Life Sciences News in Italy: March 2025

Regulatory

European Commission proposes Critical Medicines Act to address shortages and strengthen supply

On 11 March 2025, the European Commission proposed a Regulation (Critical Medicines Act) to strengthen the EU’s pharmaceutical supply chain and improve access to essential medicines. The Act aims to reduce dependencies, boost EU production, and enhance supply chain resilience by providing state aid guidance and enforcing public procurement rules to diversify supply sources. Member states can engage in joint procurement to address shortages, while global partnerships will reduce reliance on limited suppliers. Focusing on essential medicines listed in the EU List, including antibiotics, anti-thrombotic, and cancer treatments, the Act targets medicines with few alternatives and high patient risk in case of shortages. It also addresses medicines affected by market failures, such as those for rare diseases.

Regional Administrative Court overturns advertising restriction on price comparison

On 17 March 2025, the Regional Administrative Court for Lazio issued a ruling in favour of a pharmaceutical company distributing medicines in Italy, annulling the Ministry of Health’s decision to modify its proposed advertising. The company had sought authorization for a campaign highlighting the economic convenience of its larger 180g format, using the term ‘more advantageous’ to indicate a lower price per gram compared to the smaller version. The Ministry had prohibited this claim, arguing it could mislead consumers by equating the product with common consumer goods. The court found this reasoning illogical and excessive, emphasizing that economic convenience claims do not inherently violate pharmaceutical advertising regulations.

AIFA publishes new Regulation on conflicts of interest

On 19 March 2025, the Italian Medicines Agency (AIFA) published its new Regulation on conflicts of interest. The Regulation requires AIFA's employees and managers to disclose any conflict of interest to their direct superiors, identifying three levels of risk (absent or irrelevant, relevant, high). AIFA maintains the possibility to cooperate with highly professional experts. Further information on this topic is available in our December newsletter.

EMA issues reflection paper on tailored clinical approaches in biosimilar development

On 17 March 2025, the European Medicines Agency (EMA) issued a Reflection Paper on a tailored clinical approach in biosimilar development, open for consultation from 1 April to 31 October. A biosimilar is a biological medicine with an active substance similar to an already authorized reference medicinal product (RMP), established through a comprehensive comparability exercise. Current requirements include quality, in vitro and in vivo non-clinical data, and comparative pharmacokinetic, pharmacodynamic, safety, and efficacy studies. Advances in analytical sciences and regulatory experience suggest reassessing the need for in vivo non-clinical studies and Comparative Efficacy Studies (CES), particularly for less complex biologicals. This paper examines whether CES remains necessary for demonstrating biosimilarity.

EMA and HMA warn against unapproved ATMPs

On 13 March 2025, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued a warning about the risks of unregulated advanced therapy medicinal products (ATMPs) in the EU. ATMPs, which include gene, tissue, and cell-based therapies, can offer significant benefits. However, some individuals, companies, and clinics are marketing unapproved ATMPs directly to patients, often without evidence of safety or effectiveness. Authorities have identified dendritic cell therapies – immune cell-based treatments for cancer – as a concerning example. Unregulated ATMPs can cause severe side effects, and inconsistent quality, leading to health risks, financial losses, and emotional distress. EU regulators are taking action against illegal sales and urge the public to report suspicious cases to national authorities.

MDCG updates IVDs classification guidance under Regulation (EU) 2017/746

On 18 March 2025, the Medical Device Coordination Group (MDCG) updated its guidance on classifying in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746. The guidance applies to IVDs, including diagnostic or information society services provided to EU patients or through distance sales. It helps manufacturers, notified bodies, and health institutions classify IVDs before placing them on the market or putting them into service, while also supporting regulators and other stakeholders in assessing classifications.

EMA releases revised Q&A on pre-authorization procedures for centralized procedure users

On 24 March 2025, the European Medicines Agency issued revised Q&A on pre-authorization procedures for users of the centralized procedure. The guidance addresses common questions, such as how and to whom applicants should submit their dossiers, and clarifies the EMA’s position on issues typically covered in pre-submission meetings. The Q&A, along with productive pre-submission meetings, aim to help applicants submit applications that meet legal and regulatory requirements, ensuring a swift validation process.

AIFA announces deadline for annual self-certification and 7% contribution

On 4 March 2025, the Italian Medicines Agency (AIFA) made an announcement requiring all pharmaceutical companies to submit their annual self-certification detailing the total amount spent on promotional activities in 2024, excluding personnel costs, no later than 30 April 2025. By the same deadline, companies must deposit a 7% contribution of the self-certified expenses into a dedicated fund as required by Art. 48, par. 17-18, of Law 326/2003 and Art. 11, par. 1, of Law 175/2021.

