The Federal Government proposed significant changes to the regulation of biodiscovery earlier this year, when it released a model for the implementation of the Nagoya Protocol. Partner Michael Morris and Associate Julieane Bull report on the potential flow-on effects for Queensland's regulatory regime.
How does it affect you?
- The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (ABS) to the Convention on Biological Diversity (the Nagoya Protocol) entered into force on 12 October 2014.
- Australia has signed – but not yet ratified – the Nagoya Protocol, and is currently considering the preferred model for its domestic implementation.
- The Queensland Government has previously supported a review of the Biodiscovery Act 2004 (Qld) to accommodate emerging trends and international developments.
- Given recent developments at the international and national levels, those who use genetic resources and associated traditional knowledge for biodiscovery in Queensland should closely monitor that State's reform agenda.
Biodiscovery is scientific research on the genetic or biochemical make-up of a plant, animal, fungus or microbe with the purpose of developing a product or process that has commercial or other value. Biodiscovery may lead to the discovery and commercialisation of new products or processes in the pharmaceutical, nutraceutical, cosmetic, agricultural or other sectors.
Further to our recent Scintilla blog post, the Nagoya Protocol entered into force on 12 October 2014. Australia has signed – but not yet ratified – the Protocol, and is currently considering the preferred model for its implementation. Legislative and administrative changes are proposed to meet Australia's obligations as a user of genetic resources and associated traditional knowledge. Allens outlined the key reform proposals in our recent Focus: Australia releases model for implementing the Nagoya Protocol article.
In 2002, all Australian governments endorsed a nationally consistent approach to the development of frameworks for access to, and use of, biological resources. Two years later, Queensland became the first State to introduce biodiscovery legislation.
The biodiscovery industry has significant potential for growth in Queensland due to the State's outstanding biodiversity and active research landscape.
Queensland's outstanding biodiversity
Australia is one of only 17 ‘mega-diverse’ countries in the world, hosting up to 10 per cent of the world’s biodiversity of which 85 per cent is endemic. The Queensland Government states:
Queensland is Australia's most naturally diverse state. It has 13 terrestrial and 14 marine bioregions supporting more than 1000 ecosystem types, including rainforests, savannas, rangelands, the dry tropics, wetlands and the coast.
Queensland has 70% of Australia's mammals, 80% of its native birds and more than 50% of its native reptiles, frogs and plant species.1
Queensland's active research landscape
According to the latest Global Innovation Index, Australia ranks in the top 10 countries for human capital and research (and is placed 17th overall – up two positions since 2013). The Queensland Government has, for many years, promoted the State as a jurisdiction that values innovation, science and technology. The Queensland life sciences industry is estimated to invest approximately $650 million into research and development annually, and has an estimated income of approximately $4.4 billion.2 Queensland is host to a number of research institutes, including the Australian Institute of Marine Science, Queensland Museum and the Eskitis Institute for Drug Discovery (Griffith University).
Commercial biodiscovery in Queensland is regulated by the Biodiscovery Act 2004 (Qld).
The Act establishes a permit system for taking and keeping minimal quantities of certain native biological resources from State land or Queensland waters for biodiscovery. The permit is called a 'collection authority'.
A collection authority has conditions attached, and it is an offence not to comply with the conditions. A collection authority will override the requirement for any other State licence, permit or authority (such as the requirement for a permit to take or interfere with flora and fauna under Queensland's nature conservation legislation).
It is an offence to take biological resources without a collection authority, and penalties are up to (for an individual) $330,000 or two years in prison for collecting endangered, rare or vulnerable wildlife or a protected animal, and (for a corporation) $1.65 million. The Act provides for executive officer liability and it has comprehensive compliance and enforcement provisions.
An application for a collection authority must be accompanied by a proposed or approved biodiscovery plan.
A biodiscovery plan will include details of the proposed commercialisation activities (including a timetable), details of those parts of the activities that are proposed to be undertaken outside of the State or by third parties, and it will identify the proposed benefits to be delivered to the State.
The Director-General of the Queensland Government Department of Science, Information Technology, Innovation and the Arts will not approve a biodiscovery plan if he or she is not satisfied with the benefits proposed to be offered to the State, and the Director-General may impose conditions on approval of the plan.
The holder of a collection authority cannot take biological resources until a benefit-sharing agreement is in place. The benefit-sharing agreement will identify the benefits that must be provided to the State.
It is an offence to use biological resources for biodiscovery without being a party to a benefit-sharing agreement. The penalties are severe – corporations may be liable for an amount equal to the greater of $2.75 million or the full commercial value of commercialising the biological resources.
It is a statutory condition of any benefit-sharing agreement that only the commercialisation activities approved in the biodiscovery plan may be conducted by the biodiscovery entity.
In 2009, the Queensland Government commissioned an independent statutory review of the Act, which found that the legislation had generally worked well in the five years following its introduction. However, the review recommended a number of changes to legislation and relevant codes, as well as further education to improve the Act's operation.
While the Queensland Government’s response to the review supported all 32 recommendations (although some recommendations were supported in principle), a decision was made to implement the review's recommendations by reviewing the compliance code and investing in further education and stakeholder engagement, rather than amending the Act.
The statutory review recommended – and the Queensland Government supported – a further review of the Act within five years to accommodate emerging trends and international developments. It is possible that the entry into force of the Nagoya Protocol and the Federal Government's release of its preferred model for implementation of the Protocol may be the impetus for review of Queensland's biodiscovery regime.
- Queensland Government Business and Industry Portal (2014) Biodiscovery in Queensland.
- Figures are based on 2011 data. For more information, see Silvey, P. and Proctor, L. (2012) Queensland Life Sciences Industry Report 2012.