Highlights

Almost nine years after the last update, the measures revising the Essential Levels of Care (Livelli essenziali di assistenza – LEAs) were published in the Official Gazette of 30 September 2026, having been adopted in August following a comprehensive review process. The new provisions will enter into force on 30 October 2026.

The LEAs identify the healthcare services and treatments that the Italian National Health Service (Servizio sanitario nazionale – SSN) is required to provide throughout Italy, either free of charge or subject to patient cost-sharing.

The update amends the Decree of the President of the Council of Ministers (D.P.C.M.) of 12 January 2017 and is set out in two separate measures: the Decree of the Minister of Health of 3 August 2026, issued jointly with the Minister of Economy and Finance, and the D.P.C.M. of 7 August 2026.

The use of two different types of measures reflects the procedure laid down by Law No. 208/2015. As a general rule, the LEAs are updated by D.P.C.M.; however, where amendments concern the lists of services provided by the SSN or measures aimed at improving their appropriateness and do not entail costs for public finances, the law allows the update to be adopted by decree of the Minister of Health, issued jointly with the Minister of Economy and Finance.

Overall, the update covers approximately 800 services, treatments and therapies, introducing new items as well as amending, replacing or revising existing ones.

The main changes include the nationwide introduction of newborn screening for spinal muscular atrophy (SMA) and the extension of newborn screening to additional metabolic and rare diseases. New services relating to pregnancy are also provided for, including non-invasive prenatal testing (NIPT), together with new measures in the field of oncology.

The update also covers rare, chronic and disabling diseases, adding new conditions and services eligible for exemption from patient cost-sharing and revising those already included. Specialist outpatient services and prosthetic care have also been updated, with new services being introduced and certain existing services being revised or removed.

In its judgment of 2 July 2026 in Case C-427/24, the Court of Justice of the European Union ruled that, in light of the definition of ‘medical device’ set out in Article 2(1) and (12) of Regulation (EU) 2017/745, patient identification wristbands supplied without any markings and intended to be worn by patients in the healthcare sector cannot be classified as such, even though they may be individually printed with letters, numbers and/or a barcode for the purpose of recording identification details and other relevant data.

Specifically, the question referred for a preliminary ruling to the Court arose from the fact that, in an advertising document provided by the manufacturer of the products, it was stated that the identification of patients by means of such wristbands could improve their safety, in particular in the context of the administration of medicines, the performance of tests and blood transfusions, by preventing dangerous errors on the part of healthcare staff.

According to the European judges, although advertising may help to clarify the ‘intended purpose’ of the products, as defined in Article 2(12), when classifying a product as a ‘medical device’, account must be taken not only of the information provided by the manufacturer but also of whether the product objectively fulfils the functions set out in Article 2(1) of Regulation 2017/745, and the information itself must also be interpreted from the perspective of the intended user.

In the present case, the wristbands were supplied unmarked and described solely in relation to their use, namely the identification of patients, an objective which  could also be achieved by other means (via a name tag, a personalised badge or a copy of an identity document), which demonstrates that an identification bracelet, as such, has no direct influence on diagnostic or therapeutic activities, nor does it have any other specific medical purpose amongst those mentioned in the regulation.

By Orders Nos. 12114 and 12115 of 2 July 2026, the Regional Administrative Court (TAR) of Lazio referred to the Italian Constitutional Court the question of the constitutionality of the legislation governing the pharmaceutical expenditure payback mechanism (Article 1(145) of Law No. 145/2018 and Article 15(8) of Decree-Law No. 95/2012), questioning whether the financial burden imposed on pharmaceutical companies remains consistent with the principles of solidarity that originally justified its introduction.

Referring to the Constitutional Court's previous rulings on both the pharmaceutical payback scheme (Judgment No. 70/2017) and the medical devices payback mechanism (Judgment No. 140/2024), the TAR observed that the challenged legislation has, over time, resulted in the systematic and recurring imposition of a financial obligation whose annual amount is inherently unpredictable. According to the Court, the measure can no longer be regarded as addressing exceptional or contingent circumstances, nor is it limited to a predetermined period of time. It has therefore lost its original solidarity-based rationale and has evolved into an ordinary and structural instrument for financing the National Health Service. In the TAR's view, this may result in an unreasonable and disproportionate restriction on the freedom of economic initiative and an excessive interference with contractual autonomy.

These referrals depart from the most recent case law of the administrative courts, which had dismissed similar challenges concerning payback obligations for previous financial years.

With its Third Position Paper on biosimilar medicinal products, the Italian Medicines Agency (AIFA) updates its policy framework in light of developments at the European scientific and regulatory level, confirming previously established principles while clarifying certain aspects of practical application.

The document reiterates that biosimilars are not generic medicines, but biological medicinal products similar to an already authorised reference product, whose assessment is based on a rigorous comparability exercise aimed at excluding clinically meaningful differences in terms of quality, safety and efficacy. In continuity with the previous Position Paper, alignment with the European framework is further strengthened, with specific reference to centralised procedures and EMA guidelines.

The strategic role of biosimilars within the National Health Service is reaffirmed, as lower-cost therapeutic options capable of enhancing system sustainability, expanding access to care and supporting the introduction of innovative therapies.

The new Position Paper incorporates the position developed at European level, according to which authorised biosimilars may be considered interchangeable with their respective reference products, as well as with one another where they refer to the same originator, in view of the robustness of the regulatory assessment ensuring a comparable benefit–risk profile. While consistent with the previous document, this statement is now expressed in more precise terms.

In this context, particular relevance is given to AIFA’s recommendation to recognise, at national level, the possibility of an “informed switch”, whereby the pharmacist, having obtained the prescribing physician’s consent, substitutes the prescribed medicinal product with another off-patent biotechnological medicinal product or biosimilar among those awarded under the framework agreement, ensuring full traceability of prescription and dispensing, as well as appropriate patient information. AIFA further recommends, in the interest of sustainability and loyal cooperation, that for naïve patients prescriptions be oriented towards products awarded through regional tenders, and that, for patients already under treatment, a switch to awarded products be considered where appropriate. Any alternative choices must be supported by documented clinical justification. Regions are also required to promptly inform prescribing physicians and pharmacists of the awarded medicinal products.

The Position Paper also emphasises the importance of traceability and pharmacovigilance, through proper identification of medicinal products and risk management plans, with biosimilars being subject to additional monitoring.

Finally, patient associations, scientific societies and industry associations have highlighted the need for coordinated implementation of the Position Paper’s recommendations across Regions and have pointed out certain critical issues relating to public procurement procedures and framework agreements, with potential implications for therapeutic continuity and pharmacovigilance.

The Milan Court of Appeal, in a decree dated 4 March 2026, held that the claim “this company complies with high standards of positive environmental and social impact”, displayed on the website of a well-known company, was not misleading under Article 21 of the Italian Consumer Code. The Court found that the statement merely explains the meaning of the Certified B Corporation label—whose use had already been deemed lawful at first instance—and that it was accompanied by an explanatory note clarifying the private nature of the certification and the process through which it is obtained.

The case originated from an action brought by a well-known consumer association seeking to prohibit the company from using several claims concerning environmental sustainability, as well as the Certified B Corporation and B Corp marks.

The Court of first instance had held, on the one hand, that certain claims used by the company—including the above-mentioned one—constituted misleading commercial practices under Article 21 of the Consumer Code; on the other hand, it considered the use of the Certified B Corporation and B Corp marks to be lawful, as they are individual trademarks registered for classes relating to business consultancy services provided by the trademark owner. For this reason, they cannot in themselves “mislead the public as to the nature, quality or geographical origin of the product.”

Following the company’s appeal, the Court of Appeal held that the statement “this company complies with high standards of positive environmental and social impact” is not misleading under Article 21 of the Consumer Code, as it merely clarifies the meaning of the Certified B Corporation mark, next to which it appears on the company’s website. The Court also noted that allowing the use of the mark while simultaneously prohibiting a claim explaining its meaning would effectively deprive the mark of its content. Moreover, the Court observed that a different interpretation would risk indirectly anticipating the application of Directive (EU) 2024/825 on the green transition, whose provisions will apply only from 27 September 2026.

On 9 March 2026, Legislative Decree No. 30 of 20 February 2026 was published in the Italian Official Gazette, entitled “Implementation of Directive (EU) 2024/825 of the European Parliament and of the Council of 28 February 2024 amending Directives 2005/29/EC and 2011/83/EU as regards empowering consumers for the green transition through better protection against unfair practices and better information”. The decree will enter into force on 24 March 2026.

The decree amends the Italian Consumer Code (Legislative Decree No. 206/2005), introducing changes both to the rules on unfair commercial practices and to information obligations in consumer relationships. In particular, the following developments should be noted:

• article 18 of the Consumer Code introduces new definitions, including those of “environmental claim”, “generic environmental claim”, “sustainability label” and “certification scheme”. In particular, a “certification scheme” must meet a specific list of criteria, including that “monitoring of the economic operator’s compliance with the requirements of the scheme is carried out through an objective procedure by a third party whose competence and independence—both from the scheme owner and from the economic operator—are based on international, European Union or national standards and procedures”. The decree also introduces the definition of “recognised excellent environmental performance”, defined as “environmental performance compliant with Regulation (EC) No. 66/2010 of the European Parliament and of the Council of 25 November 2009 (EU Ecolabel), with a national or regional Type I eco-labelling scheme in accordance with EN ISO 14024 officially recognised in the Member States, or with the best environmental performance under other applicable provisions of EU law”;

• article 21 of the Consumer Code introduces two additional forms of misleading actions: making an environmental claim relating to future environmental performance without including clear, objective, verifiable and publicly available commitments; and advertising as consumer benefits elements that are irrelevant and do not derive from the characteristics of the product or the undertaking;

• article 23 of the Consumer Code lists additional unfair commercial practices that are prohibited, including displaying a sustainability label that is not based on a certification scheme or established by public authorities, and making a generic environmental claim where the trader cannot demonstrate recognised excellent environmental performance relevant to the claim;

• new pre-contractual information obligations are introduced for businesses regarding product durability and reparability, including the obligation to provide consumers, before the conclusion of the contract, with a reminder of the existence of the legal guarantee of conformity and, where available, information on the existence and duration of a commercial durability guarantee;

• the reminder regarding the legal guarantee of conformity for goods and the information on any commercial durability guarantee must be provided through, respectively, a harmonised notice (Annex II-octies, Part 1 of the decree) and a harmonised label (Annex II-octies, Part 2).

The new provisions will apply from 27 September 2026.

On 22 September 2025, the European Commission approved new Guidelines concerning the examination of variations to the terms of marketing authorisations (MAs) for human medicinal products and the related documentation required under such procedures.

The document, drafted in collaboration with the European Medicines Agency (EMA), aims to support the interpretation and application of Regulation (EU) No 1234/2008 (commonly known as the “Variations Regulation”) by providing detailed information on the implementation of relevant procedures — from the submission of a notification or variation application to the final outcome of the process.

The new guidelines highlight the use of tools such as Product Lifecycle Management (PLCM) — a lifecycle management document relating to the active substance — and the Post-Approval Change Management Protocol (PACMP), a protocol for managing post-approval changes concerning the active substance. These are now officially recognised as strategic tools for the long-term planning and management of complex changes.

To support the implementation of the new provisions, updated technical and procedural documentation will be made available by the end of 2025, aimed at facilitating the adjustment process for MA holders and national competent authorities.

The document replaces the previous 2013 guidance, reflecting the 2024 amendment to the Variations Regulation, and will apply from 15 January 2026. Applications submitted before that date should follow the 2013 guidance.

On September 2, the Council of State issued its opinion in an extraordinary appeal to the President of the Republic for the annulment of measures unfavorable to the personalized preparation of therapies (so-called deblistering) by a pharmacy. The authorities had denied the possibility of providing this service due to the absence of detailed national legislation comprehensively regulating this activity, and during the proceedings, the Ministry of Health highlighted the risks associated with the handling of medicines in terms of storage and tracking of individual doses.

The administrative judges ruled that deblistering should be considered permitted by law, as there are no regulations prohibiting it, considering that it is a practice aimed at ensuring higher levels of therapeutic adherence, as well as simplifying the management of medicines, especially for elderly, multi-treated, and chronic patients. Deblistering, as an after-sales service, offers personalized management of individual drug therapies for patients who particularly need chronic therapies (i.e., in nursing homes or other situations deemed useful), as it helps to avoid errors in the course of treatment.

Furthermore, careful regulation of this practice could contribute to a reduction in healthcare spending, with overall benefits for public finances.

With regard to health protection, the Council of State pointed out that pharmacies do not carry out any activity involving the division of the active ingredient, but merely ‘unpack’ the drugs from their original packaging and place them in blister packs customized for each patient, and that it would be difficult to consider this activity prohibited, given the existence of a regime of substantial liberalization of the activity of producing galenic preparations, for which pharmacies do not need to seek any authorization.

