Life Sciences News in Italy: June 2024

Regulatory

EMA issues guidance on how to mitigate medicine shortages

On 18 June 2024, the European Medicines Agency (EMA) issued guidance to marketing authorisation holders (MAHs) and other pharmaceutical industry actors on maintaining a continuous supply of their medicines on the EU market and minimising the impact of medicine shortages. These actors should identify supply chain risks and outline measures to manage them. Additionally, MAHs should develop shortage mitigation plans to address potential or actual shortages, including proposals to mitigate the impact on patients.

European Commission amends Variation Regulation

On 17 June 2024, the European Commission adopted Regulation (EU) 2024/1701 on variations (New Regulation) amending Regulation (EC) 1234/2008 (Variation Regulation) to create a simpler and more flexible legal framework while maintaining public health protection. The New Regulation introduces the “super-grouping of variations,” allowing the submission of a single set of variations for multiple marketing authorisations, including purely national authorisations across different Member States. This aims to increase flexibility and harmonization. The New Regulation will apply from 1 January 2025.

MDCG releases guidance on the clinical evaluation of orphan medical devices

On 25 June 2024, the Medical Device Coordination Group (MDCG) issued guidance aimed at manufacturers and notified bodies concerning the clinical evaluation of medical devices and accessories under Regulation (EU) 2017/745 (MDR). This guidance specifically addresses devices categorised as “orphan devices” – ie devices intended to benefit patients with a rare disease. It emphasizes compliance with clinical evaluation and investigation requirements outlined in MDR Chapter VI and Annex XIV.

AIFA details reimbursement process under the “5% Fund”

On 11 June 2024, the Italian Medicines Agency (AIFA) published a Resolution in the Official Gazette detailing reimbursement procedures for healthcare expenses under the “5% Fund” for orphan drugs. From 1 July 2024, authorisations for access to the fund will be revoked if treatment does not start within 3 months or if a reimbursement request is not submitted via the online service within 12 months. Requests must be made in a single submission at the end of the treatment period and include documented expenses. Late or improperly submitted requests will not be processed.

AIFA updates Q&A on marketing authorisation procedures

On 26 June 2024, the Italian Medicines Agency (AIFA) updated its Q&A on marketing authorisation procedures. The changes address new marketing authorisation applications under national, mutual recognition, and decentralized procedures, along with requirements for national translations of product information (SmPC, labelling). A new section on importing/exporting human blood and its products offers guidance on application submission.

HTA Coordination Group publishes guidance on joint clinical assessment

On 13 June 2024, the Member States Coordination Group on Health Technology Assessment (HTA) published two new guidance documents for joint clinical assessments under the HTA Regulation. The first document outlines how to define assessment scopes and ensure thorough reporting to aid national evaluations of clinical added value. The second document addresses handling multiplicity issues and complementary analyses in assessment reports, influencing how Member States interpret methodologies and reach conclusions nationally. These documents are essential for health technology developers preparing their assessment submissions.

EMA launches new CTIS

On 18 June 2024, the European Medicines Agency (EMA) launched a new version of the Clinical Trials Information System (CTIS) to provide earlier and more efficient access to clinical trial information in the EU. The new system eliminates the previous deferral mechanism, making information on approximately 4,000 authorised clinical trials immediately accessible, with around 500 new trials added monthly. The updated rules enhance transparency while protecting commercially confidential information, benefiting patients, clinical trial sponsors, and healthcare professionals by simplifying processes and improving access to key trial information.

AIFA identifies list of medicines that cannot be exported

On 26 June 2024, the Italian Medicines Agency (AIFA) published a Resolution with a list of medicines that cannot be exported. The Resolution aims to safeguard national supply and prevent shortages.

