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Genetic information has a number of characteristics that set it apart from other sensitive health and personal information. Unlike other personal information, genetic information is predictive. It may indicate a condition that might be expressed as a full-blown disease, a milder variant of that disease, or never be expressed at all.

Techniques of genetic testing (and the assessment of its results) are still being perfected, raising the issue of the "quality" of genetic information.² Moreover, genetic information can allow inferences to be drawn about blood relatives. It is an intimate part of an individual's identity which can not be superseded by events or changes in circumstances, and is potent for the entirety of that individual's life.

Among the wide-ranging issues that face consumers and regulators are the ethical, legal and social issues designated "ELSI" under the Human Genome Project.³ They include questions about personal privacy, discrimination, and distribution and funding of healthcare services, such as:

• Will the promise of genetic therapies compensate for their costs or for a possible reduction in other health therapies or services?

• Will consumers be willing to subsidise the opportunity for would-be parents to preselect embryos produced by in-vitro fertilisation for desirable characteristics?

• What characteristics will be deemed undesirable?

• What will be the effect on the community if only those who can personally fund such services use this knowledge?

• What is the likelihood of a dystopian genetic underclass developing?

Equity of access to genetic testing and therapies is gaining attention as a consumer issue. However, it is the ability of parties like employers, credit providers and insurers to obtain and draw conclusions from personal genetic information (and the dissuasive effect this may have on individuals considering a genetic test) which is of most concern to Australians.

Genetic testing for many medical disorders is now routine in Australia. Neonatal screening for phenylketonuria, hypothryoidism and cystic fibrosis is standard practice, and tissue samples obtained during prenatal screening for cystic fibrosis, along with the corresponding test results, can be stored indefinitely.⁴ In fact, to qualify for accreditation in Australia, laboratories are required to store clinical genetic test results, the corresponding diagnosis and other written information indefinitely after reporting the results to the requesting doctor.⁵ If the test is for the purpose of research, the result is stored for a period "in accordance with good research practice".⁴

The accumulation of such information raises questions about its appropriate use and how individuals' interests should be protected, particularly in situations where diagnostic testing and research have moved from the public to the private sector.

Are consumers currently protected?

The Commonwealth's human rights package and privacy laws, self-regulation through the National Health and Medical Research Council (NHMRC), the Therapeutic Goods Administration (TGA), the Genetic Manipulation Advisory Committee (GMAC), incidental legislation (eg, Section 29 of the Australian Institute of Health and Welfare Act 1987 [Cwlth]) and some self-regulatory measures in confined sectors provide some protection. Similarly, there is State and Territory legislation and additional legislation dealing with the donation of human tissues for specific purposes. The Australian Capital Territory's Health Records (Privacy and Access) Act 1997 covers personal health information (including genetic information) held in both public and private sectors.

However, there is presently no legislation in any Australian jurisdiction 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 (specifically, interactions and transactions in the private sector, which is not covered by the Privacy Act 1988 [Cwlth]). The Interim Office of the Gene Technology Regulator, or the regulatory system proposed in the Gene Technology Bill 2000 (Cwlth), does not seek to amend the current regulatory arrangement for genetic information and samples.

The Privacy Amendment (Private Sector) Bill 2000, introduced into the House of Representatives on April 12 this year, seeks to extend to the private sector the National Privacy Principles and privacy protection currently required under the Privacy Act. This Bill aims to establish "a comprehensive national scheme providing for the appropriate collection, holding, use, correction, disclosure and transfer of personal information by organisations in the private sector".⁶ Under this Bill, genetic information is classified as sensitive health information, in the same category as infectious health information.

Consumers' genetic information is best protected under a comprehensive privacy scheme, such as that proposed by the federal Attorney General. However, whether such protection is provided for genetic information under the Privacy Amendment (Private Sector) Bill 2000 is currently under dispute as the Bill is debated in Federal Parliament.

Privacy protection and the development of privacy "rights" in Australia should evolve with technological innovation and development. The unique nature of genetic information makes protecting such information integral to the evolution of privacy "rights" in Australia and worthy of specific legislative protection. It was from this conviction, rather than because of specific Australian examples of genetic discrimination or breach of privacy of which I was aware, that my Private Member's Bill (the Genetic Privacy and Non-discrimination Bill 1998) originated. The Privacy Amendment (Private Sector) Bill 2000 does not reflect the uniqueness of genetic information. Under the Bill, genetic information is defined as sensitive health information, being treated as prescriptive health information. This classification, when coupled with the specific exemptions for employee records and all transactions for businesses with an annual turnover of $3 million or less (estimated to exempt 94% of Australian businesses from the National Privacy Principles or similar approved privacy codes under the self-regulatory regime⁷), significantly undermines any protections to genetic privacy, specifically for online ehealth applications.

Genetic privacy may be said to be the confidentiality that should apply to any "[g]enetic data associated with an identifiable person and stored or processed for the purposes of research or any other purpose".⁸ The Bill I introduced seeks to establish a "right" to genetic privacy. It also seeks to protect Australians from genetic discrimination. Genetic discrimination may be positive or negative. Positive discrimination can be either beneficial or adverse. For example, providing reduced premiums to individuals with a favourable record of genetic health may benefit the individual, but be argued from a consumer or public policy perspective to be unconstructive. On the other hand, positive discrimination on the basis of chromosome screening for potential susceptibility to workplace carcinogens and other toxins could arguably be a positive use of the technology. However, my concern is to protect individuals from treatment by a third party which would be disadvantageous to their interests.