Ultimately, in the absence of evidence of factors posing a danger or risk to human health and safety in the deblistering activity, when carried out in compliance with the precautions prescribed in the regulatory acts adopted by some Regions, the same cannot be hindered; This is true even in regions where it has not been regulated, where the guidelines issued by the Lombardy Region can be taken as a reference point, given their general nature, until the central authority decides to draw up minimum health and safety standards to be applied throughout the country.

On August 6, 2025, the Chamber of Deputies approved the bill converting the Economy Decree (Decree-Law No. 95 of June 30, 2025). The measure contains urgent provisions for financing economic activities and businesses, as well as interventions in the fields of social policy, infrastructure, transport, and local authorities, also introducing several measures related to healthcare.

The most significant change concerns the management of the medical device payback for the years 2015–2018, as provided in Article 7. The obligations imposed on supplying companies under the payback mechanism will be considered fulfilled with the payment—within 30 days of the law’s entry into force—of 25% of the amounts indicated in the regional and provincial provisions issued under Decree-Law No. 78/2015. This payment will bar any further legal action related to the obligation to pay the sums for the mentioned years.

Another important provision, outlined in Article 5, allocates €42 million per year from 2025 to 2027 to support research, assistance, and treatment activities, with the aim of strengthening the delivery of Essential Levels of Care (LEA). The implementation of this funding is subject to the signing of an agreement at the State-Regions Conference regarding the distribution of financial resources for the National Health Service for the period 2017–2027. A substantial portion of these funds will continue to support IRCCS institutes specializing in pediatric care and oncology centers using advanced technologies such as carbon ion and proton therapy.

According to the AGCM, the investigation confirmed the allegations of unfair commercial practices by the retailer. In essence, the online pharmacy “omitted or failed to provide truthful information during the promotional phase regarding the timely delivery of products listed on its website” and “exhibited serious shortcomings in the assistance provided to consumers after the sale, failing to ensure proper complaint handling, including through an effective customer care service.”

Specifically, the online pharmacy advertised fast delivery times on its website that did not reflect actual timelines, as the company in fact reserved up to 30 days to fulfill orders, without disclosing this to consumers—leading many to complete purchases based on unjustified expectations.

 In the post-sale phase, the AGCM found numerous withdrawal or cancellation requests that were either ignored or denied by customer service. As for refunds related to undelivered or damaged products, the pharmacy often offered a coupon or discount voucher of equal value to the refund amount, to be used on a future purchase—thus violating consumers’ rights to choose the refund method, and exerting undue influence over them.

On July 31, 2025, the draft enabling bill for the Consolidated Act on Pharmaceutical Legislation was presented to the Italian Chamber of Deputies. The reform aims to simplify and streamline the current regulatory framework, which is fragmented and the result of overlapping legislative interventions over time. The new Consolidated Act seeks to establish a coherent and modern set of rules, capable of responding more effectively to the present and future needs of the pharmaceutical sector.

 Among the key elements of the draft bill are the updating of pharmaceutical spending caps and the revision of the payback mechanisms, with the goal of ensuring greater financial sustainability and enhancing the attractiveness of the system. A further priority is to strengthen the right to fair and continuous access to medicines, with particular attention to patients affected by rare, chronic, or debilitating diseases. This will involve revising distribution rules and promoting domestic production of active ingredients and excipients.

The bill also provides for the enhancement and integration of national and regional health information systems, which are to become fully interoperable with the Electronic Health Record and the Pharmaceutical Dossier. This integration aims to enable real-time monitoring of prescriptions, consumption, and stock levels, as well as the timely detection of drug shortages, supported by collaboration among companies, local authorities, and healthcare stakeholders.

Additionally, the reform calls for the strengthening of the Health Card system through full digitalization of the entire prescription and dispensing process, thereby reducing administrative burdens.

Lastly, community pharmacies are recognized as key points of care, to be structurally integrated into the broader territorial healthcare network.

With Determination No. 56 of July 17, 2025, AIFA has made available the operational instructions regarding the procedures for the granting of marketing authorization (MA) and the requirements to comply with Article 4 of Legislative Decree No. 10 of February 6, 2025, including for medicines subject to parallel importation and distribution. These instructions are included in Annex 1 and concern the obligation to place on the packaging of medicinal products a unique identifier (UI) encoded in a two-dimensional barcode (Data Matrix) and an anti-tampering device (ATD).

 According to Article 3 of the aforementioned decree, starting from February 9, 2025, all medicinal products referred to in Article 2, paragraph 1, letters a) and b) authorized for marketing in Italy must bear on their packaging a unique identifier (UI). The UI is a code generated for each individual package that enables full traceability of the medicine throughout the entire supply chain. Printed in Data Matrix format, the code includes at least the national product code, a serial number, the expiry date, and the batch number.

Additionally, all medicines marketed in Italy must carry an anti-tampering device (ATD) on their packaging. For human medicines subject to the UI requirements, the ATD must also include a security-featured label, in the form of value paper, which may also be implemented in a digital format, if provided for.

Human medicinal products not subject to the UI requirements must continue to bear the traditional pharmaceutical sticker ("bollino farmaceutico"), as set out in Article 5-bis of Legislative Decree No. 540 of December 30, 1992.

 The provisions of this determination take effect from the date of its publication on AIFA's official website, which occurred on July 17, 2025. However, the application of the new rules is framed within a two-year stabilization period, from February 9, 2025, to February 8, 2027. During this transitional phase, the UI and ATD may be replaced by the pharmaceutical sticker (bollino farmaceutico), including for batch release purposes, and the sticker may serve as an ATD for any human medicinal product.

With Resolution No. 966 of July 9, 2025, which replaces the previous Resolution No. 1535 of September 12, 2017, AIFA (Italian Medicines Agency) has redefined the evaluation criteria for the recognition of therapeutic innovation and for the management of antimicrobial agents for infections caused by multidrug-resistant organisms, implementing Article 1, paragraphs 281 and following, of Law No. 207/2024.

 The innovativeness of a medicinal product is assessed based on the technology used to produce its active ingredient, its mechanism of action, route of administration, clinical efficacy and safety, its impact on patients’ quality of life, and its implications for the healthcare system.

For this purpose, a drug is considered innovative depending on the efficacy and safety results compared to existing therapeutic alternatives listed in the national pharmaceutical formulary at the time of its introduction, within a specific therapeutic indication.

The recognition of innovative status is based on three main criteria:

1. Therapeutic need: determined by the lack of effective treatments for a specific disease or condition, or the inadequacy (in terms of efficacy/safety) of existing options.
2. Added therapeutic value: assessed based on the clinical benefit and its magnitude in terms of outcomes that are recognized as clinically relevant and validated for the specific condition. The overall benefit of the medicine under evaluation is compared to available alternatives (if any) within the National Pharmaceutical Formulary prior to its introduction. This evaluation is based on comparisons of efficacy and safety through direct comparative clinical trials or indirect comparisons with robust statistical methodologies.
3. Quality of evidence: high-quality evidence ensures the transferability of results obtained in pivotal clinical trials to real-world clinical practice.

For the first two criteria, a five-level rating scale is applied (maximum, significant, moderate, low, absent), while the third criterion is rated on four levels (high, moderate, low, very low).
Therapeutic innovation is granted when all three criteria reach at least a “moderate” level, except in the case of orphan drugs, where a “low” quality of evidence may be accepted.

Additionally, an added value may be recognized if the drug’s preclinical and clinical development has been predominantly carried out in Italy.

The recognition of innovative status is valid for a maximum of 36 months, without the possibility of extension. It entitles the product to access resources from the Innovative Medicines Fund; temporary exemption from statutory price reductions; inclusion in Regional Therapeutic Formularies (PTR); exclusion from the calculations of direct purchase pharmaceutical expenditure and market share thresholds attributed to the Marketing Authorization Holder (MAH).

 As for drugs targeting multidrug-resistant organisms, AIFA does not assess standard innovativeness for medicinal products based on active ingredients classified as “reserve” by the WHO or as active against priority pathogens on the Bacterial Priority Pathogens List. These products can access the Innovative Medicines Fund, up to an annual ceiling of €100 million, and until the expiration of patent protection or data exclusivity periods.

The resolution entered into force on July 13, 2025, the day following its publication in the Official Gazette.

The Ministerial Decree of 20 May 2025, which defines the technical and graphic features as well as the information requirements of the new anti-counterfeiting device for human-use medicines, was published in the Official Gazette on 9 July.

The device is designed to enhance the medicine control system. It is produced on a secure medium and affixed to the part of the packaging chosen by the manufacturer.

The decree aligns with European legislation, in particular Directive 2011/62/EU and Delegated Regulation (EU) 2016/161, which require the implementation of safety features on medicine packaging to enable identification and authentication.

 Manufactured by the Italian State Printing Works and Mint (IPZS), the device is a self-adhesive element measuring 40 mm wide by 25 mm high, with rounded corners (2 mm radius). It is made of security watermarked paper, contains UV-fluorescent fibers, and is free of optical brighteners. It also includes an identification code generated and assigned by IPZS to mark its internal production batch.

The device is intended to remain affixed to the outer packaging of the medicine throughout its shelf life, and is designed to be destroyed or visibly damaged if removal is attempted.
As a security document ("carta valori"), the device is subject to specific management procedures under the responsibility of the marketing authorization holder (MAH).

The decree also mandates the inclusion of specific phrases on the medicine packaging depending on its intended use. Examples include “hospital/outpatient use” for products intended for public and private healthcare facilities, or “free sample – not for sale” for those to be provided to doctors as free samples. These statements must be clearly visible and printed with indelible ink.

During the stabilization period—from 9 February 2025 to 8 February 2027, as established by Legislative Decree 10/2025 (which adapts Italian law to Delegated Regulation (EU) 2016/161)—traceability and reimbursement of human-use medicines may also be ensured through the information included in the device. This includes the AIC code, product name, serial number, and the name of the marketing authorization holder.

 The decree entered into force on 9 July 2025, the date of its publication in the Official Gazette.

The Prime Ministerial Decree (DPCM) of February 28, 2025, which incorporates the agreement signed on October 3, 2024, between the Government, the Regions, and the Autonomous Provinces of Trento and Bolzano (Official Record No. 176/CSR) regarding the establishment of the professional profile of the nursing assistant, was published in the Official Gazette (General Series No. 142 of June 21, 2025).

As a member of the care team, this intermediate role between the nurse and the OSS will carry out tasks involving direct care of individuals, following nursing plans or instructions under the supervision or in collaboration with a nurse. They will contribute useful information for care planning and may be involved by multidisciplinary assessment teams to help identify care needs. They will be responsible for maintaining safety for both themselves and the person receiving care, and for correctly performing the tasks assigned to them.

Specifically, the decree outlines three types of competencies for the new role: collaboration with nurses in detecting health parameters, signs, and functions; collaboration with nurses in performing healthcare-related assistance activities; execution of organizational tasks and coordination with other professionals and workers.

To obtain the nursing assistant qualification, which will be managed by the individual Regions, one must already hold the OSS qualification and a secondary school diploma, with at least 24 months of work experience. Alternatively, candidates without a diploma but with at least five years of OSS experience in the past eight years may access the training, provided they first complete a preparatory theoretical module of at least 100 hours.The training course itself must comprise a minimum of 500 hours and ends with a qualification exam.

At the same time, the DPCM of March 25, 2025, has updated the role of the healthcare support worker (OSS). The main changes concern the training program, which will now be at least 1,000 hours long, including enhanced practical activities through simulations, labs, and structured mentoring. The program will also cover assistance in school, prison, and psychiatric settings, in addition to traditional healthcare and social care environments.

In Judgment No. 84 of 2025, the Constitutional Court ruled that the constitutional challenge raised by the Prime Minister against the Sardinia Region’s law (Regional Law No. 12 of 2024), which allows the use of retired general practitioners to cover healthcare services in shortage areas, is unfounded.

According to the Government, the law not only violates Article 117, paragraph 2, letter f) of the Constitution by exceeding regional powers, but also contradicts the 2024 National Collective Agreement (ACN), which establishes that those receiving a retirement pension are not eligible to perform the activities covered by the Agreement.

However, the Court found the challenge to be without merit, stating that the provision in question clearly serves an organizational purpose aimed at protecting public health, by seeking to guarantee primary care for residents in disadvantaged areas lacking a general practitioner.
The Court affirmed that Regions may adopt extraordinary and temporary measures to promptly address difficulties in accessing essential levels of primary care. Indeed, preventing the Regions from adopting such measures “amounts to hindering them from intervening with their own tools to prevent these contingent critical issues from resulting in the sacrifice of the effectiveness of the fundamental right to health, depriving it of its inviolable core of minimum guarantees”.

With ruling no. 1022/2023, the Regional Administrative Court (TAR) of Lombardy upheld the request of an association that had been denied access to the special part of the Organizational, Management, and Control Model of a company managing healthcare facilities accredited by the National Health Service.

The company, in this regard, argued that the special part of the Model fell “among the documents concerning the internal organization of a private entity,” containing “economic and commercial assessments that justify its non-disclosure,” and producing “effects on the company's employees” through “analyses and evaluations of internal business processes, the disclosure of which would violate the protection of private interests and the company’s know-how.”

AIFA has published on its website the interactive map of the Clinical Trials Information System (CTIS), which shows all the Clinical Trial centres located within the European Union.

