic concepts, begun to explore the many options for access and benefit sharing on mutually agreed terms, and identified the key areas for further work.
3.39 The value placed on the Panel's work was reflected by the decision of COP5 to reconvene the Panel to continue its work. The Panel will report to an Ad Hoc Open-ended Working Group on Access and Benefit sharing established by the COP.
3.40 The COP5 decided to take the work forward in the following terms:
11. Decides to establish an Ad Hoc Open-ended Working Group, composed of representatives, including experts, nominated by Governments and regional economic integration organizations, with the mandate to develop guidelines and other approaches for submission to the Conference of the Parties and to assist Parties and stakeholders in addressing the following elements as relevant to access to genetic resources and benefit sharing, inter alia: terms for prior informed consent and mutually agreed terms; roles, responsibilities and participation of stakeholders; relevant aspects relating to in situ and ex situ conservation and sustainable use; mechanisms for benefit sharing, for example through technology transfer and joint research and development; and means to ensure the respect, preservation and maintenance of knowledge, innovations and practices of Indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity, taking into account, inter alia, work by the World Intellectual Property Organization on intellectual property rights issues.3
3.41 The Inquiry found the work of the Panel of Experts useful in its analysis of issues and identification of the complex factors affecting any access schemes.
3.42 Decision IV/9 of COP4 established the ad hoc Open-ended Intersessional Working Group on the Implementation of Article 8(j) and related provisions.
3.43 This Group's mandate includes providing advice to the COP on applying and developing legal and other appropriate forms of protection for the knowledge, innovations and practices of Indigenous and local communities; identifying objectives and activities falling within the scope of the Convention on Biological Diversity; and recommending priorities and activities on benefit sharing. This Group met in Madrid, Spain in November 1997 and in Seville, Spain, in March 2000 and reported to COP5 with a recommended program of work.
3.44 At the COP5 meeting in Nairobi, the elements of the recommended work program were refined and allocated priorities (see Appendix 8). In addition, the COP emphasised communication and cooperation with the World Trade Organization and the World Intellectual Property Organization and decided, among other things, that it would:
9. ... extend the mandate of the Ad Hoc Open-ended Inter-Sessional Working Group on Article 8(j) and Related Provisions of the Convention on Biological Diversity to review progress in the implementation of the priority tasks of its programme of work according to reports provided by the Executive Secretary, and the Parties to the meeting of the Working Group and recommend further action on the basis of this review. The Working Group should further explore ways for increased participation by Indigenous and local communities in the thematic programmes of work of the Convention on Biological Diversity. The Working Group should report to the Conference of the Parties at its sixth meeting; ..., and
14. Recognize[d] the potential importance of sui generis and other appropriate systems for the protection of traditional knowledge of Indigenous and local communities and the equitable sharing of benefits arising from its use to meet the provisions of the Convention on Biological Diversity, taking into account the ongoing work on Article 8(j) and related provisions, and transmits its findings to the World Trade Organization and the World Intellectual Property Organization, as suggested in paragraph 6 (b) of recommendation 3 of the Inter-Sessional Meeting on the Operations of the Convention (UNEP/CBD/COP/5/4, annex) ...4
3.45 The Parties to the Convention consider implementation of Article 8(j) and related provisions of the Convention a cross-cutting issue affecting virtually all sectoral and thematic areas and work programs dealt with under the Convention. These include:
3.46 References to Article 8(j), 'traditional knowledge, innovations and practices' and 'involvement of indigenous and local communities' occur, for example, in no less than 11 of the 19 decisions made at COP4.
3.47 In addition to the Ad Hoc Working Group on Article 8(j), the Executive Secretary of the Convention Secretariat has established a liaison group, comprised of representatives of Indigenous and local communities, to act as an informal reference group to provide advice on preparing documents for various meetings. Indigenous peoples in Australia have representation on this liaison group.
3.48 Representatives of Indigenous and local communities have had a very direct input into Convention processes and a direct bearing on the outcomes of all the decisions referred to above. In fact, the COP, in its meetings, has been very concerned to explore ways of increasing the direct and effective participation of Indigenous and local communities in the work of the Convention.
3.49 Indigenous peoples from Australia have generally been well-represented at meetings, and because of continuity of attendance, provide considerable leadership at the international level when dealing with issues being addressed by the COP under the Convention on Biological Diversity.
