The United Nations Conference on Trade and Development (UNCTAD) and the United Nations Industrial Development Organization (UNIDO) collaborate on a global project to strengthen pharmaceutical production in developing countries and least-developed countries (LDCs). Within this context, UNCTAD assists in the implementation of flexibilities in intellectual property (IP) rights available under the World Trade Organization's (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The full use of TRIPS flexibilities to protect public health, and, in particular, to provide access to medicines for all, is a target under Sustainable Development Goal 3 ("Ensure healthy lives and promote well-being for all at all ages").1
The availability of TRIPS flexibilities creates the legal space for the production of generic medicines, and may thus provide important incentives for foreign generic firms to invest in a country's domestic pharmaceutical sector. UNCTAD considers the use of TRIPS flexibilities as an important element to promote generic pharmaceutical investment and domestic enterprise development under sustainable investment policy frameworks.2 In order for such frameworks to be coherent and effective, policy makers should avoid discrepancies between the use of TRIPS flexibilities, the enforcement of intellectual property rights (IPRs), and domestic laws and policies on drug regulation.
This paper aims to make a contribution to the ongoing debate in Kenya and the East African Community (EAC) about substandard drugs, access to medicines, local pharmaceutical production, and the role of IPRs enforcement and drug regulatory laws.
1See SDG 3 Target: "Support the research and development of vaccines and medicines for the communicable and noncommunicable diseases that primarily affect developing countries, provide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration on the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the Agreement on Trade Related Aspects of Intellectual Property Rights regarding flexibilities to protect public health, and, in particular, provide access to medicines for all."