The aim of the map is to make comprehensive information about Clinical Trials easily accessible to patients and healthcare professionals in their geographical area. Currently available only in English, the map allows users to search for trials by medical condition and geographic location. It also includes an automatic spelling correction system to assist users in their searches. Additional EU languages will be added in future versions of the map.

The map provides contact information for the principal investigator, allowing users to directly inquire about the possibility of enrolling in a Clinical Trial of interest.

On May 13, 2025, the Court of Rome sentenced an Italian entrepreneur to two years and eight months in prison for the unlawful practice of the medical profession.
The entrepreneur provided advice on dietary regimens, nutrition programs, and methods that can be scientifically classified as “diets,” as well as on dietary supplements which, according to the public prosecutor’s investigation, could be harmful to health if taken without medical supervision. He also offered personalized diet plans through call center operators and direct communication with individual users via Facebook.

The proceedings were initiated by the President of the Rome Medical Association, who had reported the entrepreneur in 2018 for unlawfully practicing medicine.
The entrepreneur’s brother was also convicted as an accomplice and sentenced to one year and four months in prison for handling the printing and dissemination of pseudoscientific publications.

Both defendants were also ordered to compensate the civil parties involved and to pay an immediately enforceable provisional amount of €20,000 to the Rome Medical Association (OMCeO Roma).

With sentence no. 15742 of January 30, 2025, the Italian Supreme Court (Cassazione) upheld the order issued by the Court of Perugia, which had rejected the request for review filed by a beauty center against the decree validating the seizure of an anti-aging device listed in the national database of medical devices.

Indeed, although Annex XVI of EU Regulation 745/2017 provides a list of product groups without an intended medical purpose, as per Article 1(2)—including machines used in beauty centers, such as devices intended to reduce, remove, or destroy adipose tissue, or devices that emit high-intensity electromagnetic radiation to be used on the human body—the device in question must be used under medical supervision.

This is because the required patient medical history and the nature of the exclusion criteria involve expertise specific to the medical profession. Medical knowledge and tools are needed to assess these elements, and only after such evaluation and the related medical indications can the machine be used. Its operation is therefore to be considered part of a broader service that inherently requires medical skills.

In the absence of medical supervision, the precautionary principle under Article 191 of the Treaty on the Functioning of the European Union would be violated. According to this principle, if a particular policy or action could potentially harm citizens or the environment and there is not yet a scientific consensus on the matter, such policy or action should not be pursued, unless reconsidered once further scientific information becomes available. As a result, the unauthorized use of the device in such circumstances would constitute the criminal offense of unlawful practice of the medical profession.

After the judgment n. 140/2024 of the Constitutional Court, which declared unfounded the findings of unconstitutionality of the regulatory system of the payback medical devices 2015-2018, The Regional administrative court of Lazio has affirmed the legitimacy of the ministerial decrees that set the expenditure ceilings and established the breakthrough after deciding on the first appeals.

According to the Administrative Court, the posthumous fixing of regional expenditure ceilings did not affect the position of interest of the supplying companies, which could still rely on the maximum national expenditure ceiling, already set at 4.4%, and were therefore fully aware of the risk of overrun and of the aliases inherent in the supply contracts concluded with the NHS authorities.

The Regional administrative court also held that the dispute over the correct quantification, by the Regions, of the turnover that constitutes the basis for calculating the payback must be proposed before the Ordinary Court because it concerns purely cognitive operations and activities of an authoritarian nature.

The Ministry of Health defined the technical specifications for the Data Matrix code in the decree of 6 March 2025, which is the unique identification for medicinal products intended for human use. The measure implements the provisions of art. 3, co. 3 of Legislative Decree 10/2025, being part of the broader European framework outlined by Delegated Regulation (EU) 2016/161. The aim is to strengthen the traceability, authenticity and safety of medicines throughout the distribution chain.

As outlined in the article 1 of the decree, the Data Matrix in a two-dimensional, optically readable code, mandatory for most medicinal products, with the exception of those listed in Annex I of the EU regulation. It must comply with the requirements of Article 4 of Regulation (EU) 2016/161 and must to be applied by manufacturers, marketing authorization holders (M.A. holders), and all parties required under current legislation. Compliance must occur within the stabilization period established by Legislative Decree No. 10 of February 6, 2025.

Article 2 clarifies that the identification code of the medicinal product must be the same as M.A., which is assigned by the AIFA at the time of marketing authorisation in the national territory.

The information content of the Data Matrix is defined in Article 3. The code must contain five mandatory data elements: the product code (GTIN), the serial number, the M.A.-code, the manufacturing batch number and the expiry date. These data must be coded according to the specifications contained in Annex A of the decree.

The implementation of this decree does not entail any new or additional burdens on public finances, and the provisions came into force on the date of publication in the official gazette, i.e. april 10, 2025.

Annex A provides a detailed overview of the technical features of the code. The GTIN is a 14-digit numeric code. The code must comply with specific international standards: GS1 Data Matrix (ECC 200) symbology, according ti ISO/IEC 16022:2006, and GS1 Application identifier (AI) syntax, in accordance with ISO/IEC 15418:2009.

As for graphic requirements, the code must be printed on a smooth, uniform, and low-reflectivity surface.

The introduction of these new technical specifications marks a decisive step toward strengthening safety and transparency mechanisms in the distribution of medical products. Harmonization with EU standards will enable more effective control over every stage of the supply chain, helping to combat counterfeiting and more effectively safeguard public health.

Following a revision process that began in 2023, the updated version of the Nursing Professions Deontological Code came into effect on March 22, 2025, updating the previous version from 2019. It was unanimously approved by the National Council of the Federation on February 21 and was officially presented at the third national congress of FNOPI in Rimini. It is now available on the official FNOPI portal with a total of 35 updated articles.

Given the experience gained during the COVID-19 pandemic, the goal of the revision was to transform the deontological code into a truly dynamic value guide that could reflect the continuous evolution of nursing professions and the role they play within a rapidly transforming healthcare and social care context. In particular, to ensure that the ethical concepts of nurses permeate daily practice, the revision work followed three main areas: regulation; society, education, and communication; and profession. In this way, the aim was to create a tool also designed for patients and citizens, addressing responses to pandemics and global health emergencies and tackling the principles of One Health, which links human, animal, and environmental health. Among the novelties, there is the introduction of the concept of “care for caregivers,” a clear deontological commitment to mutual support, where nurses take care of themselves and each other.

In judgment no. 5459 of March 17, 2025, the Lazio Regional Administrative Court (TAR Lazio) upheld the appeal filed by the concessionary company responsible for the sale of the over-the-counter drug Voltaren Emulgel 2% in Italy, against the decision by the Ministry prohibiting the use of the advertising claim "more advantageous" in reference to the 180g format. The Ministry had considered the claim to be a purely commercial aspect, which cannot be authorized for a medicinal product.

The Administrative Court found this prohibition to be illogical and disproportionate, lacking evidentiary support. It emphasized that the characterization of a format as "more advantageous," while indicating an economic benefit, does not alter the therapeutic perception of the product nor lead to irrational use. Indeed, Legislative Decree no. 219/2006 (Pharmaceutical Code) mandates that advertising must ensure the rational use of medicines but does not prohibit highlighting economic aspects that do not distort the objective presentation of the product’s characteristics.

 Additionally, TAR Lazio observed that the phrase "more advantageous" does not mislead consumers or lead them to view the drug as a food or cosmetic product. Consequently, the Ministry’s decision was deemed disproportionate and unfounded, depriving the public of the opportunity to make a more informed choice, including from an economic perspective.

Aesgp, Efpia, and Medicines for Europe (the Pharmaceutical Industry Associations) have published a series of joint recommendations to support the implementation of electronic Product Information (ePI) and the improvement of the patient leaflet content. The gradual introduction of the ePI, which will replace the paper version within four years after entry into force of the revised General Pharma Legislation, will improve access to medication information, making it safer and more up-to-date. The transition will also offer more accessible formats, such as enlarged fonts and interactive content, ensuring options for those without internet access.
The optimization of patient information leaflets aims to simplify the availability of medication information, to improve the efficiency of regulatory processes, and to reduce environmental impact, promoting a more accessible, innovative, and safer healthcare system.

The new competition law has been published in the Official Gazette, introducing significant changes in the healthcare sector. Article 36 provides for the suspension, until December 31, 2026, of provisions related to institutional accreditation and contractual agreements with the National Health Service (NHS). This measure applies to requests for new facilities as well as the launch of new activities within existing structures. The suspension aims to allow a comprehensive review of the accreditation system and contractual agreements, pending the outcomes of the National Accreditation System Development Working Group (Trac), which will be submitted for approval by the State-Regions Conference.

Another significant update is introduced in Article 38, which amends the current regulations on the processing of Italian plasma derived from donations by unpaid volunteers. The change allows for the commercialization of blood plasma processed in a free-market regime, removing current restrictions that exclude some European companies from regional agreements. This measure explicitly aims to avoid potential infringement procedures and to ensure greater flexibility in the management and processing of plasma at the national level.

The new law represents a significant step toward revising and adapting the National Health System to the needs of an evolving context.

The Chamber of Deputies has passed the Fiscal Decree into law, introducing significant measures impacting healthcare, businesses, and workers. In healthcare, a new allocation mechanism for pharmaceutical payback has been established. AIFA will determine, by October 31 of the following year, the repayment amount for each company, divided 50% based on population and 50% according to regional spending cap overruns. Funds allocated to combat Covid-19, still available in regional budgets, can be used until December 31, 2025, to support operational plans aimed at reducing waiting lists.

For businesses, the deadline to apply for the biennial preventive agreement has been extended to December 12, maintaining the original conditions. Regarding workers, the €100 Christmas Bonus has been expanded to individuals with at least one dependent child and incomes up to €28,000, significantly increasing the number of beneficiaries to approximately 4.5 million. Sole proprietors with annual revenues or fees up to €170,000 can defer income tax payments until January 16, 2025, instead of the original deadline of December 2, 2024.

Among the approved measures, a resolution urges the Government to consider introducing mechanisms for early access to life-saving drugs, inspired by international models, to ensure timely treatments for patients with severe and rapidly progressing conditions.

Legislative Decree 129/2024 has brought the Italian legal system into alignment with the c.d. MICA Regulation, which oversees the crypto-activity markets across Europe, and it has integrated its provisions with Legislative Decree 231/2001 and Legislative Decree 24/2023. As regards Decree 231: Article 34 of the measure provides that, in case of violations of the provisions of the MICA Regulation committed in the interest or for the benefit of an institution, by persons in senior positions or employees, Administrative fines of up to 15 million euro or, if higher, 15% of the total annual turnover are available. The infringements that can be sanctioned concern behaviour such as abuse or illicit dissemination of inside information, as well as market manipulation, with specific reference to crypto-asset trading activities.

With reference to the Whistleblowing Decree, it is clarified that article 41 of the new decree extends the scope of D.Lgs. 24/2023, including violations related to the MICA Regulation on crypto-activity markets.

The Court of Cassation has emphasized that auction disruption is considered a crime under D.Lgs. 231/01 and may lead to administrative responsibility for entities in decision number 33859/2024. In particular, the offence committed by a director may expose the institution to severe penalties if it is not equipped with an effective organisational model.

The ruling stated that such an offence does not exist in contracts concluded by the public administration through private negotiations, when the latter is not part of a collective agreement. However, if the private negotiation takes place through a tender, even informal, the offence may be established. The Court pointed out that the expressions "public tender" or "private tenders" used by art. 353 c.p. do not refer exclusively to the procurement procedures, but include any kind of comparison, even atypical, aimed at identifying a public administration contractor, provided that it guarantees competition between the bidders. However, it is not enough to have more than one candidate to qualify as a tender. They must submit separate tenders and the administration must retain full freedom to choose the most advantageous tender, without it being a mere private negotiation, which cannot constitute an offence of disturbance.

The judgment therefore reaffirms the importance for companies to adopt organisational models that can prevent offences such as auction disruption. An effective model 231 should provide for targeted protocols, staff training and internal control systems to ensure transparency and prevent wrongful conduct. In addition to reducing the risk of sanctions, these measures also protect the integrity and reputation of the organisation, which are essential elements in today’s competitive landscape.

New transparency obligations for ESG (Environment, Social, and Governance) in Italy were introduced through Legislative Decree no. 125/2024, which transposed the Corporate Sustainability Reporting Directive (CSRD).The main purpose of the CSRD is to ensure a more accurate and accurate communication of companies' sustainability performance, allowing for better assessment of their environmental and social impact. Pursuant to art. 3, large companies and listed SMEs shall incorporate information on the impact of their activities in terms of sustainability and the influence of ESG factors on business results and prospects. Art. 4 extends this obligation to the parent companies, providing for a consolidated reporting for the corporate groups.

The ESG report is subject to a specific certification that can be entrusted to the same auditor or to a different entity.

The requirements are implemented gradually: from 2024 for companies already subject to the Directive on Non-Financial Reporting, from 2025 for all large companies and from 2026 for listed SMEs. From 2028, the obligation will also involve non-EU companies with significant activities in the European Union. Exemptions are provided for micro-enterprises and companies already included in consolidated reports compliant with European standards.

