Life Sciences News in Italy - July 2025

Regulatory

MoH presents draft delegation bill for a Consolidated Act on Pharmaceutical Legislation

On 31 July 2025, the Ministry of Health (MoH) presented the draft delegation bill to the Government for a Consolidated Act on Pharmaceutical Legislation (Testo Unico della legislazione farmaceutica). The reform aims to merge hundreds of fragmented laws into a single, modern regulatory framework. Key goals include simplifying procedures, ensuring equitable access to medicines, enhancing supply chain efficiency, and promoting long-term sustainability. The draft was developed with the involvement of several ministries – Health, Economy and Finance, Enterprises and Made in Italy, Environment, and Justice – and will now move through parliamentary discussion and the State-Regions Conference before implementation.

MoH publishes the Decree on new labelling rules under NMVS

On 9 July 2025, the Ministry of Health (MoH) published the Decree of 20 May 2025 in the Official Gazette, implementing the National Medicines Verification System (NMVS). The Decree outlines the technical and graphical specifications, as well as the information required on the new label, which must be affixed to packages bearing a Data Matrix code.

AIFA issues operational instructions on anti-counterfeiting requirements for medicines

On 17 July 2025, the Italian Medicines Agency (AIFA) issued operational instructions to facilitate compliance with new anti-counterfeiting measures introduced by Legislative Decree 10/2025. These measures require the placement of a unique identifier encoded in a Data Matrix barcode and an anti-tampering device on the packaging of medicinal products. The instructions, issued as an annex to AIFA Resolution No. 56 and aligned with the implementation plan of the Co-ordination Group for Mutual Recognition and Decentralized Procedures – Human, outline regulatory obligations for marketing authorization holders and parallel importers under Article 4(7) of the Decree.

AIFA publishes a Resolution on new criteria for therapeutic innovation status of medicines

On 12 July 2025, the Italian Medicines Agency (AIFA) published a Resolution in the Official Gazette updating the criteria for granting therapeutic innovation status, prioritizing medicines that address serious conditions lacking valid alternatives or offering clear added value. Medicines developed primarily in Italy may also gain extra credit. Innovation status unlocks immediate reimbursement, fast-track hospital access, and funding from the EUR1.3 billion Innovation Fund. Eligibility is assessed based on therapeutic need, added clinical benefit, and evidence quality, with more flexible criteria for rare and ultra-rare diseases.

EMA issues a report highlighting AI/ML applications across the medicine lifecycle

On 9 July 2025, the European Medicines Agency (EMA) issued a report showcasing current and potential applications of artificial intelligence (AI) and machine learning (ML) across the medicine lifecycle. The report emphasizes both benefits and challenges associated with these technologies. It organizes AI applications by development phases: drug discovery, non-clinical development, clinical trials, precision medicine, product information, manufacturing, and post-authorization. EMA highlights examples of AI use in each phase and summarizes opportunities and challenges identified by developers.

EMA updates Q&As on clinical data publication

On 2 July 2025, the European Medicines Agency (EMA) updated its Q&As on the external guidance for implementing Policy 0070 on publishing clinical data for human medicines. This guidance helps applicants navigate the clinical data publication (CDP) process by explaining how to identify, redact, anonymize, and submit documents. It answers relevant questions and compiles recommendations, references, and supporting resources to streamline submissions.

 

Data, Privacy and Cybersecurity

Italian DPA warns against misuse of generative AI for medical reports

On 30 July 2025, the Italian Data Protection Authority (Italian DPA) issued a warning about the growing use of generative AI platforms to interpret medical reports, such as lab tests and radiology scans. More specifically, the Italian DPA raised concerns over the risks to health data and the potential for inaccurate or misleading outputs from AI tools not certified as medical devices. The Italian DPA recommended that users to avoid sharing medical data with such platforms and always review platform privacy policies to understand how uploaded data is handled. Finally, the Italian DPA reiterated the need for qualified human oversight at all stages of AI system development and use.

European Commission publishes Guidelines on the scope of obligations for providers of general-purpose AI models under the AI Act

On 18 July 2025, the European Commission published Guidelines on the scope of obligations for providers of general-purpose AI models under the AI Act (Guidelines) to support the implementation of the AI Act with reference to the obligations applicable to general-purpose AI models (GPAI). These models, increasingly used across various sectors including healthcare, are subject to transparency and compliance requirements, such as the publication of documentation and summaries of the data used for training. GPAI models considered to present systemic risk are also subject to additional obligations, including specific measures for risk mitigation and cybersecurity. The Guidelines therefore serve as a valuable resource to help operators determine whether they qualify as providers, assess the applicability of exemptions, and understand how to comply with the obligations related to GPAI models under the AI Act in anticipation of its full application.

EDPB and EDPS issue Joint Opinion on simplification of record-keeping obligation

On 9 July 2025, the European Data Protection Board (EDPB) and European Data Protection Supervisor (EDPS) issued the Joint Opinion 01/2025 on the Proposal for a Regulation on simplification measures for SMEs and SMCs, in particular the record-keeping obligation under Art. 30(5) GDPR, following the preliminary feedback on the same matter issued in May (further information on this topic is available in our May newsletter). The Proposal, part of the fourth simplification Omnibus, aims to reduce administrative burdens by extending certain mitigating measures from SMEs to small mid-cap enterprises (SMCs), including further simplification provisions. The EDPB and EDPS support the objective of easing administrative burdens, provided fundamental rights remain protected. They welcomed the targeted nature of the changes but stressed the need for a proper impact assessment and clearer language in the recitals, particularly regarding what constitutes high-risk processing and the scope of the derogation.

Italian DPA publishes 2024 Annual Report

On 15 July 2025, the Italian Data Protection Authority (Italian DPA) presented its 2024 Annual Report, outlining the key actions taken throughout the year, including in the healthcare sector. The Italian DPA emphasized that the deployment of AI in digital health systems must fully comply with the GDPR, the EU AI Act, and the 2023 Guidelines on AI in healthcare, as also reiterated in the opinions issued in 2024 concerning the National Telemedicine Platform (Piattaforma nazionale sulla telemedicina) and the Health Data Ecosystem (Ecosistema dati sanitari). The report also provides significant statistical insights into the sanctions imposed and investigations conducted by the Italian DPA during 2024.

 

Antitrust

European Commission fines Alchem for participating in a pharmaceutical cartel

On 4 July 2025, the European Commission imposed a fine on Alchem for participating in a cartel in the EEA concerning the pharmaceutical ingredient N-Butylbromide Scopolamine/Hyoscine (SNBB), spanning from 2005 to 2018. Alchem had: (i) fixed the minimum sales price of SNBB charged to customers (i.e. distributors and generic drug manufacturers), (ii) allocated yearly quotas among SNBB producers, and (iii) exchanged commercially sensitive information. This decision follows the settlement of the case with the Commission by the other SNBB producers involved in the cartel, as Alchem was the only one who chose not to settle.