Isabella Barbieri -

Within the publications of the annual Financial Law, some new depositions have been set for the healthcare system and the national pharmaceutical expenditure.
The main important changes, in place , since last January are herein listed:



  • A decree (expected in March, but not yet disclosed) regarding new criteria and modalities adopted by AIFA to negotiate the price and the reimbursement of medicinal products
  • In addition, AIFA can re-open the negotiation process, with the relevant MAH even before the term of the Price & Reimbursement Negotiation Agreement



  • New dispositions to manage the pharmaceutical expenditure direct purchases (i.e medicinal products acquired by public healthcare units and hospitals) have been set
  •  A specific cap for “medicinal gas” expenditure – 0,20% and the rest of medicines – 6,69% were identified
  •  In case of direct purchases expenditure cap overshooting ,all companies will contribute to the balance procedure (procedura di ripiano), except companies with a turnover lower than 3 million di EUR
  • The overspending in respect of one of the two funds set for innovatives and oncological innovatives, is balanced by each company, MAH of innovatives and oncological innovatives respectively, in proportion to the relevant market share
  • The medicinal products not included in the European list of orphan drug, will not be longer considered orphan in Italy and therefore in case of overshooting of the pharmaceutical expenditure cap at national level, the MAH of such medicinal product will be part of the balance procedure.

Currently we expect AIFA to communicate the updated criteria for the negotiation process and to set a final decision for orphan-like medicinal products regarding their possible inclusion in the balance procedure in case of overshooting of the pharmaceutical cap expenditure.

At RPN we constantly keep up with regulatory changes in order to inform and support our clients on the consequences of the law modifications.

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