The publication of the report, which is mandatory online, is regulated by the civil code and represents a strategic opportunity for companies. It is not just a formal fulfillment, but a tool to measure and communicate the company’s commitment to sustainability, improving transparency and stakeholder confidence.

This new regulatory approach represents a decisive step towards a more equitable, inclusive and environmentally friendly economy by encouraging companies to integrate sustainability as a central element of their growth strategy.

After receiving countless questions, the AIFA Medical Sales Representatives Office has decided to give clarification on Q&A 13, which is related to the disclosure of promotional materials (PM) to non-hospital pharmacists about prescription medicines in the 'Questions & Answers' document published on 3 May 2023 on the AIFA portal.

In particular, the document states that, with the exception of hospital pharmacists, advertising for prescription drugs may only be made by reproduction of the full summary of product characteristics (RCP). This restriction also applies to advertising material produced in accordance with the procedures provided for in paragraph 4 of art. 119 of Legislative Decree 219/2006.

As regards medicinal products sold without prescription, advertising is permitted and may include other documentation, provided that it complies with the provisions of Title VIII of the same Decree.

It is also noted that information of a purely commercial nature, such as price lists, are not subject to the discipline of Title VIII and may be disclosed without prior deposit with AIFA, as clarified in D&R 24.

On October 23, 2024, during a plenary session, the European Parliament voted on Resolution 2024/2849(RSP) regarding the urgency of revising the Regulations on medical devices and in vitro diagnostic devices. The resolution emphasizes the need to simplify regulatory processes and reduce administrative burdens on companies, with the aim of accelerating the market entry of medical devices. The text highlights the importance of ensuring quicker access to medical devices for patients with rare and pediatric diseases, facilitating the collection and exchange of clinical data from national registries. The resolution underscores the urgent need to significantly accelerate the assessment timelines by notified bodies to ensure timely access for patients to innovative and life-saving medical devices. The European Commission has welcomed these requests and announced the launch of a targeted evaluation of the MDR/IVDR starting on November 15. MedTech Europe has welcomed the European Parliament's invitation to the Commission and has confirmed its commitment to work closely with the European Commission, the European Parliament, and Member States to ensure that the MDR and IVDR regulations achieve their innovation goals for public health in Europe.

The World Health Organization (WHO) has published its “Guidance for Best Practices for Clinical Trials” on its official website (www.who.int). This document aims to improve the design, conduct, and oversight of clinical trials, with the goal of bridging the gap between high-income and low- to middle-income countries. The objective is to strengthen national research and development (R&D) ecosystems to accelerate global access to safe, effective, and affordable healthcare interventions.

For the first time, the guidance provides recommendations to health authorities, regulatory bodies, and funding agencies on how to optimize clinical trials, addressing issues such as poor study quality, limited participant diversity, and structural inefficiencies that hinder progress and increase costs.

Furthermore, data from 2022 show that only a small percentage of clinical trials involve vulnerable populations, such as pregnant women and children, which negatively affects the quality of evidence and access to effective treatments. The guidelines offer practical recommendations for including these populations from the early stages of trials, ensuring a prioritized evaluation of safety.

The guidelines also emphasize the importance of involving patients and communities in the planning and conduct of trials to ensure that research meets their needs and strengthens trust.

Finally, the document highlights the disparity between high-income and low- to middle-income countries in clinical trials, with the goal of addressing these inequalities through stronger national R&D ecosystems and sustainable funding.

The Administrative Court of Piedmont, with judgment no. 979 of 30th September 2024, formulated an important clarification on public tenders for the purchase of medicinal products, according to which the ban, provided for by art. 15, paragraph 11 quater, of the law decree no. 95/2012, to create single batches in competition between biological and biosimilar medicinal products having different active ingredients also applies in the event that Aifa has stated the therapeutic equivalence among the originator products pursuant to art. 15, paragraph 11 ter, of the law decree no. 95/2012. This means that, given the peculiarities and intrinsic variability that characterize this type of medicinal product, the opinion of therapeutic equivalence between the original product A and the original product B does not automatically extend to the respective biosimilar products.

The l. 90/2024, containing "Provisions regarding the strengthening of national cybersecurity and computer crimes", introduces specific measures aimed at protecting computer security and combating computer crimes.

In particular, the new provisions impose on central public administrations, regions and autonomous provinces, metropolitan cities, municipalities with a population exceeding 100,000 inhabitants, regional capital municipalities, as well as urban public transport companies and local health authorities the obligation to notify the National Cybersecurity Agency of any IT incident of which they become aware, as well as the obligation to adopt, without delay and in any case no later than fifteen days from the communication, the remedial measures indicated by the Agency itself.

Failure to comply with these obligations may result in the application of a pecuniary administrative sanction ranging from 25,000 euros to 125,000 euros.

On July 17, the Official Journal of the European Union published Regulation EU 2024/1938 (also known as the "Substances of Human Origin" (SoHO) Regulation), which sets quality and safety parameters for substances of human origin intended for human use. Approved by the European Parliament in April and definitively adopted by the EU Council in June, the regulation represents a challenge for the competent authorities of Member States. The regulation establishes the SoHO Coordination Board to facilitate the implementation of the new rules and will come into force in 2027, three years after its adoption. The regulation will ensure greater protection for recipients and donors of all substances of human origin. The new regulatory framework will require the accreditation of all entities involved in activities that may affect the quality and safety of SoHO, from laboratories to hospitals and therapeutic centers. Additionally, common evaluation and authorization procedures will be introduced, and national control, traceability, and transparency will be strengthened.

The Regulation (EU) 2024/1860, which amends Regulations (EU) 2017/745 and (EU) 2017/746 regarding medical devices and in vitro diagnostic medical devices respectively, has been published in the Official Journal of the EU. The text introduces important changes regarding the use of the Eudamed database and imposes new obligations on manufacturers in the event of a supply interruption of devices.

Specifically, the Regulation amends provisions related to the use of Eudamed (the European database on medical devices), providing for the gradual implementation of the relevant modules (as soon as these have been verified and declared functional and the relevant notice has been published in the Official Journal of the EU), and introduces the obligation for manufacturers, in the event of interruption or cessation of supply of a medical device, to inform the competent authorities and healthcare professionals at least six months in advance, if it is reasonably foreseeable that such interruption or cessation of supply could cause serious harm or a risk of serious harm to patients or public health in one or more Member States.

Additionally, Regulation (EU) 2024/1860 extends the transition period for the application of Regulation (EU) 2017/746 based on the risk class of medical devices, in order to ensure patient safety and guarantee the continuity of supply of essential medical devices on the European market.

Regulation (EU) 2024/1860 was published in the Official Journal of the EU, Series L, on July 9, 2024, and came into force on July 29, 2024.

The Constitutional Court, in two anticipated decisions (Nos. 139 and 140 of 2024), has ruled on the legitimacy of the payback for medical devices. In the first decision (No. 139), rendered upon the appeal by the Region of Campania, the Court deemed legitimate the criteria for the allocation of the Fund established by Article 8 of Decree-Law 34/2023, which was created to alleviate the burden of payback imposed on companies. However, it declared the unconstitutionality of the provision insofar as it conditions the benefit of this reduction on the abandonment of litigation by the operators. In decision No. 140, the Court directly addressed Article 9-ter of Decree-Law 78/2015: while acknowledging the critical issues that characterize the regulatory framework, it judged the choice to have companies contribute to the payback of excess spending as overall reasonable, equating the payback to a "solidarity contribution" to ensure the supply of medical devices in a challenging economic context. According to the Constitutional Judges, the payback mechanism does not violate the legal reservation (Article 23 of the Constitution), as the Administration is only required to calculate the amount based on fully predetermined criteria, nor does it violate the principle of non-retroactivity, as the subsequent regulation (paragraph 9-bis of Article 9-ter) only governed procedural aspects without unconstitutionally affecting the private parties' reliance on maintaining the sale price of medical devices. However, the rejection of the constitutional challenges is expressly limited to the years (2015-2018) under litigation, for which the reasonable "sustainability" of the payback burdens on companies, made possible by the reduction of amounts due to the contribution under Article 8 of Decree-Law 34/2023, was deemed decisive. As a result of decision No. 139, this reduction is extended to all supplier companies regardless of their withdrawal from legal actions.

The use of the wording "skin friendly" in the advertising of biocides (in this case, a disinfectant for the skin, hands and surfaces) is misleading with respect to the risks that the product may pose to health and such as to justify the ban on its use in advertising, as it has a positive connotation that avoids the evocation of any risk and can even suggest that the product is beneficial for the skin.

This is the decision of the EU Court of Justice on the matter, adopted with judgement of 20 June 2024 (case C-296/23), considering that art. 72, par. 3, Reg. 528/2012 (dedicated to advertising on biocides, according to which "the advertising of a biocidal product shall not mention «low-risk biocidal product», «non-toxic», «harmless», «natural», «environmentally friendly», «animal friendly» or any similar indication") must be interpreted as meaning that the notion of "similar indications" contained therein includes any indication contained in advertising relating to biocidal products which, like the indications contained in that provision, refers to said products in such a way as to mislead the user as to the risks that they may present for human or animal health or as to their effectiveness, minimizing such risks or even denying their existence, without necessarily having a general character.

With resolution no. XXII/2405 of 28 May 2024, the Lombardy Region approved the provision on the testing of new community services in pharmacies, with particular reference to the implementation of telemedicine and medicinal product therapy reconciliation services, with remuneration from the Regional Health Service (SSR).

With this resolution, in particular, the Region approved: (i) the implementation plan for telemedicine services, version 1.0, which defines the project specifications of the experimentation in the field of telemedicine, including details relating to the actors involved, the expected activities, the possibilities for users and the organizational and practical implications for this service system. As a result of this implementation plan, pharmacies will be able to provide blood pressure Holter, cardiac Holter and ECG services with reimbursement paid by the SSR, it being established that pharmacies will have to use accredited health facilities for reporting and these services can be offered to patients affected from cardiovascular pathologies, with the right to extend the target during the trial; (ii) the Timeline, version 4.0, which represents the updated proposal of the timetable of the Lombardy Region for the purposes of participation in the Trial of New Services in the Community Pharmacy; (iii) the Implementation Plan for the Reconciliation of Pharmacological Therapy, version 2.0, aimed at promoting the Reconciliation of Pharmacological Therapy, as a process oriented towards prevention and reserved for patients suffering from cardiovascular pathologies, with the right to extend the target during the trial.

This is an experiment, with participation of pharmacies on a voluntary basis, which will start from the month of June until the end of 2024 and which includes the collaboration of Federfarma (the Italian federation of pharmacists) and the Pharmacists' Associations, which will guarantee the training of the pharmacists who join to the project.

The European Council has adopted a new regulation to improve the safety and quality of blood, tissues and cells used in healthcare, while also facilitating the cross-border circulation of these substances in the European Union. The regulation, called “Substances of Human Origin” (SoHO), expands the scope of SoHO to also include human breast milk and intestinal microbiota.

A broader definition of human substances is introduced, including foetal tissues and embryos, which until now had different regulations in different Member States. An EU-level SoHO Coordination Committee is established to support Member States in implementing the Regulation, together with common procedures for the authorization and evaluation of SoHO preparations.

Member States will be required to designate a national authority for SoHOs, which will authorize preparations and ensure independent and transparent oversight. Additional requirements are established for the licensing and inspection of facilities that process, store, release, import, or export SoHO.

The regulation provides for the establishment of a common IT platform, the EU SoHO platform, for registering and exchanging information on related activities. Furthermore, an early warning system is introduced to address serious incidents or reactions that may pose a risk to recipients or donors.

According to the new regulation, SoHO donations will, in principle, be voluntary and free, without financial incentives for donors. However, living donors may receive compensation or reimbursement, in accordance with national legislation.

Through these provisions, the aim is to guarantee greater protection for donors, recipients and children born through medically assisted reproduction. The new rules aim to strengthen the existing legal framework, while improving flexibility to adapt to scientific and technological advances.

The regulation will now be signed by the Council and the European Parliament and will enter into force following its publication in the Official Journal of the EU.

The Garante per la protezione dei dati personali (Italian Data Protection Authority) has identified the first guarantees to be observed for the processing of personal data concerning health for scientific research purposes, if informing the data subjects and acquiring their consent proves impossible, requires a disproportionate effort or risks making it impossible or seriously prejudicing the pursuit of the research purposes, in accordance with Art. 110 of Legislative Decree No. 196/2003 (Privacy Code), recently amended by Art. 44 of Law Decree No. 19/2024, converted into Law No. 56/2024 (see the news of 10th May 2024 https://www.studiolegaleastolfi.it/in-primo-piano/en_798_privacy-amended-article-110-of-the-italian-privacy-code-on-the-processing-of-data-for-scientific-research-purposes).

