從羅斯之正義論探討人群生物資料庫之惠益共享

Benefit-Sharing on Population-based Biobank: From the Angle of John Rawls’ “Theory of Justice”

陸詩雅(Shih-Ya Lu)

指導教授 ： 劉幸義

國立臺北大學/法律學院/法律學系/碩士(2009年)

摘要

2003年喧騰一時的「人類基因體計畫」宣告正式完成後，生物醫學之研究重心即轉向於尋找疾病與基因間之關聯，為此台灣亦著手設置台灣生物資料庫。未來商業介入人群生物資料庫之建置及利用已成為難以避免之趨勢，又為維護參與者族群及社會之公眾信賴，人群生物資料庫之研究成果該如何公平、合理的分配即為一重要之議題。

觀察Moore案及Greenberg案可知，毫無限制地承認生物科技產品專利有可能產生下列影響：人體商品化可能對人體的價值產生混淆並造成道德風險；生物科技專利利益的分配不公，也可能構成後續研發與研究的阻礙。Mosk大法官在Moore案中亦指出，僅透過告知後同意之機制似乎仍不足以保障組織樣本提供者之權利。為解決上述問題，本文回歸生物科技在研究、運用上之「惠益共享原則」之探討，並指出「正義」(justice)方為此一議題之中心，因此本文擬以羅爾斯提出之「正義原則」重新出發，試圖尋找一符合正義原則之成果分享模式。

以羅爾斯提出之正義論探討之，就正義第一原則之適用而言，為確保現行法制對於人群生物資料庫利害關係人之基本權利有足夠之保障。就參與者自主權之保障方面，告知後同意制度之設計即為此議題之核心，為探討上開議題，本文就「人體生物資料庫管理條例草案」予以檢討之；就正義第二原則之適用而言，經文獻整理出兩種可能之成果分配方案，其一，賦予參與者就人群生物資料庫之研究成果具體分享之財產權利；其二，不賦予參與者具體分享之財產權，惟透過其他制度上之設計，達成惠益共享(benefit sharing)之成果分配。

第二種分配模式則是主張以參與者之族群、社群為分享對象。而就惠益分享之方式而言，除了金錢上之分享外，尚得以其他之形式為之，此外，就基於資料庫之研究發現，應公開於公眾領域使社會得以利用，以期透過上述方式達成合理之研究成果分配。本文以為第二種分享模式相較於第一種分享模式較能體現差異原則之要求。本文建議在人體生物資料庫管理條例草案中明定對於研究成果分享之具體要求，課與人群生物資料庫之建置者及近用生物資料庫之研究者、研究機構及商業公司具體之成果分享義務，以滿足惠益分享(Benefit-Sharing)原則及基因資訊作為人類共同遺產(Human Common Heritage)之要求。另外，亦可透過主管機關訂定標準之近用契約，並在該近用契約中明定資料庫近用者應負具體之成果分享義務，以達成上開目標。

關鍵字

人群生物資料庫 ； 基因 ； 惠益共享 ； 正義 ； 羅爾斯 ； 族群 ； 自主 ； 公眾信賴 ； 聯合國

並列摘要

Since the completion of the Human Genome Project in 2003, biomedical research begins to focus on understanding the functions of genes and probe thecomplex interplay between genetic and environmental factors in causing commondiseases. Taiwan also launched the Taiwan Biobank project. While commercial involvement is almost inevitable, it is an important issue to maintain public trust, in the mean time to distribute interest reasonably.

We can see from the Moore case and Greenberg case, the unlimited acknowledgement of the patent right derived from biotech product might induce following effect: the commercialization of human body might induce moral hazard; unjust distribution of the interest from biotech’s patent right might hinder the following research and study. In Moore case, judge Mosk also point out that the mechanism of informed consent seems not enough for the protection of those tissue providers. In order to solve the problems mentioned above, this article tries to discuss this issue from the angle of Benefit-Sharing. Through this angle, this article points out that justice is a central issue. Therefore, this article tries to review this issue for John Rawls’ “the theory of justice”, and find a justice model to share the benefit from population-based biobank.

According to theory of justice brought out by Rawls: The first principle requires the law provides sufficient protection for the fundamental right of the concerning parties involved population-based biobank. This article tries to compare two different kinds of distribution model under the difference principle. First kind of model: acknowledge that the tissue provider can share property rights derived from the research. Second kind of model: instead of acknowledging tissue providers’ property rights from participating population-based biobank, the law will provide other kind of mechanism to reach the justice distribution of the research and to match the requirement of the principle of Benefit-Sharing.

The second kind of distribution model inserts that benefit-sharing should not be limited to those individuals who participated in such research. Also, benefit sharing can take different forms and is subject to varying societal and cultural values. It is not
necessarily monetary. The research data based on population-based biobank should be public in the public domain. Through the methods mentioned above to achieve reasonable research results’ distribution. This article holds that the second kind of distribution model will much fit in with the principle of difference. As a result, this article suggests that the draft of Human Biobank Administration Act should have a more concrete requirement for the instructor of population-based biobank and the user of it, such as researchers, research institution, and commercialized company to share the benefit. Though this to fulfill the principle of Benefit-Sharing. Moreover, the official authority may declare standard contract of accessing population-based biobank to make sure that requirement mentioned above to reach the goal of Benefit-Sharing.

並列關鍵字

population ； UNESCO ； public trust ； autonomy ； John Rawls ； justice ； biobank ； gene ； benefit sharing

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