Essentially Ours: Assessing the Regulation of the Collection and Use of Health-related Genomic Information

Abstract

Essentially Ours provides an account of the current modes of regulation of health-related genomic samples and data in Australia. This Occasional Paper revisits some of the issues addressed in the 2003 Report, Essentially Yours, authored jointly by the Australian Law Reform Commission and Australian Health Ethics Committee pursuant to a reference from the Commonwealth Government (‘Essentially Yours’). Essentially Yours emphasised ‘that fundamental human dignity requires that individuals have a high level of control over their own genetic material… and that human genetic information is personal, sensitive, and deserving of a high level of legal protection’. The information presented in this Occasional Paper differs from Essentially Yours in two important ways, largely resulting from the technological and societal changes that have occurred in the intervening years. The first is that the term genetics has been replaced by the term genomics. Genomics refers to the study of the whole genome whereas genetics tends to focus on individual genes. Rapid technological advances mean that genomics is now the most common form of analysis. Secondly, although genomics provides increased clinical and research opportunities, it also raises particular individual and group-member risks. These changes demand reconsideration of the ethical, legal and social implications of and regulatory responses to advances in health-related genomics in Australia.

Although the focus of this Occasional Paper is descriptive—that is, to account for the manner in which current laws apply to genomic samples and data—it necessarily brings to light regulatory gaps and fissures. In particular, traditional regulatory frameworks focus on controls at the level of the individual, either through consent or through efforts to strip genomic information of its identifiers. In the genomic era, these fail to recognise the essential nature of genomic samples and data as inherently identifiable and as shared within families, communities, and populations. This points to the need for a reorientation in the way genomic information is regulated in order to find a balance between ‘yours’ and ‘ours’.

We trust that Essentially Ours will provide a rigorous description of the regulatory landscape relevant to genomics in Australia and a tool for future legal analysis and law reform.

Note:
Funding Information: This work was informed by research undertaken pursuant to a contract for consultancy services from the Australian Government, Commonwealth Department of Health (Health/19-20/06077), as well as work funded by an Australian Research Council Discovery Project grant (DP180100269)

Declaration of Interests: None to declare.

Keywords: genomic data, health data, regulation, health law