In particular, the measure adopted by the Authority provides that, in cases where the processing for scientific research purposes concerns data relating to the health of persons who are deceased or who cannot be contacted for specific ethical or organisational reasons (attributable, for example, to the circumstance that the data subject is unaware of his/her condition or to the circumstance that contacting them would involve a disproportionate effort), the data controller, in addition to adopting appropriate measures to protect the rights, freedoms and legitimate interests of the data subject, and acquiring the favourable opinion of the competent Ethics Committee (as already provided for by Art. 110 of Legislative Decree No. 196/2003), must also carefully justify and document, in the research project, the existence of ethical or organisational reasons for which informing the data subjects and, therefore, acquiring their consent is impossible or entails a disproportionate effort, or risks making it impossible or seriously prejudicing the achievement of the purposes of the research (also documenting the reasonable efforts made to try to contact them), and carry out and publish the data protection impact assessment, pursuant to Article 35 of the GDPR, notifying the Garante.

With the same provision, the Data Protection Authority also launched the procedure for the adoption of the Deontological Rules for the processing of personal data for statistical and scientific research purposes, inviting those who intend to take part in the work to provide, within 60 days of the publication of the provision in the Official Journal, information and documentation to prove, in particular, their qualified interest in the matter (decision no. 298 of 9th May 2024).

The so-called "PNRR bis Decree" (Law Decree No. 19/2024, converted into Law No. 56/2024), which came into force on 1st May 2024, introduced an amendment to Article 110 of the Italian Privacy Code (Legislative Decree No. 196/2003), concerning the processing of personal data for medical, biomedical and epidemiological research purposes.

Article 110 identifies the cases in which the data subject's consent for the processing of data relating to health, for the purpose of medical, biomedical or epidemiological scientific research, is not necessary, i.e. when (i) the research is carried out on the basis of provisions of law or regulation or EU law (in accordance with Article 9, para. 2(j), of the GDPR) and an impact assessment is conducted and made public, or (ii) due to particular reasons, informing the data subjects proves impossible or involves a disproportionate effort, or is likely to render impossible or seriously undermine the achievement of the purposes of the research.

In such cases, the data controller must take appropriate measures to protect the rights, freedoms and legitimate interests of the data subject and the research programme is subject to a reasoned favourable opinion of the competent ethics committee.

In the version of Article 110 prior to the amendment made by Law Decree No. 19/2024, converted into Law 56/2024, it was also provided that the data controller, before proceeding with the processing itself, should submit the latter to the prior consultation of the Italian Data Protection Authority (Garante per la protezione dei dati personali), pursuant to Article 36 of the GDPR. 

Art. 44 of the Law Decree No. 19/2024, converted in Law No. 56/2024, eliminated the requirement for prior consultation with the Italian Data Protection Authority, replacing it with the observance of the guarantees identified by the Authority, pursuant to article 106, para. 2(d), of the Italian Privacy Code.

The Regulation governing the organisation and operation of the Scientific and Economic Committee for Medicines (CSE) has been published on AIFA's institutional website. The CSE has the task of performing the functions attributed in the past to the Scientific-Technical Committee (CTS) and the Price and Reimbursement Committee (CPR), following the reform initiated by Law No. 196/2022 and recently completed by the Ministry of Health Decree No. 3/2024.

The Regulations is composed of three Titles.

The first Title is dedicated to the organisational rules, in which, the members of the Committee are identified and the investigative role of the AIFA Offices is specified, supporting the assessment and subsequent issuance of opinions by the Committee, which also has the possibility of availing itself of experts with proven technical and scientific experience, as well as of setting up advisory sub-commissions on specific issues.

The second Title, on the other hand, is dedicated to the operating rules and identifies the functions, tasks and organisation of the Committee's work, which must be carried out in compliance with the general principles set out in Article 6, i.e. (i) guaranteeing universal and homogeneous access to all essential medicines; (ii) ensuring safe and appropriate ways of using medicines; (iii) adopting a pricing policy aimed at rewarding medicines with added therapeutic value and (iv) taking into account the guidelines of the EMA and other European regulatory agencies.

Within the framework of the Committee's activities, the importance of patients' associations and scientific organisations is expressly recognised. In particular, patients' associations and scientific organisations can be convened to hearings in order to broaden the Committee's knowledge in decision-making processes (cf. Art. 11).

Finally, the third Title is dedicated to the final rules and, in particular, to access to the Committee's records (reference is made to the recent regulation adopted by the Agency), to the conflict of interest and confidentiality of the members of the Committee (who may not meet representatives of pharmaceutical companies outside the Agency in connection with procedures concerning medicinal products submitted to the them for assessment), and to fees and transparency in relation to the fees received by each member.

The Government has approved a bill to regulate artificial intelligence (AI). The aim is to make the most of the benefits provided by artificial intelligence, in order to improve people's lives and to ensure safe and responsible development, establishing rules that ensure a balance between the benefits of new technologies and the risks associated with their misuse or harmful use. It also introduces general principles and specific provisions to support the use of new technologies to improve people's lives and promote social cohesion, with a focus on risk management based on a human-centred perspective.

The Bill focuses on five areas: national strategy, national authorities, promotion, copyright and criminal sanctions. Provision is made for a delegation of powers to the government to align national legislation with the EU Regulation, e.g. for the education of citizens on AI and professional training, as well as for the revision of criminal laws relating to the misuse of AI systems.

The Bill also deals with AI in the purely health-related field, prohibiting discrimination in the access to health services and guaranteeing the right to be informed about the use of AI. AI is promoted for the purpose of inclusion and accessibility of persons with disabilities, without compromising medical decision-making, prescribing that systems and data must be reliable and up-to-date to minimise errors.

The Bill also declares data management by non-profit organisations engaged in therapeutic and pharmacological research using AI to be of public interest.

Provision is also made for regulations on the electronic health record and digital health, and an IA platform, managed by Agenas, is established to support territorial healthcare. The platform will offer assistance to healthcare professionals for the management of patients, supporting doctors in their daily clinical practice with non-mandatory suggestions and facilitating patient access to the services of healthcare facilities.

Age.na.s. has published, on its institutional website dedicated to Continuing Medical Professional Education (CME), the updated version of the Handbook on Continuing Education of Healthcare Professionals, now in its second edition (the first one dates back to 2018), which collects all the latest deliberations of the National Commission for Continuing Education.

In particular, the number of training credits for the three-year period 2023-2025 remains unchanged (150), but the relative reductions are modified, providing a discount of 30 credits for healthcare professionals who build an individual or group training dossier, in accordance with point 2.2.1 of the Handbook (previously a discount of only 10 credits was provided) and a discount of 20 credits (as opposed to the 15 previously provided) for those who have fulfilled their training dossier in the previous three-year period.

Changes have also been introduced in relation to so-called Individual Training, which includes training activities not provided by providers (i.e. scientific research activities, individual tutoring, individual training activities abroad and self-training activities), with more details to describe the aforementioned activities and attributing a greater number of training credits to their performance than in the past.

Finally, new modalities for the recognition of credits from individual training activities are outlined, eliminating the now superfluous formats of accreditation applications previously attached to the Handbook.

The European Parliament provided an update on the reform process for the modernisation of the European Union's pharmaceutical legislation.

The legislative package consists of a directive and a regulation, both of which have been approved with amendments that appear to be less rigid than the first drafts, in some key points, where they take into account the grievances expressed in recent months by the pharmaceutical industry, in particular:

- the minimum regulatory period of data protection (during which other companies cannot access product data), which in the Commission's draft had been reduced from 8 to 6 years, is extended 7.5 years, i.e. almost to current levels.

- market protection (during which generics or biosimilars cannot be marketed) remains at two years, as today and as in the executive text.

Further premium regulatory protection can be added, according to the logic promoted by the Commission.

In particular, a maximum of 8.5 years of data protection will be possible, based on new conditions introduced by the European Parliament:

- 12 months of additional data protection if the product fulfils an unmet medical need;

- 6 months if comparative clinical trials are conducted;

- 6 months if a significant part of the research and product development takes place in the EU and at least partly in cooperation with EU research institutions.

An additional 12 months can be added to the existing market protection if the company obtains a marketing authorisation for an additional therapeutic indication that provides significant clinical benefit over existing therapies. Orphan drugs developed to treat rare diseases may, on the other hand, benefit from up to 11 years of market exclusivity if they address a high unmet medical need.

The new rules for marketing authorisations (MAs) for medicines change the system from the European Commission's initial proposal. Instead of requiring marketing in all EU markets within two years of the EMA's go-ahead in order to achieve an extension of regulatory protection, the new system is more flexible and aimed at helping EU countries with limited administrative resources to manage marketing procedures. Procedures for entering a national market will only be initiated at the specific request of the country concerned.

The reform package for the EU pharmaceutical system, approved by the European Parliament, is not yet final. The baton now passes to the new Parliament that will emerge from the June elections. It will be up to the newly elected representatives to negotiate with the member states to find a final agreement on the law, and the EU Council will also have to adopt a position on the reform before arriving at a final version.

The Council of Ministers approved the Simplification Bill 2024, which will come into force after publication in the Official Juarnal, introducing several measures to improve healthcare in Italy.

The Bill is accompanied by a decree simplifying access to certain public services; in Chapter II "Simplification measures in health matters" a number of new features are introduced, such as the issuing of illness certificates also remotely using telemedicine tools.

The most innovative measure involves the provision of NHS services in pharmacies. In fact, some establishments will see a sign accompanying the green cross with the name "service pharmacy", which will indicate the new services provided, such as: the inoculation of vaccines to persons aged 12 years and over, the dispensing of medical devices needed to treat patients in home, residential and semi-residential care, the possibility of choosing a family doctor and paediatrician, the delivery of medicines for home care, and even telemedicine.

Moreover, alongside the family doctor or paediatrician, the pharmacist will play an active role in carrying out diagnostic tests to combat antibiotic resistance, contributing to a more informed and targeted use of antibiotics.

While these measures represent an innovative resource, citizens will still have to wait: the full operation of the new fee schedules on outpatient specialist and prosthetic services, which regulate the remuneration of services provided within the framework of the Essential Levels of Care (LEA), initially scheduled for 1st April 2024, has been postponed to 1st January 2025.

The Italian Ministry of Health promoted a public consultation (from 17 August to 17 September 2023) with the aim of collecting comments on the draft decree and technical regulations indicated by art. 5 Law 62/2022 (so-called Sunshine Act), with regard to the electronic public register (called "Sanità Trasparente").

In particular, the Ministry specifies that the two documents were prepared by an interinstitutional working Group and that:

- the draft decree governs the type of data collected, the transmission and publication of the same, the reports of conduct in violation of the law, as well as the times for publication and storage of data;

- the technical regulations defines the subjects required to transmit data to the Ministry of Health, as well as the authentication and authorization processes of the same, the data to be transmitted, the procedures for consulting the electronic public register, as well as the infrastructural characteristics of the same.

Consultation of the decree and the related technical  regulations allows anyone to provide their own contribution on the proposed topics. The Ministry invites, in particular, to take part in the public consultation the subjects directly involved by the legislation, namely:

• manufacturing companies operating in the human and veterinary health sector;
• subjects operating in the health sector;
• health organizations

From the link https://partecipa.gov.it/processes/sanitatrasparente it is possible to download the questionnaire for the consultation (to complete it, it is necessary to register with your SPID account). As indicated by the Ministry, the data collected will be treated anonymously and the results of the consultation will be made public on 8 October 2023.

Reg. (EU) 2023/607, amending Reg. (EU) 2017/745 and 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices, has been published in the Official Journal of the EU.

In order to address the risk of shortages of medical devices in the EU due to the difficulty encountered by a large number of manufacturers (in particular, small and medium-sized enterprises) in demonstrating compliance with the requirements of the new Regulations, the European Parliament and the Council deemed it necessary to further extend the transitional period by which certain devices that continue to comply with Directive 90/385/EEC or Directive 93/42/EEC can lawfully be placed on the market.

In particular, under the specific conditions identified in Reg. (EU) 2023/607, certificates issued by notified bodies from 25 May 2017 that were still valid on 26 May 2021 and that have not been withdrawn afterwards and certificates issued by notified bodies from 25 May 2017 that were still valid on 26 May 2021 and that have expired before 20 March 2023 remain valid after the expiry of the deadline indicated on the certificate until 31 December 2027 (for all class III devices, and for class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors), or until 31 December 2028 (for all other class IIb devices, for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function).

Furthermore, devices for which the conformity assessment procedure pursuant to Directive 93/42/EEC did not require the involvement of a notified body, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to Reg. (EU) 2017/745 requires the involvement of a notified body, may be placed on the market or put into service until 31 December 2028.

With reference to in vitro diagnostic medical devices, Reg. (EU) 2023/607 amends Reg. (EU) 2017/746 by providing that devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022, and devices lawfully placed on the market from 26 May 2022 pursuant to Art. 110, para. 3, Reg. (EU) 2017/746 may continue to be made available on the market or put into service.

Reg. (EU) 2023/607 entered into force on 21 March 2023, the day of its publication in the EU Official Journal.

Cosmetics Europe, the European association of cosmetics companies, has launched 'Cosmile Europe', the database collecting information on almost 30,000 ingredients used in cosmetic products.

