Abstracts

Health Systems and the Future of Personalized Medicine: A Population Health Perspective

Personalized or precision medicine places patients at the centre of health care. It emphasizes their individuality as persons with both unique biology and personal values and beliefs.  This focus is no means new, but in recent decades has been overshadowed by evidence based medicine which uses results from clinical trials and population based studies to provide a more standardized system of patient management.  Because of ageing populations, increasing patient expectations and technological advances health systems all over the world have also been faced with rising costs. In this talk I will (a) outline the essential characteristics of personalized medicine (b) emphasize the biological heterogeneity of populations using insights from modern genomic science (c) discuss how a refocus on the individual and placing the patient at the centre of a health system may provide one way of reducing health care costs and (d) show how these considerations will require much by way of philosophical and legal analysis and insights from the social sciences.

Professor Henry T. Greely, Deane F. and Kate Edelman Johnson Professor of Law and Professor, by courtesy, of Genetics, Stanford University; Director, Stanford Center for Law and the Biosciences

Precision Medicine: The Ethical, Legal, and Practical Challenges Ahead

The goal of precision medicine, of course, is not research but medicine, the delivery of health care in ways that improve the wellbeing of people and of their societies. The potential for improving healthcare through precision medicine is vast, although perhaps somewhat more limited and somewhat slower in arriving, than in the most expansive hopes. But, as with any good new technology, precision medicine will also raise challenges as we try to incorporate it in ways that maximize its benefits and minimize any risks or harms. These include complex issues of safety regulation, reimbursement, physician duties, and patient privacy and other rights.  Effort spent now considering how to manage foreseeable challenges (and how to spot and respond to unexpected problems) should prove very useful. My talk will try both to highlight some of the difficulties and suggest some possibly useful responses.

Dr Jeffrey M. Skopek, Lecturer in Medical Law, Ethics, and Policy, Faculty of Law, University of Cambridge; Deputy Director, Centre for Law, Medicine and Life Sciences

Personalized Rationing: The Law and Ethics of Differentiation

Some of the greatest challenges that we will face in implementing precision medicine will arise from the ways in which increased precision destabilizes foundational categories and concepts in our law and ethics.  This can be seen in the pharmacogenomic stratification of patient populations, which will give rise to new and difficult questions about the conditions in which an individual patient should be able to differentiate himself from a group of similar patients in order to gain access to a treatment that is not available to the group—and conversely, the conditions in which a patient should be able to resist being differentiated from a group in order to avoid losing access to a treatment.  In this presentation, I will identify and analyze some previously unrecognized challenges concerning the law and ethics of differentiation in this area.   In doing so, I will highlight the fact that advances precision medicine will both benefit and harm patients, moving us closer not only to personalized treatment, but also to personalized rationing.

Professor Ock-Joo Kim, Professor and Chair in the Department of Medical History and Medical Humanities, Seoul National University College of Medicine

Dr. Yoon-Jung Chang, Associate Professor of Department of Cancer Control and Policy, Graduate School of Cancer Science and Policy, National Cancer Center; Associate scientist, Hospice & Palliative Care Branch, National Cancer Center; Expert secretory, Team of legislation, ethics & policy, Precision Medicine Working Group, Ministry of Health & Welfare, South Korea

Precision Medicine Ethics: Prospects on Clinical Application and Ethical Issues

Precision medicine is one of the programs that follow-up human genome project, in the hope of developing clinical applications from the personalized genome information. Individual patient’s sequence data in comparison with the database from a larger population is expected to identify specific variations that contribute to personalized treatment. This effort depends on the availability of biobanks for general population and for particular disease groups, such as cancer, for which genomic variations exert large enough influence on the prognosis. Various treatment regimens must be developed unique to the patterns of variations. Ethical and legal issues also need to be resolved toward these developments. In South Korea, discussion on the possibility of personalized medicine became active since 2010, including forums and grants supported by Ministry of Health. Korea has several strengths in the infrastructure toward the development of precision medicine. Korea Center for Disease Control has established large biobanks for population-based cohorts and patient cohorts. Korean National Health Insurance Service maintains health care data for all Koreans that can be used for research. There is a strong infrastructure for clinical trials including cancer treatment. Capacity for developing new drugs and diagnostic technologies has also significantly increased. This paper overviews the prospects on precision medicine in Korean contexts, particularly focusing on ethical and legal issues.

