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dc.titleGeneric and Biosimilar Medicines Policy Assessment Tool
dc.contributor.authorWirtz, Veronika J.
dc.contributor.authorEspín, Jaime
dc.contributor.authorGóngora, Pamela
dc.contributor.authorGuzman Cruz, Javier Humberto
dc.contributor.orgunitHealth, Nutrition and Population Division
dc.coverageLatin America
dc.coverageThe Caribbean
dc.date.available2025-10-31T00:10:00
dc.date.issue2025-09-30T00:09:00
dc.description.abstractOff-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.
dc.format.extent26
dc.identifier.doihttp://dx.doi.org/10.18235/0013731
dc.identifier.urlhttps://publications.iadb.org/publications/english/document/Generic-and-Biosimilar-Medicines-Policy-Assessment-Tool.pdf
dc.identifier.urlhttps://publications.iadb.org/publications/spanish/document/Herramientas-de-evaluacion-de-politicas-sobre-medicamentos-genericos-y-biosimilares.pdf
dc.language.isoen
dc.publisherInter-American Development Bank
dc.relation.seriesCriteria Network
dc.subjectIntellectual Property
dc.subjectGeneric Drugs
dc.subjectConflicts Resolution
dc.subjectStakeholder Ecosystem
dc.subjectDelivery of Health Care
dc.subjectPublic Expenditure
dc.subjectDiversity and Inclusion
dc.subjectPolicy Evaluation
dc.subjectCompetitiveness
dc.subjectManufacturing Industry
dc.subjectTrust
dc.subjectRegulatory Governance
dc.subjectPharmaceutical Industry
dc.subjectPharmaceutical Policy
dc.subjectBranding
dc.subjectMedicines Pricing
dc.subject.jelcodeI15 - Health and Economic Development
dc.subject.jelcodeI18 - Government Policy • Regulation • Public Health
dc.subject.jelcodeI11 - Analysis of Health Care Markets
dc.subject.jelcodeH51 - Government Expenditures and Health
dc.subject.jelcodeO54 - Latin America • Caribbean
dc.subject.keywordsOff-patent medicines;Generics; Biosimilars;pharmaceutical policy;efficiency;health systems;smart spending;Access to medicines
dc.typeLearning Materials
idb.identifier.pubnumberIDB-LM-00768
idb.operationRG-T4240
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