Life Sciences News in Italy: November 2024

Regulatory

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

On 11 November 2024, 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 Q&A target competent authorities, economic operators, and other relevant parties. The updates include a new table defining an incident and a serious incident, a new question about expected erroneous results, and guidance on whether to report serious incidents involving CE-marked devices used in clinical investigations or performance studies.

MDCG issues Q&A on gradual roll-out of Eudamed

On 21 November 2024, the Medical Device Coordination Group (MDCG) issued Q&A addressing practical aspects of the gradual roll-out of Eudamed under Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR), as amended by Regulation (EU) 2024/1860. The Q&A specify that Eudamed includes six modules and clarify that the obligations and requirements for each module will become applicable six months after the publication of the notice confirming the functionality of the module in the Official Journal.

State-Regions Conference issues positive opinion on the Legislative Decree on safety features for medicinal product packaging

On 14 November 2024, the State-Regions Conference issued a positive opinion on the Legislative Decree aligning national provisions with Delegated Regulation (EU) 2016/161 (Regulation), effective from 9 February 2025. The Regulation aims to enhance medicine safety and prevent counterfeiting by imposing specific security features on medicinal product packaging. Parliamentary committees are reviewing the Legislative Decree, holding hearings with regulatory authorities and industry stakeholders. The final approval will address feedback from industry associations and replace the initially adopted stamp system. Further information on this topic is available in our August newsletter.

EMA issues Q&A on fees and charges under Fee Regulation

On 15 November 2024, the European Medicines Agency (EMA) issued Q&A providing guidance to all marketing authorization applicants on Regulation (EU) 2024/568 regarding fees and charges payable to the EMA (Fee Regulation). The Q&A clarify that the Annexes to the Fee Regulation list all applicable fees and charges by procedure type. They also outline that reductions may apply based on the type of application, request, or procedure, as well as the applicant’s and product’s status.

HERA launches Stakeholder Hub to strengthen EU pharmaceutical supply chain

On 28 November 2024, the Health Emergency Preparedness and Response Authority (HERA) launched the HERA Stakeholders Hub, which is a secure, multifunctional platform designed to enhance collaboration across the European pharmaceutical sector. The Stakeholders Hub connects businesses, national authorities, non-governmental organizations, and other stakeholders, facilitating direct communication with HERA and between participants on medical countermeasures and critical medicines. The initiative seeks to strengthen cooperation, address vulnerabilities in the pharmaceutical supply chain, and reduce medicine shortages.

State-Regions Conference issues conditional positive opinion on the MoH Decree on tariffs

On 14 November 2024, the State-Regions Conference issued a conditional positive opinion, subject to the adoption of proposed amendments, on the Ministry of Health (MoH) Decree on tariffs, modifying the Ministerial Decree of 23 June 2023 (Decree). This Decree will come into effect on 30 December 2024, revising the nomenclature for outpatient specialist services and prosthetic assistance. This update is essential to ensure the nationwide provision of the new Essential Levels of Care (LEA), reducing regional disparities in healthcare access and aligning services with medical and scientific progresses.

AIFA identifies list of medicines that cannot be exported

On 6 November 2024, the Italian Medicines Agency (AIFA) issued a Resolution with a list of medicines that cannot be exported. The Resolution aims to safeguard national supply and prevent shortages.

AIFA announces transition from OsSC to CTIS platform

On 21 November 2024, the Italian Medicines Agency (AIFA) issued a note announcing that all ongoing clinical trials in Italy must be transitioned from the National Observatory on Clinical Trials (OsSC) to the Clinical Trials Information System (CTIS) by 30 January 2025, unless completed by that date. Trials based on Directive 2001/20/EC that are not transitioned or still in the process by the deadline will be suspended or interrupted. The OsSC will remain available for consultation as an archive. No further updates are required in OsSC for clinical trials transitioned to CTIS.

