Law reform in times of rapid scientific change

4.18 A critical issue for this Inquiry is how to make today’s law reform relevant to the scientific developments of tomorrow. The importance and the difficulty of achieving this was a common theme in submissions made to the Inquiry. For example, Louise Martinovic submitted:

There is widespread community concern that as developments in [human genetics] are occurring rapidly, the law will ‘fall behind’ and not be able to adequately protect the privacy of the individual against inappropriate discriminatory use of their genetic information.^[39]

4.19 Graham Whittaker identified the need for sound prediction and flexible solutions:

We are informed that the results of the current Human Genome Project and subsequent research, also building on existing knowledge, are likely to produce more rapid advances in human genetic technology than have hitherto been achieved. A number of experts have attempted to speculate about future developments, but the future is impossible to predict and so changes to legislation etc need to be a best effort to suit what is most likely to occur, and to allow dynamic modifications.^[40]

4.20 Similarly, the Office of the Federal Privacy Commissioner (OFPC) stated that:

It is vital for Australia as a competitive and forward-thinking nation that the institutional measures, which are proposed for the protection of genetic privacy, are capable of accommodating genetic and technological developments and their pace of change.^[41]

4.21 The Inquiry is conscious of the need for law reform to be sensitive to the dynamic environment in which medical, scientific and technological developments are taking place in the field of human genetics. That environment includes extensive debate about the impact of developing knowledge of genetic information on how we see ourselves as individuals, as family members and as citizens. The values that inform and found the ethics of our society are likely to be challenged by such new developments. Remaining open to these challenges is an essential part of this dynamic environment.

4.22 Below the Inquiry identifies seven attributes of the reform process, which are aimed at ensuring that the recommendations in this Report meet the needs that are likely to arise in the short to medium term. Prognostication may be more art than science. However, as a leading futurist has suggested, the purpose of thinking ahead in this fashion is not to provide an accurate picture of tomorrow but to improve decision making in the present.^[42]

4.23 In summary, it is the Inquiry’s view that governments and other public institutions should be sensitive to the dynamic environment in which medical, scientific and technological developments are taking place in the field of human genetics, when they consider proposals to reform laws, codes, guidelines and practices relating to human genetic information. In particular, and as discussed further below, governments and other public institutions should:

• Promote widespread community participation in the formulation of relevant rules and principles;
• Find appropriate balances between competing interests;
• Adopt processes that facilitate contributions from all relevant disciplines;
• Consider the cross-border implications of the issues, whether they be federal or international in character;
• Consider forms of regulation that are flexible and quick to adapt to changing circumstances;
• Seek simple and effective regulation through greater harmonisation of the regulatory regimes in different jurisdictions; and
• Establish and maintain such institutions as are appropriate to address, on an on-going basis, issues relating to the use and protection of human genetic information.

Widespread community participation

4.24 In IP 26, the Inquiry noted that public optimism about the potential benefits flowing from advances in human genetics is tempered by concerns arising from rapid change. The Inquiry stated that:

On the one hand, there is very strong public support for breakthroughs promising better medical diagnosis and treatments, and for assisting with law enforcement (including identification of missing persons); on the other, there is some general fear about uncontrolled or ‘mad science’, the spectre of eugenics, threats of biological warfare, reports of xenotransplantation (transplants from one species to another), the loss of privacy, and the increased possibilities for genetic discrimination.^[43]

4.25 The Inquiry also noted that a federal government agency, Biotechnology Australia, had commissioned a study of public attitudes to biotechnology, which reported as follows:

Most respondents felt that biotechnology is changing at such a rapid pace that developments cannot possibly be anticipated and legislated against. In addition, it was generally felt that Australian society and government are powerless compared to the international financial and political power of the large multinational companies driving biotechnological innovations. A key component of concern was the perception that there are no or inadequate controls over the process, motivations and outcomes of the development and application [of] biotechnology and gene technology in Australia. This was particularly a concern for those applications which were seen to raise complex, and disturbing questions about human life.^[44]

4.26 The Inquiry considers it necessary to ensure broad public consultation and community participation in any reform process if public concerns about human genetics are to be adequately addressed. Community engagement has been fundamental to the methodology of the Australian Law Reform Commission since its inception, just as public consultation is integral to the work of the Australian Health Ethics Committee (AHEC) and the National Health and Medical Research Council (NHMRC). As indicated in Chapter 1, that methodology has been followed in the present Inquiry, with the holding of a large number of public meetings; widespread dissemination of IP 26, DP 66 and genetics brochures; participation in numerous public forums on genetics; and receipt and consideration of over 310 public submissions. Similar principles should also be applied to any processes of on-going review that are established as a result of this Report.

