Is a property approach appropriate?

20.19 Submissions made to the Inquiry differed on the benefits of an ownership regime for human genetic samples. A number favoured property rights in genetic material as a means of protecting genetic privacy, with some also suggesting solutions to the drawbacks of taking a property approach.^[20]

Advantages of a property approach

20.20 A property approach to regulating human tissue has a number of advantages, including the following:

•  Property rights can be asserted against others, who do not have the right to deal with the samples. Other persons are under a correlative duty not to interfere with an individual’s rights in a sample, and are disabled from exercising rights over it.
• A property approach overcomes one of the major problems of the current consent-based approach to the use of genetic samples, namely the lack of on-going control. For example, if an individual gives consent for person A to use their tissue, and person A uses it in a manner inconsistent with that consent, the individual has a claim against that person. If, however, person A transfers the sample to company B who misuses it, the individual is not in a legal relationship with company B and generally has no claim against it.^[21]
• A property approach promotes good record-keeping and best practice because researchers are legally required to act in accordance with the rights that others hold in those samples. Similarly, property rights promote consensual use of tissue samples.
• Property rights clarify the gift relationship between donors and researchers by defining which rights over the sample may be transferred, when and how. Property rights promote and regularise the transferability of samples within a commercial setting for the same reasons.
• A violation of property rights gives an individual the ability to bring a legal action for the return or destruction of their property. An individual could bring such an action if his or her genetic samples were being used in a manner contrary to those rights. If these rights had not been alienated, then a claim could be brought against any person who interfered with the samples.^[22]
• Property rights can be transferred to others. Rights to possess and use can be transferred by the individual to researchers, who will then be entitled to deal with the genetic samples in accordance with the right they have acquired.
• Property rights include rights to the income and the capital of an object. Allowing individuals to seek financial returns on the use of their tissue would enable them to share in the profits that are sometimes made from treatments that result from research.

Disadvantages of a property approach

20.21 There are, however, some significant problems with applying property principles to human genetic samples:

• Allowing people to exercise the rights to income and capital of human tissue might be regarded as allowing the human body to be commodified. This may alter community attitudes towards bodies and their parts, and as a result alter how communities perceive and treat living humans.
• Allowing people to exercise the rights to income and capital might also alter the current situation in which individuals freely donate their tissue.^[23] Altruistic participation could be eroded.
• Sale of tissue samples would burden research by increasing costs, which would in turn be passed on to consumers.
• Individuals often discard tissue samples, intentionally or inadvertently, for example cheek cells left on dental floss.^[24] A right of possession vested in the individual from whom the samples are taken might enable that individual to bring an action against others who deal with the samples, regardless of whether they were misusing them, on the basis of interference with the individual’s right to possess the samples.
• By allowing an individual to transfer rights over their tissue samples to someone else, the individual’s interest in what is done with the sample could be lost. The individual would then be precluded from preventing uses of the samples to which he or she objects.
• The recognition of property rights would also undermine the current system of ethical approval for research, where consent to use can be waived in some situations by a Human Research Ethics Committee (HREC).^[25] It is questionable whether it would be lawful to waive consent where a person holds property rights over tissue.
• If genetic samples were regarded as property, de-identification would not extinguish the rights of the person from whom the sample was taken. De-identification is one of the current mechanisms used by researchers, with the approval of HRECs, to enable research to be carried out, while still protecting the privacy of individuals.
• Property rights are difficult to apply to genetic material, which can be copied and reproduced.^[26]
• Property rights in tissue samples are currently grounded in the common law, which develops on a case-by-case basis in response to issues that come before the courts. For this reason, the common law cannot be relied on to produce a timely and comprehensive solution to these problems.

Views on property

20.22 DP 66 proposed that the common law right to possession of preserved samples should continue to be upheld. Responses to both this proposal and the general issue of property rights in tissue samples were varied.

20.23 Many submissions supported maintaining the status quo.^[27] In doing so, a number warned of the consequences that might flow from attempting to alter the current common law position. The Law Society of New South Wales commented that any change ‘must be considered a fundamental shift in the law, and may have myriad unforseen consequences’.^[28] The Law Society recommended that no change be made to the law without further debate. The Queensland Government agreed, stating that ‘for the interim there is wisdom in maintaining the current position and practices in relation to … preserved samples’.^[29]

20.24 Very few submissions disagreed with the efficacy of retaining the law as it currently stands. However, some presented alternative models, aimed at ameliorating the adverse consequences of possessory rights or of full ownership. These alternatives are described below.

20.25 One possible approach precludes individuals from holding property rights in their own genetic material, although hospitals and researchers would be able to have a proprietary interest in samples. This model circumvents problems with individual sale of tissue, while protecting and promoting research and aspects of clinical practice.

