(ASCA) - Rome, Feb. 13 - "In recent days, the Italian Medicines Agency has sent drug companies requests for payment of the payback for the breach of the territorial pharmaceutical expenditure ceiling of 2010, which improperly also includes the quota paid voluntarily by citizens to choose the branded drug”. This is what Farmindustria reports in a note, underlining that these are requests for payment of the payback for the breach of the territorial pharmaceutical expenditure ceiling of 2010, which improperly also includes the amount voluntarily paid by citizens
A request that Farmindustria defines as "bewildering", because "it was sent over a year after the closing of the company financial statements and despite the fact that the Court of Auditors had communicated in the State General Report, at the end of June 2011, compliance with the ceiling for 2010.
And on which – he adds – strong uncertainties remain regarding the data that led to this result.
Factors of knowledge that are absolutely fundamental for individual companies, which must be placed in a position to verify the amount of their responsibility.
Aifa then asks that the companies formally declare their total adhesion, without having all the elements available. And this is unacceptable”, underlines Farmindustria, emphasizing that “this charge is also out of time, because it does not even take into account the regulatory deadlines set for verifying the overrun of the expenditure (Law 222/2007).
A truly unmanageable system for companies with both national and foreign capital. In fact, the pharmaceutical industry needs certainties to plan activities that require huge investments and long times both for the development of a drug and for the construction of hi-tech production plants.
What should companies do now, also in terms of financial statements, to make up for an unexpected breach, precisely because it was not communicated in good time? Obviously not having set aside the necessary resources, how will they explain to their shareholders and parent companies that in Italy – where they have invested by winning the competition with other producing countries – the rules change along the way?”.
For these reasons Farmindustria ”requests the rapid review of the AIFA request. Otherwise, companies could be forced to appeal to the courts to protect their reasons, starting with the request for access to the documents. Especially at a time when in Italy they are faced with record delays in public administration payments - which have grown by 30% in the last two years and with regional peaks of up to 700 days - and with public procurement dynamics of drugs that often distort the market ”.
"The pharmaceutical industry is at a crossroads in Italy - warns Farmindustria - with worrying signs of a possible rapid decline, as evidenced by the loss of thousands of jobs in recent years, and in the presence of further risks deriving from the measures contained in the Liberalization Decree Law.
A scenario that the payment request certainly does not improve and which requires the urgent restart of the pharmaceutical table at the Ministry of Economic Development”.
