從生物剽竊到衡平的生物探勘: 建構取用植物遺傳資源及其相關的民族藥學知識的法理秩序

國立交通大學[[abstract]]本論文旨於理解醫藥研發脈絡下的生物探勘的特質。並透過此認識，界定醫藥研發所使用的傳統知識的法律性質，以及建構規範醫藥研究取用生物遺傳資源以及利益分享的法律體制。 醫藥業理應樂於進入生物探勘契約關係中，以取得其所亟需的「藥引」。不過，自1990年代，醫藥業反而將取用生物遺傳資源及其相關的傳統醫藥知識的初步研究工作，轉包給中小型企業進行，促成「焦點市場」交易的興起。此轉變不僅有損於生物多樣性保育的透明化，也有礙建立衡平的利益分享機制。 為解決此問題，本文重新審視規範取用遺傳資源及其相關民族藥學知識的國際法、國內法和生物探勘契約。透過理解醫學研發脈絡下的法律社會與經濟分析，本文認為在法律陰影下的生物剽竊問題非常嚴重，因為醫藥研發程序漫長，往往超過契約存續時間，而且會有許多轉化，很難監測醫藥業者締約後的道德風險。 如同文化女性主義面對漢茲難題一般，透過脈絡理解與發揮創意，漢茲可以不用偷藥、漢茲的太太也不會死。本文認為不用鎖國、或將生物探勘壓迫到法律陰影下；相反的促進契約交易環境，把生物探勘市場的餅做大，也可以解決生物剽竊的問題。 為了促進醫藥研發的契約交易，本文將傳統知識界定為「民族藥學知識」，以作為正面積極保護傳統知識的依據。就醫藥研發創新累積的脈絡看來，賦予民族藥學知識智慧財產權，可保持原住民知識庫的完整，並提供揭露有用資訊的市場誘因，而其權利型態，可採取營業秘密，或是另類的原住民社群權。不過這不意謂著，其他類型的傳統知識不值得保護，而是說其他類型也要通過社會造福的認證，如傳統農業知識在農業生物科技產業中的貢獻，傳統民俗對音樂產業的助益等等。 不過，定義良好的權利形態只是第一步，如何有效規範生物探勘，締造雙贏，還得設計出可有效運作此權利的法律體制。不管最後所選擇的智慧財產權形態為何，該體制有兩大任務：有效率的代表原住民社群，和提供適當的契約規則來解決資訊交易所帶來的難題。前任務的失敗，往往是生物探勘計畫最後以失敗告終的最主要原因；後者，則是利益分享機制不公平，將醫藥研發成本，大部分轉嫁到資源國和原住民社群身上的癥結。 取用體制在提供契約機制處理資訊不對稱和不確定性上，可扮演非常重要的角色。他們可以發展訊號系統，表明生物遺傳資源和民族藥學知識的品質，以及篩選值得與之締約的公司。研究顯示，藉著發展生物多樣性的登錄和整合資料庫，釐清民族藥學知識和現代醫藥研究之間的介面，可以提高其附加價值，促進資源國競爭力與談判實力，保護其智慧財產權。在監測利益分享機制上，可以透過國際性的認證系統，亦即專利申請時強制揭露預先告知同意，以及採用其他的契約條款，如採用風險平均分配的契約機制，取代目前慣用的低前金、高權利金的誘因效率契約。[[abstract]]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.碩士科技法律研究