遺傳資源來源之國際驗證制度研究

Abstract

遺傳資源之取得與利益分享 (Access and Benefit-Sharing，ABS) 制度乃是落實生物多樣性公約目標的重要機制，公約簽約方於2001年通過了「波昂準則」做為各國制訂ABS相關法規的參考，包括事先告知同意、共同商定條件以及利用遺傳資源所衍生之利益應公平合理的分享等三個主要原則。然而由於缺乏有效監控遺傳資源的機制，導致ABS制度並無法在國際上順利推展。為彌補此一缺點，生物多樣性公約論壇開始討論利用驗證制度管制遺傳資源使用者的構想，並成立一個技術專家小組針對此一驗證制度進行初步的討論。本論文將對此一驗證制度進行相關研究，以探討其發展可能性。 論文首先檢視其發展背景。從各國實施ABS制度的經驗中，瞭解到各國立法與執行的問題，並分析出ABS制度在設計上具有遺傳資源之市場外部性、交易成本過高、欠缺法律明確性與監控機制等缺陷，顯示出發展遺傳資源驗證制度的重要性。接著探討此一驗證制度之可能管制模式，如以農產品產銷履歷制度、森林認證管理制度與CITES管制模式與此一驗證制度構想相互比較，發現其較類似於CITES之管制性質。再以此一驗證制度所應具有的合法性及普及性，比較「原產地驗證」、「來源地驗證」、「合法來源驗證」、「符合標準驗證」等四種驗證系統，其中以「合法來源驗證」較符合所需。 而發展此一驗證制度需具有相當的技術條件配合，包括可判別物種差異的DNA分子標記、查詢物種分佈的生物資訊資料庫等應用技術；且實施此一制度將對博物館、植物園、菌種保存機構等大型生物材料保存機構造成相當影響，尤其尚未對其保存材料建立數位資訊系統者需要較高的制度建立成本，因此必須審慎評估建立制度的成本。此外，實施此一驗證制度可能將與目前的貿易與智慧財產權等相關國際法制發生衝突。目前較可行的方式，乃是在申請專利程序中，做為「來源揭露」要件之證明。 本論文對於發展此一驗證制度提出以下建議：（1）肯定此一驗證制度發展；（2）應具有合法性、強制性及普遍適用性；（3）應建立整合性資訊系統；（4）應配合「來源揭露」要件實施。

The regime on accessing to genetic resources and fair and equitable sharing of the benefits arisen from utilization (Access and Benefit-Sharing, ABS) has been one of the major implemented mechanism of the objective of the Convention on Biological Diversity (CBD).The Conference of the Parties (COP) of CBD has adopted Bonn guidelines in 2002, which include the three major ABS principles: prior informed concerned, mutually agreed terms and benefit-sharing, as recommendable guidelines for countries to set up their ABS related legal system. However, without tools for monitoring compliance, the ABS regime could not been practiced effectively. To conquer this deficiency, the CBD forum proposed to create an international certificate system as a tool to monitor the use of genetic resources, and established a Group of Technical Experts (GTE) to deliberate the certificate system. This thesis will discuss the certificate system comparatively and analyze its feasibility. The thesis starts with the examination of the background of this certification proposal. When reviewing the prior experience of ABS regime implementation, there exist some ABS legislative problems and difficulties to apply their ABS provisions for countries; Furthermore, some deficiencies also exist in ABS regime design, for example, high transaction cost of setting up the regime and externality existence which might leads to the market failure of genetic resources. Lack of legal certainty and monitoring mechanism are two major defects of the regime. Thus, the importance of developing the monitor mechanism for the certificate system to use of genetic resources is obvious. By comparing the possible modality of this certificate proposal with agriculture food traceability system, forest sustainable management certificate system and CITES permit system, the thesis suggests that the CITES permit system would be a more probable choice for the future certificate system modality. And when consider the conditions of legitimacy and universality of the four certificate proposal; including “certificates of origin”, “certificate of source”, “certificates of legal provenance” and “certificates of compliance”, the thesis suggests that the “certificates of legal provenance” would be a more suitable choice. To operate the certificate system will need a set of technologies to trace genetic resources flows, such as using DNA molecular marker to distinguish biological species and developing the database to trace their distribution. And enforcing the certificate system will affect some ex-situ collections such as biological museums, botanic gardens and microbial collections, especially for those institutions without computerized database might be too costly to follow the system. Therefore, how to reduce the cost of the certificate system should be deliberated. Besides, enforcing the certificate system might also conflicts with current legislation such as international trade regulations and intellectual property right (IPR) related regulations. The dispute resolution might be served as an evidence of “disclosure obligation” of IPR regime. The thesis concludes the development of the certificate proposal as follows: (1) Confirm the development of the certificate system; (2) The system should be legitimate, mandatory and comprehensively applicable; (3) The system should build with establishment of integrated biological database network; (4) The system could enforced in accordance with the “disclosure obligation” of IPR regime.