Life Sciences News in Italy: February 2025

Regulatory

Legislative Decree on safety features for medicinal product packaging comes into effect

On 8 February 2025, Legislative Decree 10/2025 implementing Regulation (EU) 2016/161 came into effect, introducing new safety measures for medicine packaging. Pharmaceutical companies now have to include a unique identifier and a tamper-evident system on each package to prevent counterfeiting. The 2D datamatrix barcode replaces the traditional pharmaceutical label, while a security element ensures packaging integrity. Authorities will impose fines for non-compliance, such as failing to apply or verify identifiers. To address industry concerns, the decree provides for a transitional period (February 2025 to February 2027), allowing companies to temporarily use the pharmaceutical label and suspending penalties for implementation delays. Further information on this topic is available in our August, November, and January newsletters.

European Commission launches first request submission period for JSCs

On 3 February 2025, the European Commission launched the first request submission period for joint scientific consultations (JSCs) under Regulation (EU) 2021/2282 on Health Technology Assessment (HTA). JSCs allow health technology developers (HTDs) to discuss their development plans with regulatory authorities and receive guidance on the data, analyses, and evidence needed for joint clinical assessments of medicinal products and medical devices. The submission period closed on 3 March 2025, with consultation slots for medicinal products available in June, July, and September.

CJEU rules on advertising of prescription medicines and consumer incentives

On 27 February 2025, the Court of Justice of the European Union (CJEU) issued a judgment (C-517/23) clarifying the scope of Directive 2001/83/EC (Medicines Directive). The CJEU ruled that:

• the Medicines Directive does not apply to advertising of prescription-only medicines through discounts or fixed payments;
• notwithstanding the above, national laws may prohibit the advertising of prescription medicines through vouchers for the purchase of other products, including OTCs.

New pilot program aims to streamline EU assessment of medical devices clinical investigations

On 6 February 2025, the European Commission launched a pilot program for coordinated assessment of clinical investigations and performance studies under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). The program allows sponsors to submit a single application for assessments across multiple member states, promoting harmonized procedures and reducing administrative burdens. Sponsors benefit from unified communication, faster responses, consistent reviews, and simplified document management. To participate, the study must require authorization and include at least two member states. Eligible devices are Class III investigational devices, invasive Class IIa and IIb devices, and performance studies under Article 58 of the IVDR.

EMA publishes guidance on expert panel advice for high-risk medical devices

On 10 February 2025, the European Medicines Agency (EMA) published guidance for manufacturers on seeking advice from expert panels regarding clinical development strategies and investigations for high-risk medical devices. Manufacturers of class III and certain class IIb devices can submit requests through a portal, focusing on clinical aspects and investigations not yet started (pre-market or post-market). Developed from a 2023 pilot program, this procedure aims to promote innovation and improve patient access to safer, more effective devices.

Critical Medicines Alliance outlines EU strategy to prevent medicine shortages

On 28 February 2025, the Critical Medicines Alliance issued a report highlighting supply chain challenges for critical medicines, including overreliance on limited regions for providing active pharmaceutical ingredients, a declining EU manufacturing base, and lack of investment. To address these issues, it recommends investment in EU strategic projects, financial support through EU funding programmes and national aid, a harmonized stockpiling framework, and improved public procurement practices. The Alliance also calls for stronger international partnerships to enhance EU supply chain resilience.

MDCG updates Q&A on notified bodies requirements under MDR and IVDR

On 7 February 2025, the Medical Device Coordination Group (MDCG) issued updated Q&A on the requirements for notified bodies under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). The update clarifies organizational and general requirements, such as conflict of interest rules for notified bodies personnel, and process requirements, including recertification procedures.

 

WCC/Compliance

International operation 'Shield V' against pharma-crimes

On 6 February 2025, the Health Protection Police (NAS) published a note on the conclusion of a cross-border investigative operation, concerning “pharma-crimes”, ie counterfeiting, fraud, theft, and trafficking with regards to illicit substances and drugs. The investigation, coordinated by Europol, involved almost 30 jurisdictions, both from inside and outside the EU. The operation, named “Shield V”, follows a series of similar initiatives in recent years. In Italy, the operation brought complaints against 138 individuals and seizures of medicines worth EUR2.6 million. Particular attention was given to the online market (with the shutdown of 286 websites), and to trafficking of performance-enhancing drugs.

Driving change in Corporate Sustainability: European Commission's Omnibus Proposal on CSRD and CSDDD 

On 26 February 2025, the European Commission (EC) published the Omnibus Proposal aimed at simplifying and streamlining EU's corporate sustainability framework. The Proposal targets two critical EU Directives: the Corporate Sustainability Reporting Directive (Dir. 2022/2464/EU; CSRD) and the Corporate Sustainability Due Diligence Directive (Dir. 2024/1760/EU; CSDDD). Under the proposed rules, CSRD reporting requirements would only apply to companies with more than 1,000 employees with either a turnover of EUR50 million or a balance sheet above EUR25 million; additionally, the EC would no longer be empowered to adopt sector-specific reporting standards. On the other hand, the proposed changes to the CSDDD narrow due diligence obligations to direct suppliers only, with compliance reviews required every five years. Both the Directives would, in part, be postponed in the implementation and enforcement periods. As the Omnibus Proposal now enters the EU legislative process, the final versions of the legislative acts may undergo substantial modifications before being formally adopted. 

