A Human Genetics Commission of Australia

Is there a need?

5.36 It may be that there once was a time when the suggested solution to every significant social issue was the establishment of a specialised agency or tribunal to deal with that issue. However, as a general matter, it is now the ALRC’s strong preference to utilise or build upon existing institutions wherever possible, and the Commission

is reluctant to recommend the establishment of a new body if the functions envisaged for [it] could be as efficiently and effectively carried out by existing agencies.^[35]

5.37 However, it is sometimes the case that the establishment of a new federal body is necessary and desirable,^[36] such as where:

• there are no plausible institutional alternatives, even with a re-arrangement of functions or an addition of budget and staff for an existing body;
• such action represents an efficient and effective use of public funds; and
• the federal government has, or wants to have, a stake in the area and can contribute positively by providing leadership or coordination at the national level.

5.38 Everything written and said about emerging genetic science and technology—including in the public meetings of, and submissions to, the Inquiry—emphasises the rapid speed at which developments are taking place.

5.39 In IP 26, the Inquiry noted that:

The pace of biotechnological change equally affects Australia, and Australian governments arguably have the same need for ready access to the best possible advice about current and potential developments in human genetics and their implications for health care and human rights. … [T]here is a continuing need for our laws, and the fundamental concepts underlying those laws, to be reviewed and revised to address advances made by human genetic science and technology. However, no such standing body on human genetics currently exists in Australia.^[38]

5.40 In the case of human genetics, the pace of change challenges the capacity of governments to develop sound policy and put in place effective regulatory strategies—although the same agreement could be made, for example, in relation to new information and communications technologies, the growth of the internet and related e‑commerce applications. However, the ‘new genetics’ also contains special and further challenges for the way in which our society defines the ‘normal’, and the fundamental way in which people think about themselves and their own humanity.

5.41 In 2002, the American political philosopher Francis Fukuyama^[39] wrote that:

Some new technologies are frightening from the start, and the need to establish political controls over their development and use is obvious to all. When the first atomic bomb was detonated at Alamogordo, New Mexico, in the summer of 1945, not one of the witnesses to this event failed to understand that a terrible new potential for destruction had been created. Nuclear weapons were thus from the very beginning ringed with political controls. Individuals could not freely develop nuclear technology on their own or traffic in the parts necessary to create atomic bombs, and in time, nations that became signatories to the 1968 non-proliferation treaty agreed to control international trade in nuclear technology.

Other new technologies appear to be much more benign, and are consequently subject to little or no regulation. Personal computers and the Internet, for example, promised to create wealth, increase access to information, and foster community among their users. …

Biotechnology falls somewhere between these extremes. Transgenic crops and human genetic engineering make people far more uneasy than do personal computers or the Internet. But biotechnology also promises important benefits for human health and well-being. When presented with an advance like the ability to cure cystic fibrosis or diabetes, it is hard for people to articulate reasons why their unease with the technology should stand in the way of progress. It is easiest to object to a new biotechnology if its development leads to a botched clinical trial or to a deadly allergic reaction to a genetically modified food. But the real threat of biotechnology is far more subtle and therefore harder to weigh in any utilitarian calculus. It lies in the possibilities of human cloning, ‘designer babies’—eugenic selection for intelligence, sex, and personality—and eventually, the end of the human species as such.

In the face of the challenge from a technology like this, where good and bad are intimately connected, there can be only one possible response: We must regulate its development—and set up institutions that will discriminate between those technological advances that further human flourishing, and those that pose a threat to human dignity and well-being. These regulatory institutions must have the power to enforce these discriminations on a national and, ultimately, an international level.^[40]

5.42 Fukuyama—an unlikely champion of heavy-handed regulation, given his previous writings—went on to suggest that the new biotechnology raises so many challenges to the survival of society as we know it that formal regulation is required.