EMA launches ESMP for monitoring medicine shortages

On 28 November 2024, the European Medicines Agency (EMA) launched the European Shortages Monitoring Platform (ESMP) to streamline the reporting of shortages for centrally authorised medicines. From 2 February 2025, marketing authorisation holders (MAHs) must use the ESMP to report shortages in routine situations, during Medicine Shortages Steering Group (MSSG)-led preparedness exercises, and in crisis scenarios. During the transition period (28 November 2024 - 2 February 2025), MAHs can use either the ESMP or the existing process. After this period, the ESMP will become mandatory. Additionally, national competent authorities will also use the platform to report data during crises or MSSG-led activities, including national demand, stock levels, and patient estimates.

MDCG issues guidance on implementing Master UDI-DI for contact lenses

On 26 November 2024, the Medical Device Coordination Group (MDCG) issued guidance on implementing the Master UDI-DI system for contact lenses under Regulation (EU) 2017/745 (MDR). The guidance explains how to structure, assign, label, and register Master UDI-DIs – unique identifiers that group highly individualized devices (such as contact lenses) – in Eudamed. The UDI system improves device identification and traceability. Although all economic operators must ensure traceability, manufacturers carry the primary responsibility for implementing proper identification and traceability measures. Manufacturers must assign and register the relevant UDI-DIs in Eudamed before placing the devices (excluding custom-made ones) on the market.

AIFA issues guidelines on decision-making transparency and monitoring through AIFA Registers

On 7 November 2024, the Italian Medicines Agency (AIFA) issued guidelines aimed at increasing the transparency of its decision-making processes. The guidelines define the general evaluation criteria for establishing a monitoring system through AIFA Registers. They apply to dossiers requesting price and reimbursement approval from the National Health Service for medicines in the TN1 category (ie new medicines, orphan medicines, and/or new indications for already commercialized active ingredients). The process outlined in the guidelines do not apply to medicines recognized as innovative, as this requirement is mandated by law for such medicines.

AIFA launches survey on pharmaceutical research needs

On 28 November 2024, the Italian Medicines Agency (AIFA) published a survey to gather proposals on research needs in the pharmaceutical field. The survey will remain open until 15 January 2025. AIFA is the first medicines agency in the EU to include the promotion of research as one of its programmatic objectives. The law establishing AIFA requires pharmaceutical companies to contribute 5% of their total spending on promotional activities from the previous year to create a fund. It then allocates 50% of this fund to information and research activities.

 

WCC/Compliance

New clarifications on CSRD at national and EU level

Two documents providing interpretative guidance for the implementation of the Corporate Sustainability Reporting Directive (Dir. 2022/2464/UE – CSRD), and the related national regulation arising from Legislative Decree 125/2024 (Decree) were recently published.

• on 7 November 2024, the Italian Association among Stock Companies (Assonime) issued Circular no. 21/2024, commenting on the Decree’s contents and providing suggestions on the first critical issues. The Circular examines the CSRD’s impact on corporate governance and internal control systems and provides insight into the reporting obligations within group of companies;
• on 13 November 2024, the EU Commission published a notice offering clarifications around CSRD topics such as scope, application dates, reporting obligations of value chain information, and exemption rules. Although not legally binding, the Commission notice offers authoritative guidance for in-scope companies to comply with CSRD requirements.

ANAC submits new whistleblowing guidelines for public consultation

On 7 November 2024, the Italian National Anticorruption Authority (ANAC) submitted new whistleblowing (WB) guidelines for public consultation. Aiming to ensure an effective application of WB regulations, the draft guidelines provide further clarifications especially on internal reporting channels, also within group of companies. The guidelines also explain how WB regulations intersect with Legislative Decree 231/2001 providing for corporate criminal liability. All interested stakeholders can submit observations on the draft guidelines until 9 December 2024.

