我国专利保护制度下涉及重大公共健康问题高价药品的经济可及性

Affordability of High Cost Medicines with Significant Public Health Implications under Medicines Patent Protection System in China

目的通过典型案例分析,研究我国专利制度下涉及重大公共健康问题高价药品的可及性,提出促进这部分药物经济可及性的政策建议。方法通过文献分析和市场调查,以我国疾病负担较重,对社会、经济和政治影响较大的八类疾病临床必需的专利药物为例,测算专利制度下高价药品对个人及医保的药物治疗直接经济负担。结果化合物专利强化了专利药品的价格垄断。目标药品对我国居民,尤其是农村居民的个人经济负担十分沉重。突破化合物专利,实现平行进口或国内仿制药上市,可节约巨额药品采购费用,惠及广大国人。结论制定并实施具有公共健康视角的药品注册和知识产权保护策略,配以不断稳步扩大和加强的基本医疗保险制度,可有效促进对公共健康有重要意义,对社会、政治和经济影响重大的高价专利药品的经济可及性。

Objective To propose policy recommendations for improvement of the affordability of high cost medicines with significant public health implications under the patent system in China, Methods Through literature analysis and market investigation, this study targeted expensive life saving medicines under the patent protection, which are critical for the treatment of eight diseases with the most significant disease burden and critical social, economic and political impact for case studies, estimated the individual and insurance direct economic burden of medicines treatment. Results Chemical product patent protection enhanced medicines price monopoly. The targeted medicines brought huge financial burden to Chinese citizens, especially to the rural residents. Breaking chemical product patent protection, achieving parallel importation or making generic drugs enter into the China＇s market, can save huge amount of medicines procurement budget for the government, and benefit the general public. Conclusion Developing and implementing medicines registration and intellectual property right protection strategies with public health perspective, adding continuously improved basic health insurance programs, can effectively promote the affordability of high cost medicines with significant public health, social, political and economic implications.