我國真有引進專利連結制度之必要嗎？－－對藥事法與專利法修正草案之評析

Does Taiwan Really Need to Introduce the Patent Linkage System? Comments on the Draft Amendments to the Pharmacy Law and Patent Law

我國為了加入「跨太平洋夥伴協定」，並希望與美國進行「臺美貿易暨投資架構協定」談判，擬將美國行之多年的專利連結制度引入我國。然而，美國的專利連結制度是由法律、行政規則與司法判決綜合而成的龐雜體系，我國究竟有無修法導入專利連結制度之必要以及目前修法方向對我國醫藥產業、民眾用藥權益與健保制度究竟會造成何種影響，都是非常重要的議題。本文研究此次修法之內容，探究其與美國專利連結制度之異同，再研析引進專利連結制度應考量之法律議題。本文初步結論認為，我國不需引入專利連結制度，即已符合跨太平洋夥伴協定的相關規範；此外，我國修法方向比美國更加偏重保護原廠權益，恐對以學名藥為主的臺灣製藥業帶來相當程度的負面影響。本文建議，行政機關除應研究引入專利連結制度對學名藥廠的影響以外，也應關注專利連結制度對民眾對藥品之近用造成影響、是否會更提高健保之負擔、甚至是否會對公共健康造成影響。

Taiwan intends to introduce the patent linkage system into in response to Taiwan’s intention for joining the Trans-Pacific Partnership Agreement (TPP) and negotiating with the United States under the Trade and Investment Framework Agreement (TIFA). Patent linkage is a regulatory mechanism that has been implemented in the United States for over three decades; it is a complicated system consisting of laws, administrative regulations and judicial rulings. The necessity of introducing the patent linkage system in Taiwan through the legislation procedure, as well as the impact of the proposed amendments on Taiwan’s pharmaceutical industry, the public’s accessibility of drugs, and the National health insurance, is an important issue. This article studies the provisions of the amendments to the Pharmaceutical Affairs Act and Patent Act, compares them with the patent linkage system in the United States, and then analyzes the legal issues to be considered while introducing the patent linkage system. Our initial conclusions are, (1) Taiwan’s current legal framework is in compliance with the relevant provisions of TPP, and hence, it is not necessary for Taiwan to introduce the patent linkage system; (2) the proposed amendments lean toward the interest of the brand drug manufacturers, as compared with the laws and regulations in the States, which may cause significant negative impacts to Taiwan’s generic drug manufacturers. The authors of this article suggest that the competent administrative authority should investigate the impact of the patent linkage system on generic drug manufacturers and the public’s accessibility of drugs; in addition to that, it is also important to consider whether the patent linkage system would impose more burden on Taiwan’s National Health Insurance or adversely affect the public health.