Life Sciences News in Italy: April 2024
Regulatory
EU Parliament adopts position on the EU pharmaceutical reform
On 10 April 2024 – less than a year since the European Commission published its proposal – the European Parliament adopted its position on the EU pharmaceutical reform. Among others, the European Parliament focused on the regulatory data protection period by proposing:
- a minimum regulatory data exclusivity period of 7.5 years (during which other companies cannot refer to the pre-clinical tests and clinical trial data for the authorised reference medicinal product) in addition to 2 years of market protection (during which generic, hybrid or biosimilar products cannot be sold), following a marketing authorisation;
- additional periods of data exclusivity if the particular product addresses an unmet medical need (+12 months), if comparative clinical trials are conducted for the product (+6 months), and if a significant share of the product’s research and development takes place in the EU and at least partly in collaboration with EU research entities (+6 months), with a cap on the combined data exclusivity period of 8.5 years;
- a one-time extension (+12 months) of the 2-year market protection period if the company obtains marketing authorisation for an additional therapeutic indication which provides significant clinical benefits in comparison with existing therapies.
The reform process will continue under the new European Parliament following the European elections in June.
AIFA updates timelines for authorizing conferences and meetings
On 23 April 2024, the Italian Medicines Agency (AIFA) updated the validation timelines for sponsorship requests related to conferences and meetings. Pharmaceutical companies that intend to organise or contribute to such events still have to submit the communication to AIFA as outlined in Art. 124 of Legislative Decree 219/2006. But the validation timelines have been extended from 70 to 90 days from the start date of the event. The deadline for uploading payment receipts has been reduced from 55 to 40 days.
AIFA approves the Regulation governing the Scientific and Economic Drug Commission
On 17 April 2024, the Board of Directors of the Italian Medicines Agency (AIFA) approved the Regulation outlining the composition and functions of the Scientific and Economic Drug Commission (Commissione Scientifica ed Economica del Farmaco). The Commission – established by Decree 3/2024 of the Italian Ministry of Health amending the organizational structure of AIFA – replaces the Technical-Scientific Commission and the Pricing and Reimbursement Committee.
Ministry of Health appoints National Commission for updating Essential Levels of Assistance (LEAs)
On 12 April 2024, the Ministry of Health issued the Decree dated 18 March 2024, outlining the composition of the National Commission tasked with updating the Essential Levels of Assistance (LEA). The Commission will have a 3-year term and will be chaired by the Minister of Health. According to the Decree, representatives from the Health Council, scientific societies, and external experts in relevant fields can participate in Commission meetings at the President's request to provide their technical and scientific expertise.
European Commission launches Critical Medicines Alliance to prevent medicines shortages
On 24 April 2024, the European Commission’s Health Emergency Preparedness and Response Authority (HERA) launched the Critical Medicines Alliance to address critical medicines shortages in the EU. The Alliance, announced in October 2023, engages various stakeholders to improve availability of medicines while reducing supply chain dependencies through strategic recommendations and a multi-year plan. Discussions will focus on identifying investment projects and market incentives to improve manufacturing and procurement. The Alliance will also explore partnerships beyond the EU to expand the supply chain. Its mandate lasts for 5 years.
AIFA identifies list of medicines that cannot be exported
On 12 April 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.
WCC/Compliance
EU Parliament approves revision of the Urban Wastewater Treatment (UWWT) Directive: New obligations for pharmaceuticals and cosmetic products manufacturers
On 10 April 2024, the European Parliament approved a revision of Directive 91/271/EEC regulating the collection, treatment and discharge of urban wastewater, imposing stricter compliance requirements to reduce the increasingly concerning presence of (micro)pollutants in European waters. The new rules also introduce a regime of extended producer responsibility (ERP) for pharmaceutical and cosmetic products manufacturers, who may be obligated to cover at least 80% of the costs incurred for removing micro-pollutants from wastewater. The revised Directive is now waiting for final approval by the EU Council.
