ALRC submission in response to the Discussion Paper on Non-Consensual Genetic Testing prepared by the Model Criminal Law Officers Committee of the Standing Committee of Attorneys-General (November 2008)
Contents
Essentially Yours: The Protection of Human Genetic Information in Australia
Essentially Yours: Recommendation 12–1
The Australian Whole-of-Government response to Essentially Yours
The MCLOC Discussion Paper proposals
Obtaining bodily material with the intention of causing a genetic test to be conducted
Children and parentage testing
Causing a genetic test to be conducted
Use and disclosure of results of genetic tests
Other matters
The definition of genetic testing
Penalties
Onus of proof
The Australian Law Reform Commission (ALRC) makes the following submission in response to the Discussion Paper on non-consensual genetic testing published by the Model Criminal Law Officers Committee (MCLOC) in November 2008 (the Discussion Paper).
In making this submission, the ALRC draws on its experiences during the joint inquiry (the Inquiry) by the ALRC and the Australian Health Ethics Committee (AHEC) of the National Health and Medical Research Council (NHMRC) into the protection of human genetic information and the final report of that inquiry, Essentially Yours: The Protection of Human Genetic Information in Australia (ALRC 96, 2003).
The ALRC also draws on its recent comprehensive inquiry into privacy and the final report of that inquiry, For Your Information: Australian Privacy Law and Practice (ALRC 108, 2008).
Essentially Yours: The Protection of Human Genetic Information in Australia
The terms of reference for the genetic information inquiry directed the ALRC and NHMRC to consider, with respect to human genetic information, and the samples from which such information is derived, how best to:
-
protect privacy;
- protect against unfair discrimination; and
- ensure the highest ethical standards in research and practice.
The experience of the Inquiry, mirrored overseas, is that the rapid pace of scientific and technological change has produced two powerful, but conflicting, social reactions. 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 or deceased persons). On the other hand, there are anxieties about loss of privacy and the potential for genetic discrimination, as well as about the capacity to regulate genetic science in the public interest.
The major challenge for the Inquiry was to find a sensible path that meets twin goals: to foster innovation in genetic research and practice that serve humanitarian ends, and to reassure the community that such innovations will be subject to proper ethical, legal and other controls.
The Inquiry’s final report, Essentially Yours, covers an extensive range of activities in which genetic information plays—or soon will play—an important role. The two-volume, 1200 page report makes 144 recommendations about how Australia should deal with the ethical, legal and social implications of the New Genetics.
The report has been very well received in Australia and overseas. For example, Dr Francis Collins, who chaired the international Human Genome Project, described Essentially Yours as ‘a truly phenomenal job’, and ‘ahead of what the rest of the world is doing’. Dr Collins noted that this work meant that ‘Australia has moved ahead in rather impressive ways’.
The Australian Government provided a formal, comprehensive response to Essentially Yours on 9 December 2005, accepting the great bulk of the ALRC’s 144 detailed recommendations, including such key ones such as the establishment of a standing advisory body on human genetics (now the Human Genetics Advisory Committee of the NHMRC), and measures to regulate the collection and use of genetic information in such critical areas as employment; insurance underwriting; the delivery of clinical genetic services; ethical oversight of medical and scientific research; the ethical uses of genetic testing and information in sports; human genetic registers and databases; immigration and law enforcement. .
Essentially Yours: Recommendation 12–1
A central concern of the ALRC and NHMRC throughout the Inquiry was to ensure that as well as defining the circumstances that would amount to the unlawful use of genetic information, we also put into place measures and strategies in Australia aimed at ensuring a higher order goal: that where such information may be used lawfully, it will be used properly, fairly and intelligently. The vast majority of the 144 recommendations in Essentially Yours relate to developing a good regulatory apparatus, and especially to providing the necessary education, training and support to bring Australian medicine into the Genetic Age.
The general approach of the ALRC to all inquiries is that the imposition of the full weight of the criminal law should only be recommended as a last resort, and after careful consultation and deliberation. In this case, however, after extensive research and consultation, the Inquiry partners agreed that the circumstances warranted a recommendation to create a new criminal offence of non-consensual genetic testing. In particular, and as noted in the MCLOC Discussion Paper, the ALRC and NHMRC made the following recommendation in Essentially Yours:
12–1 The Standing Committee of Attorneys-General should develop a model criminal offence relating to non-consensual genetic testing, for enactment into Commonwealth, state and territory law. Criminal liability should attach to any individual or corporation that, without lawful authority, submits a sample for genetic testing, or conducts genetic testing on a sample, knowing (or recklessly indifferent to the fact) that the individual from whom the sample has been taken did not consent to such testing.
