PM conference programme_2016.04.05_concise_Clean(Latest)

Precision$Medicine: 

Legal&and&Ethical&Challenges 

7$C 8$April$2016 

Centennial& Campus,&The&University&of&Hong&Kong 

A"Joint"Conference"of 

The$Centre$for$Medical$Ethics$&$Law 

of$the$University$of$Hong$Kong 

and 

The$Centre$for$Law,$Medicine$&$Life$Sciences 

of$the$University$of$Cambridge 

Precision$medicine$promises$to$revolutionize$ 

disease$treatment$and$prevention$by$capitalizing$ 

on$personal$variation$in$genes,$environment$and$ 

lifestyle.$$ 

Scientific$and$technological$advances$hold$the$ 

potential$to$bring$about$unprecedented$advances$ 

in$customizing$medical$treatment$and$health$care$ 

to$the$individual. 

International$experts$in$law,$medicine$and$ethics$ 

will$convene$7$C 8$April$2016$at$the$University$of$ 

Hong$Kong$for$a$crossCdisciplinary$meeting$on$ 

challenges$and$opportunities$in$research$and$ 

clinical$care$to$shape$the$future$of$precision$ 

medicine. 

Thursday$&$Friday,$7$C 8$April$2016 

Large&Moot&Court,&2/F,&Faculty&of&Law 

Centennial&Campus,&The&University&of&Hong&Kong

Programme 

Thursday, 7 April, 2016 

8:00am – 9:00am Registration 

9:00am – 9:10am Welcome 

Terry Kaan & Kathy Liddell 

9:10am – 9:40am Opening Address 

Ron Zimmern: “Health Systems and the Future of Personalized Medicine: 

A Population Health Perspective” 

I. CHALLENGES IN THE IMPLEMENTATION OF PRECISION MEDICINE 

►► PART 1: THE HEALTH CARE SYSTEM 

9:40am – 10:20am Keynote 

Henry T. Greely: “Precision Medicine: The Ethical, Legal, and Practical 

Challenges Ahead” 

10:20am – 10:50am Morning Break 

10:50am – 11:30am Presentations 

Jeffrey M. Skopek: “Personalized Rationing: The Law and Ethics of 

Differentiation” 

Ock-Joo Kim and Yoon-Jung Chang: “Precision Medicine Ethics: 

Prospects on Clinical Application and Ethical Issues” 

11:30am – 1:00pm Roundtable 

Chair: Hilary Burton 

1:00pm – 2:00pm Lunch [1/F Podium, Cheung Yu Tung Tower, Centennial Campus, The 

University of Hong Kong] 

►► PART 2: MEDICAL TREATMENT 

2:00pm – 2:40pm 

2:40pm – 4:30pm 

4:30pm – 6:00pm 

7:00pm – 

Keynote 

I. Glenn Cohen: “Legal and Ethical Issues in Using Big Data for Predictive 

Analytics in Health Care” 

Presentations 

Terry Kaan: “Genetic Information and the Family: the Future of the Duty 

of Disclosure and the Limits of Confidentiality” 

Tracey Evans Chan: “Regulatory Challenges of Innovative Therapeutics 

and Diagnostics in Medical Practice” 

Afternoon Break 

Colm McGrath: “Liability for failure to disclose and the challenge of 

precision medicine” 

Darrell Rowbottom: “On Probabilities in Personalized Medicine” 

Roundtable 

Chair: Ron Zimmern 

Private Dinner 

Speakers and Invited Guests 

PRECISION MEDICINE: LEGAL AND ETHICAL CHALLENGES 1

Friday, 8 April, 2016 

II. CHALLENGES IN THE DEVELOPMENT OF PRECISION MEDICINE 

►► PART 1: FOUNDATIONAL RESEARCH 

9:00am – 9:40am 

9:40am – 11:30am 

11:30am – 1:00pm 

1:00pm – 2:00pm 

Keynote 

Bartha Maria Knoppers: “Activating the Right of Citizens to Benefit from 

Scientific Advances” 

Presentations 

Kazuto Kato: “Genomic Medicine in Japan: Recent Changes in the 

Government Policy, and New Ethical and Legal Challenge” 

Yann Joly: “Controlled Data Access for Precision Medicine: An Acceptable 

Trade-off?” 

