Life Sciences News in Italy: April 2025

Regulatory

Decree on technical specifications for new Data Matrix identifier on medicines enters into force

On 10 April 2025, the Decree of 6 March 2025 issued by the Italian Ministry of Health (MoH) entered into force. The Decree sets out technical specifications for the new Data Matrix unique identifier required for medicines, in implementation of Legislative Decree 10/2025. The goal is to ensure traceability, authenticity, and safety throughout the entire distribution chain, in compliance with Regulation (EU) 2016/161. The identifier must include five elements: product code, serial number, marketing authorization code, batch number, and expiry date. Manufacturers have to print it on the outer packaging or, if absent, on the primary packaging, along with a human-readable version.

Security Decree tightens rules on hemp industry

On 12 April 2025, Law Decree 48/2025 (Security Decree) entered into force, amending Law 242/2016 on hemp cultivation and its industrial supply chain. The Decree – pending conversion into law – allows hemp cultivation only if a lawful industrial purpose is clearly demonstrated. It bans the import, processing, possession, transfer, distribution, sale, transport, shipment, retail sale, and consumption of hemp flowers – including dried, shredded, or semi-processed forms – as well as extracts, resins, and oils. These activities remain regulated by the Consolidated Law on narcotics (Presidential Decree 309/1990), even when the products derive from lawful cultivation.

Regional Administrative Court upholds classification of oral CBD products as narcotic medicines

On 16 April 2025, the Lazio Regional Administrative Court issued a ruling upholding the Italian Ministry of Health’s decision to classify oral cannabidiol (CBD) products derived from cannabis as narcotic medicines. The court dismissed a legal challenge from several cannabis industry operators, who argued that CBD is not a psychotropic or addictive substance and that the necessary risk assessments were lacking. The Ministry cited the precautionary principle, highlighting uncertainties around the safety of oral CBD use. The court deemed the Ministry’s classification lawful in light of the scientific uncertainty surrounding CBD’s effects.

CJEU rules on health claims for botanicals

On 30 April 2025, the Court of Justice of the European Union (CJEU) issued a judgment in case C-386/23 on health claims relating to botanical substances. The CJEU concluded that Regulation (EC) 1924/2006 on nutrition and health claims must be interpreted as prohibiting companies from making health claims relating to botanical substances unless approved by the European Commission – except where transitional measures apply.

EMA publishes Reflection Paper on the use of Real World Data in non-interventional studies

On 1 April 2025, the European Medicines Agency (EMA) published a Reflection Paper on the use of real-world data (RWD) in non-interventional studies (NIS) to generate real-world evidence (RWE) for regulatory purposes. It outlines relevant methodological principles for the design, conduct, and analysis of NIS using various RWD sources, including clinical records, healthcare data, claims, prescriptions, and patient-reported outcomes. The paper is intended for all stakeholders involved in NIS – such as marketing authorization holders, regulators, payers, academia, RWD holders, and healthcare or patient groups – regardless of whether the studies are conducted inside or outside the EU.

EMA and HMA issue recommendations to tackle radiopharmaceutical shortages

On 14 April 2025, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued recommendations to address supply chain vulnerabilities for radiopharmaceuticals. These medicines, vital for cancer diagnosis and treatment, face increasing demand and limited EU manufacturing, causing periodic shortages. The recommendations urge EU and national authorities and industry to strengthen domestic production, upgrade infrastructure, and streamline cross-border transport. Member States should map supply chains and coordinate logistics, while companies must collaborate with regulators.

AIFA identifies list of medicines that cannot be exported

On 12 April 2025, the Italian Medicines Agency (AIFA) published a Resolution in the Official Gazette with a list of medicines that cannot be exported. The Resolution aims to safeguard national supply and prevent shortages.

 

WCC/Compliance

Confindustria and Assonime push for an overhaul of the Italian corporate criminal liability system

On 2 and 11 April 2025, two key position papers by Assonime and Confindustria were published as part of the ongoing technical roundtable discussions before the Ministry of Justice for the reformation of Legislative Decree 231/2001 on corporate criminal liability. The core proposals include:

• streamlining and rationalizing the list of predicate offenses (reati presupposto);
• introducing simplified compliance models for small and micro enterprises;
• enhancing legal certainty through clearer criteria for evaluating Models of Organisation, Management and Control; and
• rebalancing the current sanctioning and statute of limitations regimes to ensure more proportionality and legal certainty.

Crucially, both Confindustria and Assonime advocate for the introduction of forms of negotiated justice inspired by deferred prosecution agreements, allowing companies to pursue alternative resolution paths in exchange for genuine cooperation, remediation efforts, and improved compliance. 

New enforcement deadlines for the EU's corporate sustainability framework

On 17 April 2025, following the EU Commission's Omnibus Proposal to simplify and streamline EU's corporate sustainability framework, Directive (EU) 2025/794 (Directive) entered into force, postponing the enforcement deadlines previously set for Directive (EU) 2022/2464 (Corporate Sustainability Reporting Directive, CSRD), and Directive (EU) 2024/1760 (Corporate Sustainability Due Diligence Directive, CSDDD). CSRD reporting obligations are now delayed for “second wave” large enterprises from the 2026 reporting year to 2028, and for “third wave” listed SMEs and small non‑complex entities from the 2027 reporting year to 2029. Additionally, the Directive postpones the application of the first phase of the CSDDD by one year, moving the start from mid‑2027 to mid‑2028.