The ALRC and NHMRC noted that important philosophical issues are raised in relation to human dignity and autonomy, as well as the physical and emotional integrity of the individuals concerned.
For example, the collection of a sample may, in some circumstances, involve a physical harm or a trespass to the person (a battery)—such as when a person is held down and a bodily sample is taken by force. Collection may also result in emotional harm, particularly in situations where, from the perspective of the individual concerned, intimate bodily samples (such as menstrual blood or semen) are taken, or kinship or identity is questioned. Some Indigenous peoples and ethnic groups have particular cultural sensitivities about the taking and use of bodily samples, especially without their knowledge and consent.
In Essentially Yours, the ALRC and NMHRC wrote that:
The most obvious harm arising from testing of the sample is the intrusion on basic human dignity and autonomy. The harm may be also characterised as involving a breach of information privacy.Genetic testing may result in the disclosure of sensitive personal information of many kinds. Testing can reveal information about the present and future health of an individual, an individual’s identity, or his or her parentage or kinship. The fact that harm may be caused by the non-consensual disclosure of these kinds of information is recognised by laws that proscribe disclosure in other contexts, including legal and statutory duties of confidentiality, and information and health privacy legislation. [ALRC 96, para 12.13]
Given the ubiquity of genetic material, and the increasing availability (in terms of the number of testing labs in Australia and overseas and the diminishing costs), the ALRC and NHMRC could envisage many scenarios—and read of many actual cases, especially overseas—in which there would be incentives for persons and corporations to engage in surreptitious, non-consensual, genetic testing—unless such activity was made expressly unlawful and the subject of criminal sanctions.
For example, this might include:
- employers or potential employers, who believe such testing might ensure a ‘more healthy workforce’, reducing sick leave and workers compensation insurance premiums;
- insurers, who have doubts about the accuracy of health information provided by applicants for risk-rated insurance products (such as life insurance and income protection policies);
- private investigators, employed by one of the above, or others contemplating litigation and seeking information about kinship or health (eg evidence of pre-existing conditions, or forecasts of life expectancy);
- ‘bio-pirates’ seeking tissue samples for unauthorised (non-ethics approved) health, medical or pharmacological research;
- public officials (for example, an immigration officer or police officer) who are operating outside of their lawful authority;
- a journalist seeking a sensational story about an individual who is a ‘celebrity’ or otherwise newsworthy, in relation to either a parentage (or non-parentage) claim or the individual’s genetic health status.
Obviously, many of these scenarios would give rise to a great deal more than hurt feelings. The ALRC and NHMRC expressed the specific and serious concern that unless expressly prohibited, the use of genetic testing and information by employers could easily result in a real life ‘Gattaca’ scenario—a future in which a ‘genetic underclass’ struggles to find meaningful work, even when perfectly fit and able to perform to requirements, because of their (real or perceived) ‘imperfect’ genetic make-up; for example, a susceptibility to one or another late onset condition that may never actually materialise.
The Inquiry’s primary focus in this area of concern was not on surreptitious parentage testing—although we certainly received many submissions from ‘fathers’ groups’ who argued vehemently for their right to conduct non-consensual paternity testing for ‘peace of mind’ and to vindicate their ‘right to know’ (and, oddly, for such testing to be allowed to be conducted by non-accredited labs). The issue of parentage testing is discussed in further detail below.
In sum, the Inquiry was of the view that non-consensual genetic testing may compromise significant interests—and that these interests merit protection under the law—reflecting the ethical consideration of respect for individual freedom and autonomy (which is also the basis for protecting privacy and providing remedies for the harm caused by breaches of privacy).
It should be noted that it was on this same basis that the United Kingdom’s Human Genetics Commission recommended a similar course of action, which was accepted by the British Government. The Human Tissue Act 2004 (UK) s 45 (and see Schedule 4) now contains a criminal offence of non-consensual DNA testing (in the absence of ‘excepted purposes’, such as medical treatment and law enforcement).
The Australian Whole-of-Government response to Essentially Yours
In response to Recommendation 12-1, the Australian Government stated that:
The Government supports this recommendation. It has referred the proposal for a model criminal offence relating to non-consensual genetic testing to the Standing Committee of Attorneys-General (SCAG) for consideration after advice from the Model Criminal Code Officers Committee. The Commonwealth Attorney-General will recommend that SCAG consult with relevant government bodies, including the Australian Health Ministers’ Advisory Council, when considering this proposal.
