标题: | 从生物剽窃到衡平的生物探勘: 建构取用植物遗传资源及其相关的民族药学知识的法理秩序 From Biopiracy to Equitable Bioprospecting: Constructing A Legal Regime for Medicine Research, Access, and Benefit-sharing |
作者: | 许全义 Chuan-Yi Hsu 倪贵荣 Kuei-Jung Ni 科技法律研究所 |
关键字: | 生物剽窃;生物探勘;交易成本;生物多样性;文化女性主义;取用体制;契约;智慧财产权;营业秘密;生物遗传资源;民族药学知识;传统知识;关怀伦理;公有地悲剧;反公有地悲剧;保育;经济分析;诱因效率契约;风险平均分配契约;资讯不对称;道德风险;取用与利益分享;医药研究;biopiracy;bioprospecting;transaction cost;biodiversity;cultural feminism;access institution;contract;intellectual property right;trade secret;genetic resource;ethnobotanical knowledge;traditional knowledge;care ethics;tragedy of commons;tragedy of anti-commons;conservation;economic analysis;incentive-efficient contract;optimal risk-sharing contract;information assymetry;moral hazards;access and benefit-sharing;medicine research |
公开日期: | 2006 |
摘要: | 本论文旨于理解医药研发脉络下的生物探勘的特质。并透过此认识,界定医药研发所使用的传统知识的法律性质,以及建构规范医药研究取用生物遗传资源以及利益分享的法律体制。 医药业理应乐于进入生物探勘契约关系中,以取得其所亟需的“药引”。不过,自1990年代,医药业反而将取用生物遗传资源及其相关的传统医药知识的初步研究工作,转包给中小型企业进行,促成“焦点市场”交易的兴起。此转变不仅有损于生物多样性保育的透明化,也有碍建立衡平的利益分享机制。 为解决此问题,本文重新审视规范取用遗传资源及其相关民族药学知识的国际法、国内法和生物探勘契约。透过理解医学研发脉络下的法律社会与经济分析,本文认为在法律阴影下的生物剽窃问题非常严重,因为医药研发程序漫长,往往超过契约存续时间,而且会有许多转化,很难监测医药业者缔约后的道德风险。 如同文化女性主义面对汉兹难题一般,透过脉络理解与发挥创意,汉兹可以不用偷药、汉兹的太太也不会死。本文认为不用锁国、或将生物探勘压迫到法律阴影下;相反的促进契约交易环境,把生物探勘市场的饼做大,也可以解决生物剽窃的问题。 为了促进医药研发的契约交易,本文将传统知识界定为“民族药学知识”,以作为正面积极保护传统知识的依据。就医药研发创新累积的脉络看来,赋予民族药学知识智慧财产权,可保持原住民知识库的完整,并提供揭露有用资讯的市场诱因,而其权利型态,可采取营业秘密,或是另类的原住民社群权。不过这不意谓着,其他类型的传统知识不值得保护,而是说其他类型也要通过社会造福的认证,如传统农业知识在农业生物科技产业中的贡献,传统民俗对音乐产业的助益等等。 不过,定义良好的权利形态只是第一步,如何有效规范生物探勘,缔造双赢,还得设计出可有效运作此权利的法律体制。不管最后所选择的智慧财产权形态为何,该体制有两大任务:有效率的代表原住民社群,和提供适当的契约规则来解决资讯交易所带来的难题。前任务的失败,往往是生物探勘计画最后以失败告终的最主要原因;后者,则是利益分享机制不公平,将医药研发成本,大部分转嫁到资源国和原住民社群身上的症结。 取用体制在提供契约机制处理资讯不对称和不确定性上,可扮演非常重要的角色。他们可以发展讯号系统,表明生物遗传资源和民族药学知识的品质,以及筛选值得与之缔约的公司。研究显示,藉着发展生物多样性的登录和整合资料库,厘清民族药学知识和现代医药研究之间的介面,可以提高其附加价值,促进资源国竞争力与谈判实力,保护其智慧财产权。在监测利益分享机制上,可以透过国际性的认证系统,亦即专利申请时强制揭露预先告知同意,以及采用其他的契约条款,如采用风险平均分配的契约机制,取代目前惯用的低前金、高权利金的诱因效率契约。 The thesis has analysed the main issues in the design of national legal systems and institutions for bioprospecting. It focus on the economic exchange process of actors in bioprospecting and the structure of the drug industry as the main basis for conducting the analysis. In order to promoting optimal contracting for drug R&D, it has defined the right of the traditional knowledge. Using the theory of cumulative innovation and evidence listed in investigations of ethnobotany and ethnopharmacology, it argues for a narrower definition for traditional knowledge, in the sense of ethnobotanical knowledge in the case of drug research. It shows that when traditional knowledge is defined in this way, two main incentive effects accrue: to keep the knowledge pool in its entirety and the incentive to reveal valuable information. Thus defined, the right can take the form of either a trade secret or a community intellectual property right. This does not mean, however, that knowledge which falls outside the purview of ethnobotanical knowledge should not be protected. In fact, the thrust should be on conducting similar excercises in the case of traditional agricultural knowledge vis-□-vis agricultural biotechnology, traditional folklore vis-□-vis the music industry, and so on. However, a well-defined right with an easily segregable set of benificiaries is only the first step. A large onus rests on the design of institutions that will put this right into an enforceable framework. Whatever mode of intellectual property option is chosen for the right, the institutions have two major tasks: that of representing the communities effectively and of providing for rules of contract that take into account the difficulties of dealing with information as a resource. In other words, they should minimize principle-agent problems between communities and the access authority, and try to eradicate many of the market imperfections, especially related to information asymmetries and uncertainty. Access institutions could play a critical role in providing contractual mechanisms to deal with information asymmetries and uncertainty. They can help signal the quality of genetic resources and ethnobotanical knowledge, and can also screen for contract-worthy firms. It has been shown that when access institutions add value to in situ genetic diversity by way of creating inventories of genetic resources, and sort out the interface between ethnobotanical knowledge and modern drug research by investing in ethnobotanical databases, they can facilitate better bargaining conditions amongst parties. The problem of monitoring profits to ensure that the firm then still shares profits with the communities and the access authorities can be enforced through mechanisms such as the international certification systems and other contractual provisions, for example, adopting the contract mechanism of the optimal risk-sharing rather than the incentive-efficient one. |
URI: | http://140.113.39.130/cdrfb3/record/nctu/#GT009138504 http://hdl.handle.net/11536/60045 |
显示于类别: | Thesis |
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