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The ALRC Report into the Protection of Human Genetic Information: insurance, employment and privacy implications

In brief: Our final feature on the recent Australian Law Reform Commission Discussion Paper (DP 66) covers three important areas – insurance, employment and privacy.

  • Lorien Beazley discusses the use of genetic information as a basis for the granting or refusal of insurance policies;
  • Ben Arnall discusses how the protection of human genetic information could affect employment and job related issues in Australia; and
  • Johanna Gibson discusses privacy issues.

Insurance issues

Relevance

If you have a gene that predisposes you to heart disease, should you pay higher insurance premiums? Do you have to tell your insurers about your genetic make up? If you don't know your genetic make up, should you have to submit to a genetic test before you are granted insurance? DP 66 raises these issues of use of genetic information by insurers.

There is clear concern about the use of genetic information in insurance and the harm it could cause people with higher risk genetic profiles particularly as, in most cases, it is unknown whether or not the genetic pre-disposition to illness will actually manifest itself into a disease. As the Paper puts it, there is a concern about 'the creation of a genetic underclass of people who may be unable to obtain insurance coverage' or if they do, on restricted terms or for much higher premiums.

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Personal insurance in Australia

Chapter 22 of the Paper discusses the current insurance regime in Australia and divides insurance into two categories:

  • Community rated insurance. The Australian public and private health insurance system is based on 'community rating' of risk. This means everyone pays a standard premium for a particular level of coverage, regardless of the level of risk they bring to the insurance pool. Under these kinds of insurance contracts, insurers are prevented from using health information to assess an individual risk, including genetic information.
  • Mutually rated insurance. Under this kind of insurance (e.g. life insurance, disability, income protection etc), insurance premiums are proportional to the risk of the insurable event actually happening. The Australian insurance system (apart from the health insurance system) is based in legislation and in common law on this voluntary and 'mutual' disclosure of all relevant factors associated with the granting of an insurance policy. Insurers are entitled to ask for all health information (including genetic information) that will help them assess the risk of the insured event happening.

The Commission is seeking comments in relation to its view that the evidence put to it in submissions to date does not support a moving away from the current systems of insurance.

Use of genetic information in insurance

Applicants are obliged, under the Federal Insurance Contracts legislation, to disclose all information that is relevant to the insurer in assessing an application for insurance. The most obvious ramification of failing to disclose all relevant information is having the policy declared invalid and the claim disallowed.

Genetic information is clearly relevant to the assessing of risk and terms of insurance. The question then becomes whether the insurer can actually require a potential insured to actually undergo a genetic test prior to issuing (or renewing) a policy of insurance.

Two years ago, life insurers jointly agreed (with the ACCC's blessing) that they would:

  • not require insureds to undergo genetic testing, and
  • ask for the results of such tests if they had already been carried out.

We originally discussed this issue in late December 2000. Since then, the Investment and Financial Services Association (IFSA) has expanded the draft life insurance policy and formalised it into an industry standard, the Genetic Testing Policy. Under the policy, genetic test results can be used, but insurers cannot require applicants to undergo a genetic test, nor can they indirectly or directly induce applicants to take genetic tests by offering some kind of discount or preferential treatment to those who have favourable genetic test results. However, this policy is an internal industry standard and does not have the force of law.

Chapter 23 also summarises the insurer's obligations in its dealings with potential insureds including the collection and use of other health information.

Genetic discrimination in insurance

This Chapter (24) is extensive and discusses the substance of the concerns raised in the submissions.

Anti-discrimination legislation throughout Australia addresses the issues associated with mutually rated insurance and the fact that it must differentiate between individuals on the basis of certain characteristics.

The Paper helpfully discusses the regulatory framework (both at Federal and state level) surrounding discrimination (e.g. the existence of the Disability Discrimination Act (DDA)). Such legislation includes a specific exception for discrimination in insurance where the discriminatory conduct is based on actuarial or statistical data, or is otherwise reasonable.

Critical to the discussion is the focus on mutually rated insurance policies (i.e. those policies that are issued on terms and premiums appropriate to the risk associated with the applicant) and the obligation on the applicant to disclose all relevant information to enable the insurer to properly assess the risk. A number of issues were found to be paramount in the submissions.

