The Supreme Court says that there was discrimination for vetoing an unauthorized drug for a child with a rare disease

The Supreme Court (TS) has recognized that the mother of a child with a rare disease was discriminated against by the administration by not processing her request for exceptional authorization for a medicine not authorized in Spain.

Oliver Thansan
Oliver Thansan
20 February 2024 Tuesday 22:07
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The Supreme Court says that there was discrimination for vetoing an unauthorized drug for a child with a rare disease

The Supreme Court (TS) has recognized that the mother of a child with a rare disease was discriminated against by the administration by not processing her request for exceptional authorization for a medicine not authorized in Spain. La Vanguardia published a report about the hospital's veto of the drug prescribed by two of its doctors for a sick child.

The Contentious-Administrative Chamber has issued a ruling in which it establishes doctrine in relation to requests for access to public financing of a medicine not authorized in Spain, through an exceptional authorization, for the treatment of patients with rare diseases. .

In this regard, it establishes that "the request for access to public financing of a drug through an exceptional authorization does not allow whoever applies for its processing to be discriminated against with the imposition of a burden of proof of evidence, which even extends to the individualized circumstances." of other patients beneficiaries of the same exceptional authorization in the National Health System (SNS)".

The court applies this doctrine to the case of a mother who had repeatedly asked the Sant Joan de Déu Hospital in Barcelona to provide her son, with Duchenne muscular dystrophy, with access to the medication Translarna, whose active ingredient is Ataluren.

At that time, it was a drug in conditional authorization by the European Medicines Agency, it was not included in the list of the National Health System and was pending clinical trials.

The mother had the endorsement of the specialist who treated her son in the hospital and accompanied her request for a certification proving that at that time there were 33 patients treated with that drug in Spain. The hospital's refusal to process the request was based on reports issued by different institutions at the state and regional level and on the fact that he was excluded from the SNS.

A court in Barcelona agreed with the woman and considered that the hospital had violated the principle of equality due to unjustified discrimination since this authorization had been granted for patients who were in the same situation.

On the contrary, the Superior Court of Justice of Catalonia understood that it had not been demonstrated that the child's situation was the same as that of other cases in which the treatment was applied.

And now the Supreme Court points out that the autonomous Administration denied "not only the authorization, but the previous step so that the competent authority could rule on the request, since it rejected the processing of the request. It excluded all possibility of cooperation."

The ruling indicates that "it is evident" that the mother "more than justified the existence of exceptional authorizations for other patients within the National Health System."

And he emphasizes that "the existence of this discriminatory and unjustified treatment is not unreasonable due to the clinical situation of the medication that would be the subject of the exceptional authorization, especially when at the time of the application Ataluren was authorized, although conditionally for the treatment of those patients" like the appellant's son.