It has been a long time since anyone has proposed that what the world needs is more regulation. Regulation—and particularly international regulation—is not something that should be called for lightly. Before the Reagan-Thatcher revolutions of the 1980s, many sectors of the economies of North America, Europe, and Japan were vastly overregulated, and many continue to be so today. Regulation brings with it many inefficiencies and even pathologies. … But in the end, there are certain types of social problems that can only be addressed through formal government control. … Many people today believe that biotechnology should not and cannot, as a practical matter, be controlled. Both of these conclusions are wrong … .^[41]

5.43 As noted above, Australian governments have chosen to take direct, concerted action to prohibit various activities, such as human reproductive cloning, and have proposed giving the new regulator, the Embryo Research Licensing Committee of the NHMRC, strong powers, with serious criminal penalties attaching to any intentional breach.

5.44 However, this Inquiry is concerned primarily with protecting individuals against the adverse effects of the misuse of genetic information (loss of privacy, unfair discrimination) and of unethical practices (loss of autonomy), rather than the potential direct threat to the future of the human genome that may be occasioned by certain types of experimentation. The balanced strategy the Inquiry is proposing relies more on providing high level advice to government policy-makers, and putting in place measures to ensure more careful and intelligent handling of genetic information and samples, with a number of targeted interventions in certain cases where the potential harm from the misuse or misunderstanding of genetic information is great, and the impositions are minor by comparison (for example, in most employment circumstances).

5.45 There is thus a critical need to ensure that the general community is much better informed about genetics and human health, and disabused of unbalanced notions of genetic determinism. While there is currently strong public support for genetic research, there is always the danger of a backlash if the promise of such work is over-sold or poorly understood. An editorial in the British Medical Journal in 2002 put the case well:

Over time, the tendency has been to expand diagnostic and treatment boundaries, and to include in the ‘disease’ category people with milder manifestations of pathology and lower levels of risk. Genetic tests for markers that may not result in symptoms for half a century or more could be new examples of a process of premature medicalisation of attaching the ‘disease’ label before it has been established that prevention or treatment is clearly beneficial. Treating the presence of a genetic marker as though it were the clinical disease can be very unhelpful. …

Unless it is established that a genetic variant is a pointer to beneficial action, there is a potential for inappropriate medicalisation through the spread of poorly understood tests. The perceptions of risk resulting from such tests may bear little relation to the scientific facts and uncertainties. Inflated ideas about risks could result in people carrying such polymorphisms being treated unfairly in many areas, including employment or insurance. …

The antidote to genetics as a driver of medicalisation lies in remaining sceptical and level headed. Genetic claims, tests, and products should be treated in the same way that other medical markers and interventions are increasingly treated: with rigorous evaluation. The successful management of genetic medicalisation will depend on clinical evaluation, integrity, and transparency and on providing accurate information to consumers and patients. Public education about interventions based on genetic science will also be needed to prevent inappropriate social responses that may either lead to discrimination or, conversely, prohibit the adoption of tests and treatments that can reduce or prevent disability. Genetic technologies have the potential to be of major benefit to society, but their introduction must be measured, attentive to the social and ethical considerations of the day, and, most importantly, based on best evidence.^[42]

5.46 Later in this chapter, the enhancement of public and professional education about human genetics is assigned to the proposed new Human Genetics Commission of Australia as one of its areas of shared responsibility.

Submissions following IP 26

5.47 In IP 26 the Inquiry asked whether we need ‘our own version’ of the UK’s HGC.^[43] The submissions strongly favoured such an approach on its own merits, as well as by way of contrast with the alternative of trying to develop legislative or regulatory prescriptions in a timely fashion. Common key points included the rapid pace of change in genetic science; the need for high level, independent advice in this area for governments, health care professionals, industry and individuals; and the need for an agency that would promote a consistent, national approach to the many important issues.

