In review: the healthcare framework in Italy

All questions

Overview

Article 32(1) of the Italian Constitution recognises the right to health as a fundamental right of each person as well as an interest of the entire community. It also states that the Italian Republic shall guarantee free care to indigents. Accordingly, Law No. 833 of 23 December 1978 established the National Health Service (NHS). The state, Italian regions and the local territorial authorities coordinate to guarantee healthcare to people all over the Italian territory.

In particular, as a result of Constitutional Reform No. 3 of 2001 of Title V of the Italian Constitution, health protection is a matter of shared competence between the state and Italian regions.² Consequently, the state shall establish the fundamental principles with regard to health protection while regions may adopt regional laws and shall organise the healthcare services on the territory under their jurisdiction and guarantee the provision of such services.

On the other hand, the state has the exclusive competence to set the essential levels of care (LEAs),³ which shall be guaranteed throughout the national territory and which are defined by the National Health Plan (PNS).

As mentioned, the NHS is organised on three levels: national, regional and local.

The main bodies acting in the healthcare sector at national level are: the Ministry of Health, its scientific and technical advisory the Supreme Health Council, the National Institute of Health, the Italian Medicines Agency (AIFA) and the National Agency for Regional Health Services (AGENAS).

While at the local territorial level, local health agencies (ASLs), introduced by Legislative Decree No. 502 of 30 December 1992, play an essential role. ASLs are companies with public legal personality, divided into districts, prevention departments and hospital wards.

The healthcare economy

The NHS is grounded on three principles: universality, equality and equity. This means that the NHS provides health services for all citizens, without any individual, social or economic distinction. All citizens must have access to the health services included in the essential levels of care.

Moreover, Article 32 of the Italian Constitution provides for free care for indigents. To this end, the 'indigent' is considered not the poor in absolute terms but an individual who is destitute with respect to the care they need, where it is too costly for their personal economic condition.

The PNS is adopted at state level. It is valid for three years and establishes the key objectives of prevention, treatment and rehabilitation as well as the corresponding funding. In particular, the PNS contains the LEAs, which are the minimum levels of care that shall be guaranteed uniformly throughout Italy by each region.

On the other hand, each region adopts a regional health plan (PSR) to better plan and organise health services in the competent regional territory, with the aim of implementing LEAs. The PSR has a three-year duration.

Each ASL approves its own local implementation plan (PAL).

In addition to the healthcare services provided by the NHS, each citizen may decide to pay for private care outside the NHS itself.

Citizens of non-EU countries legally present in Italy may access the NHS under different conditions depending on the reason for their staying in Italy.

People do not need insurance to have access to healthcare services provided by the NHS. Specifically, the healthcare services included in LEAs are provided by the NHS free of charge or with the participation of patients in the expenditure (co-payment), through the payment of the ticket.⁴

Therefore, in Italy health insurance is not compulsory. However, citizens may decide to take out an insurance policy even if it is complementary or supplementary to the NHS. An insurance policy can be purchased by employers in favour of their employees (and sometimes their families), or by individuals for themselves and their families (e.g., through membership of specific professional groups).

One of the main advantages of private health insurance is that it allows patients to avoid the long waiting lists in public healthcare.

The NHS is financed by tax revenues. Public healthcare provided by the NHS is normally free of charge. However, for some healthcare services there is a system of co-payment by patients: this means that the cost of the healthcare performance is shared between the region and the patient. Generally, the amount of such co-payment is moderate, but the exact amount depends on the region and the healthcare treatment.

In particular, LEAs specify the services that require the payment of a ticket (e.g., thermal cures, specialist visits). Similarly, LEAs establish the healthcare services that do not involve a co-payment from patients (e.g., services provided by general practitioners and paediatricians, specialist assistance services included in programmes of screening, early diagnosis and collective prevention promoted or authorised by region, such as the pap-test for cervical cancer).

