Corporate social responsibility to improve access to medicines: the case of Brazil.

BACKGROUND: Access to medicines and the development of a strong national pharmaceutical industry are two longstanding pillars of health policy in Brazil. This is reflected in a clear emphasis by Brazil's Federal Government on improving access to medicine in national health plans and industrial policies aimed at promoting domestic pharmaceutical development. This research proposes that such policies may act as incentives for companies to pursue a strategic Corporate Social Responsibility (CSR) agenda. CSR that supports Governmental priorities could help companies to benefit significantly from the Governmental industrial policy. We sought to determine whether CSR activities of Brazilian pharmaceutical firms are currently aligned with the Federal Government's health prioritization. To do so we examined key Brazilian health related policies since 2004, including the specific priorities of Brazil's 2012-2015 Health Plan, and compared these with CSR initiatives that are reported on the websites of select pharmaceutical firms in Brazil. RESULTS: Brazil's national health plans and industrial policies demonstrated that the Federal Government has followed diverse approaches for improving access to medicines, including strengthening health care infrastructure, increasing transparency, and supporting product development partnerships. Case studies of six pharmaceutical firms, representing both public and private companies of varying size, support the perspective that CSR is a priority for firms. However, while many programs target issues such as health infrastructure, health care training, and drug donation, more programs focus on areas other than health and do not seem to be connected to Governmental prioritization. CONCLUSION: This research suggests that there are loose connections between Governmental priorities and pharmaceutical firm CSR. However, there remains a significant opportunity for greater alignment, which could improve access to medicines in the country and foster a stronger relationship between the Government and industry.

Civil society participation in the health system: the case of Brazil's Health Councils.

BACKGROUND: Brazil created Health Councils to bring together civil society groups, heath professionals, and government officials in the discussion of health policies and health system resource allocation. However, several studies have concluded that Health Councils are not very influential on healthcare policy. This study probes this issue further by providing a descriptive account of some of the challenges civil society face within Brazil's Health Councils. METHODS: Forty semi-structured interviews with Health Council Members at the municipal, state and national levels were conducted in June and July of 2013 and May of 2014. The geographical location of the interviewees covered all five regions of Brazil (North, Northeast, Midwest, Southeast, South) for a total of 5 different municipal Health Councils, 8 different state Health Councils, and the national Health Council in Brasilia. Interview data was analyzed using a thematic approach. RESULTS: Health Councils are limited by a lack of legal authority, which limits their ability to hold the government accountable for its health service performance, and thus hinders their ability to fulfill their mandate. Equally important, their membership guidelines create a limited level of inclusivity that seems to benefit only well-organized civil society groups. There is a reported lack of support and recognition from the relevant government that negatively affects the degree to which Health Council deliberations are implemented. Other deficiencies include an insufficient amount of resources for Health Council operations, and a lack of training for Health Council members. Lastly, strong individual interests among Health Council members tend to influence how members participate in Health Council discussions. CONCLUSIONS: Brazil's Health Councils fall short in providing an effective forum through which civil society can actively participate in health policy and resource allocation decision-making processes. Restrictive membership guidelines, a lack of autonomy from the government, vulnerability to government manipulation, a lack of support and recognition from the government and insufficient training and operational budgets have made Health Council largely a forum for consultation. Our conclusions highlight, that among other issues, Health Councils need to have the legal authority to act independently to promote government accountability, membership guidelines need to be revised in order include members of marginalized groups, and better training of civil society representatives is required to help them make more informed decisions.

Does Pharmaceutical Pricing Transparency Matter? Examining Brazil's Public Procurement System.

BACKGROUND: We review procurement and pricing transparency practices for pharmaceutical products. We specifically focus on Brazil and examine its approach to increasing pricing transparency, with the aim of determining the level of effectiveness in lower prices using a tool (Banco de Preços em Saúde, BPS) that only reveals purchase prices as compared to other tools (in other countries) that establish a greater degree of price transparency. METHODS: A general report of Preços em Saúde (BPS) and Sistema Integrado de Administração de Serviços Gerais (SIASG) pricing data was created for 25 drugs that met specific criteria. To explore the linear time trend of each of the drugs, separate regression models were fitted for each drug, resulting in a total of 19 models. Each model controlled for the state variable and the interaction between state and time, in order to accommodate expected heterogeneity in the data. Additionally, the models controlled for procurement quantities and the effect they have on the unit price. Secondary analysis using mixed effects models was also carried out to account for the impact that institutions and suppliers may have upon the unit price. Adjusting for these predictor variables (procurement quantities, supplier, purchasing institution) was important to determine the sole effect that time has had on unit prices. A total of 2 x 19 = 38 models were estimated to explore the overall effect of time on changes in unit price. All statistical analyses were performed using the R statistical software, while the linear mixed effects models were fitted using the lme4 R package. RESULTS: The findings from our analysis suggest that there is no pattern of consistent price decreases within the two Brazilian states during the five-year period for which the prices were analyzed. CONCLUSIONS: While the BPS does allow for an increase in transparency and information on drug purchase prices in Brazil, it has not shown to lead to consistent reductions in drug purchase prices for some of the most widely used medicines. This is indicative of a limited model for addressing the challenges in pharmaceutical procurement and puts into question the value of tools used globally to improve transparency in pharmaceutical pricing.

Participatory health councils and good governance: healthy democracy in Brazil?

INTRODUCTION: The Brazilian Government created Participatory Health Councils (PHCs) to allow citizen participation in the public health policy process. PHCs are advisory bodies that operate at all levels of government and that bring together different societal groups to monitor Brazil's health system. Today they are present in 98% of Brazilian cities, demonstrating their popularity and thus their potential to help ensure that health policies are in line with citizen preferences. Despite their expansive reach, their real impact on health policies and health outcomes for citizens is uncertain. We thus ask the following question: Do PHCs offer meaningful opportunities for open participation and influence in the public health policy process? METHODS: Thirty-eight semi-structured interviews with health council members were conducted. Data from these interviews were analyzed using a qualitative interpretive content analysis approach. A quantitative analysis of PHC data from the Sistema de Acompanhamento dos Conselhos de Saude (SIACS) database was also conducted to corroborate findings from the interviews. RESULTS: We learned that PHCs fall short in many of the categories of good governance. Government manipulation of the agenda and leadership of the PHCs, delays in the implementation of PHC decision making, a lack of training of council members on relevant technical issues, the largely narrow interests of council members, the lack of transparency and monitoring guidelines, a lack of government support, and a lack of inclusiveness are a few examples that highlight why PHCs are not as effective as they could be. CONCLUSIONS: Although PHCs are intended to be inclusive and participatory, in practice they seem to have little impact on the health policymaking process in Brazil. PHCs will only be able to fulfil their mandate when we see good governance largely present. This will require a rethinking of their governance structures, processes, membership, and oversight. If change is resisted, the PHCs will remain largely limited to a good idea in theory that is disappointing in practice.