Biodiscovery Management in Australia
[ Last Updated 16 December 2005 ]
Legal Frameworks, Contracts and Agreements for Access to Genetic Resources and Benefit-Sharing
PowerPoint Presentation Slides
to the
Bioprospecting in New Zealand Seminar, 21 February 2003
Geoff Burton
Director, Access to Genetic Resources
Environment Australia
This presentation is also available in
PowerPoint (79 KB) and
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Contents
Slide 1: Scope of Presentation
- Why did Australia decide to make its genetic resources available for commercialisation?
- What is its general approach?
- How will it work in practice?
Slide 2: Drivers for Involvement: Economic
- Harness a new and potentially valuable resource
- e.g. the value of genetic resource derived drugs to pharmaceutical industry: US$75 billion (1997) or NZ$150 billion.
- Attract investment in burgeoning, worldwide Biotechnology Industry - 5000 firms with US$200 billion capitalisation (1999)
Slide 3: Drivers for Involvement: International
- Convention on Biological Diversity including:
- Article 3 - sovereign rights over natural resources,
- Article 15 - facilitate access and obtain fair and equitable benefit sharing, and
- Article 8(j) - protection of Indigenous biodiversity knowledge and benefit-sharing from its use
Slide 4: Drivers for Involvement: Domestic - 1
- National strategy for the Conservation of Australia's Biological Diversity
- Obj 2.8 "Ensure that the social and economic benefits of the use of genetic material and products accrue to Australia
- Obj 1.8.2 use and benefits of traditional biological knowledge.
- National Biotechnology Strategy
- Access to Biological Resources (page 26)
Slide 5: Drivers for Involvement: Domestic - 2
- October 2002 - all Australian Governments adopted the Nationally Consistent Approach for Access to and the Utilisation of Australia's Native Genetic and Biochemical Resources
- Support from Bailey Inquiry (House of Representatives Standing Committee on Primary Industries and Regional Services Report Bioprospecting: Discoveries Changing the Future)
Slide 6: Character of Australia's Biodiversity
- Australia is one of 17 mega-biodiverse countries
- it has 10% of the world's biodiversity
- much of this is endemic - e.g. 85% of its marine species
- Its a developed country but its biodiversity is rich, often unusual, ancient, rare, or inadequately known to science
Slide 7: Resulting in Australia's Policy Goal
- to maximise, economic, social and environmental benefits from the ecologically sustainable use of genetic and biochemical resources whilst protecting its biodiversity and natural capital
Slide 8: Answer to First Question
- The CBD's obligation is also an economic opportunity
Slide 9: Developing an Australian Approach
- Australian Policy Context - other factors:
- Biotechnology Industry: US$750 million, 198 firms, 6th in the world but its companies are small and mostly burning capital
- Australia's has a federal system of government
- most of the genetic resources for its agriculture sector come from overseas
- good science, but often poorly commercialised
- conservative venture capital market
Slide 10: Australia's Comparative Advantages
- its mega biodiversity
- a well established system of commercial and intellectual property law in Common Law tradition
- honest and stable public administration
- a developing, coherent, legal framework to facilitate access, and
- a strong science and research base offering collaborative opportunities
Slide 11: Achieving Australia's Aims by …
- Facilitating access to genetic resources
- Encouraging investment - domestic and foreign
- Encouraging collaboration with Australian science
- Building physical and intellectual infrastructure e.g. bioinformatics
Slide 12: Access and Benefit-Sharing Agreements - Past International Experiences
- high transaction costs
- complex and sometimes onerous
- focussed on monetary gains
- time consuming
- favours large companies, universities public bodies etc
- unable to successfully deal with Traditional Knowledge
Slide 13: Access and Benefit-Sharing Agreements - Past Bad Experience
- Governments tend to have a one size fits all approach and agreements have little regard for:
- the nature of the collector
- the purpose of the collection
- cost of doing business
- contract monitoring
Slide 14: Developing an Australian Approach - 1
- Central control: separating permits from Benefit-sharing Agreements:
- All applicants must apply to a single authority for a permit.
