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.
In the course of 2022, the Health Protection Command of the Carabinieri Corp enforced 61 orders, issued by the competent directorates general of the Ministry of Health, providing for the shutdown of websites selling different types of prescription-only medicines in breach of the existing legislation.
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.
On 11 July 2022, the Ministry of Health published the “Annual National Plan of Transitional Controls on Biocidal Products” on its website, whose purpose it is to coordinate and integrate the organization of controls on biocidal products through the harmonization of control strategies and operating procedures.
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.
On 5 May 2022, the Council of Ministers preliminarily approved the bill to adapt the Italian legislation to the provisions of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. The bills are currently being examined by the competent committees of the Italian Parliament.
From 26 May 2022, Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) has applied.
• The main changes introduced by the IVDR include (i) a new classification of devices, (ii) new conformity assessment procedures that differ according to the risk class and the specific characteristics of the device, (iii) reinforced requirements relating to clinical evidence aimed at demonstrating compliance with the safety and performance requirements of the device, (iv) the introduction of post-marketing follow-up obligations for manufacturers aimed at updating the performance evaluation throughout the life cycle of the device, (v) the provision of new obligations for manufacturers, authorized representatives, importers and distributors, and (vi) the obligation for manufacturers to appoint a person responsible for regulatory compliance.
The bill on the “Annual Market and Competition 2021”, approved by the senate on 30 May 2022 and currently under examination by the Chamber of Deputies, provides for the amendment of Article 15 of Law No. 219/2005, governing the Italian transfusion system and the production of blood-derived medicines.