New State-Regions Conference Agreement on H&S training for workers

On 17 April 2025, the Italian State-Regions Conference approved the agreement under Art. 37, par. 2, of Legislative Decree 81/2008 (Agreement), aimed at defining the duration, minimum content and delivery methods of mandatory Health and Safety (H&S) training for workers in Italian companies. According to the Agreement:

• training can be delivered in‑person, via e‑learning, synchronous videoconference or in blended format (subject to platform participation monitoring);
• distinct training paths must be provided for different subjects in the H&S chain;
• final assessments are mandatory, and course records must be retained for ten years.

The Agreement will enter into force upon publication in the Official Gazette, with transitional application of prior courses allowed for up to 12 months.

CNDEC publishes paper on synergies between legality rating and 231 Models

On 28 April 2025, the Italian National Council of Certified Accountants (Consiglio Nazionale dei Dottori Commercialisti ed Esperti Contabili, CNDEC) issued a paper outlining the relevance of the legality rating, namely a certification, managed by the Italian Competition Authority (AGCM), for companies seeking to certify their ethical and regulatory standing in Italy to benefit in access to public funds, tenders, and relations with banks. In part III, particularly, the paper advocates embedding the rating criteria into a holistic, risk‑based compliance framework, especially in connection with the Model of Organisation, Management and Control adopted pursuant to Legislative Decree 231/2001, considering that this “integrated compliance” approach avoids duplication and reinforces internal controls (anti‑corruption, whistleblowing channels, information flows monitoring).

 

Data, Privacy and Cybersecurity

ACN publishes three resolutions on the implementation of NIS2 Decree

On 10 April 2025, the Italian National Cybersecurity Agency (ACN) published three key resolutions regarding the implementation of Legislative Decree 138/2024 (NIS2 Decree), which transposes Directive (EU) 2022/2555 (NIS2). These resolutions signal the commencement of the second phase of NIS2 enforcement in Italy. Resolution no. 136117 reiterates key provisions regarding entity registration, the annual updating of information, and the designation of representatives in the EU. It also introduces new organizational roles relevant to the NIS2 framework. Resolution no. 136118 sets out the procedures for notifying ACN about participation in voluntary cybersecurity information-sharing agreements, in accordance with Art. 17 of the NIS2 Decree. Resolution no. 164179 establishes the minimum technical requirements for compliance with cybersecurity and significant incident notification obligations under Art. 23, 24, 25, 29, and 32 of the NIS2 Decree. Further information on this topic is available here.

Italian DPA announces ‘Privacy in Health’ initiative

On 15 April 2025, the Italian Data Protection Authority (Italian DPA) announced the launch of the initiative ‘Privacy in Health’ (La Privacy in Salute), which aims to foster dialogue, provide in-depth analysis, and offer practical guidance on key issues related to personal data processing in the healthcare sector. This initiative is dedicated mainly, but not exclusively, to data protection officers in regions and autonomous provinces, as well as in public and private healthcare facilities. The program consists of a series of online meetings, led by managers and officials from the Italian DPA, taking place in April, June, September, and November 2025. The events are open to the public, subject to registration in accordance with the procedures indicated on the Italian DPA's website. 

EDPB publishes report on Large Language Models

On 10 April 2025, the European Data Protection Board (EDPB) published the AI Privacy Risks & Mitigations – Large Language Models (LLMs) report, drafted in the context of the Support Pool of Experts program. The report offers practical guidance and tools for both developers and users of LLM-based systems, aiming to address and manage the privacy-related risks inherent to these technologies. Central to the report is a risk management methodology designed to support the systematic identification, assessment, and mitigation of privacy and data protection risks. This framework promotes the responsible design, development, and deployment of LLM systems in compliance with data protection principles. The report also includes real-world use case examples to illustrate the practical application of the methodology in various contexts.

 

Antitrust

Advocate General delivers opinion in a pay-for-delay case before the CJEU

On 27 March 2025, AG Rantos delivered an opinion proposing that the Court of Justice of the European Union (CJEU) should dismiss the appeal against a decision of the European Commission finding that a settlement agreement concerning a patent dispute amounted to an anticompetitive pay-for-delay agreement. AG Rantos recalled the relevant EU case law on the matter and provided useful clarifications on how the lawfulness of such agreements, especially regarding their object and effects, should be assessed. For further details see here.

 

Tax

Italian Tax Authority rules on reduced VAT rate for single-dose ophthalmic drops

On 8 April 2025, the Italian Tax Authority published ruling no. 92/2025, clarifying that single-dose ophthalmic drops – classified under CN code 3004 based on a technical opinion issued by the Italian Customs Authority – qualify for the reduced 10% VAT rate under point 114, Table A, Part III of Presidential Decree 633/1972. The ruling reiterates that, as provided by Art. 1, par. 3, of Law 145/2018 (Italian Budget Law 2019), not all medical devices can benefit from the preferential rate, but only those classified under CN code 3004, in line with prior guidance issued by the Italian Tax Authority.

Farmindustria expresses concerns over US tariffs on European medicines

In an article published by Il Sole 24 Ore, Farmindustria urged the EU to negotiate with the US from a position of strength to exclude pharmaceuticals from upcoming tariffs. Farmindustria highlighted the strategic role of the industry, which exports EUR11 billion in medicinal products to the US, stressing that the US supply cannot be easily redirected. Farmindustria also warned of growing competitive pressure from China, which is investing heavily in biotech and attracting global companies. To remain competitive, it called for faster regulatory processes, stronger IP protection, and a pro-innovation ecosystem in the EU. Italy, with strong R&D and manufacturing capabilities, invested over EUR4 billion in 2024 alone and plays a key role in the sector. The industry’s message to the EU is clear: “Let us run.” Only by accelerating innovation can the EU reverse its decline, reduce reliance on China and India for drug components, and maintain global leadership in Life Sciences and patient care.