The database is part of the Cosmetics Europe Transparency Initiative and aims to provide European consumers with easy access to reliable, verifiable and scientifically supported information on the properties and functions of cosmetic product ingredients, as well as their natural or synthetic origin.

The information in the Cosmile Europe database can be searched either by the common name or the INCI name (International Nomenclature Cosmetic Ingredient) of the ingredient, or by substance group or product type.

Cosmile Europe is available in 14 languages and has been developed in partnership with the German Cosmetic, Toiletry, Perfumery and Detergent Association (Industrieverband Koerperpflege-und Waschmittel e. V.-IKW), in collaboration with the French Fédération des Entreprises de la Beauté (FEBEA) and with the technology development support of health&media GmbH, as well as with the involvement of eighteen Cosmetics Europe national association members (the database can be found at https://cosmileeurope.eu/).

The Medical Device Coordination Group ('MDCG'), a body established under Article 103 of Reg. 745/2017, which provides advice and develops guidance in the medical device sector, has approved the Guidelines for the assessment of notified bodies (MDCG 2022-13 Designation, reassessment and notification of conformity assessment bodies and notified bodies - August 2022).

The document provides guidance to National Authorities responsible for Notified Bodies (in Italy, the Ministry of Health) and to Joint Assessment Teams ('JATs', consisting of representatives of the EU Commission and national experts) in carrying out the assessment processes of Conformity Assessment Bodies ('CABs') seeking designation as Notified Bodies ('NBs') in the medical device sector, and the reassessment processes of NBs.

The aim of the Guidelines is to align and make consistent with each other the working practices of the National Authorities regarding the evaluation, designation, notification and re-evaluation of CABs and NBs, in accordance with the provisions of the European Medical Device Regulations (Reg. 745/2017, "MDR" and Reg. 746/2017, "IVDR").

In particular, the different steps foreseen for the CAB assessment and NB reassessment processes are outlined, identifying the documentation to be submitted, the timelines to be met, as well as the authorities involved and their tasks.

Law no. 62 of 31st May 2022, containing “Provisions on the transparency of relations between manufacturing companies, subjects operating in the healthcare sector and health organizations” (so-called “Sunshine Act”) was published in the Official Journal no. 135 of 11th June 2022.

With reference to the contents of the new law, please see the Highlight published on 25th May 2022 (https://www.studiolegaleastolfi.it/in-primo-piano/en_695_sunshine-act-the-text-of-the-draft-law-has-been-approved-by-the-italian-parliament).

Sunshine Act will come into force on 26th June 2022, but for its application it’s necessary to take into account the transitional period outlined by the law.

First of all, it will be necessary to wait for the notice published in the Official Journal on the starting date of the operation of the public electronic register called “Sanità Trasparente” (on which company communications will be published for transparency purposes), which must be set up within 6 months from the entry into force of the law.

Furthermore, according to art. 9 of the new law:

(i) as from the second six-month period following the one in progress on the date of publication in the Official Journal of the communication of the starting date of the operation of the “Sanità Trasparente” Register;

(ii) the disclosure obligations of shareholdings (Article 4) shall apply as from the second year following the six-month period in progress on the date of publication in the Official Journal of the communication of the starting date of the operation of the “Sanità Trasparente” Register.

It is therefore necessary now to wait for the implementation of the Register and then begin the countdown to the application of the law.

After a long journey that began in 2018, yesterday, the Italian Parliament gave its final approval to the draft law on 'Provisions on the transparency of relations between manufacturing companies, healthcare professionals and healthcare organisations', the so-called 'Sunshine Act'. The text has now to be promulgated by the President of the Republic, before being published in the Official Journal.

 The entry into force of the law will be followed by a transitional period, so that those involved can prepare to fulfil their obligations under the law.

 Here are the main contents of the Sunshine Act.

 Aims pursued and actors involved

The Sunshine Act is aimed at guaranteeing the right to knowledge of relationships of economic importance or advantage, existing between, on the one hand, the so-called manufacturing companies, i.e. the subjects, including those belonging to the Third Sector, that carry out an activity directed to the production or marketing of medicinal products, instruments, equipment, goods and services, including non-health products and  nutritional products, marketable in the field of human and veterinary health, or to the organisation of conferences and congresses concerning such objects, and, on the other hand, the subjects operating in the health sector and health organisations, including any public or even private legal person that provides health services, as defined by Article 2 of the law (Article 1).

 Subject of communications: grants, conventions and agreements

They will be subject to communication:

 1) conventions and payments in cash, goods, services or other benefits made by a manufacturing company in favour of a subject operating in the health sector (if they have a unit value of more than EUR 100 or a total annual value of more than EUR 1,000) or a health organisation (if they have a unit value of more than EUR 1,000 or a total annual value of more than EUR 2,500), and

 2) agreements between manufacturing companies and organisations that produce direct or indirect benefits, consisting in participation in conferences, training events, committees, advisory bodies or scientific committees or in the establishment of consultancy, teaching or research relationships.

 The communication must be made within the six-month period following that in which the disbursements were made and/or the agreements and conventions were entered into and, if the manufacturing company is based abroad, the fulfilment may be carried out by its representative in Italy (Art. 3).

 Subject of disclosures: shares, bonds and incomes from industrial and intellectual property rights

There is also an obligation for manufacturing companies to report, by 31th January of each year, the data of subjects operating in the health sector and health organisations that

 1) are holders of shares in the company's capital or of bonds issued by the company, registered for the previous year in the register of shareholders or in the bond register, or who

 2) have received royalties from the company in the previous year for the granting of licences for the economic use of industrial or intellectual property rights (Art. 4).

 Telematic public register

Within six months following the date of entry into force of the Sunshine Act, a public electronic register called 'Transparent Healthcare' must be set up, in which the aforementioned notifications will be published, as well as the acts imposing the sanctions provided for by the law (Art. 5, paras. 1 and 2).

The electronic public register will be freely accessible by anyone for consultation and will be equipped with functions allowing the search and extraction of the data communicated by the manufacturers (Art. 5, para. 3).

Notifications will have to be submitted electronically in accordance with the instructions that will be determined by the Ministry of Health within three months following the date of entry into force of the law (Art. 5, para. 7).

 “Right to be forgotten”

Notifications published in the electronic public register will be available for consultation for a period of five years following the date of publication, after which they will be deleted (Art. 5, para. 4).

 Consent to publication and rights of the data subject

Consent to the publication and processing of data is considered to be given when the relationship from which the obligation of transparency derives is established. Manufacturing companies will in any case be required to provide appropriate information, specifying that the communications required by law will be published on the institutional website of the Ministry of Health. The law is in any case without prejudice to the rights of data subjects provided for in Articles 15, 16, 17, 18, 19 and 21 Reg. (EU) 2016/679, i.e. the right of access, the right to rectification and the right to erasure of subject's personal data, as well as the right to restriction of processing and the right to object to processing (Art. 5, para. 6).

 Sanctions

Administrative pecuniary sanctions shall be applied in the cases of failure to communicate, communication of incomplete information and communication of false information against manufacturing companies as the parties responsible for the truthfulness of the data contained in the communications (these sanctions will be reduced by half for companies with an annual turnover of less than one million euro provided that they are not controlled by, connected to or bound by supply or subcontracting relationships with other manufacturing companies).

The Ministry of Health is responsible for supervising the implementation of the law and enforcing sanctions (Art. 6).

 Transitional period

The guideline “MDCG 2022 - 5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices” of the Medical Device Coordination Group (MDCG) has recently been published, in order to provide support in the correct classification of borderline products, i.e. products that are not immediately ascribable to a specific sector due to their nature, for which it is not easy to identify its applicable legislation.

The first part of the document provides the definitions used (a diagram is also provided to facilitate product evaluation, and to establish whether or not it falls within the definition of a medical device), as well as general rules to be applied to identify the nature of a product. Concrete examples are then provided of medical devices (specifying that if a solution contains a medicinal product as a main ingredient, the product will be considered a medicinal product; conversely, solutions incorporating medicinal substances with an auxiliary action, such as preservatives, these substances are classified as medical devices), of medical device accessories (e.g., products to treat contact lenses), as well as medicinal products (e.g., disinfectants to be used on the non-intact skin of the patient before surgery, gases to be used in anaesthesia and inhalation therapy, etc.).

The second part of the Guideline contains separate chapters on specific product categories, such as:

- herbal products (which are usually medicinal products, but it is not excluded that they may qualify as medical devices if the action of its herbal component is only ancillary, and the main action is obtained by physical or mechanical means);

- substance-based medical devices (i.e. medical devices that are composed of substances permitted for this type of product, whose main action is not by pharmacological, metabolic or immunological means);

- medical device and medicinal product combination (in order to identify the correct regulatory reference framework, the first step is to establish whether the product is an "integral" product within the meaning of Regulation 745/2017, and then to understand whether the action of the medicinal product incorporated into the device is principal or ancillary to the function performed by the medical device itself. If the main action of the integral product is carried out by the medical device, the entire product will be considered as a device, and thus be governed by Regulation 745/2017).  

In addition to providing the relevant definitions and referencing the relevant regulatory provisions, numerous examples are given as further support for the purposes of correct classification for each product category.

The document may be subject to modifications by the MDCG in order to reflect scientific and technical developments, as well as the results of regulatory discussions held by the working group.

The decree of 30 November 2021 of the Italian Ministry of Health concerning “Measures intended to facilitate and support the conduct of non-profit clinical trials of medicines and observational studies and to govern the sale of non-profit trial data and results for registration purposes, pursuant to art. 1.1.c), of legislative decree no. 52 of 14 May 2019”, which abrogates the ministerial decree of 17 December 2004 and will come into force on 6 March, has been published in Italy’s Official Journal no. 42 of 19 February 2022.

The decree applies, pursuant to article 1, to non-profit clinical trials, to low-intervention clinical trials and to observational studies. It recalls the article 2.2 of Regulation (EU) no. 536/2014 which came into force on 31 January 2022, for the relative definitions, and also sets out the requirements relating to non-profit clinical trials.

The decree envisages the sale of non-profit trial data and results, both during and after completion of trials, for registration purposes, specifying that, after the sale, the specific provisions and special terms envisaged for the non-profit trials will no longer be applicable.

Sales shall be regulated by a contract between the sponsor and the assignee that establishes the agreed amount for the purchase of the data and the results, which is to be set with the assistance of a registered patent attorney.

In the event of a sale, the sponsor of the trial or the assignee is required to (i) cover and reimburse all direct and indirect expenses associated with the trial, (ii) pay the fees due to AIFA (the Italian medicines agency) and the relevant ethics committees, and (iii) allocate a fair valuation of the sale that has taken place to support the non-profit trials.

Furthermore, the sponsor shall transmit to AIFA, to the relevant ethics committee and to the trial centres involved an official notice informing them that the sale of the data and/or results of the non-profit trials has taken place.

Art. 3 also establishes that in case a non-profit trial is requalified as a for-profit trial by its sponsor, the sponsor is required to cover and reimburse all direct and indirect expenses associated with the trial, to pay the fees due to AIFA and the relevant ethics committees and to reimburse funding received for the trial until that time.

Finally, the decree sets out additional provisions envisaging special terms for non-profit clinical trials (art. 2), the application of the provisions as per art. 72 Reg. (EU) 536/2014 regarding co-sponsorship also for non-profit trials and low-intervention clinical trials (art. 4) and the adoption by AIFA of the new guidelines for the classification and conduct of observational studies on pharmaceuticals (art. 6).

In its non-definitive judgement no. 8634 of 27 December 2021, the Council of State referred to the Plenary Session of the Council of State the decision whether or not a company owning a pharmacy which is, in turn, owned in full by another company concerned with medical care represents an instance of incompatibility under art. 7, paragraph 2 of Law no. 362/1991, according to which ownership of shares in companies owning a pharmacy “is incompatible with any other business in the field of production of pharmaceuticals, providing of scientific information on pharmaceuticals, or the exercise of the medical profession”. After recalling that the incompatibility preventing pharmacy owners from conducting medical activities, as “motivated by the conflict of interest that results from simultaneously ‘prescribing’ and ‘dispensing’ medications”, “aims to safeguard the public interest in proper performance of the pharmaceutical service and, in the final analysis, the primary interest in protection of the public health”, the Administrative Courts noted the existence of two instances in the presence of which the circumstance of incompatibility may be considered to extend to pharmacies owned by subsidiary companies, and that is, if the parent company may be said to be: a) involved in the “operation” of the pharmacy, and b) exercising the “medical profession”. With reference to the first of these circumstances, the decision under examination considered it necessary for the Plenary Session to intervene, as it was necessary to establish whether the presumption of direction and coordination of the company owning the pharmacy, attributable to the parent company under articles 2359 and 2947 sexies of the civil code, may be considered sufficient to make the latter effectively or actively “involved in the operation of the pharmacy”. As for the second case, the Council of State took the view that it must be taken into consideration that a care home is not a company of medical professionals, as it simply organises and operates care homes, availing itself of the work of physicians, who work as independent professionals and do not entrust their decisions and responsibilities to others, and the circumstance that the physicians present in the shareholding structure of the care home hold positions (as partner or member of the board) entirely separate from their medical work, not allowing them to transfer to the company the distinctive features of their profession. In addition, we must remember that the regulations dictated by Law no. 362/1991 extend the condition of incompatibility only to partners in the company owning the pharmacy, not to the partners or directors of the company owning shares in the company that owns the pharmacy. The consequences that may result from a more or less extensive interpretation of the condition of incompatibility and the general relevance of the case at hand have therefore led the Council of State to put the decision before the Plenary Session in order to avoid the risk of possibly conflicting decisions.

