Australie

Comités nationaux de bioéthique ou d'éthique des sciences

National Health and Medical Research Council (NHMRC)

The National Health and Medical Research Council (NHMRC) is Australia's peak body for supporting health and medical research; for developing health advice for the Australian community, health professionals and governments; and for providing advice on ethical behaviour in health care and in the conduct of health and medical research.

Much of NHMRC's role in providing health and research advice is managed through its committees :

NHC - National Health Committee

The National Health Committee is the Council's overarching committee for its advisory program. It manages and coordinates the development of advice and guidelines on all health issues.

Australian Health Ethics Committee (AHEC)

The Australian Health Ethics Committee is responsible for advising the Council on ethical issues relating to health, for developing and giving the Council guidelines for the conduct of medical research involving humans; and other functions as the Minister determines.

ATSIRAC - Aboriginal and Torres Strait Islander Health and Research Advisory Committee

The Aboriginal and Torres Strait Islander Health and Research Advisory Committee has been established to provide strategic advice to the Chief Executive Officer and improve the effectiveness of NHMRC's response to Indigenous health issues.

Expert Committees

The NHMRC currently has three expert advisory committees, the Cellular Therapies Advisory Committee, the Transmissible Spongiform Encephalopathies Advisory Committee, and the Water Quality Advisory Committee.

HGAC - Human Genetics Advisory Committee

The Human Genetics Advisory Committee advises the Chief Executive Officer on high-level technical and strategic issues in human genetics, and on the social, ethical and legal implications of human genetics and related technologies.

RC - Research Committee

The Research Committee is responsible for advising and making recommendations to the Council on the application and monitoring of the Reserve and advising the Council on matters relating to medical research and public health research, including the quality and scope of such research in Australia.

Victorian Biotechnology Ethics Advisory Committee, Australie

The Victorian Biotechnology Ethics Advisory Committee (VBEAC) was established by the Victorian Government to advise on issues of ethical concern relating to biotechnology and gene technology. VBEAC operated from 2002 to 2007. The Committee was responsible for the development of a Statement of Ethical Principles for Biotechnology in Victoria, launched in 2006. Currently, ethical and social issues raised by gene technology are addressed by the national Gene Technology Ethics and Community Consultative Committee (GTECCC) that reports to the Commonwealth Gene Technology Regulator and the Gene Technology Ministerial Council.

Mission :

Following negotiations between Commonwealth, State and Territory Governments, the Commonwealth Gene Technology Act 2000 was enacted in December 2000.

- The Commonwealth Gene Technology Act establishes a national scheme to regulate gene technology and provides a framework to achieve coordination across all levels of Government. The national scheme is administered through the Office of the Gene Technology Regulator (OGTR) established through the Gene Technology Act 2000, and has operated since June 2001.

-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 GMOs"

The National Framework regulates gene technology through:

- A risk assessment process where possible hazards are identified and the likelihood of their occurrence is assessed;

- A licensing scheme for industry and institutions using biotechnology to develop products or in their research;

- The establishment of a Canberra-based Office of the Gene Technology Regulator (GTR) to carry out those functions;

- The creation of a Ministerial Council for Gene Technology to develop policy principles to guide the decisions of the GTR; and

- The establishment of three independent national advisory committees with expertise in the science of gene technology , ethical matters and community concerns related to the use of gene technology.

Commonwealth regulators of gene technology, Gene Technology Committees

Office of the Gene Technology Regulator

- The Office of the Gene Technology Regulator (OGTR) is the Commonwealth statutory body that administers the gene technology regulatory system. Its functions include the licensing and monitoring of proposed activities using gene technology and enforcing the legislation.

- The OGTR also develops and publishes standards, procedural guidelines and codes of practice relating to genetically modified organisms. The Office provides information to the public, other regulatory agencies and the States and Territories about the regulation of genetically modified organisms.

- The GTR uses the advice of the Gene Technology Ministerial Council and the three national committees established by the legislation. The GTR is an independent statutory office holder under the Act. The GTR tables quarterly reports on the activities of the Office in the Commonwealth Parliament.

Gene Technology Ministerial Council

- The Gene Technology Ministerial Council is comprised of Commonwealth, State and Territory Ministers and is responsible for overseeing the operation of the national gene technology regulatory system.

- The Ministerial Council will advise the GTR on policy principles and codes of practice to underpin the system. It will also coordinate with other relevant ministerial councils in relation to gene technology, advises on the appointment of the GTR, and advises on the appointment of members to the national committees. The Minister for Health is Victoria's lead Minister for biotechnology safety and ethics and represents Victoria on the Ministerial Council.

Gene Technology Technical Advisory Committee

- The Gene Technology Technical Advisory Committee (GTTAC) replaced the Genetic Manipulation Advisory Committee operating under the previous voluntary system. The GTTAC provides scientific and technical advice to the GTR and the Ministerial Council on gene technology, GMOs and GM products. It also advises on applications made under the legislation and the need for technical guidelines in relation to GMOs and GM products.

Gene Technology Ethics Committee

- The Gene Technology Ethics Committee (GTEC) provides advice to the GTR and the Ministerial Council on the ethics of gene technology and develops ethical guidelines and directives in relation to GMOs and GM products where there are ethical concerns, including advice on policy principles for GMO dealings that should not be conducted for ethical reasons.

Gene Technology Community Consultative Committee

- The Gene Technology Community Consultative Committee (GTCCC) is a consultative committee established to advise the Ministerial Council and the GTR on community concerns relating to gene technology, and on the development of policy documents and codes of practice to guide the GTR.

Publications

Commonwealth regulators of GM products

Therapeutic Goods Administration

- The Therapeutic Goods Administration (TGA) is administered under the Commonwealth Department of Health and Aged Care, and is responsible for ensuring that medicines and medical devices available in Australia (including GM goods) are of an acceptable standard under the Therapeutic Goods Act 1989. The TGA is responsible for regulating human gene therapy, including clinical research and the marketing of products for human gene therapy.

Food Standards Australia New Zealand

- Food Standards Australia New Zealand (FSANZ) is a partnership between the Commonwealth, State, Territory and New Zealand Governments. FSANZ is responsible for developing, varying and reviewing standards for food (including GM food products) available in Australia and New Zealand, under the Australia New Zealand Food Authority Act 1991.

National Industrial Chemicals Notification and Assessment Scheme

- National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is a Commonwealth Government agency that regulates industrial chemicals for health and environmental effects, under the Industrial Chemicals (Notification and Assessment) Act 1989.

Australian Quarantine and Inspection Service

- Australian Quarantine and Inspection Service (AQIS) regulates the import and export of GM products and GMOs under the Quarantine Act 1908, the Imported Food Control Act 1992 and the Export Control Act 1982.

Australian Pesticides and Veterinary Medicines Authority

- Australian Pesticides and Veterinary Medicines Authority (APVMA) is responsible for registering all agricultural and veterinary chemicals (including GM chemicals) under the Agricultural and Veterinary Chemicals (Code) Act 1994. It ensures all chemicals on the market are safe and effective and do not have adverse effects on the environment when used as directed.

The Victorian Government is a signatory to an Inter-Governmental Agreement on the regulation of gene technology in Australia. This Agreement includes provision for the enactment of complementary State legislation to ensure the Commonwealth's coverage over gene technology is comprehensive. Complementary legislation was enacted with the Victorian Gene Technology Act 2001.

remarque : Le Comité (VBEAC) ne semble couvrir que les questions relatives aux technologies génétiques.

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Comités nationaux de bioéthique ou d'éthique des sciences