Judicialization of health: medicines by SUS and health plans

The judicialization of health is a resource that allows patients to have access to more appropriate health treatments. Although the right to medication or medical assistance is guaranteed, there are several factors that create a social context in which it is difficult to provide the population with access to the necessary medicines.

According to the Association of the Pharmaceutical Research Industry (INTERFARMA), the aging of the population, the low budget for health, delays in transfers and logistical problems in the Health System can be obstacles for patients to access the appropriate treatments.

This means that SUS or health plans are unable to attend some treatments, especially those considered to be high cost (when the unit value or the total cost of treatment is quite high).

The judicialization of health, or the opening of a legal process for obtaining treatment, is a resource and a right of the patient. The process can be initiated in cases of therapies already incorporated in SUS, in those that are in the experimental phase or in those that have already been approved by ANVISA, but still outside the list of government procedures.

Understand more about the processes of judicialization of health and what to do if you need to have access to a high-cost medication in the following text!


What is the judicialization of health?

The judicialization of health can be understood as the attempt to obtain medicines or treatments, which have been denied by the Unified Health System (SUS) or by the health plan, through legal actions.

According to Ana Amélia Gonçalves de Almeida, specialist in Medical Law, the opening of legal proceedings has been increasing in recent years in Brazil due to several issues.

Among them, it is possible to mention the lack of investment, planning and poor management of public health. This scenario generates both direct costs (the price of the drug itself) and operational costs for the State, since it requires a specific operation of the Brazilian legal system.

It is also necessary to consider that some drugs have a very high cost, making the issue not only public health, but also budgetary.

Although it is not the solution for drug and therapeutic assistance to the population, it is currently a tool that allows patients with a medical prescription to access the indicated therapy.

Both SUS and health plans have responsibility for patients, according to the criteria provided for by law.

Therefore, if a person is not able to afford his treatment and receive denials from the health plan or SUS, the judicial route is a possible alternative.

When is it necessary to go to court?

Health is a fundamental right, expressed and guaranteed by the Brazilian Constitution, and when the necessary or most appropriate treatment is not contemplated by the Public Health System or is denied by health plan operators, it is necessary to seek the Judiciary.

However, before filing a lawsuit, all administrative options must be exhausted.

Proceedings against the State

Some medicines, including high-cost ones, are part of RENAME , which is the National List of Essential Medicines. It contains those procedures and remedies that are offered free of charge by SUS, without the prior need to open legal proceedings.

However, due to budgetary issues or medication availability, patients are not always able to initiate or maintain treatment.

If the supply is denied or the medication is not on the SUS list, the person must make an administrative request at the Health Department. If there is a new refusal, the administrative channels for access to treatment are closed.

Thus, it is possible to resort to judicial channels. That is, together with the assistance of a lawyer, open a case against the State.

This also applies to drugs not yet approved by ANVISA. Although, as a rule, the State is not obliged to supply drugs in an experimental phase or not approved by the Regulatory Agency, it is possible that, in exceptional cases, the process will be favorable to (the) patient.

Health insurance lawsuit

As occurs when the possibilities of administrative request in the SUS are exhausted, patients who have a contracted health plan can sue the Judiciary, aiming at obtaining treatments.

If the health plan refuses to offer the drug, the person must then go to court. Often, the denial on the part of the private company is undue. For example, when the operator refuses to pay for treatments that are included in the ANS List, in which the minimum mandatory coverage of health plans is listed.

It is also worth noting that the ANS List refers to the minimum coverage. In other words, if patients have a medical indication for treatments or medications that are not listed, it is still possible to make an attempt to pay for them through the courts.

How to demand medications from SUS?

There are some requirements for patients to be able to claim some medication through the judicial system, established by the Federal Supreme Court. The first one refers to the existence of registration with ANVISA.

According to Ana Amélia Gonçalves de Almeida, a specialist in Medical Law, the lack of registration with the regulatory agency does not preclude the opening of the judicial process, even if there is no mandatory concession.

In this case, some rules apply, such as having already applied for registration with ANVISA, registering with agencies abroad and also proving that there is no therapeutic substitute.

In all cases, patients need to prove that it is not possible to bear the costs of treatment and that treatment is essential. For this, the presentation of a medical report and useful information about the medication, such as the package leaflet and available clinical studies, are indispensable.

