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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.
Author

Roberto Cursano has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.

Author

Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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