促进药价可支付性的知识产权制度改进路径

The Improvement Path of Intellectual Property System to Promote the Affordability of Drug Price

原研药垄断定价带来的巨额利润是知识产权制度激励原研药开发的主要工具;而且,它还通过专利保护期补偿、数据保护与专利链接等制度强化其保护,以实现药品可得性。药价可支付性的保障制度是仿制药在保护期届满后顺利进入市场,通过竞争而急剧降低药价。但知识产权制度的不同设计将影响仿制药商在保护期届满后提供相同疗效药品的能力,人们所重视的药品专利强制许可制度也不足以解决药品价格的可支付性问题。知识产权制度应强化原研药商技术披露的法律义务、拓展仿制药开发的安全港制度,也应明确合理促进药品自由竞争的立法目标,这是药品知识产权保护期届满后仿制药顺利进入市场的重要保障。此外,它还有必要规定原研药商对患者承担社会责任的软法规则。

Monopoly pricing is the main reason for huge profits of Original Drug company.Although the Drug Administration Act tries to control the drug price,the affordability of innovative drug is mainly influenced by the intellectual property law because of preventing the generical drugs into the market.Because the Compulsory Licensing is not enough to solve the affordability of drugs,the intellectual property system should strengthen the legal obligation of technology disclosure and expand the safe harbor for generic drug,it should also be a"stick"to achieve the affordability of medicine by promoting competition,and it should also stipulate soft law rules that pharmaceutical manufacturers should bear social responsibility to patients.