Abstract
In 2003, the idea of community benefit-sharing in the context of genetic research became an international norm in the International Declaration on Human Genetic Data of the United Nations Educational, Scientific and Cultural Organization. Article 19 of the Declaration states that "benefits resulting from the use of human genetic data, human proteomic data or biological samples collected for medical and scientific research should be shared with the society as a whole and the international community". This abstract principle is no longer a mere ethical suggestion. Taiwan's Human Biobank Management Act, newly enacted in 2010, has transferred this ethical norm into national law. Article 21, Paragraph 1 of the Act mandates that the "profits resulting from the commercial use of an operator and biobank shall be shared with the population or specific groups to which the respective participants belong". The Ministry of Health then promulgated the Regulations for Benefit-Sharing of the Commercial Use of Human Biobanks to provide more specific content and contour of this mandate.However, before implementing this moralistic idea into actual circumstances, two critical questions must be answered. First, is a requirement of community benefit-sharing actually justified? Second, can legislatures or agencies devise clear and feasible mechanisms that effectively address numerous problems of implementation, such as deciding with whom benefits should be shared, distributing benefits, and monitoring and enforcing benefit-sharing? Especially, it is one thing to provide it to the world as an ethical recommendation; it is another to make it a legal requirement. Legislating this idea must consider whether substantial governmental interest exists, whether the action that the law adopts substantially advances the purpose, and whether the rule is clear enough to be followed. Otherwise, such legislation would constitute an undue burden on academic freedom.This article argues in three parts that legally requiring community benefit-sharing is currently premature because theoretical and practical problems remain unsolved. Part I introduces the development of community benefit-sharing. Part II analyses and questions the rationales of community benefit-sharing. Finally, Part III explores the practical problems of implementing community benefit-sharing.