On 25 May 2023, the Senate approved in final form the Law converting Law Decree 34/2023, which provides a 52% discount with respect to the payback amounts requested by the Regions and Autonomous Provinces to those medical device companies which have not started litigation on the matter or which waive any ongoing litigation.
On 27 April 2023, the Italian Medicines Agency published on its website the Report on the Timelines of Pricing and Reimbursement Procedures of medicines during the period 2018-2022. The purpose of the Report is to ensure the principle of transparency of the administrative action and to inform citizens and economic operators about the timelines for access to reimbursed medicines.
On 3 May 2023, the European Medicines Agency launched a public consultation in order to review the rules on the publication of clinical trial information submitted through the Clinical Trials Information System (CTIS). The CTIS is the dedicated web portal for the submission of authorizations relating to clinical trials and their management in Europe, aimed at streamlining clinical trial applications and the supervision of clinical trials.
On 3 May 2023, the European Commission presented to the European Parliament and the Council a proposal for a Directive on fighting corruption. The proposal, which refers to corruption in both the public and private sector, provides for the extension of the list of criminal offenses in each EU Member State to include misappropriation, trading in unlawful influence, abuse of functions, as well as obstruction of justice and unlawful enrichment. In addition, the proposal provides for the increase in the level of applicable sanctions and the harmonization of aggravating and mitigating circumstance.
With decision No. 7759 published on 8 May 2023, the Administrative Court of the Lazio Region ruled on the determination whereby the Italian Medicine Agency rejected the request for an exemption from the withdrawal of a marketing authorization filed by the relevant holder due to the discontinuation of the supply of the active ingredient by its manufacturer.
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.