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In brief

On 16 September¬†2020, the Italian Medicine Agency (AIFA) launched a public consultation on the new “Guidelines for the preparation of Dossiers supporting reimbursement and pricing applications“, in order to implement the Decree of the Ministry of Health dated 24 July 2020, establishing “Criteria and methods by which the Italian Medicine Agency establishes, through negotiation, the prices of medicines reimbursed by the National Health System“.

Said Guidelines provide operational instructions to be used by pharmaceutical companies for the preparation of applications to start the negotiation procedure for the reimbursement and pricing of medicinal products. In this respect, the AIFA announced that at the end of the consultation, scheduled for 30 September 2020, the final version of the Guidelines shall be adopted.

It is worth mentioning that the current version of the Guidelines provides that pharma companies must inform the AIFA about the price charged in other EU Member States, including possible discounts, and that where such information are subject to confidentiality agreements, the applicant must indicate the relevant counterparty and the date and duration of the agreement. In this respect, it will be interesting to see how pharma companies will react to said requirement during the consultations with the AIFA.

The AIFA pointed out that, until the final adoption of the Guidelines, the procedure for the negotiation of the price of medicines reimbursed by the National Health System will continue to be governed by the Resolution of Inter-ministerial Committee for Economic Planning No. 3 of 1 February 2001.


Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.


Riccardo Ovidi is an associate in Baker McKenzie's Rome office.