In Italy, with a few exceptions, the public price (VAT included) of medicines reimbursed by the NHS is subject to the temporary reduction of 5% provided for in the AIFA determination of 3 July 2006 and to a further temporary reduction of 5% under the AIFA determination of 27 September 2006.
The 5% payback mechanism, introduced with the 2007 Budget Law (“Legge Finanziaria”), allows pharmaceutical companies to ask AIFA for the suspension of the 5% reduction provided for in the AIFA determination of 27 September 2006 in return to the payment to the Italian Regions of the amount equivalent to this reduction. This mechanism allows companies to make choices on the prices of their medicinal products based on the marketing strategies.
Companies that decide to join payback 5% mechanism (optional procedure) must pay the relevant amount in a single annual fee.
Differently from the previous years (payback 5% was requested to be paid in December of the same year) this year AIFA has decided to open the procedure in June. Therefore, companies are requested to pay back an amount for 2021 which is calculated on the basis of the sales data of the previous year. This amount will cover:
– a half year in case of refusal to adhere. In case of refusal it will not be possible to re-join the following year.
– the whole year in case of acceptance/renewal to adhere.
It is important to note It will be interesting to look at developments on this issue.
Regulatory Pharma Net team constantly monitors AIFA website, keeps pharmaceutical companies promptly updated on the latest news and is available to support them to comply with AIFA dispositions.