5.48 The Commonwealth Department of Health and Ageing submitted that:

A national mechanism or ‘standing body’ may be helpful in ensuring the provision of integrated advice to government on a range of human genetic matters. …

All jurisdictions are grappling with the issues relating to the protection of health information generally. Given the potential to create a ‘railway gauge’ scenario of differing legislative regimes across jurisdictions, the Department strongly supports the adoption of a nationally consistent approach to the protection of health (including genetic) information. Notwithstanding the moves in this direction with federal privacy legislation, there is a need for national coordination and leadership in developing standards, guidelines, and codes of conduct, particularly in relation to the commercial uses of genetic information.

The NHMRC, through its Research Committee, Health Advisory Committee and AHEC, has important responsibilities in advising government in relation to public health standards, medical and public health research, and ethics. The AHMAC [Australian Health Ministers Advisory Council] has established a number of important mechanisms for developing national approaches to health care issues. Notwithstanding the valuable contributions of these existing advisory mechanisms, the Department notes that a national mechanism or ‘standing body’ may be helpful to coordinate government advice and policy development on the complex issues raised by the rapid developments in human genetic information and technologies.

The recently established UK Human Genetics Commission and the breadth of matters within its purview provides one possible model that could be examined. Such a body could support a coordinated national effort to ensure that the potential benefits of emerging technological advances, particularly in relation to health, are realised for both individuals and the public while minimising any potential risks.^[44]

5.49 The Human Genetics Society of Australasia (HGSA), whose membership comprises clinical geneticists and those practising in laboratory-based human genetics in Australasia, wrote that:

The HGSA believes an independent Genetic Advisory Committee should be established to advise the Government in relation to the use of genetic testing in insurance and employment. There may also be a role for such a committee to provide ongoing advice to the Government on the complex issues, which will continue to arise from the rapidly evolving field of human genetics. It is recognised that existing government committees and working groups are considering various aspects of the impact of genetics in the health care system, and may make similar recommendations in the future. This committee might be envisaged to have a similar role to the UK Human Genetics Commission (HGC). The HGC was established following a comprehensive review of the regulatory and advisory framework of biotechnology. Its aim is to be transparent, in order to gain public and professional confidence; be streamlined, in order to avoid gaps, overlaps and fragmentation; ensure capacity to deal with rapid developments, and to take broad social and ethical issues fully into account within the field of human genetics.^[45]

5.50 The Australian Academy of Science noted that

this area of research is moving very quickly, and that laws can be difficult to amend if they no longer reflect the state of scientific knowledge and medical practice. Therefore, we urge the creation of an Australian Standing Advisory Body with both public and professional representatives to regulate issues in this area, similar to the UK Human Genetics Commission.^[46]

5.51 The Genetics Advisory Committee of the Victorian Department of Human Services supported the establishment of a standing body

to advise government on all aspects of human genetics, not just regulation/privacy. These issues could be viewed as a subset of the need to have national uniformity in population screening tests, indications and availability of other genetic tests, indications and availability of other genetic tests (eg whether through Medicare subsidy or through specific programs which receive block funding, eg the Family Cancer Genetics Service), a national approach to better information and training for health professionals as well as information to the public.^[47]

5.52 The Association of Genetic Support of Australasia wrote that:

We believe a standing body to advise the government on issues related to human genetics should be established. It is important that its representation includes those with skills to address the breadth of issues generated by the new developments in technology. The UK and Canada have embraced this policy, recognising the need for continued assessment of the impact of the new genetics and the need for development of new policies and the revision of old to meet new challenges.^[48]

5.53 The Australian Medical Association submitted that:

It is important that a more uniform, national approach to the protection of human genetic information is developed. This is to ensure that all Australians are afforded the same rights and protection.

