Life Sciences News in Italy: March 2026

Regulatory

EU Pharma Package: Final texts officially published

On 6 March 2026, the Committee of Permanent Representatives of the EU member states (Coreper) endorsed the compromise text of the new Directive and the new Regulation forming the EU pharma package, following the political agreement reached during the trilogue negotiations in December 2025. The text was subsequently approved by the European Parliament’s SANT Committee on 18 March 2026. A final plenary vote has not yet been scheduled, but is expected to take place in the autumn.

EC publishes interpretative documents on the PPWR

On 30 March 2026, the European Commission published an FAQ document and guidance clarifying the application of Regulation (EU) 2025/40 on packaging and packaging waste (PPWR). The documents provide practical direction on a number of key aspects of the new regime, including scope, definitions, producer and manufacturer responsibilities, recyclability, reuse, labelling, PFAS and other substances of concern, and waste management obligations. While the FAQ offer operational answers for businesses, authorities and citizens, the annexed guidance is intended to promote a uniform interpretation and consistent implementation of the PPWR across member states.

EU-Switzerland agreement package implications for medical devices

On 2 March 2026, the European Commission announced a broad package of agreements with Switzerland aimed at deepening and modernising the bilateral relationship. For the medical devices sector, the most relevant element is the update of the agreement on conformity assessment, which forms part of the wider Mutual Recognition Agreement framework. According to MedTech Europe, this would allow medical devices certified in the EU or Switzerland to be accepted in both markets without duplicative regulatory procedures.

AIFA publishes dossier on AI and health

On 30 March 2026, the Italian Medicines Agency (AIFA) published a press release highlighting the growing role of AI in healthcare and pharmaceutical regulation. The piece explains how AI is reshaping drug research, clinical development, and medical practice, while emphasising the central role of regulatory authorities such as AIFA, EMA, and FDA in ensuring that innovation is deployed in an ethical and data-driven manner.

EMA publishes draft guidance on clinical trials during public health emergencies

On 5 March 2026, the European Medicines Agency (EMA) published draft guidance on the conduct of clinical trials during public health emergencies in the EU. The document sets out a harmonised approach for initiating, adapting and continuing clinical trials efficiently and safely during emergencies, in line with the current EU legislative framework and post-COVID-19 ICH guidance. The draft guidance also proposes regulatory mechanisms to accelerate the authorisation of new trials and modifications to ongoing studies, while stressing that participant safety, rights and scientific robustness must remain central. The consultation is open until 30 April 2026.

MedTech Europe comments on the Digital Omnibus for AI-enabled medical technologies

On 24 March 2026, MedTech Europe published its response to the public consultation on the EU Digital Omnibus, focusing on the impact of the proposed reforms on AI-enabled medical technologies, diagnostics and digital health. For the medical devices sector, the paper calls for better alignment between the AI Act and the MDR/IVDR, including on timelines, notified body designation, definitions such as “substantial modification,” clinical investigations and performance studies, and risk-management requirements.

European Commission publishes 18th notified body survey on medical devices and IVDs

On 25 March 2026, the European Commission published the results of the 18th notified body survey under the study supporting the monitoring of the availability of medical devices on the EU market, with data status as of 31 October 2025. Based on replies from all 52 notified bodies designated under the MDR and/or IVDR, the presentation provides an updated overview of certification applications, written agreements and certification activity for medical devices and in vitro diagnostic medical devices.

 

WCC/Compliance

Assonime publishes paper on global sanctions and corporate risks

On 17 March 2026, the Association for Italian Public Limited Companies (Assonime) published a paper on “Global Sanctions and Corporate Risk: Building an Effective Control System.” The Paper provides a comprehensive analysis of companies’ growing exposure to EU sanctions and the related regulatory developments at both European and national level. Following the entry into force of Legislative Decree of 30 December 2025 implementing Directive (EU) 2024/1226, the Regulator introduced new offences for breaches of EU restrictive measures which entail corporate criminal liability under Legislative Decree 231/2001. Assonime emphasises the strategic role of corporate policies and procedures in ensuring the implementation of effective internal control systems aimed at preventing offences related to breaches of EU restrictive measures and recommends a number of key control measures.

Climate change enters workplace safety: ISO/PAS 45007 published

On 4 March 2026, ISO/PAS 45007 was made publicly available, following its release in January 2026. The specification provides a technical framework for integrating climate change-related risks into Occupational Health and Safety Management Systems, in alignment with ISO 45001. The new guidance reflects a significant shift, recognising climate change as a direct occupational risk to be addressed within existing safety frameworks. It supports organisations in identifying and mitigating such risks through the Plan-Do-Check-Act cycle, ensuring that worker protection evolves in line with changing environmental conditions.

 

Data, Privacy and Cybersecurity

Italy enters Phase 3 of the Electronic Health Record (FSE)

On 31 March 2026, Italy’s Electronic Health Record (Fascicolo Sanitario Elettronico 2.0, or FSE) entered Phase 3, marking the formal transition to the full operational status of the national electronic health record system. Pursuant to the Ministry of Health Decree of 7 September 2023, as subsequently amended, all public and private healthcare providers are now subject to a general obligation to upload and update clinical data on the FSE by that date. Phase 3 entails the full implementation of all mandatory FSE contents under Article 3 of the Decree, with the aim of ensuring that the electronic health record is complete and consistently available across the national territory. In addition, this final phase requires the full activation of all telematic services provided under FSE 2.0, which must be made accessible through a single regional user interface, including the regional FSE portal and related online services.