Use of genetic information in underwriting

Many organisations made submissions regarding whether genetic information should be used in underwriting insurance policies. As expected, the opinions ranged from being opposed ('a group of people who already have the misfortune of inheriting genetic mutations, who then suffer discrimination at the hands of insurance companies which then limits their opportunity and freedom') to being in favour ('the introduction of new testing technologies such as genetic testing does not in itself impact the underlying health of the population... therefore is not expected to increase the number of people who are declined insurance').

The Paper flags the following five options:

  1. Maintaining the status quo

    That is, making disclosure of the results of genetic tests available to insurers but not requiring (or providing incentives to) insureds to undergo genetic testing.

    The question then becomes, whether this includes an obligation on an applicant to disclose the results of genetic tests performed on them when they were children. Obviously submissions differed. The Australian Medical Association submitted that individuals should have the option to have their childhood genetic test declared 'null and void' with regard to their obligations to disclose such information to insurers. The Inquiry is seeking further comment on this issue.
  2. Introducing a two-tier system either through industry codes or through legislation

    Based on international models (such as the UK and Sweden), applicants could purchase insurance up to a predetermined monetary limit without an obligation to disclose genetic information. Once the insured seeks to exceed the limit, full disclosure of genetic information is required.
  3. Prohibiting the use of genetic information

    Bodies such as the Androgen Insensitivity Syndrome Support Group of Australia, the Genetic Support Council of Western Australia and the Haemophilia Foundation of Victoria made submissions that insurance companies should d not have access to genetic information under any circumstances. It is assumed that this does not include the disclosure of a family history of illness, but rather addresses pure DNA information.

    On the other hand, IFSA did not support a prohibition on use.

    The Inquiry did not state its views specifically on this issue, but it is clear from their overall submissions that this is not a view that is acceptable to the Inquiry based on its overarching view not to change the status quo.
  4. Developing specialised insurance products

    A range of specialised products could be designed for people with a higher level of risk because of genetic factors. These types of polices could range from those where no genetic information is required, those where cover is available for all illnesses apart from congenital illnesses, and those where genetic information is required to be disclosed. However, the costs of implementing such range of products (and the premium prices for high risk, high coverage policies based on genetic results) are potential limiting factors to the implementation of such a regime.
  5. Cross-subsidising poorer risks through an industry or Government scheme.

    The possibility of the Government subsidising those individuals with poorer risks is contentious, both from a sociological and financial point of view. The willingness of the tax payers to fund such a scheme would have to be addressed.

    The Inquiry's view is that the status quo should be maintained, provided that the Human Genetics Commission of Australia (HGCA) monitors the national and international use of genetic information in insurance and the question is reviewed in the future.
Scientific reliability and actuarial relevance

Exclusions from the anti-discrimination legislation are granted to insurers on the basis that such exclusions are based on:

  • reasonable actuarial or statistical data, or
  • otherwise reasonable grounds having regard to other relevant factors.

If insurers intend to rely on the results of genetic tests to sell policies to applicants at higher premiums or with reduced coverage, then insurers must be able to ensure that the genetic information is reliable and accurate enough to make the discrimination reasonable and therefore 'lawful'.

The Inquiry has formed the view that while there is uncertainty in the reliability of the collection of genetic information and in the interpretation and use of the results of such genetic tests, insurers should not be left to determine which information is scientifically reliable and relevant. It is suggested that some degree of independent oversight for the use of such information is needed. This would require the formation of an independent body (such as the HGCA), and appropriate mechanisms for the adoption of such policy (whether by legislation or otherwise). The Inquiry is seeking submissions in relation to the proposed use of independent advisors in the use of genetic information (and if so, how) and also for comment regarding the distinction between the use of genetic information and family history information.

Insurer's duty to provide reasons

At present, there is an obligation on insurers to provide reasons for an adverse insurance decision. The Inquiry's position is that, in addition to providing reasons in writing, insurers should ensure that those reasons are adequate or have a statistical or actuarial basis.

Review and appeal mechanisms

The Inquiry believes that this is an issue that needs improvement but that the size of the review required for this issue is outside the scope of the Paper and makes no proposals for the reform of the existing system of a 'merits review' by anti-discrimination agencies.

The Paper also highlights the need for industry and community education and training.

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Insurance and genetic privacy

The issues raised in Chapter 25 follow on from the discussions in Chapter Seven discussing the legal privacy framework for the protection of genetic privacy in general.

