The impact of development of population-based study in the biomedical field on laws and regulations: a cross-strait experience on biobank development.

Abstract

Together with the completion of the Human Genome Project, biomedical research has marched into the "Post-Genomic Era." In order to take advantage of this extracted gene related information extensively and precisely so as to realize man's biological phenomena as well as the mechanism of pathogenesis, consequentially, a large scale sample collection of different geological areas and/or ethnic groups becomes necessary for the future population based genetic research of a country and, in turn, the construction of population-based genetic database (Biobank). In recent years, both mainland China and Taiwan have not only made great progress in information and computation technologies, but have also gradually taken a close look into the quality of medicine delivery. Thus, it becomes unavoidable for both sides to create each one's population-based genetic databases (Biobank). Theoretically speaking, the Biobank development shall benefit the study on the correlation between genes and disease and also the solution for disease treatment as well. At the same time, medical diagnostic technology has also been significantly improved. It is believable that the population-based genetic database might be utilized to promote medical quality and to reduce the cost of public health delivery. Further; in the near future, it might become the "raw materials "for medical research application. However when taking promotion of public welfare as the premises for a Biobank development, the severe and multi challenge occurred against the traditional legal rules in terms of the privacy protection, public trust development, the compliance of informed consent principle, the implementation of benefit-sharing doctrine and the possible discrimination concern about the population/participants selection and some other ELSI issues. In this paper, the major legal issues encountered by the Biobank development will first be reviewed accompanied by the background information concerning the Biobank development scenario crossing the Taiwan Strait. Also, mainly following the realm of comparative policy or legal approaches, the paper learning from the fruits of this comparative study, tries to propose some recommendations for future legislative consideration by both mainland China and Taiwan. It's been this author's wish that, when establishing a large scale population based Biobank, the promotion of public trust shall be placed as the primary goal together with the emphasis on supporting publicity and transparency on the administrative practices, so as to encourage the public participation in observing the principle of altruism and, in turn, benefit the future biomedicine development.