4.27 The Inquiry believes that open and accountable processes that engage with the public are essential for several reasons.^[45] They are beneficial:

• for those consulted, because they facilitate civic participation and have a valuable educative function in an area of science that requires lifelong learning;
• for the process of law reform, because those with day-to-day experience of the law can indicate how law and practice actually affect them; and
• for reform outcomes, because laws, codes and guidelines are more effective when the people who will be regulated by them participate in their formulation.

4.28 Widespread community participation in the process of reform or review is thus seen by the Inquiry as essential to maintaining public trust.

Balance and compromise

4.29 A second attribute to consider when seeking longevity of reform proposals is the need for balance and compromise. At the outset, the Inquiry identified a major challenge as finding a ‘sensible path’ through conflicting public concerns with respect to genetic information.^[46] The balance is difficult to achieve in practice because relevant interests often compete or clash. This is evident in the submissions received on many issues considered in this Report.

4.30 One example is the conflict between the interests of genetic researchers, who need to secure the participation of many data subjects, and the interests of potential volunteers, who may fear that their participation will generate personal information that subsequently may have to be disclosed to insurers, employers or others. Another example is the conflict between the interests of employers, who must fulfil their common law and statutory duties to provide a healthy and safe work environment for their employees, and the interests of employees, who may fear adverse discrimination because of a genetic susceptibility to a disease triggered, for example, by exposure to hazardous substances in the workplace.

4.31 The need to balance interests has been recognised in the approach of similar bodies overseas. In the Foreword to a report of the United Kingdom Human Genetics Commission, Baroness Helena Kennedy remarked:

In the subtitle of this report we talk of balancing interests. This is an important aspect of our work. I am very much aware of the fact that people approach this issue of personal genetic information from varying perspectives. We have tried here to take account of a wide spectrum of views and have attempted to reach conclusions which are morally defensible and sensitive to the different interests involved.^[47]

4.32 In similar vein, the NSW Health Department stated that:

It is important that there is a mechanism to ensure that law reform, codes of practice and guidelines are sensitive and flexible enough to be effective in the dynamic environment of human genetics; and that there is balance and compromise between individual and societal rights, concerning genetic information in the community, medical profession, researchers, businesses and governments.^[48]

4.33 The Inquiry considers that black and white solutions to the complex problems thrown up by human genetics will rarely be appropriate. However, the precise balance to be struck between competing interests need not be the same for all time, nor for all societies. Moreover, a finely-tailored solution need not subjugate one group’s interests to advance those of another: an appropriate balance may be mutually beneficial. The Anti-Discrimination Board of NSW made this point in its submission when addressing the potentially competing interests of medical researchers and data subjects in the regulation of human research.

Fear of genetic discrimination is also likely to impact upon people’s willingness to participate in research. … Rather than acting as an impediment to the development and application of genetic technology, effective anti-discrimination and privacy legislation are critical to realising the public health benefits of genetic information. Conversely, if we fail to provide such protection, discrimination and privacy concerns will act as disincentives to testing and research participation and have negative consequences for individual and public health outcomes.^[49]

4.34 There is a wealth of policies and ethical pronouncements from international agencies and NGOs that readily use general terms like ‘fairness’, ‘equity’, ‘reciprocity’, ‘justice’ and ‘non-discrimination’. No one could possibly argue with such principles nor the sentiments underlying them. However, the real difficulty comes in making the choices involved in balancing legitimate but competing interests in practice. These difficulties include taking into account the reality of the high costs of medical and scientific research and of clinical trials; the current general preference of governments in industrialised countries (including Australia) for market solutions; the trends toward and pressures of privatisation, corporatisation, and commercialisation in such countries; and the limited resources and pools of expertise available for formal regulatory authorities.

Interdisciplinary approach

4.35 A third attribute of successful reform for the future is maintaining an interdisciplinary approach to the issues. The subject matter of this Inquiry is a unique fusion of law, health ethics, and medical and related sciences. This is reflected in the identity of the partners to the joint inquiry (the ALRC and AHEC); the expertise of their respective members and staffs; the portfolios of the Ministers to whom the Inquiry has reported (the Attorney-General and the Minister for Health and Ageing); the composition of the Advisory Committee;^[50] the diversity of individuals and organisations with whom consultations have been conducted; and the range of submissions.

4.36 The importance of contributions from people with differing interests and perspectives was echoed in a number of submissions. For example, in the course of rejecting the suggestion that the disclosure of genetic information to a patient’s relatives should be left in the hands of professional medical opinion, the OFPC commented that this approach fails to consider that:

the need to accommodate a range of competing interests calls for input from a number of disciplines, such as the law, science, ethics as well as health care.^[51]

4.37 The Office of the Victorian Privacy Commissioner stated that it

strongly supports the efforts of the Inquiry to engage the interest of a wide range of disciplines and to deepen community engagement in the issues raised by developments in genetics. These issues are profound. They will require the participation of specialists from a range of varied disciplines and the views of non-specialists if the laws and policies adopted are to be perceived as legitimate.^[52]

4.38 In the Inquiry’s view, successful law reform now and in the future requires that an interdisciplinary approach to these issues be maintained.