In this way, patients can seek a lawyer of their trust, the Public Defenders of their states or, when available, even the legal services offered in community service centers, especially at universities and colleges of law. Right.

What is the mandatory minimum coverage of the health plan?

The National Complementary Health Agency, ANS, defines a list of consultations, exams and treatments that health plans are required to offer according to each type of plan. The list with all these items is called the List of Procedures and Events in Health and is valid since 1999.

It is worth remembering that each plan has a different coverage, and this must be verified.

Theoretically, all those registered with ANVISA, who participate in the List of Procedures and Events in Health (ANS) should be provided.

This resolution assists people who have contracted health plans since January 1, 1999 and lists the basic and indispensable procedures that the service must offer.

Resources for diagnosis, treatment and monitoring of various diseases or health conditions are included, in accordance with Law No. 9,656.

What to do if my plan cannot cover?

In general, it is quite common for health plans to assist patients in the hospital environment, without any manifestation against the delivery of medicines. However, it is common that after being discharged or requesting medicines for home use, there is a denial of the request.

When the company refuses to provide treatment, due to the most diverse justifications (experimental medication, not indicated for certain diseases, outside the services offered by the plan’s coverage), the person must submit a legal request for obtaining it.

Thus, the guideline is to open a lawsuit, seeking assistance from lawyers, Public Defenders or legal services offered in community service centers. If it is due, the health plan has an official obligation to bear the costs of the treatment.

How long does the process take?

There is no way to stipulate an average time, or even a limit, for the action to be judged, as each demand has its peculiarities, both procedural and linked to the medical treatment itself. In general, Courts use urgency in these cases as soon as they refer to health.

However, the number of cases, the affinity of the court regarding medical issues and the release procedures can interfere with the time to obtain the medication.

Legal assistance to the person in treatment: where to look?

According to Ana Amélia Gonçalves de Almeida, a specialist in Medical Law, if the lawsuit is filed against a private health operator, the process will run in one of the so-called “common justice” courts, filed in the patient’s home court. .

However, if it is filed against a public entity, the proceeding can be conducted by the Federal Court (when the Union is a party) or in the Public Finance Courts of each state (when the lawsuit is filed only against the State and / or Municipality).

It is necessary to use the services of lawyers (as) to initiate the process. However, people who cannot afford to pay the costs should seek assistance from the state’s Public Defender’s Office.

In general, these services are available in large urban centers or even in centers of legal assistance from public and private universities and law schools.

What are the procedures for the legal process for obtaining medicines?

For the administrative request (prior to the opening of the legal process), it is necessary to forward some documents to the responsible body. It is necessary, first of all, to check if there are specific criteria, according to each responsible state or municipality.

However, in general, the necessary documents are:

  • Copy of RG, CPF and proof of residence;
  • Medical report (LME) completed, indicating the ICD code, treatment and need for the medication;
  • Copy of the National Health Card – CNS;
  • Medical prescription.

When taking the documents to the health unit, it is necessary to keep the copy of the protocol. With the denial of this appeal, you can make an administrative request or go directly to court.

For the lawsuit, it is possible to appeal to the Special Civil Court (if the amount of the treatment does not exceed 40 minimum wages in the period of 12 months) or in the so-called common justice (if the amount is higher).

Thus, it is important to have all documents that certify the refusal to receive the medication, as well as those that indicate the need for the treatment in question.

For this reason, medical reports pointing out the effects of medication, the description of the disease, attempts at other treatments (if any) and other documents indicated by lawyers and doctors are essential.

In addition, it is necessary to present 3 quotes from different pharmacies, which ensure the value of the medication.

To facilitate the organization of the necessary documents, patients can access the portal of advice on high-cost drug budgets , requesting a personalized quote.

A number of treatments are available and improved, but they are not always easily obtained by the population.

However, having access to prescription drugs is a right of patients with any health condition, as soon as it is always up to the doctor to indicate which is the most effective resource for the recovery of the person’s integrity and quality of life.

Thus, in the event that there are negatives or impossibility to obtain the indicated drug from SUS or health plans, the opening of legal proceedings is a right of any person.

The Healthy Minute brings information about health, medicines and patients’ rights, in order to facilitate and make information available!