The Italian Ministry of Health’s Directorate General for medical devices and the pharmaceutical service has issued a circular setting out indications regarding the application of the new Regulation EU 2017/745 on medical devices (which came into force from 26 May 2021), pending legislative measures for the necessary harmonisation of national and community provisions.

Specifically, the circular clarifies that the provisions of Art. 21 of Legislative Decree 46/1997 regarding the advertising of medical devices continue to apply, since they are compatible with Art. 7 Reg. 2017/745 and, consequently, that the requirements relating to the authorisation of advertising, introduced by ministerial decree 23 February 2006 and by Art. 118 of Legislative Decree 219/2006 (Pharmaceuticals Code), are still valid.

Furthermore, considering that it is the responsibility of the Member States to establish the sanctions to be applied in the event of breaches of the Regulation, pending the introduction of such sanctions, the sanctions envisaged by Art. 23 of Legislative Decree 46/1997 and by Art. 10 of Legislative Decree 507/1992 (e.g., for breaches of the laws governing post-marketing surveillance laws and reporting of accidents, confidentiality, affixing of the CE marking, registration of manufacturers of custom-made devices) remain in effect, with the proviso that sanctions relating to obligations or cases no longer contemplated by Reg. 2017/745 are not to be considered effective.

 The circular also specifies that until the European Databank on Medical Devices (Eudamed) becomes fully operational, the national provisions governing the transmission of information via the new healthcare information system (NSIS) shall continue to apply.

Moreover, the fees currently envisaged by ministerial decree 16 January 2019, by ministerial decree 14 July 2004 and by Ministry of Health circular 25 May 2021 (relating, respectively, to the issue of certificates of free sale and licenses for public advertising, as well as assessment of applications for the authorisation of clinical surveys) continue to be valid, until the fees to be applied for execution of the activities envisaged by Reg. EU 2017/745, in compliance with Art. 111 of the Regulation, have been set.

Additional indications in the circular relate to the products without an intended medical purpose listed in Annex XVI of Reg. 2017/745, recourse to harmonised standards pursuant to Art. 8 Reg. 2017/745 (which establishes that medical devices in conformity with the relevant harmonised standards, whose references have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements of the Regulation covered by those standards), notified bodies, legacy devices as at Art. 120, par. 3, Reg. 2017/745, as well as manufacturers of custom-made devices (the circular of 12 November 2021 is available on the website of the Ministry of Health www.salute.gov.it). 

Italy's Official Journal no. 283 of 27 November 2021 has published the text of law no. 175 dated 10 November 2021 containing “Provisions for the treatment of rare diseases and for the support of research into and production of orphan drugs” (the Consolidated Law on Rare Diseases), whose purpose is to ensure the protection, at multiple levels, of the health rights of individuals affected by the pathologies in question.

Specifically, after article 1 sets out the measures to guarantee the intention of the law, articles 2 and 3 define the terms rare disease and orphan drug. Article 4 assigns to the reference centres indicated by ministerial decree 279/2001 the formulation of the personalised diagnostic, treatment and care plan for an individual affected by a rare disease, and also provides a structured procedure for the transition from paediatric care to adult care.

Article 5 sets out provisions to ensure pharmaceutical support and the immediate availability of orphan drugs, and, under certain conditions, allows for drugs marketed in other countries to be imported, eventually for uses not authorised in the countries of origin, provided that such uses are envisaged by the diagnostic, treatment and care plans. Article 6 establishes a solidarity fund for people affected by rare diseases, which will finance the measures to support people affected by these pathologies, and provides for an implementing regulation to be adopted by the Ministries concerned within three months of the law coming into force.

Furthermore, the law defines the functions of the national centre for rare diseases and the creation of the national committee for the pathologies in question (arts. 7 and 8) and provides for the approval every three years of the national plan establishing objectives and related activities in this area (art 9). The law also involves the Italian Regions, requiring them to ensure the flow of information on the rare disease networks to the national centre, in part to guide and support national planning and control activities (art. 10).

The law provides that as from 2022 the national fund for the use, at the expense of the Italian national health service, of orphan drugs for rare diseases and of drugs offering hope of a cure, pending marketing, shall be supplemented by an additional contribution by the pharmaceutical companies corresponding to 2% of their self-certified expenses to the overall expenditure incurred during the previous year for promotional activities addressing healthcare personnel (the fund currently operates through the AIFA and is funded with 2.5% of the expenses in question; consequently, with the new law, the contribution of the pharmaceutical companies will rise to 4.5%).

The competent Ministries are required to identify (within 6 months of the law coming into force) the criteria and procedures for accessing the subsidies envisaged by article 12 to support research work, to promote independent research in the area of rare diseases (art. 13), and to promote measures to provide patients and their families with correct information and raise public awareness.

The law certainly lays the basis for a significant legislative change on this important and sensitive question. It will come into force on 12 December 2021.

With sentence no. 1295 of 15 February 2021, the Council of State ruled on the legitimacy of the assignment of a municipal pharmacy to its employees, by virtue of the exercise of the right of first refusal provided for by Art. 12 of Law no. 362/1991, to municipal employees, following the ruling of the Court of Justice of 19 December 2019, C-465/18, which sanctioned the incompatibility of this provision with Community law due to its conflict with Community principles on competition.   In particular, the European Court held that the EU Treaty must be interpreted in the sense that it precludes a national measure that grants an "unconditional" right of first refusal, such as that contemplated by the aforementioned Art. 12 of Law no. 362/1991, while having also stated that the "objective of capitalising on the professional experience gained may be attained through less restrictive measures such as the award of additional points under the tendering procedure to tenderers who provide proof of experience in managing a pharmacy". In this context, the supreme administrative court affirmed that "the interpretative judgement of the Court of Justice issued following a preliminary ruling is comparable to a regulatory contingency, which, as it affects a proceeding still in progress and an interest not covered by the judgement, is not suitable to cause a conflict, but a chronological succession of rules governing the same legal situation". It thus retained that the Community sentence was directly applicable to the case in question, and ordered the annulment of the awarding of the pharmacy to municipal pharmacist employees. Nevertheless, the Council of State did not retain the decision of the judges of first instance to be legitimate: they ordered the direct assignment of the pharmacy to the applicant, in the light of the interpretation of Art. 12 of Law no. 362/1991 that was made by the Court of Justice, in the sense "that it legitimises the provision of conditional forms of the right of first refusal, which can well be left to the discretion of the administration". For this reason, the judges of second instance held that the Municipality is required to "repeat the tender procedure, with the provision of a right of first refusal compatible with Art. 49 of the Treaty", taking into account that "the attribution of a points system in the tender as regards municipal pharmacy employees, to which the same sentence of the Court of Justice expressly gives "merit" as a proportionate means of "enhancement" of the skills acquired, could represent the suitable means, in the reconciliation of interests, to satisfy the public interest in health-related manners".

On September 15th, Cosmetic Europe (the European Association of the Cosmetics Industry) published the updated version of the Charter and Guiding Principles on Responsible Advertising and Marketing Communications document, first adopted in 2012. The update became necessary for the Charter to more efficiently address the challenges that today's highly digitized world entails, in the context of a fast-paced evolution of technologies, and rapid development of new forms of digital advertising and marketing communication practices.

The new document, following the path already outlined in the previous version and integrating the existing legislative framework, defines the European common line for the creation of responsible advertising and marketing communications that respect the human being, body image and human dignity, via all media.

The Charter also re-emphasizes the importance of image honesty, pointing out, in particular, the need to ensure that the digital techniques used do not alter the images of the models presented in such a way that the characteristics of the body become unrealistic and misleading with respect to the performance achievable by the product. The Charter also provides a set of new useful indications for influencer marketing, which are essentially aimed at making genuine and impartial opinions easily distinguishable by consumers with respect to the promotional messages that may be disseminated by influencers.

The Charter also includes specific commitments with reference to the responsible advertising and promotional communication towards vulnerable consumers, including children and teens, with a special focus on advertising via social media platforms, smartphones applications and games.

Another key issue addressed is responsibility in promoting the “eco-friendly” products. Marketing communication should be so framed as to empower consumers to make sustainable choices. For this purpose, specific attention is paid to a series of aspects regarding the general presentation of a product, the use of images, symbols and logos, as well as the accuracy, relevance, clarity and substantiation of environmental claims.

The text of the Charter and Guiding Principles on Responsible Advertising and Marketing Communications is available on the website of the Cosmetic Europe association (https://cosmeticseurope.eu/).

The Commission has published three guidelines for manufacturers in order to increase the safe manufacture of medical equipment given the ongoing pandemic, mainly as regards masks and other personal protective equipment (PPE), non-rinse cleansers and hand disinfectants, and 3D printing for medical use.

The first guideline (containing "Conformity assessment procedures for protective equipement") provides indications for assessing the legal and technical requirements for the production of protective devices such as masks, gloves, and surgical gowns (which are in large part considered personal protective equipment, and therefore fall within the scope of Reg. 2016/425), as well as the manufacture of devices for intensive care and other medical equipment (which may fall within the field of application of the legislation on medical devices).

The second guideline, containing "Guidance on the applicable legislation for leave-on hand cleaners and hand disinfectants (gel, solution, etc.)", provides useful tools for the correct qualification of hand cleaners and disinfectants, and clarifies when a product is to be intended as cosmetic or biocide for regulatory purposes. The document mainly serves to provide indications on the correct interpretation of labels that use terms such as "anti-bacterial": these always require a case-by-case assessment, given the manner in which the product is presented to the consumer as a whole.

The guidelines for "Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19" provide indications on the conformity assessment procedures for 3D printing and 3D printed products for medical use. It refers to applicable legislation within the EU, which includes the "harmonised European standards", and provides indications on the correct qualification of such products, which may also fall into the category of medical devices, with the consequent application of current regulatory provisions on the matter (the text of the Guidelines is available on the European Commission website, at https://europa.eu/european-union/index_en).

The EU Court of Justice has identified the criteria according to which an amicable settlement between the owner of a pharmaceutical patent and a manufacturer of generic medicines is contrary to the rules of the TFEU established to protect competition.

Notably, the Court of Justice clarified that the owner of a patent for the manufacturing process of an active ingredient that has become public domain and the manufacturers of generic medicines that are preparing to enter the market of the originator are in a potential competitive situation. In various case law, contradiction is seen on the validity of this patent or the counterfeit nature of generic medicines if it is shown that the manufacturer of generic medicines actually has the definitive approval and ability to enter the market; it should not face obstacles to such access of an insurmountable nature (a circumstance that is for the referring court to verify).

In addition, the Court ruled that the agreement to settle a pending court case between a producer of originator medicines and a manufacturer of generics in competitive situations by means of which the latter agrees not to enter the originator's market and not to continue its action of nullity of the relative patent during the period of validity of the agreement, in exchange for transfers of money by the manufacturer of the originator medicines, constitutes an agreement aimed at preventing, restricting, or distorting potential competition.

This is provided that:

i. all the available elements show that the positive transfer amount from the owner of the originator medicine to the manufacturer of generic medicines is explained only by the commercial interest of the parties in agreeing not to enter into competition based on the merits;

ii. the amicable settlement in question is not accompanied by proven beneficial effects for competition, such as to reasonably doubt that it would be substantially damaging to competition.

Lastly, the EU Court stated that an amicable agreement of the company that owns the originator that serves to temporarily keep potential generic-producing competitors out of the market constitutes the abuse of a dominant position within the meaning of Art. 102 of the TFEU, if such strategy is suitable for limiting competition (Court of Justice, judgement of 30 January 2020, in case C-307/18).

With its sentence of 19 December 2019 (case C-465/18), the EU Court of Justice ruled on the compatibility of Art. 12(2) of Law 362/1991, which grants employees the right of first refusal in the event of a transfer of ownership of a municipal pharmacy. The issue was raised by the Council of State during a dispute on the transfer of a municipal pharmacy; administrative courts found this rule to be in conflict with the principles of free competition and equal treatment contained in EU law. The Court of Justice found that the recognition of the unconditional right of first refusal granted to employees of a municipal pharmacy subject to transfer is likely to dissuade pharmacists from other Member States from participating in this procedure, constituting a restriction to the freedom of establishment provided by Art. 49 of the TFEU. This restriction was not deemed justified, as the rights of employees are guaranteed by Italian law by that provided for in Art. 2112 of the Civil Code, and employees of municipal pharmacies have not been proven to have greater professional experience, quality of service provided, or functions performed as regards the objective of protecting health. In recognising the incompatibility of the national rule with the Art. 49 of the TFEU, EU courts concluded by stating that the objective of enhancing professional experience pursuant to Art. 12 above can also be achieved through less restrictive measures, with respect to the recognition of an unconditional right of first refusal, such as the assignment of scores, as part of the tender procedure, for participants who provide proof of experience in pharmacy management.      