Global perspective

4.39 Medical science and health ethics are international disciplines and do not conform to state or national boundaries. For this reason, policy makers in the field of human genetics need to be mindful of the implications of proposals in an increasingly borderless world. In practice, the capacity for transborder transactions may limit the capacity to regulate certain kinds of conduct.

4.40 For example, in Chapters 11 and 35 the Inquiry addresses the regulation of human genetic testing, including parentage testing. At present, parentage testing is available from Australian laboratories, which may or may not be accredited according to Australian standards, and from overseas laboratories, which may or may not be accredited in accordance with the standards prevailing in those foreign jurisdictions. If parentage testing is heavily regulated in Australia, one consequence may be to encourage people to use the less regulated facilities of overseas laboratories, whose services are often marketed over the Internet. Similarly, if the conditions for medical research in Australia are excessively stringent, research facilities may move offshore to sites that are more conducive to their particular brand of research, or Australian researchers may be denied participation in international multi-centre research studies. Reflecting the latter concern, the Queensland Government commented that:

With the prevalence now of global sharing of research information, it is essential that the privacy of individuals’ genetic information and tissues samples be protected. However, provisions limiting the transborder flow of human genetic samples and information must be balanced against the possibility of excluding Australian researchers from the benefits of international collaboration and information sharing.^[53]

4.41 This is not to suggest that Australia should adopt the standards of the lowest common denominator by participating in a ‘race to the bottom’. Rather, it is to call attention to the global environment in which information, people, goods and services may move across borders, whether interstate or international. It is also to call attention to the fact that maintaining high legal and ethical standards in Australia with respect to human genetic information cannot prevent other jurisdictions from developing standards that may not comport with those at home.

4.42 In some contexts international rules are being developed to promote the observance of minimum standards in the protection of human genetic information. In 1997 the United Nations Educational Scientific and Cultural Organisation (UNESCO) adopted the Universal Declaration on the Human Genome and Human Rights. The Declaration seeks to establish high-order principles and is not binding on member States. An example of a binding instrument (though of no direct relevance to Australia) is the Council of Europe’s Convention on Human Rights and Biomedicine, which seeks to

protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine.^[54]

4.43 The Inquiry has investigated the approaches taken in a number of overseas jurisdictions to the protection of human genetic information. The Inquiry has held consultations in Australia with visiting foreign officials, including the Chair of UNESCO’s International Bioethics Committee. The Inquiry has also held consultations in a number of European countries with organisations relevant to medical ethics, insurance, employees, employers, privacy and data protection, and these have been supplemented by consultations in the United Kingdom, Canada and the United States.

4.44 The Inquiry considers that future regulation of human genetic information should be sensitive to this global environment. An examination of relevant developments in other jurisdictions enables informed choices to be made for Australia based on international best practice in the field. One submission suggested that Australia could itself promote world best practice by taking

a lead role in engendering the international harmonization of innovative genetic research practice through developing policy and regulatory frameworks under the umbrella of ‘Good Genetic Research Practice Guidelines’.^[55]

Flexible regulation

4.45 Many submissions to the Inquiry identified a critical ingredient in the regulation of human genetic information—the need for flexible mechanisms that are capable of adapting with appropriate speed to on-going developments in genetic science and medicine.

4.46 The following quotations are representative of a widespread concern among those who made submissions to the Inquiry:

We must avoid placing unrealistic expectations on legislative solutions as they are by no means a universal panacea. We need to be mindful that there are also some drawbacks to a fixed legislative approach, particularly in an area which is undergoing rapid change.^[56]

Any legislation is likely to be inadequate to deal with the rapid changes in the area of genetic information. Therefore there needs to be constant surveillance of the ethical, privacy and discrimination issues.^[57]

[The Australian Academy of Science] also notes 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.^[58]

The NHMRC Guidelines do not have the same legal effect as legislation; they are not binding. The guidelines do however, have the advantage of being capable of rapid amendment and are therefore considered by some to be a better option for regulation than the enactment of ‘genetic specific’ legislation.^[59]

[The Investment and Financial Services Association] recommends that the industry be regulated by a mandatory Industry Standard, rather than legislation, as a Standard can be rapidly updated in line with scientific advances and changes in community attitudes.^[60]

4.47 The Inquiry considers that there will be circumstances in which legislative solutions are entirely appropriate in setting benchmarks that are binding, enforceable and visible in protecting human genetic information. Accordingly, many recommendations in this Report suggest amendments to existing legislative regimes in order to afford better protection to human genetic information. However, the Inquiry generally endorses the view expressed in the above submissions in so far as they call for an awareness of the drawbacks of legislation in responding to the need for reform in circumstances of rapid advances in science and technology. Although it is not possible to endorse a particular regulatory solution in advance for all circumstances, the Inquiry’s recommendations recognise the need for a range of flexible solutions, including guidelines, codes of practice and better education. In these situations, the ethical foundations of that regulation will be clear because they reflect an accepted balance of values and principles.