Is genetic information being misused?

In the absence of legislative protection, the Insurance and Financial Services Association (IFSA) has drafted a policy for genetic testing. This policy stipulates that:

• Insurers will not initiate any genetic tests for applicants for insurance or use genetic tests as the basis of preferred-risk underwriting;

• Results of existing genetic tests are only obtained by written consent of the tested individual for the sole purpose of assessing an insurance application for the individual on whom the test was conducted;

• Strict standards of confidentiality apply to the handling and storage of the results of genetic tests; and

• 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.

However, the policy endorses disclosure of the results of any genetic test undertaken voluntarily by a potential policy holder in assessing risk and therefore premium price.

While IFSA's policy provides some protection to consumers in the absence of legislative protection, it still allows for certain negative genetic discrimination.

Under Commonwealth law, the holder of the insurance policy has a duty to disclose information which is relevant to the insurer in assessing risk (Insurance Contracts Act 1984 [Cwlth]). State and federal antidiscrimination legislation provides consumers some protection, preventing discrimination by insurance companies on the basis of a disability or impairment. However, insurers are allowed to use reasonable actuarial or statistical data (which could include genetic information) in determining risk, and are able to discriminate if assessment was based on so-called other relevant "reasonable" factors if such information is not available (Disability Discrimination Act 1992 [Cwlth], s 46).

International developments include United States President Clinton's endorsement of legislation banning genetic discrimination for employment purposes in United States federal agencies, and US presidential candidate George W Bush's announcement that he will ban genetic discrimination if elected to office. By contrast, in the United Kingdom, the government has ignored the recommendations of the Human Genetics Advisory Commission and consumers' calls for protection, and the UK has become the first country in the world to allow life insurers to require results of voluntarily taken genetic tests from any potential policy holder.^13,14

The Australian Federal Government has announced an inquiry with the Australian Health Ethics Committee and the Australian Law Reform Commission which will extend over two years. In the meantime, consumers deserve privacy protection and legislative safeguards against genetic discrimination. The Human Genetics Society of Australasia and the Australian Consumers' Association have suggested a moratorium on the use of predictive test results by insurers while the Government performs its inquiry.¹⁵

While I welcome the Government's belated recognition of the issue and its commitment to explore the most appropriate way to ensure genetic privacy and non-discrimination, Australian consumers remain unprotected and affected industries remain uncertain in the interim. A moratorium would provide such protection and certainty for our community.

References

1. Suzuki D. Inventing the future: reflections on science, technology and nature. Sydney: Allen & Unwin, 1990: 55-78.
2. Boyle P. Genetic services, social context, and public priorities. In: Aronowitz S, Martinsons B, Menser M. Techno science and cyber culture. London: Routledge, 1996: 206.
3. Human genome project information. <http://www.ornl.gov/hgmis> (accessed October 2000).
4. National Health and Medical Research Council. Ethical aspects of human genetic testing: an information paper. Canberra: NHMRC, February 2000: 24.
5. National Pathology Accreditation Advisory Council, Retention of laboratory records and diagnostic material. Canberra. AGPS, 1998.
6. Attorney General, Privacy Amendment (Private Sector) Bill 2000 Explanatory Memorandum: 6.
7. Senate Legal and Constitutional Legislative Committee. Hansard. Department of Workplace Relations and Small Business. 8 September, 2000; 46.
8. Universal Declaration on the Human Genome and Human Rights. Article 7. United Nations Educational, Scientific and Cultural Organisation, 29th Session of the General Conference, 11 November 1997. <http://unesdoc. unesco.org/images/0010/001096/109687eb.pdf> (accessed October 2000).
9. Billings P, Kohn MA, de Cuevas M, et al. Discrimination as a consequence of genetic testing. Am J Hum Genet 1992; 50: 476-482.
10. Lapham E, Kozma C, Weiss JO. Genetic discrimination: perspectives for consumers. Science 1996; 274: 621-624.
11. Geller LN, Alper JS, Billings CI, et al. Individual family and societal dimensions of genetic discrimination: a case study analysis. Sci Engineer Ethics 1996; 2: 71-88.
12. Barlow-Stuart K, Keays D. Genetic discrimination in Australia. J Law Med. In press.
13. Highfield R. UK: News -- Insurance firms to use results of gene tests. Daily Telegraph. October 13, 2000; 13.
14. Lee A, UK: British life insurers can use genetic tests. Straits Times. October 15, 2000.
15. Petschler L. Access denied: genetic testing and your insurance. Australian Consumers' Association. Choice October 2000. <http://www.choice.com.au/ articles/a101713p1.htm> (accessed November 2000).

Authors' details

Reprints will not be available from the author.
Correspondence: Senator Natasha Stott Despoja, 212 Grenfell Street, Adelaide, SA 5000.
Senator.Stott.DespojaATaph.gov.au

©MJA 2000
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