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. METHODS: 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. FINDINGS: 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. CONCLUSIONS: 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.

Mainstreaming as rhetoric or reality? Gender and global health at the World Bank.

Background: Over the past decade gender mainstreaming has gained visibility at global health organisations. The World Bank, one of the largest funders of global health activities, released two World Development Reports showcasing its gender policies, and recently announced a $1 billion initiative for women's entrepreneurship. We summarise the development of the Bank's gender policies and analyse its financing of gender projects in the health sector. This article is intended to provide background for future research on the Bank's gender and global health portfolio. Methods: First, we constructed a timeline of the Bank's gender policy development, through a review of published articles, grey literature, and Bank documents and reports. Second, we performed a health-focused analysis of publicly available Bank gender project databases, to track its financing of health sector projects with a gender 'theme' from 1985-2017. Results: The Bank's gender policy developed through four major phases from 1972-2017: 'women in development' (WID), institutionalisation of WID, gender mainstreaming, and gender equality through 'smart economics'. In the more inclusive Bank project database, projects with a gender theme comprised between 1.3% (1985-1989) and 6.2% (2010-2016) of all Bank commitments.  Most funding targeted middle-income countries and particular health themes, including communicable diseases and health systems. Major gender-related trust funds were absent from both databases. The Bank reports that 98% of its lending is 'gender informed', which indicates that the gender theme used in its publicly available project databases is poorly aligned with its criteria for gender informed projects. Conclusion: The Bank focused most of its health sector gender projects on women's and girls' issues. It is increasingly embracing private sector financing of its gender activities, which may impact its poverty alleviation agenda. Measuring the success of gender mainstreaming in global health will require the Bank to release more information about its gender indicators and projects.