On 9 February 2024, the Ministry of Health published the criteria and procedures for the collection and allocation of resources pertaining to the so-called “Fund for the Governance of Medical Devices” (pursuant to Articles 28 of Legislative Decree no. 137/2022 and Article 24 of Legislative Decree no. 138/2022 implementing Regulations (EU) 2017/745 and 2017/746) as part of a national programme dedicated to medical devices and aimed at assessing, monitoring and directing innovation in healthcare through a multidisciplinary process called Health Technology Assessment.
Specifically, the decree applies to companies that produce or distribute medical devices, large equipment and in vitro diagnostic medical devices that are sold to the National Health Service (“NHS”).
Commencing 2024, the aforementioned companies will have to make an annual contribution to the Fund equal to 0.75% of their turnover (net of VAT) from sales to NHS entities in the financial year preceding the year of payment (“Quota”) as follows:
- pay the Quota from 1 November to 31 December each year to the State budget revenue chapter No. 3616, established for this purpose; and
- make a Declaration by 31 December each year to the Ministry of Health (pursuant to Presidential Decree No. 445/2000): containing (i) turnover data and the relevant Quota and (ii) certification of payment of the Quota.
As of this year, therefore, companies in the medical device sector will be subject to a new form of ‘taxation’ to the detriment of their business activity, in addition to the payback issue currently pending before the Constitutional Court.