Naturally, the collection, use and disclosure of genetic information by insurers (as well as agents and brokers) is of extreme importance to insureds. As previously highlighted, there are two arms of privacy regulation in Australia:

  • regulation of public sector organisations (e.g. Health Insurance Commission) are bound by the 11 Information Privacy Principles under the Federal Privacy Act and the guidelines issued under the National Health Act ; and
  • private sector organisations (other than exempt small businesses) such as insurers are bound by the 10 National Privacy Principles under the private sector amendments to the Privacy Act which came into force on 21 December 2001.

[For a detailed summary of the privacy laws please go to AAR's privacy site. We also revisited some of these issues when we discussed the Genetic Privacy and Non-Discrimination Bill 1998 (Cth)].

In addition, the Insurance Council of Australia has developed its own approved Code under the Privacy Act.

Submissions received by the Inquiry did not raise any significant issues regarding community rated insurance policies. Most submissions involved mutually rated policies (where known genetic information must be disclosed).

The Inquiry considered the existing privacy protection legislation was satisfactory in the insurance context and further that insurers were already particularly vigilant in protecting client personal information, having subscribed to voluntary codes of practice prior to the introduction of the private sector changes. However, the Inquiry did flag three issues for further consideration:

  • The quality of consent to the collection and use of genetic information by insurers

Whether applicants can actually give a valid and informed consent in relation to the collection and use of their genetic information depends on the information provided by the insurers at the time of entering into the contract.

The issue of validity is critical, as consent must be voluntary. There are issues involved in the 'voluntary' nature of the consent where a probable result of a refusal to give consent is that the insurance will be declined. Also of important is the issue of 'bundled consents', broad consents where the applicant agrees to a wide range of uses of their information. The Office of the Federal Privacy Commissioner has made clear its opposition to the use of bundled consents and the Inquiry has accepted that this position should be adopted by insurers.

In relation to the granting of an 'informed consent', one recommendation suggested that separate information be included in policies specifically addressing the collection and use of genetic information. The Inquiry suggests that additional information should be provided by insurers because of the unusual characteristics of genetic information. The review of consent forms includes the review of medical authority forms.

  • The collection of family medical history by insurers

There are two issues in relation to the use of family medical history in insurance:

  1. the use of genetic information collected for one person to assess the insurance risk of a genetic relative. The Inquiry is satisfied that this does not occur; and
  2. when information is disclosed by an applicant about their family medical history, whether insurers have an obligation to inform the family members that it has collected information about them in this way (NPP1.5).

The Inquiry suggests that a Public Interest Determination should be issued by the OFPC to exempt insurers from having to make such disclosures in a similar way to the manner in which it has exempted medical practitioners from making similar disclosures in Temporary Public Interest Determination No. 2001-1.

  • The sharing of information between related insurance organisations

The Inquiry only received one submission in relation to the practice of the passing on of genetic information from one arm of an insurance organisation (e.g. general insurance) to another arm (such as life insurance) in relation to the same individual for the granting of separate insurance policies and seeks further input on this issue.

What now?

Clearly the issue of the use of genetic information in insurance will be a hotly debated topic. While the Inquiry has indicated that it is satisfied with the status quo regarding the collection and use of genetic information by insurers to date, this may change as our culture and genetic testing capabilities change.

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Employment implications

Background

The rapid development of genetic science and technology has resulted in human genetic information becoming easier, quicker and cheaper to obtain. The range of its potential applications has also expanded. The Inquiry observed that employers are likely to be increasingly interested in uncovering and using genetic information in the workplace for a variety of reasons, including:

  • to fulfil legal duties to provide a healthy and safe work environment for their employees;
  • to reduce insurance premiums and the costs associated with sick leave; and
  • to guard against future lawsuits by employees whose genetic predisposition to an illness may be triggered by environmental factors present in the workplace.

At the same time, employees have a strong interest in preserving their privacy and being protected against discrimination and unfair treatment based on their genetic status.

In formulating its recommendations, the Inquiry has sought to balance competing interests in the employment field.

Discrimination on the ground of genetic status

Although the Inquiry considered the desirability of introducing 'stand alone' legislation to address discrimination on the ground of genetic status, it has proposed that working within the existing framework of Federal, State and Territory laws is more likely to promote certainty and consistency. However, in the interests of removing any doubt as to the position, DP 66 recommends amending the existing definition of 'disability' in the Disability Discrimination Act 1992 (Cth) (the DD Act) to expressly cover unlawful discrimination based on a person¡|s genetic status. DP 66 also suggests that the States and Territories make similar amendments to their anti-discrimination legislation.

