The Regulation of Stem Cell Research in Australia
Within Australia, there is both federal and state legislation governing stem cell research. In addition to the legislation, there is a series of guidelines which set out the values and principles that apply to all research involving humans or human tissues. Prior to 2002 there was no Australian Government legislation for embryo or stem cell research and each of the states had various and differing regulations and laws.
In 2002, a historic and rare conscience vote was held following debate on new legislation that would govern embryo research and cloning. In addition at the time the States and Territories agreed to implement a nationally consistent approach. The passing of the Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002 allowed for research on excess IVF embryos including for the derivation of human embryonic stem cells and prevented not only cloning for reproductive purposes but also somatic cell nuclear transfer (SCNT).
The Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002 were amended by passage of the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006 following a review of the legislation and another conscience vote. The amended legislation, which came into effect on 12 June 2007 allowed for SCNT but continued to prohibit reproductive cloning. However the response from the states and territories to the 2006 amendments was mixed with Western Australia rejecting the amendment to allow SCNT. Victoria, New South Wales, Queensland, Tasmania, South Australia and the Australian Capital Territory, have all passed laws that mirror the Federal legislation.
Under both the 2002 and 2006 Acts, a researcher must obtain a licence from the National Health and Medical Research Council (NHMRC) Licensing Committee to use excess human IVF embryos for research including the derivation of new embryonic stem cell lines. A researcher must also obtain a licence to perform SCNT. As SCNT requires the use of a human oocyte (egg) the legislation also states that women who donate oocytes for such research cannot be financially reimbursed. The use of non-human animal eggs to make human SCNT cell lines is specifically prohibited.
Once created, research using human embryonic stem cells, like adult stem cells, must comply with relevant guidelines including the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research (2007).
The Therapeutic Goods Administration (TGA) is responsible for regulating medicines, medical devices, blood & tissues in Australia. The TGA is currently developing a national regulatory framework for human tissues and emerging biological therapies which will include stem cells. The human cellular and tissue therapies regulatory framework is expected to be implemented in 2010.
Stem Cell Regulation around the World
Legislation and regulation which govern stem cell research differ markedly from country to country and in some cases, from state to state. The variations can be attributed to cultural, ethical and religious values. The International Consortium of Stem Cell Networks maintains a list of web links and resources which map stem cell laws around the world.
In addition, the International Society for Stem Cell Research (ISSCR) assembled a task force composed of experts in science and medicine, ethics and law from 14 countries to draft the ISSCR Guidelines for the Conduct of Human Embryonic Stem Cell Research. Whilst non-binding the guidelines specify rigorous ethical standards for scientists working with human embryonic stem cells, and seek to promote responsible, transparent and uniform practices worldwide.