人群生物資料庫之醫研成果分享 －以樣本提供者為中心－

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

楊慶泉(Michael,Ching-Chuan Yang)

指導教授 ： 雷文玫

中原大學/商學院/財經法律研究所/碩士(2005年)

https://doi.org/10.6840/cycu200500640

摘要

人族群生物資料庫主要包括人群之代表者的醫療記錄，及其基因之資訊。藉族群生物資料庫醫研使用，可獲得論文發表、智慧財產權，及醫藥品的成果；然而其間的參與者，對成果之分享係俱爭議性。例如，（i）樣本提供及其利害相關者之群體，似無法積極分享成果；（ii）包括公部門、私人機構、醫療院所，及學術單位之決策者、經費贊助者、研發人員等之一方，即使在利益衝突之下，亦可共享成果等。對此群體之相對不利益係為明顯。故，提供此群體合理的法律上權利以分享成果，有其必要。
因為基因/基因資訊是資料庫中的重要內容，所以基因的法律地位應先探究，以能提供該群體一法律上的權利。本文建議將基因資訊分為四類。四類基因資訊分別為：（1）單基因疾病之基因資訊、（2）多基因疾病之基因資訊、（3）多因子疾病基因資訊（可算基因機率），及（4）多因子疾病基因資訊（無法算基因機率）與「一般基因資訊」。四類均享有基因隱私權、自主權，及人格權之非財產權，但對基因智慧財產權、民法之一般財產權，及人類共同遺產之財產權則有限。僅第四類基因資訊可為人類共同遺產；前三類基因資訊可主張基因智慧財產權。個人不宜擁有民法之一般財產權，因為基因可能為樣本提供及其利害關係者之群體所共有。若可考慮並承認群體權益的存在，前三類基因資訊可主張基因之民法上一般財產權。然而，樣本提供者與利害相關者及/或其人群的利益，可能不一致。利用四類基因資訊，本文提出相關的調和之道： (A) 禁止得利一方之利益衝突，以降低不當的成果分享；再利用一些法律見解以釐清第四類基因資訊的相關情況，而能 (B) 配合適當的加密方式，保護樣本提供者之隱私；(C) 以可行的方式對樣本提供者、及/或其利害相關者，進行再告知及再同意的取得；（D）成果分享的權利具法律效應。
結合管制立法，及群體權利的賦予，降低利益衝突並合理分享成果，並非不可能。

關鍵字

基因資訊 ； 人類共同遺產 ； 藥物基因體學 ； 智慧財產權 ； 人族群生物資料庫

並列摘要

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.

並列關鍵字

human heritage ； intellectual property rights ； genetic information ； pharmacogenomics ； population-based biobank

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