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药品强制许可制度中应用药物经济学定量方法研究

钱焊森,刘 强,马爱霞   

  1. 中国药科大学国际医药商学院,,中国药科大学国际医药商学院
  • 收稿日期:2017-02-17 修回日期:2017-02-17 出版日期:2017-04-25 发布日期:2017-04-25
  • 基金资助:
    华海药业研究生创新基金(CX15S-014HH)

Research on Application of Pharmacogenomics in the Drug Patent Compulsory License System

  1. School of International Pharmaceutical Business,China Pharmaceutical University;China,,
  • Received:2017-02-17 Revised:2017-02-17 Online:2017-04-25 Published:2017-04-25

摘要: 目的:药品强制许可制度是在危害公共健康的疾病爆发或重大疾病治疗药品昂贵不可负担时发挥作用的一种机制,其中重大疾病治疗的可负担性的衡量标准一直模糊不清,没有具体的标准与衡量方法。药物经济学作为衡量药物经济性的学科,在药品价格方面可以发挥一定的作用。方法:对国外药品强制许可成功案例进行分析,找出其判断药品价格是否可负担的方法,提出并分析将药品强制许可制度中,应用药物经济学方法衡量药品价格是否可负担的可行性。结果与结论:增量成本效果比与人均GDP比值可以用于药品价格的合理范围,科学定量地评价药品价格是否可负担,一方面可以运用在药物强制许可制度中;另一方面,也可促使企业主动降低药品的定价,有利于形成良性循环。但是由于国内药物经济学学科发展处于初级阶段,可能在实施时面临一定的困难。

Abstract: Objective: Drug patent compulsory licensing system is very significant when a variety of unexpected diseases related to public health outbreak or the affordability of expensive drugs for serious diseases is low in some country. However, there are still no specific standards and methods to measure the affordability of serious diseases. Pharmacoeconomics, serving as a tool to measure drug economic efficiency, plays an important role in measurement of the affordability of drugs. Therefore, we discussed the introduction of pharmacoeconomics to drug patent compulsory licensing system at the theoretical level. Methods: We analyzed successful cases of drug patent compulsory licensing system used in other countries, found methods to identify the affordability of drugs, and analyzed the feasibility of pharmacoeconomics serving to measure the affordability of drugs in drug patent compulsory licensing system. Results and conclusion: We devided incremental cost effectiveness ratio to per capita GDP to determine a reasonable range of the price of drugs and found a scientific and quantitative method to evaluate the affordability of drugs. It can not only be applied in drug patent compulsory licensing system but also used to urge enterprises to cut price. However, we may face some difficulties when apply it because the development of pharmacoeconomics is still at an early stage in China.