EMA and HMA issue Network Strategy for 2028 to address emerging challenges

On 18 March 2025, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued the updated Network Strategy for 2025-2028. The Strategy addresses emerging challenges, such as public health crises, focusing on six areas: improving access to medicines, leveraging data and AI for efficiency, enhancing regulatory science and innovation, addressing health threats, and ensuring the sustainability of the regulatory network. The update builds on the 2025 strategy, emphasizing the EU's competitiveness in developing and manufacturing medicines, while ensuring accessibility and availability through advanced technologies.

EMA releases revised ESMP Implementation Guide for NCAs

On 7 March 2025, the European Medicines Agency (EMA) released a revised version of the European Shortages Monitoring Platform (ESMP) Implementation Guide for National Competent Authorities (NCAs). The Guide outlines technical details and rules for NCAs to follow when submitting electronic reports to the EMA via the ESMP. It provides clear instructions on technical specifications, data sets, and reporting requirements, including crisis preparedness information as outlined in Regulation (EU) 2022/123. This includes data on stock, supply, patient estimation, medicine usage, and other relevant aspects. The Guide aims to assist NCAs in meeting their reporting obligations to the EMA.

 

WCC/Compliance

Senate approves Italian AI Bill: Criminal implications

On 20 March 2025, the Italian Senate approved the Law on Artificial Intelligence (Italian AI Bill), aligning national regulations with the AI Act. The Italian AI Bill (which still needs final approval from the Chamber of Deputies), also regulates the criminal implications of AI by:

• introducing a new criminal offence to punish the illicit dissemination of AI-generated or altered content that causes undue harm to someone;
• providing for aggravating circumstances for all offences committed via insidious or exacerbated use of AI and, specifically, for financial crimes perpetrated by any use of AI systems;
• enhancing the protection of copyright, also when the intellectual works are created with the aid of AI tools.

The government will have to adopt further regulations for cases of illegal creation and use of AI systems, also clarifying the criteria for attributing criminal liability to individuals and legal entities in relation to offences involving such systems.

 

Data, Privacy and Cybersecurity

Italy establishes Health Data Ecosystem

On 5 March 2025, the Decree 31 December 2024 establishing the Health Data Ecosystem (Ecosistema dati sanitari or EDS) was published in the Official Gazette. The EDS will become fully operational by 2026 and will extract information directly from the Electronic Health Record (Fascicolo Sanitario Elettronico). The EDS is intended to provide advanced services for healthcare professionals, patients, and healthcare institutions, ensuring greater uniformity of care and universal access to healthcare services. The platform will enable the collection and analysis of health data for various purposes, including prevention, diagnosis, treatment, rehabilitation, and international disease control. It will also support research, healthcare planning, and governance activities conducted by the Italian Ministry of Health (MoH), National Agency for Regional Healthcare Services (Agenas), Italian Regions and Autonomous Provinces, in line with their respective responsibilities.

Senate approves Italian AI Bill

On 20 March 2025, the Italian Senate approved the Law on Artificial Intelligence (Italian AI Bill), aligning national regulations with the AI Act. Like the AI Act, the Italian AI Bill (which still needs final approval from the Chamber of Deputies), focuses on the transparent, responsible and rights-compliant development and use of AI systems in different sectors of society, including healthcare and scientific research. In healthcare, the Italian AI Bill acknowledges AI’s potential while establishing regulations to ensure its used ethically and safely. Key provisions include a ban on AI-driven selection for healthcare access, a requirement to inform patients about the use of AI technologies, and performance monitoring to reduce errors. The Italian AI Bill also provides that the responsibility for the final decision with reference to the prevention, diagnosis and treatment activities remains exclusively with the physician, who must always monitor the proper functioning of the AI and check the outputs. Additionally, AI research by nonprofit entities and IRCCSs is classified as being of significant public interest, eliminating the need for explicit patient consent. Further information on this topic is available here.

Italian DPA approves new electronic invoicing system for healthcare professionals

On 21 March 2025, the Italian Data Protection Authority (Italian DPA) published a clarification regarding the new electronic invoicing system for healthcare professionals, which will come into full effect on 1 January 2026. The Italian DPA provided clarifications on the new electronic invoicing system in response to inquiries from healthcare providers regarding the processing of patient-related data. The Italian DPA confirmed that the Decree issued by the Ministry of Economy and Finance (MEF) regarding the use of fiscal data by the Italian Revenue Agency establishes appropriate safeguards for protecting patient health data. The Italian Revenue Agency will only collect the data strictly necessary for tax purposes, explicitly excluding information related to patient health (such as the description of medical services and the patient's tax code).