Collection and use of genetic information

At present, the collection and use of genetic information is not specifically regulated in the Australian employment context. The Inquiry has not favoured introducing specifically targeted legislation, partly because there is little evidence that employers are currently seeking access to genetic information about job applicants or employees. Instead, DP 66 proposes that the collection and use of genetic information in the workplace continue to be regulated within the existing framework of Federal, State and Territory legislation covering anti-discrimination and occupational health and safety, subject to a number of suggested reforms to provide additional safeguards.

Importantly, the Inquiry has not recommended a complete prohibition on employers collecting or using genetic information. Rather, it has proposed that employers should be able to collect and use genetic information in relation to their employees provided that this is reasonable and relevant and within the terms of anti-discrimination and occupational health and safety legislation, and subject to certain limitations.

Inherent requirements of the job

Currently, under the DD Act, it is not unlawful for an employer to discriminate against a person on the grounds that, because of his or her disability, the person is unable to carry out the 'inherent requirements' of the particular job. This defence is only available to an employer in relation to 'hire and fire' decisions, namely determining who should be offered employment or dismissed as an employee. The Inquiry has formed the view that it would be unfair to permit employers to deny a person employment on the basis of tests indicating that he or she had a genetic predisposition to a particular disorder that may give rise to a future inability to perform the inherent requirements of a job. This is because many factors, such as environment, lifestyle and chance, impact on a person's health apart from genetic predisposition. DP 66 therefore proposes that this exemption in the DD Act should be clarified to ensure that employers are able to rely only on a person's current ability to perform the inherent requirements of a job.

The Inquiry has also recommended that peak employer associations encourage members to produce clearly defined job descriptions that set out the inherent requirements of every position in the workplace.

Requests for genetic testing or information

The Inquiry considered that requests for, or requirements to produce, genetic information (such as family medical history or the results of past genetic tests), lay at the heart of most concerns about genetic discrimination. Noting the absence of effective restraints on the present ability of employers to request such genetic information from employees, DP 66 proposes a prohibition on all requests for genetic testing and information, except where employers can demonstrate that the information is reasonably required for a purpose that does not involve lawful discrimination (eg: ensuring that a person is able to perform the inherent requirements of the job). If this proposal is ultimately adopted, it would place a clear onus on employers to justify requests for such information.

Genetic screening and monitoring

According to DP 66, genetic screening and genetic monitoring are the two most likely contexts in which employers are likely to seek access to genetic information for occupational health and safety reasons. Genetic screening involves testing job applicants and employees for a genetic susceptibility (or predisposition) to a disease or condition that may be triggered by exposure to certain workplace hazards, such as toxic chemicals or radiation. In contrast, genetic monitoring involves the periodic testing of employees exposed to workplace hazards to assess whether there has been any genetic modification as a result of workplace exposure.

After weighing up the competing interests of employers and employees in this context, especially the concern to avoid the creation of a 'genetic underclass' of persons rendered unemployable by their genetic makeup, the Inquiry has recommended that genetic screening and genetic monitoring should be permitted, on a voluntary basis, but only where:

  • there is strong evidence of a clear connection between the working environment and the development of the condition;
  • the condition may seriously endanger the health or safety of the employee (or job applicant); and
  • the danger cannot be eliminated or significantly reduced by reasonable measures taken by the employer to reduce the environmental risks.

In addition, DP 66 proposes that employers should be allowed to collect genetic information from a job applicant or employee for the purpose of protecting the safety of other employees or the general public. However, this would only be permitted if:

  • the condition of the job applicant or employee poses a real risk of serious danger to the health or safety of third parties; and
  • the danger cannot be eliminated or significantly reduced by other reasonable measures taken by the employer to eliminate or reduce the risks.

Independent oversight of the use of genetic testing and information by employers is also suggested by the Inquiry, to ensure that test results and other information are interpreted and applied accurately.

Employment and genetic privacy

The handling of employees' personal information in the public sector and (following recent amendments) also in the private sector, is regulated by the Privacy Act 1988 (Cth). DP 66 proposes that the definition of 'employee record' in this legislation be amended to exclude genetic information held by an employer in relation to current or former employees. This would mean that, unlike other employee records, the collection and use of genetic information by employers would be given a high level of privacy protection under the Act.