Moreover, certain categories of persons are exempted from paying a ticket – for some or all healthcare services – in the case of (1) particular income situations associated with age or social status; (2) existence of specific pathologies (chronic or rare); (3) disability status; and (4) in other specific cases, such as pregnancy or early diagnosis of certain cancers.

If patients choose a private healthcare provider, they will have to pay for such healthcare service at market price.

With regard to medicines, the NHS grants certain categories of medicines free of charge.

Primary/family medicine, hospitals and social care

The first point of care assistance in a given territory is generally provided by general medicine practitioners (MMGs) as well as pediatricians in a regime of collaboration with local regional health agencies. They have their own out-patient small clinic where they see patients and their services are free to patients enrolled with them since their services are remunerated by the local health agencies based on the number of patients assisted. They assess the patient's health need and regulate their possible access to further services offered by the NHS.

The NHS provides home healthcare to those who are not self-sufficient or are in fragile condition through the provision of the appropriate assistance (e.g., medical, rehabilitation, nursing) under Article 22 of the Prime Ministerial Decree of 12 January 2017. The request for activation of home care shall be submitted to the competent ASL office and shall be supported by a prescription issued by an MMG or pediatrician, or hospital specialist.

As far as the electronic health record (FSE) is concerned, it is the set of data and digital documents related to each patient's medical story and generated by public as well as private healthcare facilities (Article 12 of Law Decree No. 179 of 18 October 2012). Article 12 of Law Decree 179/2012, as amended by Article 11 of Law Decree 34/2020 and subsequently by Law Decree 4/2022, mainly regulates the FSE. Pursuant to this provision, each healthcare provider shall register in the FSE the healthcare service provided for the patient within five days of its performance.

However, patients hardly use the FSE, which is still poorly implemented in Italy. In this context, the National Recovery and Resilience Plan (PNRR), mission 6, requires the FSE to be strengthened on the national territory. Specifically, it requires that, by 2026: (1) the FSE must be continuously fed with clinical data; (2) the FSE experience in the Italian regions be standardised; (3) data portability will be made possible; and (4) the FSE becomes the sole access to e-health. To this end, on 11 July 2022, the decree drawn up by the Ministry of Health containing the 'Guidelines for the implementation of the FSE' was published in the Italian Official Gazette.

From the data protection perspective, the Italian Data Protection Authority published FAQs on personal data protection related to the FSE.

Only the (1) patient, (2) healthcare professionals (HCPs) – public and private – who care for the patient (including the MMG), and (3) health authorities, only for governance and research purposes, can access the FSE. Other subjects such as insurance companies and employers are excluded.

The licensing of healthcare providers and professionals

As further specified below, healthcare services guaranteed by the NHS may be provided for by public establishments as well as by private ones if certain conditions are met (i.e., authorisation, accreditation and conclusion of an agreement with the competent ASL).

As far as HCPs are concerned, they must have graduated, and be licensed and registered with the relevant professional association. HCPs shall carry out and exercise their profession in compliance with the law and their professional association's code of conduct.

Since the NHS is organised on a regional basis, each region is the administration responsible for providing healthcare. To this end, the role of ASLs is essential, as they manage the supply of health services within the territory.

As anticipated, regions and ASLs provide LEAs within their competent territory. In this context, healthcare services may be provided directly by public healthcare establishments, or by private facilities on behalf of and at the expense of the NHS under certain conditions, or by private providers.

Article 8 bis of Legislative Decree 502/1992 (introduced by Legislative Decree 229/1999) regulates the exercise of healthcare activities by private providers on behalf of and at the expense of the NHS, by introducing the procedures of authorisation, accreditation and the stipulation of agreements with ASLs.

Specifically, pursuant to Article 8 ter of Legislative Decree 502/1992, healthcare and socio-sanitary establishments shall obtain a specific authorisation from the competent region for the construction of the facility itself and for exercise of the relative healthcare activity, both if these establishments intend to operate under a private regime and on behalf of the NHS. Such authorisation is required in the case of the construction of new establishments, the adaptation of existing facilities and their different use, and the expansion or transformation and the transfer to another location of already authorised establishments. This applies to specific categories of facilities, such as health and socio-sanitary establishments that provide services on a continuous or daytime residential basis.

