Center for Global Health Science and Security, Georgetown University Medical Center.
Milbank Q. 2023 Dec;101(4):1280-1303. doi: 10.1111/1468-0009.12669. Epub 2023 Aug 30.
Policy Points Given the challenges associated with negotiating the COVID-19 Trade-Related Aspects of Intellectual Property Rights (TRIPS) Waiver, there are questions as to whether the World Trade Organization is able to effectively address pandemics and global crises under the current architecture. Although the framework set out by the TRIPS Agreement does not view intellectual property (IP) rights as a means to foster public health and development, IP rights should nonetheless be interpreted through a public health lens. Countries should implement compulsory licensing provisions into their patent legislation, which increase access to medicines and allow governments (especially in developing and least-developed countries) to better protect public health.
The protection of intellectual property (IP) rights, given international legal effect through the World Trade Organization (WTO) Trade-Related Aspects of IP Rights (TRIPS) Agreement, has long been a contentious issue. In recent years, the long-standing debate on IP rights as a barrier to the access of affordable medicines has been heightened by the global vaccine inequity evidenced during the COVID-19 pandemic. The TRIPS Agreement contains a number of flexibilities that WTO members can exploit in order to accommodate their policy needs. Among these is the mechanism of compulsory licensing, whereby patent licenses may be granted without consent of the patent holder in certain circumstances. TRIPS Article 31bis created a special mechanism for compulsory licenses specifically for the export of pharmaceutical products to countries with insufficient manufacturing capacity.
We analyzed domestic patent legislation for 195 countries (193 UN members and two observers) and three customs territories. We analyzed patent legislation for provisions on compulsory licenses, including those defined in Article 31bis of the TRIPS Agreement.
We identified 11 countries with no patent legislation. Of the 187 countries with domestic or regional patent laws, 176 (94.1%) had provisions on compulsory licensing and 72 (38.5%) had provisions implementing TRIPS Article 31bis.
The results of this study have highlighted the gap in the implementation of TRIPS flexibilities in countries' national patent legislation, especially in least-developed countries. Although it will not fully solve patent barriers to the access of medicines, implementation of compulsory licensing (and specifically those for the import and export of pharmaceutical products) will provide governments with another tool to safeguard their population's public health. Further discussions are needed to determine whether the WTO can provide effective responses to future pandemics or global crises.
政策要点鉴于与协商 COVID-19 与贸易有关的知识产权（TRIPS）豁免相关的挑战，有人质疑世界贸易组织（WTO）是否能够在现有架构下有效应对大流行和全球危机。尽管 TRIPS 协议规定的框架并未将知识产权（IP）视为促进公共卫生和发展的手段，但仍应通过公共卫生视角来解释 IP 权利。各国应将强制许可条款纳入其专利立法，以增加药品的可及性，并使政府（特别是在发展中和最不发达国家）能够更好地保护公共卫生。
知识产权（IP）的保护通过世界贸易组织（WTO）《与贸易有关的知识产权协议》（TRIPS）获得国际法律效力，长期以来一直是一个有争议的问题。近年来，在 COVID-19 大流行期间，全球疫苗不平等现象加剧了人们对知识产权作为获得负担得起的药品的障碍的长期争论。TRIPS 协议包含了一些灵活性，WTO 成员可以利用这些灵活性来满足其政策需求。其中包括强制许可机制，根据该机制，在某些情况下，可以在未经专利持有人同意的情况下授予专利许可。TRIPS 第 31 条之二为专门针对向生产能力不足的国家出口药品的强制许可制定了一项特殊机制。
我们分析了 195 个国家（193 个联合国成员和两个观察员）和三个海关领土的国内专利立法。我们分析了专利立法中关于强制许可的规定，包括 TRIPS 协议第 31 条之二所定义的规定。
我们确定了 11 个没有专利立法的国家。在有国内或地区专利法的 187 个国家中，176 个（94.1%）有关于强制许可的规定，72 个（38.5%）有实施 TRIPS 第 31 条之二的规定。
本研究的结果突出表明，各国国家专利立法中在实施 TRIPS 灵活性方面存在差距，特别是在最不发达国家。虽然这并不能完全解决药品获取方面的专利障碍，但实施强制许可（特别是对药品进出口的强制许可）将为政府提供另一种工具来维护其人民的公共卫生。需要进一步讨论以确定 WTO 是否能够对未来的大流行或全球危机做出有效反应。