Morning Break 

Alison Hall: “Harm, Discretion or Duty: The Changing Nature of the 

Return of Individualized Results in Genomics Research” 

Janice Tsang: “Precision Medicine for Cancer Care - Prime Time versus 

Provocation Threat?” 

Roundtable 

Chair: Henry T. Greely 

Lunch 

►► PART 2: TRANSLATIONAL MEDICINE 

2:00pm – 2:40pm 

2:40pm – 4:30pm 

4:30pm – 6:00pm 

6:00pm – 6:10pm 

7:00pm – 

Keynote 

Donald Chalmers: “Has the Biobank Bubble Burst: A Translational 

Challenge” 

Presentations 

Kathy Liddell & John Liddicoat: “The Changing IP Landscape for 

Precision Medicine” 

Chih-Hsing Ho: “From Bench to Bedside: Secondary Use of Health Data 

for Precision Medicine” 

Afternoon Break 

Stuart Hogarth: “Lost on Planet Biomarker? Standards, Pathways, Carrots 

and Sticks for Diagnostic Development in the Post-genomic Era” 

Timo Minssen: “Lost in Translation? Opportunities & Risks of Increased 

Research & Clinical Trials Data Transparency” 

Roundtable 

Chair: I. Glenn Cohen 

Closing Remarks & Acknowledgements 

Jeffrey M. Skopek 

Official Conference Dinner 

Speakers, Delegates, and Invited Guests 


Abstracts 

Thursday, 7 April, 2016 

I. CHALLENGES IN THE IMPLEMENTATION OF PRECISION MEDICINE 

►► PART 1: THE HEALTH CARE SYSTEM 

Dr Ron Zimmern, Chairman, PHG Foundation 

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. 


►► PART 2: MEDICAL TREATMENT 

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 implcations 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. 


Friday, 8 April, 2016 

II. CHALLENGES IN THE DEVELOPMENT OF PRECISION MEDICINE 

►► PART 1: FOUNDATIONAL RESEARCH 

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 Changes in the Government Policy, and New Ethical 

and Legal Challenge 

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. 


Ms Alison Hall, Head of Humanities, PHG Foundation 

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

Genomics 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 KongFounding 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. 


►► PART 2: TRANSLATIONAL MEDICINE 

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? 


Dr Chih-Hsing Ho, Assistant Professor, Academia Sinica, Taiwan 

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. 


Biographies 

Dr Hilary Burton, Director, PHG Foundation 

Hilary Burton was the PHG Foundation’s Programme Director before 

becoming its Director (CEO) in 2010. She is a highly experienced public health 

physician who believes passionately that genomic science can, and should be 

used by public health professionals alongside the social and environmental 

determinants of health to bring about improvements in population health. Her 

special interests include the integration of genomics within mainstream 

medicine, genetics education for health professionals, and genomics and the 

developing world. Hilary trained at St Hugh’s College and The Radcliffe 

Hospital, Oxford and became a consultant in public health medicine in 1993. 

She was a member of the Department of Health’s Human Genomics Strategy 

Group and currently serves on the Joint Committee of Medical Genetics of the 

Royal Colleges and the Council for the British Society of Human Genetics. She 

is a Fellow of Hughes Hall, Cambridge, and holds an Honorary Lectureship at 

the University of Cambridge. 

