Patents » Gene Technology

Featured article from Breakthrough Newsletter (Issue 2 2008).

The Gene Technology Amendment Act 2007 aims to improve the regulation of genetically modified organisms (GMO s), without affecting intellectual property rights.

The Australian national gene technology regulatory framework comprises Commonwealth, State and Territory legislation. State and Territory legislation is harmonised with Commonwealth legislation.

In 2005-06, an independent review of the Gene Technology Act 2000 (Cth) and the intergovernmental Gene Technology Agreement 2001 was conducted. The review found that the Act and the national regulatory scheme had worked well in the five years following introduction and that no major changes were required. However, it suggested a number of minor changes, aimed at improving the operation of the Act at the margin.

As a consequence of the review, recent Commonwealth legislative amendments, brought about by the Gene Technology Amendment Act 2007 (Cth), enable the responsible Minister to invoke emergency powers to approve use of genetically modified organisms (GMOs) to address imminent threats of disease, animals, plants or environmental damage.

For example, the recent equine influenza outbreak was treated using a GMO – a vaccine. Without the amendments introduced by the Gene Technology Amendment Act 2007 (Cth), approval to use the vaccine would have taken 255 days to obtain.

Further threats envisaged to fall within the scope of the emergency powers provision include an influenza pandemic in humans for which rapid access to treatment could avert a catastrophe.

PROCEDURAL PROGRESS
The recent amendments also enable the Gene Technology Regulator to grant licences to persons having inadvertent dealings with an unauthorised GMO for the sole purpose of disposal of the GMO. Additional amendments aim to:

• Improve the mechanism for providing advice to the Gene Technology Regulator and the Gene Technology Ministerial Council on ethics and community consultations, by combining the Gene Technology Ethics Committee with the Gene Technology Community Consultative Committee
• Streamline the process for the initial consideration of licences
• Reduce the regulatory burden for low risk dealings
• Provide clarification on the circumstances in which licence variations can be made
• Clarify the circumstances under which the Regulator can direct a person to comply with the Act
• Make technical amendments to improve the operation of the Act.

Most recently, Queensland fulfilled its obligations under the Gene Technology Agreement 2001 to maintain national consistency by passing the Gene Technology Amendment Act 2008 (Qld), which was drafted to reflect the Gene Technology Amendment Act 2007 (Cth).

The changes introduced by these Acts are regulatory in nature and do not affect the patentability of subject matter related to GMOs. Therefore, these legislative amendments will affect persons having dealings with GMOs, but are unlikely to affect intellectual property rights in GMOs or in GMOassociated processes.

For further information, contact:
Dr Malcolm Lyons, Trainee Patent Attorney malcolm.lyons@griffithhack.com.au

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