Regulation of research in Australia

Throughout 1999 and 2000 the state and territory governments and the Australian Government worked together with interested parties to develop the Gene Technology Act 2000.

The Act was passed by the Australian Government in December 2000 and took effect on 21 June 2001. The legislation is the Australian Government's component of a national scheme for the regulation of genetically modified organisms (GMOs). The scheme includes legislation in every Australian State and Territory.

The objective of the Act is to protect the health and safety of people, and to protect the environment, by identifying and managing risks posed by or as a result of gene technology. It does this by creating laws for certain dealings (or activities) with GMOs.

While most GM products are regulated by agencies such as the Therapeutic Goods Administration (TGA), Food Standards Australia New Zealand (FSANZ) and the Australian Pesticides and Veterinary Medicines Authority (APVMA), GM products that were not already covered by an exisiting national regulation scheme are now regulated by the Gene Technology Regulator under the legislation.

The Gene Technology Ministerial Council is currently conducting a review of the operation of the Act and the Gene Technology Regulator is undertaking public consultation on proposed changes to clarify and improve the workability of the Gene Technology Regulations 2001.

Details about the regulatory framework for gene technology in Australia, including information on the Act, regulations, and the Gene Technology Ministerial Council (which oversees the operation of the national regulatory scheme for gene technology) can be found at the Office of the Gene Technology Regulator (OGTR) web site: http://www.ogtr.gov.au

A scientific, ethical and precautionary approach

The Act establishes three key advisory groups to provide advice, on request, to the Gene Technology Regulator and the Gene Technology Ministerial Council:

  • the Gene Technology Technical Advisory Committee (GTTAC) provides advice on scientific and technical matters
  • the Gene Technology Ethics Committee (GTEC) provides advice on ethical matters
  • the Gene Technology Community Consultative Committee (GTCCC) provides advice on community issues regarding gene technology.

Section 4 requires that the object of the Act is to be achieved through a regulatory framework which:

(aa)

provides that where there are threats of serious or irreversible environmental damage, a lack of full scientific certainty should not be used as a reason for postponing cost-effective measures to prevent environmental degradation

(a)

provides an efficient and effective system for the application of gene technologies

(b)

operates in conjunction with other Commonwealth and State regulatory schemes.

Section 4(aa) outlines a ‘precautionary approach’. This means that where there are threats of serious or irreversible environmental damage, a lack of full scientific certainty should not be used as a reason for postponing cost-effective measures to prevent environmental degradation.

However, the legislation also requires that the object of the Act is achieved by balancing a precautionary approach with the other two, equally important provisions of efficiency/effectiveness and co-regulation. A precautionary approach is, therefore, one of three 'pillars' in a regulatory framework for gene technology that seeks to protect human health and safety and the environment.

International arrangements

Working in international forums is one way Australia can encourage other countries to take up comprehensive arrangements to ensure the protection of people and the environment in the development of gene technology.

We need to ensure Australians and other nations act responsibly when exporting or transporting genetic material internationally. Likewise, we need to ensure that people importing or transporting genetic material across Australian boundaries act appropriately.

Convention on Biological Diversity

Australia is signatory to the Convention on Biological Diversity (CBD) and a member of the Intergovernmental Committee on the Cartagena Protocol on Biosafety (see http://www.dfat.gov.au/environment/bsp). In response to the CBD, an international biosafety protocol was negotiated and came into force on 11 September 2003. The protocol governs the ‘transboundary movement’ (i.e. movement across international borders) of living modified organisms resulting from modern biotechnology that may have an adverse effect on the conservation and sustainable use of biodiversity.

You can find evidence about the safety of genetically modified products by examining the different regulatory arrangements around the world and the outcomes of other countries' research. While many countries are developing or have just established arrangements for regulating GMOs, some countries rely on self-regulation by industry and scientists. The Australian arrangements under the Gene Technology Act 2000 set an international benchmark for managing the risks associated with GMOs.