制药创新激励不足的原因与FDA采取的对策

Analyses of inadequate incentives for pharmaceutical manufacturing innovation and FDA's countermeasures

本文分析了美国制药行业创新激励不足的原因,探讨和提出相应的解决方案。和专利保护与FDA监管相结合创新政策在药物发现与药品研发取得成功相比,制药行业的低效率和缺乏创新形成鲜明对比。制药工艺专利成本高、效益低,仿制药安全港条款对制药创新也存在影响,因此专利对激励制药创新作用有限。制药领域受到严格监管,cGMP、监管约束对创新激励造成限制。制药行业通常采用的商业机密保护方式,缺乏专利制度或FDA市场保护的时间限制,限制了向社会披露有用的信息,阻碍了取得重大进展所依赖的累积性创新。现行监管机制有碍制药创新所需的信息流动,对制药创新缺乏灵活性。监管改进的3个维度是严格性、灵活性和信息流动。可以采用强制创新、改善透明度、监管排他性、质量量度、针对制药创新的并行的市场保护等激励措施,探索可流转交易的优先审评凭劵的激励措施。FDA采取的制药创新激励措施包括推进药品监管科学、建立公立-私营部门合作的制药创新机构、为制药设施的技术升级投入创造激励措施、利用外部专业知识对新兴技术进行评估、促进国际协调。

The reasons for the inadequate incentives for pharmaceutical innovation were analyzed,and the corresponding solutions were discussed and recommended in this paper.In contrast to the success of patent protection and regulatory exclusivity managed by FDA in drug discovery and development,the low efficiencies and inadequate innovation in pharmaceutical manufacturing are conspicuous.In addition to high cost and low efficiencies of pharmaceutical process patents,and the safety harbor provision of Hatch-Waxman act for generic drugs also has an impact on pharmaceutical innovation.Therefore,patents have limited effects on incentives for pharmaceutical innovation.The pharmaceutical industry is subject to strict supervision,c GMP requirements,regulatory commitment,which contribute to the inadequate incentives for pharmaceutical manufacturing.Business secret protection commonly used in the pharmaceutical manufacturing has no time limits and disclosure of useful information to society and thus pose a hurdle to the cumulative innovation.Current regulatory mechanisms hinder the information flow required for pharmaceutical activity and lack regulatory flexibility for pharmaceutical innovation.Incentives such as mandatory innovation,improved transparency,regulatory exclusivity,quality metrics,parallel market protection for pharmaceutical manufacturing innovation,and incentives for priority review of revolving transactions along the three dimensions of regulatory improvements in stringency,flexibility,and information flow are recommended.FDA’s countermeasuresfor pharmaceutical innovation include advancing regulatory science,establishing public-private partnerships for pharmaceutical manufacturing innovation,creating incentives for technology upgrades in pharmaceutical facilities,using external expertise to evaluate emerging technologies,and promoting international coordination.