生物剽竊與遺傳資源取得法制之研究

Abstract

隨著生物技術之進步，人類對各種遺傳資源之利用也日漸拓展，遺傳資源在從糧農到醫藥等各領域中扮演重要角色，並帶來龐大商機，然其取得與利用也衍生出被稱為「生物剽竊」之問題。此一問題涉及生物多樣性之保育、專利制度之修改、傳統知識之保護等議題，因而受到國際關注，許多國家業已完成遺傳資源取得法制之立法以資因應。我國地處亞熱帶，擁有豐富的生物多樣性與遺傳資源，也同樣面臨生物剽竊之問題，因此實有必要對於生物剽竊與遺傳資源法制之議題進行研究，以保護我國之遺傳資源免於濫用。 本研究之目的包括：對生物剽竊之問題加以探討並建立概念定義、研究在國內法層次建立規範遺傳資源取得之法律機制以解決生物剽竊問題之可行性與必要性、對此一遺傳資源取得法制之基本原則及相關問題加以研究探討並提出建議、檢討我國現行之相關法規與學者提出之遺傳資源法草案並提出建言。為達成上述目的，本研究分為七章對生物剽竊與遺傳資源取得法制加以探討。第壹章為緒論；第貳章對生物剽竊之問題進行討論並建構概念定義；第參章從經濟分析的觀點檢視生物剽竊之問題，並導引出建立遺傳資源取得法制之必要；第肆章借鏡主要國家之立法實踐經驗並加以歸納；第伍章對遺傳資源取得法制之基本原則與相關問題進行探討；第陸章呈現我國相關法規之現況與立法之必要，介紹我國學者提出之遺傳資源法草案並加以檢討；最後於第柒章提出結論。 本研究之結論認為，生物剽竊之問題反映出了遺傳資源市場出現市場失靈之情形，若能針對此一市場失靈之情形加以改善，則不僅各種遺傳資源將能得到充分開發與利用，亦可為擁有此等資源之國家或人民提供保育之經濟上誘因。關於此一問題，國際上雖有生物多樣性公約提出之若干重要原則得以遵循，但更重要的是各國以其國內法制訂相應的遺傳資源取得法制加以落實。我國現行法規雖有部分規範似可適用於遺傳資源之取得，但仍然有所不足，亟待積極立法以資改善。我國學者提出之遺傳資源法草案業已具備遺傳資源取得法制之基本雛形，盼能獲得各界之充分參與，早日完成立法，以有效保護我國之遺傳資源，並維護國家與人民之權益。

As biological technology advances, uses of genetic resources have been expanding. While genetic resources play significant roles in sectors ranging from food and agriculture to medicine and bring on considerable commercial interests, from the access and manipulation thereof has emerged an issue called “biopiracy”, which is related to the conservation of biodiversity, the modification of patent regime, the protection of traditional knowledge and other topics. Therefore, the issue of biopiracy is gathering international concerns. Meanwhile many nations have adapted laws and regulations on access to genetic resources in response. Taiwan, blessed with high-level biodiversity and genetic resources while faced with the problem of biopiracy, should undertake reseaches on biopiracy and the regulation of access to genetic resources in order to protect its valuable resources from appropriation. This study is to discuss and define “biopiracy”, evaluate the possibility and necessity of an access regulation countering biopiracy, review the basic principles and issues related thereto of such regulation, and to look to the current state of regulations in Taiwan and the Draft Act on Genetic Resources presented by several scholars. It has seven chapters to accomplish these goals. Chapter One serves as an introduction to this study. Chapter Two discusses and defines in the context of this study “biopiracy”. Chapter Three evaluates this issue and the need for national legislation from an economic point of view. Chapter Four turns to the experiences of other nations implementing access regulations. Chapter Five presents and discusses the basic principles of access regulation. Chapter Six demonstrates the need for Taiwan to enhance regulation and comments on the Draft Act. Finally, Chapter Seven provides conclusions of this study. In general, this study concludes that biopiracy represents the failure for the market of genetic resources. Mending such market failure will not only help achieve sustainable use of genetic resources but provide economical incentives for the nations and their people that own such resources. National access regulations or access laws must be in place if the principles and objectives of the Convention on Biological Diversity are to be fulfilled. Current regulations in Taiwan are far from efficiency over this issue and a regulation specifically dealing with such issue is needed. This study finds the Draft Act, while further improvement is still required, suitable for the need for Taiwan to effectively manage and regulate access to its genetic resources.