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Implications for privacy

Introduction

In November 2001, Issues Paper 26, Protection of Human Genetic Information (IP 26) was released, containing the background to the Joint Inquiry of the Australian Law Reform Commission (ALRC) and Australian Health Ethics Committee (AHEC) of the National Health and Medical Research Council (NHMRC). The results of this Inquiry are reported in the recently released Discussion Paper 66 (DP 66), submissions to which must be made by 29 November 2002.

In announcing the Inquiry, the joint news release of the Attorney-General and the Minister for Health and Aged Care called for specific consideration of whether laws are needed to address issues associated with genetic samples and information, including privacy, inappropriate discriminatory use, and ethical considerations relevant to collection and use. To address the issues presented by this Inquiry, a broad-based expert Advisory Committee was assembled, including experts in insurance and actuarial practice, and privacy and anti-discrimination laws.

What is a right to privacy?

The nature of privacy is such that any right to it can be only negative in its application. In other words, it is a right to prevent interference or publication of certain personal information, rather than a right of positive entitlement (G. Laurie, Genetic Privacy: A Challenge to Medico-Legal Norms, 2002, Cambridge University Press). Similarly, in the context of prognostic health information, a collateral negative right 'not to know' also operates. Informed consent to testing and disclosure and the regulation of the appropriate use of genetic information is significant to this right.

The Inquiry defines privacy as a right of control over information or interference, and a right to autonomy, but ultimately it operates as a negative right in that once disclosure occurs in the relevant sense, the right to privacy in respect of that information may expire. Notably, the enforcement of any right to privacy must be through statutory means since no general enforceable right to privacy exists.

Presently, information privacy is regulated at the federal level by the Privacy Act and the privacy safeguards referred to in the Privacy Act that set out in the 11 Information Privacy Principles (IPPs) and 10 National Privacy Principles (NPPs) which have the force of law. The IPPs cover the collection, storage and security, use, disclosure and access to 'personal information' by the Federal public sector, while the NPPs establish how private sector organisations should collect, use, and disclose personal information, maintain data quality and the security of personal information, all within an open and accountable operation. The NPPs provide special provisions for 'sensitive information' and 'health information', a subset of sensitive information.

The regulatory framework for the ethical conduct of research is provided by the National Health and Medical Research Council's (NHMRC) National Statement on Ethical Conduct in Research Involving Humans together with review of research proposals through the process of Human Research Ethics Committees (HRECs).

Why is privacy important?

Submissions to the Inquiry stated that fear of genetic discrimination may have an adverse effect on the community's willingness to participate in and support genetic research. Further to achieving public confidence in genetic research, the qualities of transparency and accountability in research, testing, collection, and processes of protection, are recommended. To this end, Proposal 12-1 recommends annual reporting requirements on HRECs to the Australian Health Ethics Committee (AHEC), and public meetings of the proposed Human Genetics Commission of Australia. Strengthening of review by HRECs is addressed in Chapter 14.

The question of privacy protection for genetic information and samples also introduces concerns regarding discriminatory practices or use of that information, particularly in the context of Employment and Insurance, addressed in this edition of Biotech News.

Is genetic information special?

Genetic information is significant in its capacity to provide substantial information about a person¡|s identity and hereditary characteristics from miniscule genetic samples, such as those discarded in our everyday lives, on hair brushes, tooth brushes, cups, and so on, that may be retained and stored for indefinite periods. This has raised serious concerns in the community in respect of the collection of that information, such as in police investigations, and the discriminatory use which might occur in certain contexts such as that of employment and insurance.

Genetic information derived from a sample from one individual may also provide information about familial or related ethnic or racial groups. A higher level of sensitivity is arguably attached to this information, and a higher level of privacy protection may be warranted.

Therefore, a major issue addressed by the Inquiry is whether special legislative mechanisms need to be created to protect genetic information, and the importance of balancing the significance of privacy protection with the empowerment seen to arise from knowledge.

The Inquiry found that genetic information is not fundamentally different and does not require a new, dedicated 'Big Law'. The Inquiry rejected 'genetic exceptionalism' (a US school of thought that genetic information is unique and so much more powerful than other forms of information that specifically dedicated protective measures are required) and considered that genetic tests are simply further tools in diagnosis, treatment and healthcare that will become more commonplace in the future.

