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Friday, July 18, 2014

Nagoya Protocol to come into force on 12 October 2014

By Suman Reddy, Associate

The Nagoya Protocol is set to come into force on 12 October 2014 following its ratification by 51 State parties to the Convention on Biological Diversity (the CBD).

Australia is a signatory to the Protocol, but it is yet ratify the Protocol due to Commonwealth and State and Territory laws being currently inadequate to give effect to the Protocol domestically. We previously blogged about the Commonwealth's proposed model for implementing the Protocol.

The Protocol is an international instrument made under the CBD in order to give effect to the CBD objective of achieving the 'fair and equitable sharing of the benefits arising from the utilization of genetic resources'. However, 'the benefits arising from the utilization of genetic resources' has a wide meaning under the Protocol and effectively means any beneficial product or process derived from research conducted on biological organisms or their derivatives. This is commonly referred to as 'biodiscovery'.

The key aims of the Protocol are to create greater legal certainty and transparency for both providers and users of genetic resources by (i) establishing more predictable conditions for access to genetic resources and (ii) helping to ensure benefit-sharing when genetic resources leave their country of origin. To do this, State parties are required to implement a range of procedural and mechanical measures to give effect to access obligations, benefit-sharing obligations and compliance obligations. More information about these obligations is available on the CBD website.

The Commonwealth believes that Australian law satisfies the Protocol's obligations upon 'provider countries' - that is, those countries that provide biological resources - particularly through the access and permit requirements under the Environment Protection and Biodiversity Conservation Act 1999 and Environment Protection and Biodiversity Conservation Regulations 2000. However, Australia's obligations as a 'user country' - that is, as a country that uses the biological resources of other countries - are not given comprehensive effect under Australian law.
As we previously reported in our Focus article, the Australian Government accepted submissions on its proposed model for implementing the Protocol up to 31 May 2014, and these submissions are currently being considered by the Department of Environment.

If adopted in its current form, the Commonwealth's model of implementing the Protocol will have a number of significant implications for public and private sector organisations engaged in research, particularly with respect to the following proposals:
  • An agreement will be required between users of traditional knowledge associated with genetic resources and the holders of that knowledge. The agreement must be negotiated in accordance with a community protocol, guidelines published by the Australian Institute of Aboriginal and Torres Strait Islander Studies, or a code developed in consultation with Indigenous people. 
  • It be will be an offence to use 'illegally acquired' genetic resources or traditional knowledge associated with genetic resources, in certain circumstances. 
  • The Australian Government will be empowered to audit and monitor the use of genetic resources and associated traditional knowledge for potential breaches of the new offence provision discussed above. 
  • Recipients of Federal Government funding for research using genetic resources will be required to report on, and provide evidence for, the legal provenance of the resources. Where associated traditional knowledge will also be used, evidence of an agreement with the holders of that knowledge must be provided. 
  • Codes of conduct will be developed for different user sectors. 
  • A user of genetic resources will be able to 'remedy' the legal status of potentially illegally acquired resources by obtaining written permission from the provider country, as well as mutually agreed terms.
  • 'Trusted institutions' will be accredited to provide genetic resources for use in biodiscovery activities.
We expect each Australian State and Territory may also enact biodiscovery legislation. We note that only Queensland and the Northern Territory have enacted biodiscovery legislation in the Biodiscovery Act 2004 (Qld) and the Biological Resources Act 2006 (NT). These may provide legislative models for other States and Territories with respect to their role in assisting Australia to meet its obligations under the Protocol.

We will be closely following the Australian Government's response to submissions on its model for implementing the Protocol, and we will keep you updated of any news and developments.

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