Australia
May 24, 2005Source:
Australian Government
- Therapeutic Goods Administration
Review of the operations of
the Gene Technology Act 2000 and
the Intergovernmental Agreement on Gene Technology
Gene Technology Ministerial
Council
The Gene Technology Ministerial
Council recently held its third meeting in Adelaide. The meeting
was chaired by the Hon Tony McGrady, Queensland Minister for
State Development and Innovation. The Ministerial Council
comprises Ministers from each State and Territory responsible
for health, agriculture or industry development.
The Ministerial Council
oversees the national regulatory framework for gene technology
in Australia. This is a nationally consistent, cooperative
scheme involving the Australian Government and all States and
Territories. The scheme began on 21 June 2001 with the
commencement of the Gene Technology Act
2000 and has been characterised by a continuously high
level of collaboration throughout its development and
implementation.
Under the Act the Ministerial
Council must conduct an independent review of the operation of
the Act, including the structure of the Office of the Gene
Technology Regulator, to be undertaken as soon as possible after
the fourth anniversary of the commencement of the Act. This
falls on 21 June 2005.
The Ministerial Council has
agreed to the appointment of an independent panel of three
people to conduct the review of the Act. The panel will be
chaired by Ms Susan Timbs and include Mr Murray Rogers and Ms
Kathryn Adams. The Council also endorsed wide ranging terms of
reference for the review. The panel will be supported by a
full-time Secretariat.
The Ministerial Council also
authorised the Gene Technology Regulator, Dr Sue Meek, to
proceed with public consultation on proposed changes to clarify
and improve the workability of the Gene
Technology Regulations 2001. Seven key areas have been
identified in consultation with the Gene Technology Advisory
Committee and organisations currently involved in work with
genetically modified organisms. The suggested amendments address
a range of definitional issues, the classification of some
dealings and minor administrative improvements.
BACKGROUND
Susan Timbs
Susan Timbs has specialised
in environmental, planning and associated administrative law
since 1990.
Susan was admitted as a
solicitor in 1985 and was appointed a partner in the major
Brisbane law firm, Chambers McNab Tully & Wilson (later
Corrs Chambers Westgarth) in 1988. In 1998 Susan moved to
the leading law firm Mallesons Stephens Jaques.
As a Senior Consultant in
the National Environment and Planning Group of Mallesons
Stephen Jaques, Susan continued to specialise in
environmental, planning and administrative law. Susan headed
the Brisbane Environment and Planning Group until 2002 and
was responsible for clients operating across Australia.
On leave from Mallesons
Stephen Jaques, Susan is currently working in a health
related public policy area as National Policy Manager of
Breast Cancer Network Australia.
Murray Rogers
Murray Rogers is the Chair
of the Quarantine and Exports Advisory Council.
He is currently a member of
the Agriculture and Food Policy Reference Group which is
developing broad recommendations to improve the
profitability, competitiveness, and sustainability of the
Australian agricultural and food sector.
He has had a distinguished
career with Kellogg's, both in Australia and overseas, and
was Managing Director of the Australian Wheat Board between
1997 and 2000.
Mr Rogers is an Associate
Fellow of the Australian Marketing Institute and a Fellow of
the Australian Institute of Management.
Kathryn Adams
Kathryn Adams is a
microbiologist and a lawyer with extensive experience with
plant breeding, research and development in agriculture.
She is currently a Senior
Research Fellow at the Centre for Intellectual Property in
Agriculture, Faculty of Law, Griffith University and a
Mediator, Arbitrator and Dispute Resolution Facilitator.
Previously she was the
Executive Director of both Policy and Planning Divisions in
the Queensland Environmental Protection Agency.
Terms of Reference for Review
of the operations of the Gene Technology
Act 2000 and the Intergovernmental Agreement on Gene
Technology
The Gene
Technology Act 2000 (Commonwealth) (the Act) is the
Australian Government's component of the nationally consistent
regulatory scheme for gene technology in Australia. The object
of the Act is to protect the health and safety of people and the
environment from risks posed by, or as a result of, gene
technology by identifying those risks and managing them by
regulating certain dealings with genetically modified organisms
(GMOs). The Act establishes a regulatory framework through which
its object is to be achieved. This framework provides for a
precautionary approach and an efficient and effective system for
the application of gene technologies that operates in
conjunction with other Australian Government and State and
Territory regulatory schemes relevant to GMOs and GM products.
