a OneHealth Research Group, Faculty of Medicine, Universidad De Las Americas , Quito , Ecuador.
b Colegio de Ciencias de la Salud, Universidad San Francisco de Quito , Quito , Ecuador.
Expert Opin Ther Pat. 2019 Aug;29(8):653-662. doi: 10.1080/13543776.2019.1643323. Epub 2019 Jul 17.
: The Ecuadorian Institute of Intellectual Property (IEPI) granted several compulsory licenses between 2011 and 2017. In 2009, the President of Ecuador signed a decree that was intended to facilitate the request of compulsory licenses (CL) in the country, not only for Enfarma EP but for any privately owned local company in order to produce more accessible medicines. : The national and international regulatory framework of pharmaceutical patents and the local applicability of CL in Ecuador. The authors also analyzed the results of requesting unplanned and epidemiologically unnecessary CL at a national level. Finally, the authors reviewed the effects of requesting, granting or denying CL on price per unit in the last 7 years of available data. : The authors think that compulsory licenses are useful tools when negotiating drug prices or when the demand cannot be satisfied due to economic constrain within the local health system. However, the authors' experience suggests that Ecuador did not have an established and reliable production system neither an adequate plan before requesting CL, therefore the positive effects of this measure were not clearly established.
厄瓜多尔知识产权研究所 (IEPI) 在 2011 年至 2017 年期间授予了几项强制许可。2009 年，厄瓜多尔总统签署了一项法令，旨在促进在该国申请强制许可 (CL)，不仅是为了 Enfarma EP，也为了任何私营的当地公司，以生产更可负担得起的药品。本文介绍了国家和国际药品专利监管框架，以及 CL 在厄瓜多尔的本地适用性。作者还分析了在国家层面上申请非计划性和流行病学上不必要的 CL 的结果。最后，作者审查了在过去 7 年的可用数据中，请求、授予或拒绝 CL 对每单位价格的影响。作者认为，在谈判药品价格时，或者当由于当地卫生系统的经济限制而无法满足需求时，强制许可都是有用的工具。然而，作者的经验表明，厄瓜多尔在申请 CL 之前既没有建立可靠的生产系统，也没有制定适当的计划，因此，这项措施的积极影响并没有得到明确确立。
