Benefit-sharing in pharmaceutical research and development of population-based biobank: An analysis of sample providers

• Main Authors: Michael,Ching-Chuan Yang, 楊慶泉
• Other Authors: Wenmay Rei
• Format: Others
• Language: zh-TW
• Published: 2005
• Online Access: http://ndltd.ncl.edu.tw/handle/61571800885830502425

碩士 === 中原大學 === 財經法律研究所 === 93 === The population-based biobank (“the Biobank”) is a database with information on primarily medical history, and genes from representatives of a population. A benefit of publication, intellectual property rights, and pharmaceuticals may be derived from pharmaceutical research and development with the Biobank; however, the benefit-sharing among the participants thereof is arguable. For example, (i) unlikely a right to initiate the share of the benefit by a group, sample providers and interest-related people thereof (their family and/or the ethnic group); (ii) even under the interest-of-conflict, the party including decision-makers, fund-sponsors, bio-medical researchers in public section, private organizations, clinical institutes, academies, etc., still can share the benefit. Relative disadvantage to the group is obvious. It is therefore necessary to provide a solution with reasonable and convincing legal basis to the group in sharing the benefit, fairly and reasonably. In order to propose a legal right to the group, the legal position for a gene shall be interpreted beforehand because the gene/genetic information is key element in the Biobank. The genetic information released from the gene can be categorized into four kinds: genetic information related to (1) monogenetic diseases, (2) polygenetic diseases, (3) multifactorial diseases (genetic attribution predictable), and (4) multifactorial diseases (genetic attribution un-predictable) and non-specific disease. This article humbly concludes a gene in the Biobank may have the right to non-property, including privacy, autonomy, and personality; but only have limited rights to a property, under laws of intellectual property and civil, and a human heritage (common wealth). The right to the human heritage might be only for the fourth genetic information. The right to intellectual property might be claimed by the person having one of the first three kinds of genetic information. An individual alone might not be properly entitled to have the civil-property right, because the gene is likely shared by the group, sample providers and related people thereof. Should the group right be legally considered and admitted, the group related to one of the first three kinds of genetic information might be properly entitled to share the civil-property right. Nonetheless, the rights of a sample provider are likely inconsistent with those of the related people thereof and/or the population. With the four kinds of genetic information, this article provides ways to harmonize the individual interest and the public benefit through (A) prohibiting the interest-of-conflict among the advantageous parties so as to reduce improper share of the benefit; and further with some legal opinions to clarify the fourth genetic information involved, (B) protecting sample providers’ genetic privacy with coded measures, (C) carrying out the feasible way to re-contact and receive the re-consent from sample-providers and/or related people, and (D) legitimatizing the right to share the benefit Together with the enactment of regulation and entitlement of rights to the group, the chance to reduce conflict-of-interest and to share the benefit reasonably shall not be impossible.