Ms Daniela Ampollini

Daniela Ampollini


Healthcare & Life Sciences

Reimbursement linkage provision limited to compound patent protection
Italy | 17 March 2021

The Italian Medicines Agency recently adopted a resolution clarifying the criteria which must be met for generic medicines to be included on the Substitution List. The resolution clarifies the scope of Article 11(1bis) of Law Decree 158/2012 (known as the 'Balduzzi provision'), which contemplates a mechanism for linking the existence of patent protection for an originator drug, on the one hand, and the reimbursement classification of respective generics, on the other hand.