Amendment of the Human Tissue Acts

20.38 DP 66 considered whether the Human Tissue Acts might be a useful vehicle for new regulations dealing with the collection and handling of human tissue samples and, in particular, the use of clinical samples for genetic research.^[44]

20.39 The Inquiry considers that amending the Privacy Act as recommended in Chapter 8 is a more effective means of protecting the privacy of genetic samples than amending the Human Tissue Acts. However, amendment of the Human Tissue Acts might be an option for protecting genetic samples if the Privacy Act is not amended as suggested in this Report.

20.40 In its 1977 report, Human Tissue Transplants (ALRC 7), the Australian Law Reform Commission noted that the common law was silent on property in human tissue removed during surgery or otherwise in the possession of a doctor or hospital. The Commission concluded, for the purposes of that project, that there was ‘no reason to endow such tissue with the attributes of property’.^[45] As noted in DP 66, the current uses of tissue samples in genetic research were not envisaged at the time the Human Tissue Acts were enacted.^[46]

20.41 Following the recommendations in the Commission’s report, the Human Tissue Acts were enacted in all Australian jurisdictions.^[47] As outlined in Chapter 18, the Human Tissue Acts provide for the consensual donation of blood, tissue and organs for transplantation, and for scientific, therapeutic or medical purposes. The Acts do not contain provisions dealing with the storage of samples, access to them, transfer to other researchers, or the future use of samples.

20.42 At present, the donation of tissue removed as part of medical treatment, such as sections of tissue excised during surgery or blood leftover from testing, is excluded from the coverage of the Human Tissue Acts.^[48] There is no legislative requirement that consent be obtained to retain and use these samples. Consent to use of samples for further research must be obtained when access to the samples is sought, in accordance with the National Health and Medical Research Council’s National Statement on Ethical Conduct in Research Involving Humans (the National Statement).^[49]

20.43 In his submission, Dr Roger Magnusson referred to this omission in the Acts as a ‘loophole’, and suggested that it had facilitated the development of tissue banks in Australian hospitals and research institutions.^[50] Another submission claimed that researchers obtain samples from tissue banks in order to avoid seeking consent directly from research subjects.^[51]

20.44 The quantity of samples currently stored in research databases and laboratory collections is a major concern for the protection of the privacy of genetic samples. Many of these samples, especially those that were originally taken for therapeutic purposes, are stored without the knowledge or consent of the person from whom they were taken.^[52]

Submissions and consultations

20.45 In DP 66 the Inquiry proposed that the Human Tissue Acts should not used as the vehicle for regulating the collection, storage, access to or use of genetic samples, whether for the purposes of human genetic research or otherwise.^[53] Most submissions agreed with this proposal. For example, the Centre for Law and Genetics submitted that:

we now accept the view of the inquiry that the inclusion of genetic samples in the Privacy Act would provide the optimal solution at the present time. If the proposal to include genetic samples is not accepted, then in our view the question of whether or not the Human Tissue Acts should be extended would need to be revisited.^[54]

20.46 The Victorian Institute of Forensic Medicine submitted that:

the need for legislative clarification of the status of tissue removed in situations and for uses not currently covered by the Human Tissue Acts needs to be debated in a wider context, taking account of the important issues raised by the Discussion Paper in relation to protection of genetic information.^[55]

20.47 The Inquiry is aware of moves to instigate a national review of the Human Tissue Acts.^[56] The Department of Human Services South Australia suggested that the question of whether or not the Human Tissue Acts should be used to regulate the handling of genetic samples should be included in such a review.^[57]

20.48 There are a number of ways in which the Human Tissue Acts could be amended if a national review were undertaken, as suggested in these submissions. These include:

•  comprehensive provisions dealing with consent to the storage and use of genetic samples in research;^[58]
• making tissue removed during medical procedures subject to the consent provisions and other requirements of the Acts;^[59] and
• comprehensive provisions dealing with other aspects of the handling of tissue, including, for example, rules for the storage, use of and access to such tissue.

Inquiry’s views

20.49 The Inquiry’s preferred starting point for any comprehensive reform of the law relating to the collection, storage, use of, and access to, genetic samples is to build on existing information and health privacy legislation. As discussed in Chapter 8, this could be done by ensuring that privacy laws cover the handling of genetic samples, as well as the genetic information derived from them. Regulating genetic samples as well as information through the Privacy Act promotes uniformity and ensures that both are subject to the same regulatory controls.

20.50 If this approach is not adopted, the Human Tissue Acts may provide an alternative means of regulation. For example, amending the Human Tissue Acts could place the use of all human tissue samples under one regulatory scheme, removing confusion and promoting a consistent approach to the use of tissue in research. It could also give individuals a legal basis for complaint if they consider their tissue has been misused, and those who do not comply could be subject to criminal sanctions already provided for in the Acts.

20.51 However, on balance, the Inquiry considers that the Human Tissue Acts have a number of disadvantages, which make their potential extension problematic. One objection is that the storage and use of genetic samples would be regulated differently to the storage and use of genetic information derived from the samples. As a result, there may be overlaps, gaps or inconsistencies between the Human Tissue Acts and privacy laws.

20.52 Furthermore, the Human Tissue Acts were primarily intended to deal with the donation of blood, tissue and organs for transfusion, transplantation, and other therapeutic purposes; the removal of tissue after death; and the regulation of commerce in human tissue. To amend the Acts to regulate other aspects of the handling of human tissue may create unnecessary complexity in the existing legislative scheme.

20.53 The Human Tissue Acts have been reviewed over the last few years to deal with the retention and use of body parts after death. There may be practical reasons to refrain from further change until existing law reform processes have run their course.^[60] As each State and Territory has enacted its own Human Tissue Act in substantially similar terms, any overhaul of the legislation might adversely affect harmonisation and the smooth running of accepted processes for the collection and use of tissue in treatment and research.

20.54 A further argument against amending the Human Tissue Acts is that the Acts require consent to be obtained prior to the removal of tissue. To extend the requirement of prior consent to the collection of research samples that are removed during therapeutic procedures may be administratively onerous, potentially distressing to patients, and inconsistent with the present regulatory framework for the ethical conduct of research, based on the National Statement.^[61] The present regulatory framework provides for the waiver of consent in specified circumstances and gives guidance on the information that should be provided to individuals donating tissue for research. The system for ethical review of research proposals by HRECs allows a flexible approach to be taken on consent issues.

20.55 With these considerations in mind, the Inquiry is of the view that, until such time as the Human Tissue Acts are subject to a comprehensive national review, the regulation of the collection, storage, access to, or use of genetic samples (whether for the purposes of human genetic research or otherwise) should not rely primarily on amendments to the Human Tissue Acts.