On 22 May 2024, the Italian Constitutional Court held a public hearing to discuss the issue of the legitimacy of medical device payback regulation, as raised by the Lazio Regional Administrative Court, for conflicting with Articles 3, 23, 41, and 117 of the Constitution.
The European Medicines Agency’s Medicines Shortages Steering Group recently developed a list of recommendations in hopes of increasing the availability of critical medicines flagged for supply chain vulnerabilities or risks.
The European Parliament voted in favor of a digital EU Health Data Space for electronic health records. Despite various policy concerns about data privacy, increasingly urgent health demands render efficient access to personal electronic health data necessary across all Member States.
On 10 April 2024, the European Parliament, in a plenary session, approved new proposals for a directive and regulation on medicinal products for human use. The two texts will now have to be approved by the European Council. These proposals aim at ensuring safer, more efficient, and high-quality medicines for EU citizens, at promoting innovation and development of medicines to address unmet medical needs, and at strengthening the research on new medicines to tackle antimicrobial resistance.
On 18 April 2024, the State and Regions’ Conference approved the Agreement proposed by the Ministry of Health for the implementation of an active pharmacovigilance program.
The Agreement will be implemented by signing conventions between the Italian Medicine Agency (AIFA) and single Regions, through which the Pharmacovigilance Funds, relating to the years 2018, 2019, 2020, 2021 and 2022, will be disbursed, for an overall total of EUR 58.5 million.
The Aesgp (Association of the European Self-Care Industry), Efpia (The European Federation of Pharmaceutical Industries and Associations) and Medicines for Europe have published a position paper containing a set of recommendations on how to make package leaflets for medicines more comprehensible to patients in order to ensure their appropriate, safe and effective use.
The Constitutional Court has set the public hearing for 22 May 2024, to discuss the legitimacy of the payback regulation for medical devices. Hundreds of manufacturers of medical devices are awaiting the Constitutional Court’s decision, since, should the Court confirm the legitimacy of the legislation in question, they will be required to pay EUR 1.1 billion on account of the expenditure overruns for the four-year period 2015-2018, in addition to the payback due for the following years.
The Italian Medicines Agency has summarized the distribution methods that can be applied in the event of shortages of drugs included in transparency lists. These measures can be implemented in order to guarantee pharmaceutical assistance at the regional level, avoid charges to citizens and optimize economic resources.
The EU Court of Justice, in its judgment given in Case C-291/22 P, annulled the European Medicines’s decision denying marketing authorization for a drug, finding that the evaluation process was vitiated by the presence within the Committee for Medicinal Products for Human Use of an expert who was in a situation of conflict of interest.
On 31 January 2024, the Italian Medicines Agency (AIFA) published the Guidelines on applications for marketing authorizations submitted through the national procedure. The purpose of the Guidelines is to provide detailed information about (i) the correct submission of applications for marketing authorization and the relevant administrative and technical documentation, (ii) the steps and timeframes for the AIFA’s assessment of such applications, including any requests for clarification and/or further documentation, and (iii) the publication of the results of the preliminary assessment, the procedures for issuing the final resolutions as well as for their notification and publication in the Official Gazette.