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With Law No. 108 of 5 August 2022 (converting Decree-Law No. 68 of 16 June 2022 into law, with amendments), the Italian government introduced a favorable regime for authorized car distributors that will have a major impact on the sector. The new legislation applies to all vertical relationships between the manufacturer or importer of vehicles and the authorized distributor for the sale of vehicles that have not yet been registered, as well as vehicles that have been registered by the authorized distributors for not more than six months and have not traveled more than 6,000 kilometers.

On 13 August 2022, the new law implementing EU Directive 2019/1152 will go into force. Some important clarifications on the new law have been issued by the National Labour Inspectorate. We are expecting additional clarifications to be issued by competent authorities in the coming days and weeks, since there are still a number of provisions in the new law that require official guidance on their application.

With Decree dated 29 April 2022, published in the Official Gazette on 24 May 2022, the Ministry of Health approved the organizational guidelines on the “Digital model for the implementation of home-care”. The guidelines set out a reference model for the implementation of various telemedicine services in the home-care setting, through the identification of innovative processes for taking care of patients at home and the enhancement of multi-professional and multidisciplinary collaboration between the various professionals.

On 31 May 2022, the National Coordination Centre of Ethics Committees updated the templates for the conduct of clinical trials on medicinal products and clinical investigations on medical devices that identify the minimum content of the agreement between sponsors/CROs and clinical sites to ensure the uniformity of administrative, economic and insurance aspects.

With judgment No. 705 of 21 May 2022, the Administrative Court of the Tuscany Region upheld the complaint against the decision to award a tender for a framework agreement for the supply of coronary stents to the regional health service, under which tenderers were required to offer the “most recently marketed” device. In his regard, the plaintiff complained that the successful tenderer offered a product that was on the market for years, although the same product was in line with the technical requirements set out in the tender specifications.

With Judgment No. 544 of 18 July 2022, the Administrative Court of the Basilicata Region dismissed the appeal against the decision to award a tender for the supply of flu vaccines to the regional health service. In this regard, the plaintiff challenged the allocation of the type and quantity of flu vaccines to be supplied into separate lots, based on the alleged violation of the principles of competition and non-discrimination.