New EU Directive to step up efforts in the fight against environmental crimes
On 11 April 2024, Directive (EU) 2024/1203 aimed at strengthening the protection of the environment through criminal law was adopted. It replaces the previous legislations dating back to 2008 and 2009. By furtherly harmonizing the EU-wide minimum rules in the field, the Directive:
- requires criminalization of a broad list of conducts (e.g., serious breaches of legislation on chemicals);
- increases the sanctioning thresholds, both for individuals and legal entities responsible for such crimes; and
- promotes international cooperation for the investigation and prosecution in the field.
EU member states will have to transpose the Directive into national legislation before 21 May 2026.
EU Parliament approves Corporate Sustainability Due Diligence (CSDD) Directive
On 24 April 2024, the European Parliament approved the CSDD Directive, which sets to impose important due diligence requirements to prevent the adverse impacts of large companies on human rights and environment. The Directive applies, amongst others, to EU companies and parent companies with over 1,000 employees and a worldwide turnover higher than EUR450 million, also in respect of their operations with commercial partners (e.g. suppliers). In cases of non-compliance, the new legislation imposes fines of up to 5% of companies’ net worldwide turnover. The CSDD Directive is now waiting for final approval by the EU Council.
EU Parliament approves Regulation to ban products made with forced labour from the EU single market
On 23 April 2024, the European Parliament gave its approval for a new draft Regulation banning from the EU single market products made with forced labour. While requiring fines for non-compliant companies, the Regulation provides rules to enforce the ban, including on:
- investigations by member states’ Authorities and the European Commission;
- new IT solutions; and
- cooperation, also with third countries.
The Regulation is now waiting for final approval by the EU Council.
IP
OECD and EUIPO publish report on Illicit Trade in Fakes during COVID 19
The Organization for Economic Co-operation and Development (OECD) and the European Union Intellectual Property Office (EUIPO) published a report entitled “Illicit Trade in Fakes under the COVID 19”. The document provides an insight into trends observed in the trade of counterfeit products during the COVID-19 pandemic. The analysis shows that counterfeiting during the pandemic involved medicines, test kits, personal protective equipment and other related medical products. With regard to Italy, there was an influx of counterfeit health products coming from extra-EU countries, including masks, gloves, and antibacterial gels, which often infringed trademarks rights and were of inferior quality.
Data, Privacy and Cybersecurity
EU Parliament approves Regulation for the European Health Data Space
On 24 April 2024, the European Parliament approved the EHDS, signalling a fundamental step toward creating a robust European Health Union.
This significant milestone was achieved through a collaborative effort, with the EU Parliament and the EU Council reaching an agreement on 14 March 2024 on the proposed Regulation submitted by the Commission on 3 May 2022. The EHDS Regulation is one of the pillars of the Commission’s ambitious “European Data Strategy” aiming to enhance people’s access to and control over their health data and enable its reuse for public interest purposes, including scientific research.
The text of the Regulation will now have to be formally approved by the EU Council. It will enter into force 20 days after publication in the Official Journal of the European Union, which is expected in autumn.
Italy unveils 2024-2026 Artificial Intelligence Strategy
On 6 April 2024, the Italian Digital Agency (AgiD) and the Department for Digital Transformation released the executive summary of Italy's Artificial Intelligence Strategy for 2024-2026. The summary articulates the Italian government's vision and framework for AI development over the next 3 years, centred around four key pillars: scientific research, public administration, business, and training.
In the domain of scientific research, the document emphasises its critical role in enhancing quality of life and societal well-being and proposes a number of actions to bolster Italy's AI research ecosystem.
Italian government approves the proposal for a Law supplementing the AI Act
On 23 April 2024, the Italian government approved the proposal for a Law supplementing the AI Act, which will be submitted to the Italian Parliament for approval. The proposal addresses the use of AI in different fields, including the healthcare sector and scientific research. It emphasises the importance of advancing AI applications in healthcare while ensuring the protection of individuals’ rights, freedoms, and interests, notably regarding personal data protection. The proposal also contains provisions aimed at promoting responsible AI use in healthcare. The proposal also declares the processing of personal data performed for scientific research in the implementation of AI systems for therapeutic and pharmacological purposes to be of significant public interest and allows secondary use of health data for this purpose. The proposal intends to establish an AI platform under the auspices of the National Agency for Regional Health Services (AGENAS) to streamline healthcare professionals' engagement, provide advisory services, and facilitate access to healthcare services.
