“The AIFA board of directors will decide whether the contraceptive pill can be dispensed by the National Health Service or not, so we are waiting for the board”. This was underlined by the Undersecretary for Health, Marcello Gemmato, on the sidelines of the event ‘Rare diseases, orphan and pediatric drugs’, promoted by Altems with the contribution of Farmindustria. The next Board of Directors of the Italian Medicines Agency, as published on the institution’s website, is scheduled for May 24th.
“There are many pathologies – Gemmato said – and we would like them all to be covered by the NHS, but many are not. The National Health Service must be able to respond to all needs and the contraceptive pill is one of the needs that in this moment they emerge; it is under scrutiny by the AIFA board of directors”.
For the launch of the reform of the Italian Medicines Agency (Aifa) “the latest decrees are missing and it is more a technical question than a political one. It will be completed within weeks, however the deadline should be by October”, Gemmato also underlined. Last 4 May, the Council of Ministers, pending the reorganization of AIFA, in fact extended to 1 October 2023 the term of office of the members of the Technical-Scientific Advisory Commission (CTS) and of the Prices and Reimbursement Committee (CPR ) of the Agency. That of AIFA, Gemmato pointed out, “is a profound reform that must have the right gestation and bureaucratic times. AIFA had been in a cast of plaster for years and this reform has been expected for some time, a period of reflection is appropriate to bring out the best possible reform. The deadline should be by October”. With the new Aifa, he explained, “the de facto dispute that had led to two top figures, the general manager and the chairman of the board of directors who did not have the legal representation of the institution and this led, when the two figures entered into conflict and unfortunately this has occurred over the years, to a plastered Aifa “. Now, “the recognition of a top figure is envisaged, which is that of the chairman of the board of directors; the general manager is instead replaced by a scientific director and an administrative director; the two commissions, prices and reimbursements and the technical-scientific commission, are merged in a single commission. This – he concluded – precisely to streamline and speed up the authorization procedures for drugs”.
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