Life Sciences New in Italy: June 2025

Regulatory

EU pharmaceutical reform enters final negotiations

On 4 June 2025, the Council of the European Union adopted its position on the revision of EU pharmaceutical legislation, introducing amendments to the text of the new directive and new regulation proposed by the European Commission in April 2023 and subsequently modified by the European Parliament in April 2024. The Council’s revisions address key provisions concerning regulatory data protection and market exclusivity periods, the availability of medicines, transferable exclusivity vouchers, and intellectual property exemptions for generic medicines. Trilogue negotiations with the European Parliament and the European Commission began in Brussels on 17 June 2025 with the aim of reaching a final agreement by the end of the year.

MDCG and AIB publish FAQ on interplay between AI Act and medical devices rules

On 19 June 2025, the Medical Device Coordination Group (MDCG) and the Artificial Intelligence Board (AIB) jointly published a FAQ document addressing the interplay between Regulation (EU) 2024/1689 (AI Act) and Regulation (EU) 2017/745 (MDR) & Regulation (EU) 2017/746 (IVDR). The guidance clarifies how manufacturers, notified bodies and competent authorities should apply both regulatory frameworks when dealing with AI-enabled medical devices. This initial set of clarifications responds to frequent industry questions and aims to support consistent implementation across the EU.

MDCG updates guidance on qualification and classification of Medical Device Software

On 17 June 2025, the Medical Device Coordination Group (MDCG) published updated guidance on how to qualify and classify software under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). The document guides Medical Device Software (MDSW) manufacturers in determining when software – including Medical Device Artificial Intelligence (MDAI) – qualifies as a medical device. It explains how to apply classification rules and outlines requirements for placing MDSW on the market. This guidance also covers software applications, regardless of platform, including those running on mobile devices, or cloud systems.

MDCG issues Q&As on performance studies of IVDs under IVDR

On 18 June 2025, the Medical Device Coordination Group (MDCG) published Q&A on performance studies of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR). The document targets sponsors of performance studies – ie studies conducted to establish or confirm the analytical or clinical performance of an IVD and carried out under the IVDR. It also provides guidance for manufacturers supplying IVDs used in studies sponsored by other parties, as well as for sponsors of combined studies.

MDCG issues guidance on safe online distribution of MDSW apps

On 16 June 2025, the Medical Device Coordination Group (MDCG) issued guidance on safely offering medical device software (MDSW) apps through online platforms. The apps support healthcare tasks, such as managing insulin pumps or detecting skin cancers, and are often downloaded directly by patients. The guidance clarifies the responsibilities of app platform providers under Regulation (EU) 2017/745 (MDR), Regulation (EU) 2017/746 (IVDR), and Digital Services Act (DSA). It also outlines how providers must support manufacturers in meeting transparency and safety requirements and specifies the information manufacturers should supply when making their apps available.

European Commission and EU member states launch pilot coordinated assessment for clinical trials and performance studies

On 13 June 2025, the European Commission and EU member states launched a pilot project to simplify approval for combined studies of medicines and medical devices. Through the COMBINE programme, sponsors can submit a single application, fostering smoother coordination with involved member states. This approach lowers administrative burdens, enhances transparency, and ensures consistent assessments. The pilot accepts a limited number of studies where sponsors test a medicine together with a companion diagnostic. Its purpose is to evaluate the process and gather valuable feedback to improve future procedures.

AIFA clarifies submission process for MA variations

On 12 June, the Italian Medicines Agency (AIFA) issued a notice to clarify the correct submission process for variations to the terms of marketing authorizations (MAs) for medicines approved through the national or mutual recognition/decentralized (MR/DC) procedures, under Regulation (EC) 1234/2008. The notice aims to help pharmaceutical companies ensure proper compliance and includes specific details on how to submit Supergrouping and Worksharing applications.

 

Data, Privacy and Cybersecurity

Healthcare sector representatives sign the Data Pact

On 6 June 2025, representatives from the Italian Ministry of Health, the European Commission, parliamentary committees, regional authorities, the research community, and other key stakeholders signed the Data Pact at the Chamber of Deputies. The pact aims to drive Italian and European healthcare and research forward through the effective and shared implementation of the European Health Data Space (EHDS) (further information on this topic is available in our January Newsletter) and Italy’s Health Data Ecosystem (Ecosistema dei dati sanitari or EDS) (further information on this topic is available in our March Newsletter).

The five key objectives of the Data Pact are:

1. facilitate EDS implementation by June 2026 and support Italy’s involvement in MyHealth@EU and HealthData@EU;
2. build collaboration and trust across the health ecosystem;
3. promote responsible innovation through early adoption of technical standards (privacy by design, privacy by default), governance procedures, and control tools, to safely and ethically test innovative services based on EDS and EHDS data;
4. prepare Health Data Access Bodies (HDABs) by defining roles, responsibilities, and shared workflows among HDABs, digital health authorities, and private entities; and
5. foster public-private partnerships to enable the secure use of anonymized data for research and prevention.

