@misc{37126,
title = {Generic and Biosimilar Medicines Policy Assessment Tool},
author = {Wirtz, Veronika J. and Espín, Jaime and Góngora, Pamela and Guzman Cruz, Javier Humberto},
year = {2025},
doi = {10.18235/0013731},
abstract = {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.},
url = {https://doi.org/10.18235/0013731}
}