Life Sciences News in Italy: August 2024
Regulatory
AIFA updates Guidelines for the classification and conduct of observational studies on medicines
On 20 August 2024, the Italian Medicines Agency (AIFA) published in the Official Gazette the Guidelines for the classification and conduct of observational studies on medicines. The Guidelines apply to all categories of observational studies on medicinal products, offering clear and precise guidance on their proper classification and the key operational aspects to be considered in regulatory activities, particularly by Ethics Committees. The Guidelines update and replace the previous version issued in 2008, which no longer adequately addressed the evolving needs of the sector.
Council of Ministers approves Legislative Decree on safety feature regulations for medicines packaging
On 30 August 2024, the Council of Ministers preliminarily approved a Legislative Decree to align national legislation with Commission Delegated Regulation (EU) 2016/161, which complements Directive 2001/83/EC by laying down rules for the safety features on medicinal products packaging. The Decree introduces key provisions, including the requirement for a unique identifier and tamper-evident security elements on medicine packaging, the enhancement of market surveillance and control procedures for medicine safety, the creation of a national archive with detailed information on medicine safety characteristics, and the establishment of a sanctioning system.
Regulation (EU) 2024/2041 prohibits health claims on monacolin K
On 19 August 2024, Regulation (EU) 2024/2041 came into effect, amending Regulation (EU) 432/2012 on the health claim for monacolin K from red yeast rice. In recent years, monacolin K has been used in supplements for maintaining normal LDL cholesterol levels. Due to safety concerns, the European Commission had already restricted monacolin K to less than 3 mg per daily serving in 2022. The Regulation further prohibits any health claims related to monacolin K on food products. Consequently, the health claim “Monacolin K from red yeast rice contributes to the maintenance of normal blood cholesterol levels” is no longer permitted on food products as of 19 August 2024.
EMA launches program to support the development of orphan medical devices
On 2 August 2024, the European Medicines Agency (EMA) launched a pilot program offering free expert advice on developing and assessing orphan medical devices in the EU. Orphan devices are intended for diseases affecting fewer than 12,000 individuals annually and address unmet medical needs. Running until the end of 2025, the program aims to create a long-term support process for manufacturers and notified bodies. Prioritizing devices for life-threatening conditions, paediatric use, and innovative technologies, this initiative enhances existing efforts to boost innovation and ensure the safety of medical devices.
AIFA publishes Guidelines on regulatory simplification and decentralization for conducting clinical trials
On 20 August 2024, the Italian Medicines Agency (AIFA) published in the Official Gazette the Guidelines on regulatory simplification and elements of decentralization for conducting clinical trials of medicines in accordance with Regulation (EU) 536/2014. The Guidelines address various organizational aspects of clinical trials and provide clarifications to ensure the correct national application of provisions contained in, or not expressly prohibited by, EU regulations and guidelines. Key topics include the use of third-party service providers, reimbursement of expenses for clinical trial participants, home delivery of investigational medicines, allocation of costs for investigational medicines, and conducting clinical trials in non-hospital settings.
WCC/Compliance
New predicate offence of corporate criminal liability under 231 Decree
On 8 August 2024, Law 112/2024 was published in the Official Gazette. The Law entered into force on 10 August 2024 and definitively converted the "Prisons" Decree, which introduced the offence of wrongful destination of movable assets (indebita destinazione di denaro o cose mobili, Art. 314-bis of the Italian Criminal Code). In addition, the new offence has been included among those triggering corporate criminal liability in Italy, pursuant to Art. 25 of Legislative Decree 231/2001. As such, provided that the relevant conduct affects the EU's financial interests, legal entities charged with this offence may face a pecuniary sanction up to EUR310,000.
Data, Privacy & Cybersecurity
Italian DPA publishes FAQs on the right to be forgotten for cancer survivors
On 9 August 2024, the Italian Data Protection Authority (Italian DPA) published a set of FAQs on the right to be forgotten for cancer survivors (further information on this topic is available in our February Newsletter). The FAQs address the implementation and scope of Law 193/2023, whose violations may result in sanctions under the GDPR. In particular, the FAQs detail the data that must be included in the "certificate on the right to be forgotten for cancer survivors" (certificato di oblio oncologico) and the retention periods applicable to archive the certificate and the relevant request. Further guidance is provided for banking, financial, investment and insurance service providers and employers which are prohibited from asking for and using information on individuals’ cancer diagnoses after five or ten years from their treatment.
Italian DPA publishes its opinion on the proposal for a Law supplementing the AI Act
On 2 August 2024, the Italian Data Protection Authority (Italian DPA) published its opinion on the proposal for a Law supplementing the AI Act (further information on this topic is available in our April Newsletter). While the Italian DPA expresses overall support for the proposal, it stresses the need for several crucial amendments to enhance the protection of individuals' personal data. With specific reference to the use of high-risk AI systems in the healthcare sector, the Italian DPA recommends the upcoming Law to include stringent limitations on data usage. According to the Italian DPA, these limitations should address data storage practices and impose strict prohibitions on the transmission, transfer, and communication of health data. Additionally, the Italian DPA advises to include provisions to prioritize the use of synthetic or anonymized data.
Italian DPA states that Apulia Regional Law on HPV vaccination certificate for students violates privacy laws
On 2 August 2024, the Italian Data Protection Authority (Italian DPA) published a resolution concerning Apulia Regional Law 22/2024, which mandates HPV vaccination certification for students (further information on this topic is available in our May Newsletter). The Italian DPA has determined that this Regional Law violates privacy laws. The Italian Constitutional Court is currently reviewing the Regional Law's constitutional legitimacy, particularly regarding potential jurisdictional conflicts between the Italian State and the Apulia Region. Nonetheless, the Italian DPA has emphasized that, irrespective of the forthcoming ruling, the data processing activities required by the Apulia Regional Law fail to adhere to the GDPR principles of necessity and proportionality.
Antitrust
EU Commission seeks comments on draft Guidelines on exclusionary abuse of dominance
On 1 August 2024, the European Commission launched a public consultation to seek feedback on the draft Guidelines on exclusionary abuse of dominant position. Those interested are invited to submit their comments by 31 October 2024. The Guidelines aim to increase legal certainty regarding the enforcement of Article 102 of the TFEU, specifically with regard to exclusionary abuses.
Tax
Italian Revenue Agency publishes ruling no. 175
On 21 August 2024, the Italian Revenue Agency published ruling no. 175 on the VAT rate applicable to several products qualified as nutritional supplements/medical devices. These products are subject to a reduced VAT rate of 10% since they are included in the items listed at no. 114, Table A, Part III, annexed to the Presidential Decree 633/72 (Italian VAT Decree). In addition, if products cannot be included under any item listed in the abovementioned table, they will be subject to the ordinary VAT rate (ie 22%).