Professor I. Glenn Cohen, Professor of Law, Harvard Law School; Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics

Legal and Ethical Issues in Using Big Data for Predictive Analytics in Health Care

This talk will discuss a series of legal and ethical issues in using big data for predictive analytics in health care —  the use of electronic algorithms that forecast clinical events in real time to improve patient outcomes and reduce costs. The talk will cover the 4 phases of such projects — collection of data to build a model, building a model, testing the model in real world settings, and wide scale deployment of the model.

Mr Terry Kaan, Associate Professor of Law, The University of Hong Kong; Co-Director, Centre for Medical Ethics and Law

Genetic Information and the Family:  the Future of the Duty of Disclosure and the Limits of Confidentiality

Current paradigms of the legal and ethical relationship between physicians and patients are largely focused on the rights (and obligations) of the individual patient.  What are the implications for current legal and ethical paradigms with the advent of precision medicine, and in particular, if and when whole genome sequencing becomes an ubiquitous and standard procedure?  What legal and moral implications are raised for clinicians in the acquisition and holding of such genetic information, not only at the time of the acquisition of the data, but also for the future as as medical and informational technology advances to make possible and reliable what was not at the time of sequencing?  This presentation focuses in particular on the legal and ethical burdens which may be unwittingly assumed by clinicians (and researchers) for the future when genetic data acquired many years ago may potentially give rise to unanticipated liability in the future.  Clinicians may not be under a legal or ethical obligation to test for conditions for which no reliable test (both as to test methodology as well as to the predictive value of the result) currently exists.  But as technology and genetic knowledge advances, do the same clinicians and data holders acquire an unanticipated burden and obligation if and when technology makes genetic analysis for these conditions cheap and reliable, to the extent that they become standard professional practice?  Is the current focus of the common law on individual rights justified (particularly in the context of the duty of confidentiality, and in the duty to give full disclosure of risks) in the context of heritable genetic data shared by closely related family members tenable for the future, particularly where wishes (and interests) of individual family members are in conflict?’

Mr Tracey Evans Chan, Associate Professor, Faculty of Law, National University of Singapore

Regulatory Challenges of Innovative Therapeutics and Diagnostics in Medical Practice

The advent of new technologies in precision medicine raises the challenge of preparing the healthcare regulatory framework for the potential wave of new therapeutics and associated diagnostics. This presentation will examine some of the issues that arise in ensuring that these new treatments/diagnostics are safe and effective.

Mr Colm McGrath, WYNG Research Fellow in Medical Law and Ethics, Trinity Hall, University of Cambridge

Liability for Failure to Disclose and the Challenge of Precision Medicine

This paper examines the role of personalised medicine in medical intervention and treatment. It does so by focusing on the law surrounding risk disclosure and securing the patient’s consent to treatment in the UK. This is an area of law which has undergone significant change in the last year following the decision of the UK Supreme Court in Montgomery v Lanarkshire Health Board. That decision, which has introduced uncertainty as to when a clinician ought to offer a particular treatment as an alternative to other suggested treatments, has the potential to greatly influence the availability of some precision treatments in practice in the UK.

Professor Darrell Rowbottom, Head of Philosophy & Professor, Lingnan University

On Probabilities in Personalized Medicine

Personalised medicine may involve personalised, ‘one off’, treatments. But how might we arrive at reasonable probability estimates for the success of such treatments? Imagine, for example, that a new drug is synthesised in order to treat a patient. This drug has never been tested before. Moreover, in so far as it is ’tailor made’, it is not possible to test it satisfactorily on anyone other than the patient. So how could a doctor have reasonable grounds for prescribing the drug? Call this ‘the problem of the untestable drug’. In this talk, I’ll propose a solution to it.