Authorisation for the provision of healthcare activities is also required for dental, medical and other HCPs' clinics where they are equipped to offer outpatient surgery services, or diagnostic and therapeutic procedures of particular complexity or involving a risk to patient safety, as well as for facilities exclusively dedicated to diagnostic activities and for the provision of home care (pursuant to Article 8 ter (2) of Legislative Decree 502/1992).

Private and public establishments shall meet certain minimum organisational (e.g., use of guidelines and good practice protocols), technological and structural (e.g., earthquake and fire protection) requirements in order to be able to carry out healthcare or social-health activities.

An authorised healthcare establishment may provide healthcare services on behalf of the NHS only if further quality standards are met and if it is accredited by the competent region, pursuant to Article 8 quater of Legislative Decree 502/1992. Specifically, the region may issue institutional accreditation to authorised facilities (public or private) and to HCPs that request it if certain conditions are met. In particular, accreditation is subject to: (1) the applicant's compliance with further quality requirements; (2) the applicant's functionality with respect to regional planning guidelines (dependent on regional healthcare needs); and (3) the positive verification of the activity carried out and the results achieved.

The document 'Disciplinary Rules for the Revision of the Accreditation Regulations', adopted on 20 December 2012 by an agreement between the Italian government, the regions and the autonomous provinces, identified certain requirements that all healthcare establishments must possess for institutional accreditation.

Establishments accredited to the NHS are eligible to carry out healthcare activities on behalf of the NHS. However, to this end, healthcare establishments shall stipulate an agreement with the competent ASL (Article 8 quinquies of Legislative Decree 502/1992), which establishes the maximum number of services that can be provided by the healthcare establishment (reimbursed through public resources) and the relative fee-based remuneration.

As far as HCPs are concerned, the NHS currently recognises 30 healthcare professions that require enrolment in the competent professional association. By way of example, there are professional associations for surgeons and dentists, veterinarians and pharmacists. Each professional association lays down a code of conduct containing ethical principles to be complied with in professional practice. HCPs must continue to train during their career through the system of continuing medical education.

HCPs within the NHS are public employees. However, physicians of a public hospital may carry out private practice within the outpatient and diagnostic facilities of the hospital itself. In this case, physicians shall provide for the healthcare service upon payment of the service based on market value by the patient, and, consequently, they shall issue an invoice for the healthcare service performed.

Any subject exercising a healthcare activity illegally is punished with imprisonment from six months to three years and a fine from €10,000 to €50,000, under Article 348 of the Italian Criminal Code. Moreover, this rule also provides for the confiscation of all items used to commit the offence and the transmission of the sentence to the competent professional association for the purposes of applying a ban of one to three years from the profession or activity regularly practised.

Ownership of healthcare businesses

In Italy it is possible for entrepreneurs and public investors to establish, run and manage private hospitals, inpatient and outpatient clinics. To open a private healthcare establishment, the premises have to be approved by the local regional healthcare agency as compliant with local laws and regulations on health and hygiene safety. In addition, the opening of private health activities is subject to specific authorisation as specified above.

Regions and accredited private hospitals can sign specific framework collaboration agreements whereby those private hospitals are considered as public regional hospitals (i.e., the region reimburses the private hospital for delivering healthcare services to patients so that the patients are not required to pay for the healthcare services and treatments they receive).

All private hospitals are required to appoint a healthcare director who is a doctor with full responsibility for the provision by the hospital of healthcare services to patients.

Marketing and promotion of services

Article 1(525) of Law No. 145 of 30 December 2018 (the 2019 Budget Law) states that private healthcare establishments as well as professionals enrolled in the registers of relevant HCP associations may carry out informative communications provided that such communications exclusively contain information about professional qualifications and specialisations and the characteristics and prices of the services offered (under Article 2 of Law Decree No. 223 of 4 July⁵).

