Weisbrot, David --- "Mad Science or Modern Miracles?" [2001] ALRCRefJl 17; (2001) 79 Australian Law Reform Commission Reform Journal 5

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Reform Issue 79 Spring 2001

This article appeared on pages 5 - 9 of the original journal.

Mad science or modern miracles?

The Australian Law Reform Commission (ALRC) and the Australian Health Ethics Committee (AHEC) have released the first consultation document in their joint inquiry, Protection of Human Genetic Information (ALRC Issues Paper 26).

David Weisbrot* summarises the content of the issues paper.

It is a rare day when the news media fails to contain some coverage of an exciting development or a worrying controversy (or both) arising out of genetic research and technology.

On the one hand, there is 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, the loss of privacy, and the possibilities for genetic discrimination.

In Australia, a survey commissioned for the federal government agency Biotechnology Australia in April-May 2001,¹ which updated a similar study from 1999, showed 80 per cent of the community had some level of concern about gene technology.

The same survey also revealed:

• an increased acceptance of some applications, such as testing embryos for predisposition to disease (25 per cent, from 20 per cent) and using human genes in medicines and vaccines (29 per cent, from 22 per cent);

• a decreased acceptance of using animal genes in plants (31 per cent, down from 51 per cent), or of modifying human genetic material with animal genes (44 per cent, down from 51 per cent), and an increase in the perceived risk of using human genes in animals to grow organs for transplantation (75 per cent, up from 66 per cent). Particular concern was expressed about cloning, with 58 per cent stating they believed it would make things worse in the next 20 years; and

• significant concern that screening for genes that may cause incurable diseases may lead to discrimination (59 per cent).

One of the conclusions drawn from the Biotechnology Australia survey was that:

“Most respondents felt that biotechnology is changing at such a rapid pace that developments cannot possibly be anticipated and legislated against ... 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.”²

Similar sentiments have been expressed in surveys conducted in the UK and Europe – although, with a recent history of problems involving foot and mouth disease, mad cow disease, CJD, nuclear fallout from Chernobyl, threats to pursue human cloning, and so on, Europeans are somewhat more cautious about the benefits and risks of biotechnology, and definitely more sceptical about the ability of government to regulate effectively in this area.

The joint inquiry

The major challenge for the ALRC/AHEC joint inquiry is to find a sensible path through this ambivalence to develop policies to recommend to government which meet the public appreciation of the need to foster innovations in genetic research and practice that serve humanitarian ends, while providing sufficient reassurance to the community that such innovations are subject to proper ethical scrutiny and legal control.

Although relatively easy to articulate, achieving the proper balance is difficult in practice, since various interests will compete and clash across the spectrum of activity. Some examples of these conflicting needs are outlined below.

Genetic researchers, who require ready access to a pool of research materials (tissue banks, data banks, registers and so on), ideally containing as many identifiable markers as possible to select the relevant research subjects, with the aim of making important medical discoveries (gene therapy, regenerative medicine, smart drugs) – versus the interests of the individuals whose information or tissue is held, who want to assert their right to human dignity and autonomy (requiring informed consent before use or re-use) and who need to be confident of the privacy and security of that information.

Genetic researchers, who need to be able to secure the willing and active participation of many volunteers — versus the legitimate fear of many potential volunteers that participation will generate information they may subsequently be required to disclose to insurers, employers or others.

Employers, who must act to fulfil their common law and statutory duties to provide a healthy and safe work environment for all employees — versus the fear that in so doing they may later face a law suit alleging disability discrimination.

Doctors and hospital authorities, who often must make very difficult decisions in advising about diagnostic testing, therapeutic options and the allocation of scarce resources and who might be aided in this respect by access to genetic information — versus an individual patient’s legitimate concerns about privacy and the right to consent (or not) to genetic testing and to the disclosure and use of any genetic tests results.

Insurers, who underwrite many forms of insurance policies by assessing the level of risk each person brings to the pool and may wish to use genetic test information for this purpose (in the same way that they currently use other health information, including family history) – versus the fear of applicants that they may be denied insurance or offered a policy with loadings or exclusions, as well as the problem that such a fear may lead persons to avoid genetic testing in the first place.

Current regulations

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.

Weighing up whether these various forms of regulation meet, or can be made to meet, the greater challenges thrown up by the use of new genetic technologies may well call into question some basic aspects of existing anti-discrimination and privacy laws, and ethical governance of medical research. It is beyond the terms of reference and the resources of this joint inquiry to undertake a fundamental review of the structure, philosophy and content of all of these areas. The inquiry sees its primary brief as tailoring the existing regimes, to the extent possible, to the particular needs and demands of genetic testing and information, and to recommend new forms of regulation where necessary to meet any resulting gaps.

Even where legislative action is seen as necessary, it may be more desirable to amend existing legislation, such as the Privacy Act 1988 (Cth), the Disability Discrimination Act 1992 (Cth), or National Health and Medical Research Council Act 1992 (Cth), to take account of the special characteristics of genetic information, rather than enacting legislation to deal specifically with genetic information, as distinguished from all other health and personal information. This may avoid further complicating the existing fragmented and overlapping set of federal, state and territory legislation relating to health information.

Successfully fulfilling this brief not only involves providing adequate protections against the unlawful use of genetic information, but also putting into place measures aimed at ensuring that where such information may be used lawfully, it is used properly, fairly and intelligently.

Is genetic information special?

One of the key issues for the inquiry is whether genetic information is so fundamentally different (qualitatively or quantitatively) from other forms of health information that it requires a special regime to regulate its collection, use and disclosure.