EDPB adopts final version of Guidelines 02/2024 on Article 48 GDPR

On 4 June 2025, the European Data Protection Board (EDPB) adopted the final version of Guidelines 02/2024 on Article 48 GDPR. The purpose of the Guidelines is to clarify the scope of Article 48 of the GDPR, which governs the limits on recognizing and enforcing judicial or administrative decisions from third countries requiring the transfer of personal data. The Guidelines provide practical mechanisms for companies called upon to respond to requests for transferring or disclosing personal data from authorities of third countries.

If an EU controller or processor receives a personal data request from a third-country authority, this qualifies as a data transfer under the GDPR and must be based on a valid legal basis and appropriate ground for the transfer pursuant to Chapter V of the GDPR. In this regard, an international agreement can serve as both a legal basis and a transfer mechanism, if no such agreement exists or it lacks these elements, other legal bases or transfer mechanisms must be considered.

Italian DPA issues fine for unlawful use of private messages in disciplinary proceedings

On 27 June 2025, the Italian Data Protection Authority (Italian DPA) published a Resolution in which it imposed a fine of EUR420,000 on a company for unlawfully processing the personal data of an employee, later used as grounds for dismissal. The case originated from a complaint submitted by the employee, who reported that the company had relied on screenshots of content from her Facebook profile and private chats on Messenger and WhatsApp to support disciplinary actions. The Italian DPA concluded that the use of such data violated the principles of lawfulness, purpose limitation, and data minimization under the GDPR. It further emphasized that personal data shared on social media or private messaging platforms—despite being accessible to others—cannot be freely processed for any purpose.

Italian DPA fines a school for unlawful use of fingerprint recognition system

On 27 June 2025, the Italian Data Protection Authority (Italian DPA) published a Resolution in which it fined a secondary school EUR4,000 for unlawfully processing biometric data of administrative staff through a fingerprint recognition system. The system was used to record staff attendance and to prevent vandalism and damage to school property. The biometric system was applied only to staff members who had consented to its use and had opted out of traditional attendance methods. The Italian DPA reiterated that the use of biometric data in the workplace is only lawful when expressly authorized by a specific legal provision that safeguards workers’ rights. Such processing must pursue a public interest and meet strict criteria of necessity and proportionality.

 

Antitrust

Italian Council of Ministers approves the Draft Annual Law for Competition

On 4 June 2025, the Italian Council of Ministers approved the Draft Annual Law for Competition. The Draft Law sets out provisions concerning the healthcare sector, including the revision of criteria for access and eligibility criteria for issuing and renewing accreditation and reimbursement agreements. The criteria must take into account the need to ensure continuity of care, while safeguarding competition through a distinction of public procedures for examining renewals and new requests. This is essentially aimed at preventing previous experience from constituting a barrier to entry for newcomers.

 

Tax

Italian Revenue Agency publishes Ruling on VAT treatment applicable to healthcare services provided by a foundation

On 19 July 2025, the Italian Revenue Agency published Ruling 163/2025 on the VAT treatment applicable to healthcare services provided by a foundation. According to the Italian Revenue Agency, healthcare services rendered by a foundation through licensed medical professionals (including doctors, nurses, physiotherapists and psychologists), whether under private arrangements (Solvent) or covered by the National Health Service (SSN) for people over the age of 65, qualify for VAT exemption under Article 10, par. 1, no. 18) of the VAT Decree. Conversely, services provided by a foundation through social-health workers (OSS) are subject to VAT at the ordinary rate, regardless of whether the costs are borne privately or by the SSN, since OSS personnel don’t meet the subjective requirements for VAT exemption.

Italian Revenue Agency publishes Ruling on tax treatment for VAT and income tax purposes applicable to the recharging of costs by a ‘lead’ ASL

On 18 June 2025, the Italian Revenue Agency published Ruling 160/2025 on tax treatment for VAT and income tax purposes applicable to the recharging of costs by a “lead” Local Health Authority (ASL). The Italian Revenue Agency clarified the VAT and corporate income tax (IRES) treatment of cost recharges made by a ASL appointed as “lead entity” for the integrated management of regional healthcare logistics. Specifically, the Ruling confirms that the recharges fall outside the scope of VAT pursuant to Article 4, par. 4, of Presidential Decree No. 633/1972, as they don’t constitute economic activities; and they’re not relevant for IRES purposes, as they reflect mere cost allocations within the institutional framework of public healthcare entities.

Italian Revenue Agency publishes Ruling on reduced VAT rate for food supplements

On 18 June 2025, the Italian Revenue Agency published Ruling 158/2025 on reduced VAT rate for food supplements. Under no. 80 of Table A, Part III, of the VAT Decree, a 10% VAT rate applies to the supply of mineral-based food supplements and mineral-enriched water concentrates not intended for immediate consumption but for dilution (eg those containing potassium, magnesium, calcium, zinc, iodine, selenium or manganese). This provision covers “food preparations not elsewhere specified” under customs code 21.06.90. The Customs Agency has confirmed that the products in question fall under this category and are therefore eligible to be subject to the reduced 10% VAT rate.