4.48 It may also be appropriate in some circumstances to adopt co-regulatory approaches, where legislation establishes a basic framework supplemented by more detailed industry or professional codes. The Privacy Act 1988 (Cth) provides one such model, with its National Privacy Principles (NPPs) promulgated by the OFPC; its approved (organisation-based) privacy codes; and the possibility of exemptions pursuant to the OFPC’s public interest determinations.^[61]

4.49 The importance of flexibility also suggests that it is desirable to undertake periodic review of this area to ensure that laws and practices meet society’s needs as human genetics develops.

Simplified and harmonised regulation

4.50 During the course of the Inquiry, the ALRC and AHEC have investigated a number of regulatory regimes that are based on state or territory law, either alone or in combination with federal law. In some cases these regimes seek to achieve similar goals by similar means; in others the goals or the means differ from one jurisdiction to another. Some regulatory regimes have been formulated as the result of a deliberate policy of intergovernmental co-operation; in others the regimes have arisen in a piecemeal fashion as one jurisdiction models the practices of another, or pursues its own innovations. Examples of the legislative schemes considered in this Report include laws on:

• Information and health privacy;
• Anti-discrimination;
• Human tissue used for transplantation;
• Occupational health and safety;
• Workers’ compensation; and
• Forensic procedures.

4.51 Many consultations and submissions voiced considerable concern, bordering sometimes on dismay, about the diversity between jurisdictions in the regulation of similar activity. For example, in relation to information and health privacy legislation, the Commonwealth Attorney-General’s Department remarked on the practical difficulties that arise when organisations are required to comply with a number of related but conflicting laws:

It leads to greater expense when they have to seek professional advice regarding their legal obligations and implement different procedures for compliance. Where relevant it can also lead to forum shopping by consumers in relation to complaint-handling. This is an unsatisfactory situation and should be avoided by having national standards where possible.^[62]

4.52 In relation to forensic procedures legislation, the Office of the Victorian Privacy Commissioner noted that

At a minimum, the development of statutory models around the country reveals that uniformity is lacking. This raises obvious concerns, particularly in relation to the national pooling of DNA data. The quality and security of the stored data will only be as good as the weakest safeguards among the various participants.^[63]

4.53 The divergence between federal, state and territory regimes is an inevitable consequence of a federal system of government. Such a system has compensating advantages: it facilitates innovation and experimentation, and it avoids an undue concentration of power in one level of government. However, the real costs of divergence can be seen in the duplication, gaps and inconsistencies in the regulation of a variety of conduct relevant to the protection of human genetic information. This often leads to confusion amongst those to whom the laws are directed and it may ultimately undermine the willingness of individuals to observe the law.

4.54 With these considerations in mind, the Inquiry believes that effective protection of human genetic information will require the worst disparities between jurisdictions to be eliminated over time. Processes will also have to be put in place to seek greater inter-governmental cooperation in relevant areas. Subsequent chapters of this Report address the need for harmonisation in particular contexts such as information and health privacy legislation (Chapter 7), anti-discrimination law (Chapter 9), and forensic procedures legislation (Chapter 40).

Appropriate institutions

4.55 The Inquiry believes that in order for reform to be successful in meeting the challenges of the future, it is essential to establish and maintain appropriate institutions. Bodies like the ALRC and AHEC have an important function to perform in developing a policy framework for protecting human genetic information. However, the present Inquiry is limited by its Terms of Reference: the completion of the present Report signals the end of the Inquiry’s formal function in relation to this project. The ALRC, in particular, is limited by its constituting Act to reporting on matters referred to it by the Attorney-General.^[64]

4.56 However, advances in scientific knowledge will continue apace, requiring social and political responses. In Chapter 5 the Inquiry proposes the establishment of a standing body, which would have a continuing role in advising government on all aspects of human genetic science, as developments occur. Such a body has been established already in the United Kingdom, under the name of the Human Genetics Commission,^[65] and in the Canadian province of Ontario, under the name of the Advisory Committee on Genetics. As Chapter 5 indicates, there has been broad support in submissions to the Inquiry for the establishment of such a body in Australia, with many of the submissions linking the need for a standing body to the challenges posed by rapidly changing science.