Pharma Value analysed and summarised Title VI - Health, focusing on the articles concerning the governance of pharmaceuticals (Art. 42 - Refinancing of the SSN, Art. 43 - Redetermination of pharmaceutical expenditure ceilings, Art. 44 - Changes to the methods of distribution of medicines, Art. 48 - Financing for the updating of LEAs).

TITLE VI - Health

Art. 42 - Refinancing the NHS

The level of financing of the standard national health requirement to which the State contributes is increased by:

• 3,000 million for the 2024
• 4,000 million for the 2025
• 4,200 million for the 2026

Earmarked for the purposes of the Articles:

• 10- Re-funding of the CCNL fund for public employees for 2022-2024

• 42- Increase in the hourly rate of additional services for medical staff and health sector personnel working in NHS companies and institutions

• 43- Redetermination of pharmaceutical expenditure ceilings

• 44- Changes to the way medicines are distributed

• 45- Measures to reduce waiting lists
• 46- Updating the expenditure ceiling for purchases of health services from private individuals

• 48- Funding for updating LEAs
• 50- Further measures to strengthen the National Health Service and territorial care
• 66- Research organisations not supervised by the Ministry of Universities and Research

Article 43 - Redetermination of pharmaceutical expenditure ceilings

• The roof of the expenditure pharmaceuticals for direct purchase is recalculated to the extent of8,5% as from 2024
• The roof of the expenditure contracted pharmaceuticals is restated in the value of the 6,8% as from 2024

Art. 44 - Changes to the way medicines are distributed

No later than 30 March 2024 and annually thereafter, the Italian Medicines Agency (AIFA) shall update the hospital-territory continuity of care (PHT) handbook by identifying the binding list of medicinal products that, due to their pharmacological characteristics, can be transferred from the A-PHT classification scheme, as well as the binding list of off-patent PHT medicinal products that can be allocated for conventional distribution through pharmacies open to the public.

For conventionally dispensed drugs, as from 1 March 2024 the system of remuneration of pharmacies for the reimbursement of drugs dispensed under the National Health Service is replaced by a variable quota and fixed quotas:

a) the 6% on the public price excluding VAT for each drug pack;

b)a fixed fee of EUR 0.55 for each pack of a medicine with a retail price not exceeding EUR 4.00;

c)a fixed fee of EUR 1.66 per pack of a medicine with a retail price between EUR 4.01 and EUR 11.00;

d)fixed fee of EUR 2.50 for each medicine pack with a retail price of more than EUR 11.00;

e) a fixed fee of EUR 0.1 per packet of medicine on the transparency list.

For essential medicines and medicines for chronic diseases, the price to the public is unchanged.

In addition, they are recognised:

a) a fixed fee of EUR 1.20 for each drug dispensed by pharmacies with SSN turnover net of VAT not exceeding EUR 150,000.00

b) a fixed fee of EUR 0.58 for each medicine dispensed by pharmacies - excluding those referred to in point c) - with SSN turnover net of VAT not exceeding EUR 300,000.00

c) a fixed fee of EUR 0.62 for each drug dispensed by subsidised rural pharmacies with SSN turnover net of VAT not exceeding EUR 450,000.00

Notwithstanding the quotas set for essential medicines and medicines for chronic diseases, as of as from 1 March 2024, the following discounts cease to apply:

a) discount for the benefit of the SSN proportional to the price of the drug for the different types of pharmacy defined pursuant to Article 1(40) of Law No. 662 of 23 December 1996 (rebates of 3.75%, 6%, 9%, 12.5% on pharmacy fees 66.65%, wholesalers 6.65 and pharmacists 26.7%for drugs other than essential drugs and drugs for chronic diseases but of major therapeutic interest or other than those not subject to prescription

b) discount provided for by AIFA Determination of 9 February 2007 (payback 5%)

c) discount referred to in Article 1(3) of Decree-Law No 156 of 24 June 2004, converted, with amendments, into Law No 202 of 2 August 2004 (discount of of 6.8% equal to 4.12 % on the retail pricemade by the manufacturer, for medicines intended for the domestic market that are reimbursable by the SSN, excluding products dispensed in hospitals, medicines on transparency lists, wholesalers and pharmacies)

d) discount referred to in Article 11(6) of Decree-Law No. 78 of 31 May 2010, converted, with amendments, into Law No. 122 of 30 July 2010 (discount of 1.82% on wholesalers' shares3% and pharmacists 30.35% on the public price of medicinal products of class A)

È establishedwithout new or increased burdens on public finance, a special technical table that, as of from 1 March 2024 and on an annual basis, monitors expenditure trends related to the provision of the SSN drug dispensing service by pharmacies. The participants are:

• representatives of the Ministry of Health
• representatives of the Ministry of Economy and Finance
• representatives of AIFA
• representatives of the Permanent Conference for Relations between the State, Regions and Autonomous Provinces of Trento and Bolzano
• representatives of the most representative pharmacy associations

Article 48 - Funding for updating LEAs

In order to allow for the updating of the LEAs, a quota equal to

• 50 million of euro for the year 2024
• 200 million of euro from the year 2025from the level of financing of the standard national health requirement to which the State contributes.