Professor Donald Chalmers, Distinguished Professor, University of 

Tasmania; Deputy-Director, Centre for Law and Genetics 

Donald Chalmers is Distinguished Professor at the University of Tasmania and 

in the Centre for Law and Genetics. He is a Foundation Fellow of the Australian 

Academy of Law and a Fellow of the Australian Academy of Health and Medical 

Sciences. In 2010, he received the NHMRC Ethics Award, the Distinguished 

Service Medal, University of Tasmania and the Australian Red Cross 

Distinguished Service Award. His major research interests focus on medical 

research ethics and the regulatory aspects of human genetics. He has been chief 

investigator on Australian Research Council discovery grants, with colleagues on 

the legal, ethical and governance implications of genetics, particularly 

commercialisation, biobanking and personalised medicine and on an NHMRC 

program grant on cancer genetics, He has published in health law and genetics, 

research ethics and law reform criminal law, legal studies trusts, authored a 

number of government and Law Reform Commissioner reports and made regular 

submissions to government enquiries. Throughout his career, he has been 

involved in teaching, administration and served on many State, national and 

international committees. 


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

University of Singapore 

Tracey Evans Chan is an Associate Professor in the Faculty of Law, NUS, and 

specializes in biomedical law and ethics. He has published in the field both locally 

and internationally, and served in a number of Singapore expert committees on 

matters such as surrogacy, transplant ethics, human-animal combinations in 

biomedical research and mitochondrial germline modification. Professionally, he 

was called to the Singapore Bar in 1998 and then spent two years clerking for the 

Supreme Court of Singapore before joining academia. He recently concluded a 

year-long secondment to the Singapore Ministry of Health as a Deputy Director 

in the Regulatory Policy and Legislation Division, where he assisted in the policy 

work for the recently enacted Human Biomedical Research Act 2015. 

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 

Yoon-Jung Chang, M.D., Ph.D, is actively participated in policy development in 

hospice & palliative care (HPC) in South Korea. She was a representative 

interviewee of South Korea for ‘the 2015 Quality of Death Index: Ranking 

palliative care across the world’ a report by the Economist Intelligence Unit. Her 

major research interests focus on HPC policy, and risk communication and 

biomedical ethics in cancer care & Cancer research. Recently she joined the 

Precision Medicine Working Group, Ministry of Health & Welfare as an expert 

secretory. 


Professor I. Glenn Cohen, Professor of Law, Harvard Law School; 

Director, Petrie-Flom Center for Health Law Policy, Biotechnology & 

Bioethics 

Glenn Cohen is a Professor of Law at Harvard Law School and Director of the 

Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics. He is 

one of the world's leading experts on the intersection of bioethics and the law, as 

well as health law. He was the youngest professor on the faculty at Harvard Law 

School both when he joined the faculty in 2008 (at age 29) and when he was 

tenured as a full professor in 2013 (at age 34). His current research projects relate 

to health information technologies, mobile health, reproductive technology, 

research ethics, rationing in law and medicine, health policy, FDA law and medical 

tourism. He is the author of more than 70 articles and chapters and his awardwinning 

work has appeared in leading legal medical, bioethics, and public health 

journals. Prior to becoming a professor he served as a law clerk to Judge Michael 

Boudin of the U.S. Court of Appeals for the First Circuit and as a lawyer for U.S. 

Department of Justice, Civil Division, Appellate Staff, where he handled litigation 

in the Courts of Appeals and (in conjunction with the Solicitor General’s Office) 

in the U.S. Supreme Court. In his spare time, he still litigates, most recently having 

authored an amicus brief in the U.S. Supreme Court for leading gene scientist Eric 

Lander in Association of Molecular Pathology v. Myriad, concerning whether human 

genes are patent eligible subject matter, a brief that was extensively discussed by 

the Justices at oral argument. 

