Life Sciences News in Italy: January 2024
European Commission proposes to extend IVDR transitional period
On 23 January 2024, the European Commission adopted a Proposal to extend the transitional period for in-vitro-diagnostic medical devices under Regulation (EU) 2017/746 (IVDR). The Proposal addresses potential shortages and grants manufacturers more time to comply with the new requirements of the IVDR, specifically until 31 December 2027 for high-risk (Class D), 31 December 2028 for high/moderate-risk (Class C), and 31 December 2029 for lower-risk (Class B and Class A sterile) devices. Additionally, the Proposal aims to speed up the implementation of completed sections of the European Database on Medical Devices (EUDAMED) and requires advance notice from manufacturers before interrupting the supply of critical devices, also affecting medical devices regulated under Regulation (EU) 2017/745 (MDR). The Proposal will now be forwarded to the European Parliament and Council for adoption.
New AIFA organizational structure becomes effective
On 15 January 2024, the Decree 3/2024 of the Italian Ministry of Health was published in the Official Gazette. The Decree amends the organizational structure of the Italian Medicines Agency (AIFA). Effective from 30 January 2024, the Decree eliminates the role of the General Director and introduces two new managerial positions: the Administrative Director and the Technical-Scientific Director. The Decree also abolishes the Technical-Scientific Commission and the Pricing and Reimbursement Committee, transferring their functions to the newly established Scientific and Economic Drug Commission.
AIFA identifies list of medicines that cannot be exported
On 5 January 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.
Legislative Decree 218/2023 on veterinary medicines
On 3 January 2024, Legislative Decree 218/2023 was published in the Official Gazette. The Decree aligns Italian national legislation with Regulation (EU) 2019/6 on veterinary medicinal products. Effective from 18 January 2024, the Decree addresses Member States’ responsibilities, covering areas like stockpiles and distribution. It regulates marketing authorizations, clinical trials, and includes provisions on homeopathic and generic veterinary medicines.
Updated list of healthcare facilities that can conduct Phase I clinical trials
On 8 January 2024, AIFA published the updated list of Italian healthcare facilities that can conduct Phase I clinical trials. The list includes facilities that have self-certified compliance with AIFA Resolution 809/2015, which outlines minimum requirements for the functioning of healthcare facilities engaged in Phase I clinical trials of medicinal products involving patients and/or healthy volunteers.
Italian Sunshine Act: Implementing decree expected in the first months of 2024
Following the Italian Sunshine Act (Law 62/2022), the new comprehensive framework for transparency of relationships between healthcare professionals and pharmaceutical companies has been waiting for the approval of the relevant implementing decree. In the summer, a draft decree, along with the technical guidelines for establishing the “Transparent Healthcare” platform, was submitted for a public consultation involving private sector entities, healthcare organizations and NGOs. On 8 October 2023, the consultation’s conclusive report was published. It can be expected that the implementing decree may finally be approved in the first months of 2024.
European Sustainability Reporting Standards (ESRS) enter into force
On 1 January 2024, the European Sustainability Reporting Standards (ESRS) entered into force. The ESRS – set forth by Commission Delegated Regulation (EU) 2023/2772 – establishes a common framework for evaluating and reporting on the material impacts, risks, and opportunities in the context of environmental, social, and governance (ESG) sustainability matters. The first entities obligated to publish, in 2025, a sustainability report for the financial year of 2024 will include those previously subject to the Non-Financial Reporting Directive, many of which are operating in the pharma sector, as they include large, listed companies, or parent companies of large corporate groups.
The establishment of the NMVOas a pharmaceutical anti-counterfeiting and traceability system
On 17 January 2024, the National Medicines Verification Organization (NMVO Italy) was established. This represents the first step in preparing the pharmaceutical sector for the Italian implementation of Directive (EU) 2011/62 and Delegated Regulation (EU) 2016/161 on the prevention of medicines counterfeiting. Most importantly, the introduction in Italy of the European framework on medicines traceability and anti-counterfeiting will reform the regulations concerning pharmaceuticals packaging and circulation, replacing the electronic vignette (bollini elettronici) system. Reuniting the main actors of the pharmaceutical industry (including Federfarma and Farmindustria), the NMVO will monitor the next legislative steps and support the upcoming institutional discussions.
New incentives to promote innovation and patent registrations
On 11 January 2024, Law 206/2023 entered into force. The law is intended to encourage the growth of the “Made in Italy” manufacturing system, including companies operating in the Life Sciences sector. Article 6 provides for incentives – named Voucher 3I – Investire In Innovazione – for startups and micro-enterprises, aiming at promoting the development of innovation processes. Vouchers 3I can be used to buy consulting services to assess inventions’ patentability, carry out prior art searches, draft patent applications to be filed with the Italian Patents and Trademarks Office, and extend national applications abroad. EUR8 million has been allocated for 2023 and EUR1 million for 2024.
EU Data Act enters into force
On 11 January 2024, Regulation (EU) 2023/2854 on harmonized rules on fair access to and use of data entered into force. The Regulation is known as the Data Act. Positioned as a key element of the European strategy for data, the Data Act aims to remove barriers to a well-functioning EU market for both personal and non-personal data. It introduces new obligations, particularly for manufacturers of connected products, providers of related services, data processing service providers, and data holders that make data available. While the Data Act is a comprehensive and sector-neutral legislation, it will have a substantial impact on the healthcare sector. Recital 14 identifies medical and health devices and health and lifestyle equipment among the connected products targeted by the Regulation. The Data Act will be fully applicable from 12 September 2025.