The AMA believes that gene technology has the potential to revolutionise both preventative medicine and the management of a vast range of medical conditions. We are keen to see the development in this country of a framework that provides for an acceptable medical use of genetic information based not only on the best available scientific evidence but also relevant social, ethical and legal considerations. …

A standing body should be established to advise the government on issues related to human genetics. This body should have wide community representation to ensure that a diversity of opinions is considered.^[49]

5.54 The Institute of Actuaries of Australia, which has taken a strong interest in this area because of the potential effects of emerging genetic science on insurance,^[50] submitted that:

Given the very rapid progress taking place in genetics it is likely that community views will also change rapidly. New issues are likely to emerge requiring fresh thinking on suitable controls or on the continued applicability of controls that are already in place. In times of rapid change, there would be benefit to the Government in having a standing body available to alert it to matters of interest and to provide advice, this body should include consumers and experts from all interested disciplines.^[51]

5.55 Privacy NSW submitted that:

The establishment of such a body is critical, particularly whilst genetic privacy regulation in Australia remains undeveloped and as the efficacy of any new legislation is monitored. The model provided by the UK’s Human Genetics Commission includes appropriate representation in terms of expert and lay membership.^[52]

5.56 The Office of the Federal Privacy Commissioner noted that:

there is a need for a body of sufficient authority and status to serve as a focus and as a paradigm for the work of our social institutions. A multi-disciplinary body would be capable of identifying and responding to the influences of, and the interplay between, science, the health and legal professions, research and commerce. With these capacities, it would be an invaluable source of advice for government.^[53]

5.57 The Australian Privacy Charter Council wrote that:

These issues are too important to only be the subject of a one-off inquiry, however thorough. We are attracted to the idea of a standing committee or commission, properly resourced and genuinely independent, to monitor developments, and to play an adjudicative role in relation to exceptional uses, retention, data linkage etc.^[54]

5.58 Support in similar terms came from the Neurofibromatosis Association of Australia; the Australian Society for Medical Research; the New South Wales Nurses’ Association; the New South Wales Genetics Service Advisory Committee; Women’s Health Victoria; the Australian Huntington’s Disease Association (NSW); the Androgen Insensitivity Syndrome Support Group Australia; the Disability Discrimination Legal Service; the Queensland University of Technology’s Human Research Ethics Committee; Sydney IVF Limited; the National Council of Jewish Women; and a number of individuals and support groups with particular interests and experience in this area.^[55]

Submissions following DP 66

5.59 In DP 66, the Inquiry made a specific proposal that ‘a Human Genetics Commission of Australia (HGCA) should be established under federal legislation as an independent, stand-alone, statutory authority with sufficient resources to fulfil its mission’.^[56]

5.60 About 40 written submissions received in response to DP 66 directly addressed this matter, with almost all of them expressing support^[57]—often strong support—for the proposal.^[58] Other submissions assumed the establishment of an HGCA, referring to the role and importance of such a body in dealing with specific issues, such as the identification of ‘sensitive’ genetic tests, the approval of certain tests for use by the insurance industry or employers, and the enhancement of community and professional education in the area of human genetics.

5.61 The NSW Health Department submitted that:

Subject to agreement about funding arrangements the Department supports the proposal for a standing advisory body on human genetics as has been done in the UK, Canada and elsewhere. An overarching body such as the proposed Human Genetics Commission of Australia would achieve a coordinated approach to all issues. The Department notes that the regulation of gene technology with respect to plants and animals has been formalised through the Office of the Gene Technology regulator, but the same has not yet occurred with respect to human genetics.

