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In May 2011, the Brazilian Ministry of Health announced the distribution of the first batch of locally produced generic tenofovir disoproxil fumarate (TDF) to support its program of universal and free access for the treatment of HIV/AIDS. The inclusion of TDF in the public health program illustrates what has been considered the 'Brazilian model' of HIV/AIDS response, as it illustrates the current phase of the Brazilian pharmaceutical economy. Brazil is known for having managed to control the expansion of HIV/AIDS through a unique initiative combining the public health and the industrial production of generics. But, if at first local manufacturers could freely copy ARVs and produce cheaper generic versions that were delivered to the Ministry of Health, since the country started to grant patents on drugs in 1996, the sustainability of this policy has been challenged by the high cost of patented second-line HIV/AIDS treatments. In order to assure continuity of the local production of ARVs, and keep the program of public health alive, Brazilians are now forced to deal with conflicts of drugs' intellectual property rights in order to open the path to generic production. This article aims to describe the experiences surrounding TDF in Brazil and the unprecedented conflicts and challenges it has brought for our different interviewees. Blurring the frontier between the public and the private, the TDF case was driven at the same time by an ethic of drug access and regulation of drug quality, which has inspired Brazilians to intervene and transform the world they live in., (© 2014 John Wiley & Sons Ltd.)

Background: 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., Methods and Findings: 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., Significance: 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.

"Access to medicines" is a broad concept. After a review of three authoritative frameworks that help to identify its constitutive components, this essay summarizes the actual situation on the ground in low- and middle-income countries on the basis of recent empirical work. An analysis of survey data from 36 countries concluded that developing countries should promote generic medicines as a key policy option for improving access to medicines. Taking an international perspective to that recommendation, this essay reviews the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and, particularly, how this agreement has been applied in practice. As shown by the experience of Thailand, Brazil, and the Philippines, in order to deal effectively with international pressures for an excessive application of the TRIPS Agreement, some sort of conversion experience appears to be required, which then leads to a switch from a private enterprise, supply-driven approach to a public health vision that insists on universal and affordable access. But moral conviction is not sufficient. In order to muster and sustain the political will to face down international forces, civil society and government offices must be able and ready to show the costs and other adverse consequences of the TRIPS-based model for medicines. This calculation needs to reach beyond the health sector and calls for new alliances, nationally as well as internationally., (© 2010 American Society of Law, Medicine & Ethics, Inc.)

Brazil's large-scale, successful HIV/AIDS treatment programme is considered by many to be a model for other developing countries aiming to improve access to AIDS treatment. Far less is known about Brazil's important role in changing global norms related to international pharmaceutical policy, particularly international human rights, health and trade policies governing access to essential medicines. Prompted by Brazil's interest in preserving its national AIDS treatment policies during World Trade Organisation trade disputes with the USA, these efforts to change global essential medicines norms have had important implications for other countries, particularly those scaling up AIDS treatment. This paper analyses Brazil's contributions to global essential medicines policy and explains the relevance of Brazil's contributions to global health policy today.

ANTIRETROVIRAL ROLLOUT IN BRAZIL AND THAILAND: Brazil and Thailand are among few developing countries to achieve universal access to antiretroviral therapy. Three factors were critical to this success: legislation for free access to treatment; public sector capacity to manufacture medicines; and strong civil society action to support government initiatives to improve access. LOCAL PRODUCTION OF AFFORDABLE, NON-PATENTED DRUGS: Many older antiretroviral drugs are not patented in either country and affordable generic versions are manufactured by local pharmaceutical institutes., Efforts to Ensure Access to Expensive, Patented Drugs: Developing countries were not required to grant patents on medicines until 2005, but under US government threats of trade sanctions, Thailand and Brazil began doing so at least ten years prior to this date. Brazil has used price negotiations with multi-national pharmaceutical companies to lower the price of newer patented antiretrovirals. However, the prices obtained by this approach remain unaffordable. Thailand recently employed compulsory licensing for two antiretrovirals, obtaining substantial price reductions, both for generic and brand products. Following Thailand's example, Brazil has issued its first compulsory license., Lessons Learned: Middle-income countries are unable to pay the high prices of multinational pharmaceutical companies. By relying on negotiations with companies, Brazil pays up to four times more for some drugs compared with prices available internationally. Compulsory licensing has brought treatment with newer antiretrovirals within reach in Thailand, but has resulted in pressure from industry and the US government. An informed and engaged civil society is essential to support governments in putting health before trade.

