Summary of this Part
This Part provides for the establishment of the:
- Gene Technology Technical Advisory Committee (the scientific committee);
- Gene Technology Community Consultative Group (the community committee); and
- Gene Technology Ethics Committee (the ethics committee).
Key provisions in this Part and major changes as a result of consultation on the draft Bill
The Gene Technology Technical Advisory Committee (Division 2)
At present GMAC provides recommendations on all applications for contained research, field trials and general releases involving GMOs.
The new scientific committee will replace GMAC, and will be responsible for providing expert scientific advice to the GTR on applications made under the legislation. The scientific committee will also advise the GTR and the Ministerial Council on other matters related to gene technology, GMOs and GM products and on the need for, and proposed content of, policy principles, policy guidelines, codes of practice and technical and procedural guidelines for GMOs and GM products.
During consultations, various suggestions were made about the proposed scientific committee, such as:
- the membership of the committee should include expertise in several fields not currently represented on GMAC, for example, a public health professional and someone with experience in risk assessment;
- the committee should be able to draw on additional expertise where necessary, to assist in the preparation of advice on applications. This was viewed as particularly important, since the rapid development of the technology, and its application across an ever-broadening group of organisms, would mean it would be difficult for the ‘core’ committee members to have the relevant expertise on all the applications that might come before them for advice;
- the committee should include members with a variety of perspectives, including experts supporting both ‘reductionist’ and ‘holistic’ approaches to the issues; and
- clear conflict of interest and disclosure of interest provisions will need to apply to committee members.
- it will be comprised of up to 20 members appointed by the Commonwealth Minister for Health following consultation with the GTR, other relevant Commonwealth Ministers, State/Territory Ministers and relevant scientific, consumer, health, environmental and industry organisations;
- members will include experts in relevant scientific fields including risk assessment, public health and ecology and a layperson;
- members may be supplemented by additional expert advisers appointed by the Minister on an ad hoc or ongoing basis. These advisers may be appointed to assist the committee in its deliberations on specific applications or classes of applications;
- it will be able to establish subcommittees to assist in the performance of its functions. At present, GMAC has two main sub-committees – the Release Sub-committee and the Scientific Sub-committee – it is anticipated that these sub-committees will be re-established under the new system;
- members will be paid in accordance with a determination of the Remuneration Tribunal;
- members will be subject to strict disclosure of interest provisions which will be contained in regulations made under the Bill. Regulations will also describe the way in which matters are to be resolved by the committee, reporting requirements and procedures for convening meetings of the committee.
The Gene Technology Community Consultative Group (Division 3)
Given the high level of community interest in gene technology, it is important that both the GTR and the Ministerial Council remain “in touch” with community views on issues surrounding the regulation of gene technology. Both the GTR and Ministers will benefit from the community’s input into the development of the policy guidelines and codes of practice which will underpin the regulatory scheme.
This Part therefore establishes the Gene Technology Community Consultative Group (the community committee) to fulfill this role. The committee will:
- be responsible for advising the GTR and the Ministerial Council about GMOs, specifically on matters of general concern, and the need for policy principles, policy guidelines, codes of practice and technical and procedural guidelines for GMOs and GM products;
The Committee may:
- advise on how they think community consultations might most effectively be undertaken;
- provide their views on matters such as the transfer of genes from animals to plants;
- provide advice on draft codes of practice developed by the GTR;
- suggest that certain policy principles be developed where none exist; and
- raise issues of ethical concern that they wish to be examined by the ethics committee.
- comprise up to 12 members who possess skills or experience relevant to gene technology. This may include skills or experience in areas like environmental issues, consumer issues, the impact of genetechnology on the community, and public health issues;
- be subject to strict disclosure of interest provisions in the same way as the members of the scientific committee. Regulations will also describe the way in which matters are to be resolved by the committee, reporting requirements and procedures for convening meetings;
- be paid in accordance with a determination of the Remuneration Tribunal. During consultations, community members considered it important that community representatives on committees be properly remunerated for their contribution to the legislative scheme.
The Gene Technology Ethics Committee (Division 4)Top of page
During consultations, stakeholders expressed a range of views about the proposed ethics committee, including:
- the consideration of ethics issues must be quite separate from the GTR’s consideration of scientific issues;
- a properly constituted ethics committee should provide expert advice direct to the Ministerial Council and should also develop ethical guidelines to underpin the new scheme;
- the committee should develop ethical guidelines only after comprehensive community consultation (including consultation with the community committee), and those guidelines should then be observed by all people undertaking, or proposing to undertake, work with GMOs and GM products; and
- there should be cross-membership between all of the committees.
National Health and Medical Research Council Act 1992.
A new and separate ethics committee has therefore been established in the
Gene Technology Bill 2000. The committee will:
- advise the GTR and the Ministerial Council on ethical issues relating to gene technology, and the need for and content of, policy principles and codes of practice which will cover dealings with GMOs. Once developed by the committee, the policy principles and codes of practice will be issued by the Ministerial Council. The policy principles will be prohibitive in nature (describing activities which must not be conducted on ethical grounds) and the codes of practice will be permissive in nature. The codes of practice will describe the types of ethical considerations which must be taken into account by researchers proposing to undertake work involving gene technology;
- comprise up to 12 members with expertise in matters such as ethics and the environment, health ethics, applied ethics, law, religious practices, and animal health and welfare. The committee will also include a member of the scientific committee and a member of AHEC;
- be able to draw on expert advisers, who may be appointed by the Minister on an ad hoc or ongoing basis to assist the work of the Committee;
- be subject to strict disclosure of interest provisions, in the same way as the members of the other committees. Regulations will also be made to regulate the way in which matters are resolved by the Committee, reporting requirements and procedures for convening meetings of the Committee; and
- be paid in accordance with a determination of the Remuneration Tribunal.
Proposed Governance Structure for Gene Technology Regulation