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3.50 A summary of access and benefit-sharing systems in several nations is at Appendix 9. While to date, examples of other national approaches have been limited, delegates to COP5 were advised that over 50 nations are now developing legislation and other legal instruments to establish access schemes.
3.51 The Inquiry has carefully considered other nations' approaches to these issues and the decisions taken at COP5 but, in developing our recommendations, has been mindful of the need for a system which is appropriate to Australia's particular political, legal and institutional structures.
3.52 When the Food and Agriculture Organization Commission on Genetic Resources for Food and Agriculture adopted the International Undertaking on Plant Genetic Resources in 1983, genetic resources were regarded as the common heritage of mankind. The Convention on Biological Diversity, however, recognised national sovereignty over biological resources. Negotiations to revise the Undertaking to bring it into harmony with the Convention have been under way since 1993 in the Commission on Genetic Resources for Food and Agriculture. Australia, as both a supplier and importer of genetic resources, has significant interests in the outcomes of these negotiations. In common with other Parties to the Convention, Australia holds the view that national systems for access to biological resources should not include material covered by the Undertaking. I have taken this into account in the Inquiry and reflected this in my recommendations.
3.53 The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement requires, as a general rule, that patents be granted in all areas of technology without discrimination (Article 27).
3.54 Article 27.3(b) provides a limited exception to this rule: World Trade Organization (WTO) members do not have to, but may, provide protection for plant and animal inventions and for essentially biological processes for producing plants or animals. Members do have to provide patent protection for micro-organisms, and for non-biological and microbiological processes. They also have to provide some form of protection for new plant varieties -- this could be patents, a sui generis system such as plant breeder's rights, or a combination of both.
3.55 The International Union for the Protection of New Varieties of Plants (UPOV) system is accepted to be one such sui generis system. It is, however, criticised in some quarters and cannot be regarded as the single or definitive means of implementing TRIPS obligations for plant variety protection.
3.56 Article 27.3(b) was a negotiating compromise, and essentially imported the text of European law existing at the time of the TRIPS negotiations. Other parties, principally the United States, considered there should be more limited exceptions to the general principal that patent protection be available in all fields of technology. This led to agreement to review the provisions of Article 27.3(b) in 1999, four years after TRIPS came into force.
3.57 That review is still taking place. There are two general approaches to the review:
3.58 The TRIPS Agreement only came fully into effect for most developing countries in January 2000 -- hence the original exchange of factual information in 1999 concentrated on the approaches taken by industrialised countries (a few developing countries made voluntary contributions to the review, but most did not provide information).
3.59 The actual legal scope of Article 27.3(b) is very limited -- it is a limited exception to a general rule on the scope of patentable subject matter. The review process has been seen as an opportunity to address a much broader range of concerns, covering:
3.60 Overlapping with this review process was the WTO Ministerial Conference at Seattle late in 1999. Preparations for Seattle saw the tabling of several substantive proposals for amending the provisions of TRIPS, which were more far-reaching than the original scope of the Article 27.3(b) review. This reflects the interests of some parties in linking biotechnology intellectual property and environmental issues with broader WTO negotiations.
3.61 The factual aspect of the Article 27.3(b) review has resulted in the tabling of information on the approach taken by some 35 WTO Member countries in relation to intellectual property protection for plant and animal inventions.
3.62 Many countries have exceptions to scope of patentability roughly corresponding to the text of Article 27.3(b) (partly because this mirrors existing European Union law), and most have plant variety rights systems corresponding to the UPOV system. Developing country members of the WTO are in the process of notifying their national intellectual property laws and undergoing separate reviews of their national legal systems for TRIPS consistency -- while this process is distinct from the Article 27.3(b) review as such, it will nonetheless shed light on the approach they have taken to implementing Article 27.3(b).
3.63 It is increasingly difficult to distinguish between proposals for substantial renegotiation of TRIPS, specifically tabled under the Article 27.3(b review, and general proposals tabled in the context of an overall round of trade negotiations, such as the proposals tabled in the lead-up to the WTO Seattle Ministerial Conference.
3.64 In addition, TRIPS as a whole is due for a general review of implementation commencing in 2000. This review will see concerns raised about the linkage between TRIPS and the Convention on Biological Diversity and related issues, such as protection of traditional knowledge and access to biological resources.
3.65 Substantive proposals fall into three general categories:
3.66 In the immediate term, debate is likely to continue without a clear conclusion, although the progress towards TRIPS implementation by developing countries should provide a broader factual basis for determining the real scope and impact of the provisions of Article 27.3(b).
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