- Permits granted by if:
- collection is ecologically sustainable; and
- a benefit-sharing agreement has been reached with resource provider
(NB: delegated PIC may mean provider is a different body to permit authority)
Slide 15: Developing an Australian Approach - 2
- Permits:
- simple to apply for
- decision within set time limits
- required information defined
- usually nominal cost or fee
Slide 16: Developing an Australian Approach - 3
Benefit-sharing agreements:
- Based on normal commercial law
- Must be flexible, to suit the interests of both parties and circumstances of the proposed activity
- Publish examples of various "model" contracts
Slide 17: Balancing Benefits in Agreements - Random Collection
Negotiation factors to take into account:
- random sampling produces 1 product for 1- 10,000 to 100,000 samples
- face value of samples low, but ensure royalty provision represents market rate
- focus on low cost benefits to collector, high reward to owner e.g. taxonomic voucher specimens, parallel collecting, local employment, knowledge transfer, management intelligence
Slide 18: Balancing Benefits in Agreements
- whether ownership of samples is retained
- low cost licence for specific uses -the more uses the more valuable the licence
- early milestone payments low
- milestone notification
- infrastructure investment offset against cost of access
- local partners
- intellectual property and third-party transfer
Slide 19: Focussed Collection - 1
Factors which add value increase probability or which reduce cost of collection, namely:
- traditional knowledge about location, state and properties of biota
- whole of species bioinformatics
- location & taxonomic information
- recollection opportunities
- prior art about related species
Slide 20: Focussed Collection - 2
- Success effect: area of one discovery leads to interest by others
- e.g. Yellowstone National Park in the United States following commercialisation of Thermus Aquitas, Great Barrier Reef following discoveries in cone shells, sponges and corals
Slide 21: Non Commercial Science - Non Application of Benefit-Sharing Agreements
- Science community reports increasing difficulty obtaining access to genetic resources worldwide
- solution: exclude non-commercial scientific research from benefit-sharing requirement
- use permits to control activity but provide safeguards against biopiracy
Slide 22: Non-Commercial Scientific Research - Approval Criteria
- collection is ecologically sustainable
- must have the provider's permission
- must provide a copy of all research outcomes to provider or publish
- offer taxonomic specimen to approved body
- must enter a benefit-sharing agreement if any wish to commercialise
- deterrent penalties
Slide 23: Maximising Value - 1
- encourage race to develop discoveries i.e. be reluctant to grant exclusive rights over access to specific species unless rewards for doing so exceed probable gain from competition
- re-collection confidence - protect collection area
- publish species data about areas and have clear rules and procedures.
Slide 24: Maximising Value - 2
- Reducing transaction costs increases value
- this is particularly important to small firms with limited capital.
Slide 25: Intellectual Property - 1
- Value of intellectual capital is traditionally crystallised when IP is taken out, however also consider
- venture capital or development capital step: when discoverer seeks market funds
- an agreed statement of provenance accompanying but separate from IP may increase success by reducing commercial risk to any capital provider.
Slide 26: Intellectual Property - 2
- Ownership - some recent experience:
- it has been found that some companies, particularly small companies, prefer the provider (a state Government) to retain ownership of IP and grant an exclusive licence
- their reasoning being that the provider is better placed to police and defend any encroachment on the IP than its creator
Slide 27: Sharing Experiences
- Over the next few months Australia will be circulating within Australian governments draft encyclopaedia of contractual terms and examples of model contracts applying those terms to various situations.
- These will be later published and made available to the WIPO IGC Data base
Slide 28: Summary and Conclusion - 1
- Australia is likely to be the first megabiodiverse OECD country to apply the Bonn Guidelines
- it faces all the policy issues arising under the CBD as it is a user, a provider, a developed country with unexplored biota, a country with delegated PIC and one with Indigenous peoples with recognised rights
- it is on a learning curve and is determined to share its experiences
Slide 29: Summary and Conclusion - 2
- Australia has always been a biological laboratory for nature
- over the next few years it is going to be a laboratory for implementing the third objective of the CBD
- Its also working to be a favoured place to undertake research
- it will only succeed if it takes a flexible realistic approach to contracts and the utilisation of IP.
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