Maneuver to vote, still new for the pharmaceutical sector
In the final version of the budget law some interventions concerning the pharma sector and pharmacies
Aboutpharma editorial staff – 28 December 2018
There budget law arrives on December 29 in the Chamber for the last parliamentary passage. Compared to the approved text during the first passage to Montecitorio, the examination in the Senate Budget Commission produced some innovations on the pharmaceutical and pharmaceutics front. To describe them is a dossier of the Parliament. Let's see, in summary, some new elements compared to the first version of the manoeuvre.
The payback
From 2019, the maneuver introduces a new discipline for monitoring compliance with the pharmaceutical expenditure ceilings for direct purchases, i.e. hospital pharmaceutical expenditure, and the corresponding shelf (payback) in the event of overrun by pharmaceutical companies, with the aim to overcome the determination mechanism calculated on the budget assigned to the same companies (so-called budget company) with the most method - deemed "most appropriate" - of the market shares of each company (paragraphs 574-583).
Negotiations
With the aim of ensuring "criteria updated to the evolution of pharmaceutical policy, a specific decree of the Minister of Health is envisaged which will dictate the criteria for the negotiation phase of the price of drugs between the Italian Medicines Agency (Aifa ) and the pharmaceutical company that owns the Marketing Authorization (paragraphs 553-554).
Ad hoc funds
At the level of the state budget, the transfer to the estimates of the Ministry of Economy and Finance from that of the Ministry of Health) of the Funds for the contribution to the reimbursement to the regions for the purchase of innovative and innovative oncological medicines is arranged, without prejudice to the competence already attributed to the Ministry of Health for the regulation of the operating procedures for the disbursement of the allocated resources (paragraph 550).
Pharmacies
For affiliated pharmacies with low turnover - less than 150 thousand euros - the exemption from the mandatory discount has been introduced for the benefit of the National Health Service (paragraphs 551 and 552) .
VAT for medical devices
Among the measures to reduce the tax burden and stimulate growth, one concerns medical devices. According to the changes made by the Senate, the application of the reduced VAT of 10 percent on medical devices based on substances, normally used for medical treatments, for the prevention of diseases and for medical and veterinary treatments (paragraph 3).
To know more: the text of the budget law to the final vote
