ART Clinics: Oversight

ART Clinics: Oversight

Introduction

The regulation and oversight of ART clinics in Australia occurs via general and specific laws and regulation.

General regulation of all professional health practitioners in Australia require that they must be registered, must adhere to the general law, and follow professional codes of conduct.

The power to pass specific laws regarding ART falls to the states and territories. In Australia, some states have comprehensive legislation (Western Australia, Victoria), others only have laws on certain aspects of ART (New South Wales, South Australia), and others do not have legislation at all (Northern Territory, Australian Capital Territory, Queensland, Tasmania).

At a national level there is also a self-regulatory system operated via the Fertility Society of Australia (FSA) and the Reproductive Technology Accreditation Council (RTAC), which set certain standards of practice across Australia; and the National Health and Medical Research Council Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research (the NHMRC Ethical Guidelines), which set out ethical principles that all ART clinics in Australia should follow.

Why don't we have just one National law?

The regulation of ART falls to the states (like many other matters related to health). It is not within the Commonwealth government’s powers to regulate ART.

State and Territory Laws

ART Clinics: Oversight; State Laws
Clinical practice and research are regulated in different ways across Australia. All states/territories adhere to the above national guidelines and self-regulatory oversight. Some states/territories also have laws requiring registration or licensing of clinics.
Table: General oversight requirements for clinics in States/Territories of Australia
* Click on the state/territory in the table if you wish to go directly to more information about it, otherwise scroll down to read information about them all!

Registration Systems

NSW

The Assisted Reproductive Technology Act 2007 (NSW) governs assisted reproductive technology services, the registration of assisted reproductive technology service providers and the prohibition of commercial surrogacy.

The Act states its objectives as being a) to prevent the commercialisation of human reproduction, and (b) to protect the interests of a person born as a result of ART treatment, a person providing a gamete for use in ART treatment or for research in connection with ART treatment, and a woman undergoing ART treatment. 1

Persons who provide ART services must be registered. 2

Registration will be granted after application to the Director General providing the following information:

(1) the name of the ART provider;

(2) the address of each premises at which the ART provider provides ART services;

(3) the name of each registered medical practitioner who undertakes or supervises ART services provided by the ART provider; and

(4) the name of each person who provides counselling services in relation to ART services provided by the ART provider.

Such information is then held on the ‘register’.

A person may be prohibited from carrying on a business that provides ART services if they are found to have contravened the Act, legislation governing research involving human embryos and cloning, 3 or relevant surrogacy legislation; 4 or have been refused accreditation by RTAC.

Victoria

Legislation in Victoria that regulates ART is the Assisted Reproductive Treatment Act 2008 (Vic).

The regulatory regime in Victoria (which was once one of ‘licensing’) is now one of ‘registration’.

The Assisted Reproductive Treatment Act 2008 (Vic) establishes the Victorian Assisted Reproductive Treatment Authority (VARTA), whose functions are, amongst other things, to administer the registration procedures required under the Act, as well as conduct community education and consultations about treatment procedures and the best interests of children born as a result of treatment procedures. 5

In order to register as an ART provider in Victoria a person must hold RTAC accreditation. 6 VARTA may impose conditions on registration, and may suspend registration (if contravention of requirements for RTAC accreditation occurs). 7

It is an offence not to notify VARTA if RTAC accreditation is no longer held, with a penalty of up to 240 penalty units or 2 years imprisonment. 8

The Act also establishes a ‘Patient Review Panel’ whose function is to consider applications from patients on a wide range of ethically complex issues, including surrogacy arrangements, posthumous use of gametes and failure to meet the eligibility criteria set out in the Act.

The Assisted Reproductive Treatment Act 2008 (Vic) also contains a number of guiding principles as follows:

  1. the welfare and interests of persons born or to be born as a result of treatment procedures are paramount;
  2. at no time should the use of treatment procedures be for the purpose of exploiting, in trade or otherwise the reproductive capabilities of men and women or children born as a result of treatment procedures;
  3. children born as the result of the use of donated gametes have a right to information about their genetic parents;
  4. the health and wellbeing of persons undergoing treatment procedures must be protected at all times;
  5. persons seeking to undergo treatment procedures must not be discriminated against on the basis of their sexual orientation, marital status, race or religion. 9

Such principles enshrine in law the minimal ethical standards considered necessary for the practice of ART.

