On 18 March 2023, two decrees of the Ministry of Health, dated 26 January 2023, were published in the Official Gazette to implement the advertising provisions laid down in Legislative Decrees No. 137/2022 on medical devices and No. 138/2022 on in vitro diagnostic medical devices.
With decree dated 7 April 2023, the Administrative Court of the Lazio Region rejected the request of a medical device company to shorten the statutory time limit for discussing its petition to suspend the enforcement of payment orders issued by Regions and Autonomous Provinces pursuant to the Italian payback legislation.
In a press release dated 3 April 2023, Confindustria Dispositivi Medici (the Italian Association of Medical Device Companies) announced the submission to the European Commission of a complaint to initiate infringement proceedings against Italy for the breach of the EU legislation on the matter of competition, market access and public procurement resulting from the Italian law governing the payback for medical devices.
On 26 April 2023, the European Commission presented its long-awaited proposal for the review of the pharmaceutical legislation. The main objectives of the proposal include the creation of a Single Market for medicines aimed at ensuring that all patients across the EU have timely and equitable access to safe, effective, and affordable medicines; the offering of an attractive and innovation-friendly framework for research, development, and production of medicines in Europe; the drastic reduction of the administrative burden by speeding up procedures significantly, reducing authorization times for medicines, so they reach patients faster; and the enhancement of the availability of medicines.
During the Council of Ministers of 28 March 2023 the Government adopted a Law Decree on “Urgent measures to support families and companies in the purchase of electricity and natural gas, as well as on health and tax compliance”, which has not yet been published in the Official Gazette, introducing new measures on the payback for medical devices.
In a circular letter sent to the Regional and Autonomous Provinces Health Departments on 27 March 2023, the Ministry of Health clarified that the marketing authorizations holders directly engaged in the distribution of their medicinal products are required to obtain a distribution license under Article 100 of Legislative Decree 219/2006.
On 28 February 2023, the Italian Medicines Agency published on its website the updated version of the “Simplified Pricing and Reimbursement Procedure for Generic and Biosimilar Drugs”.
On 27 February 2023, the EMA announced the launch of a pilot project for the benefit of small and medium-sized enterprises aimed at providing scientific advice on clinical development strategy and clinical investigation proposals for class III medical devices and class IIb active devices intended to administer or remove medicines.
With judgment No. 2434, published on 8 March 2023, the Council of State upheld the appeal against the AIFA’s decision ordering the withdrawal from the market of a homeopathic drug on the basis of a discrepancy between the drug identified in the MA renewal application and the one actually marketed.
On 20 March 2023, Regulation EU 2023/607 was published in the Official Journal of the European Union, amending the transitional provisions of Regulations EU 2017/745 on medical devices and 2017/746 on in vitro diagnostic medical devices.