The National Framework 2006 was developed by GTEC in the context of its responsibilities under the GT Act. In 2000, the Commonwealth of Australia, published the Australian Biotechnology: A National Strategy (Biotechnology Australia 2000) which expressed commitment to the development of biotechnology and safeguarding human health, and ensuring the protection of the environment. The establishment of the national regulatory system for gene technology was considered a key component of the Australian Biotechnology: A National Strategy. The National Strategy stated “Consistent with safeguarding human health and ensuring environmental protection, that Australia captures the benefits of biotechnology for the Australian community, industry and environment” (at page 7).
The National Framework was developed with reference to the work of earlier Australian committees, including the Genetic Manipulation Advisory Committee (GMAC 1987–2001), the Recombinant DNA Monitoring Committee (1981–87), and the Academy of Science Committee on Recombinant DNA Molecules (1975–81). The Academy of Science Committee on Recombinant DNA Molecules was created in 1975 to oversee the development and use of gene technology in Australia. The Recombinant DNA Monitoring Committee took over this function in 1981, but was succeeded in 1987 by the GMAC following the development of new techniques for modifying the genetic make-up of cells. GMAC was a non-statutory body, which assessed risks to human health and the environment posed by novel techniques of genetic manipulation.
GTEC circulated draft versions of the National Framework 2006 and received submissions covering a wide range of issues from a diversity of sources. Comments included suggestions for aligning the National Framework with existing guidelines, concern about how the principles would be implemented and regulated, and recommendations that sections on environmental ethics be strengthened.
Overall, submissions supported the need for, and intent of, the National Framework 2006 to provide a foundation for future discussions and guidelines relating to ethics in gene technology, as well as establishing a consistent approach to assessing the ethics of such technology in Australia.
The Gene Technology Act 2000The development of the Gene Technology Bill 2000 (the Bill) took place over a two-year period and was a collaborative effort between the Australian Government, and state and territory governments. It involved an extensive public consultation process that included circulation of a consultation paper titled; Proposed national regulatory system for genetically modified organisms — How should it work? Calls for submissions and invitations to public forums were published in newspapers in all jurisdictions, on the Interim Office of the Gene Technology Regulator’s website, and mailed directly to more than 2500 interested individuals and organisations.
In 1999, the Interim Office of the Gene Technology Regulator developed draft legislation for gene technology regulation, following an extensive consultation process involving a wide range of key stakeholders, including the public.
This comprehensive process generated broad agreement that the object of the GT Act would be 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 through the regulation of certain dealings with GMOs. Many submissions stressed the importance of ethics in the development of gene technology, as well as a rigorous scientific assessment of risks. These submissions influenced the introduction of a specialist ethics committee in the draft legislation.
The Bill was referred to a Senate Committee Inquiry and also subjected to extensive parliamentary debate over a six-month period. This resulted in a number of amendments before the GT Act passed into law in December 2000, and commenced operation on 21 June 2001.
In 2000, the Gene Technology Bill 2000 was passed to become the Gene Technology Act 2000 (the GT Act), and Australian Biotechnology: A National Strategy (2000) (the National Strategy), developed by Biotechnology Australia, was released.
The GT Act, supported by the Gene Technology Regulations 2001, an Intergovernmental Agreement signed by all jurisdictions, and corresponding legislation enacted in each state and territory, constitutes Australia’s nationally consistent scheme for regulating dealings with GMOs (including experimentation, production, breeding, importation, or use of GMOs in manufacture) to protect human health and safety and the environment. The GT Act and corresponding state and territory legislation is administered by an independent statutory office holder, the Gene Technology Regulator (the Regulator). The scheme operates in conjunction with other regulatory systems (Figure 1).
The GT Act sets down a comprehensive and rigorous process for the scientific identification, assessment and management of risks posed by gene technology. The GT Act also includes comprehensive consultation processes as part of risk-assessment procedures for intentional releases of GMOs into the environment, and allows associated ethical issues to be considered.
The GT Act also set down a range of requirements for the nationally consistent scheme supported by penalties for non-compliance. In particular:
- licences from the Regulator are required to undertake contained research, field trials, or commercial releases of GMOs
- dealings with GMOs are prohibited unless they are: Licensed; a notifiable low risk dealing (NLRD); Exempt or on the GMO Register
- organisations conducting research or dealing with GMOs must be accredited
- accreditation of an organisation requires Institutional Biosafety Committees (IBCs) to be established to provide oversight of and monitor research
- research on GMOs cannot be undertaken without certification of the accredited organisations’ laboratories (to specified containment levels).
The GT Act acknowledges the value of public trust through the inclusion of procedures, particularly those to ensure transparency and consultation. Transparency and public participation are required at many stages in the regulatory system, such as:
- during consideration of licensing applications and assessments (section 52)
- inclusion on the GMO Register (section 81)
- the operation of the advisory committees (part 8)
- the issue of policy principles or codes of practice (sections 22, 24).
Under the GT Act, three committees were originally established to provide advice to the Regulator. These committees are the Gene Technology Technical Advisory Committee (GTTAC), the Gene Technology Community Consultative Committee (GTCCC), and the Gene Technology Ethics Committee (GTEC). Part 8 of the GT Act sets out the range of skills or experiences that committee members must have.
After the 2006 review of the legislation, the GTEC and GTCCC were combined to form the Gene Technology Ethics and Community Consultative Committee (GTECCC) in 2008.