From UNESCO’s Declaration to National Law : Challenges of Legislating Community Benefit-Sharing of Genetic Research

In 2003, the idea of community benefit-sharing in the context of genetic research became an international norm in UNESCO’s International Declaration on Human Genetic Data. 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 sufficiently address the problems of implementation? Based on Taiwan’s statutes and regulations, this paper explores these two questions and argues that legally requiring community benefit-sharing is currently premature because numerous problems regarding theoretical justification and practical feasibility remain unsolved. Any countries considering the establishment of community benefit-sharing should more cautiously address the issues that this paper raises