Life Sciences News in Italy: September 2024
Regulatory
EMA issues reflection paper on the use of AI in the lifecycle of medicines
On 9 September 2024, the European Medicines Agency (EMA) issued a reflection paper on the use of AI in the medicinal product lifecycle, covering development, authorisation, and post-authorisation. The reflection paper outlines relevant principles for regulatory evaluation to ensure the safe and effective use of AI in medicines. It reflects the EMA's experience in a rapidly evolving field and should be read alongside legal requirements and broader EU principles and legislation on AI.
TAR suspends the Decree of the Ministry of Health on CBD
On 10 September 2024, the Regional Administrative Tribunal (TAR) issued an order suspending the Decree issued by the Ministry of Health (MoH) on 27 June 2024, which included oral cannabidiol (CBD) compositions from cannabis extracts in the table of narcotic medicines established by Presidential Decree 309/1990. TAR granted a precautionary request from several companies, recognizing the potential economic harm from the immediate implementation of the Decree. By choosing to maintain the status quo until the merits hearing, scheduled for 16 December 2024, TAR took precautionary measures to prevent market destabilization.
Ministry of Health appoints new members of the National Coordination Centre for ethics committees
On 23 September 2024, the Italian Ministry of Health (MoH) issued a decree appointing the new members of the National Coordination Centre for ethics committees for clinical trials on medicinal products and medical devices (Coordination Centre). The members serve a three-year term and may be reappointed. The Coordination Centre provides support and advice to ethics committees, monitoring their activities to ensure compliance with Regulation (EU) 536/2014 on clinical trials (CTR).
AIFA launches new platform to manage pharmacovigilance funds
On 16 September 2024, the Italian Medicines Agency (AIFA) announced the launch of a new platform to optimize the management of pharmacovigilance funds, which are relevant for the operation of regional centres and the implementation of active pharmacovigilance projects. This improves the understanding of the benefit-risk profile of medicines once they are on the market and used in real-world conditions. Available from 1 October, the platform aims to increase financial efficiency and ensure transparent management.
WCC/Compliance
Legislative Decree on Corporate Sustainability Reporting published in the Official Gazette
On 10 September 2024, Legislative Decree 125/2024 implementing Directive 2022/2464/UE EU on Corporate Sustainability Reporting Directive (CSRD), was published in the Official Gazette. The Decree modifies the previous regulations on non-financial reporting, requiring in-scope legal entities to provide investors and the general public with detailed information on their sustainability impact on people and the environment. Sustainability reports have to include the entity's sustainability goals and strategy, a risk assessment of its negative impacts and measures for mitigation. Reporting obligations will be progressively applicable, starting from initially large and public interest entities (from fiscal year 2024) up to smaller companies (from fiscal year 2026).
Assonime publishes position paper on corporate criminal liability for offences perpetrated abroad by seconded employees
On 11 September 2024, Assonime (Italian Association among Stock Companies) published a position paper analyzing the possibility of holding an entity criminally liable pursuant to Legislative Decree 231/2001 (Decree 231) for offences committed by employees seconded abroad. It's already well established that legal entities may be held liable under Decree 231 for offences committed outside Italy, in accordance with the general principles of the Italian Criminal Code. Assonime's paper further concludes that the juridical nature of employee secondment does not preclude the potential corporate criminal liability for the employing company, provided that all other conditions for liability under Decree 231 are met. Moreover, the paper suggests possible controls to be implemented by seconding entities to prevent illicit conducts by seconded employees.
IP
Upcoming calls for proposals to support the industrial property rights of SMEs
On 2 September 2024, the Ministry of Enterprises and Made in Italy published in the Official Gazette the Directorate Decree issued on 31 July 2024. The Decree aims to allocate funds to support industrial property rights for small and medium-sized enterprises, including those in the life sciences sector. Of the EUR32 million allocated, EUR20 million are specifically earmarked for patents. The procedures for submitting applications will be announced shortly.
Data Privacy & Cybersecurity
Framework Convention on AI gathers first signatures
On 5 September 2024, the Council of Europe announced that the Framework Convention on Artificial Intelligence (Convention) gathered its first signatures. The Convention mandates that signatory states regulate the entire lifecycle of AI systems through legislative and administrative measures. Its goal is to promote technological innovation while safeguarding human rights, democracy and the rule of law. The Convention addresses AI use by public authorities and private entities but excludes national defence and research, unless such activities threaten human rights or democratic principles. It aims to fill legal gaps created by rapid AI advancements, complementing existing international standards.