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 

Hank Greely is the Deane F. and Kate Edelman Johnson Professor of Law and 

Professor, by courtesy, of Genetics at Stanford University. He specializes in 

ethical, legal, and social issues arising from advances in the biosciences, 

particularly from genetics, neuroscience, and human stem cell research. He 

directs the Stanford Center for Law and the Biosciences and the Stanford 

Program on Neuroscience in Society; chairs the California Advisory Committee 

on Human Stem Cell Research; and serves on the Neuroscience Forum of the 

Institute of Medicine, the Advisory Council for the National Institute for General 

Medical Sciences of NIH, the Committee on Science, Technology, and Law of 

the National Academy of Sciences, and the NIH Multi-Council Working Group 

on the BRAIN Initiative. He was elected a fellow of the American Association 

for the Advancement of Science in 2007. He graduated from Stanford in 1974 

and from Yale Law School in 1977. He served as a law clerk for Judge John Minor 

Wisdom on the United States Court of Appeals and for Justice Potter Stewart of 

the United States Supreme Court. After working during the Carter 

Administration in the Departments of Defense and Energy, he entered private 

practice in Los Angeles in 1981 as a litigator with the law firm of Tuttle & Taylor, 

Inc. He began teaching at Stanford in 1985. 


Ms Alison Hall, Head of Humanities, PHG Foundation 

As Head of Humanities at the PHG Foundation, Alison is actively involved in 

policy analysis, evaluation and implementation. Professionally qualified as a lawyer 

and a nurse, with a master’s qualification in health care ethics, her work focuses 

on ethical, legal and social issues (ELSI) in biomedical technologies, and includes 

regulatory and legal policy analysis and briefings on the governance of human 

tissue, data protection and in vitro-diagnostic devices reform. Recent work 

includes leading a two year policy development project working with stakeholders 

on the ethical, legal and societal implications of implementing genomic 

sequencing into clinical practice (Hall A, Finnegan T, Alberg C, PHG Foundation 

(2014) Realising Genomics in Clinical Practice. ISBN 978-1-907198-15-1) and 

contributing legal and regulatory analysis to a report on data sharing to support 

clinical genetics and genomics practice (Data sharing to support UK clinical 

genetics and genomics services, PHG Foundation (2015) ISBN 978-1-907198-20- 

5). At EU policy level, with the Wellcome Trust, she has led advocacy on the 

genetic testing provisions in the proposed EU in vitro diagnostic devices 

regulation. Internationally, she has chaired a group developing a Data Sharing 

Lexicon as part of the regulatory and ethics activities of the Global Alliance for 

Genomics and Health. She has also co-authored PHG Foundation reports on 

ethical, legal and societal impacts of biotechnological advances including genomic 

stratification in cancer prevention and non-invasive prenatal diagnosis, and has 

over 20 peer-reviewed publications. Nationally, she has contributed to 

professional guidance including ‘Consent and Confidentiality in Clinical Genetic 

Practice’ published by the UK Joint Committee on Genomics in Medicine. She 

is currently on the UK Data Access Committee for METADAC, on the ethics 

and policy committee of the British Society for Genetic Medicine, and is a lay 

member of an NHS research ethics committee. 

Dr Chih-Hsing Ho, Assistant Professor/Assistant Research Fellow, 

Academia Sinica, Taiwan 

Chih-hsing Ho is Assistant Professor/Assistant Research Fellow at Academia 

Sinica, Taiwan. Her research focuses on the nexus of law and medicine in general, 

with particular attention to the governance of genomics and newly emerging 

biotechnologies, such as big data and biobanks. She is currently a Co-Principal 

Investigator for a health cloud project in Taiwan, and is responsible for designing 

an adequate regulatory framework for the secondary use of personal data and 

health-related data linkage. She holds a Ph.D. in law from the London School of 

Economics (LSE) where she was an Olive Stone Scholar. She obtained her first 

law degree from Taiwan, and later received her LLM from Columbia Law School 

and a JSM from Stanford University. Before moving back to Taipei in 2014, she 

had been working at the Centre for Medical Ethics and Law (CMEL) at the 

University of Hong Kong. 


Dr Stuart Hogarth, Senior Research Fellow in the Department of Social 

Science, Health and Medicine at King's College London 

Stuart Hogarth is a Senior Research Fellow in the Department of Social Science, 

Health and Medicine at King's College London. His research focuses on the 

political economy of diagnostic innovation. His work combines empirical research 

on the development, assessment and adoption of diagnostic technologies, with 

normative analysis of public policy and commercial strategy. He has produced 

reports on intellectual property rights and regulatory frameworks in personalized 

medicine for the European Commission, Health Canada and the Human Genetics 

Commission. 

