Life Sciences News in Italy: December 2025

Regulatory

European Parliament and Council reach deal on EU pharmaceutical reform

On 11 December 2025, the Council and the European Parliament reached a deal on the “EU pharmaceutical reform,” a new set of rules that will increase patients' access to medicine and make the EU’s pharmaceutical sector fairer and more competitive. The reform introduces several measures, including on:

• Regulatory protection: Companies will benefit from an eight-year data protection period and one year of market protection, which can be extended under certain conditions;
• Antimicrobial resistance: The reform introduces a new transferable exclusivity voucher incentivizing pharmaceutical companies to help combat antimicrobial resistance by developing priority antibiotics;
• Competitive regulatory framework: The reform simplifies the European Medicines Agency’s (EMA) internal functioning, to enable it to treat market authorization requests more rapidly.

The reform also addresses key provisions concerning the availability of medicines and intellectual property exemptions for generic medicines. The provisional agreement now needs to be endorsed by both the Council and the European Parliament, before being formally adopted and entering into force upon publication in the EU’s Official Journal. Read our previous update here.

European Commission proposes revision of MDR and IVDR

On 16 December 2025, the European Commission (EC) published a proposal to revise Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). The proposal introduces several measures with a significant impact on the medical device industry, including:

• Amendments to classification rules, which may result in a lower risk classification for certain products, including medical device software. These changes could also reduce the number of AI-enabled medical devices classified as “high-risk” under Regulation (EU) 2024/1689 (AI Act);
• Clarification of the interaction with the AI Act, specifying that most requirements applicable to high-risk AI systems under the AI Act would not apply to AI-based medical devices, to avoid regulatory overlap and duplicative compliance obligations;
• Extension of CE Certificate validity, by removing the current five-year maximum validity period for CE Certificates of Conformity issued by Notified Bodies.

The proposal will now follow the ordinary legislative procedure and will be examined by the European Parliament and the Council, which may introduce amendments to the text proposed by the EC.

European Commission presents proposal for a Biotech Act

On 16 December 2025, the European Commission (EC) published a proposal for a Biotech Act aimed at strengthening Europe’s biotechnology sector and accelerating the transition of innovation from research to market. The proposal introduces new funding and investment mechanisms, including a health biotech investment pilot developed in cooperation with the EIB Group, and provides targeted support to boost bio-manufacturing. It also seeks to incentivize companies to carry out research and production in the EU and fast-track the development of innovative therapies through the use of AI, data and regulatory sandboxes. The proposal will now be examined by the European Parliament and the Council as part of the legislative process.

MDCG publishes new guidelines

Between 15 and 19 December 2025, the Medical Device Coordination Group (MDCG) published the following three new guidelines:

• Guidance on Breakthrough Devices (BtX)
• Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices
• Timelines of the implementation of “Master UDI-DI” to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles

Although these guidelines aren’t legally binding, they provide useful information on how relevant provisions in Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) should be interpreted and applied.

MoH publishes guidelines on MDR Annex XVI products

On 3 December 2025, the Italian Ministry of Health (MoH) published guidelines addressed to manufacturers of products without an intended medical purpose, as listed in Annex XVI to Regulation (EU) 2017/745 (MDR). The document aims to ensure a consistent interpretation and harmonized application of the relevant regulatory provisions. In particular, it addresses the applicable regulatory framework, the timelines and conditions governing the transitional regime, product classification, market surveillance and advertising requirements.

AIFA updates guidelines on P&R procedure

On 23 December 2025, AIFA updated its guidelines for compiling the dossier supporting the Health Technology Assessment (HTA) of a medicinal product for pricing and reimbursement purposes. The document provides a comprehensive framework for the HTA of medicines to support informed decisions regarding their reimbursement and price borne by the Italian National Health Service (SSN). The guidelines will apply from 1 April 2026.

 

WCC/Compliance

Italian National Anti-Corruption Authority publishes guidelines on internal whistleblowing reporting channels

On 12 December 2025, the Italian National Anti-Corruption Authority published the final version of the Guidelines on internal whistleblowing reporting channels. The Guidelines provide operational guidance on the establishment and management of internal reporting channels for legal entities falling within the scope of Italian Legislative Decree 24/2023 on whistleblowing. They set out the reporting procedures, the roles and responsibilities involved in handling whistleblowing reports, and practical instructions for aligning compliance programs adopted pursuant to Legislative Decree 231/2001 on corporate criminal liability. The Guidelines represent a key reference framework for public and private legal entities, which have to adapt their organizational arrangements, internal procedures and compliance programmes in line with the applicable regulatory framework. 

