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Qld Biodiscovery Act 2004

In brief: In the previous edition of Biotech News, we reported that the Queensland Government had, in line with its Smart State Strategy, passed the Biodiscovery Act 2004 (Qld) (the Act) to establish a new regulatory framework for the exploration and exploitation of the State's biological resources. In this edition, Lawyer Alison Rush summarises the objectives of the Act and discusses how the new regulatory scheme will operate in practice. This article is not only relevant to research institutions and private sector organisations involved with R&D in Queensland, but should also be of interest to similar organisations in the rest of Australia, as the Commonwealth and other State and Territory Governments are now planning to enact similar legislation.

Biodiscovery in Queensland

Many products have been derived from nature through high tech scientific research. This research systematically examines natural biodiverse samples and searches for molecular, biochemical and genetic information which may be used to develop a medicine or other useful product. The branch of biotechnology that explores the potential of biodiversity is known as biodiscovery.

In short, biodiscovery can be described as the search for active compounds in biological material (such as plants, animals, fungi and other microorganisms) that can be developed to make therapeutic drugs, vaccines and other commercial products.

Queensland's native plants and animals are used to develop a number of commercial products that improve health and quality of life. For example, investigations are being made into whether venom from cone shells could produce a pain killer better than morphine, new sunscreens are being made from coral and natural herbicides are being produced from North Queensland plants.

Considering that biodiscovery contributes not only to the local economy, but also to improve quality of life in general, it is not surprising that environmental and commercial objectives underpin the Biodiscovery Act 2004 (Qld) (the Act). On an environmental level, the Act promotes the sustainable exploration of Queensland's biological resources. From a commercial point of view, the Act provides research organisations with more streamlined procedures for biodiscovery activities and guarantees Queensland a share in the rewards of any successful biodiscovery research using the State's biological resources. Each of these objectives are discussed below.

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Streamlined regulatory framework

Before the Act was passed, there were a myriad of separate laws in Queensland that regulated different aspects of biodiscovery research. A practical consequence of that was, for example, if a research organisation wanted to conduct experiments on a unique plant/animal bacteria to find a new antibiotic, it first had to obtain several permits from the various government agencies that administered legislation in relation to the State's flora and fauna (e.g. the Forestry Act, Land Act, Nature Conservation Act, Fisheries Act, Marine Parks Act, Native Title Act and Wet Tropics World Heritage Protection and Management Act).

The main purpose of the Act is to provide a more efficient administrative and regulatory framework than this previous system. To this end, the Act provides that a research organisation need only obtain a single permit, namely a Collection Authority, from one agency (the Environmental Protection Agency) to collect biological samples. The Collection Authority authorises the holder of the authority to enter upon specified State, private or native title land or State waters, at certain times and upon certain access conditions, and to take specific biological material.

To enhance Queensland's knowledge of its native biological resources, the holder of the Collection Authority is also obliged to lodge samples of the material collected under the Authority with Queensland Museum (for animal material), the Queensland Herbarium (for plant material) or another nominated agency/institution for other biological materials (e.g. fungi, micro-organisms).

Taking biological material from a site without a Collection Authority is a criminal offence punishable by a penalty of up to $225,000 for an individual, and $1,125,000 for a corporation.

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Benefits to be shared with Queensland

Another objective of the Act is to ensure that Queensland gets a share of the benefits derived from the use and commercialisation its biological resources. The types of benefits that Queensland anticipates to receive under the Act include:

  • more investment into Queensland's biotechnology industry;
  • collaborations with Queensland research organisations;
  • technology transfer;
  • job creation in the scientific, technical, legal, financial and administrative industries;
  • development of new or improved products for agricultural, medical and industrial purposes; and
  • royalties.

The benefits to the State will be secured by a legally binding Benefits Sharing Agreement between the State and the various biodiscovery entities concerned with the commercialisation of native biological material or the intellectual property derived from such material. All biodiscovery entities (which include both research institutions and private sector organisations) must enter into a Benefits Sharing Agreement with the State before conducting research upon native biological material.

The Benefits Sharing Agreement requires a biodiscovery entity to carry out research and commercialisation activities in accordance with a Biodiscovery Plan, which is a document setting out information such as the timetable for each of the activities, the activities proposed to be carried inside/outside Queensland and the activities which the entity proposes to outsource.

The conduct of biodiscovery research or commercialisation without a Benefits Sharing Agreement in place is a criminal offence punishable by a penalty of $375,000. Also, to ensure biodiscovery entities comply with the terms of the Biodiscovery Plan, severe financial penalties will be imposed for any acts/omissions that are not in accordance with the Biodiscovery Plan.

The Benefits Sharing Agreement will only apply to the State, and not to private land owners or native title holders with rights of exclusive possession. All affected private land owners and native title holders are required to enter into a separate benefit sharing contract with the biodiscovery entity. That benefit sharing contract is a private contract, and therefore will not be regulated by the Act.

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Environmental and conservation considerations

The environmental objective of the Act is to facilitate sustainable use of the State's biological resources and prevent environmental degradation. Achieving this aim will help to reduce the loss of biological diversity in Queensland, and therefore, conserve future opportunities for useful discoveries and innovation based on biodiscovery.

To achieve this objective, biodiscovery entities are obliged to comply with the (high level) terms of the Biodiscovery Code of Compliance (the Code), as well as the (specific) terms contained in the Biodiscovery Collection Protocol (the Protocol). The Code sets the general standards for collection activities, meanwhile the Protocol sets out in detail the collection activities relevant to the specific plant/animal species, or the specific collection area. For example, how to minimise damage and disturbance to the surrounding flora and fauna, how to comply with protection measures developed under other legislative schemes to ensure the environmental management practices of specific areas are maintained.

A breach of the relevant Code or Protocol will result in severe punishment for the biodiscovery entity responsible.

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The Future

Professor Kamal Puri, a University of Queensland academic, has criticised the new regulatory framework, arguing that it would be difficult to monitor and enforce. Another concern about the new system is that it has the potential to impede commercialisation in Queensland by overburdening research organisations with compliance obligations (such as the need for a Biodiversity Plan) and financial obligations (such as the obligation to pay royalties, and the cost of regulatory compliance).

While the new regulatory framework is not without its critics, it is expected that the introduction of the Act will have positive long term effects on the biotechnology industry in both Queensland, and the rest of Australia. The Commonwealth Government has already prepared similar draft legislation, and the governments of Western Australia and the Northern Territory have indicated their intention to follow suit.

Over the next few years we can expect that Australia, which is widely regarded as one of the 'megabiodiverse' countries of the world, will progress towards a regulatory framework that fosters biodiscovery, maximises opportunities for investment in Australian R&D efforts and supports the sustainable use of its unique biodiversity platform.

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