Serialization of medicines — the implementation decree
On 7 February 2025, the Legislative Decree aligning the Italian legislation to the rules laid down in the Delegated Regulation (EU) 2016/161 concerning the serialization of medicinal products for human use was published in the Official Journal.
The Decree, which came into force on 8 February 2025, establishes that starting from 9 February 2025, medicines for human use must bear on the packaging the unique identifier in a two-dimensional barcode and the anti-tampering device, while providing a two-year transition period during which new safety features can be replaced by the existing pharmaceutical sticker.
The entry into force of the Decree triggers the need for pharmaceutical companies to regulate their relationships with all operators in the distribution chain in order to allocate their respective responsibilities and to adapt their compliance systems to ensure that product flows complies with the new regulatory requirements.
Medical Device payback: final hearing before the Administrative Court
A public hearing took place on 25 February 2025, before the Regional Administrative Court of Lazio, to hear the merits of a limited number of cases (the so-called "pilot cases" previously referred to the Constitutional Court) concerning the appeals and challenges against the payback on medical devices for the years 2015-2018.
During the discussion, the Administrative Court raised an ex officio issue of jurisdiction regarding the payment orders issued by the various Italian regions, which various medical device companies challenged with ad hoc appeals for additional grounds (motivi aggiunti), envisaging the possibility of a lack of jurisdiction by the Regional Administrative Court.
In the absence of a referral of the proceeding to the Court of Justice of the European Union (CJEU), the Regional Administrative Court of Lazio will issue, in the next few weeks, its first rulings on the merits of said disputes on an issue that has raised major critical issues for the medical device industry.
In the meantime, the Emilia-Romagna region notified to the medical device companies, an order concerning the recalculation of the payback amounts due in the amount of 48%.
The deadlines for payment are extended until 31 December 2025, although the 60-day period for lodging an appeal against the said order runs, in any case, from the date of its notification.
High-risk medical devices: new procedure from EMA to request scientific advice
The European Medicines Agency (EMA), in collaboration with the European Commission, announced the establishment of a standardized procedure to allow the manufacturers of high-risk medical devices to request scientific advice.
According to EMA reports, the new procedure allows manufacturers of Class III devices and Class IIb active devices (intended for the administration or removal of medicines) to submit their requests for advice through a dedicated portal.
EMA will publish a detailed report in the coming weeks on the pilot program, which was launched back in February 2023, that helped shape this exciting new phase.
Regional Administrative Court of Lombardia: the verification of the equivalence of protections of proposed alternative National Labor Collective Agreement (CCNL) is mandatory
Pursuant to Article 11, paragraph 4, of Legislative Decree No. 36/2023 and the more recent provisions introduced by Legislative Decree No. 209/2024 (so-called "Corrective Rules"), an award decision that the contracting authority has taken in the absence of prior verification of the equivalence between the protections provided by the CCNL indicated in the tender as applicable and the one actually applied by the bidder is to be considered unlawful.
This is what was affirmed by the Regional Administrative Court of Lombardia, in the decision No. 296 of 30 January 2025, which found the appellant's ground of appeal to be well-founded in the part where it aimed to stigmatize the violation of Article 11 of Legislative Decree No. 36/2023, and in particular of the third paragraph of the rule, according to which before proceeding with the awarding of the contract, the administrations acquire the declaration of equivalence of protections, to be verified in the manner set forth in Article 110.
The Judges said, in fact, "that the awarding administration should have proceeded, in compliance with the provisions of Article 11, paragraph 4, Legislative Decree 36/2023 ratione temporis applicable, to verify the content of the aforementioned declaration, also in the manner set forth in Article 110 of the same legislative decree, which, however, did not happen, as the Administration merely accepted supinely the declaration made by the successful bidder."
In the case at hand, the fulfillment required ex lege of the contracting administration (i.e., verification of the declaration of equivalence) was entirely omitted, since there was no trace, either in the tender minutes or in the awarding determination, of the actual fulfillment of the verification regarding the content of the declaration of equivalence made by the other party.
