CAJ | 학술논문

购买仿制药问题涉及到药品专利及其强制许可制度。在后TRIPS时代,发达国家正致力于通过如《跨太平洋伙伴关系协议（TPP）》这样的诸边贸易谈判,将《TRIPS协定》所确立的药品专利保护标准提升至所谓的TRIPS-plus标准,在药品专利的授权条件、保护期限及药品的市场准入等方面都采用更高的保护标准,但这种努力目前很难为发展中国家所接受。为公共健康目的,《TRIPS协定》及《多哈宣言》就药品的强制许可作了明确规定,但这种权利限制措施在实施时应作严格限定,仅仅是专利药品的高价不能成为实施药品专利强制许可的理由。在不能实施专利强制许可的情况下,无法负担高价专利药品的病人为自用目的而非营利性购买国外仿制药的行为不应认定为非法。
구매방제약문제섭급도약품전리급기강제허가제도。재후TRIPS시대,발체국가정치력우통과여《과태평양화반관계협의（TPP）》저양적제변무역담판,장《TRIPS협정》소학립적약품전리보호표준제승지소위적TRIPS-plus표준,재약품전리적수권조건、보호기한급약품적시장준입등방면도채용경고적보호표준,단저충노력목전흔난위발전중국가소접수。위공공건강목적,《TRIPS협정》급《다합선언》취약품적강제허가작료명학규정,단저충권리한제조시재실시시응작엄격한정,부부시전리약품적고개불능성위실시약품전리강제허가적이유。재불능실시전리강제허가적정황하,무법부담고개전리약품적병인위자용목적이비영리성구매국외방제약적행위불응인정위비법。
The acts of buying generic drugs are related to the system of pharmaceutical patent and its compulsory license system. In the post TRIPS era, the developed countries are committed to so called TRIPS-plus high standard to pharmaceutical patent protection through Plurilateral Trade negotiations. They want to adopt high standard to protect pharmaceutical patent in patent licensing conditions, length of patent protecting and pharmacy market accessing. But it＇s difficult for developing countries to accept such goal so far. For the purpose of public health, TRIPS agreement and the Doha declaration made explicit provisions on pharmaceutical compulsory license, but the implementation of restricting patent rights should be strictly limited, and high price of patent drugs itself should not be the reason to implement compulsory license. The action of patients who buy generic drugs for themselves with nonprofit purpose from abroad because of unaffordable high price of patented drugs should not be recognized as illegal.