The Department notes that the content of most of the … proposals has been, or is currently, the subject of AHMAC and NPHP Working Groups concerned with genetic testing. An overarching body such as the proposed HGCA would be preferable in achieving a coordinated approach to all issues.^[59]

5.62 The Royal College of Pathologists of Australasia submitted that:

The College wishes to lend its support to the proposal to establish the HGCA. The rapidly advancing knowledge base of human genetics will continue to pose new questions and challenges for Australian society in the years to come. The proposed HGCA will enable the work of the Commission to continue in the future, so that legislative frameworks and ethical safeguards can adapt to the social needs of the Australian community in response to these challenging issues.^[60]

5.63 Haemophilia Foundation Victoria wrote that:

As medicine and technology develop at a swift pace, it is essential that the government be advised as appropriate by a group of suitably qualified individuals who are fluent in human genetics, as well as in sociological, ethical and legal issues. HFV believes that a body such as the proposed Human Genetics Commission of Australia (HGCA) is essential to keeping governments informed regarding this dynamic, fast paced branch of science.^[61]

5.64 In submissions and consultations the Inquiry also heard strong and consistent views that there is an urgent need for a more coordinated, national approach to harmonised laws and procedures to replace the existing, confusing ‘patchwork’; for better compliance and effective regulation;^[62] and for a coordinated national approach to related bioethical issues.

5.65 The Genetic Support Network of Victoria submitted that:

It is clearly evident that in a population of small numbers separated by vast distances such as we have here in Australia, people affected by rare genetic conditions will benefit from a national organisation.^[63]

5.66 Similarly, the Department of Health and Human Services Tasmania argued that:

the key reason for having a national body from the point of view of Tasmania, and we presume other smaller States and Territories, is that we do not have the capacity to develop, assess and provide genetic health services in isolation.^[64]

5.67 The Commonwealth Department of Health and Ageing affirmed their earlier support, stating that:

Given the rapid advances in genetic technology and the wide range of social, ethical and legal issues raised by new technologies, there is a need for a robust approach to responding to new issues to ensure better health outcomes. In the view of the Department a holistic approach to dealing with new developments has the value of ensuring that emerging issues are identified and responded to in a timely manner and that overlapping issues are dealt with in a consistent manner. It is the view of the Department that it is necessary to strive for a nationally consistent approach to privacy, ethical and discrimination issues. … [T]he Department supports the establishment of a high-level advisory body to assist in these endeavours.^[65]

Establishment as a statutory authority

5.68 In the light of the consultations and submissions, the Inquiry believes that there are convincing grounds for establishing a standing body to deal with issues affecting human genetics in Australia. The Inquiry maintains its strong preference for such a body to be established as an independent, federal statutory authority, under the name of the Human Genetics Commission of Australia. Establishing the body in this form will:

• make clear its independence, and thus preserve public confidence in its findings and advice;

• encourage the public to communicate with the HGCA, even where the material is personal and sensitive and people might feel uncomfortable about communicating in this way with ‘the Government’;

• demonstrate its status as a permanent agency;

• demonstrate its status as a multidisciplinary body, whose work extends beyond a single government department;

• develop and maintain both in-house expertise and networks of experts and stakeholders;

• ensure sufficient budget resources to fulfil its mission; and

• provide it with sufficient operational flexibility to deploy its resources most effectively.

5.69 There is ample constitutional foundation for the legislation necessary to establish such a body. In common with many offices or bodies established by federal legislation (such as the OGTR and the Office of the Privacy Commissioner), the Commonwealth is able to rely on a suite of legislative powers for this purpose.^[66] For example, the HGCA’s role in relation to insurance is supported by s 51(xiv) of the Constitution (‘insurance’), and its role in immigration by s 51(xxvii) (‘immigration and emigration’). In addition, there are federal powers in relation to trade and commerce (s 51(i)), corporations (s 51(xx)) and external affairs (s 51(xxix)), to name a few.

