On September 20, 2024, the Federal Supreme Court (STF) concluded the virtual trial of Extraordinary Appeal No. 566.471 (Theme 6), which discussed, among other issues, the establishment of criteria for the supply, via lawsuits, of high-cost drugs approved by the National Health Surveillance Agency (Anvisa), but not incorporated into the Brazilian Public Health System (SUS).
The case originated in a decision handed down by the Rio Grande do Norte Court of Justice (TJRN), which obliged the state government to provide the plaintiff with high-cost medication for emergency treatment of a heart condition. Initially, the discussion only involved the need to supply high-cost medicines via legal action, but the issue has evolved to cover any medicines not incorporated into SUS.
The Rapporteur of the case, Justice Marco Aurélio, voted for the need to supply the medicine if the plaintiff’s financial incapacity and the indispensability of the treatment are proven.
However, after the resumption of the trial, on 09.06.2024, the majority of the Justices joined in the joint vote, disagreeing with the Rapporteur’s vote, of Justices Gilmar Mendes and Luís Roberto Barroso, in order to establish that:
- If a medicine is not on SUS list, it cannot be supplied by court decision. This can only happen in exceptional situations, as long as the drug is registered with Anvisa, and as long as the following cumulative requirements are met: (i) the administrative refusal to supply is proven, (ii) there is no alternative in SUS, (iii) robust scientific evidence is presented to support the efficacy and safety of the requested drug, (iv) the clinical indispensability of the treatment is demonstrated, as well as the plaintiff’s financial inability to afford the product.
- It was stipulated the need for (i) proof that there was no request to incorporate the drug, or that there was a request, but Conitec (National Commission for the Incorporation of Technologies into the Unified Health System) is taking too long to analyze it – or that Conitec unlawfully denied incorporation, and (ii) judges to consult the Technical Support Center of the Judiciary (NatJus) whenever available, or other entities and people specialized in the area of health, so that their decisions are not made based solely on prescriptions, reports or medical reports presented by the plaintiff.
- If the judge authorizes the supply of the medicine, he or she must notify the competent bodies so that they can assess the possibility of incorporating the medicine into SUS.
The decision represents an attempt by the STF to contain the advance of judicialization in the country, however, it could open up space for judicial questioning of Conitec’s decisions. After the publication of the paradigm ruling, the proceedings suspended at the 1st and 2nd level must be resumed in order to apply the thesis formed by STF.
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