Science and Research
John Voumard, Inquiry Chair
© Commonwealth of Australia, 2000
ISBN 0642547157
1.1 From the outset, I have focused on developing an access scheme which is practical and fair, and which minimises transaction costs and maximises certainty for all parties. The scheme is designed to integrate with the Environment Protection and Biodiversity Conservation Act 1999 (EPBC Act) and be readily enshrined in regulations under s301 of the Act (see Appendix 1 for selected sections of the Act).
1.2 The recommended scheme reflects four key concepts:
1.3 The scheme also takes into account the diversity of land tenures in Commonwealth areas and can be integrated into a nationally consistent approach for regulating access to biological resources.
1.4 Under the proposed scheme, either the owner or holder of resources in the particular Commonwealth area, is empowered to negotiate a benefit-sharing contract with the proponent (bioprospector). The contract will be based on a model contract to be developed and agreed by industry, Indigenous organisations and other stakeholders. The model contract will include provisions for benefit sharing through non-monetary and monetary benefits, such as fees, milestone payments and royalties, from sources including products derived from the material collected and intellectual property rights.
1.5 The contract only has effect if the Minister for the Environment and Heritage issues an access permit. The Minister may issue the permit on being satisfied that there is:
1.6 The proposal that the Minister issue access permits means the community's broader interests are protected through requirements that the environment be protected and that scientific knowledge be made available to the community. The exercise of this permitting power is transparent and accountable, with the basis for Ministerial decisions set out in the s301 regulations, and review rights also specified. Linkage with the benefit-sharing contract is achieved through a requirement in the regulations that the contract include a provision that it takes effect only if an access permit has been issued.
1.7 Regulations under s301 of the EPBC Act will establish this scheme, harnessing existing legal and administrative arrangements to the benefit of the owners of biological resources, whether public or private, while ensuring the broader public interest is protected.
1.8 I have concluded that Environment Australia should perform the role of the central administering agency and that, in establishing and managing the access scheme, it should:
1.9 In developing this scheme I have borne in mind the importance of a nationally consistent approach to access to biological resources and the work undertaken towards this goal by the Commonwealth, State and Territory Governments over more than eight years. Accordingly, the scheme is designed to be broadly compatible with existing and possible future State and Territory regimes.
1.10 To this end the Inquiry has considered the differing forms of land tenure in State and Territory jurisdictions. I believe the use of benefit-sharing contracts protects the common-law rights of landholders and ensures the owner of biological resources shares directly in their use. This applies whether the area is in public or private ownership and whether or not ownership of the plants, animals and micro-organisms has been asserted.
1.11 In developing the proposed scheme I have been guided by a range of principles and considerations. Foremost among them are the Inquiry's terms of reference and the Commonwealth Government's Biotechnology Strategy. Additional guiding principles and considerations are outlined below and others are detailed in Chapter 3, 'Background to the Inquiry'.
1.12 The terms of reference require the Inquiry to advise on a scheme that could be implemented through regulations under s301 of the Environment Protection and Biodiversity Conservation Act 1999 to 'provide for the control of access to biological resources in Commonwealth areas'. The Inquiry's terms of reference are at Appendix 2 and the press release from the Minister for the Environment and Heritage, announcing the Inquiry, is at Appendix 3.
1.13 The terms of reference require the proposed scheme to take into account Australia's obligations under the Convention on Biological Diversity and the objectives of the National Strategy for the Conservation of Australia's Biological Diversity. The terms of reference drew the Inquiry's attention to the provisions in the Convention dealing with equitable sharing of benefits arising from the use of biological resources and from the use of Indigenous knowledge. Attention was also drawn to the objectives of the National Strategy, such as to ensure there are no adverse effects on the viability or conservation status of species or population and that the social and economic benefits from using Australia's biological resources accrue to Australia.
1.14 When considering these points, I have taken the view that there are some commonalities in the ideas of the equitable sharing of benefits and of accruing social and economic benefits to the country. Both involve consideration of public and private benefits and both require the application of fairness and the concept of ownership to allow distribution to be determined. I have sought to identify each of the factors applying in each case so that when these considerations are compared with the recommended scheme, the scheme can be seen to meet these criteria.
