Oral Presentation Australasian Association of Bioethics & Health Law and New Zealand Bioethics Conference

Law and genomic data sharing: beyond consent (1006)

Norah Grewal 1 2 , Ainsley J Newson 1 2
  1. Australian Genomics, Melbourne, Australia
  2. The University of Sydney, Sydney Health Ethics, Sydney School of Public Health, Sydney, Australia

A key aspect of genomics is the sharing of genetic and related health data: across borders, among unrelated entities, and between clinical and research contexts. But uncertainty abounds, both because these contexts are intermingling and because technological advances put pressure on existing regulation. In this paper, we draw on relevant examples to explore and assess potential legal barriers to genomic data sharing in Australia. We find that it can be difficult to utilise the nascent concept of ‘translational research’ because the Australian information privacy statutes treat research and healthcare as discrete purposes. For example, a laboratory that wishes to share existing clinical data for research must satisfy a ground such as consent each time. But even when people give consent to share, in some states the laboratory might only be able to share with interstate or overseas recipients when the obtained consent is specific to this transfer. That is, broad consent – commonly used when obtaining research permissions in clinical practice – is not sufficient for all cross-border genomic data transfers. However, consent is merely one of several lawful grounds for sharing. If other grounds like ‘public interest’ are under-explored, then consent risks becoming an unjustified ‘cure-all’, impractical to apply at scale. Similar grounds exist within the new European General Data Protection Regulation. In response, we highlight opportunities for Australian legal reform that build on existing grounds for sharing genomic data beyond consent. These would harmonise the current overlapping regime without requiring a complete overhaul, nor specific regulation.