Legal control over personal genetic data: how far should we go?

Public and legislative debate about the misuse of personal information and data has been building for the best part of the past twenty years. Technological developments making the collection, storage and use of information easier have increased public awareness and concern about the need for privacy.

A number of common laws provide incidental privacy protection for Australians, and so-called privacy rights are reflected under international conventions which Australia recognises, namely Article 12 of the Universal declaration of Human Rights (1948) and Article 17 of the International Convenant on Civil and political Rights (1966) which provides:

. . .no one shall be subject to arbitrary or unlawful interference with his [or her] privacy.

A privacy right of this scope should form the basis of the protection and legal control over the use of personal information in Australia and provide the basis of a comprehensive domestic legal privacy regime.

Personal information should be protected through a comprehensive and national enforceable regime. As a legislator I believe in the fundamental principle that a person has the right to know what personal information is held about them, whether the information is lawfully held and whether or not that information is correct.

Genetic technology, one of the great revolutions in medicine (as the headlines say) is now on its way to a clinic near you. The US$3billion federally funded Human Genome Project, completed only a few months ago already provides the map from which phenotypes (diseased, behavioral or otherwise) and genetic sequences will be linked.

Genetic information will pose some of the most challenging public policy and legislative questions over the coming years, as we struggle to ensure that the potentially positive aspects of this information revolution are encouraged and pursued and that the community is protected from possible negative applications.

But these already challenging decisions and questions are further complicated by the fact that the information provided by genetic testing will not always be as accurate as expected.

Genetic testing may be for a condition that might never fully express itself as a disease, or express itself only in a reduced form of the disease.

The quality of genetic information, that is its predictive nature and its application extends beyond the individual to blood relatives are two of the fundamental distinctions that set it apart and provide a special case, setting it apart from other sensitive health information.

I introduced my Genetic Privacy and Non-Discrimination Bill in 1998, first and foremost to stimulate debate, highlight pressing concerns and provide policy initiatives to the Federal Government on an issue which had not been considered in any extensive capacity by the Federal Parliament: the appropriate use and protection of genetic information.

Existing regulation in Australia dealing with genetic privacy and non-discrimination relies on a number of Commonwealth, State and Territory legislative instruments, self-regulatory guidelines and the common law.

Despite this multifaceted approach, there is no legislation dealing specifically with genetic privacy and non-discrimination and there are a range of sectors in Australia which are not regulated and have no requirements to conform to any privacy or non-discrimination practices. The existing regulations to which I refer applied to about 30 per cent of medical research funded in Australia at the time that I introduced my Bill.

I am of the view that genetic privacy (and genetic discrimination) is best dealt with in a comprehensive privacy scheme. The debate has moved on considerably since I first introduced my bill, though it was never intended to stand without broader privacy issues being addressed. It was instead a contribution to the ongoing debate about privacy and related issues.

My Bill was based on the Boston University School of Public Health’s Genetic Privacy Act introduced into the US congress on 11 March 1997. It establishes, first and foremost, that all samples collected for genetic testing must be undertaken with informed consent.

To facilitate the attainment of informed consent for the collection of a DNA sample, the Bill recognises that counselling should be a key component of any genetic testing for the individual and ensures that counselling will be available. If counselling is not available the Bill ensures that this will be highlighted in every case.

The Bill also includes special provisions for genetic information and samples for research purposes to be regulated with special consideration.

The Bill acts further to outlaw genetic discrimination – as the name implies – except in certain circumstances, such as cases of positive discrimination in the workplace. For example, the use of chromosome screening in certain potentially dangerous workplaces such as a plant that uses potentially carcinogenic chemicals.

It recommends that penalties should be imposed for breaches of privacy and for discrimination and recommends that a body be established for complaints, investigation and enforcement of privacy breeches and discrimination and names the Human Rights and Equal Opportunity Commission under the Privacy Act 1988 and the Disability Discrimination Act 1992 (Cth) as the most appropriate bodies for the job.

Where samples are collected for the purposes of research, the questions of confidentiality and consent are relevant because of the sensitive information which may be made available.

However, specific consent may be inappropriate where samples might be used in research not contemplated at the time the sample was collected and where DNA samples have been collected and stored for other purposes and have relevance to a new research project.

The Privacy Commissioner noted at the time that the Bill "Largely sets out good practice in the research context", however, "the main question is whether incorporation of these standards in a Bill of this kind are desirable at this point in time".

