Life Sciences News in Italy: January 2025

Spotlight: Launch of the Master's Program in Pharmaceutical and Health Law

We're pleased to announce we've launched the Master's Program in Pharmaceutical and Health Law, organized in collaboration with Sapienza University of Rome. Featuring participation from lawyers, professors and in-house experts, the program explores the key legal and regulatory aspects of the pharmaceutical and healthcare sectors, offering a unique opportunity to stay up-to-date with the latest legislative and regulatory developments.

Discover the full program and enrol now! Click here to learn more.

 

Regulatory

HTA Regulation comes into effect

On 12 January 2025, Regulation (EU) 2021/2282 on Health Technology Assessment (HTA) became applicable, introducing an EU framework to improve access to innovative health technologies. It promotes collaboration among member states and simplifies processes for health technology developers. Companies have to submit a unified EU-level file for Joint Clinical Assessments (JCA), avoiding duplication and enhancing HTA quality. JCAs must be completed within 30 days of medicine authorisation. Patients, clinicians, and other stakeholders must be systematically consulted. Initially, the provisions cover new cancer medicines and advanced therapy medicinal products, expanding to high-risk medical devices in 2026, orphan medicines in 2028, and all new medicinal products by 2030.

CTR becomes fully implemented following the conclusion of the transition period

On 31 January 2025, Regulation (EU) 536/2014 (CTR) was fully implemented, concluding the three-year transition from Directive (EC) 2001/20/EC (CTD). Over 5,000 clinical trials transitioned via the Clinical Trials Information System (CTIS). Sponsors now have to submit all new applications via CTIS. The CTIS also offers a public database for healthcare professionals, patients, and the public, ensuring transparency. In 2025, authorities will enhance CTIS, reinforcing the EU's role in clinical research with harmonized processes.

Italian Council of Ministers approves Legislative Decree on safety features for medicinal product packaging

On 28 January 2025, the Italian Council of Ministers definitively approved the Legislative Decree aligning national legislation with Delegated Regulation (EU) 2016/161, which supplements Directive 2001/83/EC by establishing detailed rules on the safety features appearing on the packaging of medicinal products. The Legislative Decree incorporates the opinions expressed by the State-Regions Conference and the relevant Parliamentary Committees. The Legislative Decree is awaiting publication in the Official Gazette, expected in February. Further information on this topic is available in our August and November newsletters.

AIFA announces revocation of clinical trial authorizations for non-compliance with the CTR

On 24 January 2025, the Italian Medicines Agency (AIFA) announced that clinical trial authorizations under Directive 2001/20/EC would be revoked as of 31 January 2025 for sponsors that failed to submit a transition request to Regulation (EU) 536/2014 (CTR) by 30 January 2025. Trials with pending transition requests will be suspended until they get approval via the Clinical Trials Information System (CTIS). Following revocation or suspension, all trial activities must cease immediately, including patient visits and interventions. Sponsors have to notify all involved parties and ensure participant safety. Non-compliance may result in civil and criminal liability for sponsors and for those conducting the trial.

European Commission adopts rules for joint scientific consultations on medical devices under HTA Regulation

On 24 January 2025, the European Commission adopted the Implementing Regulation (EU) 2025/117 establishing rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices, under Regulation (EU) 2021/2282 (HTA Regulation). The Implementing Regulation outlines procedures for these consultations, including requesting submissions from health technology developers, consulting stakeholders, and cooperating with the European Medicines Agency (EMA) when developers request a joint scientific consultation in parallel with an expert panel consultation. These consultations allow developers to engage with HTA bodies, receive guidance on clinical evidence requirements, and prepare for joint clinical assessments. This is the fifth implementing act adopted under the HTA Regulation.

EMA updates policies on managing competing interests for experts and board members

On 14 January 2025, the European Medicines Agency (EMA) published updated policies on managing competing interests for scientific committee members and experts (Policy 0044) and Management Board members (Policy 0058). Adopted in December 2024, these policies will take effect in May 2025. The EMA revised Policy 0044 to align with recent court rulings and enhance impartiality in its assessments. During public consultation in late 2024, stakeholders, including academia and the pharmaceutical industry, supported clear conflict management rules. The update maintains a balanced approach, considering the nature of declared interests and the expert's role in decision-making or advisory activities. Policy 0058 was updated to align with Policy 0044.

AIFA identifies list of medicines that cannot be exported

On 16 January 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.

MDCG updates Q&A on vigilance terms under MDR and IVDR

On 7 January 2025, the Medical Device Coordination Group (MDCG) updated Q&A on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). The updates, aimed at competent authorities, economic operators, and other relevant parties, include minor amendments, such as adjustments to align with Regulation (EU) 2024/1860.