Dr Yann Joly, Associate Professor, Faculty of Medicine, Department of 

Human Genetics, McGill University; Research Director, Centre of 

Genomics and Policy 

Yann Joly, Ph.D. (DCL), Ad.E. is a Lawyer Emeritus from the Quebec Bar and 

the Research Director of the Centre of Genomics and Policies(CGP). He is a 

research fellow from the Fonds de recherche du Québec- Santé (FRQS) and an 

associate researcher at the Centre de recherche en droit public (Université de 

Montréal). He also works as an ethics and legal consultant in the private sector 

and serves as the Data Access Officer of the International Cancer Genome 

Consortium (ICGC). His research activities lie at the interface of the fields of 

intellectual property, health law (biotechnology and other emerging health 

technologies) and bioethics. He has served as a legal advisor on several ethics 

committees in the public and private sectors. Prof. Joly is a member of the 

Scientific Committee of the legal journal Lex Elextronica and an Advisory Board 

member of the Current Pharmacogenomics and Personalized Medicine Journal. 

He recently received the Quebec Bar Award of Merit (Innovation) for his work 

on the right to privacy in the biomedical field. 

Mr Terry Kaan, Associate Professor of Law, The University of Hong 

Kong; Co-Director, Centre for Medical Ethics and Law 

Terry Kaan’s research interests span from tort law to medical ethics and law. He 

has published articles and book chapters with regard to the issues of traditional, 

contemporary and alternative medicine, and genetic privacy. His current research 

is on how genetic testing impacts doctor-patient relationship. 


Professor Kazuto Kato, Professor of Biomedical Ethics and Public 

Policy, Graduate School of Medicine, Osaka University, Japan 

Kazuto Kato, PhD is Professor of Biomedical Ethics and Public Policy at the 

Graduate School of Medicine, Osaka University, Japan. He is also Project 

Professor of the Institute for Integrated Cell-Material Sciences (iCeMS) at Kyoto 

University. He has a PhD degree in developmental biology from Kyoto 

University. After finishing postdoctoral research at the University of Cambridge 

with Sir John Gurdon, he started to work on the ethical and social issues of 

genomics and stem cell research. He has been serving as members of various 

international projects/academic societies such as Ethics Committee of Human 

Genome Organization (HUGO) (Currently, HUGO Committee on Ethics, Law 

and Society), ELSI group of the International HapMap Project. In 2010, he was 

appointed as a member of the Expert Panel on Bioethics of the Council for 

Science, Technology and Innovation Policy (CSTP) of the Cabinet Office, Japan. 

Professor Ock-Joo Kim, Professor and Chair in the Department of 

Medical History and Medical Humanities, Seoul National University 

College of Medicine 

Ock-Joo Kim, M.D., Ph. D., a graduate from Seoul National University College 

of Medicine, trained in biomedical ethics and medical history at University of 

Minnesota, Harvard University and Western IRB. Since 2002 she has worked in 

research governance systems including establishment of the KAIRB (Korean 

Association of IRBs). After the Hwang Scandal, she collaborated with various 

governmental agencies and academia to rebuild research ethics systems and 

promote research ethics education in Korea. As an expert in biomedical research 

ethics, she was involved in the total revision of the Bioethics and Safety Act and 

the operation of the National Bioethics Policy Institute. She is currently director 

of the Center for Human Research Protection at the Seoul National University 

Hospital and a member of IRBs in university and hospitals. She serves as a 

member of various government committees in bioethics including Central 

Advisory Committee of Korean Ministry of Food and Drug Administration, and 

Expert Committee under National Bioethics Review Boards. As a member of the 

Board of Trustees of the Korean Bioethics Association and the Korean Society 

for Medical Ethics, she played major roles in publishing biomedical ethics 

textbooks in Korea, including Clinical Ethics (2014) and Medical Ethics (2015). Her 

main research areas are clinical ethics, research ethics, and public health ethics and 

she has published many articles including recently “Ethical considerations of 

MERS-CoV outbreaks in Korea.” 