5.70 Even in the absence of specific legislative powers, the High Court has held that the Commonwealth has an implied nationhood power, by which it may ‘engage in enterprise and activities peculiarly adapted to the government of a nation and which cannot otherwise be carried on for the benefit of the nation’.^[67] This power has been held to be a possible basis for legislation establishing the Commonwealth Scientific and Industrial Research Organisation (CSIRO) and the Australian Bicentennial Authority,^[68] and is particularly adapted to an organisation like the HGCA, which has educational and advisory functions in relation to matters of genetic science and human health. Moreover, under s 81 of the Constitution, moneys may be appropriated from Consolidated Revenue ‘for the purposes of the Commonwealth’, and this has been held to authorise the Commonwealth expending moneys ‘on inquiries, investigation and advocacy in relation to matters affecting public health, notwithstanding the absence of specific legislative power’.^[69]

5.71 Given the broad subject matter covered, the HGCA should have strong links with a number of relevant federal ministries, including the Department of Health and Ageing; the Attorney-General’s Department; Prime Minister and Cabinet; the Department of Education, Science and Training; and the Department of Employment and Workplace Relations.

5.72 However, given that statutory authorities normally are required to have a direct relationship with a particular department for budget and accountability purposes, the Inquiry agrees with the view of the Canadian authorities that this logically should be the Department of Health and Ageing. The central concerns of the HGCA will mainly relate to human health—and this is often true even where the policy advice is being applied in another context, such as employment.

5.73 As noted above, there was overwhelming support in the submissions and consultations for the proposition that the HGCA be established as an independent, statutory authority.^[70]

5.74 An alternative approach put to the Inquiry involved the establishment of the genetics advisory body as another Principal Committee of the NHMRC. In consultations, the CEO of the NHMRC, Professor Alan Pettigrew, was strongly of this view. The submission of the South Australian Department of Human Services also suggested this, noting that there are advantages in placing under the one umbrella such bodies as AHEC, the new Embryo Research Licensing Committee, and the HGCA.^[71]

5.75 Earlier in this chapter, the Inquiry noted its strong preference not to establish a new government agency where an existing one could be expanded or adapted for the purpose, unless there were compelling reasons to the contrary. However, after considerable debate, the Inquiry has firmed in its view that establishing the HGCA as a committee of the NHMRC would be less satisfactory for a number of reasons. These include the fact that:

• the need for real and perceived independence is critical to winning public confidence—in an area in which there is significant anxiety about whether scientific and medical research is being properly regulated in the public interest;

• the role envisaged for the HGCA goes well beyond traditional ‘health and medical’ concerns, and extends to a very wide array of matters, such as insurance, employment, immigration, parentage, access to services and so on;

• establishment as an NHMRC Principal Committee would mean that the HGCA would be significantly less likely to gain the necessary resources to operate full-time and establish a high profile; and

• establishment as an NHMRC Principal Committee would mean that the HGCA would be significantly less likely to maintain continuity of programs and preserve long-term corporate memory—and, similarly, would be less likely to develop and retain expertise in-house amongst its continuing staff.

5.76 The submission from the Commonwealth Department of Health and Ageing strongly supported the establishment of a high-level advisory body focussing on the rapid developments in human genetic technologies. However, while the Department agreed that such a body needs to be independent and well-resourced,

it considers that establishment as a statutory body is not appropriate. Where the advisory body recommends that new regulations are required, these could be developed in cooperation with one of the existing regulatory authorities, professional bodies or industry associations and then administered by the relevant existing authority.^[73]

5.77 The Department appears to be equating ‘statutory authority’ with ‘regulatory authority’ in the submission, which is not the intention of the Inquiry. As noted above, the Inquiry accepts the view that the HGCA should be an advisory body, leaving any regulatory functions in this area to others. However, the Inquiry remains of the view that the best way to guarantee the standing and independence of the HGCA would be through establishment under its own Act of Parliament—in much the same way that the ALRC is a federal statutory authority (but not a regulatory authority) constituted under the Australian Law Reform Commission Act 1996 (Cth).

5.78 However, the Inquiry wishes to note that if our favoured approach (see Recommendation 5–1, below) is rejected by Government, the alternative approach of establishing a body with similar functions as a new Principal Committee of the NHMRC would be far preferable to leaving Australia without any expert advisory committee at this critical time in the development of genetic science and the consequent challenges and opportunities raised for our society.