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Appendix 3: Australian Bioprospecting Frameworks


Bioprospecting - Harnessing Benefits for New Zealand: A Policy Framework Discussion

[ Last Updated 23 July 2007 ]


Within this section…

Bioprospecting in Australia

The biological resources in Australia have long been of potential interest to bioprospectors. An example of this is the Natural Product Discovery (NPD) centre at Griffith University (Queensland), which was established in 1993 with the beginning of a partnership between this university and Swedish pharmaceutical firm AstraZeneca. This collaboration is one of the largest public-private partnerships in Australia. AstraZeneca has invested A$100 million into the NPD programme. The centre collects, screens and isolates material found in plants, micro-organisms and marine animals with the aim of discovering biologically active compounds that may lead to the development of new pharmaceuticals. To date, 41,000 samples have been examined. There have been a number of benefits from this partnership including strengthening of Griffith University's research capabilities, increasing scientific links with Sweden, and the gathering of valuable information about environmental biodiversity. For example, more than 3,000 sponges have been collected during research conducted by NPD, and over 50 per cent of these were new to science.

Source: Royal audience for drug discovery scientists [link to Griffith University website]; Case Study - Biotechnology/Pharmaceutical: Astrazeneca [link to Invest Australia website]

As the information box above illustrates, bioprospectors find Australia an interesting source of biological resources. In view of this and other considerations, State, Territory and Commonwealth governments have been spurred on to develop the following policies:39

  • The National Strategy for the Conservation of Australia's Biological Diversity, developed to provide a general framework for protecting Australia's biodiversity. Objective 2.8 states:

    Ensure that the social and economic benefits of the use of genetic material and products derived from Australia's biological diversity accrue to Australia.

  • The National Biotechnology Strategy, launched in 2000.
  • The Nationally Consistent Approach for Access to and the Utilisation of Australia's Native Genetic and Biochemical Resources, endorsed by all State/Territorial governments in 2002. This framework sets general principles that must be applied when developing or reviewing access and benefit sharing systems established within Australian jurisdictions.40

Australian Commonwealth areas

Commonwealth areas in Australia consist of areas of land, sea and airspace owned or managed by the Australian government. They include national parks such as Kakadu and Uluru-Kata-Tjuta, all declared marine protected areas, and the band of marine area between the outer edge of the Australian Fishing Zone and three nautical miles from the coast.

One of the aims of the bioprospecting policy implemented by the Australian Commonwealth government is to encourage research and bio-based industry development by, for example, facilitating access to resources, and offering legal certainty and user flexibility. Operationally, this framework can be divided up into two broad categories, namely commercial and non-commercial activities.41

Framework for commercial activities

A simplified and idealised pictorial representation of the bioprospecting framework for Commonwealth areas is given in Figure 3. Bioprospecting activity in Commonwealth areas is regulated by the Environment Protection and Biodiversity Conservation Act 1999.42

Figure 3: Commonwealth area bioprospecting framework

(Steps 2 and 3 may be interchanged)

[insert figure]

Step 1: Contact the Competent National Authority: A first point of contact for potential bioprospectors who need information about the bioprospecting process in Australia is provided by the Australian Commonwealth government, Department for the Environment and Heritage. This department has the dual role of being the first point of contact for Australia, as well as being the Competent National Authority (i.e. responsible for bioprospecting activities) in Commonwealth areas.

Steps 2 and 3: It is important to note these steps are interchangeable:

  • Step 2: The applicant must negotiate a benefit sharing agreement/contract with the access provider of the biological resource.43
  • Step 3: The applicant requests an access permit from the Minister for the Department of Environment and Heritage to undertake bioprospecting44 activities in Commonwealth areas.

Step 4: Before permits are issued by the Minister for the Department of Environment and Heritage, they must be satisfied that two basic conditions are met – namely that there is no environmental harm involved and that a benefit sharing agreement is in place. The order in which these two conditions are met is not important. In more detail, considerations include:

  • that an environmental assessment (if required) has been undertaken;
  • that the proposed access is ecologically sustainable and consistent with the conservation of Australia's biodiversity;
  • that submissions from interested parties (if required) have been taken into account;
  • that there is an adequate benefit sharing agreement between the parties addressing the following issues:
  • informed consent of any indigenous owners of biological resources (when applicable);
  • mutually agreed terms;
  • protection for and valuing of "indigenous knowledge"; and
  • if practicable, provision for some benefits to be used for biodiversity conservation in the area from which the resources are to be sourced.

