Study On The System Of Access To Human Genetic Resources And Benefit Sharing

The Human Genetic Resources play an important role in the biomedical research. Due to the life patent, the biotechnological products developed from the human tissues may bring great economic interests, thereby causing a dilemma that the patentee and biotechnology company share the high profits while the human genetic resources providers are excluded from the circle of interests. This thesis discusses the tough issue and designs the innovative means to resolve it.Except for the preface and conclusion, this article consists of four chapters.Chapterâ… introduces two typical cases of access to human genetic resources and benefit sharing in the U.S., and presents the problems encountered in China.Chapterâ…¡analyzes the legal nature of human genetic resources. First, this article points out the distinction in the legal basis between human genetic resources and animal & plant genetic resources. Second, this paper discusses that the tissues separated from the body have the characteristics of thing and the ownership of the removed tissues belongs to the originator. Finally, this thesis states that human genetic resources provider is neither the patentee nor the joint inventor pursuant to the patent law. Therefore, human genetic resources providers do not share the patent rights but share the interests brought by the biotechnology products.Chapterâ…¢discusses the mechanism for access to human genetic resources. First, this article examines informed consent doctrine both in the physician-patient context and in the researcher-tissue source context, thereby requiring researchers or physicians to disclose the potential commercial interests in the human tissues. Then, this paper proposes that genetic privacy of research participant shall be protected due to the fact that genetic information is paramount to one's life.Chapterâ…£discusses the mechanism for benefit sharing. First, this article states that the justification of benefit sharing is participant's property rights in human tissues. Second, the scope of benefit sharing, clarified in this thesis, includes not only the profits of the products but also the diagnostic and therapeutic tools developed from the human resources. Third, after analyzing two models raised by the U.S. scholars, this article proposes the alternative model that would protect the interests of the human genetic resources providers and motivate the development of biotechnology...