On the Judicialization of Health and Access to Medicines in Latin America.

In a context of rapid technological innovation and expensive new products, the paper calls for the generation of real-world data to inform decision-making and an international discussion on the affordability of new medicines, particularly for low- and middle-income countries. Without these, the challenges of health judicialization will continue to grow.

Realizing the right to health in Latin America, equitably.

This special issue "Realizing the Right to Health in Latin America and the Caribbean" provides an overview of one of the most challenging objectives of health systems: equity and the realization of the right to health. In particular, it concentrates on the issues associated with such a challenge in countries suffering of deep inequity. The experience in Latin America and the Caribbean demonstrates that the efforts of health systems to achieve Universal Health Coverage are necessary but not sufficient to achieve an equitable realization of the right to health for all. The inequitable realization of all other human rights also determines the realization of the right to health.

Integrative Review of Managed Entry Agreements: Chances and Limitations.

BACKGROUND AND OBJECTIVE: Managed entry agreements (MEAs) consist of a set of instruments to reduce the uncertainty and the budget impact of new high-priced medicines; however, there are concerns. There is a need to critically appraise MEAs with their planned introduction in Brazil. Accordingly, the objective of this article is to identify and appraise key attributes and concerns with MEAs among payers and their advisers, with the findings providing critical considerations for Brazil and other high- and middle-income countries. METHODS: An integrative review approach was adopted. This involved a review of MEAs across countries. The review question was 'What are the health technology MEAs that have been applied around the world?' This review was supplemented with studies not retrieved in the search known to the senior-level co-authors including key South American markets. It also involved senior-level decision makers and advisers providing guidance on the potential advantages and disadvantages of MEAs and ways forward. RESULTS: Twenty-five studies were included in the review. Most MEAs included medicines (96.8%), focused on financial arrangements (43%) and included mostly antineoplastic medicines. Most countries kept key information confidential including discounts or had not published such data. Few details were found in the literature regarding South America. Our findings and inputs resulted in both advantages including reimbursement and disadvantages including concerns with data collection for outcome-based schemes. CONCLUSIONS: We are likely to see a growth in MEAs with the continual launch of new high-priced and often complex treatments, coupled with increasing demands on resources. Whilst outcome-based MEAs could be an important tool to improve access to new innovative medicines, there are critical issues to address. Comparing knowledge, experiences, and practices across countries is crucial to guide high- and middle-income countries when designing their future MEAs.

Funding and Service Organization to Achieve Universal Health Coverage for Medicines: An Economic Evaluation of the Best Investment and Service Organization for the Brazilian Scenario.

BACKGROUND: There are many health benefits since 31 years after the foundation of the National Health Service (NHS) in Brazil, especially the increase in life expectancy. However, family-income inequalities, insufficient funding, and suboptimal private sector-public sector collaboration are still areas for improvement. The efforts of Brazil to achieve universal health coverage (UHC) for medicines have resulted in increased public financing of medicines and their availability, reducing avoidable hospitalization and mortality. However, lack of access to medicines still remains. Due to historical reasons, pharmaceutical service organization in developing countries may have important differences from high-income countries. In some cases, developing countries finance and promote medicine access by using the public infrastructure of health care/medical units as dispensing sites and cover all costs of medicines dispensed. In contrast, many high-income countries use private community pharmacies and cover the costs of medicines dispensed plus a fee, which includes all logistic costs. In this study, we will undertake an economic evaluation to understand the funding needs of the Brazilian NHS to reduce inequalities in access to medicines through adopting a pharmaceutical service organization similar to that seen in many high-income countries with hiring/accrediting private pharmacies. METHODS: We performed an economic evaluation of a model to provide access to medicines within public funds based on a decision tree model with two alternative scenarios public pharmacies (NHS, state-owned facilities) versus private pharmacies (NHS, agreements). The analysis assumed the perspective of the NHS. We identified the types of resources consumed, the amount, and costs in both scenarios. We also performed a budget impact forecast to estimate the incremental funding required to reduce inequalities in access to essential medicines in Brazil. FINDINGS: The model without rebates for medicines estimated an incremental cost of US$3.1 billion in purchasing power parity (PPP) but with an increase in the average availability of medicines from 65% to 90% for citizens across the country irrespective of family income. This amount places the NHS in a very good position to negotiate extensive rebates without the need for external reference pricing for government purchases. Forecast scenarios above 35% rebates place the alternative of hiring private pharmacies as dominant. Higher rebate rates are feasible and may lead to savings of more than US$1.3 billion per year (30%). The impact of incremental funding is related to medicine access improvement of 25% in the second year when paying by dispensing fee. The estimate of the incremental budget in five years would be US$4.8 billion PPP. We have yet to explore the potential reduction in hospital and outpatient costs, as well as in lawsuits, with increased availability with the yearly expenses for these at US$9 billion and US$1.4 billion PPP respectively in 2017. INTERPRETATION: The results of the economic evaluation demonstrate potential savings for the NHS and society. Achieving UHC for medicines reduces household expenses with health costs, health litigation, outpatient care, hospitalization, and mortality. An optimal private sector-public sector collaboration model with private community pharmacy accreditation is economically dominant with a feasible medicine price negotiation. The results show the potential to improve access to medicines by 25% for all income classes. This is most beneficial to the poorest families, whose medicines account for 76% of their total health expenses, with potential savings of lives and public resources.

