Inquiry’s views

19.92 The handling of samples and information held in human tissue collections is regulated by a complex, fragmented and overlapping set of legislation and guidelines. In relation to some aspects of the handling of some genetic samples and information there is no clear need for further regulation because detailed rules have already been established and are observed.

19.93 An example is the current regulation of retention periods for pathology laboratory samples and records. As discussed above, NPAAC guidelines contain comprehensive and specific minimum requirements for retention of laboratory records and diagnostic materials, reflecting best laboratory practice.^[127] Pathology laboratories must comply with NPAAC guidelines in order to be accredited and ongoing accreditation requires periodic assessment.^[128] Laboratories also have to comply with federal, state or territory information and health privacy legislation. Such legislation generally requires that personal information, such as that in laboratory records, be destroyed or de-identified if it is no longer needed for the purpose for which it was collected.^[129] In the circumstances of a complaint or investigation by a privacy regulator, the specific requirements of the NPAAC guidelines, which require retention of records for minimum periods primarily for review and confirmation of results, can be tested against more general legislative standards requiring destruction or de-identification when the records are no longer needed.

19.94 The implementation of many of the recommendations made elsewhere in this Report would strengthen the privacy protection and other regulation of genetic samples and information held in human tissue collections. For example, the Inquiry’s recommendation that the Commonwealth, States and Territories enact new legislation to require laboratories to be accredited for genetic testing would ensure more complete compliance with NPAAC guidelines (see Chapter 11).

19.95 Similarly, while the National Statement already governs the use in research of genetic samples and information held in human tissue collections, the Inquiry makes a range of recommendations intended to strengthen the protection provided by the National Statement. These include recommendations made in relation to mechanisms for achieving compliance with the National Statement, waiver of consent and obtaining consent to unspecified future human genetic research (see Chapters 14 and 15).

19.96 Importantly, while the handling of newborn screening cards is generally subject to Commonwealth, state and territory information and health privacy legislation, the Inquiry has recommended that new legislation should be enacted to ensure that minimum, legally enforceable, privacy standards apply to the handling of all genetic samples (see Chapter 8).

19.97 Certain aspects of the regulation of human tissue collections require further attention. In particular, submissions and consultations highlighted continuing professional and public concern about the long-term storage and secondary use, in research and law enforcement, of newborn screening cards. The Inquiry has concluded that these concerns require a regulatory response. Participation in newborn screening programs is vitally important for detecting certain treatable genetic conditions at an early stage and full participation in these programs should be encouraged. Lack of clarity about retention periods and permissible secondary uses may undermine newborn screening programs.

19.98 For this reason, the Inquiry recommends that Australian Health Ministers’ Advisory Council (AHMAC) develop nationally consistent rules in relation to the collection, storage, use and disclosure of, and access to, newborn screening cards. These rules will need to be consistent with the minimum privacy standards set out in information and health privacy legislation, but should augment those legislative standards with more specific provisions.

19.99 As discussed above, a key area of concern relates to the disclosure of newborn screening cards for law enforcement purposes. Privacy legislation allows disclosure of personal information where it is reasonably necessary for the enforcement of the criminal law or of a law imposing a pecuniary penalty, or for the protection of the public revenue.^[130] These provisions are permissive only—they permit agencies or organisations holding personal information to disclose it without breaching privacy legislation, but do not require disclosure. It is therefore open to those agencies or organisations holding newborn screening cards to restrict the circumstances in which they will disclose them. The MOUs developed in New South Wales and Victoria constitute an attempt to do so in those jurisdictions. However, there is no national consistency in the procedures by which police or other law enforcement agencies may obtain access to newborn screening cards.

19.100 The Inquiry recommends, in particular, that AHMAC, in consultation with state and territory Attorney-General’s Departments and police services should develop nationally consistent rules governing disclosure of newborn screening cards for law enforcement purposes. These rules should provide for disclosure only with the consent of the person sampled or a person authorised to consent on his or her behalf, or pursuant to a court order, including a search warrant.

19.101 Another area of concern is in relation to the secondary use of newborn screening cards in research. While there have been some attempts to articulate policies on research use of these collections, the issue clearly requires further attention from state and territory health authorities, and the development of a national approach through AHMAC. There should be broad consultation to assess and define the potential research value of newborn screening card collections—for example, whether research use should be limited to epidemiological studies using de-identified samples. If collections of newborn screening cards are to be used commonly in research, health authorities need to review the consent processes they use, and may need to engage with their communities in a discussion about the acceptable research uses of newborn screening cards.

19.102 Newborn screening card collections constitute perhaps the best known and most extensive collections of human genetic samples. However, while newborn screening card collections are the subject of much of the detailed discussion in this chapter and were the focus of many of the concerns expressed in submissions and consultations, the need for nationally consistent rules in relation to other human tissue collections should be reviewed by AHMAC. The issues raised in relation to the secondary use in research and for law enforcement purposes also apply to other human tissue collections. The need for additional regulation of human tissue collections may depend in part on the implementation of recommendations made elsewhere in this Report—notably in relation to the Inquiry’s recommendation that new legislation be enacted to ensure that minimum, legally enforceable privacy standards apply to the handling of all genetic samples (see Chapter 8).

19.103 Accordingly, the Inquiry recommends that AHMAC, in consultation with the Human Genetics Commission of Australia (HGCA), the NHMRC and key professional bodies, should review the need for nationally consistent rules in relation to the collection, storage, use and disclosure of and access to other human tissue collections, including collections of pathology samples and banked tissue.

19.104 In developing these rules, it will be important to identify and balance the relevant ethical considerations, including those applying at individual and community levels. At the individual level, respect for the personal autonomy of parents and concern to benefit the health of newborn children can be in tension. In this context, the narrative experiences of families may be valuable. At a community level, the ethical considerations include the benefit of research and the enforcement of criminal law to the community. The development of these rules should be informed by an ethics of discussion.^[131]