Moreover, these informative communications are only allowed if they are aimed at guaranteeing the safety of health treatment. Any promotional or element of suggestion is prohibited, in order to protect the patient's free and conscious decision and dignity, their right to appropriate information on health services and public health.

In the case of breach of provisions concerning healthcare services advertising, Article 1(536) of the 2019 Budget Law provides that HCP associations take disciplinary action against enrolled professionals or companies and notify such violations to the Italian Communications Authority (AGCOM) for the purpose of the possible adoption of sanctioning measures.

Moreover, Article 56 of the Physicians Code of Conduct regulates health information advertising. It provides, inter alia, that health communication shall always be truthful, correct and functional to the object of the information, and never ambiguous, misleading or disparaging. Moreover, this rule confirms that health information communication may only concern professional titles and specialisations, professional activity, the features of the health service offered and its fee.

In addition, Article 170 of Royal Decree No. 1265 of 27 July 1934 bans the conduct of a physician or veterinary surgeon who receives money or other benefits or accepts a promise to facilitate the spread of medicinal products or any other product for pharmaceutical use. Similarly, Article 171 of Royal Decree No. 1265/1934 prohibits this type of conduct by pharmacists. Finally, Article 172 of Royal Decree No. 1265/1934 fines any subject who gives or promises to give money or other benefits to a HCP or pharmacist for such purposes.

Procurement of services and goods

Provision of healthcare services is usually commissioned by the local MMGs, who are in collaboration with local regional health agencies. Their services are free to patients enrolled with them. MMGs can prescribe specific diagnostic or therapeutic treatments and send patients to hospitals for further investigations.

As mentioned above, the NHS is substantially free of charge for patients (services are financed by the government from the taxes paid by citizens). Only a small percentage of costs of the procedures are allocated to the patients through the payment of a ticket. So, the sector is funded by the central government and the regions.

Private insurance is useful in cases where a patient wishes to access private care upon payment. Public hospitals also provide for private care services to patients who can and are willing to pay. While the level of the service is the same, the private regime allows patients to shorten the waiting list, which is usually very long under the public regime, especially for elective diagnostic clinical procedures and exams. Private healthcare is accessible to every paying patient regardless of whether they have insurance coverage or not.

Regarding opportunities to sell health services to buyers, the advertising of healthcare services is possible subject to certain restrictions provided by law (no promotional cut).

On 1 April 2023, Legislative Decree No. 36/2023 – the new Italian Public Procurement Code – came into force. It will become effective from 1 July 2023 and, at the same time, will repeal the previous Italian Public Procurement Code (i.e., Legislative Decree No. 50/2016).

Tender authorities are national or regional procurement agencies.

Reimbursement of services and goods

The healthcare services included in the LEAs are guaranteed by the NHS free of charge or, in specific cases, with the co-payment of the patient.

In addition, the NHS reimburses certain categories of medicines. In particular, AIFA classifies medicines into three main classes for price and reimbursement: class A (i.e., essential medicines and medicines for chronic diseases) are reimbursed by the NHS as well as medicines in class H, which can be used exclusively in hospitals. All other medicines are included in class C and are paid for by patients.

AIFA negotiates with pharmaceutical companies the price of medicines reimbursed by the NHS, based on the criteria established by the Decree issued by the Ministry of Health on 2 August 2019.⁶

Digital health developments

On 17 December 2020, the State–Regions Conference approved the 'National guidelines for the provision of telemedicine services' (the Guidelines) drafted by the Ministry of Health. The Guidelines updated the previous guidelines about telemedicine dated 2014, by replacing them.

The Guidelines specify that the fee for a telemedicine service shall be equivalent to the tariff for the same service carried out in the traditional way within the LEAs, including any cost-sharing. They also classify and describe the several telemedicine services, such as the televisit, tele-consultation and tele-assistance. Moreover, the Guidelines identify the modalities for the provision of telemedicine services may be provided within the NHS as well as by private healthcare establishments.