Italian Parliament amends Art. 110 of the Italian Privacy Code
On 23 April 2024, the Italian Parliament marked a significant milestone by approving an amendment to Art. 110 of the Italian Privacy Code, addressing "Medical, Biomedical, and Epidemiological Research."
The amendment eliminates the requirement for prior consultation with the Italian Data Protection Authority (Italian DPA) and its approval regarding research programs involving the processing of health data for scientific purposes, when obtaining consent from data subjects is unattainable.
This requirement – which presented a significant impediment to scientific research, particularly for retrospective studies – has now been overcome thanks to the approved amendment. The decision of the Italian Parliament marks a crucial step in fostering a more conducive environment for retrospective scientific research.
Italian MEF publishes procedures for exercising right to opt out to the transfer of digital health data to the FSE
On 20 April 2024, the Italian Ministry of Economic and Financial affairs (MEF) published in the Official Gazette the Decree dated 11 April 2024. The Decree rules on the procedure for exercising the right to opt out of the automatic transfer of Italian patients’ digital health data – related to services provided by the National Health Service until 18 May 2020 – to the Electronic Health Record (Fascicolo Sanitario Elettronico or FSE). According to the Decree, the Health Insurance Card system (Sistema Tessera Sanitaria) will include a dedicated functionality within each patient’s personal area for opting out. This functionality will remain active for 60 days. During this period, patients can opt out or revoke their previous choice on the transfer of their health data to the FSE. Digital documents already uploaded to the regional FSE with the patient’s specific consent are exempted from the opt out.
Advocate General’s Opinion on the definition of ‘data concerning health’
On 25 April 2024, the Court of Justice of the European Union (CJEU) published the Advocate General's Opinion in Case C-21/23 addressing the interpretation of a number of provisions of the General Data Protection Regulation (GDPR), including the definition of "data concerning health.” One of the questions submitted to the CJEU involved determining whether the data of customers purchasing pharmacy-only, non-prescription medicines through an online platform constitute "data concerning health” according to Art. 9, par. 1, of the GDPR. Pursuant to the Advocate General’s Opinion, the data doesn’t fall under the category of “data concerning health” since, in principle, only speculative or vague conclusions regarding the health status of the individual purchasing the pharmacy-only, non-prescription medicines bought online can be inferred. But the matter should be left for the referring court to scrutinize on a case-by-case basis.
Ministry of Health publishes new Decree on the right to be forgotten for cancer survivors
On 24 April 2024, the Italian Ministry of Health (MoH) published the Decree dated 22 March 2024 on the Official Gazette.
The Decree provides a list of oncological conditions for which shorter terms will apply to exercise the right to be forgotten, which range from 1 to 7 years. This term deviates from the standard 10-year post-treatment term provided by Law 193/2023, regarding the accrual of the right to be forgotten for cancer survivors.
EU Parliament endorses proposal for Regulation on additional rules for the enforcement of GDPR
On 10 April 2024, the European Parliament endorsed the proposal for a Regulation outlining additional procedural rules pertaining to the enforcement of the GDPR. The Regulation provides detailed rules to support the smooth functioning of the cooperation and consistency mechanism established by the GDPR, harmonising rules in:
- rights of complainants;
- rights of parties under investigation; and
- streamlining cooperation and dispute resolution.
The Regulation will reduce disagreements and facilitate consensus among supervisory authorities from the initial stages of the process. The text should now undergo scrutiny in discussions between the Council, the Parliament, and the Commission.