Proposal 7-3 calls for amendments to the Privacy Act to clarify the inclusion of genetic information as 'health information' regardless of whether the information is collected in relation to the health of an individual or provision of health services to that individual.

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Consensual genetic testing and privacy
Home Use, Mail-order and Internet Genetic Testing

Access to mail-order or internet testing kits and services cannot be regulated so as to limit such testing to accredited laboratories at the request of medical practitioners. Informed consent is an important element of the both the IPPs and NPPs and is unlikely to be possible to regulate in respect of home use genetic testing, because of the nature of the access to mail-order testing.

The Inquiry recommends amendment of the Therapeutic Goods Act 1989 (Cth) and Therapeutic Goods Regulations 1990 (Cth) to enable the Therapeutic Goods Administration (TGA) to regulate home use. Further, it is recommended that the HGCA develop codes of practice and other advice on home use genetic testing, including advice to the TGA.

Consent

Information Privacy

The most obvious harm arising from non-consensual genetic testing is an intrusion on basic human dignity and autonomy which may be characterised as a breach of information privacy. Misuse of that information may also breach an individual's 'right not to know'.

Further, the scope of that consent is complicated by the nature of genetic research, as genetic samples may be retained for very long periods to be applied in as yet unspecified research and stored in comprehensive human genetic research databases. The Inquiry recommends a new chapter in the National Statement to address human genetic research databases and the provision of guidelines dealing specifically with these issues of consent to future unspecified research.

Current legal protection

The current framework of protection against non-consensual collection and use of bodily samples cannot regulate the use of information derived from the collection of ¡nothing???discarded¡¨ genetic material, such as saliva from a glass, and so on.

To remedy this, the Inquiry proposes amendment of the Privacy Act to define ¡nothing???personal information¡¨ to include bodily samples from an individual whose identity is apparent or whose identity may be ascertained from the sample itself (as in kinship and parentage testing).

The Privacy Act is also restricted to the Federal public sector and the private sector, and will have no application where acts are performed by individuals in their private capacity: s 7B(1). A further exemption arises in the case of journalists, if the collection and testing is done in the course of journalism: s7B(4).

Further, the NPPs may have no application if the laboratory does not know the identity of the individual from whom the sample was taken. In this case the laboratory would not be dealing with 'personal information' under the Act regardless of whether this information is available to the individual submitting the sample.

Waiver

The need for consent may be waived under s 95 or s 95A of the Privacy Act upon consideration that the public interest in the research substantially outweighs the public interest in privacy, as determined by an independent HREC.

Some groups expressed concern that the National Statement dispenses with the need for fully informed consent where genetic information is not initially collected for research but is ultimately used in this way. On the other hand, requiring consent for research on archival tissue may be a serious limitation on research activity. The Inquiry suggests that concerns about this waiver provision could be addressed by strengthening ethical review by HRECs.

Consent is Impracticable

NPP 2.1(d) provides for the use or disclosure of health information for research purposes without consent, where obtaining that consent is impracticable in the circumstances. That use or disclosure must be in accordance with the guidelines issues by the NHMRC and approved by the Privacy Commissioner under s 95A of the Privacy Act.

Recommendations

Proposal 5-4 recommends that the Standing Committee of Attorneys-General initiates the development of a model criminal offence to regulate non-consensual genetic testing for ultimate enactment into Commonwealth, state and territory law.

Proposal 5-5 recommends attaching criminal liability to any individual or corporation as a necessary deterrence to the submission of samples without lawful authority, or the conduct of tests without ascertaining the identity of the individual from whom that sample was taken and ensuring that the requisite consent was obtained.

Proposal 12-1 seeks to impose reporting requirements upon HRECs to AHEC, and further discussion is invited on the kind of information that should be included in those reports with respect to waiver of consent. Similarly, the Inquiry asks whether any changes are needed to the National Statement or the s 95 or s 95A Guidelines under the Privacy Act in relation to the question of waiver consent, whether for collection, use, or disclosure of samples or information for research.

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Genetic samples and genetic information

The Inquiry examined the existing framework of Australian laws and noted a mix of strategies from legislation and subordinate legislation, to official standards and codes of practice, such as those advanced by the Privacy Commissioner. Voluntary industry codes and standards of best practice are also likely to be relevant in achieving privacy protection for genetic information and samples.