Confidentiality agreements: a challenge in market regulation.

BACKGROUND: Sustainability and the ability to maintain the right to health, with the guarantee of access to quality medicines and health services, have been a great challenge for countries with universal health systems. The great technological advances bring with it an expressive increase in the expenditures of the health systems, especially those directed towards the acquisition of high-cost drugs, which are still under patent protection, have a high cost and, in some cases, present uncertainties about their effectiveness and safety. As a way of maintaining the proper functioning of the systems and guaranteeing access to these medicines, some countries started to negotiate discounts with manufacturing companies. Pricing agreements have been adopted by developed countries with the objective of reducing their spending on high-cost medicines and, although they represent an opportunity for better negotiation with the industries, they violate the principle of transparency that regulates the world market. However, the existence of confidentiality agreements has meant that the declared prices are not the actual prices, unfairly harming the countries that use these price lists as beacons in their systems. METHODS: Representatives of health, judicial, legislative, patient organizations and academics from eight countries in Latin America and South Korea participated in a meeting in September 2017 in Chile to discuss price confidentiality agreements and the impact on public health policies. During the meeting, participants were presented with a hypothetical case to subsidize the discussion on the topic. Divided into groups, participants should propose recommendations for the problem by pointing out the pros and cons if each proposed recommendation was adopted. The groups were then confronted by a simulated jury and finally issued a single and final recommendation for the problem. RESULTS: The topic was widely discussed and recommendations were raised by the participants. Among them, it is worth noting the elaboration of norms that regulate the negotiations of prices between the countries bringing transparency and harmony in the adopted conducts. In addition, the possible consequences and potential impacts of confidentiality on drug prices and inputs, such as information asymmetry and inequity of access between countries, were pointed out. CONCLUSION: Despite there are efforts to make price negotiations more transparent, there is still no well-established standardization that promotes a well-functioning market. Confidentiality agreements hamper the fairness of access to essential health products.

Who should pay for the continuity of post-trial health care treatments?

BACKGROUND: The bioethical debate in the world on who should pay for the continuity of post-trials treatment of patients that have medical indication remains obscure and introduces uncertainties to the patients involved in the trials. The continuity of post-trial treatment was only incorporated in the 2000s by the Helsinki Declaration. The Universal Declaration on Bioethics and Human Rights, published in 2006, points out that post-trial continuity may present a broader scope than just the availability of the investigated medicine. In the latest version of this Declaration, in 2013, it was stated that "prior to the start of the clinical trial, funders, researchers and governments of the countries participating in the research should provide post-trial access for all participants who still require an intervention that was identified as beneficial. This information should also be disclosed to participants during the informed consent process". However, a systematic review on the registration of phase III and IV clinical trials, from the clinical trials website, demonstrated that the understanding of the various guidelines and resolutions is conflicting, generating edges in the post-trial setting. For the health authorities of countries where clinical trials take place, the uncertainties about the continuity of the treatments generate gaps in care and legal proceedings against health systems, which are forced to pay for the treatments, even if they are not included in the list of medicines available to the population. METHODS: Fifty-one representatives from the health, judicial, legislative, patient and academic organizations of eight countries of Latin American and South Korea took part in a meeting in Chile, in 2017, to discuss the responsibility of the treatment continuation after clinical trials. From a hypothetical case of development of a new drug and its studies of efficacy and safety, the participants, divided in groups, proposed recommendations for the problem and pointed out the pros and cons of adopting each recommendation. The groups were, afterwards, confronted by a simulated jury and, finally, issued a final recommendation for the problem. Then, an analysis was made on the content of the recommendations and the pros and cons in adopting conservative or liberal positions, besides the possible impacts of a restrictive regulation regarding the conduction of clinical trials, pointed out by the groups, before and after the simulated jury. RESULTS: The theme was widely discussed and about 12 recommendations were proposed by the participants. The main ones took into account aspects related to patients' rights, economic factors and the development of new technologies, above the position of industry and research institutes, as well as the legislation in force in each country. CONCLUSION: The countries of Latin America and South Korea, currently, do not have laws that address patients' rights, moreover, there is no definition on who should be responsible for post-trial treatments. It is suggested that the World Health Organization issue a resolution recommending that all associated countries determine that the pharmaceutical and medical device industries, or those that sponsored it, should continue to provide treatment to all patients who participated in clinical trials and have medical indication to the continuity.

