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The Contentious-Administrative Chamber, Fourth Section, of the Supreme Court has issued a ruling establishing doctrine on requests for access to public funding for a drug not approved in Spain through an exceptional authorization, intended to treat patients with rare diseases.

It has established that: “the request for access to public funding for a drug through an exceptional authorization under Article 18 of Royal Decree 1015/2009 does not allow the person requesting its processing to be discriminated against by imposing a burden of proof based on evidence that even extends to the individual circumstances of other patients benefiting from the same exceptional authorization in the National Health System.”

The Supreme Court has applied this doctrine in the analyzed case, ruling in favor of the appeal filed by a mother who had repeatedly requested Sant Joan de Deu Hospital in Barcelona to provide her minor son, affected by Duchenne muscular dystrophy, with individualized access to the medication Translarna, whose active ingredient is “Ataluren.”

At that time, the medication had conditional approval from the European Medicines Agency (EMA), was not part of the drugs funded by the National Health System (NHS), and was in the clinical trial phase.

The mother, supported by the specialist who treated her son at the hospital’s recommendation, justified her request with a certification showing that at that time 33 patients in Spain were being treated with this drug. The hospital’s refusal to process the request was based on reports from various national and regional institutions and on the exclusion of the medication from the NHS.

A court in Barcelona ruled in favor of the woman, determining that the hospital had violated the principle of equality by unjustifiably discriminating, as authorization had been granted for patients in the same situation. However, the High Court of Justice of Catalonia (TSJC) argued that the principle of equality prevents discrimination, but does not prohibit differentiated treatment if it is justified, and argued that it had not been proven that the child’s situation was identical to other cases where treatment had been authorized.

Disagreeing with the TSJC, the Supreme Court maintains that the Administration’s refusal to provide the medication was not based on an individual assessment of the minor’s situation, but on general criteria, such as the exclusion of the drug from the NHS and the reports from institutions. In this way, the Supreme Court emphasizes that this action constitutes a violation of the principle of equality, resulting in unjustified discrimination against the minor for not considering their specific case and the specialist’s recommendation. This ruling highlights the need for individual assessment in exceptional cases for access to unauthorized treatments, emphasizing the Administration’s commitment to the principle of equality and against unjustified discrimination.

Furthermore, the Supreme Court reasoned that it: “developed a sufficiently precise and concrete argumentative activity regarding the evidence of the existence of discrimination, which is why it was the Administration that was obliged to prove, not only that its actions were absolutely unrelated to any purpose that violated fundamental rights but also that the violation attributed to it did not objectively represent acts contrary to the prohibition of discrimination (STC 233/2007, of November 5, FJ 4).”

Finally, the resolution establishes that: “the existence of this discriminatory and unjustified treatment is not devoid of reason due to the clinical status of the medication that would be subject to the exceptional authorization, especially when at the time of the request Ataluren was authorized, albeit conditionally, for the treatment of those patients who, like the appellant’s son, suffered from Duchenne muscular dystrophy due to a nonsense mutation in the dystrophin gene (genetic diagnosis) from the age of 5 and who retained the ability to walk.”

Source: C.G.P.J.

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