Exploring the implications of collapsing boundaries in health law and ethics

Dr Lisa Eckstein1, Professor Dianne Nicol1, Associate Professor Mark Taylor2, Dr Jessica Bell2

1University of Tasmania, Hobart, Australia, 2Melbourne Law School, University of Melbourne, Carlton, Australia

New technological developments, alongside changing social and funding conditions, are blurring boundaries that have long served to determine responsibilities of persons and entities. This workshop aims to explore the ongoing pertinence of traditionally binary distinctions between, for example, research and clinical practice, private and public, and identified and de-identified. The workshop will provide an opportunity for a facilitated conversation among participants about the potential destabilisation of these demarcations, and what this might mean for future regulatory regimes. Discussion will be triggered by the below scenario: a hopefully realistic portrayal of collapsing boundaries in health law and ethics.

A rare disease program is being run out of a public hospital with funding sourced from a major drug company. A 14-year old patient is admitted to the program after a long-running odyssey to diagnose her progressive muscle wasting. To assist diagnosis, whole-genome sequencing (WGS) is performed on the patient and her biological parents. The program identifies a rare mutation in the patient leading to a diagnosis that previously has only been recorded in fourteen known cases. Based on one available case study, the treating team administer the patient with a drug currently approved for marketing for certain forms of cancer. The patient shows early signs of improvement and her ‘miracle cure’ gains widespread media attention. As a part of the standard protocol for the program, the three WGSs are uploaded to an online database, stripped of identifiers other than country of origin, clinical diagnosis, and self-identified racial/ethnic ancestry. An external research team accesses the sequences and finds a cancer predisposition. They question whether the finding should be returned.


Biographies:

This workshop will be presented by Dr Lisa Eckstein, Professor Dianne Nicol, A/Professor Mark Taylor, and Dr Jessica Bell. The presenters are members of the Centre for Law and Genetics and Helex@Melbourne respectively, where their research focuses on the ethical and legal implications of genetic and other emergent technologies, from multi-disciplinary perspectives. The idea for this workshop stems from a joint meeting of the CLG and Helex@Melbourne, and the presenting authors gratefully acknowledge the contributions of all in attendance.

Authors: Dr Lisa Eckstein, Professor Dianne Nicol, A/Prof Mark Taylor, Dr Jessica Bell, Professor Don Chalmers, Professor Margaret Otlowski, Professor Jane Kaye, Dr Harriet Teare, Dr Megan Prictor, Dr Rebekah McWhirter, Dr Jane Nielson