挑战与回应:我国药品专利制度的未来——以药品专利与健康权的关系为视角

发布时间：2019-05-10 07:54

【摘要】：健康权是最基本的人权,提高药品的可及性是保障健康权的重要手段之一,也是各国的国际义务。药品专利制度垄断了专利药品的价格,提高了仿制药的行政审批门槛,阻碍了民众的药品可及性,间接地对健康权的实现起到了消极影响。美国借助FTAs在世界范围内推行高标准的药品专利保护,众多"超TRIPS"标准的药品专利制度是美国FTAs的主要特征。这些逐渐具有国际化趋势的美式药品专利制度打破了药品专利与公共健康之间的脆弱平衡。我国面临严峻的公共健康问题,鉴于此,我们应当善用公共安全条款和强制许可条款,为保护健康权而适当放松仿制药的进口,同时简化仿制药审批流程,缩短仿制药的审批时间,努力实现药品专利与公共健康的平衡。
[Abstract]:The right to health is the most basic human right. Improving the accessibility of medicines is one of the important means to guarantee the right to health, and it is also the international obligation of States. The drug patent system monopolizes the price of patented drugs, improves the threshold of administrative examination and approval of generic drugs, hinders the drug accessibility of the people, and indirectly has a negative impact on the realization of the right to health. With the help of FTAs, the United States promotes high standards of drug patent protection in the world, and many "super TRIPS" standard drug patent systems are the main characteristics of FTAs in the United States. These American drug patent systems, which gradually have the trend of internationalization, break the fragile balance between drug patents and public health. China is facing serious public health problems. In view of this, we should make good use of public safety provisions and compulsory licensing provisions to appropriately relax the import of generic drugs in order to protect the right to health, and at the same time simplify the examination and approval process of generics. Shorten the examination and approval time of generic drugs, and strive to achieve the balance between drug patents and public health.
【作者单位】：西南政法大学国际法学院;
【基金】：教育部人文社会科学一般项目(16YJAGJW003)的研究成果
【分类号】：D923.42

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