“There are distortions and differences in the regionalization of healthcare. Article 32 of the Constitution guarantees the right to healthcare for all citizens without distinction, I say this with all the distinctions of those who know that we have budgetary difficulties. This ministry has endowed the National Health Fund for this year by 2 billion and 150 million more. Next year there will be 2 billion and 300 million more and, for 2025, there will be 2 billion and 600 million more. they pour almost 7 billion into the coffers of the Fsn, a peak never touched in the history of the republic”. So the Undersecretary for Health, Marcello Gemmato, speaking this morning in the Senate at the presentation of the VI Annual Report of the Orphan Medicines Observatory (Ossfor), which takes a national and regional snapshot of the orphan drug market in our country as at 31 December 2021 .
“I asked for the delegation to rare diseases because in recent years, even if not as a protagonist because in the opposition, I have followed all the works punctually and contributed to the approval of Law 175 of 2021 which passed unanimously, a non-accessory element – underlines Gemmato – testifying that there is an extraordinary attention of politics to rare diseases”.
On the implementation of the NSF, Gemmato defends the Meloni government. “Of course, if we parameterize the percentage of GDP in 2020-21, in which Italy was closed with the pandemic – he explains – the denominator was thinning and the numerator rose, we reached 7%. In the recovery phase, however , we are at 6.3-6.4%, which is an increase in the NSF in absolute terms.Without arguing – continues the undersecretary – in the drafting of the last Economic and Financial Document of the last Government it was stated verbatim that, after the peak due to pandemic investments – masks, respirators and vaccines – the NSF had increased from 114 to 124-126 billion. This value had to return to normal and then fall. Which we did not do – he reiterates – but we implemented it. I say this because, since the pharmaceutical expenditure is linked to the NSF and will cover 15% of that expenditure, it is clear that if the amount increases, the amount that can be spent on drugs also increases” not only for rare patients, “and this is a comfort to all”.
Regarding the implementation of the provisions of the Consolidated Act on orphan diseases, “on 24 September the Committee for rare diseases was set up, but it had not been convened – recalls the undersecretary – We did it and started thinking about the framework law and to its determination to reduce diversity in the approach to the treatment of rare diseases. It is clear – Gemmato remarks – that the National Recovery and Resilience Plan can and must have a strong impact on this. I have expressed strong criticisms of the 1,350 Community houses that should serve in territorial healthcare, but are parameterized for every 45-50 thousand inhabitants. This is not territorial healthcare if I think of it compared to internal, depressed areas, where there are no hospitals. The other macro theme is the absence of medical, nursing and health personnel who can supervise the Community Houses which, however, I recognize, can have a compensating role between what is lacking today in the assistance territorial za, together with the community hospitals envisaged by the Pnrr and such as telemedicine”.
As a pharmacist and hospital pharmacist, the undersecretary recalls that “hospital pharmacies in dispensing medicines, selecting the right amount of medicine”, provide the patient with a rare disease “particularly personalized care. These professionals could therefore improve therapeutic adherence and, by dosing the drug, save the State since, we know, they are very expensive drugs”.
In approaching the possibility of approving new drugs, for Gemmato “it is quite evident that a somewhat packed AIFA – pass me the term – between the general manager and the chairman of the board of directors entailed enormous delays in the approval of new drugs on the market The Government has taken charge, with an amendment to the Calabria bill, much contested by the opposition, of overcoming the governance of this anomaly in Aifa. With a single commission there is an instrumental restructuring to approve new drugs more quickly and respond to the needs determined by rare diseases in which the speed of approval is not an indeterminate variable with respect to the “therapeutic” response and quality of life.
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