 

WCC/Compliance

Italian Parliament approves new legislative provisions on cybersecurity: New criminal offences and sanctions

On 19 June 2024, the "DDL Cyber" was definitively approved. The new legislation aims to tackle cybercrime, especially when it could damage the State or certain sectors of national strategic importance. The DDL Cyber:

• introduces new criminal offences (eg extortion through cybercrime);
• sets aggravating circumstances when cybercrimes are committed to the detriment of interests of public relevance (eg health); and
• increases penalties for pre-existing offences, including cybercrimes set forth by Legislative Decree 231/2001 regulating corporate criminal liability.

The approval immediately followed the recent initiation of the process for the implementation in Italy of NIS 2 Directive (2022/2555/EU), which sets to strengthen the resilience and security of networks and information systems. For further details see here.

Sustainable finance and small-medium enterprises: New Italian Ministry of the Economy document casts light on the importance of 231 Models

On 25 June 2024, the Italian Ministry of the Economy issued a document for public consultation setting out 45 indicators which will help unlisted sustainable finance and small-medium enterprises (SMEs) (up to 250 employees) in mapping and reporting their sustainability efforts, also in view of accessing several forms of “green” and sustainable financing. Indicator no. 43 focuses on the crucial relevance of adequate trainings on the contents of the Ethical Codes and the 231 Models adopted by organisations, once again marking their importance as a guarantee of legal and virtuous conduct of business activities.

 

IP

UPC Milan Central Division finally opens its doors

On 27 June 2024, the Milan Central Division officially became operational. The inauguration ceremony, organised by the Milan technical panel for the unitary patent coordinated by Mrs. Marina Tavassi, was held a few days later in the Court of Milan. Attending the event were the Italian Minister of Foreign Affairs and International Cooperation, Antonio Tajani; the Minister of Justice, Carlo Nordio; the Presidents of the Court of first instance and of the Court of Appeal of Milan, Giuseppe Ondei and Fabio Roia; the President of Lombardy, Attilio Fontana; and the President of the Court of Appeal of the UPC Klaus Grabinski.
The Milan Central Division, which will work alongside the Paris and Munich Central Divisions, is responsible for disputes concerning patents covering inventions that fall under category A of the International Patent Classification (IPC), ie “Human Necessities,” which also includes pharmaceutical inventions (not covered by supplementary protection certificates) and medical devices.
The opening of the Milan Central Division is a significant opportunity for Italy to strengthen its position in the field of patent protection.

 

Data, privacy & cybersecurity

Italian DPA publishes FAQs for IRCCS

On 6 June 2024, the Italian Data Protection Authority (Italian DPA) published a list of FAQs regarding the legal requirements for Scientific Hospitalization and Treatment Institutes (IRCCS) to process personal data collected while providing healthcare assistance, for further research purposes. The FAQs specifically address the primary privacy concerns that IRCCS face when processing patients’ data for research. This includes identifying the legal basis for data usage, ensuring transparency, and the necessity to conduct a Data Protection Impact Assessment.

Italian DPA updates its guidelines on email metadata retention for employers

On 6 June 2024, the Italian Data Protection Authority (Italian DPA) updated the guidelines on “Computer programs and IT services for managing email in the workplace and metadata processing,” following a public consultation. This update narrows the scope of the initial decision by clarifying that the sole metadata referred to in the guidelines corresponds to information recorded in logs generated by the server systems that manage and route email (known as Mail Transport Agent) and the workstations in interactions between the various servers and between these servers and the terminals sending messages. The updated guidelines confirm that the retention of metadata necessary for the functioning of the email system’s infrastructure is permissible for a limited period, not exceeding 21 days, extending the previously identified retention period of 7 days. The generalized retention of metadata for a longer period of time can only take place with the prior agreement with the trade union representatives or the prior authorization of the Territorial Labor Office, without prejudice to the need to ensure compliance with the storage limitation principle. The guidelines are sector neutral, but may affect any company operating in Italy, including those in the Life Sciences sector.