Professor Bartha Maria Knoppers, Director, Centre of Genomics and 

Policy, Faculty of Medicine, Department of Human Genetics, McGill 

University 

Bartha Maria Knoppers, PhD (Comparative Medical Law), holds the Canada 

Research Chair in Law and Medicine (Tier 1: 2001 - ). In 2007, she founded the 

international Population Project in Genomics and Society (P3G) and 

CARTaGENE Quebec’s population biobank (20,000 indiv.). Former holder of 

the Chair d’excellence Pierre Fermat (France: 2006 - 2008), she was named 

Distinguished Visiting Scientist (Netherlands Genomics Initiative) (2009 - 2012) 

and received the ACFAS prize for multidisciplinarity (2011). She is Chair of the 

Ethics Working Party of the International Stem Cell Forum (2005 - ); Co-Chair 

of the Sampling/ELSI Committee of the 1000 Genomes Project (2007 - 2013); 

Member of the Scientific Steering Committee of the International Cancer 

Genome Consortium (ICGC) (2009- ); Chair, Regulatory and Ethics Working 

Group - Co-Founder and Member, Transitional Steering Committee (TSC) of the 

Global Alliance for Genomics and Health. She holds four Doctorates Honoris 

Causa, is Fellow of the American Association for the Advancement of Science, of 

The Hastings Center (Bioethics) and of the Canadian Academy of Health Sciences 

(CAHS) and Officer of the Order of Canada and of Quebec. She also received an 

award “Prix Montreal In Vivo: Secteur des sciences de la vie et des technologies 

de la santé” in 2012 and in 2013 was named “Champion of Genetics” by the 

Canadian Gene Cure Foundation. 

Dr Kathy Liddell, Herschel Smith Lecturer in Intellectual Property Law; 

Director, Centre for Law, Medicine and Life Sciences, University of 

Cambridge 

Kathy Liddell is Herschel Smith Lecturer in Intellectual Property Law and 

Director of the Centre for Law, Medicine and Life Sciences in the University of 

Cambridge. Her research focuses on a variety of issues such as patent protection 

in the field of pharmaceuticals and medical diagnostics, and the regulation of 

medical research and complex technologies such as genetic testing and stem cell 

products. She is the author of a wide range of articles in leading academic journals, 

a number of reports and briefing papers, and is co-editor of The Limits of Consent 

(OUP 2009). 


Dr John Liddicoat, Philomathia Post-Doctoral Research Associate in 

Intellectual Property Law and Genetics, Faculty of Law, University of 

Cambridge 

Conference Rapporteur 

John Liddicoat joined the University of Cambridge in October 2015 after 

submitting his PhD at the University of Tasmania; he also holds a BSc(Hons) and 

LLB(Hons) from the University of Melbourne. His research interests lie in the 

development and use of new technology. John has published work on various 

intellectual property law issues, and enjoys commentating on doctrinal issues as 

well as emergent scientific issues – he is particularly interested in genomic and 

biotechnology related developments. John has a keen interest in the design of 

legal research and uses a broad range of qualitative and quantitative methods. His 

two current primary areas of research are: 1. Investigating the role of intellectual 

property rights in genomic medicine; and 2. Examining innovation policies 

adopted by biobanks. John has also contributed to law reform in Australia. He 

has co-authored submissions to various law reform enquiries and has also been 

invited to give oral evidence to a legislative committee. 

