Pharmaceutical companies vs. the State: who is responsible for post-trial provision of drugs in Brazil?

This paper discusses the post-trial access to drugs for patients who participated in clinical trials in Brazil. The ethical guidance for clinical trials in Brazil is arguably one of the clearest in the world in attributing to research sponsors the responsibility for providing post-trial drugs to patients who participated in their experiments. The Federal Constitution recognizes health as a fundamental right to be fulfilled by the State. Based on the Brazilian constitution and on the National Health Council resolutions, courts have been accepting patients' claims and ordering the State and the pharmaceutical companies to provide these patients with the tested treatment in the quantity and duration they need it. This generous interpretation of the duties of the pharmaceutical companies and the State makes the Brazilian model for post-trial access unique when compared to the experience of other countries and thus should be followed with attention by future research in order to assess its consequences for patients, research sponsors, and the public health system.

The right to health in the courts of Brazil: worsening health inequities?

This article analyzes the recent and growing phenomenon of right-to-health litigation in Brazil from the perspective of health equity. It argues that the prevailing model of litigation is likely worsening the country's already pronounced health inequities. The model is characterized by a prevalence of individualized claims demanding curative medical treatment (most often drugs) and by a high success rate for the litigant. Both elements are largely a consequence of the way Brazilian judges have interpreted the scope of the right to health recognized in Article 6 and Article 196 of the Brazilian constitution, that is, as an entitlement of individuals to the satiSfaction of all their health needs with the most advanced treatment available, irrespective of its costs. Given that resources are always scarce in relation to the health needs of the population as a whole, this interpretation can only be sustained at the expense of universality, that is, so long as only a part of the population is granted this unlimited right at any given time. The individuals and (less often) groups who manage to access the judiciary and realize this right are therefore privileged over the rest of the population. This is potentially detrimental to health equity because the criterion for privileging litigants over the rest of the population is not based on any conception of need or justice but purely on their ability to access the judiciary, something that only a minority of citizens possess. This paper examines studies that are beginning to confirm that a majority of right-to-health litigants come from social groups that are already considerably advantaged in terms of all socioeconomic indicators, including health conditions. It is a plausible assumption that the model of right-to-health litigation currently prevalent in Brazil is likely worsening health inequities.

Direito à saúde, recursos escassos e equidade: os riscos da interpretação judicial dominante / The right to health, scarce resources, and equity: inherent risks in the predominant legal interpretation / Droit à la santé, faibles ressources et équité: les risques de l'interprétation judiciaire dominante

This article discusses the right to health as provided by the Brazilian Constitution in light of the increasing number of court rulings that order government to supply health products and services that have not been incorporated into public policies by other means. Using the Constitution's concept of health as the point of departure, authors demonstrate that guaranteeing the right to health requires more comprehensive social and economic policies. They argue that scarcity of resources places a limit on the formulation of public policies and that equity should be the underlying principle for orienting resource allocation. The article contends that the interpretation of the right to health as the individual right to unlimited care (the predominant position in the Brazilian Judiciary) is sustained to the detriment of the Constitutional principles of equity and universality, and that this interpretation results in a reversal in the primary objectives of the Unified National Health System (SUS), transforming it into an instrument for the perpetuation of the country's persistently daunting health inequities.

Dans ce travail, on discute le droit à la santé figurant dans la Constitution brésilienne, à la lumière de nombreuses sentences judiciaires obligeant les pouvoirs publics à offrir des produits et services de santé absents des politiques publiques. On part de la conception de santé établie dans la Constitution pour montrer que sa mise en œuvre dépend d'une action plus globale des politiques sociales et économiques. On constate que le manque de ressources empêche le démarrage de ces politiques, dont le principe capital serait l'équité qui guiderait leur mise en place. On soutient que l'interprétation du droit à la santé comme droit individuel et illimité, tel que le Pouvoir Judiciaire le pratique, est maintenue aux dépens des principes d'équité et d'universalité établis dans la Constitution, interprétation menant à l'inversion des objectifs fondamentaux du Système Unique de Santé (SUS), qui en fait un instrument de perpétuation des iniquités dans le domaine de la santé au Brésil.

Eutanásia e Homicídio. Matar e deixar morrer: uma distinção moralmente válida? / Euthanasia and homicide. Killing and letting die: a morally significant distinction?

O presente artigo aborda o problema da interrupção ou omissão do tratamento de manutenção da vida de pacientes terminais sob o prisma da eutanásia e do homicídio. O autor avalia criticamente a distinção proposta por alguns entre omissão terapêutica e eutanásia passiva e discute a relevância moral da doutrina dos atos e omissões, que admite a eutanásia passiva, porém, rejeita a eutanásia ativa.

Questionamentos judiciais e a proteçäo contra o paciente: um sofisma a ser corrigido pelo gerenciamento de riscos / Judicial inquiries and the protection against the patient: a sophism to be corrected through rish management

Discute o crescente aumento dos questionamentos judiciais de pacientes contra prestadores de serviços de saúde, e suas principais causas. Aponta como sofismática e prejudicial ao tratamento do problema a qualificaçäo do paciente como adversário e critica a manutençäo do relacionamento paternalista/autoritário hoje em vigor. Propöe a correçäo desse sofisma com a requalificaçäo do paciente de acordo com a realidade da sociedade de massas contemporânea, de modo a transformá-lo em consumidor, titular de direitos a serem respeitados. Com base nessa premissa, indica o gerenciamento de riscos (risk management) com a melhor opçäo para o combate deste problema e aponta o respeito ao consentimento esclarecido e a adequada documentaçäo dos procedimentos como principais medidas a serem adotadas