Life Sciences News in Italy: February 2024

Regulatory

AI Act progresses toward formal adoption

On 13 February 2024, the European Parliament endorsed the provisional agreement on the Artificial Intelligence Act (AI Act) at committee level. The AI Act needs to be formally adopted by both the Parliament and the Council of the European Union, with the final vote from the Parliament planned for 13 March 2024. The AI Act will significantly affect the medical device industry, particularly targeting AI systems classified as “high risk” by imposing specific mandatory requirements. As many medical devices incorporating AI systems will fall into this category, manufacturers will face additional obligations beyond those outlined in Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR).

CJEU rules on distance selling non-prescription medicinal products

On 29 February 2024, the Court of Justice of the European Union (CJEU) ruled that a company that does not have the status of pharmacist can operate a website that merely connects pharmacies and customers for the sale of non-prescription medicines, insofar as the service is specific to and distinct from the sale itself.

Italian Ministry of Health adopts guidelines on veterinary medicines

On 8 February 2024, the Italian Ministry of Health issued guidelines on the implementation of Legislative Decree 218/2023 and Regulation (EU) 2019/6 on veterinary medicines. The guidelines cover labelling, traceability, and the validity of prescriptions, among other aspects. The guidelines also clarify the procedures for delivering free samples and the requirements for importing from third countries.

AIFA identifies list of medicines that cannot be exported

On 20 February 2024, the Italian Medicines Agency (AIFA) published a Resolution with a list of medicines that cannot be exported. The Resolution aims at safeguarding national supply and preventing shortages.

Italian Ministry of Health appoints new AIFA President and members of the Scientific and Economic Drug Commission

On 2 February 2024, the Italian Minister of Health appointed the members of the new Scientific and Economic Drug Commission (Commissione scientifica ed economica del farmaco) of the Italian Medicines Agency (AIFA). Lara Nicoletta Angela Gitto was appointed as Chairperson, alongside other members selected by the Minister of Health (Giancarlo Agnelli, Walter Marrocco, and Vincenzo Danilo Lozupone). The new designated members also include Ida Fortino, Elisa Sangiorgi, Giuseppe Toffoli, and Giovanna Scroccaro. Their tenure spans three years, with the possibility of renewal for one additional term. The Commission also incorporates the technical-scientific director of AIFA and the president of the National Institute of Health (ISS). Francesco Fera has been appointed President, succeeding Giorgio Palù.

 

WCC/Compliance

International cooperation in the fight against pharma-crimes: The results of operation Shield IV

On 14 February 2024, the Italian Ministry of Health disclosed the conclusion of a cross-border investigative operation, concerning pharma-crimes (counterfeiting, fraud, theft, and illicit trafficking of pharmaceuticals), known as Shield IV. The investigation, coordinated by Europol, spanned nearly 30 jurisdictions, encompassing both EU and non-EU countries. In Italy, with the support of the Health Protection Police (NAS), the operation resulted in 5 arrests, 126 criminal complaints, and seizures of medicines worth EUR 9 million. The investigation focused on the online market, where 79 websites have been shut down, and on trafficking of new psychoactive substances and dietary supplements.

NAS concludes investigations into regulatory and legal compliance in retirement homes

On 28 February 2024, the Italian Ministry of Health issued a press release on the conclusion of multiple investigations conducted by the Health Protection Police (NAS) throughout Italy on more than 600 retirement homes, aimed at detecting possible irregularities and non-compliance. In 191 cases (32% of the inspected homes), the NAS found different types of wrongdoings, including some with possible criminal relevance. The offenses included violations of health and safety rules, abusive exercise of medical profession, and detention of expired medicines. The NAS said it will continue to closely monitor the adequacy of the standards of assistance offered by retirement homes and similar structures to protect the health of vulnerable people, verifying compliance with safety legal requirements.

Anti-counterfeiting of medicines: Italian government to implement Delegated Regulation (EU) 2016/161

On 24 February 2024, Law 15/24 was published in the Official Gazette. The Law tasked the Italian government with adopting, within 12 months from its entry into force, all the appropriate measures to bring national legislation in line with the provisions of Delegated Regulation (EU) 2016/161 on the prevention of medicines counterfeiting. Specifically, the government will have to:

• introduce measures to ensure unique identifiers and tamper-proof devices are used on medicine packaging;
• guarantee manufacturers have enough time to update their technology;
• set the modalities for the Ministry of Health and the Italian Medicines Agency (AIFA)’s controls on potential cases of counterfeiting; and
• redefine the relevant sanctioning system.

