96. The representative of Australia said that Australia was a mega-diverse country with possibly the world's highest level of endemic genetic resources, much of which had yet to be characterized. Australia also had an indigenous community which had accumulated traditional knowledge over thousands of years of interaction with the Australian continent. At the same time, Australia was a developed country with a burgeoning biotechnology industry and a large agriculture sector, as well as large agricultural and environmental research sectors which were reliant on access to genetic resources. For these reasons, Australia had a strong interest in facilitating research, encouraging innovation and capturing the benefits from that innovation, ensuring that Australia was able to exercise appropriate control over these resources and ensuring that the benefits from such access were equitably shared. To do this successfully, the rights of all stakeholders had to be balanced so that research and innovation prospered and so that owners of genetic resources and traditional knowledge were respected and obtained appropriate benefits from any outcomes.
97. These were precisely the factors that had influenced the development of Australia's own access and benefit-sharing regime under the Environment Protection and Biodiversity Conservation Act of 1999. The Regulations under the Act had come into force only on 1 December 2005 and were based on the Bonn Guidelines. The Regulations established a contract-based permit system to manage the access and distribution of benefits derived from native genetic and biochemical resources. In a nutshell, to gain access to the material, one needed to obtain a permit from the Minister for the Environment or his delegate and to provide evidence of a benefit-sharing agreement with the owner or manager of the biological resource. The legislation clearly set out the criteria that needed to be met.
98. In addition, Australia was in the process of developing a model contract as a guide to assist the parties when developing a benefit-sharing agreement. It would not be mandatory, but aimed to provide assistance and incorporate best practice examples from similar agreements worldwide. The model contract was designed to address one of the main critiques of the contract-based system, i.e. that indigenous communities and other owners of genetic resources and traditional knowledge were not in a position to negotiate effectively. Overall, the purpose of this legislation was to give investors in the industry confidence and security when committing to large and sustained investment in research and development whilst also ensuring that Australia's genetic resources were used in an environmentally sustainable manner, on mutually agreed terms with prior informed consent and with an equitable return for Australia.
99. There was not necessarily a relationship between Australia's access and benefit-sharing regime and its intellectual property or patent regimes. Parties could include terms in the contract that stipulated that if the resources were commercialized including through a patent, certain benefits would flow. This recognized that many uses could be made of genetic resources and traditional knowledge outside the patent system and that biopiracy could occur outside the patent system. The issue of biopiracy, therefore, should be addressed at the access phase. As the contract system was still new, a number of licences were under negotiation, but none had been completed yet. It was still too early to assess the system, but it was going well in terms of delivering real benefits to genetic resource and traditional knowledge owners.
100. He said that his delegation had proposed focusing Members' attention on access and benefit sharing regimes. It was interested in hearing from other Members the details of the practical problems that they had experienced in implementing and operating their regimes. Referring to the statements made by the Philippines that its national access and benefit-sharing regime had not worked adequately in the prevention of biopiracy, and therefore it supported using the patent system as a solution to biopiracy, he said that there were many possible reasons for this unfortunate experience. It was vital to examine the nature of the problems experienced by Members, the reasons why they had occurred and what was the most appropriate solution.
101. Another representative of Australia said that it remained unclear to her delegation how the disclosure requirement itself would have prevented the granting of patents in the turmeric and other cases that had been discussed in the TRIPS Council. The argument for the disclosure requirements seemed to be that patent applicants would be less likely to lie when confronted with an explicit disclosure requirement or that an explicit disclosure requirement would provide patent examiners with additional clues in determining prior art. However, her delegation believed that such arguments would not justify an amendment of the TRIPS Agreement or other international patent treaties. Instead, her delegation saw value in pursuing more practical ways to prevent the granting of erroneous patents, such as the database system proposed by Japan. In addition, she wondered whether it was appropriate for the TRIPS Agreement to enforce the objectives of prior informed consent and benefit sharing provided by other international agreements. She expressed her concern over the uncertainty that the disclosure requirement would engender in the patent system, given that many Members had not yet established access and benefit-sharing regimes. Invalidating patents because of non-compliance with access and benefit-sharing regimes that might not exist or were unclear would put at risk the integrity of the patent system with implications for the ability to share benefits. She also expressed concern over the burden imposed on patent offices by the disclosure requirements.
102. In conclusion, she reiterated her delegation's approach to this issue: first, a clear examination of the problem, second, development of options for solutions, and third, negotiations. Accordingly, he believed that it was premature and inappropriate to move to negotiations at this stage. Members could not amend the TRIPS Agreement unless they had identified the problem with national access and benefit-sharing regimes. Therefore, Members should start with technical discussion to identify the problem, and then develop proposals for options for an appropriate solution, and then move to negotiations on those options. Many safeguards and balances had been built into the patent system, and when Members considered a new measure, they should ensure that the measure was capable of meeting its objectives while preventing adverse consequences.
