The trend towards a national approach

In areas of relevance to this Inquiry

5.2 The current methods of regulation and conflict resolution involve a patchwork of federal, state and territory laws; official guidelines; personal and professional ethics; institutional restraints; peer review and pressure; oversight by public funding authorities and professional associations; supervision by public regulatory and complaints-handling authorities; private interests; and market pressures.

5.3 One fundamental question is the extent to which a national approach to the regulation of human genetics may be required, rather than relying upon the traditional mix of federal, state and territory laws as well as other formal and informal mechanisms.

5.4 The location of regulatory authority in a federal system is always a matter of some contention. Uniformity has obvious advantages in terms of clarity and certainty. However, in a rapidly developing area of science and technology, there also may be something to be said for allowing innovation and experimentation on a state-by-state basis. Given the wide array of activities covered by this Report, and the constitutional limitations on federal legislative power,[2] only a cooperative approach involving the Commonwealth, States and Territories would assure the successful establishment of a comprehensive national scheme.[3]

5.5 To a significant extent, the shift towards a national approach is already taking place (see Part B). For example, the extension of privacy protections to cover the private sector was achieved through federal law, regulations and processes, and is overseen by the Federal Privacy Commissioner (see Chapter 7). Aspects of federal anti-discrimination law and industrial law already cover the field (see Chapters 8 and 30). Intellectual property rights in relation to genetics are determined according to federal laws and international agreements.[4]

5.6 The regulation of ‘therapeutic devices’ now has a national framework through the Therapeutic Goods Administration (TGA) (see Chapter 11). The regulation of plant and animal genetics in Australia is now the responsibility of the federal Office of the Gene Technology Regulator (OGTR).[5]

5.7 In June 2001, the Council of Australian Governments (COAG)—representing the federal, state and territory governments—agreed that it was strongly in the public interest to adopt a national approach to human cloning, stem cell research and related matters. In September 2001, a report of the House of Representatives Standing Committee on Legal and Constitutional Affairs recommended a uniform, national approach to legislation and the establishment of a national licensing body to regulate research involving embryonic stem cells and prohibit human reproductive cloning.[6] On 5 April 2002, COAG formally agreed to adopt a nationally consistent approach to legislation dealing with human cloning, stem cell research and related matters, with a national regulatory framework for the licensing and monitoring of embryonic stem cell research (under specified conditions).[7]

5.8 On 27 June 2002, the Prime Minister, the Hon John Howard MP, introduced the Research Involving Embryos and Prohibition of Human Cloning Bill 2002. The Bill subsequently was split into two and after considerable debate enacted into law as the Research Involving Human Embryos Act 2002 (Cth) and the Prohibition of Human Cloning Act 2002 (Cth). The latter creates a number of serious criminal offences, carrying maximum penalties of 10 to 15 years. The former Act also creates a number of criminal offences,[8] covering unauthorised use of an ‘excess ART embryo’.[9] However, for these purposes, the most important feature of that Act is that it establishes a new Principal Committee of the National Health and Medical Research Council (NHMRC)—the Embryo Research Licensing Committee—to regulate all research in Australia involving human embryos (including embryonic stem cells), through a national system of licensing (ss 20–28), monitoring and sanctions for breach (ss 33–41).

5.9 According to the Regulation Impact Statement tabled with the original Bill, this new national regulatory system has been necessitated by:

  • the current lack of consistency in regulatory coverage of human cloning and other unacceptable practices across the jurisdictions;

  • the absence of a comprehensive, nationally consistent system for the regulation of research involving human embryos;

  • the fundamental ethical issues posed by destruction of embryos for research and other uses;

  • the ‘uneven playing field’ for researchers created by the inconsistent regulation, which may reduce the competitiveness of some researchers relative to their counterparts in other jurisdictions; and

  • the impact that the current lack of certainty or national consistency in the regulatory environment may have on Australia’s international competitiveness.

5.10 Under the Act,[10] the Embryo Research Licensing Committee has responsibilities for administering the licensing system, maintaining a publicly available database containing information about licensed embryo research, and monitoring compliance with the legislation.[11] The Financial Impact Statement contained in the Explanatory Memorandum to the original Bill estimated that:

Following the passage of the legislation, costs are realistically expected to be approximately $3m per annum, with an upper maximum of $6m. This involves a fixed cost to support the NHMRC Licensing Committee and provide for ongoing compliance monitoring related to the prohibited practices.

Emerging Canadian approach

5.11 In Canada, which has a federal system similar to Australia’s, there also have been strong moves towards a national approach to biotechnology regulation. The Premiers of all provinces and territories have agreed to make genetics one of five priority areas for national work, and at the August 2001 Premiers Conference, Ontario committed to producing a report on genetics and human health. The resulting report, Genetics, Testing and Gene Patenting: Charting New Territory in Healthcare, was accepted unanimously at a special Premiers Conference in Vancouver in January 2002. The Report calls for concerted national action aimed at

the development of a shared vision across jurisdictions and for the development of shared resources. In short, it is a call for a comprehensive, patient-centred framework to assist jurisdictions in maximizing the benefits offered by new technologies and to set paths for collaborative work to better understand and address the risks. A comprehensive framework, if developed, could move Canada and all provinces and territories into the forefront of preparing for the impact of genetics. This preparation will need to take several forms. There is a strong need for greater public engagement, for increased capacity in our health system to incorporate change, and for examining new ways in which we regulate and protect.[12]

5.12 The Report recommended the establishment of an ‘interjurisdictional co-ordinating body’[13] or human genetics commission, along the lines of the UK Human Genetics Commission, to provide national leadership, oversight and regulation in this area:

The report urges governments to work together to ensure appropriate and comparable quality standards are in place across all jurisdictions providing genetic testing including: appropriate criteria for deciding when to test, monitoring processes for lab quality, protocols for ensuring appropriate counselling and support, and processes regarding test reviews for accuracy and reliability.

