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Gene Technology

Gene Technology Ministerial Council

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

• Scope/objectives
• Composition
• Chairing arrangements and meeting program
• Associated meetings of officials
• Secretariat arrangements
• Commonwealth contact
• Gene Technology Act 2000 and Gene Technology Regulations 2001
• Policy principles
• 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
• Guidelines for Emergency Response Under the Gene Technology Act 2000 and the Gene Technology Agreement
• Gene Technology (Equine Influenza Vaccine) Emergency Dealing Determination 2007
• Gene Technology (Equine Influenza Vaccine) Emergency Dealing Extension Determination 2008

• Communiques
  
  • Inaugural Gene Technology Ministerial Council communique (24 May 2002)
• Second Gene Technology Ministerial Council communique (31 July 2003)
• Gene Technology Act given green light (27 April 2006)
• Gene Technology Ministerial Council (GTMC) - Joint Communique (27 October 2006)
• Gene Technology Ministerial Council (GTMC) - Joint Communique (4 May 2007)
• Gene Technology Ministerial Council (GTMC) - Joint Communique (31 August 2007)
• Gene Technology Ministerial Council (GTMC) - Joint Communique (22 May 2009)

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 (the 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 by special majority any extension of an emergency dealing determination;
4. approve the appointment (and, if necessary, the dismissal) of the Regulator, and of the chairpersons of the Gene Technology Technical Advisory Committee (GTTAC) and the Gene Technology Ethics and Community Consultative Committee (GTECCC) and advise the responsible Commonwealth Minister on the appointment of the members of those bodies;
5. ensure co-ordination with other Ministerial Councils on matters relating to gene technology and, in particular, harmonisation of regulatory processes relating to GM products;
6. oversee generally the implementation of the Scheme;
7. consider and, if thought fit, agree on proposed changes to the Scheme;
8. initiate a review of the Scheme in accordance with the specifications of the Gene Technology Agreement; and
9. 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 primary industries.

Gene Technology Ministerial Council Members
(as at 31 March 2010)

QLD:
The Hon Andrew Fraser MP
Treasurer, Minister for Employment and Economic Development
Commonwealth:
The Hon Mark Butler MP
Parliamentary Secretary for Health
NSW:
The Hon Steve Whan MLA
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 Terry Redman MLA
Minister for Agriculture and Food, Minister for Forestry
TAS:
The Hon David Llewellyn MHA
Minister for Primary Industries and Water
NT:
The Hon Kon Vatskalis MLA
Minister for Health
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 annually (or at such longer intervals as the Council determines).

The Ministerial Council meets at such times and places as a majority of the members determine.

Associated meetings of officials

The Ministerial Council is supported by the Gene Technology Standing Committee (the Standing Committee). The Standing Committee comprises senior officials from all jurisdictions and is chaired by the Australian Government Department of Health and Ageing.

Secretariat arrangements

The Regulatory Policy and Governance Division of the Department of Health and Ageing provide secretariat support for the Ministerial Council and Standing Committee.

Secretariat contact details:

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

Phone: 02 6289 1088
Fax: 02 6289 8060
Email: gtmc.secretariat@health.gov.au

Commonwealth contact

The first point of contact for Ministerial Council or Standing Committee business is the 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 Regulator.

Gene Technology (Recognition of Designated Areas) Principle 2003

Under the Gene Technology Act 2000, 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 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 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 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.Top of page

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 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 Ministerial Council 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 expired on 20 September 2008.

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