Precision medicine: drowning in a regulatory soup?

Dianne Nicol is a Law Professor at the University of Tasmania, Australia and Director of the Centre for Law and Genetics. The broad theme of her research is the regulation of biotechnology and human genomics and genetics. She is particularly interested in the commercialization of genetic knowledge and patenting of genetic inventions, as well as the specific regulatory issues associated with genetic, genomic, cloning and stem cell technologies, and biobanking. Tania Bubela is Professor and Associate Dean (Research) in the School of Public Health, University of Alberta, Canada. Her research program in intellectual property and health law focuses on barriers to the effective translation novel biotherapeutics and the governance of large collaborative science networks in genomics, gene therapy, and stem cell biology. Don Chalmers is a Law Professor at the University of Tasmania in Australia and was founding Director of the Centre for Law and Genetics. He has broad research interests in the ethical, legal, and social implications of genetic and stem cell technologies. He is Chair of the Data Access Committee of the International Cancer Genome Consortium ICGC and has served on numerous other Australian and international ethics and law reform committees. Jan Charbonneau is a marketing academic. Her research focuses on public attitudes and behaviors, survey methodology, and educational materials including two textbooks. She is currently taking time out of her marketing career to do a PhD in law at the University of Tasmania in Australia looking at how best to protect consumers in the emerging DTC genetic testing market. Christine Critchley is an Associate Professor and social psychologist at Swinburne University, Australia. Her research focuses on public reactions to social issues or dilemmas (including stem cell research, genomics, and biobanking). She leads Swinburne's Computer Assisted Telephone Interviewing Facility and established the Swinburne National Science and Technology Monitor, a representative, annual national survey that tracks public opinion on science and technology. Joanne Dickinson is an Associate Professor in Genetics at the University of Tasmania, Australia and Theme Leader in Cancer, Genetics, and Immunology at the Menzies Institute for Medical Research. Her field of research is the discovery of genetic variants contributing to complex disease and as such has experience with current genetic technologies in her work, preparation of patents, biobanking, and ethical issues surrounding human genetic research. Jennifer Fleming is a Postdoctoral Research Fellow at the Centre for Values, Ethics and the Law in Medicine, University of Sydney, Australia. Her research interests extend across the disciplines of applied research ethics and regulation of biomedical research, particularly concerning disease specific biobanks, clinical trials, novel therapies, globalization of biomedicine, biopolitics, and community engagement. Alex Hewitt completed formal Ophthalmology training in 2011 and the following year he was the Novartis Research Fellow at the Lions Eye Institute in Australia. He is currently a Principal Investigator at the Centre for Eye Research Australia, as well as at the Menzies Research Institute Tasmania, University of Tasmania. His main research interests lie in the molecular mechanisms of blinding eye disease. Jane Kaye is Professor of Health, Law, and Policy at the University of Oxford and Director of the Centre for Law, Health and Emerging Technologies at Oxford: (HeLEX). She investigates the relationships between law, ethics, and practice in emerging technologies in health. The main focus of her research is on genomics with an emphasis on biobanks, privacy, data-sharing frameworks, global governance, and translational research. Johnathon Liddicoat is the Philomathia Postdoctoral Associate in Law at the University of Cambridge and an Adjunct Research Fellow in the Faculty of Law at the University of Tasmania. His research centers around doctrinal patent law and the organization of scientific resources. He is particularly interested in the development and commercialization of genetic technologies, the patenting of genetic inventions, and access to bioresources. Rebekah McWhirter is a Postdoctoral Research Fellow with the Menzies Institute for Medical Research and Centre for Law and Genetics at the University of Tasmania, Australia. Her research focuses on the genetic causes of disease, ethical and legal issues in genetic research, and genetics in Indigenous health. Margaret Otlowski is Dean of Law at the University of Tasmania, Australia and Deputy Director of the Centre for Law and Genetics. She has longstanding experience in health law and bioethics, through research, serving on national committees, and consultancy work for government agencies. Her work has focused on legal and ethical issues in relation to genetics and genomics including privacy, consent, genetic discrimination, and biobanking and other regulatory aspects. Nola M. Ries is Senior Lecturer and Deputy Head of the School of Law at the University of Newcastle, Australia and an External Research Fellow with the Health Law Institute, University of Alberta, Canada. Her research and teaching activities focus on health law, privacy law, research ethics, regulation of new health technologies, and legal aspects of health system reform. She is a recipient of the 2015–16 Australian Fellowship in Health Services Research and Policy. Loane Skene is a Professor of Law in the Melbourne Law School and Adjunct Professor in the Faculty of Medicine, Dentistry, and Health Sciences at the University of Melbourne in Australia. She has broad research interests in health and medical law and has served on numerous Australian ethics and law reform committees. Cameron Stewart is a Professor and Pro Dean at Sydney Law School, Australia. He is a member of the Centre for Health Governance, Law and Ethics and an associate of the Centre for Values, Ethics and the Law in Medicine, Sydney Medical School. He has broad research interests in health and medical law and has served on a number of ethics and law reform committees. Jennifer Wagner is the Associate Director of Bioethics Research for Geisinger Health System and is a practicing attorney in Pennsylvania, USA. She recently served as a 2014–2015 AAAS Science & Technology Policy Fellow in a US Senator's office. Her research has focused broadly on the intersections of anthropology, genetics, and law. She has been particularly interested in DNA ancestry tests, personal genomics in sports, human rights, and separation of powers issues. Nik Zeps is Director of Research at St John of God Perth Northern Hospitals. He has research interests in biobanking, clinical trials, and molecular pathology, as well as ethical regulation of use of human biospecimens and associated clinical data and conduct of clinical trials. He is a founding director of the Australian Clinical Trials Alliance and co-chair of the Communications Committee of the International Cancer Genome Consortium for Precision Medicine. As US President Barack Obama noted in his 2015 State of the Union address, precision medicine promises to deliver ‘the right treatments, at the right time, every time to the right person’ which ‘gives us one of the greatest opportunities for new medical breakthroughs that we have ever seen’.1 These comments were a prelude to a $215 million funding commitment by the President to his Precision Medicine Initiative, the aim of which is to ‘pioneer a new model of patient-powered research that promises to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients’.2 The objectives include an undertaking to modernize the current regulatory landscape. Some six months prior to this address, a group of international scholars in the disciplines of law, biomedicine, bioethics, and the social sciences met at the other end of the world in Hobart, Australia to workshop the challenges involved in formulating a coherent regulatory framework for precision medicine. The inspiration for the workshop title, Leading or Limping? Regulation of Personalized Medicine, came from a famous observation by one of Australia's most eminent High Court judges, Justice Victor Windeyer in the case of Mount Isa Mines Ltd v Pusey (1970) 125 CLR 383 at 395, where he referred to the law as ‘marching with medicine but in the rear and limping a little’. The language of personalized medicine, rather than precision medicine, was used at the workshop, because at that time it was the more common term.3 The terms ‘precision’, ‘personalized’, and ‘medicine’ already hint at some of the regulatory challenges that lie ahead. ‘Precision’ implies that the product or service being offered is accurate and targeted. 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