The MCLOC Discussion Paper proposals
The ALRC welcomes the Discussion Paper prepared by the MCLOC, and generally supports the Committee’s draft model offence to criminalise obtaining bodily material with the intention of causing a genetic test to be conducted without consent or other lawful authority, and the draft model offence to criminalise causing a genetic test to be conducted without consent. The ALRC does, however, have the following specific comments on the draft offences.
Obtaining bodily material with the intention of causing a genetic test to be conducted
The ALRC notes that one of the draft offences criminalises the taking of bodily material with the intention of causing a genetic test to be conducted without consent. The ALRC considered, in Essentially Yours, that the taking of bodily material per se should not amount to a criminal offence, because of the ubiquity of such material, and the danger of innocent conduct being caught in the process—such as a beautician sweeping up human hair or a waiter removing glasses and cutlery that contain traces of saliva. However, the ALRC accepts that the taking of bodily material coupled with the intention of causing a genetic test to be conducted without consent could appropriately form the basis of a criminal offence.
Children and parentage testing
The draft provisions set out in the MCLOC Discussion Paper leave the issue of consent to genetic testing by, or on behalf of, a child—including parentage testing—to relevant state or territory law. In Essentially Yours, the ALRC and NHMRC expressed the view that the federal law should recognise a child’s right to give or withhold consent to the testing of his or her own genetic material, where the child has sufficient maturity and understanding of the process and its implications to safeguard his or her own interests. The ALRC and NHMRC recommended therefore that where a child attains 12 years of age, and has sufficient maturity to make a free and informed decision, testing of the child’s genetic material be performed only with the express written consent of the child or pursuant to a court order. The child’s maturity, and the voluntariness of the child’s consent, would need to be assessed by an independent professional, being a family and child counsellor as defined under the Family Law Act 1975 (Cth), a social worker or a psychologist [Recommendation 35–7].
Where a child is under 12 years of age or lacks sufficient maturity to make a free and informed decision, the ALRC and NHMRC recommended that genetic testing should only be performed with the written consent of all persons with parental responsibility for the child, or pursuant to a court order [Recommendation 35–9]. This approach recognises that parents share duties and responsibilities concerning the care, welfare and development of children and protects children against testing by one parent, without the knowledge or consent of the other parent. Where one person with parental responsibility withholds consent or cannot reasonably be contacted, a court would then be authorised to make a decision in relation to the matter. The ALRC and NHMRC also considered that access to counselling before and after parentage testing would minimise the emotional and psychological impact of such testing on the persons involved.
This approach to parentage testing was developed following extensive consultation and consideration. There are a number of issues that stand behind the recommended approach. First, parentage testing does not take place in a legal vacuum. Existing laws already set out a regulatory framework where the testing is conducted for the purpose of family law proceedings. Parentage testing conducted under the Family Law Act 1975 (Cth) is regulated by Part VII Division 12 and by Part IIA of the Family Law Regulations. Those laws provide a benchmark against which ‘unregulated testing’ may be measured.
Second, the information that is revealed by parentage testing is particularly sensitive. Parentage testing goes beyond the common notion of ‘familial information’—it not only provides information about related persons, but goes to the very nature and identity of the family itself. The context in which parentage information is revealed is often highly emotionally charged and may give rise, for example, to feelings of betrayal. This is one reason the ALRC and NHMRC strongly supports pre- and post-test counselling.
Third, parentage testing differs from many other kinds of genetic testing. For many medical purposes, useful information can be obtained by testing the genetic material of a single person, to look for particular markers known to be associated with medical conditions. Parentage testing, by contrast, tests for kinship/relationship—and thus requires the participation of two or more individuals in order to reveal useful information about the biological relationship between those persons. In addition, those who have parental responsibility for the child are directly affected by the outcome of the testing procedure. Under existing Australian law, the outcome of parentage testing may have important consequences for the financial obligations of a father or mother to support and maintain a child. In response to financial incentives, fraudulent practices might arise both in seeking to attribute parentage where none exists, and in seeking to deny parentage where it does exist.
