艾滋病抗病毒药品强制许可国际现状与我国实施强制许可可行性分析

Compulsory license of antiretroviral (ARV) drugs for HIV/AIDS:review of international situation and analysis of its feasibility in China

目的分析国际国内艾滋病抗病毒(ARV)药品强制许可状况,为中国实施强制许可提供建议。方法在回顾知识产权与公共健康的冲突及可能解决途径的基础上,分析中国对部分ARV药品实施强制许可的必要性及可行性,以及中国实施强制许可后需要重点考虑的问题。结果中国ARV药品费用控制形势严峻,对部分费用高的药品实施强制许可有其必要性。目前国际国内法律环境为强制许可提供了有力支持,国内已具备仿制生产技术和能力,还有相关国际组织的支持以及其他国家的经验可借鉴,故中国对部分ARV药品实施强制许可具有可行性。结论中国可对部分ARV药品实施强制许可。除需应对国际上的质疑和诉讼考验之外,同时还应注重确保强制许可药品的质量,发展国内药品研发生产能力,以及对包括ARV药品在内的基本药物统筹考虑降低费用,增加药品可及性的综合策略和可行措施。

Objective To analyze international and domestic compulsory licensing of ARV drugs for HIV/AIDS and give relevant policy suggestions. Methods On the basis of reviewing the conflicts between pharmaceutical patents and public health and possible solutions, the necessity and feasibility of enforcing compulsory license of several ARV drugs in China were analyzed, and some issues were taken into account if compulsory license is practiced in this country. Results Considering the importance of controlling cost of ARV drugs to make them available and accessible to the population in need, it is essential to enforce compulsory license of some expensive ARV drugs. Owing to international and domestic legal support, domestic capacity of producing generic drugs, assistance from related international organizations and learning experiences of other countries, China is in a position to implement compulsory licensing of ARV drugs. Conclusion China is capable to implement compulsory licensing of some ARV drugs. Other than preparing for possible international challenges and lawsuits from patent holders or foreign governments, we should focus on quality assurance of drugs produced by compulsory licensing, strengthening drug research and development, increasing production capacity of domestic pharmaceutical factories, and developing strategies and feasible measures of drug supply by taking all essential drugs as a whole to reduce drug cost and improve drug accessibility.