Modeling HIV/AIDS Drug Price Determinants in Brazil: Is Generic Competition a Myth?

Brazil became the first developing country to guarantee free and universal access to HIV/AIDS treatment, with antiretroviral drugs (ARVs) being delivered to nearly 190,000 patients. The analysis of ARV price evolution and market dynamics in Brazil can help anticipate issues soon to afflict other developing countries, as the 2010 revision of the World Health Organization guidelines shifts demand towards more expensive treatments, and, at the same time, current evolution of international legislation and trade agreements on intellectual property rights may reduce availability of generic drugs for HIV care.Our analyses are based on effective prices paid for ARV procurement in Brazil between 1996 and 2009. Data panel structure was exploited to gather ex-ante and ex-post information and address various sources of statistical bias. In-difference estimation offered in-depth information on ARV market characteristics which significantly influence prices. Although overall ARV prices follow a declining trend, changing characteristics in the generic segment help explain recent increase in generic ARV prices. Our results show that generic suppliers are more likely to respond to factors influencing demand size and market competition, while originator suppliers tend to set prices strategically to offset compulsory licensing threats and generic competition.In order to guarantee the long term sustainability of access to antiretroviral treatment, our findings highlight the importance of preserving and stimulating generic market dynamics to sustain developing countries' bargaining power in price negotiations undertaken with originator companies

Incorporation des technologies pharmaceutiques et accessibilité financière aux traitements contre le VIH/Sida dans les pays en voie de développement : une analyse de la réponse brésilienne

En 2010, l'Organisation Mondiale de la Santé (OMS) a publié de nouvelles recommandations pour le traitement contre le Vih/Sida dans le but d'améliorer la qualité des thérapies antirétrovirales (TARV) distribuées dans les pays en voie de développement (PED). Cependant, les coûts de plus en plus importants liés à l'incorporation des antirétroviraux (ARV) de nouvelle génération, associés à l'intensification de la protection des droits de la propriété intellectuelle (DPI), accentuent le déséquilibre entre les priorités d'expansion de la couverture des patients et les objectifs d'amélioration des traitements, ce qui favorise la pérennité d'un double standard de soins dans le monde. Cette thèse a pour objectif d'analyser les déterminants de l'incorporation des nouvelles technologies et de l'évolution des prix des ARV pour mieux comprendre leur impact sur la qualité et l'accessibilité financière des TARV dans les PED. La présente recherche est basée sur la politique brésilienne de TARV et les leçons qu'elle peut apporter dans la lute contre l'épidémie du Vih/Sida. La première partie de la thèse porte sur les critères utilisés pour l'incorporation des nouveaux médicaments dans les protocoles cliniques de TARV. L'étude part des méthodes de l'analyse de contenu et statistique pour examiner l'impact des prix des ARVs sur les recommandations thérapeutiques et comment celles-ci influencent la pratique médicale.In 2010, the World Health Organization (WHO) published new HIV/AIDS treatment recommendations which aim at improving the quality of antiretroviral therapy (ART) delivered in developing countries. Nonetheless, the higher costs of incorporating new and more potent antiretrovirals (ARVs), coupled by the intensification of intellectual property rights (IPRs) protection, put in evidence a growing trade-off between patient coverage expansion priorities and treatment quality objectives, which tend to favor the perpetuation of a double standard of HIV care in the world.This thesis aims at analyzing the determinants of technology incorporation and price evolution in HIV care as the basis for discussing how these can impact both the quality and affordability of ART in low and middle-income settings. The present research takes as reference the Brazilian ART policy and the insights it may provide in the fight against the HIV/AIDS epidemic. The first part of this thesis addresses the criteria used for the incorporation of novel drugs in ART guidelines. Content and statistical analyses are used to examine the impact of ARV prices on therapeutic recommendations and how the latter have been able to influence clinical practice. They show that, although efficacy, toxicity and dosing convenience represent major determinants of ART incorporation decisions in Brazil, costs have most recently started influencing deferral in the use of new ARVs. The second part takes into account the role of patent protection on pharmaceutical innovation and pricing, further employing descriptive and econometric approaches to analyze ARV market structure and prices in Brazil

Patentes farmacêuticas e saúde pública: desafios à política brasileira de acesso ao tratamento anti-retroviral Pharmaceutical patents and public health: challenges for the Brazilian antiretroviral treatment policy

O preço elevado de medicamentos patenteados tem intensificado o debate em torno do impacto do regime da propriedade intelectual sobre o acesso a tratamentos de saúde, merecendo destaque o caso do HIV/AIDS. A política brasileira de tratamento anti-retroviral, parte de um programa nacional que integra medidas de prevenção e promoção da saúde, permitiu o alcance de uma ampla cobertura com qualidade, tendo sido apontada como modelo para outros países. Não obstante, conforme amadurece o Programa Nacional de DST e AIDS, os gastos com a incorporação de anti-retrovirais patenteados ao esquema terapêutico para pacientes em tratamento atinge um peso, cada vez maior, em seu orçamento. O presente artigo toma em conta os desafios apresentados pelas patentes farmacêuticas à saúde pública e discute possíveis caminhos para a sustentação da política de acesso universal e gratuito ao tratamento contra HIV/AIDS no Brasil.<br>The high prices of patented drugs have fueled the debate regarding the impact of the intellectual property system on access to treatment, with a special focus on HIV/AIDS. The Brazilian policy for antiretroviral treatment, part of a comprehensive program that includes both disease prevention and health promotion activities, has allowed the country to meet goals for coverage and quality and has been considered a model for other countries. However, as the Brazilian STD/AIDS Program reaches maturity, the increasing incorporation of patented drugs into the AIDS treatment regimen imposes an increasing burden on the country's health budget. This article discusses the public health challenges raised by pharmaceutical patents and discusses possible ways to sustain the national policy for free, universal access to HIV/AIDS treatment