Agenas suspends the tender process for the implementation of an AI healthcare platform
On 9 January 2024, the National Agency for Regional Healthcare Services (Agenas) temporarily suspended the tender process for the implementation of an AI platform to support primary healthcare assistance services. This decision was taken as a precautionary measure in response to a request from the Italian Data Protection Authority. The Authority urgently sought relevant information to conduct a comprehensive data protection impact assessment on the proposed AI platform, in accordance with Article 36 of the General Data Protection Regulation (GDPR). Agenas anticipates receiving the necessary information from the Ministry of Health, and, in the interim, has opted to postpone the original deadline for bid submissions. The initial deadline, originally set for the end of January 2024, will be rescheduled at a later stage. Agenas commits to promptly communicate and disclose the new deadline well in advance.
Digitalization of public contracts
As of 1 January 2024, certain provisions of Legislative Decree 36/2023 (New Public Procurement Code) concerning the digitalization of public contracts take full effect. It includes Articles:
- 19 (digital principles and rights)
- 20 (principles on transparency)
- 22 (national ecosystem of procurement (e-procurement))
- 23 (national database of public contracts)
- 24 (virtual file of the economic operator)
- 25 (digital procurement platforms)
- 28 (transparency of public contracts)
- 29 (rules applicable to communications)
- 30 (use of automated procedures in the life cycle of contracts)
- 31 (registry of economic operators participating in public contracts).
Digitalization applies to all contracts, of any amount, in ordinary sectors and special sectors. It is worth mentioning the centrality of the ANAC (Anticorruption Authority) database, the virtual file of the economic operator, and changes in the legal publicity of tender documents.
Payback of medical devices: updates on the status of the proceedings before the Constitutional Court
The Administrative Court of Rome adopted a total of 16 orders of remittal to the Constitutional Court concerning the payback of medical devices through which it has incidentally promoted the judgment on the constitutional legitimacy of Article 9-ter of Law Decree 78/2015, on the grounds of conflict with Articles 3, 24, 41, and 117 of the Italian Constitution. The Constitutional Court published the first remission orders in the Official Gazette of 17 January 2024, having ascertained that they are formally in compliance. From the date of the publication of the order, the procedural deadlines for the parties to enter an appearance, and the term for setting of the hearing begin to run.
European Commission publishes new report on competition law enforcement in the pharma sector
On 26 January 2024, the European Commission published a report on the enforcement activities carried out in the pharmaceutical sector by the European Commission and the National Competition Authorities between 2018 and 2022. The report provides details about antitrust cases (investigations resulted in 26 final decisions, either accepting commitments proposed by pharmaceutical companies or leading to the imposition of fines, for a total of EUR780 million) and merger control cases between pharmaceutical companies.
Anticipi Decree repeals obligation to electronically file daily accounts to the Health Insurance Card System
As of 1 January 2024, the Anticipi Decree (Law Decree 145/2023) takes effect. The Anticipi Decree repeals the obligation to electronically file daily accounts (corrispettivi giornalieri) to the Health Insurance Card Systems (Sistema Tessera Sanitaria) by persons who perform transactions pursuant to Article 22 of the Presidential Decree 633/72 (e.g. hospitals, IRCCS institutions, and pharmacies) and who are required to send data on health/veterinary expenses to the system.
Milleproroghe Decree postpones e-invoicing ban in the healthcare sector
The Milleproroghe Law Decree (Article 3(3) of Law Decree 215/2023) extends the ban on e-invoicing in the healthcare sector. As of January 2024, in relation to B2C services, the invoice still requires either hard copy or extra-Sdl electronic format.
Italian Revenue Agency confirms Superbonus 110% will remain in force until the end of 2025
On 8 January 2024, the Italian Revenue Agency confirmed that the “Superbonus 110%” (Article 119(10-bis) of Law Decree 34/2020) dedicated to the socio-sanitary sector will remain in force until the end of 2025. The Superbonus is applicable by certain socio-sanitary institutions (eg ONLUS, Odv, and APS) to expenses incurred on limited types of real estate properties:
Owned on the basis of specific rights;
In which healthcare activities, simple sanitary assistance and/or ancillary activities are carried out.
Italian Supreme Court on the right to recover input VAT
On 9 January 2024, the Italian Supreme Court published a ruling on the right to recover input VAT.
The appealing company, which manufactures and distributes dietary supplements and cosmetics, challenged the Italian Tax Authority’s refusal to refund the input VAT paid on the purchase of manufacturing equipment, which never became operational.
The Supreme Court, in accordance with the established national/EU case law, confirmed that to grant a VAT refund on the mentioned purchase, there needs to be a direct and immediate link with the taxable person’s economic activity. The Supreme Court rejected the appealing company’s arguments because:
The production of limited samples of product was not in itself sufficient to prove the actual exercise of a productive activity; and
The taxpayer did not give evidence of either the connection between the purchase and the business activity, or the reasons behind the lack of industrial production (eg force majeure).
Minimum wage increases for employees in the Chemical-Pharmaceutical sector
On 8 January 2024, trade unions of the Chemical-Pharmaceutical sectors and employers’ associations executed an Agreement to Sustain the Employees of the Chemical-Pharmaceutical Industry. The Agreement is binding for companies that apply the relevant industry-wide national collective bargaining agreement. The Agreement provides for the anticipation of the increase of the monthly minimum wages, which was originally agreed as of 1 July 2024, retrospectively from 1 January 2024. The increases vary proportionally depending on the employees’ level, taking as average benchmark the increase of EUR68 for the level D1.