Mr Colm McGrath, WYNG Research Fellow in Medical Law and 

Ethics, Trinity Hall, University of Cambridge 

Colm McGrath is a member of the Cambridge Centre for Law, Medicine and Life 

Sciences based at the Faculty of Law, where he has taught Tort Law, Contract 

Law, Comparative Law, European Legal History and Roman law. Between 2009 

and 2014 he was a scientific assistant at the Institute for European Tort Law in 

Vienna and a lecturer at the University of Graz where he taught private law and 

healthcare law. His research focuses on the comparative analysis of private law 

and the nature of professional liability, in particular the liability and regulation of 

the medical profession. He is the Co-General Editor of the long-running Journal 

of Professional Negligence and the Book Reviews Editor for the Journal of 

European Tort Law. 


Dr Timo Minssen, Associate Professor of IP & Innovation Law, University 

of Copenhagen, Centre for Information & Innovation Law 

Timo Minssen’s research concentrates on Intellectual Property, Competition- & 

Regulatory Law with a special focus on the pharma, life science & biotech sectors. 

His studies comprise a broad variety of legal issues that emerge during the lifecycle 

of related products and processes—from the regulation of research and incentives 

for innovation to technology transfer and commercialization. Timo is also 

scientific advisory board member of the Copenhagen Centre for Regulatory 

Sciences (CORS) and co-heads the Copenhagen Biotech & Pharma Forum 

(CBPF). He is a frequent lecturer on a variety of biotech and pharma related topics 

with many publications in leading international journals. In 2012 he published the 

comprehensive study “Assessing the Inventiveness of Biopharmaceutical 

Technology under European and US Patent Law,” which was awarded with the 

Swedish King Oscar stipendium. He is also a regular contributor on Harvard Law 

School’s “Bill of Health” blog. At present he is collaborating with Oxford 

University Press on a book in pharmaceutical competition law. 

Professor Darrell Rowbottom, Head of Philosophy & Professor, 

Lingnan University 

Darrell P. Rowbottom is Professor and Head of Philosophy at Lingnan 

University, Hong Kong. His research focuses on general issues in the philosophy 

of science (e.g. scientific method, scientific realism, and scientific progress) and 

the philosophy of probability (e.g. intersubjective probability and measurement 

paradoxes). He also has interests in epistemology, metaphysics, and the 

philosophy of education. His textbook Probability was recently published 

by Polity Press; an edition in simplified Chinese is set to be published by Shanghai 

People’s Publishing House. He is currently completing a research monograph, 

The Instrument of Science, which articulates and defends a new form of 

instrumentalism about science. 

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 

Jeffrey Skopek’s research interests centre on advances in the biosciences that 

destabilize categories and concepts that play a foundational role in our law and 

ethics. He is currently working on projects that explore challenges posed by 

developments in personalized medicine, biobanking, and big data. He previously 

taught at Harvard Law School, where he was a research fellow at the Petrie-Flom 

Centre for Health Law Policy, Biotechnology, and Bioethics. Prior to entering 

academia, he served as a law clerk to the Chief Judge of the United States Court 

of Appeals for the First Circuit. He has been awarded Fulbright, Gates, and 

Truman Scholarships and holds a J.D. (magna cum laude) from Harvard Law 

School, a Ph.D. and M.Phil. in the History and Philosophy of Science from the 

University of Cambridge, and an A.B. in History (with distinction) from Stanford 

University. 


Dr Janice Tsang, Specialist in Medical Oncology, Clinical Assistant 

Professor Department of Medicine, The University of Hong 

KongFounding Convenor, Hong Kong Breast Oncology Group 

Janice Tsang is the Clinical Assistant Professor at the Department of Medicine, 

and the Assistant Dean (Alumni Relations) at the Li Ka Shing Faculty of Medicine, 

The University of Hong Kong. Her research interests lie mainly in breast oncology 

including conduction of clinical trials, translational research and psychosocial 

oncology. Being the first female academic medical oncologist at The University 

of Hong Kong, Dr. Tsang was awarded the 2014 Hong Kong Ten Outstanding 

Young Persons Award, and the 2012 Hong Kong City Lady Award (Professional 

& Academic Category) as the only medical professional receiving this award for 

the year. She was also the winner of the Psychosocial Oncology Young 

Investigator Award at the 16th Hong Kong International Cancer Congress & 6th 

Annual Meeting of Centre for Cancer Research in 2009 and was bestowed the 

Faculty Teaching Medal in 2012, and the Outstanding Teaching Award (Team 

Award) for Medical Humanities in 2013 in recognition of her being one of the 

pioneers in incorporating Medical Humanities in the formal medical curriculum. 

