Law No. 178 of 30 December 2020 'State budget for the financial year 2021 and multi-year budget for the three-year period 2021-2023' was published in the OJ https://bit.ly/3hyknS8

Paragraphs 475-477 contain the remodulation of the ceilings for pharmaceutical expenditure for territorial pharmaceutical agreements and for direct purchases, which were set at 7% and 7.85% respectively (today 7.96% and 6.89%).

On the basis of trends in the market for pharmaceuticals and care requirements, these percentages may be redetermined annually, when the budget bill is being prepared, on a proposal by the Ministry of Health, after consulting Aifa, and in agreement with the MEF.

The payback procedures for pharmaceutical companies and the timeframe for the reimbursement of pharmaceutical expenditure for direct purchases in 2018 and 2019 were also changed.

Existing caps apply if the payback payment is less than EUR 895m. Any underpayments will be recovered by Aifa on 2021 payback with an increase of 20%.

The entry into force of the measure is 01/01/2021.