This is not an area in which it is especially useful to draw on the language of ‘rights’—whether that be a child’s ‘right’ to know his or her biological parentage, or a man’s ‘right’ to know who are his biological offspring. Rather, this is an area that requires a careful balancing of interests of mothers, fathers and children in different biological and social relationships with each other. To privilege the interest of one party by accepting a claim to an absolute right fails to give adequate regard to the legitimate interests of others involved in the equation.
Fourth, the direct accessibility of parentage testing currently surpasses that of many other forms of genetic testing. Parentage testing does not require the referral of a medical practitioner, and it is often consumer-initiated. Moreover, direct-to-consumer genetic testing kits (or, more accurately, genetic sampling kits) are readily available, and there is widespread advertising of local and offshore testing facilities via the Internet and other media. For these reasons, some of the detriments associated with widespread and unregulated access to genetic testing have become apparent in the particular context of parentage testing. These may provide valuable lessons for the regulation of other kinds of genetic testing in the future.
For these reasons, it is the ALRC’s view that MCLOC should give further consideration to the question of non-consensual genetic testing of children and, in particular, parentage testing. This issue is examined in considerable detail in Chapter 35 of Essentially Yours.
Causing a genetic test to be conducted
The ALRC notes that, in relation to the offence of obtaining bodily material with the intention of causing a genetic test to be conducted, A must know that B does not consent, or be reckless in relation B’s consent. However, in relation to the offence of causing a genetic test to be conducted, the Discussion Paper indicates that A must know that B did not consent. As the Discussion Paper does not discuss the reasons for the different approach adopted in the two draft offences, it is difficult to know whether this was inadvertent, or there is some inter-relationship with other elements or principles of criminal responsibility specified in the Code.
However, it would seem appropriate in both offences to have to prove that A knows that B does not consent, or is reckless as to B’s consent. In Essentially Yours, the ALRC and NHMRC expressed the view that to require
Use and disclosure of results of genetic testslaboratories, and those that manage them, not be ‘recklessly indifferent’ as to the circumstances in which they receive samples for testing does not impose an unduly onerous obligation. The standard of scrutiny expected of laboratories will depend on the source of the request for testing. For example, where a laboratory receives a request for a routine medical test from a medical practitioner, the laboratory need not ‘look behind’ the request. More scrutiny may be needed where testing, such as parentage testing, is provided directly to the public. In any case, laboratories that take appropriate steps to ensure that relevant consent forms have been signed by the appropriate persons (in circumstances that raise no suspicion about their validity) would not commit any offence. (Essentially Yours [12.62])
In Essentially Yours, the ALRC and NHMRC expressed the view that there would be significant difficulties involved in defining a criminal offence for unauthorised use and disclosure of genetic information (Essentially Yours [12.53]). The MCLOC Discussion Paper does, however, propose a criminal offence for the use or disclosure of genetic information without consent.
The ALRC notes that the consent requirement in the proposed use and disclosure offence relates to the use or disclosure of the genetic information. The offence does not require that the genetic information was derived from a genetic test that was conducted without consent. Thus, it will be an offence to use or disclose genetic information derived from a genetic test, even though the genetic test was conducted lawfully, with informed consent. In the ALRC’s view, however, the primary harm to be addressed by the new criminal offences is the harm to the human dignity and autonomy of an individual by testing a person’s genetic material without his or her knowledge and consent (absent countervailing legal authority, such as a court order).
The ALRC remains concerned and notes that, if this offence is to proceed, it will be important to ensure that all legitimate use and disclosure of genetic information without consent is protected— including, and especially, in the clinical health services and health and medical research contexts.
Currently, the Privacy Act 1988 (Cth) provides that personal information—now defined expressly to include genetic information—may be used in a number of circumstances without consent. For example, health information, including genetic information, may be used and disclosed without consent where: the information is used for public health or safety research (such as epidemiological studies); it is impracticable to seek individual consent; and the research is conducted in accordance with guidelines approved by the Privacy Commissioner.
The current guidelines state that such research only may proceed on the basis of approval by a Human Research Ethics Committee (HREC). The ALRC notes that the proposed defence set out in the MCLOC Discussion Paper—for the use or disclosure of information where the use or disclosure is authorised by or under another law of the State [or Territory] or a law of the Commonwealth—appears to be wide enough to allow this activity to proceed.
The MCLOC has asked for views on whether ‘authorised by or under law’ should be included as a defence or whether the absence of such authorisation should be an element of the offence. In the ALRC’s view, the absence of such authority should form an element of the offence, so that the prosecution is required to establish the absence of such authority, rather than requiring the accused to raise the existence of legal authority as a defence.