Pharmaceutical industry advocates for ePI transition

On 8 January 2025, pharmaceutical industry associations (AESGP, EFPIA, and Medicines for Europe) issued position papers advocating for electronic Product Information (ePI). The proposal outlines a phased transition to ePI, aiming for full implementation within four years after the entry into force of the revised pharma legislation. This will replace paper leaflets, offering up-to-date, accessible information via digital platforms. ePI enhances patient safety, health literacy, and regulatory efficiency. It will streamline supply chains, improve access in smaller markets, and reduce administrative burdens for both industry and regulators.

 

Data, Privacy and Cybersecurity

Council of the EU formally approves the EHDS

On 21 January 2025, the Council of the EU published a press release announcing the formal approval of the European Health Data Space (EHDS) Regulation, following the approval of the European Parliament in April (further information on this topic is available in our April Newsletter). The EHDS is one of the pillars of the European Data Strategy and aims to facilitate the exchange and access to health data in the EU. The EHDS is designed to empower individuals by giving them greater control over their health data while also enabling companies and organizations to leverage health data for research and innovation (secondary use). The Regulation will now be formally signed by the Council and the European Parliament and will enter into force 20 days after the publication in the EU's Official Journal.

EDPB issues guidelines on pseudonymization

On 16 January 2025, the European Data Protection Board (EDPB) published its Guidelines 01/2025 on pseudonymization. The Guidelines provide companies with a structured methodology for how to securely pseudonymize personal data whenever required to minimize the processing of personal data. The Guidelines also provide practical examples, including in the healthcare sector, demonstrating how to apply the recommended pseudonymization techniques in real-world scenarios. The Guidelines are currently under public consultation.

EDPB publishes report on enforcement of data subjects' rights in the context of AI-complex algorithms

On 23 January 2025, the European Data Protection Board (EBPB), released a report written by a pool of experts on enforcing data subjects' rights in the context of AI-complex algorithms. The report explores the methodologies for ensuring compliance with data protection rights, particularly focusing on the right to rectification and erasure when applied to AI models. The methodologies include technologies to delete and unlearn data through retraining the model from scratch, exact unlearning methods and approximate unlearning techniques. The report highlights the importance of adopting privacy by design techniques when developing AI systems, to ensure the proper enforcement of data subjects' rights.

 

Antitrust

Amendments to rules on Italian Competition Authority investigations enter into force

On 23 January 2025, the Decree of the President of the Republic 214/2024 entered into force, modifying the current rules on investigation proceedings by the Italian Competition Authority (ICA). The decree introduces some significant amendments. These amendments include: (i) the possibility for ICA to convene third parties to a hearing at any time during the investigation; (ii) the exclusion of the right of access to documents concerning relations between ICA and EU institutions and between ICA and other national competition authorities; (iii) a presumption of non-confidentiality for the information included in the documents seized by or provided to the ICA on which the right of access can be exercised. Further information on this topic is available here.

CJEU releases new judgement on the right to compensation for antitrust damages

On 28 January 2025, in a preliminary ruling, the Court of Justice of the European Union (CJEU) held that national legislations cannot prevent people who may have suffered cartel damages from assigning their rights to compensation to a third-party provider of legal services that can assert them collectively in a stand-alone action for damages. That is if no other possibilities exist, under national law, to group together the individual claims that would ensure the effectiveness of the exercise of the right to compensation. And if bringing individual actions for damages is impossible or excessively difficult. Further details are available here.

 

Tax

Italian Budget Law 2025 extends Corporate Income Tax extra deduction and introduces Corporate Income Tax rate reduction

On 1 January 2025, Law 207/2024 (Italian Budget Law 2025) came into force. The Italian Budget Law 2025 introduced, among others, these tax reliefs:

• Corporate Income Tax extra deduction – For fiscal years 2025, 2026 and 2027 the annual deductible cost of newly hired personnel with a permanent contract has been increased by 20% (up to 30% for certain workers) if the entity meets specific conditions. The conditions include an increase in the number of employees with a permanent contract and an increase in the overall number of employees at the end of the fiscal year.
• Corporate Income Tax rate reduction – For fiscal year 2025, the IRES rate has been reduced to 20% (instead of the ordinary tax rate of 24%) for entities that:
• allocate at least 80% of the profits for fiscal year 2024 to a specific equity reserve;
• don't distribute it for at least two fiscal years; and
• invest a share of the allocated profits in new high-tech tangible and intangible assets to be used in productive facilities located in Italy.

The Italian Budget Law introduced additional requirements related to the number of employees hired and the investment's timing and minimum lock-up period.