The fourth panel of the federal regional court of the 5th region – TRF5 unanimously agreed on Tuesday afternoon (August 21) with the request for reconsideration, drawn up by the Federal Council of the Brazilian Bar Association (CFOAB). Amicus Curiae, to determine the supply of the Spinraza (Nusinersen) medication to the SV child of the SV. The Union must immediately take the necessary measures to make the medicine available and will still have to pay a 1% fine on the value of the bad faith case. The Collegiale responded to the CFOAB's request for the presentation of documents and new facts that demonstrate the effectiveness of the medication, according to the National Agency for Sanitary Surveillance (Anvisa).
Before the trial began, lawyer Felipe Sarmento, a representative of the CFAOB, asked to clarify that he was presenting new documents showing that the panel had been misled by the Ministry of Health. The grievance rapporteur, federal judge Rubens Canuto, noted that the technical note, drawn up and signed by three doctors from the Ministry of Health, was absent with regard to data essential to the assessment of the case, in particular with regard to the recognition by Anvisa of the efficacy of the medicinal product for the treatment of type 3 AML, regardless of the age of the patient. patient relationship.
This new information, revealed during a public hearing in the federal senate and contained in an opinion prepared by Anvisa, was not included in the archives at the time of the first test. The fact that the Ministry of Health omitted this information in the technical note, on the basis of which it postponed and obtained the suspension of the delivery of the medicine, ordered the Union to pay a fine for bad faith.
"In the case of a Technical Note, the information should be reported as complete." It should have been clear that Anvisa had recognized and recorded the efficacy of the drug, although the physicians later considered any consideration of this fact, with the intention of To challenge, what not, and again, this is too absurd, three doctors write a document like this, without a reference to this information, "said the magistrate.
The rapporteur's voice was fully accompanied by the other members of the fourth panel, federal judges Roberto Machado and Leonardo Coutinho.
Spinraza – In a provisional order, the Third Federal Court of the Judicial Branch of Paraiba (SJPB) has ordered the Ministry of Health, the federal agency of the Union, to take the necessary measures for the free delivery, within 10 days, of the drug Spinraza ( Nusinersen) to SV LP, 12, affected by Spinal Muscular Atrophy Type III, or AME Type 3, a genetic disease, which leads to weakening of the muscles due to the failure of the neurons due to the degenerative process of the spinal cord.
The decision in the first degree took into account the medical prescription in the administration to determine that in the first year of treatment six bottles of the medication would be offered and from the second year two bottles with intrathecal administration by a lumbar puncture. The administration of the drug would be started with four seizure doses on days 0, 14, 28 and 63 and then maintained for six months every six months during treatment.
The Union filed a complaint against TRF5 for the suspension of the drug. On that occasion, the fourth panel of the Court decided unanimously to stop the determination of the supply of the drug, in response to a request from the federal prosecutor general (AGU), because of the information from the "professional information leaflet".
The contents of this document, provided by the laboratory on the Anvisa website, were ratified in Technical Note 1397/2018-NJUD / SE / GAB / SE / MS, from the Department of Health, signed by three physicians. This official statement states that "despite the doctor who prescribes the drug Spinraza to patient L.P.S.V., 12-year-old child, AME type III, this patient is not included in the group that has benefited from the use of this medication because it contains exclusion criteria: patients with AME type III were not included in the Nusinersena-Spinraza studies"(Bold from the original).
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