This month, our specialist life sciences team in Italy covers the key issues in the sector, including:

• Regulatory; 
• White Collar Crime and Compliance;
• IP; 
• Data, Privacy & Cybersecurity; 
• Product Liability; 
• Antitrust; and
• Tax. 

REGULATORY

Council of the EU approves AI Act

On 21 May 2024, the Council of the EU approved the Artificial Intelligence Act (AI Act). The AI Act will be published in the EU Official Journal and will enter into force 20 days later. It will apply two years after its entry into force, except for specific provisions. The AI Act adopts a risk-based approach, imposing stricter rules on higher-risk AI systems, such as medical devices incorporating AI systems.

EU Council amends MDR and IVDR to prevent shortages

On 30 May 2024, the Council approved a Regulation amending Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), aiming to prevent shortages and increase transparency. Key provisions include:

• extending the transition period for certain in vitro diagnostic medical devices (IVDs) to prevent shortages of critical IVDs while maintaining safety standards;
• gradually implementing EUDAMED, requiring manufacturers to provide product information to existing EUDAMED modules;
• an obligation for manufacturers to notify authorities, health institutions, healthcare professionals, and economic operators of any supply interruptions for critical medical devices or IVDs.

The Regulation will take effect after it is published in the EU Official Journal.

EU Council approves regulation on substances of human origin

On 27 May 2024, the Council of the European Union approved the Regulation on standards of quality and safety for substances of human origin intended for human application (SoHO Regulation). The SoHO Regulation, repealing Directives 2002/98/EC and 2004/23/EC, aims to ensure maximum safety and quality of substances of human origin throughout the entire supply chain. It introduces specific provisions for children born via medically assisted reproduction and establishes stricter standards for all substances of human origin, including intestinal microbiota and human breast milk. The SoHO Regulation will be published in the EU Official Journal and enter into force 20 days later. It will apply from mid-2027, with some provisions taking effect the subsequent year.

European Commission adopts Implementing Regulation (EU) 2024/1381 on the joint clinical assessment of medicines under the HTA

On 23 May 2024, the European Commission adopted the Implementing Regulation (EU) 2024/1381 for the EU joint clinical assessments of medicines, giving patients faster access to treatments. The rules define assessment timelines and procedures to provide scientific evidence to member states and facilitate more effective decisions about new medicines in national health systems. Adopted pursuant to Regulation (EU) 2021/2282 on Health Technology Assessment (HTA Regulation), these rules introduce a new approach to using EU expertise in evaluating new medicines, supporting healthcare systems in delivering quality care with new technologies. These rules represent the first of six acts to be adopted under the HTA Regulation.

EMA updates Q&A on medicinal product-medical device combination products

On 3 May 2024, the European Medicines Agency (EMA) updated its Q&A for applicants, marketing authorisation holders of medicinal products, and notified bodies concerning the implementation of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). The Q&A provide guidance on medical devices that form an integral product with medicinal products, medicinal products that include a medical device in the secondary packaging of the marketed medicinal product (co-packaged), consultation procedure for ancillary medicinal substances that are integral part of medical devices, and consultation procedure for companion diagnostics.

MDCG updates Guidance on appropriate surveillance of legacy devices

On 27 May 2024, the Medical Device Coordination Group (MDCG) released an updated version of the guidance on appropriate surveillance regarding the transitional provisions under Art. 120 of Regulation (EU) 2017/745 (MDR) for legacy devices, ie devices covered by certificates issued according to Directive 90/385/EEC or Directive 93/42/EEC and placed on the market after the date of application of the MDR (ie 26 May 2021). The Guidance outlines the tasks that notified bodies have to carry out as part of appropriate surveillance to ensure compliance with all relevant requirements.

AIFA updates Q&A on active substances

On 10 May 2024, the Italian Medicines Agency (AIFA) updated its Q&A on the procedures for authorizing and registering active substances. The Q&A, intended for manufacturers and importers of active substances and medicinal products, were developed to harmonize expectations during inspections, clarify ambiguities and uncertainties, and standardize inspections for both small molecules and biotech active pharmaceutical ingredients.