On 18 November 2021, the State–Regions Conference adopted a document containing the 'Guidelines for the provision of telerehabilitation services by the health professions'. It provides uniform guidelines for the NHS on tele-rehabilitation services.

Moreover, the PNRR promotes the development of telemedicine. In this context, the 'Organizational Guidelines containing the Digital Model for the Implementation of Home Care' were adopted by the Ministerial Decree of 19 April 2022. These guidelines provide a reference model for the implementation of telemedicine services in the home setting. In addition, AGENAS published a public tender notice aimed at the 'design, implementation and management of the enabling services of the national telemedicine platform'. The relevant contract for the development of the national telemedicine platform was awarded in March 2023.

Moreover, on 21 September 2022, the Ministry of Health approved a Decree titled 'Approval of the guidelines for telemedicine services – Functional requirements and service levels' (published in the Italian Official Gazette on 2 November 2022).

As for electronic prescriptions (e-prescriptions) for prescription medicines reimbursed by the NHS, they were introduced by the Ministerial Decree of 2 November 2011. However, their actual implementation in the NHS took place during the covid-19 emergency period. Several regulations have been adopted on this matter. These steps forward led to the implementation of the system of e-prescriptions in the NHS even after the end of the covid-19 emergency.

Coronavirus

The covid-19 emergency period sped up the implementation of telemedicine services as well as the adoption of regulation on e-prescriptions.

First, Ordinance 651/2020, issued by the Head of the Civil Protection Department on 19 March 2020, allowed a citizen to receive remotely from their physician the e-prescription number needed to collect the prescription medicine from the pharmacy, limited to the state of emergency due to covid-19.

The Decree issued by the Ministry of Economy and Finance on 25 March 2020 extended the application of the alternative methods to the paper memorandum of the prescriptions to the period after the end of the covid-19 emergency. This ministerial Decree extended the scope of use of the e-prescription to medicines with AIFA therapeutic plan and medicines distributed on behalf of the NHS.

Moreover, under the Note issued by the Ministry of Health and Ministry of Economy and Finance on 14 May 2020, certain narcotic and psychotropic medicines and specific medicines with strong analgesic activity may be prescribed with an e-prescription for the treatment of a specific category of patients with severe pain.

On 30 December 2020 the Ministry of Economy and Finance adopted a decree that allows the possibility for physicians to issue e-prescriptions also for medicines not reimbursed by the NHS. This Ministerial Decree specified the modalities of transmission of the e-prescription memorandum. Specifically, e-prescriptions may be transmitted from physician through a specific online platform, via email or text message upon the patient's request, and by means of the patient's electronic health record. The Ministerial Decree of 1 December 2022 issued by the Ministry of Economy and Finance amended the Ministerial Decree of 30 December 2020. Thanks to this modification, parapharmacies (which sell over-the-counter or self-medication medicines) can also receive and manage e-prescriptions for over-the-counter or self-medication medicines.

On 3 March 2022, the Ministry of Health issued a Note titled 'Start of dematerialisation of prescriptions for medicines not reimbursed by the NHS'.

Future outlook and new opportunities

In May 2022, the European Commission published a proposal for a Regulation on the European Health Data Space with the aim of making significant progress towards a single market for digital health services and products (i.e., the European Health Data Space (EHDS)).

On 21 April 2021, the European Commission issued a Proposal for a Regulation concerning laying down harmonised rules on artificial intelligence and amending certain Union legislative Acts. In June 2023, the European Parliament adopted its position on the first EU rules to contain risks and promote ethical use of artificial intelligence (AI). The adoption of the European Regulation on Artificial Intelligence is expected shortly.

On 23 February 2022, the European Commission adopted the proposal for a Regulation on harmonised rules on fair access to and use of data (the Data Act). On 28 June 2023, the European Parliament and the EU Council reached an agreement on the proposal, which will now need to be formally approved.

