We update you on legislation being approved that could impact the companies operating in the MedTech sector in Italy.
MedTech Payback was introduced by Law No. 125/2015 for companies operating in the medical device sector that sells medical devices in Italy to the Italian National Healthcare System. The law was not applied until 2022 due to lack of the implementing decree.
Law Decree No. 115/2022 (implemented by Law No. 142/2022 published in O.G. of 21 September 2022) reactivated the payback on medical devices by starting to provide the implementing rules. In particular, the law requires the companies selling medical devices to make payments to the Italian state if medical device expenditures exceed regional maximum ceilings. Payments are equal to a percentage of the turnover on the expenditures exceeding the maximum regional/national caps (between 40% – 50% overrun of the expenditure ceiling for each year).
Between December 2022 and January 2023 several Regions and Autonomous Provinces published the measures requiring medical device companies to pay the payback amounts aimed at covering the overrun of the expenditure ceiling for the purchase of medical devices for the years 2015, 2016, 2017 and 2018. Many companies who did not agree with the payback mechanism and the criteria used to calculate the amount requested, filed appeals on the matter of payback for medical devices toward the Italian Administrative Court (so called T.A.R.).
Yesterday the Italian Government approved a new Decree which, among other measures, provide also some measures for the MedTech payback as following:
1) For companies that do not renounce to the dispute activated in the Administrative Italian Court (so called TAR), the MedTech payback remains confirmed equal to the amount already communicated;
2) For companies that renounce the dispute or have not appealed the provision, they will have a discount on the amount to be paid as MedTech payback and the payment must be done within June 30, 2023.
3) Finally, for all the companies the VAT included in the payments due can be recovered as credit.
Please consider in addition that the above mentioned decree has been approved in the meantime – Decree n. 34, 30 March 2023.
Contact:
Dr. Sandra Ragaz, Partner
Leader Pharma & Life Science – International Indirect Tax & Regulatory
sandra.ragaz@pwc.ch
PwC Switzerland
Felice De Lillo, Partner
felice.de.lillo@pwc.com
PwC Italy
Saverio Mantini, Director
saverio.mantini@pwc.com
PwC Italy
Photo by Mathew Schwartz on Unsplash