Italian DPA fines two healthcare professionals for using patient data for election campaigning

On 21 March 2025, the Italian Data Protection Authority (Italian DPA) published two resolutions (Doc. web no. 10107219 and 10107246) reaffirming that personal data collected in the context of healthcare services cannot be used for election campaigning without patients' explicit consent. The Italian DPA fined two healthcare professionals for using patients’ personal data to promote their candidacies in local elections. One physician sent letters to their patients, explicitly referencing their medical conditions. Another healthcare professional emailed 500 patients but failed to use the blind copy function, exposing recipients' email addresses and inadvertently revealing their medical status. The Italian DPA also clarified that even disclosing the need for medical treatment qualifies as processing health data. The two healthcare providers were fined for EUR10,000 each.

 

Antitrust

Italian Competition Authority updates turnover thresholds of Italian merger control regime

On 24 March 2025, the Italian Competition Authority (ICA) released a communication updating the turnover thresholds triggering a filing obligation of concentrations to the ICA. The communication raised the threshold from EUR567 million to EUR582 million. The merger control threshold relates to the total turnover generated in Italy by all the undertakings involved in a concentration. The second threshold concerning the turnover generated individually in Italy by each of at least two of the undertakings involved in a concentration remains unchanged (EUR35 million).

Italian Competition Authority adopts new guidelines on the criteria for quantifying sanctions for antitrust infringements

On 10 March 2025, the Italian Competition Authority adopted new guidelines on the criteria for quantifying sanctions. The main changes compared to the previous version concern the determination of the basic amount of sanctions with reference to infringements committed by associations of undertakings and in the context of public tender procedures. Guidelines also address the impact of aggravating and mitigating circumstances on the amount of the sanction. For further details see here.

Italian Competition Authority adopts new communication on non-imposition and reduction of sanctions

On 10 March 2025, the Italian Competition Authority (ICA) adopted a new communication on the non-imposition and reduction of sanctions. The communication introduces specific brackets to determine the potential reduction in sanctions that can be granted to applying undertakings, depending on the order the ICA receives requests for sanctions reductions. Requests can be submitted in written or oral form. The non-imposition or reduction can be granted only if participation in the cartel ceased, and if the entity genuinely cooperates with the ICA. For further details see here.

Italian Competition Authority adopts new guidelines on Antitrust Compliance Programs

On 10 March 2025, the Italian Competition Authority (ICA) published a new version of its Antitrust Compliance guidelines, providing guidance on the development, implementation and evaluation of Antitrust Compliance Programs. While the list of features that such programs should have are basically in line with those identified in the previous version of the guidelines, the ICA has now adopted a stricter approach about the possibility to apply a mitigating factor (and a reduction of the fine) to undertakings that are liable for antitrust infringements for having adopted an Antitrust Compliance Program. For further details see here.

Call for evidence on the new Strategy for European Life Sciences

On 20 March 2025, the European Commission launched a call for evidence to gather the views of stakeholders (including experts) to provide useful information to design the Strategy for the European Life Sciences. The strategy aims to boost competitiveness and prosperity, accelerate green and digital transitions, create new jobs, and reduce dependencies on external sources. It is part of the political guidelines of President von der Leyen and is included in the Competitiveness Compass. The call for evidence will close on 17 April 2025.

 

Tax

Italian Revenue Agency clarifies eligibility for ‘Superbonus’ tax benefit in healthcare and social service sector

On 10 March 2025, the Italian Revenue Agency published resolution no. 19/E, which clarifies the application of Art. 119, par. 10-bis, of Legislative Decree 34/2020 (converted into Law 77/2020), regarding the eligibility for the ‘Superbonus’ tax benefit for entities operating in the healthcare and social service sector.
Non-Profit Organizations (ONLUS), Voluntary Organizations (OdV), and Social Promotion Associations (APS) providing healthcare and social services can calculate eligible expenses for the ‘Superbonus’ based on property surface area.
The resolution also establishes that the right of superficies (a property right limited to a building constructed on another's land) is considered equivalent to ownership, usufruct, bare ownership or gratuitous loan. This means that organizations holding property through superficies can also access the benefit. This interpretation aligns with the purpose of supporting entities operating in large buildings essential for community healthcare services. Consequently, this resolution explicitly reverses the previous stance excluding superficies from eligibility.