Better health and ageing for all Australians

Gene Technology

Gene Technology Ministerial Council (GTMC)

The Gene Technology Ministerial Council (Ministerial Council) was established by the intergovernment Gene Technology Agreement 2001, to govern the activities of the Gene Technology Regulator.

Scope/Objectives

The Ministerial Council is established by the intergovernmental Gene Technology Agreement 2001 (the Agreement). Functions conferred upon the Council by the Agreement are to:
  1. issue policy principles, policy guidelines and codes of practice to govern the activities of the Gene Technology Regulator and the operation of the Scheme (the "Scheme" refers to the national legislative scheme to protect the health and safety of people and to protect the environment, by identifying risks posed by, or as a result of, gene technology and by managing those risks through regulating certain dealings with genetically modified organisms);
  2. approve proposed regulations for the purpose of the Scheme;
  3. approve the appointment (and, if necessary, the dismissal) of the Regulator, and of the chairpersons of the Gene Technology Advisory Committee, the Gene Technology Community Consultative Committee, and the Gene Technology Ethics Committee, and advise the responsible Commonwealth Minister on the appointment of the members of those bodies;
  4. ensure co-ordination with other Ministerial Councils on matters relating to gene technology and, in particular, harmonisation of regulatory processes relating to GM products;
  5. oversee generally the implementation of the Scheme;
  6. consider and, if thought fit, agree on proposed changes to the Scheme;
  7. initiate a review of the Scheme in accordance with the specifications of the Gene Technology Agreement; and
  8. perform any other function conferred on the Council by the Gene Technology Agreement.
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Composition

Membership of the Council includes one member from the Commonwealth and all States and Territories. Each member is to be nominated by their Head of Government. Currently, the Council comprises Ministers from a range of portfolios including health, agriculture and environment.

Gene Technology Ministerial Council Members
(as at 7 April 2008)

QLD:
The Hon Desley Boyle MP

Minister for Tourism, Regional Development and Industry
Commonwealth:
Senator the Hon Jan McLucas
Parliamentary Secretary to the Minister for Health and Ageing
NSW:
The Hon Ian Macdonald MLC (Chair)

Minister for Energy, Primary Industries, Mineral Resources and State Development
VIC:
The Hon Daniel Andrews MP

Minister for Health
SA:
The Hon John Hill MP

Minister for Health
WA:
The Hon Kim Chance MLC

Minister for Agriculture, Forestry and Fisheries
TAS:
The Hon David Llewellyn MHA

Minister for Primary Industries and Water
NT:
Mr Christopher Natt MLA

Minister for Primary Industry and Fisheries
ACT:
Mrs Katy Gallagher MLA

Minister for Health
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Chairing Arrangements and Meeting Program

The Agreement provides for the Ministerial Council to determine the rotation of the position of Chair. The current Chair of the Council is the member representing the State of New South Wales (Minister for Energy, Primary Industries, Mineral Resources and State Development, the Hon Ian Macdonald MLC).

The GTMC meets at such times and places as a majority of the Council determines.
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Associated meetings of officials

The GTMC is supported by the Gene Technology Standing Committee (GTSC). The Standing Committee comprises senior officials from all jurisdictions and is chaired by the Commonwealth Department of Health and Ageing.
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Secretariat arrangements

The Regulatory Policy and Governance Division of the Department of Health and Ageing provide secretariat support for the GTMC and the GTSC.

Secretariat contact details:

Gene Technology Ministerial Council Secretariat
Department of Health and Ageing
Regulatory Policy and Governance Division
Research Policy and Biotechnology Branch
GPO Box 9848
MDP 138
Canberra ACT 2601

Phone: 02 6289 4213
Fax: 02 6289 8060
Email: gtmc.secretariat@health.gov.au

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Commonwealth Contact

The first point of contact is the Gene Technology Ministerial Council Secretariat.
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The Gene Technology Act 2000 and the Gene Technology Regulations 2001

The Gene Technology Act 2000 (the Act) was developed in consultation with all Australian jurisdictions over a number of years to establish a nationally consistent regulatory system for gene technology.

The object of the Act is to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with genetically modified organisms.

The Act also establishes a statutory officer, the Gene Technology Regulator, to make decisions under the Act.

The Act is supported by the Gene Technology Regulations 2001 (the Regulations); an inter-governmental agreement; and corresponding legislation that is being enacted in each State and Territory.

At the 3 July 2008 Council of Australian Governments (COAG) meeting, all jurisdictions signed the inter-governmental agreement reaffirming their commitment to a nationally consistent scheme for gene technology.

The operation of the Act and Regulations is overseen by the Gene Technology Ministerial Council.

The Gene Technology Act 2000 (this link will take you to the ComLaw internet site)
The Gene Technology Regulations 2001 (this link will take you to the ComLaw internet site)
The Office of the Gene Technology Regulator
The Gene Technology Agreement (PDF 50 KB)
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Policy principles

A key part of the scheme is the provision for policy principles that may be issued by the Ministerial Council to guide the operation of the national regulatory system. They also govern the work of the Gene Technology Regulator.