 

Data, Privacy and Cybersecurity

Italian Data Protection Authority sets new limits on email metadata retention for employers

On 6 February 2024, the Italian Data Protection Authority (IDPA) published new guidelines on the “Computer programs and IT services for managing email in the workplace and metadata processing”. The guidelines are sector neutral but may affect any company operating in Italy, including those in the Life Sciences sector. The guidelines prohibit employers from retaining email metadata – including details like date, time, sender, recipient, subject, and size of emails sent by employees – for a period exceeding seven days. This retention window can be extended by an additional 48 hours if there is a substantiated and documented necessity. If organisations seek to prolong the retention period beyond the specified limit, they must make an agreement with Trade Unions or get authorisation from the Local Labour Office (Direzione Territoriale del Lavoro). They also have to implement privacy-related measures (including Data Protection Impact Assessment and Legitimate Interest Assessment) to comply with the IDPA’s guidelines.

On 27 February 2024, the IDPA suspended the enforceability of the guidelines and launched a public consultation aimed at gathering feedback and suggestions from stakeholders on two main points: (i) the appropriate duration for retaining metadata, and (ii) the potential uses of this metadata that may require retention beyond the seven-day-term. Depending on the feedback received, the IDPA may provide clarifications or amend the guidelines. Otherwise, the guidelines will become applicable 60 days after the expiry of the consultation deadline.

Italian Ministry of Health sets up working group on the right to be forgotten for cancer survivors

The Italian Ministry of Health (MoH) is setting up a working group to implement the “Law on the right to be forgotten for cancer survivors” (Law 193/2023), which became effective on 2 January 2024. Among others, the law prohibits banking, financial, investment and insurance service providers from asking for and using information on individuals’ cancer diagnoses after ten or five years from their treatment. While the MoH hasn’t made an official announcement on the working group, this news was disclosed by one of its appointed members.

 

Product Liability

CJEU discusses case submitted by the Italian Supreme Court on the extension of the producer’s liability to the supplier

On 8 February 2024, the Court of Justice of the European Union (CJEU) discussed a case referred as a preliminary ruling by the Italian Supreme Court.

On 13 March 2023, the Italian Supreme Court asked the CJEU for a preliminary ruling on the following issue: “Is an interpretation that extends the producer’s liability to the supplier, even where the latter has not physically placed its own name, trademark or other distinguishing feature on the item, on the sole ground that the supplier has a name, trademark or other distinguishing feature that is in whole or in part the same as that of the producer, consistent with Article 3 of Directive 85/374/EEC? If it is not consistent with that provision, why is that the case?”

The CJEU ruling hasn’t been published yet, but it will affect litigation against medical device suppliers that are part of the same group as manufacturers.

 

Public Procurement

Medical Device Governance Fund: Ministry of Health defines criteria for paying annual fees

On 9 February 2024, the Decree issued by the Ministry of Health on 29 December 2023, establishing the criteria and procedures for paying the annual fees destined to the “Fund for the Governance of Medical Devices”, was published in the Official Gazette. The Decree requires companies producing or distributing medical devices and large medical equipment and in vitro diagnostic medical devices to pay an annual fee of 0.75% of their turnover, which must be self-declared every year. The payment is due between 1 November and 31 December of each year. Starting in 2024, without prejudice to the right to appeal before the Administrative Judge, medical device companies will have to pay a new form of contribution in addition to the pending payback issue.

 

Tax

Italian Revenue Agency Videoconference provides clarifications on Superbonus 110% (as per Circular no. 3/2023)

On 1 February 2024, the Italian Revenue Agency clarified the application of the Superbonus 110% for expenses incurred, by 31 December 2025, by certain socio-sanitary institutions (e.g. ONLUS, OdV and APS). The rules apply to institutions that, under Article 119(10-bis) of Law-Decree 34/2020:

• carry out socio-sanitary and welfare services, and whose board members don’t receive any remuneration or allowances;
• possess (including property, usufruct, or free loan) properties falling within cadastral categories B1 (i.e. non-profit structures used for specific social and welfare activities), B2 (i.e. nursing, hospitals, polyclinics) and D4 (i.e. for-profit hospitals and polyclinics).