To ensure transparency, all permit approvals are published on the internet.45

There is a permit application fee of A$50 for commercial research. Applications for permits can be completed online. To avoid delay in decision making and granting permits, specific timeframes are included in the regulations.

Framework for non-commercial activities

Permit requirements for obtaining access for non-commercial scientific research are more flexible and less detailed. The applicant is simply required to obtain written permission from the access provider and provide a statutory declaration that includes agreeing to certain obligations.46 There is no fee for access to biological material for non-commercial research.

Made easy – a biodiversity survey

This Commonwealth system made a non-commercial biodiversity survey conducted by the South Australian Museum in a remote Commonwealth area a relatively straightforward exercise. The access provider was the Department of Defence (Commonwealth). With the help of the Department of Environment and Heritage, permission for access was obtained. The museum signed the statutory declaration stating that the research was for non-commercial purposes and that, if the non-commercial nature of their work should change, they were obliged to negotiate a full benefit sharing agreement with the Department of Defence. The final outcome of the project was that taxonomic specimens were collected and good information on the distribution of biodiversity in this area was obtained.

Source: Genetic Resources Management Policy, Department of the Environment and Heritage, Commonwealth government, Australia.

Australia's Northern Territory

The Northern Territory of Australia consists of areas of land, sea and airspace owned or managed by the Northern Territory government. This accounts for about one sixth of Australia's total land mass and 13,500 km of coastline as well as the associated marine area extending out from the coast to the limit of the Australian Fishing Zone.

One of the purposes of the bioprospecting framework47 implemented by the Northern Territory government is to ensure that bioprospecting is managed to foster the growth and development of the Territory and that it is carried out in a sustainable manner.

Bioprospecting framework

Under Northern Territory policy, all bioprospecting activities come under its jurisdiction. In other words, commercial and non-commercial activities are, in principle, not differentiated, and a benefit sharing agreement is still required for either pursuit. One of the advantages of not distinguishing between the two pursuits is that samples can be easily traced, and this improves the recognition of biopiracy.48 In addition, in the event of non-commercial bioprospecting becoming commercial in nature, the benefit capture process is simplified.

Made easy – biopiracy detection

The Northern Territory's permit and benefit sharing framework provides a system of traceability and allows possible instances of biopiracy to be readily identified. The utility and importance of the arrangements were demonstrated when an officer of the Northern Territory government came across an article on the internet referring to plant samples taken from the Territory and the results of research on those samples. According to the article, the plant had shown efficacy against malaria, anthrax and golden staph amongst others, and two patents had been registered. The researcher was from an overseas institution.

Investigation of the government's records showed that the researcher did not have a permit, nor did the researcher's organisation. Contact was made with the researcher, and legal discussions are continuing. Under the Northern Territory's legislation, these samples can be retrospectively covered by a benefit sharing agreement.

Source: Department of Business, Economic and Regional Development, Northern Territory government, Australia.

A simplified and idealised pictorial representation of the bioprospecting framework for the Northern Territory is given in Figure 4. Bioprospecting activity is regulated by the Biological Resources Act 2006, the Biological Resources Regulations 2006, the Policy for Access to and Use of Biological Resources in the Northern Territory, as well as the Strategy for Conservation through Sustainable Use of Wildlife in the Northern Territory.49

Figure 4: Northern Territory bioprospecting framework

[insert image]

Step 1: Contact the Competent National Authority. As with the Commonwealth example, the first point of contact for potential bioprospectors who need information about the bioprospecting process in Australia is provided by the Department for the Environment and Heritage, Australian Commonwealth government. This Authority would then direct the bioprospector to the relevant organisation in the Northern Territory.

Step 2: The bioprospector makes a permit application to the Permit Issuing Authorities, namely the Parks and Wildlife and the Fisheries Group departments. After evaluation, this permit is then passed on to the Department of Business, Economic and Regional Development (DBERD) for further assessment. It is important to note that, if a benefit sharing agreement already exists, it may accompany the permit application.

