On 10 February 2021 the Italian Medicines Agency (AIFA) adopted a resolution clarifying the criteria which must be met for generic medicines to be included on the Substitution List (Official Journal of the Italian Republic, 16 February 2021, 39).
The Substitution List applies to products distributed throughout Italy in conventional pharmacies. It does not refer to drugs that are exclusively dispensed in hospitals. The list groups the products based on the criterion of 'equivalence' and sets out the maximum reimbursement price for the products belonging to each group. Pharmacists must refer to the Substitution List when:
- automatically substituting a prescribed product for the cheapest product; or
- requesting a patient's co-payment in cases where the prescription does not allow substitution or the patient refuses the cheapest product.
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. Under the Balduzzi provision, an approved generic cannot be classified as a reimbursable medicinal product until the originator's patent or supplementary protection certificate (SPC) has expired. This means that the National Health Service should not pay for generics until such expiry date has passed. This provision has obvious implications for the Substitution List, which includes only reimbursable products.
The AIFA has now clarified that for the purposes of applying the Balduzzi provision, only SPCs or compound patents are relevant. The resolution states that "[a]ny other type of patent, including inter alia process patents, will be considered irrelevant".
In recent years, administrative judges have considered the Balduzzi provision's scope of application on several occasions, and numerous decisions have been issued on this matter. However, none of these decisions were completely satisfactory. Rather, they were poorly reasoned and unclear to a considerable extent.
The AIFA has now clarified the situation; however, some questions remain regarding the relevance of patent protection with respect to the various rules applied by administrative authorities in the context of reimbursing or purchasing medicinal products. For instance, questions remain as to the relevance of second medical use patents in the context of regulating public tender procedures relating to the supply of hospital drugs.