1.15 The arrangements I have recommended are designed to fit in with the EPBC Act's integrated permit system for easier administration and to help ensure environmental protection.
1.16 The terms of reference also require that the scheme meet four other goals. These are that it:
1.17 Simple, transparent regulations with low transaction costs make for certainty. The use of a model contract developed and endorsed by industry, government, Indigenous owners and other key stakeholders also adds to the certainty and confidence of all parties and reduces the adverse consequences of any inequality in bargaining power between the proponent and the provider.
1.18 On 3 July 2000 the Minister for Science, Industry and Resources, Senator Nick Minchin, launched the National Strategy for Australian Biotechnology. The Strategy includes, as an objective, 'The development of measures to enhance access to Australian biological resources'.
1.19 Among the strategies to meet that objective is the need to:
1.20 I believe the Inquiry has made a significant contribution to meeting these goals.
1.21 Reviewing the extensive literature on the subject of access to biological resources has illustrated the complexity of this subject. In our discussions with stakeholders, expressions of good luck were almost invariably offered in recognition of this. To deal with this complexity, I established the following principles to guide the work of the Inquiry:
1.22 I also drew on the four 'overarching principles, or desirable features', for development of an access scheme put forward in Environment Australia's submission. These are that the scheme should:
1.23 I have listened carefully to the concerns of traditional owners in Commonwealth areas, particularly about the misuse of their knowledge of biodiversity. This issue has also been the subject of many submissions and representations. The Inquiry has sought to come to terms with the limitations of the existing legal system in protecting and valuing this knowledge. I believe the best protection presently available for the rights of Indigenous peoples to their biological resources and their intellectual property can be achieved through inclusion of appropriate contractual terms. The solutions the Inquiry recommends are practical and, most importantly I believe, empowering for the Indigenous communities which have leased their land to the Commonwealth.
1.24 In addition, I have recommended further consultations with Indigenous owners to help them understand the issues and to undertake projects which will preserve and protect Indigenous knowledge.
1.25 I have considered the situation where Indigenous knowledge is shared among communities beyond the boundaries of Commonwealth areas and have made recommendations which may help Indigenous communities in Commonwealth areas address this issue.
1.26 Many of the elements in the proposed model contract will reflect existing commercial contracts and will therefore be familiar to industry, science and governments and promote certainty -- both within Australia and abroad. Australia has the good fortune to have a well developed legal and administrative system that integrates with systems in the rest of the developed world. The approach taken in the course of this Inquiry takes advantage of this integration.
1.27 Australia has a further comparative advantage in that, unlike many biodiversity-rich countries, it is also a developed country and one which is both a user and provider of genetic resources. It is therefore well placed to strike a balance between ensuring that, in exchange for facilitating access to its biological resources for biodiscovery purposes, there is a reasonable sharing of the benefits produced.
1.28 Australia has about 13 per cent of the world's biodiversity. The genetic and bio-chemical make-up of this rich biota is a potential source of new chemical and pharmaceutical products.
1.29 However, Australia has only a limited window of opportunity to take advantage of current interest in its biodiversity and to share in the benefits from its use. From evidence given to the Inquiry and discussions with stakeholders, it is clear that the technology involved in bio-assaying and screening is advancing rapidly. The speed at which plants, animals and micro-organisms are analysed and their potential use assessed has accelerated dramatically over recent years. This fact, coupled with rapid advances in the broader biotechnology industry, means that if Australia is to secure a share in the benefits flowing from this revolution it needs to have its legal and regulatory house in order at both the Commonwealth and State levels.
1.30 When the Minister announced the Inquiry, he said it would consider public submissions and conduct hearings around Australia. The Minister appointed an expert reference group to help the Inquiry Chairman: the group comprised Ms Katherine Wells (environment), Professor Ronald J Quinn (industry), Ms Elizabeth Evans-Illidge (science), Ms Henrietta Fourmile (now Marrie) (Indigenous issues) and Mr Sandy Donaldson (intellectual property law).