Thomas Murray, who chaired a Human Genome Project-associated Task Force on Genetic Information and Insurance, has noted that substantial information about a person’s identity and genetic make-up can be gathered for analysis from ‘the tiny bits of genetic material we scatter around us without much thought’, such as ‘the cells mixed in our saliva and the bulbs at the base of the hairs we continuously shed’ – which is also what makes it a potent force for police investigations, where the saliva on a licked postage stamp can help solve a major crime.³

However, genetic information is not only pertinent to an individual but may tell us something about close blood relatives, in both succeeding and preceding generations. For example, demonstrating that an individual is a carrier of cystic fibrosis implies that one of that person’s parents is also a carrier. In some cases, genetic information is pertinent to whole communities. For example, Tay-Sachs disease is primarily (but not exclusively) found in persons of Ashkenazi (European) Jewish descent; sickle cell anaemia primarily affects persons of black African descent; and haemochromatosis is very common in persons of northern European descent. Thus, genetic information can be said to flow ‘from before the cradle to after the grave’.

There are greater pressures to discover, gain access to and use genetic information than is the case for traditional health information. Its predictive nature makes it of particular interest in situations where information about a person’s future, even though potentially imprecise, could be incorporated into decision making by the individual and/or by others (such as employers, insurance companies or public authorities).

Further, opportunities for access to genetic information in the health sector are increased by the multidisciplinary nature of much medical practice and developments in information technology. Its novelty also creates a risk that both the information and its implications will be misunderstood or over-stated by health professionals, the families of those tested, or others in the community who have access to the information.

Developments in genetics pose ethical questions for individuals and families, as well as for society. Some arise from the nature of genes and genetic information, which are both personal and shared with family members and, in many cases, with people outside the family (eg, with members of an ethnic group).

Other questions arise from the fact that, until now, individuals and society have not had to deal with predictive information of such quantity and ostensible accuracy, and there is no considered community view about access to and use of an individual’s predictive genetic information by family members and people or organisations outside the family.

Community and professional education and the ready availability of information when needed can minimise misunderstanding of, over-reaction to, and misuse of, genetic information.

Outline of IP 26

The ALRC/AHEC issues paper is a comprehensive examination of the complex legal and ethical issues under review.

The issues paper looks at scientific developments in modern genetics, including the Human Genome Project, and some of the key issues and controversies that are emerging at this intersection of law and medicine. This material includes a basic primer on the science of genetics and genetic testing. The available advisory and regulatory approaches are also discussed in general terms.

Key issues discussed in the issues paper include:

• an account of privacy law in Australia, with special reference to health and medical records and information;

• a review of existing anti-discrimination law and practice in Australia, with special reference to the possible application of disability discrimination law to the area of genetic information, as well competing or complementary regimes governing such areas as occupational health and safety;

• the role of ethics – and specifically the sub-field of bioethics – in regulating medical research and protecting societal interests;

• the web of professional ethics, law and regulation that covers medical research involving human beings;

• the use, re-use or application of genetic information and samples in human genetic databases, including human tissue banks and the archives maintained by private pathology laboratories;

• the role of medical practitioners as frontline providers of diagnosis, interpretation, and advice to patients – including genetic testing, information and counselling;

• systemic issues in health administration raised by the creation or handling or human genetic information, including privacy protection for health records and population screening programs, such as those conducted in schools or particular communities, as well as routine newborn screens (Guthrie tests);

• the use of genetic information in employment, both in the workplace as well as in the process of applying for work; and

• the potential use of genetic testing and information for the purposes of underwriting insurance policies.

The issues paper also considers the range of areas outside of employment and insurance in which genetic information might be used to determine eligibility for, or the provision of, goods, services or entitlements. For example, should genetic information be used to determine eligibility for certain social security and training programs? Or used by hospitals to determine the allocation of scarce resources? Or used as part of immigration screening for proof of a family relationship, or the good health of an intending immigrant? Or used to prove Aboriginal or Torres Strait Islander identity? Or used by school or nursing home authorities as a factor in determining admissions? Or used by sporting bodies to determine whether a person is fit to participate?

Also under consideration are issues of principle and practice in relation to the collection, storage and use of genetic information by law enforcement authorities, including in relation to the development of the National Criminal Investigation DNA Database (NCIDD) operated by the executive agency CrimTrac. IP 26 asks a range of questions relating to the presentation and admissibility of DNA evidence in court, both in criminal matters as well as in civil proceedings (such as in relation to establishing paternity in a Family Court matter or determining the award of damages in a personal injury suit).

The future course of the inquiry

The release of the issues paper by the ALRC and AHEC signals the commencement of an intensive round of national consultations. These consultations will include open public hearings so that members of the Australian community may make submissions to the inquiry, as well as meetings with particular interest groups, industry representatives, and experts in all relevant fields. For further information on consultations, please contact the ALRC.

The feedback received from submissions and consultations will be incorporated into a second consultation document. This document – a discussion paper – will contain a more detailed and scholarly treatment of the issues under review and indicate the inquiry’s thinking in the form of specific reform options, to which the community can respond.

The final report is scheduled to be presented to the Attorney-General and the Minister for Health and Aged Care in 2001.

* Professor David Weisbrot is the President of the Australian Law Reform Commission. He is leading the ALRC/AHEC reference into the protection of human genetic information.

Endnotes

1. Millward Brown (for Biotechnology Australia) Biotechnology Public Awareness Survey Final Report (July 2001) published at <www.biotechnology.gov.au/

MBsurveyresults.pdf>.

2. Ibid, at 29.

3. T Murray ‘Genetic Exceptionalism and “Future Diaries”: Is Genetic Information Different from Other Medical Information?’ in M Rothstein (ed) Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era (1997) Yale University Press, New Haven, 60.