Italian DPA fines local health authority for unlawful use of the electronic health record
On 10 April 2024, the Italian Data Protection Authority (Italian DPA) published a Resolution regarding the failure by a local healthcare authority (Azienda sanitaria dell’Alto Adige) to appropriately configure access procedures to the electronic health record (Dossier Sanitario Elettronico). Specifically, numerous data subjects reported instances of unauthorized access to their electronic health records by healthcare personnel not involved in their care. The investigation revealed that the electronic health record management system allowed healthcare professionals to self-certify the reasons for accessing the records manually. Additionally, access was granted by default to a wide range of professionals unrelated to patient care, including administrative staff. The Italian DPA fined the local healthcare authority and mandated it to implement comprehensive technical and organisational measures to safeguard the security of personal data and prevent further unauthorized access.
Italian DPA sanctions healthcare authorities following cyberattack
On 10 April 2024, the Italian Data Protection Authority (Italian DPA) published three Resolutions (no. 194, 195 and 196) imposing sanctions on the Lazio Region, the local healthcare authority, and its IT system management company in response to a serious data breach involving the Lazio Region’s health system in 2021.
The breach, instigated by ransomware introduced through a laptop used by an employee of the Lazio Region, resulted in the disruption of numerous healthcare services, including the possibility of managing medical examination bookings, process payments, and register vaccinations. Investigations revealed that the Region relied on outdated systems and failed to implement adequate security measures to promptly detect personal data breaches and ensure network security, rendering regional healthcare facilities unable to access the system and provide essential services during the cyberattack. The IT system management company also neglected to take necessary actions to manage the breach and mitigate its repercussions.
Product Liability
The ‘Apparent Producer’ according to the Advocate General’s opinion
On 18 April 2024, the Advocate General of the Court of Justice of the European Union (CJEU) published its opinion on Case C-157/23 on the interpretation of the supplier’s liability for defective products. The Advocate General proposes to interpret Art. 3, par. 1, of Directive 85/374 in an extensive way and to consider the supplier of a defective product liable, when “presents itself to consumers as its producer,” ie as an “Apparent Producer.” According to the Advocate General, the supplier will be deemed liable as a producer “even where it has not physically placed its own name, trademark or other distinguishing feature” on the defective product if “the name of the supplier is the same, in the most relevant term, as the name, trademark or other distinguishing feature of the actual producer, that both belong to the same group of companies and that the allegedly defective [product] bears the trademark which is characteristic of both.”The Advocate General stated that Art. 3, par. 3, of Directive 85/374 – which limits the suppliers’ liability – does not apply to the “Apparent Producer.”
Although the case regards vehicles, the CJEU will rule on the interpretation of Directive 85/374, applying also to defective medical devices, which might be superseded by the new (not yet approved) EU Directive on liability for defective products.
Antitrust
European Commission’s Competition Policy Brief discusses how to assess innovation in pharma mergers
On 17 April 2024, the European Commission published the latest Competition Policy Brief, which focuses on how non-price parameters of competition are considered in the context of EU merger control. Non-price parameters include quality and product differentiation, data protection and privacy, sustainability, capacity and reliability of supply, and innovation. Particularly, the European Commission focuses on how to assess competition on innovation in the context of mergers in the pharmaceutical sector.
Italian Competition Authority publishes report on the fact-finding inquiry on hearing aids markets
On 26 March 2024, the Italian Competition Authority (ICA) published its final report on the fact-finding inquiry on the hearing aids markets in Italy. The report identified potential concerns pertaining to transparency and lack of information on price and technical specifications of products. The ICA subsequently submitted its remarks to the Italian national and regional governmental bodies about the measures to strengthen informative guarantees in the relevant markets. For further details click here.
Italian Supreme Administrative Court confirms fines on a pharma company for abuse of dominant position
On 29 March 2024, the Italian Supreme Administrative Court (Consiglio di Stato) dismissed the appeal against the judgement of the Administrative Court that had confirmed fines imposed by the Italian Competition Authority on a pharma company for the abuse, through the application of excessive and unfair prices, of its dominant position on the market for the production and sale of medicines for the treatment of an ultra-rare disease called Cerebrotendinous xanthomatosis (CTX).