The report notes the need for appropriate capacity to monitor trends in medical genetics and assist all jurisdictions in addressing the ethical, legal and service delivery issues they will face. Stressing the need for a coordinated approach, the report suggests the possible creation of a human genetics commission to assist all jurisdictions.

The report also notes the importance of ensuring comparable quality assurance regimes and standards are in place and urges jurisdictions to cooperate in developing common approaches. In terms of federal review and approval processes, the report stresses the need for vigilance in the review and approval of new kit-based forms of genetic tests.[14]

5.13 The Canadian Government has accepted the Report as the basis for national (federal and provincial) work in genetics, and a working group (the Coordinating Committee on Genetics and Health) has been established to look at a range of implementation issues, including whether to establish the ‘interjurisdictional co-ordinating body’.

Adding a regional or international dimension?

5.14 The Inquiry’s Terms of Reference are focussed on determining the best regulatory framework for Australia, and the recommendations in this Report are geared towards that end. However, if at some time in the future the Federal Government saw an advantage in taking a regional or international approach to the protection of human genetic information, there is nothing in the pattern of recommendations that should restrict this. Some submissions to this Inquiry noted that they increasingly operate internationally, at least in terms of sharing information, expertise and experiences.[15]

5.15 For example, the Human Genetics Commission of Australia (proposed below) could be ‘regionalised’, in the same way that Food Standards Australia New Zealand[16] is a statutory authority that spans the Tasman, with responsibility for developing food standards based on scientific and technical criteria.[17] The Australian and New Zealand governments have agreed in principle to establish a single trans-Tasman body to take over the combined roles of the Australian TGA and the equivalent New Zealand body (Medsafe) in regulating therapeutic goods.[18]

5.16 Similarly, if the Australian Government considered that it was a pacesetter in this field, it could move in time to share this expertise with other countries in the region, or internationally, along the lines of the work of the Australian Centre for International Agricultural Research—a statutory authority established with a mandate to mobilise Australia’s research capacity to help solve agricultural research problems in developing countries.[19]

[2] Section 51 of the Constitution specifies the principal areas in which the Commonwealth Parliament may legislate, such as with respect to interstate and international trade and commerce, taxation, defence, immigration, insurance, and intellectual property rights.

[3] There are a number of ways in which this could be achieved, ranging from a referral of powers to the adoption of uniform laws by each jurisdiction. The recent difficulties of achieving a national approach to corporate regulation that also survives constitutional scrutiny by the High Court indicates the traps in this area. See Re Wakim; Ex parte McNally (1999) 198 CLR 511.

[4] Especially the Patents Act 1990 (Cth) and the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS) annexed to the Marrakesh Agreement Establishing the World Trade Organization, 15 April 1994, ATS 8, (entered into force on 1 January 1995), which Australia incorporated into domestic law with the Patents (World Trade Organization Amendments) Act 1994 (Cth). See Australian Law Reform Commission and Australian Health Ethics Committee, Protection of Human Genetic Information, IP 26 (2001), ALRC, Sydney [1.65]–[1.78]. As discussed in Ch 1, the ALRC has received separate terms of reference to inquire into Intellectual Property Rights over Genetic Materials and Genetic Related Technologies, with special reference to human health.

[5] See Australian Law Reform Commission and Australian Health Ethics Committee, Protection of Human Genetic Information, DP 66 (2002), ALRC, Sydney [3.13]–[3.29] for a description of the role, structure and powers of the OGTR.

[6] House of Representatives Standing Committee on Legal and Constitutional Affairs, Human Cloning: Scientific, Ethical and Regulatory Aspects of Human Cloning and Stem Cell Research (2001), Parliament of the Commonwealth of Australia, Canberra.

[7] M Metherell and D Smith, ‘Stem-cell Go-ahead as PM Gives Way’, The Sydney Morning Herald, 6 April 2002, 1; J Kerin, ‘States Agree to PM’s Stem-cell Limits’, The Australian (Sydney), 6 April 2002, 4.

[8] See ss 10–12.

[9] As defined in s 9.

[10] See ss 14–15 regarding the functions and powers of the Embryo Research Licensing Committee.

[11] See ss 33–41.

[12] Province of Ontario, Report to Premiers — Genetics, Testing and Gene Patenting: Charting New Territory in Healthcare, <>, 20 February 2003.

[13] Ibid, Recommendations 14–15, xxi.

[14] Ibid, iv.

[15] See, for example, Association of Genetic Support of Australasia, Submission G284, 25 December 2002.

[16] Previously known as the Australia New Zealand Food Authority, established under the Australia New Zealand Food Authority Act 1991 (Cth).

[17] Parliamentary Secretary to the Federal Minister for Health and Ageing, New Food Standards Australia New Zealand Launched, <>, 20 February 2003.

[18] See Therapeutic Good Administration and Medsafe, A Proposal for a Trans Tasman Agency to Regulate Therapeutic Goods, <>, 20 February 2003.

[19]Australian Centre for International Agricultural Research Act 1982 (Cth). See also Australian Centre for International Agricultural Research, About ACIAR, <>, 20 February 2003.