title: Production of antiretroviral drugs in middle- and low-income countries.
abstract: This review outlines the main issues concerning the production of antiretroviral (ARV) drugs in middle- and low-income countries and the relevant political, legal and technical requirements for supporting such production. The requirements for efficient local production, including the manufacture of generic and branded products and public demand, have been considered from economic, market and socio-political perspectives. A steady and consistent government policy is crucial to success. Additional crucial factors in establishing local production are adequate infrastructure, qualified human resources in technical and managerial areas, and production-distribution logistics systems. The creation or strengthening of a national drug regulatory agency is a basic requirement. Production of ARVs relies on the structure of the international market for active pharmaceutical ingredients (APIs), which are highly monopolized for inclusion in branded or patented drugs, or are concentrated in a few Asian generic companies. Countries seeking to begin local production must develop strategies to overcome the various barriers. For instance, sub-Saharan African countries may benefit from developing multilateral health agreements with neighbouring countries. Such agreements are recommended and should be complemented by technology transfers, especially for the manufacture of APIs. Achieving a production level that is sustainable in the long term is crucial to maintaining patients' access to ARVs.
authors.affiliation: Consultant on ARV Development and Public Health, Brazil. eloan@infolink.com.br.
authors.forename: Eloan dos Santos
authors.initials: Edos S
authors.lastname: Pinheiro
authors.forename: Karin
authors.initials: K
authors.lastname: Brüning
authors.forename: M Fernanda
authors.initials: MF
authors.lastname: Macedo
authors.forename: Antonio C
authors.initials: AC
authors.lastname: Siani
mesh_terms: D019380:Anti-HIV Agents / Q000191:economics* / Q000600:supply & distribution; D023241:Antiretroviral Therapy, Highly Active / Q000191:economics*; D003906:Developing Countries; D004345:Drug Industry / Q000458:organization & administration*; D016568:Drugs, Generic / Q000191:economics* / Q000600:supply & distribution; D006078:Government Programs / Q000191:economics; D017408:Guidelines as Topic; D015658:HIV Infections / Q000188:drug therapy* / Q000191:economics; D006297:Health Services Accessibility; D006801:Humans; D007391:International Cooperation; D011057:Politics; D055818:Public-Private Sector Partnerships / Q000191:economics; D018581:Technology Transfer; D000078329:Workforce; D014944:World Health Organization
chemical_list: D019380:Anti-HIV Agents; D016568:Drugs, Generic