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Italy: Council of State confirms legitimacy of AIFA’s determination amending medicinal product supply regime

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In brief

With Decision No. 2928 of 19 April 2022, the Council of State confirmed the legitimacy of the AIFA’s resolution modifying the supply regime of a medicinal product used for emergency contraception by removing the need for the medical prescription

  • The above resolution had been challenged by a number of associations for the protection of human life, claiming that the AIFA resolution was unlawful as being adopted by an ‘instrumental body’ rather than by the competent Ministry of Health. In rejecting the appeal, the administrative judge highlighted that the existing legislation entrusts the AIFA, on an exclusive basis, with the performance of several functions, including those relating to the classification of medicinal products, their therapeutic indications and the criteria of the relevant prescriptions.
  • In light of these considerations, the Council of State confirmed the AIFA’s exclusive competence on the matter of medicinal products’ supply regime and the legitimacy of the challenged resolution.
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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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