ABSTRACT
Recent changes to Federal Therapeutic Goods Administration legislation have seen the limited introduction of the drug mifepristone to Australia for the purpose of early medical abortion. At the same time it has become evident that both methotrexate and misoprostol, licenced and available for other indications, are being used safely and appropriately for early abortion by Australian medical practitioners. Early medical abortion is widely practiced overseas where its safety and effectiveness are well supported by current evidence. However, abortion law in many states is still contained within the Criminal Codes and does not reflect current evidence-based abortion practice. In other states and territories restrictions on where abortions may be performed pose potential barriers to the introduction of mifepristone for medical abortion. There is an urgent need for abortion law to be clarified and made uniform across the country so that the best possible services can be provided to Australian women.
Subject(s)
Abortifacient Agents, Steroidal , Abortion, Legal/legislation & jurisprudence , Family Planning Services/legislation & jurisprudence , Legislation as Topic , Mifepristone , Women's Rights/legislation & jurisprudence , Australia , Female , Government Regulation , Humans , Pregnancy , Pregnancy Trimester, First , Public OpinionABSTRACT
Mifepristone (RU486), which is used for early medical abortion, can only be obtained in Australia under the Authorised Prescriber legislation (Section 19[5] of the Therapeutic Goods Act 1989 [Cwlth]); two of the authors have permission to obtain, prescribe and administer this drug in Cairns, Queensland. From July 2006 to April 2007, 10 women who fulfilled the Therapeutic Goods Administration (TGA) criteria of "life-threatening or otherwise serious" indications underwent medical abortion with mifepristone/misoprostol, and 12 women conforming with abortion requirements of Queensland law, but not TGA legislation for mifepristone administration, had medical abortions with the less preferable methotrexate/misoprostol combination. Although it is now more than a year since the cross-party vote in federal Parliament in February 2006 confirmed wide support for the right of Australian women to a medical abortion, we believe we are at present the only medical practitioners in Australia with permission to use mifepristone. Obtaining Authorised Prescriber status from the TGA is of necessity a complex and protracted process, involving ethics committee approval and auditing, and regular reporting to the TGA. Because of the current restrictions, we believe that women seeking medical abortion in Australia face barriers not experienced by women in other comparable countries, and that drug manufacturing and distributing companies may be discouraged from seeking to market mifepristone in Australia.