European Parliament and Council reach agreement on first EU Anti-corruption Directive

On 2 December 2025, the European Parliament and the Council reached a first provisional agreement on the proposal for a Directive on combating corruption presented by the European Commission on 3 May 2023. The Directive aims to harmonize criminal law rules across EU member states and strengthen the EU’s anti-corruption framework. In particular, the agreement:

• Introduces common definitions of specific criminal offences (including corruption, misappropriation and trading in influence);
• Extends criminal liability to legal persons for offences committed for their benefit by individuals holding a leading position in the entity, together with the introduction of effective, proportionate and dissuasive pecuniary sanctions, including fines calculated as a percentage of the entity’s worldwide turnover;
• Introduces specific mitigating circumstances, including the adoption of compliance programmes, the timely disclosures of relevant information to the competent authorities, and the adoption of remedial measures;
• Enhances cooperation with EU bodies, including the European Anti-Fraud Office (OLAF), the European Public Prosecutor’s Office (EPPO), Europol and Eurojust, particularly in relation to cross-border corruption cases.

The provisional agreement marks a significant step towards a more uniform and robust EU anti-corruption framework, with substantial implication for compliance programmes and corporate criminal liability.

 

Data, Privacy and Cybersecurity

Commission renews adequacy decisions to allow personal data transfers to the UK

On 19 December 2025, the European Commission announced the renewal of the two adequacy decisions originally adopted in 2021 concerning the free flow of personal data with the UK. These decisions ensure the continued free and secure transfer of personal data between the EEA and the UK, on the basis that the UK legal framework continues to provide data protection safeguards that are essentially equivalent to those guaranteed under EU law.

Italian DPA fines a company for lack of adequate security measures

On 17 December 2025, the Italian Data Protection Authority (Italian DPA) published a resolution imposing an administrative fine on a company for unlawfully processing customer data in the absence of adequate security measures. The investigation was initiated following a complaint alleging deficiencies in the security mechanisms governing registration for the company’s online customer area, which enabled users to access billing information and consumption history. The Italian DPA found that registration could be completed using only the service holder’s tax code and an arbitrary email address, allowing unauthorized individuals to gain unlawful access to additional personal data, including the customer’s home address and telephone number. In light of these security gaps and other GDPR violations, the Italian DPA imposed an administrative fine of EUR300,000.

 

Antitrust

ICA fines pharma retailer for unfair commercial practices

On 1 December 2025, the Italian Competition Authority (ICA) published its decision concluding an investigation against an online retailer of pharmaceutical and healthcare products, imposing a fine of EUR2 million for deceptive and aggressive unfair commercial practices. These practices included providing misleading information on product delivery, availability and shipping times; failing to deliver or significantly delaying the delivery of products paid for by consumers; unilaterally cancelling orders after payment had been processed; and obstructing consumers from exercising their rights during the after-sales phase. This decision reflects the ICA’s continued scrutiny of e-commerce practices, including in the pharmaceutical sector.

 

Tax

Italy's 2026 Budget Law introduces new fiscal measures

On 30 December 2025, Italy's 2026 Budget Law (Law 199/2025) was approved and published in the Official Gazette. The law introduces several significant measures, including an extraordinary opportunity to release tax-suspended reserves and the reintroduction of enhanced depreciation to support new productive and sustainable investments. In particular:

• Release of tax-suspended reserves: Pursuant to paragraphs 44 and 45, reserves existing as of 31 December 2024 and still outstanding at the end of fiscal year 2025 may be released, in whole or in part, subject to a 10% substitute tax. This tax replaces both corporate income tax (IRES) and regional tax (IRAP) and must be reported in the 2025 income tax return.
• Enhanced depreciation regime: Under paragraphs 427 to 436, the acquisition cost of eligible assets located in Italy is increased solely for depreciation and finance lease purposes. The uplift is set at 180% for investments up to EUR2.5 million, 100% for investments between EUR2.5 million and EUR10 million, and 50% for investments between EUR10 million and EUR20 million. The incentive applies to investments made between 1 January 2026 and 30 September 2028 in assets produced in the EU or EEA. Eligible assets include interconnected Industry 4.0 technologies and renewable energy systems for self-consumption, including energy storage facilities. Access to the benefit requires electronic filings through a platform managed by the GSE.