22 March 2021 | Evelina Marchesoni Associate

By resolution dated February 10, 2021 the Italian Medicines Agency (AIFA) clarified the criteria for generic medicinal products to be inserted in the Substitution List (“Lista di Trasparenza”).

In particular AIFA specified that only patents/SPCs on the active ingredient per se affects the reimbursement procedures for generic medicinal products in compliance with Article 11 (1-bis) of the
Italian Law Decree no. 158/2012, converted by Italian Law no. 189/2012 (“Balduzzi Provision”).

Balduzzi Provision and its effects

According to Balduzzi Provision “[…] equivalent medicinal products shall not be classified as drugs reimbursed by National Health System with effect prior to the date of expiry of the patent or of the SPC, as published by the Ministry of Economic Development […]”.

This rule temporarily impedes only the actual reimbursement by the Italian National Health System (“NHS”) of a generic product until the expiry of the patent/SPC covering the relevant reference product (i.e. the originator's product).

In other words, the Balduzzi Provision does not prevent generic companies from applying for reimbursement, from completing the relevant procedure and from obtaining the relevant decision from AIFA but prevents that decision on reimbursement being effective prior to the expiry of the originator's patent/SPC.

Indeed in the decision on reimbursement adopted by AIFA prior to the expire of the originator's patent/SPC a statement is added clarifying that, in compliance with Balduzzi Provision, the classification of a medicine reimbursed by the NHS is effective as from the day after the date of expiry of the reference patent/SPC. 

The scope of application of Balduzzi Provision

As written, the scope of Balduzzi Provision was not entirely clear.

In particular, inter alia, it was debated if Balduzzi Provision applies only to some categories of patent or to all.

In the few decisions of the Italian administrative Courts dealing with this issue:

  • the Courts assessed it in relation to the specific circumstances of the case;
  • only insofar it was necessary to adopt a decision in relation to said specific circumstances;
  • by using arguments often not correct from a patent law perspective, in particular confusing the different categories of patents.

As a consequence, the aim of the recent resolution of AIFA was to clarify that Balduzzi Provision applies only to patents/SPCs on active ingredient per se and that "further categories of patents, including process patents, are not relevant".

Is Balduzzi Provision clear now?

The hope is that said resolution has actually clarified (and limited) the scope of Balduzzi Provision, at least as far as the relevant category of the patents/SPCs.

However it cannot be excluded that AIFA and the Administrative Courts will not be able always to correctly adopt this resolution, not being specialised in patent matters.

This resolution confirms once again that the Balduzzi Provision is conditional upon expiry of a patent. Therefore, even though it restricts the effectiveness of a reimbursement price rather than obtaining a marketing authorisation, it should be regarded as a form of patent linkage, contrary to European Union law, and should therefore be abrogated. This has been pointed out several times by the Italian Competition Authority, most recently on the recommendation submitted on 23 March 2021 by the Italian Competition Authority to the President of the Council of Ministers regarding competition and market law.