1.31 Calls for submissions were advertised in the national press and major metropolitan newspapers on 15 January 2000. I sent letters inviting submissions to key organisations and individuals with interests in environment, industry, research and Indigenous issues. The Inquiry Secretariat also sent notices to approximately 600 organisations and individuals. Submissions were due by 3 March 2000 but late submissions were accepted and considered. The Inquiry received 80 submissions. A list of submissions received is at Appendix 4.
1.32 I held meetings with key stakeholders and conducted public hearings in Canberra and Brisbane. This included the presentation of evidence by telephone at the public hearings. A list of my consultations and the people who presented evidence at the hearings is at Appendix 5.
1.33 Chapters 5, 6 and 7 detail how consultations were conducted in relation to environmental, Indigenous, industry and research interests respectively. In each of these chapters I have sought to reflect, in some detail, the issues and concerns relating to the immediate interests of each group. It should be noted, however, that, to some extent, this division is arbitrary as many submissions (particularly those from key stakeholders) addressed issues not only of concern to their immediate mandate, but also related issues (for example environmental groups discussed Indigenous issues) and aspects of a possible scheme in general. I have sought to reflect this in each chapter.
1.34 The Inquiry made considerable efforts to consult key stakeholders within its terms of reference and timeframe. Nevertheless, my consultations revealed that many stakeholders would benefit from further opportunities to understand the issues and, particularly where they will be directly affected by the scheme, to contribute to its development and implementation. I have made specific recommendations to this end to ensure the concerns of particular groups are met.
1.35 In addition, I believe publication of this report will promote increased understanding of these complex issues in the community and that all stakeholders' interests would be served through opportunities to comment on the draft regulations. I believe this will also encourage stakeholders to commit themselves to working in a constructive and cooperative way towards development of a nationally consistent system.
1.36 Through the course of the Inquiry I engaged in discussions with senior officials from State Governments and encouraged them to make submissions. I sought to hear their views on policy issues and, in particular, to understand what they saw as key elements in an access scheme. I put forward the view that this was an opportunity for the States to have input into developing the Commonwealth's scheme. I made the further point that, by so doing, they could contribute to developing a nationally consistent approach through introduction of a Commonwealth scheme that would be compatible with their approaches.
1.37 I was met with cooperation and frankness and gained valuable insights. Queensland, in particular, expressed a strong interest in participating in working with the Commonwealth towards developing a nationally consistent approach. South Australia, at officials level, has independently come to similar conclusions to that of the Inquiry about the principles and practical approaches underlying any access regime and has developed options for consideration by government and the community.
1.38 The input I received from the States and Territories has informed my thinking and influenced the scheme I am recommending. It has provided additional confidence to my belief that our recommended scheme has the capacity to make a substantial contribution to development of a nationally consistent approach to managing access to Australia's biological resources. Chapter 8 discusses State and
1.39 I have made recommendations about consultations with certain stakeholders, particularly traditional owners of national parks and State and Territory governments, in later chapters.
Recommendation
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1.40 The Inquiry has observed some confusion about the meaning of the phrase 'access to biological resources', particularly with regard to where to draw the line between bioprospecting (for biodiscovery purposes) and harvesting animals and plants for commercial use. This is partly because of the breadth of the definition of biological resources in s528 of the EPBC Act. The definition states:
biological resources includes genetic resources, organisms, parts of organisms, populations and any other biotic component of an ecosystem with actual or potential use or value for humanity.
1.41 The term 'biological resources' is often used interchangeably with 'genetic resources'. However, in the EPBC Act (and the Convention on Biological Diversity, on which the Act's definitions are based), they are defined separately. 'Biological resources' includes 'genetic resources', among other things. In some respects, 'genetic resources' is a more helpful term when discussing access because it is the genetic and biochemical make-up of biological resources, not the biological resources as such, in which biodiscovery companies are generally interested.