South Australia

South Australia’s regulatory framework is set out in the Assisted Reproductive Treatment Act 1988 (SA) and Assisted Reproductive Treatment Regulations 2010.

The ART Act (SA) requires that ‘[t]he welfare of any child to be born as a consequence of the provision of assisted reproductive treatment in accordance with this Act must be treated as being of paramount importance, and accepted as a fundamental principle, in respect of the operation of this Act’. 10

In South Australia ‘registration’ of people wishing to provide ART is again required. A person must not provide assisted reproductive treatment in South Australia unless the person is authorised to do so in accordance with the regulations and registered with the Minister of Health and Ageing. 11 Penalties of up to $120000 may be imposed.

To be registered the applicant must establish that he or she is a fit and proper person to be registered; and holds any licence, accreditation or other qualification required by the regulations for the purposes of registration; and satisfies any other requirements prescribed by the regulations. 12

The regulations provide that ‘a current RTAC license is required for the purposes of registration’. 13

The Minister may impose conditions on registration and may suspend or cancel such registration in certain circumstances. 14

Northern Territory

No specific reproductive technology legislation exists in the Northern Territory.

However, reproductive medicine services in the territory are provided by South Australian clinicians operating under guidelines consistent with the South Australian legislation.

The NT Department of Health requires its clinics to adhere to South Australian legislation to the extent that it does not conflict with Northern Territory laws.

(Note, there are some differences between SA and NT laws – for example, the South Australian legislation complies with the Sex Discrimination Act 1984 (Cth) and allows access to infertility treatments for all infertile women, but the Northern Territory Anti-Discrimination Act 1992 provisions preventing discrimination in relation to services do not apply to the carrying out of an ‘artificial fertilisation procedure’ (which includes both AI and IVF procedures.) 15

Licensing System

Western Australia

The Human Reproductive Technology Act 1991 (WA) governs ART in Western Australia.

The main purposes of the legislation are to

  • establish the Western Australian Reproductive Technology Council (RTC);
  • require the compilation of a Code relating to the practice of, the procedures used in, and the ethics governing, human reproductive technology;
  • make provision with respect to the use of that technology in relation to artificially assisted human conception and for the regulation of certain research; and
  • other related purposes. 16

The RTC generally administers and enforces the Act.

The Human Reproductive Technology Act establishes a system of licensing for persons or organisations that either carry out ART procedures or maintain storage facilities for human sperm, eggs or embryos.

No artificial fertilisation 17 procedure may be carried out except pursuant to a licence. Licenses are granted by the Commissioner of Health. Before a practice licence (or exemption) is granted, the Commissioner must refer an application to the RTC, which provides oversight. 

The Human Reproductive Technology Act also creates a number of offences which may arise when a person carries out certain activities without a licence, or conducts research or diagnostic activities not approved by the council or pursuant to a licence. 18

Note: Although the legislation requires the compilation of a ‘Code of Practice’ — which is to be published by the RTC and is intended to set out guidelines and establish ethical standards required of licensees — no such code exists. Instead, guidelines are contained in directions formulated by the Commissioner, to allow for greater flexibility than would be possible under a code.

Self-regulation

Queensland, ACT and Tasmania

Queensland, the ACT and Tasmania do not have legislation governing ART.

Health professionals, clinics, and those generally practising in the area of ART follow the NHMRC Ethical Guidelines and the RTAC Code of Practice (the RTAC Code). 

National

ART Clinics: Oversight; doctors talking to each other

National Self-Governance: Fertility Society and RTAC

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. 19

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,
  • counselling,
  • information to be provided to patients,
  • consent,
  • laboratory services,
  • treatment methods,
  • record keeping,
  • ethics and research,
  • quality control, and
  • accreditation.

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.

National Ethical Guidelines on ART Clinical Practice and Research

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,
  • counselling,
  • 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.

Other Relevant National Laws

ART Clinics: Law book
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. 20

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.

Find out more

Use the links below to find out more about:

Notes:

  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).