我国解决公共健康危机的法律策略探析

Exploratory Analysis on the Legal Strategies of Solving the Public Health Crisis of Our Country

对我国解决公共健康危机的国内法律策略进行探析,提出八种解决措施:强制许可、平行进口、专利权的例外、对限制竞争行为的控制、BOLAR例外、禁止反向支付、对传统知识和遗传资源予以知识产权保护以及医药专利审查制度——"事先同意"法律制度。其中前四种措施是国际社会上一直以来倡导的主要措施,后三种是新的解决公共健康危机的法律措施,其创新点在于:第一,呼吁将禁止反向支付纳入法律,并与BOLAR例外相结合使用,促进仿制药品的尽快上市;第二,将公共健康、医药品专利以及传统知识和遗传资源的知识产权保护三者紧密相连,通过对传统知识和遗传资源予以知识产权保护来应对发达国家的医药品专利;第三,"事先同意"法律制度是巴西提出的一种旨在保护公共健康,应对医药专利的新的法律制度,该制度规定凡是涉及医药品专利的申请都必须经过国家知识产权局和国家公共卫生监督局的公共审查,并且国家公共卫生监督局有是否授予专利的最终决定权。

This paper proposes our country eight kinds of legal strategies. They are compulsory licensing, parallel import, the exception of patent protection, to control the limiting competition behaviors, the BOLAR exception, to prohibit reversed payment, to give the traditional knowledge and the genetic resources IPRs protection and the legal mechanism of Prior Consent. The latter three strategies are new and also the paper＇s three innovative points. First of all, appeal the law to prohibit reversed payment, unify this with the BOLAR exception, and promote the drugs into the market as soon as possible. Secondly, put the public health, medicine patent and the IPRs protection of traditional knowledge and the genetic resources together. Through giving the traditional knowledge and the genetic resources IPRs protection to treat the developed countries＇ medicine patents, they can settle the public health crisis. Finally, the legal mechanism of Prior Consent is a new strategy that Brazil proposed for the purpose of protecting the public health, which divides the examination of patent applications for pharmaceutical products and processes between two federal agencies, National Institute of Intellectual Property （INPI） and National Sanitary Supervision Agency （ANVISA）. ANVISA has the obligation to render the final decision, granting or denying a patent.