The Bill reflects most of the requirements of the NHMRC then draft Statement on Ethical Conduct in Research Involving Humans and enshrines the DNA sample must be "essential to the research project" and the "the potential benefit of the research project to society outweighs the potential risks to the research subjects" as necessary for the collection of any information.

In any legislative scheme it is necessary to balance the possible legal requirement for specific consent and confidentiality against the public interest for conducting research, and the possible difficulties obtaining specific consent in every circumstance. Though despite the equivocal nature of confidentiality in the public interest, on balance I am of the view that specific consent should be necessary as it would be unethical to diagnose an individual anonymously as they might not be warned to obtain treatment (subject to their not wanting to know), or be able to warn others.

Non-consensual disclosure of confidential information is not exempted under my Bill as it does not maintain the doctor-patient relationship and as medical research is generally not considered a fundamental public responsibility (for example in the way that enforcement of the criminal law is traditionally considered).

Since the introduction of the Genetic Privacy and Non-discrimination Bill in 1998 the Senate has considered the issue through referral to the Senate Legal and Constitutional Legislative Committee which reported in March 1999.

The Committee recommended the creation of a national working party, tasking the appropriate Commonwealth departments with the administration and consultation process, and the inclusion of State and Territory representatives, experts and representatives of stakeholder groups in the working group.

It also recommended that the Bill not proceed, pending a thorough examination of genetic privacy and discrimination issues including consideration of insurance, employment, provision of goods and services, clinical diagnosis and treatment, conduct of medical and other research and genetic information concerning children.

Though the Senate passed a motion earlier this year acknowledging that no action had been taken, it was not until the media got wind of the documented cases of genetic discrimination in Australia that the Attorney-General and Minister Wooldridge were forced to announce an inquiry.

Since the introduction of my Bill, the domestic public policy regarding the effective protection of genetic information, has developed extensively. In only two years an issue which was generally rarely considered outside expert communities, is now the subject of Channel 9 comedy debates and a Federal Government inquiry.

We have seen since this time President Clinton endorse legislation to protect employees of federal agencies in the United States from negative genetic discrimination on the basis of employment records, the completion of the Human Genome Project, and the impact of science fiction works such as GATTACA which can not be underestimated for impact on the public psyche.

Public concern is growing and will not be stemmed by scientists simply stating that it is ‘O.K.’ or ‘safe’ – that the experts have it under control. The days of ‘trust me I am wearing a white coat’ are long gone. The public are demanding balanced information and effective regulation. It is only through such measures that community confidence will be won.

Back in Australia, academic debate surrounding the issue has also evolved significantly. David Keays’ research at the University of Melbourne has provided the community and the Parliament with evidence the nature of which some of us have expected for sometime – documented domestic cases of genetic discrimination – before which we only had international studies from which to extrapolate.

IFSAs genetic testing policy stipulates that insurers will not initiate any genetic tests on applicant for insurance, that insurers will not use genetic tests as the basis of preferred risk underwriting, that insurers will ensure that results of existing genetic tests are only obtained by written consent of the tested individual and that the information be only used in the assessment of an insurance application in respect of the individual on whom the test was conducted – not relatives of the tested individual. The policy stipulates that strict standards of confidentiality apply to the handling and storage of the results of genetic tests and that access to the results of genetic tests will be restricted to the insurer’s underwriters and reinsurers, and only other third parties with written authorisation of the insured individual.

These are welcome developments. However, the policy does state that insurers may request that all existing genetic test results be made available to the insurer for the purpose of classifying risk.

This is the one point that I have grave reservations about. The comments of President Clinton I think demonstrate the catastrophic impact that such a policy may have when he stated that:

We ... know that one of the main reasons women refuse genetic testing for susceptibility to breast cancer is the fear that the insurance companies may either deny them coverage or raise their rates to unaffordable levels.

If such information was required by insurance companies I fear that Australian women will deny themselves testing and further examination. If one more woman feels comfortable about taking a genetic test for breast cancer then I think my Bill would be proven worthwhile.

I disagree with IFSAs argument that responsible industry self-regulation is more likely to serve the interests of consumers and policy holders, though I do acknowledge that this is a significant step forward in a domestic policy climate that is receiving no direction from Government.

With the absence of leadership from the Government on the issue (an issue which some Government offices still deny exists) IFSA must be commended for attempting to grapple with this complex issue.

I hope that my Bill has, in some way, added to the public and legislative debate regarding the need for legal protection against the misuse of genetic information and therefore is a step in the wider evolution of privacy rights in Australia.