Strategies for price reduction of HIV medicines under a monopoly situation in Brazil

Abstract

OBJECTIVE To analyze Government strategies for reducing prices of antiretroviral medicines for HIV in Brazil.METHODS Analysis of Ministry of Health purchases of antiretroviral medicines, from 2005 to 2013. Expenditures and costs of the treatment per year were analyzed and compared to international prices of atazanavir. Price reductions were estimated based on the terms of a voluntary license of patent rights and technology transfer in the Partnership for Productive Development Agreement for atazanavir.RESULTS Atazanavir, a patented medicine, represented a significant share of the expenditures on antiretrovirals purchased from the private sector. Prices in Brazil were higher than international references, and no evidence was found of a relationship between purchase volume and price paid by the Ministry of Health. Concerning the latest strategy to reduce prices, involving local production of the 200 mg capsule, the price reduction was greater than the estimated reduction. As for the 300 mg capsule, the amounts paid in the first two years after the Partnership for Productive Development Agreement were close to the estimated values. Prices in nominal values for both dosage forms remained virtually constant between 2011 (the signature of the Partnership for Productive Development Agreement), 2012 and 2013 (after the establishment of the Partnership).CONCLUSIONS Price reduction of medicines is complex in limited-competition environments. The use of a Partnership for Productive Development Agreement as a strategy to increase the capacity of local production and to reduce prices raises issues regarding its effectiveness in reducing prices and to overcome patent barriers. Investments in research and development that can stimulate technological accumulation should be considered by the Government to strengthen its bargaining power to negotiate medicines prices under a monopoly situation.

Trends in medicines procurement by the Brazilian federal government from 2006 to 2013

“…If price reduction strategies are not implemented, Brazil’s selection, incorporation, and purchase of high-priced innovative drugs, e.g., the recently adopted direct acting antivirals (DAAs) for hepatitis C (sofosbuvir, daclastavir, and simeprevir), may challenge the continuity of provision, given the same level of financing, if other access mechanisms such as generic production cannot be achieved [25]. Furthermore, the new medicines are under patent protection, and competition is limited or nonexistent [20, 26, 27]. …”

Compras públicas de medicamentos para hepatite C no Brasil no período de 2005 a 2015

“…From the perspective of industrial policy and local production efforts, one option is to use flexibilities such as "experimental use" and "Bolar exception" to obtain the registration (market authorization) for generic versions. This would enable the government to estimate production costs, have better references on the mark ups of the pharmaceutical companies, and to help the government in the issuing of compulsory licenses if price negotiations are not satisfactory 37 . This strategy can also be adopted while patent applications are pending decision.…”

Estrategias para promover el acceso a medicamentos de interés en salud pública: revisión estructurada de la literatura

“…• Crear apoyos financieros e incentivos públicos (premios [17,20,24], subsidios, compromisos de compra anticipada [20], reducción de impuestos o precios de los servicios públicos [15]) para la i+d nacional, con el fin de incrementar la disponibilidad interna de ingredientes farmacéuticos activos [15,22,32] y de medicamentos genéricos de bajo precio y con calidad asegurada, que respondan a las necesidades de salud insatisfechas [4,9,21,24,29] y fortalezcan el potencial de exportación [15,22]. El conocimiento generado por esta i+d debe ser de libre acceso, con el fin de intercambiar conocimientos y tecnologías que faciliten el desarrollo de nuevos productos en salud [4,17,20].…”

“…• Establecer acuerdos multilaterales en salud con los países vecinos, que incluyan transferencias de tecnologías, como los ingredientes farmacéuticos activos [22]. • Aplicar las flexibilidades del acuerdo sobre los "Aspectos de los derechos de propiedad intelectual relacionados con el comercio" (adpic), reafirmadas en la "Declaración de Doha": licencias obligatorias, excepción bolar * e importaciones paralelas [4,[13][14][15]17,23,25,28,29,32]. • Modificar las normativas que regulan el otorgamiento de patentes, aplicando estándares más rigurosos de invención, que estén a favor de los intereses en salud pública [4,15,23,24,28,29] y eviten el reverdecimiento de patentes [4,24].…”

“…• Negociar licencias voluntarias con los titulares de las patentes, mediante la participación en fondos comunes de patentes (Medicines Patent Poolmpp-) [4,17,20,23,25,32].…”