In brief
With Judgement No. 3278/2022, the Council of State confirmed the legitimacy of the decision by which the Italian Medicine Agency (AIFA) declared the forfeiture of an MA for failure to market the drug pursuant to Article 38, paragraph 7 of Legislative Decree No. 219/2006 (“Sunset Clause“).
Key takeaways
- The appellant company argued that the exemptions from forfeiture provided for by letters A and D of the AIFA Guidelines on the Sunset Clause applied in this case, pursuant to which the forfeiture does not operate in cases where there is a shortage of a medicinal product for which there is no alternative drug available on the market (letter A) or when a variation procedure is pending at the time of the submission of the request for exemption, including a procedure for the variation of the supplier of the active ingredient (letter D).
- In this regard, the AIFA considered the aforementioned cases of exemption not applicable since, with respect to the criterion under letter A, the appellant company had never notified the AIFA about the shortage of the relevant drug, with the consequence that the same product had never been included in the list of drugs for which there is a temporary shortage, and that, in any case, other products pertaining to the same therapeutic category with similar indications were available on the Italian market. With regard to letter D, the AIFA excluded the application of this criterion because, to apply, the variation procedure must already have been started at the time of the request for exemption, whereas, in the relevant case, the variation was submitted subsequently.
- In its decision, the administrative judge confirmed the reasonableness of the assessments made by the AIFA, pointing out that the forfeiture of the MA operates ope legis and not as a result of the AIFA resolution, and that, once such forfeiture occurs, no extension could apply.