WCC/COMPLIANCE

New guidelines for the 231 Model of private healthcare companies

On 13 May 2024, the Italian National Council of Accountants (Consiglio Nazionale dei Dottori Commercialisti ed Esperti Contabili) issued guidelines for drafting and implementing the Model of Organisation, Management, and Control provided for by Legislative Decree 231/2001 (231 Decree) of private healthcare companies (aziende sanitarie private, such as private care homes, healthcare residencies, and rehabilitation centres). The guidelines focus on the predicate criminal offences set forth by the 231 Decree that might be the most relevant for such entities, and on the typical internal processes and risk-areas where such crimes could be committed.

Court of Milan clarifies requirements for a 231 Model adequate to exempt legal entities from corporate criminal liability

A recent judgement by the Court of Milan reverted to the long-debated interpretation of the elements that a Model of Organisation, Management and Control (231 Model) shall entail to be deemed adequate for the purpose of exempting legal entities from the corporate criminal liability set forth by Legislative Decree 231/2001.

In general terms, the Court stated that the adequacy of a 231 Model can be grounded on adequately conducting risk mapping and risk assessment activities, and defining and effectively implementing a procedural framework guaranteeing clear attribution of roles and responsibilities and strict segregation of duties. In the case at hand, the Court ruled that adopting effective internal controls, even if not formalized in the 231 Model, may still be relevant for excluding corporate criminal liability. Click here for further details.

EU Council approves Corporate Sustainability Due Diligence Directive

On 24 May 2024, the EU Council gave the much-awaited final approval for the adoption of the Corporate Sustainability Due Diligence (CSDD) Directive. The CSDD imposes due diligence requirements on in-scope EU large companies and all their value chain significant to prevent potential adverse impacts on human rights and environment. The CSDD will enter into force 20 days after publication in the EU Official Journal. From that point, EU member states will have two years to transpose the Directive into their legal systems. The rules will then start applying at different paces set by the Directive.

IP

WIPO member states adopt new Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge

On 24 May 2024, member states of the World Intellectual Property Organization (WIPO) adopted the new Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge. The Treaty addresses the relationship between intellectual property, genetic resources and traditional knowledge, including special provisions for indigenous people and local communities. It establishes a new disclosure requirement for patent applicants whose inventions are based on genetic resources or associated traditional knowledge. The new Art. 3 provides that if an invention claimed in a patent application is based on genetic resources, each contracting party must require applicants to disclose the country of origin or the source of the genetic resources. In addition, if the invention claimed in a patent application is based on traditional knowledge associated with genetic resources, each contracting party will have to require applicants to name the indigenous people or local community that provided the traditional knowledge.

The Treaty will enter into force three months after fifteen eligible parties have deposited their instruments of ratification or accession.

DATA, PRIVACY & CYBERSECURITY

Italian DPA issues guidelines on protecting personal data from web scraping

On 30 May 2024, the Italian Data Protection Authority (Italian DPA) released guidelines to help public and private operators of websites and online platforms, including those in the Life Sciences sector, protect personal data from indiscriminate web scraping. The guidelines consider feedback from a survey launched by the Italian DPA last December. The document recommends several concrete measures to prevent or mitigate web scraping. Although these measures are not strictly mandatory, website and online platform operators should carefully consider implementing them to avoid potential challenges related to breaches of the principle of accountability.

Italian DPA launches investigation into HPV vaccination certificate requirement for students

On 28 May 2024, the Italian Data Protection Authority (Italian DPA) launched an investigation in relation to Puglia region’s proposed legislation mandating HPV vaccination certification for students. The Italian DPA has highlighted that, according to the GDPR, there is a general prohibition on processing health data unless specific exemptions apply. The authority also noted that, under current laws, vaccination certificates can only be requested by school personnel in cases of mandatory vaccinations, which is not the case for HPV vaccination.

