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In brief

With a press release dated 15 October 2020, the Italian Medicines Agency (“AIFA“) announced the adoption of a new streamlined procedure on pricing and reimbursement of generic and biosimilar drugs.


Said procedure applies to generic and biosimilar drugs having the same packaging as the originator in terms of dosage units, amount of active ingredient, pharmaceutical form, route of administration, and delivery method. Conversely, equivalent and biosimilar drugs having additional indications or a different packaging with respect to those of the originator are excluded.

The new procedure introduces a considerable simplification of the negotiation of price and class of reimbursement. Indeed, for generic and biosimilar drugs whose reference products fall within those considered essential and fully paid for by the NHS (Class “A” or “H”), the procedure provides for a gradual reduction in the involvement of the AIFA’s Technical-Scientific Committee and Pricing and Reimbursement Committee where the marketing authorization holder submits a price proposal in compliance with the discounts listed in the Decree of the Ministry of Health dated 4 April 2013.

As regards generic and biosimilar drugs whose reference product belongs to Class “C” (i.e. drugs the cost of which is entirely borne by citizens), the inclusion of the new medicine in the same Class “C” follows the authorization phase, without any negotiation with the Health Technology Assessment and the AIFA’s Committees.

Lastly, the AIFA introduced specific rules for cases in which the patent protection of the active ingredient expires after a period longer than one year with respect to the submission of the reimbursement application and which vary depending on whether the marketing authorization holder agrees to the discounts established in the above-mentioned Ministerial Decree.

Author

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.

Author

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

Author

Irene Carlet is a Law Clerk/Intern in Baker McKenzie's Rome office.