Abstract
BackgroundIt is now 25 years since the adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the same concerns raised during its negotiations such as high prices of medicines, market exclusivity and delayed market entry for generics remain relevant as highlighted recently by the Ebola and COVID-19 pandemics. The World Health Organization’s (WHO) mandate to work on the interface between intellectual property, innovation and access to medicine has been continually reinforced and extended to include providing support to countries on the implementation of TRIPS flexibilities in collaboration with stakeholders. This study analyses the role of intellectual property on access to medicines in the African Region.MethodsWe analyze patent data from the African Regional Intellectual Property Organization (ARIPO) and Organisation Africaine de la Propriété Intellectuelle (OAPI) to provide a situational analysis of patenting activity and trends. We also review legislation to assess how TRIPS flexibilities are implemented in countries.ResultsPatenting was low for African countries. Only South Africa and Cameroon appeared in the list of top ten originator countries for ARIPO and OAPI respectively. Main diseases covered by African patents were HIV/AIDS, cardiovascular diseases, cancers and tumors. Majority countries have legislation allowing for compulsory licensing and parallel importation of medicines, while the least legislated flexibilities were explicit exemption of pharmaceutical products from patentable subject matter, new or second use of patented pharmaceutical products, imposition of limits to patent term extension and test data protection. Thirty-nine countries have applied TRIPS flexibilities, with the most common being compulsory licensing and least developed country transition provisions.ConclusionsOpportunities exist for WHO to work with ARIPO and OAPI to support countries in reviewing their legislation to be more responsive to public health needs.
Highlights
It is 25 years since the adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the same concerns raised during its negotiations such as high prices of medicines, market exclusivity and delayed market entry for generics remain relevant as highlighted recently by the Ebola and COVID-19 pandemics
This paper focuses on the role of intellectual property rights on access to medicines, it is recognized that limited access to medicines in countries of the World Health Organization (WHO) African Region3 is a multidimensional problem
Face-to-face meetings were organized with officers of the two organizations to explain the objectives of the study and to clarify that the data required was in the areas/fields that can potentially be applied in medical inventions using the World Intellectual Property Organization (WIPO) international patent classification (IPC) codes
Summary
It is 25 years since the adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the same concerns raised during its negotiations such as high prices of medicines, market exclusivity and delayed market entry for generics remain relevant as highlighted recently by the Ebola and COVID-19 pandemics. In March 2020, Gilead Sciences, WHO, intellectual property and access to medicines The earliest articulation of WHO’s mandate to work on the interface between access to medical products, R&D in rare and tropical diseases, and trade can be traced back to 1996, in a World Health Assembly (WHA) resolution on the Revised Drug Strategy which requested the WHO DirectorGeneral (DG) to support Member States in their efforts to improve access to essential drugs; to encourage the promotion of R&D of drugs for rare and tropical diseases; and to report on the impact of WTO concerning national drug and essential medicines policies and make recommendations for collaboration between WTO and WHO as appropriate This mandate has been continually reinforced through subsequent assembly resolutions.. This mandate has been continually reinforced through subsequent assembly resolutions. It has been extended over time to include upon request, providing technical and policy support to Member States, on formulating coherent trade and health polices and the implementation of TRIPS flexibilities in collaboration with other relevant international organizations
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