開發中國家在「與貿易有關之智慧財產權協定」下藥品取得困難之研究—尋求可以兼顧會員公共健康政策的國際智慧財產權體制

Abstract

愛滋病、瘧疾、結核病等流行病在許多開發中國家大規模地肆虐，造成嚴重的公共健康危機。雖然這些疾病均為可得治療或管理，然而，在公共衛生基礎建設不足的開發中國家，卻有相當多數的人們因為藥品價格的高昂而無法取得維持生命所需的藥品，不但造成數百萬計生命的喪失，人力資本的減損更導致經濟的衰退及跨世代的發展危機。 在「與貿易有關之智慧財產權協定」（以下簡稱TRIPS協定）制訂之前，開發中國家尚得依賴較為廉價的學名藥，作為藥品的來源，然而，隨著TRIPS協定的全面生效，倘若藥品仍受到專利權的保護，絕大多數會員境內的學名藥廠僅能在例外的情形製造學名藥。由於藥品市場上替代品的減少，藥品的價格因而上升，更惡化藥品取得的問題。 部分開發中國家試圖藉由平行輸入及強制授權機制尋求對藥品取得問題的解決，但是，已開發國家及跨國製藥公司卻認為這些措施已經違反TRIPS協定的相關規定，並以貿易制裁威脅開發中國家。因此，藥品取得的困難—如何確保開發中國家人民對於藥品的取得而不致減損藥廠對於新藥的研發意願，在WTO下遂成為會員關注及爭執的焦點。為解決開發中國家所面臨的嚴重公共健康危機，WTO於2001年11月在卡達首都多哈召開部長會議，通過了「TRIPS協定與公共健康宣言」（以下簡稱多哈公共健康宣言），在經過冗長的談判後，於2003年8月30日作出關於「TRIPS協定與公共健康宣言第六段之履行」 決議（以下簡稱多哈公共健康宣言第六段決議）。 專利制度與公共健康的衝突究竟應該如何解決？本文認為效率與分配的價值均為WTO體系及TRIPS協定所必須考量的，因此，在解決衝突時，自須兼顧二種價值的追求。在效率方面，專利制度存在之正當性是建立在抵換關係上，其作為工具並非不具成本的，專利制度雖得以鼓勵創新，並藉由創新刺激經濟成長，但另一方面，專利制度會增加人民接近創新技術的困難，而在藥品專利的領域中，WTO更應正視會員因為無法取得必需藥品所造成的鉅額社會成本。從分配的角度觀察，WTO應提供會員永續發展的機會，至少必須確保專利制度運行的結果，在每個會員境內所帶來的效益均超過其成本。本文認為，TRIPS協定內的各種彈性機制，對於效率和分配價值的追求而言，均有其助益及重要性存在。本文自效率及分配的觀點檢視多哈公共健康宣言及第六段決議，認為WTO截至目前為止對於藥品取得問題的處理方向是正確的。 本文建議，在國際層面，會員均必須體認國際上需要一個平衡及具彈性的專利體制；其次， WTO應檢討TRIPS協定關於技術移轉規定之落實情形，並思考TRIPS協定中對技術移轉之規範密度是否足夠；此外，本文亦呼籲WIPO應積極履行其義務，協助開發中國家依據TRIPS協定、多哈公共健康宣言及宣言第六段決議的內容，制訂符合開發中國家利益之法律。在會員的國內層面，本文認為，開發中國家可以在TRIPS協定賦予的權限內擇定合宜的專利保護程度及建置彈性機制，且必須重視核准上市資料之保護對於學名藥加入市場競爭的影響，避免因核准上市資料的高度保護而造成藥品取得的障礙，此外，創造使製藥產業願意施行差別定價的環境，也是重要的。

A variety of epidemics such as HIV/AIDS, malaria and tuberculosis have ravaged numerous developing countries on an enormous scale, resulting in severe public health crises. Although those diseases are curable or manageable, some treatments, for example, the antiretroviral medications for AIDS, are prohibitively expensive. Consequently, many people in developing countries that lack adequate health infrastructures cannot afford expensive drugs. Without life-saving drugs, millions of people lose their lives; the loss of human capital may even cause economic decline and developmental crises across several generations. Prior to the enactment of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement), developing countries could depend on cheap generic drugs. However, under the full implementation of the TRIPS Agreement, as a patent has been granted and remains in force, the generic pharmaceutical manufacturers of most WTO members can supply generic drugs only in exceptional circumstances. Consequently, as substitutes for patented drugs decrease, prices of pharmaceuticals could rise and access to drugs could worsen. Some governments of developing countries sought solutions to the access dilemma in the form of parallel imports and generic versions of patented drugs made under compulsory licenses. Nevertheless, multinational pharmaceutical companies and some developed countries protested that those measures contradicted the provisions of the TRIPS Agreement, and threatened to impose trade sanctions. Therefore, the dilemma of access to essential medicines, i.e., how to ensure access to drugs in developing countries without discouraging the innovation of new drugs, has been the focus of controversy under the WTO. To solve the problem and clarify the divergent interpretations of the TRIPS Agreement, WTO members adopted the Doha Declaration on the TRIPS Agreement and Public Health (Doha Declaration) in 2001 and approved a decision on 30 August 2003 after lengthy negotiations. This article argues that it is necessary to contemplate both efficiency values and distributive values under the WTO in the context of health crises. From the perspective of efficiency, patent systems are trade-off and unavoidable evil resulting from the market failure. Though patents facilitate innovation, thereby contributing to economic growth and welfare, the negative impacts on efficiency, specifically access to technology, cannot be ignored. In the access dilemma, WTO members must pay attention to the enormous social costs due to the unavailability of essential drugs. From the angle of distribution, the WTO has to provide developing country members with opportunities for sustainable development. At least, the WTO must assure the benefits resulted from the operation of patent systems outweigh the costs for each member in the events of public health crises. This article finds that the flexibilities contained in the TRIPS Agreement, for example, the compulsory licenses, are beneficial and vital to the pursuit of efficiency values and distributive values. To solve the access dilemma, effective use of the flexibilities plays an important role. Bearing these in mind, this article highly values Doha Declaration and the subsequent decision. Moreover, in the international level, this article suggests that WTO members should shape a balanced and flexible intellectual property regime, reexamine related provisions about technology transfer under the TRIPS Agreement, and monitor and evaluate the executive effects of the 30 August decision. Additionally, WIPO have to assist WTO developing country members to amend their law according to Doha Declaration and the subsequent decision. In the national level, this article suggests that developing country members should seek an appropriate protection level of the patent system, make effective use of the flexibilities embedded in the TRIPS Agreement, prevent the protection for marketing approval data from blocking the marketing of generic drugs, and create conditions beneficial for differential pricing.