In a note published on 2 March 2022, the Italian Medicines Agency (AIFA) confirmed that all pharmaceutical companies must, by no later than 30 April 2022:
- Declare the total expenses incurred in 2021 for promotional activities towards physicians, pharmacists, and other healthcare professionals;
- Pay the relevant contribution, which Law 175/2021 increased from 5% to 7% of those expenses.
Starting from this year, the contribution that pharmaceutical companies must pay to AIFA pursuant to Law Decree 269/2003 (converted into Law 326/2003) increased by 2%, now amounting to 7% of the total expenses for promotional activities towards physicians, pharmacists and other healthcare professionals incurred in the previous year. The contribution increased from 5% to 7% following the recent approval of Law 175/2021, which aims at allocating more resources to R&D in rare diseases. In the European Union, a rare disease is one that affects no more than 5 in 10,000 people.
Law Decree 269/2003 established the national fund for the use of orphan drugs (i.e. medicines for the diagnosis, prevention, or treatment of rare diseases) in Italy. Article 48 thereof requires pharmaceutical companies to pay to AIFA a 5% yearly contribution calculated on the basis of their expenses for promotional activities, and allocates the 50% of this sum to the fund for the use of orphan drugs. Under Law Decree 269/2003 the fund for the use of orphan drugs is thus financed by a contribution equal to 2.5% of the promotional costs borne by pharmaceutical companies.
Article 11 of Law 175/2021 provides that, starting from 2022, pharmaceutical companies must support the national fund for the use of orphan drugs with an additional 2% of the total expenses for promotional activities towards physicians, pharmacists, and other healthcare professionals. As Law Decree 269/2003 already granted a 2.5% share of these expense towards the fund for orphan drugs, this now amounts to 4.5%. With its note dated 2 March 2022, AIFA confirmed that this is drawn from a total 7% yearly contribution required from pharmaceutical companies conducting promotional activities in Italy.