REFUSAL OF THE HEALTH PLANE OF THE SUPPLY OF IMMUNOBIOLOGICAL MEDICINES, CONSEQUÊNCIAS AND POSSÍVEIS SOLUÇÕES FOR THE REDUÇÃO DA JUDICIALIZAÇÃO DA SAÚDE

Abstract

In recent years, a large portion of the Brazilian population has sought help from health plans, a form of escape from the already overwhelmed SUS (Unified Health System). Contrarily, when plan users need it for a more serious event, they often end up receiving a "no" answer.

It is widely understood that after the enactment of the 1988 National Constitution, there was a national increase in public awareness of their rights, with a growing demand for judicialization in all spheres, and healthcare was undoubtedly one of them.

Therefore, there has been an increase in the judicialization of healthcare in Brazil, especially when, in the case of health plan providers, patients' requests for medication or treatment are denied.

This is the context in which the field of legal science finds itself, faced with the need to intervene to guarantee life, health, and human dignity.

Another important aspect is that, when a health plan denies a claim, pain, suffering, anguish, distress, and often worsening of the disease itself, result.

This research will seek, through a critical and innovative approach, to clearly and clearly demonstrate that life is the greatest good and that health and life should not be relativized.

Furthermore, the judicialization of health is a recurring theme in Brazilian courts. The goal is to understand the context of judicial decisions and whether they actually have a coercive/educational effect. Beyond guaranteeing the rights of those seeking legal recourse, it goes further by seeking mechanisms to reduce the increase in litigation and to find a path toward dejudicialization, guided by greater dialogue between patients, doctors, and health plan providers.

In this context, it is essential to seek new concepts and see new horizons that can encompass peaceful and efficient solutions that do not involve judicialization.

The aim of this research is to elucidate the main consequences of health insurance plans' refusal to provide medications for the treatment of autoimmune diseases, and what measures can be implemented to reduce the judicialization of healthcare.

RESEARCH PROBLEM

In Brazil, health insurance plans' refusal to provide immunobiological medications to their beneficiaries represents one of the main obstacles to comprehensive and effective access to healthcare, a constitutionally enshrined right. This behavior has generated a series of challenges, not only legal but also social and medical, directly impacting the treatment and quality of life of patients suffering from serious or chronic illnesses, whose treatment often depends exclusively on these high-cost medications.

Administrative denials, based on the lack of a provision in the National Supplementary Health Agency (ANS)'s list of procedures or the medication's experimental nature, often disregard individualized medical prescriptions and fundamental principles of the Brazilian legal system, such as the right to health, life, and human dignity. This reality imposes a disproportionate burden on beneficiaries, forcing them, in many situations, to seek legal recourse as the only alternative to ensure the prescribed treatment.

Given this scenario, the following research question is outlined:

How does health insurance plans' denial of coverage for immunobiological medications impact beneficiaries' fundamental rights, especially regarding access to healthcare, the resulting legal and social consequences, and the effectiveness of court decisions within the Brazilian legal system? Given this situation, is there any possibility of reducing judicialization?

Based on this issue, we intend to contribute to the academic and legal debate on the effectiveness of public and private health policies, and to the search for solutions that effectively respect the constitutional principles of human dignity, health and access to justice.

HYPOTHESIS

The hypothesis is that the denial by health insurance companies of coverage for immunobiological medications, even when regularly prescribed by a qualified professional, constitutes a direct affront to the fundamental rights to health and life, enshrined in the 1988 Federal Constitution, and is therefore legally unjust. Such conduct, even when supported by administrative guidelines from the National Supplementary Health Agency (ANS), is incompatible with the principles of human dignity, solidarity, and the social function of contracts, justifying the role of the Judiciary as a means of ensuring the effectiveness of the right to health and curbing abusive practices in the supplementary health sector.

OBJECTIVES

1.3.1 General Objective

To analyze the liability of health insurance companies when denying coverage for medications for autoimmune diseases, in light of the Constitution, legislation, and case law.

