Recent legislative news in the life sciences sector under the Budget Law

Some of the numerous provisions in the Budget Law wield significant impact on the life sciences sector. These include:

• Dispensing of medicines: In accordance with the new Budget Law, pharmacies affiliated with the National Healthcare Service (“NHS”) will dispense medicines that previously were generally available only at hospital pharmacies^[2].
• Remuneration system for pharmacies: As of March 1,^, 2024 the current system of remuneration of pharmacies for reimbursement of drugs covered by the NHS will be replaced by a system of variable fees and fixed amounts^[3].
• Incentives for small pharmacies: To bolster the presence of pharmacies in all areas of the country, pharmacies that do not exceed certain turnover thresholds will receive additional fixed fees for sales of medicines^[4].
• Changes to pharmaceutical spending ceilings: The pharmaceutical spending ceiling for direct expenditure increases to 8.5% (+0.2%) beginning in 2024. The expenditure ceiling for drugs dispensed by territorial pharmacies under agreement with the NHS drops to 6.8% (-0.2%).
• Updating of LEA: For updating the Essential Levels of Care (LEA), the Budget Law allocates EUR 50 million for 2024 and EUR 200 million annually starting in 2025.

In addition, there are Decrees of the Italian Ministry of Health regarding narcotic drugs:

• Decree of the Italian Ministry of Health of December 27, 2023, updating the list of narcotic drugs and psychotropic substances included in Table I of Presidential Decree No. 309/1990;
• Decree of the Italian Ministry of Health of December 12, 2023, updating the list of (i) companies authorized to manufacture, use, and distribute narcotic drugs, as well as companies using authorized third-party warehouses for the purposes of wholesale trade in narcotic substances; (ii) companies licensed to carry out activities involving substances classified as drug precursors (Category 1).

Finally, there are further developments for the health sector in the draft-law pipeline. What is known as the “Development Decree” was approved by the Italian Council of Ministers on December 19, 2023, and according to the provisional text available to date it should be expected to contain provisions on dematerialization of prescriptions for drugs not covered by the NHS, simplification of pharmaceutical assistance for chronic patients, and measures to counter medicine shortages, among others.

[1] Law of December 30, 2023, no. 213.

[2] Under Article 1, par. 224, the Italian Medicines Agency (AIFA) shall update the hospital-territory formulary (PHT) by establishing a binding list of medicines that, due to their pharmacological characteristics, can have their classification changed from A-PHT (see AIFA resolution of October 29, 2004) to Class A.

[3] Specifically, according to Article 1, par. 225, the fixed fees and variable fees granted to pharmacies are determined as follows: (a) 6% of the price to the public net of VAT for each pack of medicine (variable); (b) a fixed fee of EUR 0.55 for each pack of medicine with a price to the public not exceeding EUR 4.00; c) a fixed fee of EUR 1.66 for each pack of medicine with a retail price between EUR 4.01 and EUR 11.00; d) a fixed fee of EUR 2.50 for each pack of medicine with a retail price of more than EUR 11.00; e) an additional fixed fee of EUR 0.10 for each pack of medicine on the transparency list. The latter fee will rise to EUR 0.115 as of January 1, 2025.

[4] According to Article 1, par. 227, these pharmacies are granted: EUR 1.20 for each medicine dispensed by a pharmacy with NHS turnover (net of VAT) not exceeding EUR 150,000; b) an additional fixed fee of EUR 0.58 for each medicine dispensed by a pharmacy, excluding subsidized rural pharmacies, with NHS turnover (net of VAT) not exceeding EUR 300,000; c) an additional fixed fee of EUR 0.62 for each medicine dispensed by a subsidized rural pharmacy with NHS turnover (net of VAT) not exceeding EUR 450,000.