1.42 The problem also arises from the lack of a definition of 'access' in s528. However, the Explanatory Memorandum provides some guidance:
This clause [s301] provides that the regulations may control access to biological resources (as defined in clause 528) in Commonwealth areas. Examples of access to biological resources are: collecting living material, viewing and sampling stored material, and exporting material for purposes such as taxonomic research, conservation, research, and potential commercial product development.
1.43 In undertaking its task, the Inquiry has taken the view that 'access to biological resources' refers to the process whereby samples from individual organisms are gathered, their genetic and biochemical make-up and other attributes determined, and their potential use assessed.
1.44 The boundary between this process and harvesting for commercial use is reached when the material is required for a different purpose, such as for producing a product or for consumption. Such activities are beyond the scope of the scheme we have developed. They do, however, come within the ambit of other provisions of the EPBC Act relating to environmental impacts or other Commonwealth legislation dealing with the commercial use of living resources more generally, such as the Fisheries Management Act 1991 or the Great Barrier Reef Marine Park Act 1975.
1.45 The Inquiry nevertheless considered the situation where collection of material for commercial use was not otherwise regulated and the use was related to extraction of its biological components. I suggest that in such circumstances this gap would be filled if the regulations under s301 of the EPBC Act applied.
1.46 The Inquiry has concluded that the scheme should apply to biological resources native to Australia and not to exotic plants and animals that have come here since European contact. In reaching this conclusion the Inquiry has been guided by Articles 3 and 15 of the Convention on Biological Diversity which recognise the right of sovereign states to exploit their own resources and their responsibility not to damage the environments of other countries or impose restrictions that run counter to the objectives of the Convention.
1.47 The Inquiry has taken the view that if Australia were to seek to gain benefits deriving from using other countries' biodiversity, it would be acting counter to the objectives of the Convention. In such circumstances it would be open to criticism and possible accusations of biopiracy. Similarly, in the Inquiry's view, Australia would not wish other countries holding Australian native biological resources to obtain benefits from using its genetic content. The Inquiry is aware that extensive holdings of Australian biota are in public and private overseas collections from where they are made available to other countries.
1.48 The Inquiry has considered the degree to which the scheme should cover resources held in Commonwealth ex situ collections. This has been complicated by legal advice to the effect that the power to make regulations about ex situ collections is arguable and that the regulations would need to be examined before a concluded view could be drawn. The difficulty arises because s301 of the EPBC Act appears to deal only with access to in situ biological resources while the Explanatory Memorandum expresses the intention to include ex situ collections. I have taken the view nevertheless that, in principle, ex situ collections should be covered by the scheme. I am supported in this view by legal advice which, while qualified on the point, concludes that the power to do so exists. However, I am persuaded that material which is the subject of existing international agreements, such as the Food and Agricultural Organisation International Undertaking on Plant Genetic Resources, should be excluded. Collections of non-native species would also be excluded, while some collections may not be relevant, such as collections whose constituting instruments would preclude bioprospecting.
1.49 The submission from the Chair of the Council of Heads of Australian Herbaria points to the development of a nationally consistent approach to access and benefit sharing among their constituent ex situ collections as part of their participation in developing the Common Guidelines for participating Botanic Gardens on access to genetic resources and benefit sharing (Appendix 6). Accordingly, I am of the view that it would be appropriate for the Minister to consider deferring application of the scheme to those Commonwealth organisations involved, pending the outcome of the development of the Common Guidelines if, in his view, deferral would aid progress to a common Australian position.
1.50 This step would also contribute to the momentum towards a nationally consistent approach by the Commonwealth and the States and Territories.
1.51 These matters are discussed in detail at Chapter 8.
1.52 Submissions and representations to the Inquiry raised the dangers of biopiracy, that is, where biological resources are taken unlawfully (often out of the country). Biopiracy denies the originating community the opportunity to share in benefits which may flow from use of their resources. At first glance the problem seems difficult to address satisfactorily, but the Inquiry has made recommendations which should help. These recommendations are directed at:
1.53 They also involve using the model contract across Australian jurisdictions and establishing a nationally consistent approach to managing access to biological resources. This issue is discussed in detail in Chapter 2 'Penalties' and Chapter 8 'Export of biological resources'.