Objective: The expense of acquiring antiretroviral drugs in Brazil has given rise to debate about the sustainability of the policy of universal access to AIDS medications, despite the evident benefits. The objective of this study was to analyze the evolution of the Ministry of Health's spending on acquiring antiretroviral drugs from 1998 to 2005, the determining factors and the medium-term sustainability of this policy (2006-2008)., Methods: The study on the evolution of spending on antiretrovirals included analysis of their prices, the year-by-year expenditure, the number of patients utilizing the medication, the mean expenditure per patient and the strategies for reducing the prices maintained during this period. To analyze the sustainability of the policy for access to antiretrovirals, the cost of acquiring the drugs over the period from 2006 to 2008 was estimated, along with the proportion of gross domestic product and federal health expenditure represented by this spending. The data were collected from the Ministry of Health, the Brazilian Institute for Geography and Statistics (IBGE) and the Ministry of Planning., Results: The expenditure on antiretrovirals increased by 66% in 2005, breaking the declining trend observed over the period from 2000 to 2004. The main factors associated with this increase were the weakening of the national generics industry and the unsatisfactory results from the process of negotiating with pharmaceutical companies., Conclusions: The Brazilian policy for universal access is unsustainable at the present growth rates of the gross domestic product, unless the country compromises its investments in other fields.

Background: In Brazil, there is free antiretroviral (ARV) distribution to patients with HIV disease by the National Health System. Adherence to the treatment is one of the main factors that health services can manage to increase the effectiveness of the ARV medication. The aim of this study is to evaluate the cost-effectiveness of initial adherence to the ARV therapy and to identify factors that influence patient's costs and global evolution., Methods: Prospective study of HIV infected patients receiving their first ARV prescription in two public referral centers to HIV/Aids, Brazil. The non-adherence was defined as the intake of <95% of the prescribed doses for 3 days prior to the first follow-up visit. A cost-effectiveness ratio was calculated for either groups, the adherent and the non-adherent. Univariate and multivariate analysis were performed using multiple linear and binary logistic regression models., Results: 79.7% of the 197 participants was adherent to the ARV treatment and the ratio cost-effectiveness obtained for this group (2667.67 Eros) was smaller than the ratio observed among the non-adherent group. Multivariate analysis (p < 0.05) showed that adherence to ARV therapy and use of protease inhibitors in the treatment were associated with higher direct cost of care. The favorable global evolution was associated with being asymptomatic, TCD4+ linphocyte count >200 cels/mm3 and be adherent to the ARV treatment., Conclusions: The observed results supported the ARV therapy as a cost-effective intervention. However, low adherence increases the risk of therapeutic failure and illness progression that results in a negative impact on the cost-efectiveness of the ARV therapy.

I explore the relationship between public health and human rights by examining the Brazilian government's policy of free and universal access to anti-retroviral medicines for people with HIV/AIDS. The Brazilian government's management of the HIV/AIDS epidemic arose from initiatives in both civil society and the governmental sector following the democratization of the country. The dismantling of authoritarian rule in Brazil was accompanied by a strong orientation toward human rights, which formed the sociopolitical framework of Brazil's response to the HIV/AIDS epidemic. Even if the Brazilian experience cannot be easily transferred to other countries, the model of the Brazilian government's response may nonetheless serve as inspiration for finding appropriate and lifesaving solutions in other national contexts.