试析TRIPS-plus条款对药品专利强制许可制度的影响

Analyse the Influence of TRIPS- plus Terms on Pharmaceutical Compulsory License

药物可及性问题是解决公共健康问题的关键因素,药品强制许可制度是一个国家获取基本健康药物的工具之一,而由发达国家主导的双边或多边自由贸易协定、投资保护协定中含有的TRIPS-plus条款会影响药品强制许可制度的施行。TRIPS-plus条款对药品强制许可制度的影响主要体现在对未披露数据的独占保护,专利保护期的延展,旧药品新用途可获专利,专利撤销理由缩小,限制可以适用强制许可的情形,提高补偿标准,明确限制强制许可下生产的产品出口等方面。

Drug accessibility is a key factor to solve the problem of public health,drug compulsory license system is one of the tools for access to basic health medicine. while the TRIPS- plus clause dominated by the developed countries on bilateral or multilateral free trade agreement,the investment protection agreement will have a serious effect on the drug compulsory license system. The terms of the TRIPS- plus effect on drug compulsory license system is mainly reflected in the exclusivity protection of undisclosed data,extend protection period of patent,patents shall be available for any new uses or methods of using a known product,small range for revocation reasons,narrow the situations of using compulsory licensing,raising the compensation standards,limitations under compulsory licenses to manufacture products for export etc.