 

Data Privacy & Cybersecurity

NIS2 Directive: ACN publishes Determination on the procedures for registering on its platform

On 26 November 2024, the Italian National Cybersecurity Agency (ACN) issued a Determination detailing the procedures for registering on the ACN platform. Key elements of the Determination include the appointment of a designated contact point and a detailed description of the registration process. Additionally, the Determination grants the ACN authority to conduct random checks to verify the accuracy of the submitted information. Entities subject to Italian jurisdiction and within the scope of the NIS2 Directive must complete their registration on the ACN platform by 17 January 2025 or 28 February 2025, depending on the specific sector in which they operate. 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.

Independent experts present first draft of General-Purpose AI Code of Practice

On 14 November 2024, a group of independent experts presented the first draft of the General-Purpose AI Code of Practice. It aims to detail the AI Act rules for providers of general-purpose AI models and general-purpose AI models with systemic risks. Although the first draft is light in detail, this approach aims to provide stakeholders with a clear sense of direction of the final Code’s potential form and content. Key areas of focus include transparency, a taxonomy of systemic risks, robust risk assessments, and stringent risk mitigation strategies, encompassing both technical and governance measures. The final version of the Code should be ready by 1 May 2025.

EMA publishes Data Quality Framework for EU medicines regulation: Application to Real-World Data

On 4 November 2024, the European Medicines Agency (EMA) published the Data Quality Framework for EU medicines regulation: Application to Real-World Data. This document outlines specific recommendations for assessing Real-World Data (RWD) quality, as derived from the Data Quality Framework (DQF) for EU Medicines regulation. This framework establishes principles and definitions for evaluating data used in medicine regulatory contexts. The document provides background on how data quality can impact the use of RWD to generate Real-World Evidence (RWE) for regulatory assessment. It further provides guidance for the characterisation of systems and processes underpinning data and their impact, key metrics to assess different aspects of data quality within a dataset, as well as guidance to use metrics to assess the suitability of a dataset by a fitness-for-use assessment in relation to a specific research question.

Italian DPA fines company for using algorithms in the working environment

On 22 November 2024, the Italian Data Protection Authority (Italian DPA) published a Resolution in which it fined a company for, among other violations, carrying out automated processing of its employee’s data without adopting the measures required by the GDPR. Specifically, the company used automated decision-making systems to assign work orders during shifts and to prioritize booking schedules. The Italian DPA determined that the company failed to adopt necessary protective measures, particularly in ensuring employees’ rights under GDPR. This included the right to request human intervention, express their views, and contest decisions made by the algorithm. The Italian DPA imposed a EUR5 million fine, which underscores the importance of adhering to GDPR requirements regarding automated processing and employee data.

 

Antitrust

ICA publishes new Regulation on investigation procedures in matters of consumer protection and misleading and comparative advertising

On 19 November 2024, the new Regulation on investigation procedures carried out by the Italian Competition Authority (ICA) became effective. Among the novelties, the Regulation:

• clarifies the definition of “consumer” and “professional”;
• introduces the power to suspend the deadline of the proceedings for up to one year;
• simplifies the procedure for assessing commitments and the possibility for directly, immediately, and currently harmed third parties to participate in the proceeding;
• introduces the possibility to dismiss more easily de minimis cases;
• amends the procedure on public consultation on unfair clauses.

EU Commission publishes report on killer acquisitions in the pharma industry

28 November 2024, the EU Commission published a report analysing “killer acquisitions” in the pharmaceutical sector during the 2014-2018 period. Among the deals scrutinized, the report identified 89 pharmaceutical transactions – spanning various types such as mergers and acquisitions (M&A), asset purchases, licensing agreements, and research and development (R&D) collaborations – involving overlapping R&D projects that were subsequently discontinued post-transaction. The report noted that these discontinuations warrant closer scrutiny, as no technical or safety reasons were found to justify the discontinuation of the projects. The report also provides guidance on policy recommendations, highlighting the importance of a case-by-case approach and on referrals based on Art. 22 of the EU Merger Regulation.