Developing a framework to assess off-patent medicines policies in Latin America and the Caribbean.

Background: Countries in Latin America and the Caribbean (LAC) often lack a systematic approach to assessing the maturity and effectiveness of their policies for promoting off-patent (generic and biosimilar) medicines. Currently, no comprehensive, region-specific methodology exists that encompasses both generics and biosimilars. The objective of this paper is to develop a framework for assessing the performance of off-patent medicines policies that LAC countries can use to identify opportunities to improve access to these medicines in their territories. Methods: Through a scoping review of over 300 studies, this study identifies key supply- and demand-side policy interventions to promote generics and biosimilars, along with corresponding outcome indicators. This informs a logic-model-based framework, where supply-side policies are organized according to the pharmaceutical value chain, and demand-side policies are based on the target population. Results: The framework maps key policy actions, such as regulation, pricing, and substitution, to expected outcomes, such as affordability, uptake, and trust. The review highlights major regional gaps, including insufficient biosimilar policies, limited empirical evaluations, and the unique duality between public and private healthcare sectors in LAC. The existing literature gives greater attention to demand-side policies as potential factors driving higher market participation in generic and biosimilar medicines. Within this component, the emphasis is on factors aimed at education and awareness initiatives for users (41.6%). Supply-side policies are discussed less frequently, with price regulation (28.9%) most cited. By contrast, limited attention is given to other key factors such as horizon scanning, and mark-up regulation. Conclusion: The proposed framework serves as a diagnostic, analytical, and benchmarking instrument for policymakers and academia. It facilitates structured assessment, supports policy design, and fosters regional learning. Piloting and further empirical research are recommended to refine and validate the framework using a specific tool designed for this purpose.