The Fertility Society of Australia (FSA) is the peak self-regulatory body representing scientists, doctors, researchers, nurses, consumer groups, patients and counsellors in reproductive medicine in Australia and New Zealand.
The FSA states its vision and objectives are:
- To provide clinical guidance and direction to improve the standard of reproductive medical practice in Australia including medical review and quality assurance activities.
- To determine, oversee and improve the standard of fertility service offered in Australia and New Zealand.
- To encourage research in reproductive health.
- To provide a basis for affiliation between all professional and consumer groups involved in the delivery and receipt of fertility treatment in Australia and New Zealand.
- To provide educational opportunities for FSA members to raise the standard of care.
- To assist government and other interested parties in developing strategies relating to fertility in Australia and New Zealand.
- To create a forum for the discussion on the problems associated with infertility and fertility control.
- To facilitate an interdisciplinary approach to these problems.
- To establish rules for membership of the Society and
- to make and maintain a register of members of the Society.
The Reproductive Technology Accreditation Committee (RTAC) is a self-regulatory body that accredits ART clinics. It was established by the FSA in 1986.
RTAC reports to the FSA Council and local state authorities where required.
Accreditation of ART treatment centres by RTAC is the basis of a nationally consistent approach to overseeing ART clinical practice. ART clinics are reviewed by independent auditors every year.
The RTAC Code of Practice (written by the FSA), is to be observed in clinics or centres involved in the treatment of patients with ART. They include guidelines on
- staffing and resources,
- information to be provided to patients,
- laboratory services,
- treatment methods,
- record keeping,
- ethics and research,
- quality control, and
RTAC also requires compliance with the NHMRC Ethical Guidelines, by ART treatment centres to gain accreditation.
Infringement of the RTAC Code results in increasing responsive measures from RTAC. These start with a letter from the RTAC chairman outlining the guidelines and infringement. If a second breach occurs a request for an explanation is made. If the explanation is deemed unacceptable by the RTAC Committee, a letter of warning is issued to the clinic. Any further infringements may result in limited or loss of accreditation.
In some states the law requires adherence to the RTAC Code for legislative registration or licensing purposes. In those states, significant fines may also be imposed for breaching the code.
The National Health and Medical Research Council, Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research (NHMRC Ethical Guidelines) are published by Australia’s leading expert body on the development and maintenance of public and individual health standards.
The NHMRC Ethical Guidelines address many ethical issues that arise in relation to ART, including
- ethical principles that govern clinical practice,
- accreditation and approval processes,
- research requirements,
- storage of human tissue,
- record keeping,
- complaints and appeals processes, and
- prohibited and unacceptable practices.
Clinics adhere to the NHMRC Ethical Guidelines as part of the RTAC accreditation process, and in some states are required to do so pursuant to the law. However, the Guidelines are not subject to the same parliamentary approval processes as legislation and they do not have the force of law. They also do not apply to the extent to which they are inconsistent with the law of a particular state.
With respect to research, the NHMRC Ethical Guidelines are used by Human Research Ethics Committees and researchers who apply for ethical approval of any proposed research involving participants in ART, human eggs, sperm and/or embryos.
Also relevant to the governance of ART are laws that pertain to research involving human embryos and cloning, and prohibit human cloning for reproductive purposes.
In addition, the regulation of drugs, poisons and other therapeutic goods under the Therapeutic Goods Act 1989 (Cth) and therapeutic goods regulatory regime may also be relevant (for example regarding ART culture medium).
Laws that generally govern the practice of health practitioners Australia wide are also relevant in terms of professional registration and conduct.
References [ + ]
|1.||↑||Assisted Reproductive Technology Act 2007 (NSW), s 3.|
|2.||↑||Assisted Reproductive Technology Act 2007 (NSW), s 6.|
|3.||↑||Human Cloning for Reproduction and Other Prohibited Practices Act 2003 (NSW); the Research Involving Human Embryos (New South Wales) Act 2003 (NSW); the Prohibition of Human Cloning for Reproduction Act 2002 (Cth); the Research Involving Human Embryos Act 2002 (Cth).|
|4.||↑||Surrogacy Act 2010 (NSW).|
|5.||↑||Assisted Reproductive Treatment Act 2008 (Vic) Part 10.|
|6.||↑||Assisted Reproductive Treatment Act 2008 (Vic) s .74|
|7.||↑||Assisted Reproductive Treatment Act 2008 (Vic) s .75|
|8.||↑||Assisted Reproductive Treatment Act 2008 (Vic) s .78|
|9.||↑||Assisted Reproductive Treatment Act 2008 (Vic) s 5|
|10.||↑||Assisted Reproductive Treatment Act 1988 (SA), s 4A.|
|11.||↑||Assisted Reproductive Treatment Act 1988 (SA), s 5.|
|12.||↑||Assisted Reproductive Treatment Act 1988 (SA), s 6.|
|13.||↑||Assisted Reproductive Treatment Regulations 2010 (SA), Cl 6.|
|14.||↑||Assisted Reproductive Treatment Act 1988 (SA), s 9.|
|15.||↑||Anti-Discrimination Act 1992 (NT), s 4(8)|
|16.||↑||Human Reproductive Technology Act 1991 (WA), s 4 (and also Long Title).|
|17.||↑||Artificial fertilisation is defined in the Act as ‘any artificial insemination procedure, or in-vitro fertilisation procedure’: Human Reproductive Technology Act 1991 (WA), s 3.|
|18.||↑||Human Reproductive Technology Act 1991 (WA), s 6-7.|
|19.||↑||See Fertility Society of Australia, ‘About FSA’, website at http://www.fertilitysociety.com.au/home/about/.|
|20.||↑||See for example, the Prohibition of Human Cloning for Reproduction Act 2002 (Cth); the Research Involving Human Embryos Act 2002 (Cth).|