药品研发、参考定价与知识产权——中澳自由贸易协定和后续的中国双边贸易协定中的一个议案

Pharamaceutical Development, Reference Pricing Systems and Intellectual Property

文章针对的是在中澳自由贸易协定中提出的一个议案,旨在促进医药产品研究和产业合作。该议案认为,如果能将按“与贸易有关的知识产权”(TRIPS)的标准对药品的平行进口和强制许可给予保护的条款写入中澳贸易协定和后续的双边贸易协定,再加上美国Bolar条款对仿制药(即通用名药)的推动,中国必将取得相当的优势来保证WTO制订的TRIPS协定继续维持对本国药品有利的条款。目前,市场正受到一系列美国为保护“创新性”药品和旨在终止药品参考定价体制而提出的涉及知识产权的双边贸易协定的威胁。因此,上述举措对于保持药品参考定价体制显得尤其重要。

This article focuses on issue of encouraging resear ch and industry collaborations with respect to pharmaceuticals in a proposed China -Australia Free Trade Agreement. It argues that by including in this trade deal and in subsequent bilateral trade deals, provisions protecting existing TRIPS s tandards of parallel importation and compulsory licensing of pharmaceuticals, as well as the “Bolar” springboarding of generic medicines, China will be ultima tely in a stronger position to ensure the World Trade Organisation TRIPS agreeme nt continues to retain provisions favourable to its own pharmaceutical interests . This is particularly true in relation to the preservation of reference pricing systems, under threat from a series of US bilateral trade deals with intellectu al property provisions protective of “innovative” medicines and beginning to t arget the “elimination” of pharmaceutical reference pricing systenis。