1.3.2 Specific Objectives

Understand, in light of specialized doctrine and current legislation, the theoretical and normative foundations related to the right to health, emphasizing its concepts, definitions, and essential aspects.
Analyze the right to health and life as fundamental and social rights, focusing on the obligation of health plans to provide high-cost medications to beneficiaries.
Investigate the role of the Judiciary in enforcing the right to health, especially in light of denials of coverage by health plan providers.
Evaluate recent decisions by the Federal Supreme Court (STF) and the Superior Court of Justice (STJ) regarding the liability of health plans, in light of Law No. 14,454/2022, which amends Law No. 9,656/1998, regarding the coverage of treatments not covered by the ANS.
Examine the position of the Court of Justice of Pernambuco (TJPE) and other national courts regarding the awarding of compensation for moral damages resulting from the refusal of providers to provide high-cost medications.
Discuss strategies for improving the services provided by health plans, in accordance with Laws No. 8,080/1990 and No. 9,656/1998, with a view to reducing the judicialization of access to healthcare.

JUSTIFICATION

Given the above, this research is justified by the social, legal, and scientific relevance of the denial of coverage for immunobiological drugs by health plan providers, a problem that has intensified in the contemporary Brazilian scenario. The growing number of lawsuits filed by beneficiaries seeking guaranteed access to essential medical treatments highlights not only the fragility of supplemental health regulatory mechanisms but also the need for a critical analysis of the legal limits of providers' actions regarding consumers' fundamental rights.

Immunobiological drugs represent an important advance in the treatment of serious, chronic, and autoimmune diseases, often representing the only viable therapeutic alternative to ensure patients' survival and quality of life. However, because these therapies are expensive and not always included in the list of procedures of the National Supplementary Health Agency (ANS), their coverage is often denied by providers, even when a well-founded medical prescription is provided. This reality has led to the massive judicialization of similar cases, creating a burden on the judiciary and creating uncertainty for both beneficiaries and healthcare professionals.

Therefore, the choice of this topic is further justified by the need to promote critical reflection on the limits of contractual autonomy in the context of supplementary healthcare, in light of the constitutional principles of human dignity, the right to health, and the social function of contracts. The study seeks to understand the extent to which denials based solely on the lack of contractual provision or inclusion in the ANS list are consistent with consumer rights and the foundations of the democratic rule of law.

Furthermore, the study aims to contribute to academic debate and the development of legal and administrative solutions that can help reduce the judicialization of healthcare without compromising the protection of fundamental rights. In this sense, this dissertation aims to critically analyze the prevailing case law, current regulations, and possibilities for improving the regulatory system, proposing alternatives that balance the economic interests of health care providers with ensuring equitable and effective access to healthcare.

Finally, it is justified by the current relevance and complexity of the topic, which involves legal, medical, regulatory, and ethical aspects, requiring an in-depth, multidisciplinary study to understand the impacts of judicialization and the strategies needed to promote a fairer, more efficient, and more respectful supplementary healthcare system.

SCOPE

This research focuses on the legal analysis of denials of coverage for immunobiological drugs by health insurance companies in Brazil, focusing on the implications of this practice for the right to health and the case law of Brazilian courts, especially after the enactment of Law 14,454/2022. The study focuses on supplementary healthcare, directly excluding claims related to the Unified Health System (SUS), and considers decisions issued since the 2010s.

In addition to the normative and case law analysis, the research aims to identify and discuss legal and administrative mechanisms that can contribute to reducing the judicialization of these cases, promoting a balance between consumer rights and the sustainability of the private healthcare sector.

DESSERTATION STRUCTURE

The dissertation is divided into five main chapters. The first chapter addresses the introduction, which includes a delimitation of the topic, justification, general and specific objectives, and hypothesis. The second chapter presents the theoretical framework.

The third chapter is devoted to methodological procedures. The fourth chapter presents the results and discussions, while the fifth addresses the concluding remarks. Finally, the bibliographical references are presented.