The WHO is announcing the publication of six country case studies that explore the ecosystem for local production of pharmaceuticals, vaccines, and biologicals in low- and middle-income countries (LMICs). This comprehensive research underscores WHO's ongoing commitment to supporting member states in strengthening local production to improve access to essential medical products.
The six countries included in the study are Bangladesh, Kenya, Nigeria, Pakistan, Senegal, and Tunisia. The case studies were conducted by the Local Production and Assistance (LPA) Unit, within the Innovation and Emerging Technologies (IET) Department, part of the Access to Medicines and Health Products Division, at WHO. The LPA Unit's mission is to support sustainable local production and technology transfer in LMICs, helping them achieve timely and equitable access to quality, safe, and effective essential medical products.
In these case studies, WHO used a rigorous methodology that included interviews, consultative meetings, literature reviews, policy analysis, and questionnaires from July to November 2022, depending the countries. These assessments provide insights into each country's local production ecosystem, including available policies, initiatives, financing, regulatory systems, patent protection, research and development, market structure, and capacity for local production.
The case studies offer a holistic view of the various challenges and opportunities for local production, with proposed recommendations to help LMICs strengthen their local manufacturing capabilities. This research aligns with the WHO's landmark resolution WHA74.6, which emphasizes the role of local production in improving access to medicines and other health technologies and in achieving universal health coverage and the Sustainable Development Goals.