Case of the twins: president of Infarmed takes over email from the General Secretariat of Health, but says that this did not interfere with access to the medicine
The president of Infarmed reiterated today that requests for access to the medicine administered to Portuguese-Brazilian twins “were evaluated simultaneously” and did not receive any external interference, following an email from the General Secretariat of the Ministry of Health.
“There was no interference. The requests were evaluated simultaneously in completely equivalent ways given the information underlying each one. This issue is unrelated to the basis of Infarmed’s evaluation and decision”, Rui Santos Ivo explained to the deputies.
The leader of the National Authority for Medicines and Health Products was testifying today at the parliamentary commission of inquiry into the case of the Portuguese-Brazilian twins treated in 2020 at the Hospital da Santa Maria (Lisbon) with the drug Zolgensma.
To the deputies, Rui Santos Ivo said that, in addition to the contact received by the Santa Maria Hospital, he never spoke “about the process” with the former Secretary of State for Health António Lacerda Sales, with the son of the President of the Republic, Nuno Rebelo de Sousa , or with the Ministry of Health.
The person responsible explained that “it is normal for Infarmed to be questioned through its medicine information center”.
“We have requests arriving from all institutions, arriving from the Assembly of the Republic, arriving from other sovereign bodies, arriving from public institutions, arriving from citizens, arriving from agents that are regulated by Infarmed. We try to respond to all these requests. They are in large numbers and often the response capacity can be more limited”, he said, in response to Chega deputy Cristina Rodrigues.
Rui Santos Ivo recalled, however, that Infarmed “ended up taking three months” to respond to the children’s father, after receiving the email from the General Secretariat of the Ministry of Health.
“He did so even before having any contact with the hospital itself. I believe that the hospital’s contact occurs two weeks later”, he indicated, noting that Infarmed’s responsibility is to respond to all “requests that arrive at the medicine information center “.
The president of the National Authority for Medicines and Health Products once again mentioned that the requests, made between March 2nd and 3rd, 2020, were flagged on February 29th of the same year by the Hospital de Santa Maria, saying that the analysis is carried out by a team of experts.
“The analysis of these requests is not carried out by me personally, they are carried out by experts from Infarmed and by the institution’s technical bodies and, therefore, they were treated, just like other requests of this nature. This is how it was done”, said Rui Santos Ivo .
In parliament, the leader recalled that the information that was displayed in the hospital unit’s email “was immediately sent to the expert in charge of medication evaluation”.
“The information that is in Infarmed is information related to the data regarding the clinical case, which the experts will analyze in order to be able to give indications to the Board of Directors who will then make the decision, whether or not that medicine is suitable for use” , he highlighted.
Rui Santos Ivo also said that requests are individual and that it is always the doctor who “checks whether the medicine is essential”.
“We are not talking about an assessment in the abstract, but a specific assessment for that patient”, he explained.
In January, Rui Santos Ivo had already said in parliament that he had not been under any pressure to authorize the use of Zolgensma.
“I had no pressure on this authorization from anyone (…). Infarmed is only aware of the processes when they are referred to us by health institutions. And that was the case that happened here”, he said at the time.
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