European Commission publishes FAQs on the Data Act
On 6 September 2024, the European Commission published the Frequently Asked Questions on the Data Act (FAQs), one of the pillars of the European Data Strategy. Although the Data Act is sector-neutral, it is expected to have a significant impact on the life sciences industry, given the sector's strong focus on innovation and extensive use of advanced technologies. Although non-binding, the FAQs offer important clarifications on several aspects of the new legislation, such as the intersection between the Data Act and the GDPR, and the data in scope and clarifications on the definitions of "connected product" and "related service." The FAQs also further clarify the new notions of "data holder," "user" and "third party." The Data Act will become applicable on 12 September 2025.
Legislative Decree implementing the CER Directive published in the Official Gazette
On 23 September 2024, Legislative Decree 134/2024 implementing Directive (EU)2022/2557 on the resilience of critical entities (CER Directive) was published in the Official Gazette. The CER Directive complements the existing cybersecurity compliance framework established by the NIS2 Directive. The primary aim of the CER Directive is to harmonize security measures in providing essential services and strengthen cross-border cooperation among critical entities, including those in healthcare. It introduces a broader and more comprehensive approach to protecting critical infrastructure, partly to enable EU member states to better address cross-border interdependencies and manage the potential impacts of threats and incidents. The Legislative Decree will enter into force on 18 October 2024.
European Commission publishes guidelines on the Data Governance Act
On 24 September 2024, the European Commission published the New practical guide to the Data Governance Act (Guide). The Data Governance Act (DGA), which came into effect a year ago, aims to facilitate voluntary data sharing for the benefit of businesses and citizens by creating a more secure and trustworthy framework for sharing data. The Guide simplifies the DGA's provisions, offering clear explanations for each chapter to help stakeholders better understand and implement the regulation. The Guide highlights key provisions, such as the ability to re-use specific categories of protected data and explains the concept of "data altruism," where individuals or companies voluntarily and without compensation allow their data to be used for objectives of general interest, including healthcare.
CJEU clarifies the corrective power of supervisory authorities under the GDPR
On 26 September 2024, the Court of Justice of the European Union (CJEU) published its judgement in Case 768/21 addressing the corrective power of supervisory authorities under the GDPR. More specifically, the CJEU ruled that supervisory authorities are not required to impose corrective actions, such as administrative fines, simply because a data breach has occurred. If a fine is not necessary to correct the issue or ensure GDPR compliance, the authority is not obligated to impose one. This could apply, for example, when the data controller has promptly taken effective measures to stop the breach and prevent it from happening again. The CJEU reminded that the GDPR gives supervisory authorities discretion in deciding how to address violations based on the specific situation.
Antitrust
European Commission publishes report on the future of European competitiveness
On 9 September 2024, the European Commission published a report addressing the emerging "competitive gap" in the EU pharmaceutical sector. The report proposes to increase incentives for R&D investment in the EU, streamlining burdensome bureaucratic procedures, facilitating international partnerships – including those with non-member states – and introducing guidelines for the safe use of AI in developing medicine.
CJEU overturns General Court's judgement in Illumina/Grail merger
On 3 September 2024, the Court of Justice of the European Union (CJEU) issued a judgement which overturns the previous General Court's judgement on the Illumina/Grail merger. The CJEU has annulled the decision of the European Commission that accepted the referral request submitted in accordance with Art. 22, par. 1, of EU Merger Regulation (EUMR). According to the CJEU's judgement, the European Commission cannot review transactions referred by national competition authorities when they don't meet the thresholds required for the notification under EUMR and national merger control laws.
Tax
Italian Revenue Agency publishes ruling no. 179 on VAT exemption in the provision of healthcare and rehabilitation services
On 12 September 2024, the Italian Revenue Agency published the ruling no. 179 on VAT exemption applicable to the provision of healthcare and rehabilitation services. The ruling clarifies that healthcare and social services provided to in-house patients in rehabilitation centres benefit from the VAT exemption under Art. 10, no. 21, of Presidential Decree 633/72 (Italian VAT Decree), even when these services are provided outside those facilities, as long as they are covered by the same "global" service agreement.
