Kaplan Warren A, Laing Richard
Boston University School of Public Health, Boston, MA, USA.
Health Policy Plan. 2003 Sep;18(3):237-48. doi: 10.1093/heapol/czg030.
Fees charged by drug regulatory authorities (DRAs) may be used as a policy instrument to speed up regulatory approval, to encourage retention of quality staff and to stimulate introduction of generics versus new chemical entities. Often, the cost recovery function of these registration fees is not related to the true cost of the pharmaceutical regulatory process. In this paper, we scaled new drug registration fees of various DRAs to indices of economic development - the GNP per capita and the total government health expenditure per capita. Based on our analyses of 34 countries, most DRA registration fees for new drug applications for developing/non-OECD countries are less than the current GNP/capita of that country or are about US dollars 5000 for each US dollars 1000 spent per capita on healthcare. At present, each US dollars 1000 new drug registration fee for the developing/non-OECD countries analyzed corresponds to a total pharmaceutical market share of about US dollars 85 million. Our analyses further suggest little relationship between DRA registration fees and drug approval times in developing countries. The situation is complex, however, as policy tradeoffs are important to consider. Differential registration fees, presumably designed to encourage locally produced versus imported products, may violate international trade regulations. Moreover, certain DRA registration fees may provide perverse incentives for the pharmaceutical industry. Developing countries should require that DRA registration fees be based on accurate accounting of the cost of services provided. At present levels, these fees could be increased without disincentive to the pharmaceutical industry. For new drug registration fees, our analyses suggest that developing countries could charge between 1-5 times their GNP per capita or between US dollars 17000 and US dollars 80000 for each US dollars 1000 spent per capita on healthcare.
药品监管机构（DRA）收取的费用可作为一种政策工具，用于加快监管审批、鼓励留住高素质员工以及刺激仿制药而非新化学实体的引入。通常，这些注册费的成本回收功能与药品监管过程的实际成本并无关联。在本文中，我们将各个DRA的新药注册费与经济发展指标——人均国民生产总值（GNP）和人均政府卫生支出进行了对比。基于我们对34个国家的分析，发展中国家/非经合组织国家新药申请的大多数DRA注册费低于该国当前的人均GNP，或者是人均医疗保健支出每1000美元对应约5000美元。目前，所分析的发展中国家/非经合组织国家每1000美元的新药注册费对应的药品市场总份额约为8500万美元。我们的分析进一步表明，发展中国家的DRA注册费与药品审批时间之间关系不大。然而，情况较为复杂，因为政策权衡是需要考虑的重要因素。差别注册费大概是为了鼓励本地生产而非进口产品，但可能违反国际贸易法规。此外，某些DRA注册费可能会给制药行业带来不良激励。发展中国家应要求DRA注册费基于所提供服务成本的准确核算。就目前的水平而言，这些费用可以提高而不会对制药行业产生抑制作用。对于新药注册费，我们的分析表明，发展中国家可以收取人均GNP的1至5倍，或者人均医疗保健支出每1000美元收取17000美元至80000美元。