Gene Technology (Recognition of Designated Areas) Principle 2003

Under the Gene Technology Act 2000, the Gene Technology Ministerial Council (the Ministerial Council) has the power to issue a policy principle which would recognise States' and Territories rights to designate under State and Territory law special areas that are either for genetically modified (GM) or non-GM crops for market purposes. The Gene Technology Regulator must then act consistently with the policy principle.

At its 24 May 2002 meeting, the Ministerial Council agreed to start work on this policy principle. The Gene Technology Standing Committee (the Standing Committee), consisting of senior Commonwealth, State and Territory government officials, developed a draft policy principle and related documents. These documents were released for public comment in May 2003.

Once the consultation process was completed, a report of the outcome of the consultation was prepared and used to inform consideration of the final policy principle by the Ministerial Council. On 31 July 2003, the Gene Technology Ministerial Council agreed to the issuing of the Gene Technology (Recognition of Designated Areas) Principle 2003. The policy principle was published in the Commonwealth Government Special Gazette No. S340 on Friday 5 September 2003 and were tabled in each House of the Australian Parliament on 9 September 2003.

A copy of final policy principle, explanatory statement, and final regulatory impact statement are available from this website. Alternatively, hard copies can be obtained by emailing GTMC.secretariat@health.gov.au.
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Statutory Review of the Gene Technology Act 2000 and the Gene Technology Agreement


The statutory review of the Gene Technology Act 2000 that was conducted in 2005/06 introduced the Guidelines for Emergency Response.
Statutory Review of the Gene Technology Act 2000 and the Gene Technology Agreement 2001 - Part 1 (PDF 396 KB)
Statutory Review of the Gene Technology Act 2000 and the Gene Technology Agreement 2001 - Part 2 (PDF 268 KB)
Statutory Review of the Gene Technology Act 2000 and the Gene Technology Agreement 2001 - Part 3 (PDF 396 KB)
Statutory Review of the Gene Technology Act 2000 and the Gene Technology Agreement 2001 - Part 4 (PDF 201 KB)
Statutory Review of the Gene Technology Act 2000 and the Gene Technolopgy Agreement 2001 - Part 5 (PDF 1192 KB)

State, Territory and Australian Governments' Response to the Recommendations of the Statutory Review of the Gene Technology Act 2000 and the Gene Technology Agreement 2001 (PDF 215 KB)

Guidelines for Emergency Reponse under the Gene Technology Act 2000 and the Gene Technology Agreement


These Guidelines were issued by the Gene Technology Ministerial Council on 4 May 2007.

The purpose of the Guidelines is to provide guidance on the use of the emergency provisions of Gene Technology Act 2000, and the relevant clauses in the Gene Technology Agreement 2001. The Guidelines relate to two emergency provisions that may be invoked by the the Commonwealth Minister responsible for gene technology. These provisions are:
    1. The Minister may issue an emergency dealing determination (EDD) that expedites the approval process for dealing with a genetically modified organism (GMO) in an emergency.

    2. The Minister may declare a thing to be a GMO for a limited period where the thing poses a threat, there is uncertainty that the thing meets the definition of a GMO in the Act and it is likely the declaration will address the threat. This provision already exists in the legislation.


Guidelines for Emergency Response under the Gene Technology Act 2000 and the Gene Technology Agreement
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Gene Technology (Equine Influenza Vaccine) Emergency Dealing Determination 2007


The EDD was made to authorise dealings with the GMO that comprises the vaccine for equine influenza (EI) which is marketed in the United States as ‘RECOMBITEK FLU’ and in Europe as ‘PROTEQFLU’ or ‘PROTEQFLU TE’. The purpose of the EDD was to address an actual threat to the horse population in Australia.

Before the EDD was made, a number of consultations occurred, including:
    • advice from the Commonwealth Chief Veterinary Officer that there is an actual threat to the horse population in Australia and that the use of the vaccine would, or would be likely to, adequately address the threat;
    • advice from the Gene Technology Regulator that any risks posed by the dealings in the EDD are able to be managed to protect the health and safety of people and the environment;
    • the States and Territories through the GTMC in relation to the making of the proposed EDD; and
    • the then Minister for the Environment and Water Resources, the Australian Quarantine and Inspection Service, the Australian Pesticides and Veterinary Medicines Authority and Animal Health Australia.

The EDD commenced on 20 September 2007 and was approved for a period of six months.

Emergency Dealing Determination 2007 (this link will take you to the ComLaw internet site)Top of page

Gene Technology (Equine Influenza Vaccine) Emergency Dealing Extension Determination 2008


On 18 March 2008, an extension to the Gene Technology (Equine Influenza Vaccine) Emergency Dealing Determination 2007 was made to allow the continued use of the EI vaccine to address the continued threat from EI to the horse population in Australia.

The extension to the EDD followed a consultation process similar to the initial making of the EDD.

The decision to extend the EDD for a further six months was unanimously endorsed by members of the GTMC.

The EDD will now expire on 20 September 2008.

Emergency Dealing Extension Determination 2008 (this link will take you to the ComLaw internet site)
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