A Study on Constructing the Cross-Strait Legal System in Protection of Pharmaceutical Test Data under TRIPS Agreement

台灣與中國大陸分別於2001年與2002年先後加入世界貿易組織(World Trade Organization，以下簡稱WTO)，隨著經貿自由化進程的開展，兩岸也面臨了前所未有的挑戰。其中最嚴峻的挑戰之一來自於法規環境之改變，在TRIPS協定第39.3條之要求下，會員國必須建立起藥品試驗資料保護之制度。 台灣與中國大陸製藥產業皆以學名藥廠為主，卻不約而同選擇資料專屬保護制度作為履行TRIPS協定第39.3條之立法模式。從市場進入之角度而言，資料專屬保護制度形同是學名藥品進入市場之障礙。在此一制度下，專利藥品將得以繼續維持市場獨占之地位以及其價格上優勢，使得學名藥品上市時間延後五年之久，導致嚴重影響國民取得、使用藥品之權益。此一問題的根源，毋寧在於實踐協定義務之立法模式選擇不當，以及相關配套措施之建制不完善。因此，實有對兩岸藥品試驗資料保護制度加以深入討論之必要。 本文認為，平衡兼顧國際義務履行、促進醫藥產業發展、提升國民用藥權益三大面項之需求，乃架構健全之藥品試驗資料保護制度不可或缺之要素。然而，在兩岸在立法上，卻較側重試驗資料權利人之保護，不僅僅是符合TRIPS協定義務，已然是超出TRIPS協定標準，導致藥品試驗資料之超高保護與智財權促進公益之本質衝突之情況。另一方面，歐美在自由貿易協定中推動超過TRIPS協定標準之試驗資料保護條款，試圖透過自由貿易協定加強智慧財產權保護，雖然兩岸目前在各自自由貿易協定中並沒有納入超過TRIPS協定標準之試驗資料保護條款，但此為未來各自對外洽簽自自由貿易協定不得留意之趨勢。 台灣和中國大陸醫藥產業結構雖相似，但在優勢和強項各有不同，有相當大的互動與合作機會。在未來兩岸架構之安排上，妥善處理藥品試驗資料保護所涉及平衡國際義務履行、促進醫藥產業發展、提升國民用藥權益之三個面向議題，方能夠達到促進醫藥研究發展、提升國民用藥權益之目標，也才能夠為兩岸合作建立起堅實的基礎。This paper illustrates important issues involed in implementing Pharmaceutical test data protection in Taiwan and China. The protection of pharmaceutical test has been a controversy between the brand-name drug companies and the generic pharmaceutical companies. Under Article 39.3 of the Agreement on Trade-related Aspects of Intellectual Property Rights (the TRIPs Agreement) annexed to the World Trade Organization (WTO) Agreement, WTO members are obliged to protect undisclosed pharmaceutical test data against unfair commercial use. On one hand, the protection provides incentive for innovation and rewards the innovator for its investment in generating the required regulatory test data as proof of the safety and effectiveness of a new drug. By imposing non-reliance and non-disclosure obligations on governments, innovation and investment are encouraged. On the other hand, when it comes to pharmaceutical products, for many illnesses there is only one known active component available, and thus it is in the interest of society that more than one competing product using that same component will be developed. Therefore, the public interest in access to affordable medicines should be taken into account. The issue arises from three aspects that require balancing: fulling the international obligations, providing incentives for innovation, and ensuring full public access to affordable medicines. To obtain an understanding of Article 39.3 of TRIPs, Chapter II contains an introduction to the WTO’s regime for protection of undisclosed information and the negotiation history thereof. Chpater III goes on to highlight the implementation of Article 39.3 of TRIPs in Taiwan and China, pointing out the defect of Pharmaceutical Affairs Act, the controversial scope of pharmaceutical test data protection in relation to cases under the Copyrights Act. Furthermore, the experimental Use Exception on Patent Law and Pharmaceutical Affairs Act will be dicussed. After the patent term of a certain drug has expired, the more quickly the generic drug is approved in the market, the sooner the price of this drug drops. However, it is important to note that in the context of Article 39.3 of TRIPs, the TRIPs flexibilities accorded to Members under the unfair competition approach are being rapidly narrowed down through bilateral and regional agreements. Chaper V examines how Taiwan and China responsed in their FTAs. When this approach intersects with domestic law and domestic market, the issue is whether Article 39.3 of TRIPs Agreement makes access to medicine more costly. In the following, Chpater VI will introduce Free Trade Agreement as a tool for Taiwan and China to deal with the issue.To balance the needs including fulfilling international obligation, providing incentives for innovation and ensuring full public access to affordable medicines, this paper will propose a possible solution concerning pharmaceutical test data protection at the end