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Dr Jeffrey M. Skopek, Lecturer in Medical Law, Ethics, and Policy, Faculty of Law, University of<br />

Cambridge; Deputy Director, Centre for Law, Medicine and Life Sciences<br />

Personalized Rationing: The Law and Ethics of Differentiation<br />

Some of the greatest challenges that we will face in implementing precision medicine will arise from the ways in<br />

which increased precision destabilizes foundational categories and concepts in our law and ethics. This can be seen<br />

in the pharmacogenomic stratification of patient populations, which will give rise to new and difficult questions<br />

about the conditions in which an individual patient should be able to differentiate himself from a group of similar<br />

patients in order to gain access to a treatment that is not available to the group—and conversely, the conditions in<br />

which a patient should be able to resist being differentiated from a group in order to avoid losing access to a<br />

treatment. In this presentation, I will identify and analyze some previously unrecognized challenges concerning the<br />

law and ethics of differentiation in this area. In doing so, I will highlight the fact that advances precision medicine<br />

will both benefit and harm patients, moving us closer not only to personalized treatment, but also to personalized<br />

rationing.<br />

Professor Ock-Joo Kim, Professor and Chair in the Department of Medical History and Medical<br />

Humanities, Seoul National University College of Medicine<br />

Dr Yoon-Jung Chang, Associate Professor of Department of Cancer Control and Policy, Graduate<br />

School of Cancer Science and Policy, National Cancer Center; Associate scientist, Hospice &<br />

Palliative Care Branch, National Cancer Center; Expert secretory, Team of legislation, ethics &<br />

policy, Precision Medicine Working Group, Ministry of Health & Welfare, South Korea<br />

Precision Medicine Ethics: Prospects on Clinical Application and Ethical Issues<br />

Precision medicine is one of the programs that follow-up human genome project, in the hope of developing clinical<br />

applications from the personalized genome information. Individual patient's sequence data in comparison with the<br />

database from a larger population is expected to identify specific variations that contribute to personalized<br />

treatment. This effort depends on the availability of biobanks for general population and for particular disease<br />

groups, such as cancer, for which genomic variations exert large enough influence on the prognosis. Various<br />

treatment regimens must be developed unique to the patterns of variations. Ethical and legal issues also need to be<br />

resolved toward these developments. In South Korea, discussion on the possibility of personalized medicine<br />

became active since 2010, including forums and grants supported by Ministry of Health. Korea has several strengths<br />

in the infrastructure toward the development of precision medicine. Korea Center for Disease Control has<br />

established large biobanks for population-based cohorts and patient cohorts. Korean National Health Insurance<br />

Service maintains health care data for all Koreans that can be used for research. There is a strong infrastructure for<br />

clinical trials including cancer treatment. Capacity for developing new drugs and diagnostic technologies has also<br />

significantly increased. This paper overviews the prospects on precision medicine in Korean contexts, particularly<br />

focusing on ethical and legal issues.<br />

PRECISION MEDICINE: LEGAL AND ETHICAL CHALLENGES 4

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