Life Sciences News in Italy: August 2025

Regulatory

AIFA Resolution on the filing of MA applications enters into force

On 12 August 2025, Resolution 1034/2025 issued by the Italian Medicines Agency (AIFA) entered into force. It streamlines and updates the procedures for filing applications for granting, renewing and varying marketing authorisations (MA) for medicinal products.

MDCG updates Guidance on implementation of the Master UDI-DI solution for contact lenses

On 26 August 2025, the Medical Device Coordination Group (MDCG) updated its Guidance on the implementation of the Master UDI-DI solution for contact lenses. The document provides detailed instructions on terminology, assigning identifiers to both standard and made-to-order lenses, labelling requirements, vigilance reporting, registration in EUDAMED, and compliance timelines – specifically the mandatory application starting on 9 November 2026.

AIFA publishes report on evaluation criteria for attributing therapeutic innovativeness

On 6 August 2025, the Italian Medicines Agency (AIFA) published the summary report of its public consultation on the evaluation criteria for attributing therapeutic innovativeness. The report consolidates anonymised feedback from patients’ associations, stakeholders, and other participants, as part of the process to define transparent and inclusive criteria for recognising innovative therapies under the law.

 

Data, privacy and Cybersecurity

Italian DPA fines company for unlawfully processing employees’ health data

On 1 August 2025, the Italian Data Protection Authority (Italian DPA) published a resolution imposing a fine of EUR50,000 on a company for unlawfully processing employees’ health data collected through a questionnaire given to staff returning from sick leave. Employees had to attend a meeting with their manager, during which they completed a questionnaire. The completed forms were then forwarded to the HR department and, in certain cases, to the company doctor to evaluate possible workplace adjustments. The Italian DPA identified multiple violations of the GDPR, including the absence of a clear and transparent privacy notice, the lack of a valid legal basis for processing health data, the collection of information irrelevant to employment purposes, and the disproportionate retention of health data, in some cases for up to ten years.

Italian DPA fines company for failing to implement appropriate security measures

On 1 August 2025, the Italian Data Protection Authority (Italian DPA) published a resolution imposing a fine of EUR80,000 on a life insurance company for failing to adopt adequate technical and organisational measures to protect customer data. The case originated from a complaint by a customer whose personal data relating to life insurance policies had been disclosed to an unauthorised third party and later used in court proceedings. The Italian DPA found that the disclosure occurred because company staff responded to information requests without properly verifying the legitimacy of the email addresses used, which in fact did not belong to the customer. The Authority also noted that the company failed to notify the personal data breach within the 72-hour deadline required under the GDPR.

 

Antitrust

Italian Competition Authority sanctions online pharmaceutical e-commerce platform

On 4 August 2025, the Italian Competition Authority (ICA) published its decision concluding an investigation against an online retailer of pharmaceutical and healthcare products, imposing a fine of EUR1.1 million for engaging in two unfair commercial practices: (i) providing misleading information on product delivery, availability and shipping times; and (ii) obstructing consumers in exercising their rights during the after-sales phase.

Italian Competition Authority conditionally authorises a merger in the pharmaceutical sector

On 18 August 2025, the Italian Competition Authority (ICA) published its decision concluding the investigation into the merger between CEF and UNICO, both active in the wholesale distribution of medicines and healthcare products. Due to the limited substitutability with other types of supply, the ICA identified a separate market for full-line wholesalers, with a geographic dimension corresponding to the area falling within a 100 km distance from the parties' warehouses. Given the overlaps in the parties' activities and resulting competition risks, the ICA conditionally approved the transaction, requiring the divestiture of two business units and the adoption of certain behavioural commitments.

European Commission launches review of Foreign Subsidies Regulation

On 12 August 2025, the European Commission launched the first review of the Foreign Subsidy Regulation. The Regulation entered into force in 2023 with the aim of preventing distortions to competition caused by subsidies granted by non-EU countries to undertakings active on the internal market. The Regulation currently imposes notification obligations on parties involved in certain mergers and public procurement procedures. All interested parties can provide feedback to the European Commission by 18 November 2025.

European Commission seeks input to revise Rescue and Restructuring Guidelines

On 22 August 2025, the European Commission launched a Call for Evidence and public consultation to gather feedback on the planned revision of the Rescue and Restructuring Guidelines on State Aid. These Guidelines set out the conditions under which aid to non-financial undertakings in difficulty may be deemed compatible with EU rules. The revision seeks to clarify key aspects and adapt the Guidelines to the evolving political context, ensuring that public funding is channelled appropriately. Stakeholders are invited to submit feedback by 14 November 2025.

 

Tax

EU and US announce new Framework Agreement on trade

On 21 August 2025, the EU and the US published a Joint Statement announcing a new Framework Agreement on reciprocal, fair, and balanced trade. The accord covers a broad range of areas, with several provisions of particular relevance for the Life Sciences sector:

• From 1 September 2025, the US will apply only Most Favored Nation (MFN) tariffs (15%) to EU generic pharmaceuticals and their chemical precursors, providing greater predictability in market access.
• Enhanced technical cooperation on standards and expanded use of conformity assessments to promote regulatory alignment.
• Joint initiatives to streamline sanitary certification in food trade.
• EU commitments to reduce compliance burdens under the Corporate Sustainability Due Diligence Directive (CSDDD) and the Corporate Sustainability Reporting Directive (CSRD).