Professor Bartha Maria Knoppers, Director, Centre of Genomics and Policy, Faculty of Medicine, Department of Human Genetics, McGill University

Activating the Right of Citizens to Benefit from Scientific Advances

The Framework for Responsible Sharing of Genomic and Health Related Data of the GA4GH is founded on article 27 of the Universal Declaration of Human Rights.   Article 27 maintains the right of citizens to benefit from scientific progress and was enshrined in later binding  international  legal instruments.  How has this right been interpreted?  What does it (or could it) mean? The position that we need to “activate ” this right will create obligations on governments to facilitate and promote data sharing. Supporting this positive obligation may serve to change the imbalance of power between citizens and health researchers , data stewards and physicians as we move more towards translational medicine. 

Professor Kazuto Kato, Professor of Biomedical Ethics and Public Policy, Graduate School of Medicine, Osaka University, Japan

Genomic Medicine in Japan:  Recent Developments in National Policy, and New Ethical and Legal Challenges

Dr Yann Joly, Associate Professor, Faculty of Medicine, Department of Human Genetics, McGill University; Research Director, Centre of Genomics and Policy

Controlled Data Access for Precision Medicine: An Acceptable Trade-Off?

The major goal of translational research in precision medicine will be to link genomic information to personal information collected periodically, including the patient’s lifestyle, clinical history, and response to treatment. These rich datasets will need to be securely shared between researchers from both the private and public sectors to promote rapid scientific advancement and the development of new diagnostics and treatments. ‘’Controlled access’’, a process where researchers requesting access to the data must complete an access agreement for personal and institutional identification, can substantially improve the security of such data sharing initiatives. This presentation will highlight the main component of the controlled access approach to data sharing focussing on its potential for research in personalized medicine. The legal, ethical and social challenges and opportunities of using such an approach will be critically assessed.

Harm, Discretion or Duty: The Changing Nature of the Return of Individualized Results in Genetics Research

The advent of genomic sequencing has generated a rich debate about the potential for generating, interpreting, validating and reporting incidental and secondary findings.  The view that it is desirable to ‘actively look’ for well characterised clinically actionable secondary findings is gaining traction, provided that this can be justified in the participant’s or patient’s best interests. There is less clarity about how these developments might impact on researchers undertaking genetics and genomics research and how these might change the nature of the duties and responsibilities that researchers owe to research participants and the liabilities that might result. This presentation assesses these developments and the extent to which adopting personalised approaches within genomic research might change the nature of the relationship between the researcher and research participant. It also explores some wider consequences for research design, management and funding.

Dr Janice Tsang, Specialist in Medical Oncology, Clinical Assistant Professor Department of Medicine, The University of Hong Kong
Founding Convenor, Hong Kong Breast Oncology Group

Precision Medicine for Cancer Care – Prime Time versus Provocation Threat”?

Cancer is an aging disease and a public health issue. With the emerging aging population, cancer has become an complex health threat with various unmet needs of patients living with the disease. Over the past 2 decades, there have been great breakthroughs in the changing landscape of the management of cancer – from the advent of targeted therapy to personalized treatment to the current second wave of personalized medicine with “Precision Medicine” which involves the increasing visibility of molecular genomic profiling and the potential added value of next generation sequencing which is now moving towards to the clinic at a fast tempo.

While cancer patients and family members are having high expectation on the holistic cancer care and their mindfulness with “Precision Medicine” and the easy access to new information of research and development, this presentation is going to give a bird’s eye view of the current status of Precision Medicine in oncology with updates of the potential clinical application, yet the attempt to comment whether this is the prime time for all cancer patients, or this is just the end of another beginning and the emerging potential ethical challenge with some of the controversies coming from the harvest of translational research.

Professor Donald Chalmers, Distinguished Professor, University of Tasmania; Deputy-Director, Centre for Law and Genetics

Has the Biobank Bubble Burst: A Translational Challenge

Biobanks have been heralded as essential tools for translating biomedical research into practice and for driving precision medicine towards improved pathways for healthcare treatment and services. Biobanking has made significant progress in relation to their ethical, legal and social governance, however, operational, sustainability and funding challenges have emerged. There are questions about their overall viability and value in light of the significant resources, particularly funding, required to keep them running. This is largely influenced by, although not in the least limited to, pressures. This talk reviews four waves of challenges for biobanks since their recognition in the early 2000s, with reference to six countries, and considers some future challenges. This talk had its genesis in a discussion and later joint paper on biobanks during the Centre for Health, Law and Emerging Technologies (HeLEX) conference in Oxford UK, co-sponsored by the Centre for Law and Genetics (University of Tasmania) in 2015.

