Simoens Steven, Van Dyck Walter, Janssens Rosanne, Barbier Liese, Luyten Jeroen
Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Onderwijs & Navorsing 2, bus 521, Herestraat 49, 3000, Leuven, Belgium.
Healthcare Management Centre, Vlerick Business School, Reep 1, 9000, Ghent, Belgium.
Appl Health Econ Health Policy. 2025 Apr 19. doi: 10.1007/s40258-025-00956-x.
Although compulsory licensing of medicines is traditionally discussed in the context of low- and middle-income countries tackling high prices, it has recently sparked debate in several high-income countries. This study aims to examine the industrial and health consequences of compulsory licensing when applied by a high-income country. Our literature review found that the impact of compulsory licensing is challenging to predict as it can have multiple (opposing) consequences in terms of economic activity, patient outcomes and public health. Compulsory licensing can, under particular circumstances, serve as a lever of industrial policy in a country that wishes to develop its domestic generic pharmaceutical industry. However, originator pharmaceutical companies and other industries may reduce investment, which can be negative for countries with a high presence of innovators, adversely impacting long-term economic activity. Compulsory licensing may also induce state retaliation against the license-issuing country. From a health policy perspective, compulsory licensing likely increases patient access to expensive medicines and frees up resources that can be invested in other (health) programs. However, pharmaceutical companies may delay medicine launches or cancel clinical trials in the license-issuing country. Although there are benefits resulting from a credible threat to use compulsory licensing, the overall desirability of actually using it depends on the specific context and needs to be assessed on a case-by-case basis.
尽管药品强制许可传统上是在低收入和中等收入国家应对高价药品的背景下进行讨论的，但最近它在几个高收入国家引发了争论。本研究旨在考察高收入国家实施药品强制许可对产业和健康产生的影响。我们的文献综述发现，强制许可的影响难以预测，因为它在经济活动、患者治疗结果和公共卫生方面可能会产生多种（相互对立的）后果。在特定情况下，强制许可可以成为一个国家发展其国内仿制药产业的产业政策杠杆。然而，原创制药公司和其他行业可能会减少投资，这对于创新企业高度集中的国家可能产生负面影响，对长期经济活动不利。强制许可还可能引发他国对许可发放国的报复。从卫生政策角度看，强制许可可能会增加患者获得高价药品的机会，并释放出可用于其他（卫生）项目的资源。然而，制药公司可能会推迟在许可发放国推出药品或取消在该国的临床试验。尽管使用强制许可的可信威胁会带来一些好处，但实际使用强制许可的总体可取性取决于具体情况，需要逐案评估。