On 26 April 2023, the European Commission adopted a proposal for a new Directive and a new Regulation with the aim to reform EU pharmaceutical legislation. This proposal aims to replace the current pharmaceutical legislation as well as the legislation on medicines for children and for rare diseases.

With respect to medical devices, we are in the midst of a transition phase with the gradual implementation of EU Regulation 745/2017 (MDR) and of EU Regulation 746/2017 (IVDR). Legislative Decree No. 137 of 5 August 2022 has adapted the Italian legislation to the provisions established by the MDR, and it has replaced Legislative Decree No. 46/1997 concerning the regulation of medical devices. On the other hand, Legislative Decree No. 138/2022 ensured the adaptation of Italian legislation to the provisions stipulated in the IVDR. In addition, Italy is adopting further Decrees to ensure full implementation of the MDR and IVDR: for instance, in June 2023, the Italian Ministry of Health published four Decrees concerning clinical investigations of medical devices in the Italian Official Gazette. Moreover, EU Regulation 607/2023 modified the MDR and IVDR with regard to transitional provisions for certain categories of medical devices and in vitro diagnostic medical devices.

Several legislative initiatives are also foreseeable in the near future for the implementation of the objectives of the PNRR, including a reform of the Italian IP system.

A new Italian Procurement Code has been adopted with the issuing of the Legislative Decree No. 36 of 31 March 2023.

On 31 January 2022, EU Regulation 536/2014 on clinical trials of medicines for human use went into effect. Therefore, the Italian legal system is adapting its regulation on clinical trials to the new rules established by the Regulation. In particular, Law No. 3 of 11 January 2018 provides for the adoption of several ministerial decrees for the correct application of the Regulation.

In this context, AIFA published on its website clarifications and models of documents to be completed in compliance with the Regulation, such as the following templates: 'principal investigator curriculum vitae' and 'declaration of interests'. In particular, AIFA published a 'Guidance on the assessment by territorial ethics committees of the document referred to in Article 7(1) of Regulation (EU) No. 536/2014', updated on 12 May 2023. Moreover, the National Coordination Centre for Ethics Committees published new draft agreements for carrying out clinical trials on medicines and medical devices.

In addition, with regard to non-profit clinical trials, the Decree of 30 November 2021, issued by the Ministry of Health, was finally published in the Official Gazette in February 2022 and entered into force in March 2022. For the first time, a ministerial Decree allowed the transfer of data and results of non-profit clinical trials (ongoing or already ended) for registration purposes.

On 30 January 2023, the Ministry of Health adopted a Decree concerning the definition of criteria for the composition and functioning of territorial ethics committees, and a Decree regarding the determination of the single fee for clinical trials, attendance fees and reimbursement of expenses for participation in meetings of the national coordination centre of territorial ethics committees for clinical trials on medicinal products for human use and medical devices, territorial ethics committees and national ethics committees.

Law No. 62 of 31 March 2022 (the Italian Sunshine Act) regulates provisions on the transparency of relations between manufacturing companies, healthcare subjects and healthcare organisations. It requires disclosure for transfer of value in the healthcare sector under certain conditions. However, the Italian Sunshine Act has not become effective yet, pending the official setting up of the telematic public registry on the website of the Ministry of Health. Specific data concerning the transfers of value will be published in this transparency register and will be accessible to everyone for five years. The public registry was supposed to be established by the end of 2022, but nothing has been published yet.

Conclusions

The healthcare sector in Italy is going through a profound period of transformation and modernisation. Protection of IPRs, data sharing, consistency with the EU legal framework, modernisation of healthcare assistance and diagnosis by means of adoption of new technologies (e.g., telemedicine, AI) and more agile scientific assessment, evaluations and analysis both in the R&D space and in the regulatory space (e.g., real-world evidence based approach; rolling review approval process) are just a few of the opportunities and challenges that Italy will have to face to build a more modern, efficient, effective and quicker way of providing healthcare to its population.