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 Recommended 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.
The National Biotechnology Strategy (NBS), which outlines the Government’s vision for biotechnology, aims to ensure that “consistent with safeguarding human health and ensuring environmental protection, that Australia capture the benefits of biotechnology for the Australian community, industry and the environment” (National Biotechnology Strategy, 2000, p.7). The Gene Technology Act 2000 (Cth) was introduced as a measure to ensure that human health and safety and the environment are safeguarded whilst the research and commercial development objectives of the NBS are achieved. The system of regulation imposed by the Act should therefore be seen as part of a broader set of objectives that the Government has for the success of biotechnology in Australia.
The Gene Technology Act 2000 (Cth) has an apparently simple object, “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”. (GT Act s 3). The Act, and its operation through the Office of the Gene Technology Regulator (OGTR) and the Gene Technology Regulator, was intended as a ‘gap-filler’. In other words, it would operate in conjunction with other Commonwealth and State regulatory schemes relevant to GMOs and GM products, such as AVPMA, FSANZ, TGA, AQIS, and NICNAS. Additionally, some supervision of ethical practice in scientific establishments is left to committees that work under auspices other than the OGTR, such as human research and animal ethics committees. However, significant matters of risk assessment and risk management of GMOs that are not covered by these other schemes and committees do rest with the OGTR. In addition, there is an unstated but real need to consider the cumulative impact of the regulatory system on the research and development of GMOs in a manner consistent with the vision enunciated in the NBS.
GTEC’s view is that two key aspects of the NBS need to be addressed more explicitly by the Act and the operations of the OGTR. These are “raising public awareness and informing community dialogue” and “consideration of ethical issues” (NBS, pp.7-8). GTEC acknowledges that Biotechnology Australia has a public awareness program but we believe that the OGTR can make a significant contribution to public awareness of the regulation of biotechnology in Australia and, in particular, to addressing some of the social and ethical concerns expressed by the public. GTEC also believes that ethical issues need to occupy a more central place within the regulatory system and that the two statutory committees, GTEC and GTCCC, have the potential for a greater role in considering those aspects of the operations of the OGTR that bear upon social and ethical concerns relevant to the operations of the Act and to the regulation of gene technology in general.
B. Summary of Activities and Role of GTEC: 2001 - 2004