Trade-Related Aspects of Intellectual Property Rights Flexibilities and Public Health: Implementation of Compulsory Licensing Provisions into National Patent Legislation.

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. CONTEXT: 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.

methodsWe 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.

findingsWe 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.

conclusionsThe 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.