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An Analysis of International Norm and Legal Systems for Genomic Research and Precision Medicine outside Korea and their Implications for the Korean Legal System

  • Journal of the Korea Bioethics Association
  • 2017, 18(2), pp.77-93
  • Publisher : The Korean Bioethics Association
  • Research Area : Interdisciplinary Studies > Interdisciplinary Research

LEE, Seo-hyung 1

1이화여자대학교

Accredited

ABSTRACT

A recent paradigm shift, triggered and facilitated by the convergence of information and enhanced network connectivity, is effecting changes in medical trends. Precision medicine is one such trend that commands ever-increasing attention. This concept goes beyond the analysis of genomic information through the human genome project—it aims to provide medical care tailored to individual clients by bringing genomic information together with information on their health and everyday life. However, the emergence of genomic research and precision medicine poses various ethical, legal, and social problems. Privacy and secret protection, information security, and the exercise of the right to self-determination are some of the most notable issues arising from the collection of wide-ranging personal information, such as genomic information, from a number of unspecified individuals for the purpose of precision medical services. It has also been pointed out that the advance consent model has a limited effect within the context of precision medicine given its immanent characteristics, and some of the issues that have gained less attention so far, including the sharing of commercial profits, call for further consideration. Major countries outside Korea have engaged in social discussions over an extensive period of time with the aim of establishing legal systems that seek to promote genomic research and precision medicine while ensuring an appropriate level of protection for personal information. This leads to an increasing demand in Korea to follow suit and design a legal system that can provide society with an adequate capacity for addressing the changing trends in genomic research and precision medicine. In light of these considerations, this study presents the legal trends in major non-Korean jurisdictions with the aim of facilitating a social agreement within Korea on the trajectory of development in genomic research and precision medicine as well as on the establishment of a necessary legal system. Indeed, the adequate understanding and consideration of other countries’ legal trends contributes to the continued discussion of which legal system is suitable to Korea. Specifically, this study discusses the Taipei Declaration of the World Medical Association and examines the legal systems on precision medicine and the protection of personal information in such major countries and regional blocs as the U.S., the European Union(EU), and Japan. It is to be noted that the paradigm shift has been continuing over a long period of time: from the first to the third industrial revolutions. Korea is thus not in any particular hurry; what truly matters for Korea will be taking its time and engaging in adequate, long-term social discussions in order to facilitate its efforts to establish a legal system that can promote the development of genomic research and precision medicine.

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