In Australia there are various government bodies and pieces of legislation that are involved in the regulation of Gene technology and its application. In other words, its an area that is heavily regulated by government in Australia. In some other countries gene technology and its application is not so heavily regulated by government. In these countries industry self regulate.
Government bodies that play a role in overseeing gene technology research and its application are:
The OGTR provides guidance on monitoring and compliance activities under the Gene Technology Act 2000. Additionally it issues technical and procedural guidelines plus certification of facilities and accreditation of organisations.
The NHMRC is Australia’s leading expert body promoting the development and maintenance of public and individual health standards. This is achieved through the development of consistent health standards, fostering medical research and training and giving consideration to ethical issues relating to health. One of its key functions is to foster consideration of ethical issues relating to health. Under the National Health and Medical Research Council Act 1992, the Council has developed the Ethical Conduct in Human Research (2007) guidelines which are subject to rolling reviews. Therefore any gene therapy research on humans would have to comply with the guidelines and meet the Council’s ethical standards.
The TGA is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products. Therefore any gene therapies would have to be approved by the TGA.
Government legislation that impact on gene technology research are:
- Gene Technology Act 2000
- Prohibition of Human Cloning Act 2002
- Research Involving Human Embryos Act 2002
- Therapeutic Goods Act 1989
- National Health and Medical Research Council Act 1992.