Ultimately, the Inquiry recommends a national approach in order to achieve uniformity, whilst maintaining flexibility through a cooperative approach involving the Commonwealth, states and territories.

Remedy existing laws

The Inquiry resolved that the best means of addressing the inadequacies of existing legislative protection of genetic information is through changes to current general information and health privacy laws, rather than through a new dedicated regulatory framework. Creating dedicated schemes would pose considerable practical difficulty, and genetic information already forms part of the ordinary clinical health information understood by current regulatory regimes. Furthermore, many privacy issues raised by genetic information pertain to information privacy, such as that concerning medical records and other health information.

Proposal 7-1 calls for the harmonisation of information and health privacy legislation by Commonwealth, state and territory governments through the development of nationally consistent rules for handling all health information. As well as the call for amendments to include genetic information in the definition of health information under the Act in Proposal 7-3, Proposal 7-4 recommends amendments to ensure that all small businesses are subject to the Act.

National Health Privacy Code

The Inquiry suggests that nationally consistent rules may be achieved through the development of a National Health Privacy Code, the draft of which was recently developed by the National Health Privacy Working Group. The Code is in its initial and confidential consultation phase, with invitations to key stakeholders to comment on the draft. A revised draft will be released for wider public comment after the comments have been considered.

The relevant terms which define the scope of the Privacy Act are 'personal information' and 'record'. 'Personal information' is defined as:

'information or an opinion (including information or an opinion forming part of a database), whether true or not, and whether recorded in a material form or not, about an individual whose identity is apparent, or can be reasonably ascertained, from the information or opinion': s 6(1).

In order for personal information to attract the protection of the Privacy Act, it must exist in the tangible form of a record, that is, a document, database, or photograph or other pictorial representation: s 6(1).

The Office of the Federal Privacy Commissioner (OFPC) accepts that under the Privacy Act, genetic samples are not personal information and therefore do not come within the coverage of the Act. The OFPC notes that the Privacy Act currently distinguishes between informational privacy and bodily privacy, with the consequence that, in relation to the definition of personal information, bodily samples may be excluded from protection under the Act. The Inquiry reports that an amendment to the definition of personal information would extend the coverage to include such samples and therefore remedy the current gap in protection.

In Proposal 7-2 the Inquiry recommends appropriate amendments to the definitions of 'personal information' and 'record' to include bodily samples. Proposal 7-2 reads:

'The Privacy Act 1988 (Cth) should be amended expressly to: (a) define personal information to include bodily samples from an individual whose identity is apparent or can reasonably be ascertained from the sample; and (b) define a 'record' to include a bodily sample.'

The Inquiry notes that problems may arise in the blurring of distinctions between 'information privacy' and 'genetic privacy' and asks for further consideration on this point. The Inquiry explicitly asks for submissions as to whether the Privacy and Personal Information Protection Act 1998 (NSW) (which has operated in respect of bodily samples since 2000) provides an appropriate model for these amendments and on the implications of the proposal for current audit, investigative, enforcement (generally through complaint mechanisms) and related provisions of the Privacy Act.

Human Tissue Acts

The Human Tissue Acts were raised as possible means of regulation, but the Inquiry believed that this may lead to overlap with the privacy legislation. The Inquiry therefore recommends relying on existing information and health privacy legislation and not on the Human Tissue Acts for regulating the collection, storage, access to, or use of genetic samples.

De-identification

The Privacy Act will not apply to information that is de-identified, because the individual¡|s identity will not longer be apparent or able to be ascertained reasonably. Under NPP 10.3, health information may be collected for research purposes without consent, only where that information does not identify the individual.

Questions were raised as to whether genetic information could ever be properly de-identified while the individual from which the sample was taken is still alive. This is because under the NHMRC's National Statement, information is only ever properly de-identified where the process is irreversible. De-identified genetic samples may possibly be re-identified where subsequent genetic samples are taken from that individual and matched with samples on human genetic databases; however, the Inquiry ultimately rejected this argument.

Import and export of samples

Under NPP 9, 'transborder data flows' of personal information by an organisation to a foreign country are prohibited, unless an exception (such as consent, or reasonable attempts to gain consent) applies. The Inquiry has recommended that such restrictions apply not only to genetic information but also genetic samples. As a result NPP 9 would permit the ongoing export of genetic samples subject to the relevant safeguards. The Inquiry asks whether such export should be restricted to jurisdictions providing protection equivalent to that of the Privacy Act and National Statement and whether NPP 9 provides an appropriate model for the regulation of such export.