Step 3: DBERD evaluates the permit application with a number of considerations in mind, including if:

  • the activity under consideration is bioprospecting;
  • the proposed collection site is under Northern Territory jurisdiction;
  • sufficient information has been provided with the permit application;
  • the proposed activity will be conducted without significant damage to the environment, namely in accordance with existing Northern Territory law;
  • there are economic and social impacts from the application;
  • the business, financial and professional credibility of the bioprospector is adequate;
  • the interests of indigenous people in the use and ownership of traditional knowledge, innovations and practices on indigenous land have been considered; and
  • benefit sharing agreements are:
    • in evidence. If no agreement exists, permit issue is conditional on the formation and suitability of the contract. If an agreement does already exist, DBERD evaluates if it is adequate;
    • between a bioprospector and a private resource provider. The nature, distribution and application of benefits flowing from such an agreement are determined by the parties involved. However, private resource access providers have to certify to the Northern Territory government that the agreement in place is in alignment with legal requirements; and
    • between private owned/leased land as well as indigenous landholders. If this is the case, these parties may request guidance and advice from DBERD when entering into a benefit sharing agreement with the bioprospector.

Step 4: Once DBERD is satisfied that all conditions have been met, they notify the Permit Issuing Authorities that they may issue a permit to the bioprospector.

Collection permits are valid for a maximum of 12 months. If the bioprospector wishes to renew, a renewal fee may apply, the level of which is determined on a case by case basis.50 The bioprospector may also be required to sign a Deed of Variation to include the new permit number under the existing agreement.51

When benefits are in excess of a nominal monetary value per year, a percentage thereof is transferred to an appropriate fund or organisation that supports biodiversity conservation projects in the Northern Territory.

For successful applicants, the fulfilment of benefit sharing terms and conditions is determined by DBERD through periodic performance reports submitted by the applicant.

Annual reports are submitted to the Minister for Business and Economic Development on any significant developments.

Resource access provider helps researchers patent their bioactive compound

An Australian university52 (the bioprospector) contacted the Northern Territory government (the resource access provider) regarding undertaking bioprospecting in the Northern Territory. A benefit sharing agreement was entered into and a permit issued. The bioprospector found a new anti-inflammatory compound and, as agreed under the reporting requirements of the benefit sharing agreement, notified the resource access provider. The bioprospector and the resource access provider agreed it would be appropriate to register a provisional patent in order to further explore commercialisation opportunities. Costs for the provisional patent were shared equally between both parties.

Source: DBERD, Northern Territory government, Australia.

39 See Biodiversity [link to DEH website].

40 These principles include certainty, transparency and accountability for facilitating biodiscovery; sustainable use of biological resources; and equitable sharing of benefits.

41 Regardless of the commercial or non-commercial nature of an activity, bioprospectors are required to keep sample records that include:

42 See Genetic resources management in Commonwealth areas [link to DEH website].

43 This benefit sharing agreement/contract does not come into effect unless a permit is issued. It can be negotiated and agreed upon, but it has no validity without the agreement of the Minister for the Department of Environment and Heritage.

44 In Australia, the term "biodiscovery" is often used in a way that is more or less synonymous with what many countries refer to as bioprospecting.

45 See Permit Report [link to DEH website].

46 These include accepting the obligation to negotiate a full benefit sharing agreement should the purpose of research and development change, and to obtain permission from the access provider before passing the sample on to anyone else.

47 In this policy framework, bioprospecting and biodiscovery are separate activities. Bioprospecting is defined as "the taking of samples of biological resources, existing in situ or maintained in an ex situ collection of such resources, for research in relation to any genetic resources, or biochemical compounds, comprising or contained in the biological resources". Biodiscovery is defined as "research on samples of biological resources, or extracts from those samples, to discover and exploit genetic or biochemical resources of actual or potential value for humanity". Because of the broadness of the bioprospecting definition, certain activities could be unintentionally classified as bioprospecting, for example, the taking of aquatic life within the meaning of the Northern Territories Fisheries Act. To overcome this situation, the Northern Territories government has specifically excluded such activities.

48 The term "biopirate" is used for those who acquire biological samples for biodiscovery and commercialisation purposes without, for example, fair compensation to the access provider.

49 See Policy for access to and use of biological resources in the Northern Territory [link to NT Government website] and Conservation through sustainable utilisation of Wildlife [link to NT Government website].

50 The price of a renewal fee is fixed at the nominal amount reflecting the existence of the benefit sharing agreement between the parties involved and subsequent benefits flowing to the broader Northern Territory community.

51 A Deed of Variation is essentially an amendment to a contract. In this case, the original agreement is still in place, and the new permit number is simply brought under the original agreement by the Deed of Variation. This removes the requirement of negotiating a whole new agreement.

52 For reasons of confidentiality, this university cannot be named.


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