On August 1, 2019, the State-Regions Conference expressed its positive opinion on the draft of Inter-ministerial Decree between the Ministry of Health and the Ministry of Economy and Finance, which establishes new criteria and procedures for price negotiation of medicines reimbursed by the National Healthcare Service.

The draft Decree provides for relevant changes to the previous system, regulated by the Determination, of the Inter-ministerial Committee for Economic Planning No. 3, dated February 1, 2001. Particular emphasis is given to the “added therapeutic value” that the medicinal product must ensure with respect to the main treatments to which it is compared, thus replacing the previous reference to the “advantageous cost-effectiveness” ratio. The draft Decree also requires pharmaceutical companies to support their requests with information and self-certifications attesting their production capacity and ability to manage unexpected events, also establishing the activities to be undertaken to ensure the proper supply of medicines to the National Health Service, as well as information concerning the patent status of the relevant medicinal product.

Another important innovation is the possibility for the Italian Medicines Agency (AIFA) to start the price negotiation procedure and the introduction of a 180-day term within which said procedure has to be completed. In this respect, the draft Decree also provides an accurate description of the various steps to be followed during this phase, specifying the duties of the AIFA’s Technical-Scientific Commission and Pricing and Reimbursement Committee.

Prices continue to be valid for a 24-month period, although the draft Decree introduces new circumstances under which the AIFA can recommence the negotiation procedure. Lastly, the draft Decree increases the time available to pharmaceutical companies to propose changes in the conditions of the reimbursement agreement by providing that said proposals must be received by the AIFA at least 60 days before the expiry of the agreement (the previous term was 90 days).

Upon obtaining the positive opinion of the Council of State, the draft Decree must be reviewed by the Court of Auditors and, subsequently, published in the Italian Official Gazette.