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.
Italy: The new National Ethics Committee for trials of public research organizations has been established
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.
Italy: The new decree on the assignment of results of non-profit studies for registration purposes
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.
Covid-19
On 17 February 2022, the we launched our Central Asia in Focus webinar series, discussing trends, challenges and opportunities in the region. In our five-episode webinar series, we will be discussing a wide range topics with experts from Banking & Finance, corporate, regulatory and other practices.
Episode 1: Update on recent developments in Kazakhstan: Aviation
Episode 2: Data protection and Covid-19: Trends, insights and comparison with the GDPR
Antitrust / Competition
In this regional update, we provide you with a practical overview of the most notable antitrust legal developments of quarter 1 in 2022 that may affect your business.
Anti-Corruption
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.
United States
In this panel discussion with Tiffany McConnell King (Corporate Director and Division Counsel, Global Sustainment and Modernization, Northrop Grumman Corporation) and Kirk Foster (Assistant General Counsel and Director of Compliance and Privacy, HII Mission Technologies), Marilyn Batonga (Partner, Baker, McKenzie) and Maurice Bellan (Partner, Baker McKenzie), we uncover the latest trends and analyze enforcement actions related to international government procurement, focusing on risks based on conduct abroad as well as False Claims Act risks.
Sanctions
The guide provides the latest developments and updates to in-house counsel and business executives on: regulations and compliance; clinical trials; marketing, manufacturing and distribution of pharmaceuticals and medical devices; pricing; digital health; patents; and COVID-19.
Data Privacy
This paper seeks to promote a better understanding of the key considerations for establishing cross-border linkages between two or more national fast payment systems, thereby paving the way for national authorities to pursue more of these linkages in the future.