With judgment No. 2149 dated 19 January 2022, the Court of Cassation acknowledged the liability of a manufacturer of medical devices for damages suffered by a patient due to their medical devices breaking during surgery.
On 23 March 2022, the “National Ethics Committee for trials conducted by public research organizations and other public organizations of a national nature” (“National Ethics Committee”) was established within the National Institute of Health (NIH) in accordance with the provisions of the decree of the Ministry of Health dated 1 February 2022. The National Ethics Committee was settled on 23 March at the Italian NIH to replace the Ethics Committee of the NIH, which has been in office until now.
On 16 February 2022, the Decree of the Ministry of Health dated 30 November 2021 governing the assignment for registration and commercial purposes of data relating to nonprofit clinical studies (“Decree”) was published in the Official Gazette. Said Decree repeals the previous Ministerial Decree dated 17 December 2004.
On 18 March 2022, the National Agency for Regional Health Services (Agenas) published a notice to collect proposals for public-private partnerships aimed at awarding the concession for the design, implementation and management of the national platform for telemedicine provided for by the “Health” mission of the National Recovery and Resilience Plan.
On 16 February 2022, the European Commission published the final version of Annex 21 to the Good Manufacturing Practice (GMP) Guidelines governing the importation of medicinal products, which will enter into force on 21 August 2022.
Baker McKenzie’s Sanctions Blog published the alert titled EU introduces additional sanctions against Russia on 17 March 2022. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
On 22 February 2022, the Chamber of Deputies approved the bill for the conversion into law of decree-law No. 228/2021, which shall now be discussed by the Senate for its final approval by 28 February 2022.
On 31 January 2022, Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (EMA) was published in the Official Journal of the EU.
On 24 January 2022, the Decree of the Ministry of Health dated 10 November 2021 updating the National Classification of Medical Devices was published in the Italian Official Gazette.
With its judgment No. 946/2022, the Council of State confirmed the legitimacy of the Guidelines for the treatment of patients with SARS-CoV-2 infection issued by the Ministry of Health. In this respect, the administrative judge emphasized, however, that the Guidelines provide mere recommendations rather than mandatory provisions, which, from a legal standpoint, must be considered as nonbinding indications for the prescribing physician.