Generic and Biosimilar Medicines Policy Assessment Tool

Off-patent medicines (generics and biosimilars) play a central role in enhancing healthcare efficiency, accessibility, and sustainability in Latin America and the Caribbean (LAC). To support countries in strengthening pharmaceutical policies, the Inter-American Development Bank has developed an assessment tool to evaluate off-patent medicines policies, identify gaps, and inform evidence-based recommendations. The tool distinguishes between supply-side policies directed at regulatory agencies and ministries of health responsible for marketing authorization, pricing, and reimbursement and demand-side policies, which target prescribers, dispensers, and patients. It is structured in three components: a qualitative assessment of policy adoption, a quantitative assessment of policy outcomes, and an annex capturing the country context, including pharmaceutical expenditure. While this first version has not yet been applied, a pilot in at least two countries is planned to test its utility and refine its structure. Designed for policymakers, the tool provides a systematic approach to conducting national situation analyses and formulating actionable strategies to expand the use of off-patent medicines across LAC health systems.