The 5th Civil Panel of the Court of Justice of the Federal District and Territories (TJDFT) granted an injunction to determine that the DF provides self-injectable adrenaline to the nine-year-old girl, who suffers from asthma and has episodes of anaphylactic reaction when in contact with ice water. Failure to comply with the decision may result in a fine.
The child’s legal representative alleges a serious clinical condition, which attending physician prescribed essential drug treatment, under penalty of risk to life. It argues that, despite not being standardized, the medicine is registered with the National Health Surveillance Agency (Anvisa) and has no substitutes listed on the SUS lists. For me, it states that the State must provide the necessary urgent medical treatment to disabled citizens.
The DF reported that the Federal Supreme Court (STF) signed an understanding that exempts the State from supplying medicines not registered with Anvisa. It states that cumulative parameters were established to define the responsibility of the public entity for the supply of non-standardized medicines, among which there is an express requirement for the medicine to be registered with the regulatory body. According to the defendant, Law 12,401/11 provides that the supply of medicines by the Public Authorities must comply with official clinical protocols or observe the list of medicines established by state managers, with a view to preserving equality, as well as budgetary and actuarial balance. Finally, it notes that there are alternative medicines in the SUS and there is no proof that they are ineffective in the author’s case.
In the decision, the reporting judge noted that the Health is everyone’s right and the State’s duty, which must implement social and economic policies in order to enable those in need to achieve this right. Like this, It is not up to the federative entity to refuse coverage to the most appropriate treatmentin order to restore the patient’s health, as per medical indication and NATJUS/TJDFT favorable opinion.
The judge noted that the girl’s clinical history is compatible with cold urticaria, including an episode of anaphylaxis. “In view of the situation, the assistant immunologist allergist highlighted that the The only effective treatment to treat anaphylaxis is the administration of Adrenaline, which, however, is a medicine only available in a Health Unit”, he reported. Therefore, when the patient has an anaphylactic reaction, she must be able to self-inject the medication until she is taken to an emergency department, as the “potentially fatal disease must be treated immediately”.
According to the judge, the Superior Court of Justice (STJ) established that the mere The fact that the medicine is not included in the SUS basic list does not exempt federal entities from the constitutional duty to provide comprehensive pharmaceutical assistance. Despite this, the National Council of Justice (CNJ) recommends that whenever possible, preliminary decisions on health must be preceded by notes of scientific evidence issued by the Judiciary Technical Support Center (NatJus) and/or consultation of the relevant database.
In this case, NatJus/TJDFT issued a favorable opinion to the request, taking into account the minor’s clinical history and the fact that anaphylaxis represents one of the most dramatic clinical emergency conditions, both due to the unpredictability of its appearance and the potential severity of its evolution. . The body also highlighted that the adrenaline constitutes the first and most important treatment for anaphylaxis and should be administered as soon as anaphylaxis is recognized to prevent progression for life-threatening symptoms.
The panel identified that the substance is the same as that contained in drugs registered with Anvisa. The only difference is the method of dispensing. “You registered are presented only in the form of an injectable solution and what is intended in this case is a self-injectable pen. This is because, in the pen, the dose is limited to the preset value, thus avoiding the application of wrong doses, which is of great importance considering that the use will be made by those responsible, without medical training, or by the child themselves, who must carry a pen, due to the imperative of immediate application”, explained the judge.
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