One concern that is unlikely to be addressed by the proposed defence, however, is that criminalising the use and disclosure of genetic information without consent may also have a chilling effect on the exchange of information among members of medical treatment teams. Under the Privacy Act, members of a treatment team may use or disclose health information about an individual to each other if such use or disclosure is directly related to the reason the information was collected, and the individual would reasonably expect the information to be used and disclosed in this way. While these provisions do not require express consent to each and every use and disclosure within treatment teams, during the ALRC’s Privacy inquiry we heard evidence that members of the medical profession interpret these provisions in an overly cautious manner, seeking express consent to every exchange. This tendency has the capacity to impact adversely on the treatment of the individual. This issue is considered in detail in Chapter 63 of the ALRC report, For Your Information: Australian Privacy Law and Practice (ALRC 108). The Federal Privacy Commissioner has issued detailed guidance on this matter in Information Sheet 25, Sharing Health Information to Provide a Health Service. The ALRC’s concern is that further regulating the use and disclosure of genetic information—and, in particular, imposing the threat of criminal sanctions for such activity—may exacerbate this over-cautious tendency at the expense of good health outcomes.
MCLOC also may wish to refer to Chapter 25 of For Your Information, which contains a detailed consideration of the Use and Disclosure principle in the Privacy Act.
Finally, the ALRC is concerned that the proposed defences set out in the MCLOC Discussion Paper, including the ‘authorised by or under law’ defence, may not sit comfortably with some broad exemptions from the Privacy Act.
For example, acts done and practices engaged in by media organisations in the course of journalism are exempt from the operation of the Privacy Act 1988 (Cth). This does not mean, however, that media organisations are authorised by or under law to use or disclose genetic information without consent. Thus, while media organisations are largely exempt from the Privacy Act, such organisations will be subject to the new criminal offences, including the proposed new offence for the use or disclosure of genetic information without consent. Consequently, MCLOC may wish to consider the basis for the exemptions set out in the Privacy Act. (The exemption for media organisations and the need to balance the right to freedom of expression with the protection of individual privacy is considered in detail in Chapter 42 of For Your Information.)
The definition of genetic testing
The concept of ‘genetic testing’ is obviously central to the proposed offences, all of which tie in an requirement that such testing be intended or occasioned, or information gained from testing be unlawfully disclosed. However, the ALRC has some concerns that the MCLOC Discussion Paper lacks clarity in this critical area.
Does ‘genetic testing’ require an analysis of DNA to determine identity (for law enforcement or parentage purposes) or to find markers associated with genetic health conditions?
The definition provided in 5.3.1(1) (p 15 of the DP) refers to ‘a test or procedure in which the bodily material of a person is used to reveal genetic information about that person’. There is no reference to DNA testing, and it is possible that many biochemical tests (such as for hypercholestorolaemia) routinely ordered by doctors would fall under this broad definition. It is also likely that many ‘Level 1’ tests—which under the National Pathology Accreditation Advisory Council (NPAAC) Guidelines do not require formal, written consent—would be caught, creating significant uncertainty, if not criminal liability.
The ALRC appreciates the real difficulties in crafting a definition of ‘genetic testing’ which is both precise enough to satisfy the demands of the criminal law and flexible enough to accommodate the rapid advances in science and technology. However, our view is that s 45 of the probably handles this better by referring to ‘an analysis of DNA for the purpose of obtaining scientific or medical information about the person whose body manufactured the DNA’ and the ‘results’ of such an analysis.
In any event, given the critical importance of getting this right, the ALRC strongly urges MCLOC to liaise closely with the NHMRC and NPAAC in formulating an accurate and appropriate definition, before finalising its consultations in this area.
The DP suggests a maximum penalty of two years imprisonment (p 23), based upon the likely harm to, and long-term consequences for, victims and their families, as well as the penalty specified for some other analogous offences.
The ALRC notes that s 45 of the UK Human Tissue Act 2004 specifies a maximum penalty of three years imprisonment; however, we agree with MCLOC that a two year maximum would be preferable in Australia—including the ability of the courts to hear such matters in the exercise of their summary jurisdiction.
The ALRC supports the alternative approach set out on p 35 of the DP—that is, we would prefer that the essence of the suggested defences be incorporated into the elements of the offences, which the prosecution has to establish in the first instance.
See also the discussion above regarding the proposed ‘by or under law’ defence, and the ALRC’s specific concern in relation to ethics-approved health and medical research.