She has conducted over 70 clinical trials including local, regional and international 

multi-centred clinical trials, and has been serving as Chairperson for Data 

Monitoring Committee, Steering Committee Members for major multi-centred 

clinical trials, and various International and Regional Advisory Boards. She is a 

key opinion leader in breast oncology both locally and regionally. She is also the 

Founding Convenor of the Hong Kong Breast Oncology Group (HKBOG) 

which is now a member of the “Breast International Group” (BIG), being the 

third Asian member after Japan and Taiwan. 

Dr. Tsang is currently the Programme Director for Medical Oncology in the Hong 

Kong Island at the Hong Kong College of Physicians, a member of the Coordinating 

Committee (CoC) for Medical Oncology at the Hospital Authority, and 

the Deputy Chairperson for the Institutional Review Board for the Hong Kong 

West Cluster/ HKU, She was the Director of Cancer Centre at the Queen Mary 

Hospital (2014-2015), and she has various appointments in different professional 

bodies such as the Honorary Advisor for various cancer self-help groups including 

the Hong Kong Christian Cancer Care Association, Hong Kong Caner Fund etc. 

She is also the Founding Vice President of the Hong Kong Women Doctors 

Association, and Warden of the Starr Hall, HKU. 


Dr Ron Zimmern, Chairman, PHG Foundation 

Ron Zimmern is a Public Health Physician with a special interest in public health 

genomics and personalized medicine. He is Chairman of the Foundation for 

Genomics and Population Health, the ‘PHG Foundation’, the successor to the 

Public Health Genetics Unit which he established in Cambridge in June 1997 and 

on which he served as its Director until 2010. 

Ron graduated in 1971 following medical training at Trinity College, Cambridge 

and the Middlesex Hospital, London. He specialized initially in neurology, and 

was appointed Lecturer at the Clinical School in Cambridge in 1976. He obtained 

a law degree at Cambridge in 1983, after which he trained in public health 

medicine. He was Director of Public Health for Cambridge and Huntingdon 

Health Authority from 1991 to 1998, and of the Institute of Public Health at the 

University of Cambridge from 2002 to 2008. He was for many years an Associate 

Lecturer at the University of Cambridge and has been an Honorary Consultant in 

Public Health Medicine at Addenbrooke's Hospital. 

Ron has served on many national committees concerned with genomics in the 

UK since 1997. He has an Honorary Professorship in Public Health at the 

University of Hong Kong and sits on the Management Committee of its Centre 

for Medical Ethics and Law. He is also a member of the External Advisory 

Committee of the University of Cambridge’s Centre for Law, Medicine and Life 

Sciences within the Law Faculty; and of the Centre for Personalized Medicine at 

St Anne’s College, Oxford. He is a Life Fellow of Hughes Hall in Cambridge and 

a Fellow of Hong Kong University and of the University of Cardiff. He now 

serves as a Non-Executive Director of Papworth Hospital and on the Ethics 

Advisory Committee of Genomics England. His special interests and expertise, 

in addition to public health genomics and personalized medicine, include strategic 

planning, the relationship between clinical services and teaching and research, 

priority setting in the NHS, and the law and ethics of medicine. 

Note: Abstracts and Biographies are subject to change 

Contact Information 

Contact LML 

Centre for Law, Medicine and Life Sciences 

University of Cambridge 

lml@law.cam.ac.uk 

http://www.lml.law.cam.ac.uk 

Contact CMEL 

Centre for Medical Ethics and Law 

The University of Hong Kong 

cmel@hku.hk 

www.cmel.hku.hk

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