EDPB and EDPS adopt Joint Opinion on the European Biotech Act Proposal

On 10 March 2026, the European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS) adopted the Joint Opinion 3/2026 on the Proposal for a Regulation on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health (European Biotech Act) (Joint Opinion). The Joint Opinion supports the European Commission’s objective of strengthening Europe’s biotechnology and biomanufacturing sectors, particularly in the healthcare field, while streamlining the regulatory framework applicable to clinical trials. The Joint Opinion includes a series of recommendations to ensure compliance of the new legislative framework with GDPR principles, especially in the area of data retention, secondary use, and data protection roles.

EDPB and EDPS adopt Joint Opinion on the Cybersecurity Package

On 18 March 2026, the European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS) adopted the Joint Opinion 4/2026 on the Proposal for a Cybersecurity Act 2  and the Proposal on amendments to the NIS 2 Directive (Joint Opinion). The Joint Opinion supports the European Commission’s objective of strengthening Europe’s cybersecurity framework while simplifying compliance obligations for organisations. The EDPB and the EDPS welcome the proposed reinforcement of the role of the EU Agency for Cybersecurity (ENISA), the measures aimed at facilitating the uptake of cybersecurity certification and addressing ICT supply chain risks as well as the creation of a single-entry point for personal data breach notifications.

European Commission publishes FAQ on the European Health Data Space

On 26 March 2026, the European Commission published Frequently Asked Questions on the European Health Data Space, providing further clarification on the implementation timeline, scope and practical application of the European Health Data Space (EHDS) Regulation (EU) 2025/327. The updated guidance supports the transition phase following the entry into force of the EHDS framework and offers operational indications for patients, healthcare professionals, manufacturers and researchers.

 

Antitrust

Italian Competition Authority updates merger control turnover thresholds

As of 16 March 2026, the turnover thresholds that trigger the obligation to notify a merger to the ICA have increased to EUR595 million (from EUR582 million) for the combined turnover in Italy of all parties to a merger and to EUR36 million (from EUR35 million) for individual turnover in Italy of at least two of the parties to a merger.

Italian Competition Authority sets its annual contribution for 2026

On 3 March 2026, the Italian Competition Authority (ICA) set the annual contribution for 2026 at EUR0.055 (reduced from EUR0.08) per EUR1,000 of the turnover reported in the latest approved financial statements of companies with total annual revenues exceeding EUR50 million. Each company’s contribution is capped at EUR275,000 and must be paid by 31 July 2026.

European Commission invites comments on draft new State Aid General Block Exemption Regulation

The European Commission has launched a public consultation on the draft of a simpler State Aid General Block Exemption Regulation. The main changes include new conditions for small amounts of aid for specific projects or activities, such as for R&D, regardless of the size of the company; updated rules to stimulate R&D and innovation; and stronger incentives to upskill and reskill workers to boost competitiveness. The Commission invites member states and all interested parties to comment on the draft by 23 April 2026.

 

Tax

Italian Revenue Agency clarifies VAT treatment of dietary supplements

On 3 March 2026, the Italian Revenue Agency published Tax Ruling No. 64/2026, clarifying the VAT treatment applicable to dietary supplements on the basis of their customs classification by the Italian Customs and Monopolies Agency (ADM). The ruling examines products classified under CN code 2106 (other food preparations) and CN code 1806 (chocolate and cocoa-based preparations). The Agency confirmed that products falling under CN code 2106 are subject to the reduced 10% VAT rate pursuant to Table A, Part III, No. 80 of Presidential Decree No. 633/1972. It also clarified that products classified under CN code 1806, and specifically subheading 1806 90 70, may benefit from the 10% reduced rate under Table A, Part III, No. 64, provided they’re marketed in non-luxury packaging. Overall, the ruling confirms that the applicable VAT rate depends on the correct customs classification of the product.

Italian Revenue Agency clarifies VAT deductibility of transaction costs in MLBO structures

On 2 March 2026, the Italian Revenue Agency published Tax Ruling No. 58/2026, aligning its administrative practice with Italian Supreme Court case law, confirming the VAT deductibility of transaction costs incurred by SPVs in MLBO structures. The costs – such as legal, tax and accounting advisory fees, as well as due diligence expenses – may be qualified as preparatory investment costs functionally linked to the target’s business activity and subsequent merger, thus meeting, in principle, the “inherence” test under Articles 4 and 19 of the VAT Decree.

This shift follows the Supreme Court’s 2024 decisions, which rejected the previous classification of SPVs as “static" holding companies. However, the ruling adopts a restrictive approach on VAT recovery: the filing of an “integrative VAT return” isn’t allowed, as the failure to deduct is considered a conscious choice. Instead, VAT recovery is permitted via refund claims, subject to strict evidentiary conditions.