Section 194 of the Act
stipulates that the Ministerial Council for Gene Technology must
cause an independent review of the operation of the Act,
including the structure of the Office of the Gene Technology
Regulator (OGTR), as soon as possible after the fourth
anniversary of commencement of the Act. The Act states that the
review must undertaken by people the Ministerial Council agrees
possess appropriate qualifications, and include people who are
not employed by the Commonwealth or a Commonwealth authority.
The report of the review must tabled in each House of the
Parliament within 12 months after the fourth anniversary of the
commencement of the Act.
In establishing this review,
the Ministerial Council is aware of the Australian Government's
position on biotechnology, as outlined in the National
Biotechnology Strategy: "Consistent with safeguarding human
health and ensuring environmental protection, that Australia
capture the benefits of biotechnology for the Australian
community, industry and the environment." The Ministerial
Council is also aware that there are a range of concerns amongst
stakeholders and the public regarding gene technology and its
regulation in Australia.
Having particular regard to:
and noting the object and
regulatory framework set out in the Act, the Ministerial Council
has established the following Terms of Reference for the review
of the operation of Act:
Scope of Act
- Review the scope of the
Act to determine whether the policy objectives remain valid;
and consider other issues, technologies or organisms that
may be included in the scope of the Act, including:
-
consideration of economic, marketing and trade, cultural
and social impacts, and re-examine how ethical issues
are considered
- the
definitions in the Act, including of the environment,
and the need for the definition of other terms,
including health
-
consideration of the technologies and organisms covered
by the Act
-
consideration of a trait based or novel organism based
regulatory scope
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Act achieving objects
- Investigate
whether the object of the Act is being achieved and whether
the regulatory framework stipulated in section 4 of the Act
is still appropriate.
Operation of the Act
- Examine the structure and
effectiveness of the OGTR.
- Review the consultation
provisions of the Act including:
- their
effectiveness with respect to their costs and benefits,
including the value of advice received, and the
transparency and accountability they provide
- the
functions and roles of the statutory advisory committees
- the
statutory timeframes for applications under the Act
- the
stakeholders included in consultations for various
applications under the Act
- Determine whether the
powers of the Act allow enforcement of compliance which is
effective and appropriate to the circumstances including
instances where GMOs may be detected that are present
unintentionally.
Regulatory burden
- Examine whether compliance
and administrative costs, including information
requirements, for organisations working in gene technology
are reasonable and justified compared to benefits achieved
and possible alternatives to legislation.
- Review the system of
approvals and the application of regulatory requirements
commensurate to the level of risk.
Interface with other systems
- Examine the nationally
consistent scheme for gene technology regulation in
Australia and identify any need for, and ways to achieve,
improvements in its consistency, efficiency and
coordination.
- Examine the interface
between the Act and other Acts and schemes (either
Australian Government or State and Territory) that regulate
gene technology and gene technology products. Identify any
discrepancies, including regulatory gaps and areas needing
consistency and harmonisation of provisions.
Changing circumstances
- Examine
emerging trends and international developments in
biotechnology and its regulation and whether the regulatory
system stipulated by the Act is flexible enough to
accommodate changing circumstances.
Changes to the legislation
- Recommend
amendments to the Act (including consideration of those
recommendations made by State or Territory Parliamentary
Committees), or alternatives to legislation, which improve
the effectiveness, efficiency, fairness, timeliness and
accessibility of the regulatory system.
IGA achieving its aims
- Investigate
whether the Intergovernmental Agreement on Gene Technology
is achieving the aims listed in its Recitals.
The persons undertaking the
review are to advertise nationally, consult with key interest
groups and affected parties, receive submissions, and take into
account overseas experience. Those consulted should include
State and Territory Governments, the Gene Technology Advisory
Committees, the Australian Government authorities and agencies
prescribed by the Gene Technology
Regulations 2001, including the Environment Minister, as
well as the public. |