20.26 By upholding the possessory rights, this model would allow hospitals and researchers to maintain the integrity of their collections, and would protect samples from arbitrary interference. By not granting other rights (such as rights to the income) hospitals and researchers would be prevented from profiting from samples, and the culture of altruistic participation in research would be maintained. This approach allows for regulation through principles of consent to be maintained. Privacy NSW agreed on the efficacy of using informed consent principles to protect privacy.^[30] Professor Loane Skene agreed with this approach, but advocated fuller property rights than possession for hospitals and researchers.^[31]

20.27 A second approach, proposed by Genetic Health Services Victoria, is a modified version of the approach granting only possessory rights, described above. Tissue samples, such as the blood spots on newborn screening cards, would be owned by the health service that took the sample. However, that ownership would be subject to the requirements of National Pathology Accreditation Advisory Council standards and the Privacy Act.^[32] The Human Genetics Society of Australasia supported this approach.^[33] The Australian Biospecimen Network proposed a similar approach, which would provide hospitals and others with full property rights over tissue to be exercised with regard to the notion of ‘moral ownership’.^[34]

20.28 As discussed above, property law is best understood as a ‘bundle of rights’. A number of approaches took advantage of this fact, and proposed prohibiting individuals from holding particular rights in tissue samples, which may be seen as problematic. For example, a third approach would allow individuals to hold property rights in their tissue to enable them to control its use, but would not give individuals the right to transfer these rights. Doctors and researchers would be able to use tissue samples under some form of lease agreement, after the presentation of a research proposal. It was suggested that lease agreements could be made publicly available and be overseen by an independent body.^[35]

20.29 Rights to income and capital could also be excluded from the ‘bundle of rights’ in order to address concerns about commodification, the erosion of altruistic participation in research, and the cost burden of having to pay for samples. Uniting Care NSW & ACT suggested allowing only limited property rights, in order to prevent commercial exploitation.^[36]

20.30 The Australian Academy of Science argued against individual property rights on the basis that genetic samples should be a community resource for health. The Academy made the point that if genetic samples were the personal property of the individual from whom they were taken, all research use would be encumbered by this interest.^[37] The Life Sciences Network submitted:

We believe that health samples and records (maintained within a system which assures confidentiality about individuals) should be seen as part of our community resource for health, rather than as a form of personal property of the individual receiving care or treatment. The aggregated results of this knowledge bank confer a substantial community benefit.^[38]

20.31 Other approaches focused on the concept of custodianship. Dr Nikolajs Zeps of the Western Australia Tissue Bank suggested a model whereby tissue banks would be able to hold and use tissue as a custodian. The individual would retain the right to withdraw custodianship and could request the destruction or transfer of their samples as they wished:

Ideally the donor would delegate all responsibility for the use of their tissue to a Tissue Bank that distributes tissue under the auspices of [Human Research Ethics Committee] approval for those wishing to use tissue.^[39]

20.32 Each approach could also include a legal presumption that certain rights are transferred when samples are provided to overcome the problems that arise where tissue samples are discarded inadvertently. For example, it could be assumed that in providing a blood sample to a pathology laboratory, the individual transfers a right of possession. It could also be assumed that in some instances individuals have abandoned their rights over genetic samples, perhaps only on the condition that they are not misused.

Inquiry’s views

20.33 As evidenced in other parts of this Report, the Inquiry considers it important to regulate the use of human genetic samples in order to ensure adequate protection of genetic information. In seeking to meet this goal, property rights have some clear benefits: they clarify the legal rights of donor and recipient; they facilitate on-going control by the donor until such time as the property is alienated; they enable the donor or other property owner to seek legal remedies for unlawful interference with propriety rights; and they enable a donor to share in the financial benefits that may accrue from use of the tissue.

20.34 However, the Inquiry has come to the view that the drawbacks of a property approach are considerable and outweigh the potential benefits at the present time. The recognition of property rights in human tissue has developed slowly in a piecemeal fashion under the common law, as new situations have been brought before the courts. As several submissions noted, there may be unforeseen consequences of extending property law to cover genetic samples, due largely to the strength of the rights that property law provides. As a result, property law may be a rather ‘blunt instrument’ for protecting a person’s interest in his or her genetic samples.^[40]

20.35 The Inquiry recognises the need to avoid placing undue burdens on the conduct of research, given the considerable community benefit that is derived from the development of medical treatments and tests. Altruistic participation in research is regarded as beneficial to the community as it reinforces a sense of unity and sharing.^[41] At present, virtually all research participation in Australia, including the use of tissue samples, occurs without remuneration of sample donors. Recognising an individual’s right to sell tissue, as one incident of a property interest, would not only create an additional economic barrier to research, it would undermine the valuable system of community involvement in research.

20.36 Some alternative property models proposed in submissions addressed a number of specific concerns by removing various incidents of property from the ‘bundle of rights’ usually associated with property. However, once all the desirable limitations are imposed to obviate the adverse consequences of full ownership, the effect is very similar to the changes to the Privacy Act recommended in Chapter 8. This view was also expressed in submissions, with the Centre for Law and Genetics commenting that

if the proposal to extend the Privacy Act (and parallel state and territory legislation)to include genetic samples is accepted, then many of the arguments supporting the need to create property rights in genetic samples will be satisfied.^[42]

20.37 On balance, the Inquiry considers that the protection of genetic samples can be achieved more effectively by the changes to the Privacy Act recommended elsewhere in this Report.^[43] In coming to this view, the Inquiry supports the circumstances in which the common law recognises a property right in preserved samples, and the process by which the courts develop the law incrementally in the context of specific cases. However, any legislative reform designed to extend the law of property to genetic samples would require a much broader debate within the community, in which the implications of an extension would need to be carefully weighed. This Inquiry has not been the occasion for such a debate.