Direito à saúde: judicialização dos tratamentos em fase experimental e dos tratamentos novos não registrados

Abstract

After World War II, the development of the value of the dignity of the human person occurred, with a reconfiguration of the ethical paradigms of the international order. There was a process of constitutionalisation worldwide and the constitutional state model expanded, consecrating human dignity as a universal and immanent legal value to the human being. The new state model triggered the expansion of guarantees and fostered access to the rights considered essential to guarantee this dignity, resulting in the phe-nomenon ofjudicialization, since the unmet demands became recurring lawsuits in the courts. Post-positivism represents this moment of redefinition, serving as a theoretical foundation for the present work. Once the idea of a purely programmatic Constitution has been withdrawn, there has been a greater role for the Public Power in the provision of essential universal services. The opportunity was opened to question who is responsible for ensuring this benefit, in order to evaluate the jurisdiction of the Judiciary to determine the provision of treatment or services based on the principie of separation ofpowers, as well as the reservation of the possible. ANVISA was created in order to protect the health of the population, but not ali medicines possibiy able to achieve this are included in its approved list. The situations of experimental treatments and those not approved by the competent national body are a complex point of the theme and the object of the present study. In Brazil, the Ministry of Health publishes a list of medicines and procedures that must be provided free of charge, the National List of Essential Medicines - RENAME. However, even though this list is updated periodically, the various questions remain about its adequacy and suitability for the fulfillment of health demands. Some cases of negative supply of drugs not registered by ANVISA have become emblematic, such as synthetic phosphoethanolamine and cannabis sativa drugs, the former being considered experimental treatment and the latter, unrecorded new treatment. The problem lies in knowing the limits ofwhat must be ensured. It was hypothesized that constitutional directives have normative force and are arranged to ensure the existential minimum to ali citizens who are submitted to it, being fully applicable. This understanding finds theoretical balance in Post-positivism, from the constructions of Dworkin (2002) and Alexy (2013) on the normativity of the principies and the maximum of the proportionaiity of the second. Under the methodology of deductive analysis, the research developed from the conceptualization of what would be the experimental drugs, from which they have understood the doctrine and jurisprudence about its concession, as weli as the national normative guidelines. The objective of this study was to understand whether it is reasonable for the pubiic body to deny the provision of experimental treatments designed in both species - experimental treatment and new unrecorded treatment - to those individuais who lack them and even measure. To reach the objectives of the study, in addition to the aforementioned theoretical framework, articles and decisions of the Federal Supreme Court were studied. Health norms have an open character, which gives the applicator the power-duty of interpretation at the time of application, observing their commitment to justice and equity. list of medicines and inputs generates predictability to the public budget, however, it can not present the system from being predicted if the ineffectiveness of the treatments provided to a special situation is demonstrated. The search for judicial intervention aims at the achievement of the substantial equality advocated constitutionally, and the work presented parameters for these decisions.