Dr Kathy Liddell, Herschel Smith Lecturer in Intellectual Property Law; Director, Centre for Law, Medicine and Life Sciences, University of Cambridge

Dr John Liddicoat, Philomathia Post-Doctoral Research Associate in Intellectual Property Law and Genetics, Faculty of Law, University of Cambridge

The Changing IP Landscape for Precision Medicine

A difficult, but crucial, challenge for the future of precision medicine is to improve the translation of basic genomic science into affordable and widely adopted new treatments. This is essential if genomics is to become, as is widely hoped, an everyday reality in healthcare. One issue is how to raise or recoup funding to meet the significant costs associated with understanding how genetic correlations work in particular individuals in a clinically useful way. This is particularly complex in light of the changing landscape of intellectual property incentives for precision medicine. This presentation focuses on two recent IP developments: (1) the dramatic decrease in the economic strength of DNA-related patents following several landmark rulings by the US Supreme Court (for example, Alice Corp, Myriad and Prometheus); and (2) increasing public attention on the IP and access policies for major biobanks, and associated calls for ‘open innovation’. We will also outline some of the new research questions raised by this changing landscape. For example, in what ways have the patent strategies and business models of precision medicine innovators changed? Are other IP rights taking on greater significance?

From Bench to Bedside: Secondary Use of Health Data for Precision Medicine

Many biomedical projects have been relying on large consortia of repositories, such as networks of biobanks, to increase the overall size of bio-samples and data for statistical significance. Nevertheless, the increasing need for transmission and linkage of health data for secondary usage has brought new challenges to translational research. The current models and privacy frameworks for the secondary use of health data focus predominately on techniques and rules of anonymization or de-identification. These data-centric perspectives fail to adequately address issues such as data control, access and sharing, all of which are imperative to data subjects in terms of deciding how they would like their health information to be used for future research. This talk will investigate these challenges, especially with regards to the secondary use of health data in precision medicine. It aims at proposing a transparent and community-based data sharing model to improve the pitfalls of data-centric models for the secondary use of health data in translational research.

Dr Stuart Hogarth, Senior Research Fellow, Department of Social Science, Health and Medicine, King’s College London

Lost on Planet Biomarker? Standards, Pathways, Carrots and Sticks for Diagnostic Development in the Post-genomic Era

In this talk I will situate current debates about the development and regulation of molecular diagnostics in the broader historical context of longstanding efforts to provide greater conceptual clarity and scientific rigour to diagnostic research. I will offer some suggestions as to why repeated complaints of poor scientific standard and calls for reform have had limited impact, review examples of recent initiatives championed by a variety of institutional actors, and conclude by proposing that current developments may finally offer some hope of significant and sustained change.

Dr Timo Minssen, Associate Professor of IP & Innovation Law, University of Copenhagen, Centre for Information & Innovation Law

Lost in Translation? Opportunities & Risks of Increased Research & Clinical Trials Data Transparency

Recent US and European initiatives reflect a growing policy consensus favoring greater clinical trials and research transparency. New legislation, publishers and industry-driven projects promote independent verification of drug data, which provides a better framework for international collaboration. Greater transparency also increases public trust in research results, drugs and industry and the possibility of facilitating large cross-border clinical trials. Yet, the costs and concerns associated with opening up research and clinical trial data are also significant—for patients (protection of personal data and patient privacy), for research (misuse of clinical trial data) and for technology transfer and commercialization (obstacles to IP protection and increased exposure to litigation). This presentation will discuss these issues from an interdisciplinary perspective in order to sketch out legal mechanism that could be useful for unlocking and safe-guarding the full potential of greater transparency.