On 2 October, the Advocate General at the EU Court of Justice filed his conclusions in Case C-465/18 on the request for a preliminary ruling filed by the Council of State on 18 July 2018, aimed at understanding if the principles of freedom of establishment, non-discrimination, equal treatment, protection of competition, and freedom of movement for workers, pursuant to Articles 45, from 49 to 56 and 106 of the TFEU, Articles 15 and 16 of the Charter, and the canon of proportionality and reasonableness contained therein, preclude a national regulation, namely Art. 12(2) of Law no. 362/1991, which, in the event of transfer of the ownership of a municipal pharmacy, assigns the right of first refusal to the employees of such pharmacy.

In the opinion of the Advocate General, the rules on the freedom of establishment pursuant to Art. 49 of the TFEU precludes national legislation, which recognises the right of first refusal to municipal pharmacy employees in the event of its transfer, as this discipline has the effect of hindering and discouraging pharmacists of other Member States to exercise their right to participate in the tender procedure to purchase a municipal pharmacy located within the Italian Republic.

This rule does not seem to constitute a restriction on the freedom of establishment as justified by general interest, such as the protection of public health, since the aim is to guarantee the continuity of employment of pharmacists of municipal pharmacies in order to safeguard their rights in the event of the transfer of ownership of such pharmacy, which is based on social and occupational considerations rather than those of public health. Lastly, the Advocate General pointed out that this objective cannot be justified for the protection of employees against dismissal in the event of transfer of a municipal pharmacy, against the protection guaranteed by Art. 2112 of the Italian Civil Code.

On 12 June 2019, the new decree on clinical trials for medicinal products for human use (Leg. Decree 52/2019) was published in the Official Journal. In implementing the provisions of Art. 1 of Law 3/2018 (the so called "Lorenzin Law") "delegating powers to the government with regard to clinical trials for medicinal products and provisions for the reorganisation of health professions and the healthcare managers of the Ministry of Health", the new decree impacts current legislation on clinical trials (Leg. Decree 200/2007 and Leg. Decree no. 211/2003). Among the main changes made by Legislative Decree 52/2019, it is noted that Art. 1, "in order to enhance non-profit clinical trials with a low level of intervention" introduces the possibility of transferring the relative data and results for registering purposes, with the obligation of the sponsor to sustain and reimburse direct and indirect trial-related expenses, as well as the relative tariffs if the trial is requalified as a for-profit activity, inclusive of potential revenue deriving from the enhancement of intellectual property. The issuance of a specific decree of the Ministry of Health is foreseen, which provides for a discount scheme for good clinical practice inspections on phase I studies, and the competence for sanctions is transferred from the Ministry of Health to AIFA, as the Authority competent in the field of clinical trials for medicinal products. Article 2, which amends Leg. Decree 211/2003, provides for a single national form for the purpose of submitting an application for the opinion to the Ethics Committee, and requires AIFA to publish the list of facilities authorised to conduct clinical trials. Chapter II of the decree contains provisions for coordination with Reg. 536/2014 on trials, and, in addition to referencing the definitions contained therein, establishes that the Ministry of Health, by means of a decree, adapts the governance on the suitability of facilities at which the clinical trial is conducted to the provisions of the European Regulation, and that within 90 days from the issuance of this decree, AIFA identifies the requirements for the authorisation of centres to conduct trials from phase I to phase IV. The Ministry of Health must also identify the criteria and guidelines for the authorisation of centres for clinical trials of advanced therapies, and AIFA, having consulted the National Coordination Centre of Ethics Committees, will have the task of identifying suitable methods to protect the independence of clinical trials and ensure the absence of conflicts of interest. In this regard, it is envisaged that, in order to guarantee neutrality and impartiality, the subjects appointed with the validation and subsequent evaluation of the application for authorisation of a clinical trial make a declaration as to the absence of conflicts of interest, and that the Ministry of health, subject to agreement in the State-Regions Conference, orders the suppression of any territorial Ethics Committees that violate the terms and procedures on the evaluation of clinical trials or the rules on transparency and on the absence of conflicts of interest. Lastly, two ministerial decrees must, respectively, redefine the procedures for evaluating and authorising clinical trials, and identify the general criteria on the basis of which universities can initiate master's degrees on the methodology of clinical research and trials (Leg. Decree no. 52 of 14 May 2019, published in Official Journal no. 136 of 12 June 2019).

"EU institutions and bodies are required to respect the fundamental rights of the European Union, which include the right to good administration enshrined in Article 41 of the Charter" [of fundamental rights], which, in paragraph 1, establishes that every person has the right to have his or her affairs handled impartially.

The requirement of impartiality aims to guarantee equal treatment, which is a basic principle of European law, in order to avoid situations of potential conflict of interest for officials acting on behalf of institutions. Given the fundamental importance of guaranteeing independence and integrity as regards both internal operation and the external image of EU institutions, this requirement of impartiality must cover all of the circumstances that an official called upon to comment on a case must reasonably understand as likely to appear, in the eyes of third parties, as capable of influencing independence in the matter.

Consequently, the requirement of impartiality must be ensured both from a subjective point of view, in the sense that none of the members of the institution concerned must express preconceived opinions or personal prejudices, as well as from an objective point of view, in the sense that the institution is bound to offer sufficient guarantees to exclude any legitimate doubt as regards potential prejudice.

On the basis of these principles, in annulling the judgement of the first instance, the EU Court of Justice declared the decision adopted by the European Commission on the renewal of the marketing authorisation of a medicinal product to be illegitimate. The decision was adopted on the basis of the opinion given by the Committee for Medicinal Products for Human Use (CHMP) of the EMA, whose main rapporteur was an employee of the national authority that had previously issued a decision refusing the renewal of the marketing authorisation for said medicinal product. Furthermore, the employee had defended the aforementioned authority in the appeal against the decision before national judges, and initiated the procedure before the Committee itself (EU Court of Justice, judgment of 27 March 2019, in case C-680/16P).

On 28 May 2019, the World Health Organisation (WHO) approved the resolution proposed by Italy, together with 18 other countries, to improve the transparency of the prices and patents of medicinal products, vaccines and other healthcare products. The purpose of the initiative is to help the Member States take better-informed decisions when purchasing healthcare products, negotiate more accessible prices and thereby broaden public access to these products. The availability of comparable information should facilitate greater cost-effectiveness and equal access to healthcare products.

The resolution invites the Member States, in accordance with their national laws, to implement systems for public dissemination of information on the actual prices of healthcare products and to guarantee greater transparency of information about the status of their patents.

Furthermore, the Director General of the WHO is entrusted with a number of tasks to support and monitor the activities introduced by the Member States. Specifically, the DG is asked to support the development of national policies concerning the transparency of healthcare markets, and to convene the Fair Pricing Forum every two years, at which the Member States and all interested parties may take part to examine price accessibility and transparency and the costs of healthcare products.

With judgement no. 608 of 22 May 2019, the Piedmont Regional Administrative Tribunal (TAR) issued a ruling on a new question concerning the possibility for the Italian regional authorities to enable medical practitioners other than those employed by or with an agreement with the Italian national health service (SSN) to prescribe health services whose costs are borne by the SSN.

The TAR developed its reasoning from an examination of the challenged resolution of the Regional Council to investigate the resolution’s compatibility with the relevant national laws, specifically art. 2 decree law no. 443/1987, which expressly restricts use of prescription pads for state-funded services to medical practitioners employed by or with an agreement with the SSN. Consistently with the reconstruction of a previous ruling of the Constitutional Court (judgement no. 1103 of 20 December 1988), the TAR cites two fundamental reasons for the restriction ex art. 2 legislative decree no. 443/1987: on the one hand, it meets the need to restrict prescriptions, or proposed services deliverable by the SSN, to practitioners of proven competence; on the other, it avoids an anomalous and uncontrolled increase in prescription of medicinal products.

According to the reconstruction of the Piedmont TAR in the judgement in question, the laws subsequent to the above-mentioned decree law do not have either an implicit or an explicit revoking effect, indeed they highlight that the restriction is still evident in the relevant legislation, specifically in the technical regulations on the dematerialisation of hard-copy medical prescriptions (decree 2 November 2011 on “Dematerialisation of the hard-copy medical prescription, as per art. 11, paragraph 16, legislative decree no. 78/2010 - Medical Card Project”): prescribing cannot be mixed with the delivery of healthcare services, which would only appear to be exercisable also by accredited private healthcare bodies.

For these reasons the TAR annulled the ruling of the Piedmont Regional Council which extended the power to prescribe services whose costs are borne by the SSN to medical practitioners in private bodies (Piedmont TAR, Section I, ruling no. 608 of 22 May 2019).

On April, 17th, the European Parliament approved the text of the new regulation on supplementary protection certificates; in amending Regulation (EC) 469/2009, it introduces the possibility for pharmaceutical companies established in the European Union to produce generics and biosimilars during the validity period of the supplementary protection certificate (SPC) of the originator product of reference in order to export them to a third country where the product patent has expired or never existed. It will also be possible to produce generics and biosimilars before the SPC of the originator product expires, in order to stock them in the EU and put them on the market immediately after the expiry of the certificate. The newly approved regulation also provides that certain information (such as manufacturer name and address, purpose of production, the Member State of production or storage) is communicated by the manufacturer of generics and/or biosimilars to the competent authority and to the holder of the SPC. These new provisions will apply from the date of entry into force of the regulation for new certificates requested from such date, and from 1 July 2022 will also apply to those previously requested and effective after the entry into force of the regulation itself.

The Regulation governing the organisation and operation of the Scientific and Economic Committee of Medicines (CSE) has been published on AIFA's institutional website. The CSE has the task of performing the functions attributed in the past to the Scientific-Technical Committee (CTS) and the Price and Reimbursement Committee (CPR), following the reform initiated by Law No. 196/2022 and recently completed by the Ministry of Health Decree No. 3/2024.

The Regulation is composed of three Titles.

The first Title is dedicated to the organisational rules, in which the members of the Committee are identified, the investigative role of the AIFA Offices is specified, supporting the assessment and subsequent issuance of opinions by the Committee, which also has the possibility of availing itself of experts with proven technical and scientific experience, as well as of setting up advisory sub-commissions on specific issues.

The second Title, on the other hand, is dedicated to the operating rules and identifies the functions, tasks and organisation of the Committee's work, which has to be carried out in compliance with the general principles set out in Article 6, i.e. (i) guaranteeing universal and homogeneous access to all essential medicines; (ii) ensuring safe and appropriate ways of using medicines; (iii) adopting a pricing policy aimed at rewarding medicines with added therapeutic value and (iv) taking into account the guidelines of the EMA and other European regulatory agencies.

Within the framework of the Committee's activities, the importance of patients' associations and scientific organisations is expressly recognised. In particular, patients' associations and scientific organisation can be convened to hearings in order to broaden the Committe's knowledge in decision-making processes (cf. Art. 11).

Finally, the third Title is dedicated to the final rules and, in particular, to access to the Committe's records (reference is made to the recent regulation adopted by the Agency), to the conflict of interest and confidentiality of the members of the Committe (who may not meet representatives of pharmaceutical companies outside the Agency in connection with procedures concerning medicinal products submitted to it for evaluation), and to fees and transparency in relation to the fees received by each member.

The EU Court of Justice has identified the criteria according to which an amicable settlement between the owner of a pharmaceutical patent and a manufacturer of generic medicines is contrary to the rules of the TFEU established to protect competition.

Notably, the Court of Justice clarified that the owner of a patent for the manufacturing process of an active ingredient that has become public domain and the manufacturers of generic medicines that are preparing to enter the market of the originator are in a potential competitive situation. In various case law, contradiction is seen on the validity of this patent or the counterfeit nature of generic medicines if it is shown that the manufacturer of generic medicines actually has the definitive approval and ability to enter the market; it should not face obstacles to such access of an insurmountable nature (a circumstance that is for the referring court to verify).

In addition, the Court ruled that the agreement to settle a pending court case between a producer of originator medicines and a manufacturer of generics in competitive situations by means of which the latter agrees not to enter the originator's market and not to continue its action of nullity of the relative patent during the period of validity of the agreement, in exchange for transfers of money by the manufacturer of the originator medicines, constitutes an agreement aimed at preventing, restricting, or distorting potential competition.

This is provided that:

i. all the available elements show that the positive transfer amount from the owner of the originator medicine to the manufacturer of generic medicines is explained only by the commercial interest of the parties in agreeing not to enter into competition based on the merits;

ii. the amicable settlement in question is not accompanied by proven beneficial effects for competition, such as to reasonably doubt that it would be substantially damaging to competition.

Lastly, the EU Court stated that an amicable agreement of the company that owns the originator that serves to temporarily keep potential generic-producing competitors out of the market constitutes the abuse of a dominant position within the meaning of Art. 102 of the TFEU, if such strategy is suitable for limiting competition (Court of Justice, judgement of 30 January 2020, in case C-307/18).