Distributional health and financial benefits of increased tobacco taxes in Colombia: results from a modelling study.

BACKGROUND: In Colombia, smoking is the second leading modifiable risk factor for premature mortality. In December 2016, Colombia passed a major tax increase on tobacco products in an effort to decrease smoking and improve population health. While tobacco taxes are known to be highly effective in reducing the prevalence of smoking, they are often criticised as being regressive in consumption. This analysis attempts to assess the distributional impact (across socioeconomic groups) of the new tax on selected health and financial outcomes. METHODS: This study builds on extended cost-effectiveness analysis methods to study the new tobacco tax in Colombia, and estimates, over a time period of 20 years and across income quintiles of the current urban population (80% of the country population), the years of life gained with smoking cessation and the increased tax revenues, all associated with a 70% relative price increase of the pack of cigarettes. Where possible, we use parameters that vary by income quintile, including price elasticity of demand for cigarettes (average of -0.44 estimated from household survey data). FINDINGS: Over 20 years, the tax increase would lead to an estimated 191 000 years of life gained among Colombia's current urban population, with the largest gains among the bottom two income quintiles. The additional annual tax revenues raised would amount to about 2%-4% of Colombia's annual government health expenditure, with the poorest quintiles bearing the smallest tax burden increase. CONCLUSIONS: The tobacco tax increase passed by Colombia has substantial implications for the country's population health and financial well-being, with large benefits likely to accrue to the two poorest quintiles of the population.

Looking for Evidence of the Impact of Introducing a Human Rights-Based Approach in Health: The SaluDerecho Experience.

This paper summarizes the background, methodology, results, and lessons learned from SaluDerecho, the Initiative on Priority Setting, Equity and Constitutional Mandates in Health. Originally facilitated by the capacity-building arm of the World Bank in 2010, it was implemented in Latin American countries and later expanded to other regions of the world. Segmentation, decentralization, and lack of coordination in health systems; weak information systems; stratified societies; and hierarchical power relations in participating countries are some of the characteristics that inhibit a human rights-based approach to health. Hence, deliberate interventions like SaluDerecho are vital. Facilitating the participation of multiple stakeholders in a more informed and transparent dialogue creates a "safe" working environment to co-create policy solutions to improve transparency and accountability. The proposed evaluation methodology involves several steps that begin with an assessment of behavioral changes in actors (including policy makers, citizens, payers, and health care providers) that reshape relationships and, over time, change the functioning of health systems. Despite certain limitations, SaluDerecho has provided evidence of positive change among participating countries.

Universal health coverage and litigation in Latin America.

PURPOSE: Over the last five years many middle-income Latin American countries have seen a steep increase in the number of cases litigating access to curative services. The purpose of this paper is to explore this complex phenomenon and outline some of its roots and impacts. DESIGN/METHODOLOGY/APPROACH: The authors use an interdisciplinary approach based on a literature review and workshops convened to discuss the issue. FINDINGS: A range of reasons can explain this increased legal activity. These include: a renewed judicial approach to the enforcement of the right to health; a more demanding public interest; an increased prevalence of non communicable diseases; and limited capacity for fair benefit package. ORIGINALITY/VALUE: The findings in this paper argue for the need to incorporate a rights-based approach to health policy as a foundation of societal efforts to achieve universal health coverage in Latin America.

Occupational risks in Latin America and the Caribbean: economic and health dimensions.

