Life Sciences New in Italy: October 2025

Regulatory

European Commission adopts rules for joint clinical assessments of medical devices and in vitro diagnostic medical devices

On 17 October 2025, the European Commission (EC) adopted Implementing Regulation (EU) 2025/2086 establishing procedural rules for joint clinical assessments of medical devices and in vitro diagnostic medical devices, under Regulation (EU) 2021/2282 on Health Technology Assessment (HTA Regulation). The HTA Regulation foresees the adoption of implementing acts, detailing the procedural rules for the different elements in the regulation. This is the sixth and last implementing regulation to ensure the proper application of the HTA Regulation. The HTA Regulation became applicable on 12 January 2025. For further details on the HTA Regulation see here.

MoH defines priorities for HTA assessment in 2025

On 17 October 2025, the Italian Ministry of Health (MoH), in collaboration with Agenas, identified the following priorities for Health Technology Assessment (HTA) evaluations for 2025:

• Continuous Glucose Monitoring (CGM) in patients with diabetes
• Treatments for benign prostatic hyperplasia
• Optune Gio®, a system for delivering Tumor Treating Fields (TTF) therapy in treating glioblastoma
• GammaPod™, a technology for stereotactic breast radiotherapy

This should be viewed in the context of the new rules on HTA introduced under Regulation (EU) 2021/2282 on Health Technology Assessment (HTA Regulation). The HTA Regulation has applied since 12 January 2025. For further details see here.

European Commission updates guidelines on the use of Auxiliary Medicinal Products in clinical trials

On 30 October 2025, the European Commission (EC) published updated recommendations on the use of Auxiliary Medicinal Products (AxMP) in clinical trials.

AxMPs are medicines used for the needs of a clinical trial as described in the protocol, but not as investigational medicinal products. AxMPs include medicines used as rescue medication, as challenge agents, to assess endpoints in the clinical trial, or as background treatment. The document provides indications on the use of authorised and unauthorised AxMPs, and on relevant safety reporting requirements.

European Commission updates guidelines on decentralized elements in clinical trials

On 1 October 2025, the European Commission published updated recommendations on decentralized elements in clinical trials. The document addresses the roles and responsibilities of the sponsor and investigator, electronic informed consent, IMP delivery, trial-related procedures at home, data management, and monitoring in decentralized clinical trials – that is, trials conducted outside the traditional “clinical trial site.” The document was drafted in a collaboration between the HMA Clinical Trial Coordination Group (CTCG), EC Clinical Trial Expert Group (CTEG), and the EMA GCP Inspectors Working Group (GCP-IWG).

AIFA publishes clarifications on Legislative Decree on safety features for medicinal product packaging

On 1 October 2025, the Italian Medicines Agency (AIFA) published clarifications on the application of Legislative Decree 10/2025. The document provides indications on the unique identifier, on the tamper-evident system to prevent counterfeiting, and on the relevant transitional regime. Legislative Decree 10/2025 came into effect on 8 February 2025, implementing Regulation (EU) 2016/161 and introducing new safety measures for medicine packaging. For further details on Legislative Decree 10/2025 see here.

 

IP

EPO Study highlights Italy’s strategic role in life sciences research

On 28 October 2025, the European Patent Office (EPO) published its study “The Role of European Public Research in Patenting and Innovation,” which highlights Italy’s strong position in the life sciences sector. Italian universities and public research organisations are major contributors to European patents in biotechnology, pharmaceuticals and medical technologies. Between 2001 and 2020, they filed over 1,700 European patent applications, with the National Research Council (CNR), the Italian Institute of Technology (IIT), and the National Institute for Nuclear Physics (INFN) standing out as the most active applicants. Research-driven Italian startups also show a strong focus on health technologies, further confirming the country’s scientific excellence. To fully unlock the commercial potential of Italy’s life sciences research, greater collaboration with industry and more integrated technology transfer mechanisms will be essential.

 

Data, Privacy and Cybersecurity

Italian Institute of Health launches the National Center for Artificial Intelligence and Innovative Technologies for Health

On 15 October 2025, the Italian Institute of Health (Istituto Superiore di Sanità) announced the launch of the National Center for Artificial Intelligence and Innovative Technologies for Health (IATIS). The IATIS will focus on six key areas that represent the pillars of future healthcare, aiming to create an ecosystem where innovation promotes equity, sustainability and participation. Areas of expertise include:

• telemedicine, biomedical engineering, and digital medicine
• nanotechnologies and innovative therapies
• chemistry and physics for medicine
• AI and robotics
• health technology assessment and medical devices
• space and underwater biomedicine

In addition to developing technological solutions, IATIS will promote a new cultural model based on collaboration among different disciplines, including medicine, engineering, computer science, economics, law and ethics, creating a common language among researchers, clinicians and public decision-makers.

ESMO publishes guidance on the use of large language models in clinical practice

On 18 October 2025, the European Society for Medical Oncology (ESMO) published the Guidance on the use of Large Language Models in Clinical Practice. Although the guidelines don’t have the force of law, they can serve as a valuable resource for companies in the oncology sector, helping them navigate and adopt the use of AI. More specifically, the guidelines highlight opportunities of using AI in the oncology sector such as improved patient education and symptom management, streamlined clinical workflows, and enhanced data processing. At the same time, it addresses challenges including data privacy, algorithmic bias, regulatory compliance, and the risk of unsupervised use. The guidelines outline three distinct levels of use, recognising that the risks and benefits vary depending on the user, and offering tailored guidance for each specific context of application. The first category concerns patient-facing applications such as chatbots and virtual assistants, the second category covers tools for healthcare professionals, including systems for decision support, documentation or translation. The third category refers to institutional systems that aren’t interacting directly with users but are deployed in the background at healthcare institutions, operating unobtrusively in EHR systems.

 

Antitrust

CJEU upholds fine for pay-for-delay agreement 

On 23 October 2025, the Court of Justice of the European Union (CJEU) dismissed an appeal brought against the decision of the European Commission finding that a settlement agreement concerning a patent dispute amounted to an anticompetitive pay-for-delay agreement. According to the CJEU, the transfers of value under the agreement could only be explained by mutual commercial interest in avoiding competition, restricting competition by object. The decision follows the Opinion delivered by AG Rantos on 27 March 2025. Further information on this topic is available in our April newsletter.

ICA clears pharmaceutical merger without investigation 

On 6 October 2025, the Italian Competition Authority (ICA) published on its bulletin the decision not to investigate the merger involving the acquisition of joint control over Genetic Farma – a company which mainly acts as a Contract Development and Manufacturing Organisation – by Galileo Pharma and Oxford Pharma. The transaction, predominantly vertical, involves only marginal horizontal overlaps, as the parties operate at different stages of the pharmaceutical supply chain. Considering the low market shares held by the parties and the presence of qualified competitors, the ICA concluded that the merger didn’t raise competition concerns. 

AG delivers Opinion on the protection of personal data in the context of antitrust investigations

On 23 October 2025, Advocate General Medina (AG) issued a supplement to her Opinion in joined cases C-258-260/23 concerning the seizure of business emails by national competition authorities (NCAs) in antitrust proceedings. The supplement followed the judgment of the CJEU in Landeck, which held that a prior review by as judge or an independent administrative body is required before law enforcers can access personal mobile phones for criminal investigation purposes. The AG clarified that seizures carried out by NCAs concern business information relating to legal persons, which affect individuals only incidentally, so they’re not comparable to accessing personal mobile devices. Consequently, according to the AG, the principles established in Landeck wouldn’t apply and NCAs wouldn’t require prior judicial authorisation to seize internal business emails, provided that adequate and effective procedural safeguards are in place.