The Human Genetics Commission of Australia (HGCA)

In response to the reference to a 'version' of the UK's Human Genetics Commission (HGC) in Issues Paper 26, submissions overall showed support for establishing an independent standing body to give high-level advice to government, develop policy in critical areas, and contribute to public and professional education initiatives.

Proposal 3-1 recommends the establishment of a Human Genetics Commission of Australia (HGCA) under federal legislation as an independent, stand-alone statutory authority. Proposal 3-5 recommends the HGCA comprise a diverse membership of both 'expert' and community representatives. In addition to the provision of high-level technical, ethical, legal, and social advice to governments (through the establishment of both a Technical Committee and Ethical, Legal and Social Implications Committee, Proposal 3-4), Proposal 3-2 describes the HGCA's roles to include also national leadership, consultation, policy development, education, and coordination and integration of programs and initiatives. The HGCA will have specific responsibility for identifying particularly sensitive testing procedures, regulating the use of testing by insurance industry, and performing any other related functions.

Further to the achievement of public confidence in genetic technologies and the appropriate use of genetic information, the body would be transparent and accountable to the community, operating in public and conducting regular consultation with relevant government departments and authorities, as described in Proposal 3-6.

The right not to know

The Inquiry understands the so-called right not to know to mean a right to be protected from information that may be derived from a person's own body.

Special issues are raised by the familial nature of genetic information and by its particular predictive or prognostic power, making the right not to know relevant not only to the individual from whom the sample is taken, but also genetic relatives possibly affected by that information.

NPP 1.5 provides that if an organisation collects personal information about an individual from another individual, reasonable steps must be taken to ensure that the person is or has been made aware of the collection. The collection of genetic information may give rise to an obligation to notify genetic relatives, but the nature of that notification is not a straightforward issue.

In order to avoid undue restrictions on health professionals, disclosure may be allowed in certain situations where there is serious or imminent risk to that relative giving rise to a duty to warn, or disclosure is required by law. Proposal 18-1 calls for amendment of NPP 2.1(e)(i) of the Privacy Act so that disclosure is permitted in circumstances of serious risk. Proposal 18-2 recommends collateral amendments of state and territory legislation. Proposal 18-3 calls for the NHMRC to develop relevant guidelines in this regard.

Restrictions on the collection of family medical history information may be eased by obtaining a Public Interest Determination under the Privacy Act for an organisation operating a genetic register for public health purposes. The Inquiry also recommends relevant amendments to state and territory legislation in accordance with this. Whether or not this PID should apply to the use and disclosure of that information as well is something upon which the Inquiry seeks further submissions.

Databases

The Inquiry also reviewed the protection of health information contained in databases held by Commonwealth or state agencies, or private sector organisations.

State or territory authorities such as public hospitals, universities, or research institutes, will not be covered by the Privacy Act and protection will depend on the legislation available in the particular state or territory. Presently only NSW, Vic and the ACT has privacy legislation providing protection for health information held in public sectors. Queensland has an Information Standard (No 42 and 42A) that deals with this issue, but no legislation.

This protection is complicated where researchers are affiliated with centres funded by an external source or work in collaboration with private sector organisations.

Proposal 15-1 recommends amendment of the National Statement to provide ethical guidance on the operation of human genetic research databases. Licensing or registration of databases is raised as a possible means for ensuring the protection of privacy of genetic information in research in an internationally competitive context. Licensing bodies with powers of inspection could ensure compliance and examine privacy protection policies. Limitations could be placed on the maintenance of databases in the particular case and the specific privacy and related issues arising from specific types of databases. Ultimately the HGCA could perform a significant role in this kind of regulatory activity.

Similarly, a gene trustee or other independent intermediary could be imposed as a condition of licensing or registration, as a model research protocol for human genetic research. The gene trustee is conceived as an administrative body that operates as an independent third party controlling the information used to identify data and samples held in a database.

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Alternative for protection – property rights in genetic samples

The Inquiry maintained that full property rights in genetic samples should not be granted, but recommended that the common law right to possession of preserved samples to which hospitals and others may be entitled, be upheld.

Comments and submissions on the proposals and questions raised in Discussion Paper 66 should be made by 29 November 2002.

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