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Review of the National Component of the Gene Technology Regulatory System

In brief: Partner Sarah Matheson and Lawyer Caroline Ray outline the Term of Reference for the review of the operations of the Gene Technology Act 2000 and the Intergovernmental Agreement on Gene Technology.

Background

As previously reported in Biotech News, the Gene Technology Ministerial Council recently announced the appointment of an independent panel to review the operation of the Gene Technology Act 2000 (Cth) (Act). In this edition, we outline the composition of the panel and the Review's Terms of Reference.

Section 194 of the Act requires the Ministerial Council to cause an independent review of the operation of the Act, including the structure of the Office of the Gene Technology Regulator (OGTR), to be undertaken as soon as possible after 21 June 2006 (the fourth anniversary of the commencement of the Act) with the report to be tabled in Parliament by 21 June 2006.

The panel comprises:

  • Ms Susan Timbs (a specialist in environmental, planning and associated administrative law, currently on leave from Mallesons Stephen Jaques and working in the health related public policy area as National Policy Manager of Breast Cancer Network Australia);
  • Mr Murray Rogers (Chair of the Quarantine and Exports Advisory Council, member of the Agriculture and Food Policy Reference Group and former managing director of the Australian Wheat Board); and
  • Ms Kathryn Adams (microbiologist and lawyer with experience in plant breeding, research and development in agriculture, a Senior Research Fellow at the Centre for Intellectual Property in Agriculture, Faculty of Law, Griffith University, formerly Executive Director of both Policy and Planning Divisions in the Queensland Environmental Protection Agency).

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Terms of Reference

The Terms of Reference for the Review are broad, calling for an examination of the following:

  • the scope of the Act, to determine whether policy objectives remain valid and consider other issues, technologies or organisms that may be included in the scope of the Act;
  • whether the object of the Act is being achieved and whether the regulatory framework is still appropriate;
  • the operation of the Act – in particular, the structure and effectiveness of the OGTR, the consultation provisions and whether the powers of the Act allow effective and appropriate enforcement of compliance;
  • the regulatory burden of the Act – whether compliance and administrative costs (including information requirements) are appropriate compared to benefits achieved and whether the system of approvals and application of regulatory requirements correspond with the level of risk;
  • the Act's interface with other systems – any need for, and ways to achieve, improvements in the consistency, efficiency and coordination of the national scheme and any discrepancies between the Act and other legislation and schemes;
  • whether the Act's regulatory system can accommodate changing circumstances, in light of an examination of emerging trends and international developments in biotechnology;
  • any recommended amendments to the Act or alternatives to legislation which improve the regulatory system; and
  • whether the Intergovernmental Agreement on Gene Technology is achieving its aims.

In undertaking the review, the panel is to advertise nationally, consult with key interest groups and affected parties, receive submissions and consider overseas experience.

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Public Submissions

In its consultation package prepared for the Review of the Act, the Ministerial Council acknowledges that there is a range of concerns amongst stakeholders and the public regarding gene technology and its regulation. Recognising the potentially competing commercial interests and community concerns in this area, the Ministerial Council has called for submissions from interested parties addressing the review's terms of reference. Submissions should be sent by COB 15 July 2005 to:

Gene Technology Ministerial Council Secretariat
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Facsimile: 02 6232 8196
Email: GT.Review.Secretariat@health.gov.au

Unless requested to be kept confidential, all submissions will be made publicly available.

Biotech News will continue updating you with further developments in relation to this Review.

For further information, please contact:

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