For these socio-sanitary institutions, the Superbonus 110% also applies to expenses related to installing photovoltaic systems with a power up to 200 kW.

State General Accounting Office sets deadlines for healthcare and veterinary expenses

On 8 February 2024, the State General Accounting Office (Ragioneria Generale dello Stato) provided that the submission of healthcare expenses incurred as of 1 January 2024 will take place:

• by 30 September of each year, for expenses incurred in the first half of the year; and
• by 31 January of the following year for the expenses incurred in the second half of the previous year.

The new deadline affects all healthcare operators required to send data to the Health Insurance Card System (Sistema Tessera Sanitaria).

Italian Revenue Agency provides clarifications on Allowance for Corporate Equity (ACE)

On 8 February 2024, the Italian Revenue Agency published Tax Ruling no. 38/2024 and clarified that, for calculating the ACE benefit:

• the share premium reserve with tax suspension restriction due the application of Art. 110(8) of Law-Decree 104/2020 is relevant as equity increase as the tax suspension restriction does not change its nature as an “equity” reserve. The reserve is not relevant for “Super ACE” allowance provided that the capital increases were performed in 2012 and 2016; and
• the decrease in the shareholders’ equity attributable to the transition to the IFRS 9 accounting standard does not affect ACE base at the time of the FTA recognition, without prejudice to the need to adjust the profits of subsequent years when the events giving rise to this reserve occur.

Italian Revenue Agency provides clarifications on Old Patent Box

On 9 February 2024, the Italian Revenue Agency published Tax Rulings no. 39 and 41, providing clarifications on the “Old” Patent Box (OPB) legislation. The OPB was a favourable tax regime introduced to incentivize research and development activities, including for companies in the Life Sciences sector. The regime allowed a partial de-taxation of income from the use of specific intangible assets (i.e. software, knowhow, industrial patents and designs). More specifically:

• Tax Ruling no. 39: a company in 2018 entered into a OPB ruling agreement with the Italian Revenue Agency for the direct use of intangibles in the fiscal years (FY) from 2015 to 2019. However, although it could already recover the OPB benefit within its 2018 tax return, it remained inactive and did not file any supplementary return. As a consequence, the taxpayer lost the OPB benefit for 2015 and 2016 since for those FYs the deadline for filing supplementary returns has expired.
• Tax Ruling no. 41: in case of signing an amendment to an already signed OPB ruling agreement covering complementary intangible assets for specific fiscal years, the taxpayer can take advantage of the OPB benefit by filing supplementary tax declarations relating to FYs covered by the OPB amended agreement. As an alternative, the total OPB benefit can be included in the tax return for the FY in which the amendment was signed.

Italian Revenue Agency provides clarifications on New Patent Box

On 9 February 2024, the Italian Revenue Agency published Tax Ruling no. 40, providing clarifications on the “New” Patent Box (NPB) regime, which provides for a 110% “Super deduction” of the research and development costs incurred for certain intangibles (i.e. software, industrial patents and designs), including for companies operating in the Life Sciences sector. More specifically, as indicated by the Tax Ruling, the NPB benefit is granted to companies belonging to a consortium if it, operating according to the cost recharge mechanism, is the instrument through which the research and development activities are carried out and the investment risk is shared. If the consortium outsources research and development activities to entities controlled by the consortium companies, the expenses incurred by the consortium and passed on to the consortium companies would not be eligible for the NPB relief.

Italian Revenue Agency provides clarifications on the criteria for allocating tax credits in de-mergers

On 22 February 2024, the Italian Revenue Agency published Tax Ruling no. 48, providing clarifications on the tax credit in relation to expenses incurred for (i) sanitising environments and tools, and (ii) purchasing personal protective equipment and other devices, including the expenses related to COVID-19 buffers (Art. 32 of Law-Decree 73/2021). According to the clarifications, the tax credit would not qualify as a tax asset (posizione soggettiva) under Art. 173(4) of DPR 917/1986 (TUIR). So it would represent an autonomous element of the net assets of the demerged company capable of being distributed, in the demerging plan, according to the will of the parties.