This study analyzes health and economic aspects of occupational safety in Latin America and the Caribbean. Work-related injuries and illnesses represent a primary health risk in the region. Specific factors negatively affect work safety in the region: the structure of the labour market, the lack of adequate resources for enforcement, prevention and research, the hazard profile, as well as the presence of vulnerable groups in the workforce. This study estimates that between 27,270 and 73,500 occupational fatal accidents occur in the region each year. It also calculates that the economic costs of these hazards represent between 2 and 4% of regional Gross Domestic Product. The paper concludes by discussing public policies that could address this problem and improve compliance with appropriate safety standards in the region.

A Concepção econômica de custos

Aborda os aspectos microeconômicos da saúde ocupando-se da concepção econômica dos custos e introduz o leitor em outros conceitos básicos tais como custo-oportunidade (ou custo social), custo médio marginal e as diferenças entre custo econômico e custo contábil.

Demanda e demanda em saúde

Aborda os aspectos conceituais da demanda global e da demanda em saúde, seus determinantes e o conflito, ou as diferenças entre demanda (procura do serviço) e "necessidade".

III- Impacto econômico das causas externas no Brasil: um esforço de mensuraçäo / III- Economic impact of external causes in Brazil: an attempt at measurement

Procurou-se obter uma primeira estimativa do impacto econômico das lesöes e envenenamentos no Brasil, medido através dos gastos hopitalares com internaçäo - dias de permanência geral e em Unidades de Terapia Intensiva. Säo analisadas internaçöes em hospitais conveniados com o Sistema Unico de Saúde, através das AIH - Autorizaçäo de Internaçäo Hospitalar, sendo verificado que essas internaçöes geram um gasto anual, correspondendo a, aproximadamente, 0,07 do Produto Interno Bruto do País. Com relaçäo à mortalidade, o impacto econômico foi analisado por meio do indicador Anos Potenciais de Vida Perdidos. Os acidentes e violências representaram cerca de 2,6 milhöes de anos de vida perdidos, em 1981, e 3,4 milhöes, em 1991. O aumento verificado foi cerca de 30 por cento, enquanto que para o conjunto de dados os óbitos apresentaram-se em queda. Apesar de algumas limitaçöes, é possível estimar a dimensäo geral do impacto econômico das causas externas. Espera-se que essas limitaçöes sirvam de estímulo a novas investigaçöes e aprofundamentos.

A evoluçäo do país e de suas doenças / The development of the country and its diseases

Sintetiza os resultados principais do projeto de pesquisa "A trajetória do desenvolvimento social no Brasil nas décadas de 70 e 80: a história contada pela evoluçäo dos indicadores de saúde e nutriçäo da populaçäo (AU)

A evolução do país e de suas doenças / Developing of the country and its diseases

Sintetiza os resultados principais do projeto de pesquisa "A trajetória do desenvolvimento social no Brasil nas décadas de 70 e 80: a história contada pela evolução dos indicadores de saúde e nutrição da população

A concepçäo econômica de custos / The economic concept of costs

Traduz e explica conceitos econômicos em uma linguagem mais acessível ao näo-economista, particularmente àquele ligado à área da saúde, apresentando a noçäo de custo de oportunidade e mostra sua relevância esta área

Mudanças no cenário econômico / Changes in the economical scenery

Caracteriza, de maneira sintética, o padräo do desenvolvimento econômico brasileiro ao longo das últimas três décadas, relacionando-o à evoluçäo de variáveis importantes na determinaçäo das condiçöes de saúde e nutriçäo, como a distribuiçäo de renda, a pobreza e as políticas públicas

Evoluçäo da desnutriçäo infantil / Evolution of infant malnutrition

Analisa dois inquéritos nutricionais de abrangência nacional, no que se refere à evoluçäo de fatores que influenciam o atendimento das necessidades básicas de uma populaçäo

A evoluçäo do país e de suas doenças: síntese, hipóteses e implicaçöes / The evolution of the country and its diseases: synthesis, hypothesis and implications

Refere os capítulos desenvolvidos no livro, e constata a mudança do perfil de morbi-mortalidade da populaçäo brasileira

O estado nutricional das crianças brasileiras: a trajetória de 1975 a 1989 / The nutritional status of Brazilian children: the trajetory from 1975 to 1989

Faz o balanço líquido das décadas de 70 e 80, seja com relaçäo à saúde infantil, com relaçäo às condiçöes gerais de vida da populaçäo, analisando dois inquéritos nutricionais de abrangência nacional (AU)