Italian DPA admonishes a mother for sharing photos of her paralyzed daughter online

On 21 May 2024, the Italian Data Protection Authority (Italian DPA) released a resolution admonishing a mother for sharing photos of her paralyzed daughter online. The Italian DPA emphasized that disclosing health data must adhere to the Deontological rules on the processing of personal data in the exercise of journalistic activity (Deontological rules), which apply not only to journalists but to anyone sharing content publicly. Deontological rules establish clear limits to the disclosure of health data, emphasizing respect for the dignity, privacy, and personal decency of patients, especially those with severe or terminal illnesses. The Italian DPA concluded that an admonition was sufficient, as the mother acted in good faith to draw media attention to her daughter’s condition.

Italian DPA issues guidelines following the amendment of Art. 110 of the Italian Privacy Code

On 21 May 2024, the Italian Data Protection Authority (Italian DPA) released guidelines concerning medical research, detailing safeguards for retrospective studies where a patient’s consent cannot be obtained. The Italian DPA issued the guidelines following the amendment of Art. 110 of the Italian Privacy Code (refer to our previous issue). With the same resolution, the Italian DPA also promoted the initiation of the process for adopting new deontological rules on data processing for statistical or scientific research purposes. The Italian DPA invites all stakeholders who are eligible to endorse these guidelines to inform the Authority.

ANTITRUST

Italian Competition Authority adopts notice about the procedure for exercising its powers relating to fact-finding investigations

On 7 May 2024, the Italian Competition Authority (ICA) adopted a notice detailing the procedure that the ICA itself will follow when exercising the powers it was recently granted by the Italian legislator in the context of fact-finding investigations. The powers allow the ICA to impose on the involved undertakings the structural or behavioural measures deemed necessary to eliminate the distortions of competition identified by the ICA in the context of a fact-finding investigation, regardless of the existence of any anticompetitive conduct. Click here for further details.

European Commission publishes a Competition policy brief on Antitrust in Labour Markets

On 3 May 2024, the European Commission published a Competition policy brief on the topic of Antitrust in Labour Markets. In the absence of previous European Commission decisions on this subject, it sets out useful indications to assess the compatibility with competition rules of wage-fixing and no-poach agreements, clarifying that such agreements are likely to qualify as restrictions by object under Art. 101 TFEU. The European Commission also stated that these agreements are unlikely to meet the relevant requirements to qualify as ancillary restraints and to benefit from an exemption under Art. 101, par. 3, TFEU. Click here for further details.

TAX

Italian Revenue Agency publishes interpellation no. 106

On 16 May 2024, the Italian Revenue Agency published the interpellation no. 106, clarifying that the ordinary VAT rate has to be applied to the supply of Collective Protection Devices (which consist of a cover/curtain system to be applied to the hospital beds of patients connected to a suction and filtration system, for the control of hospital infections – CPD), since CPDs don’t fall within any other category of goods for which a reduced VAT rate is applicable, as per the VAT Decree.

Italian Revenue Agency publishes interpellation no. 107

On 16 May 2024, the Italian Revenue Agency published the interpellation no. 107, confirming that the “Additional Remuneration for 2023”, as granted to pharmacies for the reimbursement of drugs dispensed under the National Healthcare System (pursuant to Art. 1, par. 532, of Law 197/2022), contributes to the formation of the relevant tax base for IRES and IRAP purposes.

EMPLOYMENT

Metasalute Fund: Flexible Benefit 2024

On 21 May 2024, the Metasalute Fund published a notice informing all members that, with reference to the provisions of the CCNL for the Mechanical Engineering and Mechanical Installation Industry and the CCNL for the Gold and Silver Sector currently in force, workers enrolled in the Fund can choose to allocate the amount provided by the Flexible Benefit to Metasalute.

Workers enrolled in the Fund interested in allocating the welfare shares to Metasalute had to inform their company sufficiently in advance of the closing of the window scheduled for 31 May.

Ministry of Labour publishes list of qualified subjects for periodic inspections of work equipment

On 16 May 2024, the Ministry of Labour adopted by Ministerial Decree the 51st list of qualified subjects for carrying out periodic inspections of work equipment.