Italian Ministry of Justice issues criteria to be applied in relation to business associations' codes of conduct

On 10 February 2025, the Italian Ministry of Justice released a guidance paper setting out the criteria that associations representing business entities have to apply when drafting their codes of conduct. Particular attention has been placed on the effectiveness and sector-specificity of the codes of conduct, that, as provided for by Art. 6, par. 3, of Legislative Decree 231/2001, associated entities can take into account in adopting their 231 Model. This would also prevent approaches of “cosmetic compliance” from the associated entities.

US President suspends enforcement of the Foreign Corrupt Practices Act

On 10 February 2025, President Donald Trump's administration issued an Executive Order decreeing a six-month suspension of the enforcement of the Foreign Corrupt Practices Act (FCPA), one of the United States’ main extraterritorial anti-bribery and corruption regulations. During this suspension period, the US Attorney General is prevented from initiating any new investigation or enforcement action pursuant to the FCPA, unless they determine that an individual exception should be made, and is required to review all pending cases “to restore proper bounds on FCPA enforcement and preserve Presidential foreign policy prerogatives.” For more information, see our client alert

 

IP

European Commission withdraws proposal for Regulation on Standard Essential Patents 

On 11 February 2025, the European Commission (EC) published the yearly Commission Work Programme. One of the most critical aspects is the withdrawal of the proposal for Regulation on Standard Essential Patents (SEPs) due to “no foreseeable agreement.”

Originally developed in the telecommunications sector, SEPs have gradually spread to other fields, including Life Sciences, and are increasingly technologically advanced. Examples include devices for remotely measuring and monitoring physiological parameters or digital therapeutics. The withdrawal of the proposal was welcomed by some major players who had been sceptical, particularly regarding the jurisdiction that would have been granted to the European Union Intellectual Property Office (EUIPO), which does not primarily focus on patent matters. Many stakeholders still consider a harmonized regulation on Standard Essential Patents to be urgent. A final legislative solution could take years and is unlikely to be reached before the next EC takes office in five years.

 

Data, Privacy & Cybersecurity

NIS2 Directive: ACN extends the deadline for registration 

On 28 February 2025, the deadline for companies falling within the scope of the NIS2 Directive to register on the National Cybersecurity Agency (ACN) portal officially expired. However, ACN has granted an extension for registering on the portal until 10 March 2025 for companies that initiated the registration process on the portal before the original 28 February deadline. On 10 February, the Italian Government published the Decree of the President of the Council of Ministers No. 221 of 9 December 2024 in the Official Gazette, which sets out the criteria for the application of the safeguard clause provided for under Legislative Decree 138/2024. Notably, the NIS2 Directive explicitly applies to manufacturers of medical devices, pharmaceutical companies, organizations engaged in clinical research, and other key stakeholders in the life sciences sector.

AI Act provisions on prohibited AI systems enters into force

On 2 February 2025, Article 5 of Regulation (EU) 2024/1689 (AI Act), which outlines the categories of prohibited AI systems, became fully applicable. The provision establishes a strict framework prohibiting the commercialization, use, or deployment of AI systems deemed fundamentally incompatible with the core values and legal principles of the EU. Infringements of these prohibitions carry significant financial penalties, with the most severe violations – such as the deployment of explicitly banned AI systems – subject to fines of up to EUR35 million or 7% of company’s global annual turnover, whichever is higher.

Italian DPA approves draft Decree on the National Telemedicine Platform

On 28 February 2025, the Italian Data Protection Authority published its opinion on the draft Decree of the Ministry of Health governing the processing of personal data within the National Telemedicine Platform (Piattaforma nazionale di telemedicina) provided for by the Piano Nazionale di Ripresa e Resilienza (PNRR). The Italian DPA formally approved the draft Decree acknowledging that it had incorporated the extensive revisions previously requested. Now the draft Decree specifies the type of data processed and the operations that can be carried out, the reasons of significant public interest and the specific and appropriate measures to protect the rights of data subjects. Special emphasis has been placed on strengthening technical and organizational security measures to ensure a level of protection proportionate to the risks involved.

 

Antitrust

Italian Supreme Administrative Court rules on unfair commercial practices involving companies accredited by National Health Service

On 28 January 2025, the Italian Supreme Administrative Court (Consiglio di Stato) ruled on an appeal brought by a company fined for an unfair commercial practice by the Italian Competition Authority. The court confirmed that the rules on consumer protection apply to the (commercial) relationship between a patient and a company active in the supply of therapeutic aids that is accredited with the Italian National Health Service. For further details see here.

 

Tax

Italian Revenue Agency rules on the 15% substitute tax on compensation for additional services rendered by healthcare personnel

On 3 February 2025, the Italian Revenue Agency published ruling no. 2, according to which the relief introduced by Art. 7 of Legislative Decree 73/2024 cannot be applied to the compensation paid to private healthcare personnel if the national collective agreements mentioned by the provisions do not apply to them. The relief relates to the substitute tax of 15% on the compensation paid for additional services rendered by healthcare personnel.

Italian Revenue Agency rules on tax treatment of Group Medical Practice Association

On 7 February 2025, the Italian Revenue Agency published ruling no. 23. It clarifies the tax treatment of Group Medical Practice Association:

• the income deriving from common costs recharged by the Association to doctors is subject to IRES and IRAP;
• the Association would benefit from VAT exemption provided that specific conditions are satisfied;
• the entities, including associations, whose purpose is cooperating in VAT-exempt activities carried out by their members, would also benefit from VAT exemption.