Italian DPA launches investigation into local health authority for requiring COVID-19 vaccine certification

On 12 June 2024, the Italian Data Protection Authority (Italian DPA) launched an investigation into the local health authority (ASL) of Lecce following reports that some nursing students were denied hospital internships for not having received the fourth dose of the COVID-19 vaccine. The local health authority of Lecce justified its position based on a regional law mandating vaccination for healthcare workers. The local health authority now has 15 days to inform the Italian DPA of the legal basis and purpose for processing personal data related to the fourth vaccine dose as a condition for internships. The Italian DPA noted that since 1 November 2022, the COVID-19 vaccination requirement is no longer in effect for healthcare professionals and related workers.

AGENAS announces the begin of data population for the National Telemedicine Platform

On 19 June 2024, the Italian National Agency for Regional Health Services (AGENAS) announced in a press release that the data population for the National Telemedicine Platform (PNT) will begin in the coming days, in collaboration with several pilot regions. The PNT is scheduled to be presented to all interested stakeholders on 1 October 2024. The platform will ensure interoperability with the Electronic Health Record (Fascicolo Sanitario Elettronico 2.0) and the Health Data Ecosystem (Ecosistema dei Dati Sanitari). The goal of the PNT is to enhance equitable patient care across the National Health Service, ensuring that all patients receive consistent and high-quality healthcare services, regardless of their location.

Italian DPA announces corrective and sanctioning procedures for violations in implementing the Electronic Health Record

On 26 June 2026, the Italian Data Protection Authority (Italian DPA) announced the initiation of corrective and sanctioning procedures against 18 Italian regions and the autonomous provinces of Bolzano and Trento. This follows the detection of numerous violations in implementing the new Electronic Health Record (Fascicolo Sanitario Elettronico 2.0), established by the Ministry of Health decree of 7 September 2023. An investigation launched at the end of January revealed that these 18 regions and the two autonomous provinces of Trentino Alto Adige had significantly deviated from the standard privacy notice prepared by the Ministry and approved by the Italian DPA. These discrepancies indicate that certain rights and measures introduced by the decree, designed to protect patients, are not uniformly guaranteed across the Italian territory. The violations identified in the regions and autonomous provinces vary in severity and responsibility, and they could lead to the application of sanctions under the GDPR.

 

Antitrust

Italian Competition Authority closes investigation into alleged cartel in the production and sale of radiopharmaceuticals without ascertaining any infringements

On 21 May 2024, the Italian Competition Authority closed the investigation against some undertakings operating in the market for the production and sale of radiopharmaceuticals for an alleged breach of Art. 101, par. 1, TFEU in the context of public tenders, without ascertaining any infringement. The investigation was opened following a leniency application submitted by one of the undertakings involved. For further details see here.

European Commission approves up to EUR 1 billion of State Aid by six Member States for the first important project of common European interest in the health sector

On 28 May 2024, the European Commission approved the “IPCEI Med4Cure” project. It was jointly notified by Belgium, France, Hungary, Italy, Slovakia and Spain which will provide up to EUR1 billion in public funding to finance research and development projects covering all key steps of the pharmaceutical value chain. The IPCEI project aims to accelerate medical advancement and foster resilience in the EU health industry.

European Commission sends statement of objections to Alchem over the first pharmaceutical EU cartel case

On 13 June 2024, the European Commission informed Alchem of its preliminary view that, with other market participants, it has breached EU antitrust rules by participating in a long-lasting cartel concerning the pharmaceutical ingredient N-Butylbromide Scopolamine/Hyoscine (SNBB). The European Commission has concerns that Alchem may have coordinated and agreed with other market participants to fix the minimum sales price of SNBB for customers and to allocate quotas.

 

Tax

Italian Supreme Court rules on philanthropic disbursements in healthcare sector

On 7 June 2024, the Italian Supreme Court (Corte di Cassazione) published decision 15966 on philanthropic disbursements in the healthcare sector. According to the Court, the deductibility of philanthropic disbursements (pursuant to Art. 100, par. 2(a), of Presidential Decree 917/1986 – TUIR) is subject to: the subjective requirement of the beneficiary, which must be a legal person, and the objective requirement of the activity carried out by the latter, which must be one among those indicated in Art. 100, par. 1, TUIR, including social and healthcare activities.