Order — ECLI:EU:C:2026:284
Date: 2026-03-25
Language of the case: Italian
Court formation: Seventh Chamber
Procedure: Reference for a preliminary ruling
Origin: Italy

Summary C-181/25 – 1 
Case C-181/25 
Summary of the request for a preliminary ruling pursuant to Article 98(1) of 
the Rules of Procedure of the Court of Justice 
Date lodged: 
4 March 2025 
Referring court: 
Consiglio di Giustizia amministrativa per la Regione siciliana 
(Italy) 
Date of the decision to refer: 
27 February 2025 
Appellant: 
Autorità Garante della Concorrenza e del Mercato (AGCM) 
Respondent: 
Assessorato Regionale della Salute 
Intervening parties: 
Sanicam Palermo SpA 
A.I.O.P. Associazione Italiana Ospedalità Privata – Regione Sicilia 
Centro Medico Mantia SRL 
Emoteam Laboratorio Analisi Società Consortile a r.l. 
  
Subject matter of the main proceedings  
Appeal by the Autorità Garante della Concorrenza e del Mercato (Competition 
Authority, Italy; ‘the AGCM’) against judgment No 2341/2023 of the Tribunale 
Amministrativo Regionale per la Sicilia (Regional Administrative Court, Sicily, 
Italy; ‘the TAR Sicily’), which dismissed the action for compliance brought by the 
AGCM, seeking compliance, on the part of the Assessorato Regionale della Salute 
della Regione Sicilia (Regional Department of Health, Sicily, Italy; ‘the Regional 
Department of Health’), with judgment No 2967/2020 of the TAR Sicily annulling 
EN 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-181/25 
 
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decreto n. 2087 (Decree No 2087) of the Regional Department of Health’, of 
9 November 2018, on the ground of infringement of the principles of equal 
treatment and protection of competition. 
Subject matter and legal basis of the request 
In relation to public funding of private healthcare, the referring court seeks to 
ascertain the effects of the exclusion of ‘healthcare services’ from the scope of 
Directive 2006/123/EC, in particular with regard to the protection of competition 
in the market for healthcare provided by accredited private entities and paid for by 
public funds. The referring court is also uncertain as to the compatibility with EU 
law of national and regional provisions which, for the purpose of planning in 
advance the State resources to be allocated to private healthcare facilities, are 
based on the so-called historical expenditure criterion, or which predetermine a 
fixed entry budget, established in advance in absolute terms or in relation to the 
value of the budgets allocated to other accredited private entities that are already 
active in the same market. 
Questions referred for a preliminary ruling  
(1) ‘Does the exclusion of “healthcare services” from the scope of Directive 
2006/123/EC have any effect on the full implementation of the principles of the 
protection of competition in the specific field of access of accredited private 
entities to the conclusion of contracts referred to in Article 8-quinquies of decreto 
legislativo n. 502 (Legislative Decree No 502) of 1992, pursuant to Article 3(3) 
TEU and Article 3(1)(b), Articles 106 and 116 and Article 117(1) TFEU?’; 
(2) ‘If the answer to Question 1 is in the negative, is the so-called historical 
expenditure criterion used for allocating to accredited private enterprises the 
budget relating to the conclusion of individual contracts pursuant to Article 8-
quinquies of Legislative Decree No 502 of 1992, when applied exclusively or 
predominantly or, in any event, in a preponderant way by the regional 
administration, contrary to Article 3(3) TEU and Article 3(1)(b), Articles 106 and 
116 and Article 117(1) TFEU?’; 
(3) ‘Do the provisions of Article 3(3) TEU, Article 3(1)(b), Articles 106 and 
116 and Article 117(1) TFEU and, more generally, the principles of the protection 
of competition and the free market, preclude regional provisions which, as regards 
access to the market for healthcare provided by accredited private entities and 
financed by public funds, and, therefore, in respect of the first contract, provide 
for a fixed entry budget, predetermined by the regional administration and 
independently of assessments of the efficiency and capacity of the provider, the 
specific needs of the patients to be met, the location of the services on the 
territory, the number of staff and the technological equipment available to the 
provider?’; 
ASSESSORATO REGIONALE DELLA SALUTE 
 
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(4) ‘If, in answering Question 3, it is considered that the establishment of a 
fixed entry budget is compatible with the provisions of Article 3(3) TEU and 
Article 3(1)(b), Articles 106 and 116 and Article 117(1) TFEU and, more 
generally, with the principles of the protection of competition and the free market, 
does that compatibility depend on the value of the entry budget predetermined by 
the regional administration, considered in absolute terms or in relation to the value 
of the budgets allocated to other accredited private entities already contracted and 
operating in the same sector or branch of specialisation?’. 
Provisions of European Union law relied on 
Directive 2006/123/EC on services in the internal market; in particular, recital 22 
and Article 2(2)(f), according to which that directive does not apply to ‘healthcare 
services whether or not they are provided via healthcare facilities, and regardless 
of the ways in which they are organised and financed at national level or whether 
they are public or private’. 
The TEU, in particular Article 3(3). 
The TFEU, in particular Article 3(1)(b), Articles 106 and 116, Article 117(1) and 
Article 267. 
Provisions of national law relied on 
Decreto legislativo n. 502 (Legislative Decree No 502) of 30 December 1992, in 
particular: 
Article 8(7), which recognises as healthcare providers all entities, both public and 
private, that have relationships ‘based on the criterion of accreditation of 
institutions, on ‘payment for services’ arrangements and on adoption of the system 
for verifying and reviewing the quality of the activities carried out and the 
services provided’; 
Article 8-bis: ‘1. The regions shall ensure the essential and uniform levels of 
assistance referred to in Article 1 by using hospitals directly managed by local 
health authorities, hospital trusts, universities and scientific institutes for research, 
hospitalisation and healthcare, as well as entities accredited under Article 8-
quater, in accordance with the contractual arrangements referred to in Article 8-
quinquies. 2. Citizens shall exercise the freedom to choose the place of treatment 
and medical professionals as regards accredited entities with whom specific 
contractual arrangements have been put in place. Access to the services is subject 
to a specific medical prescription, proposal or request made on the Servizio 
sanitario nazionale (National Health Service, Italy; ‘the National Health Service’) 
form. 3. The establishment of healthcare facilities and the exercise of healthcare 
activities, the exercise of healthcare activities on behalf of the National Health 
Service and the exercise of healthcare activities borne by the National Health 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-181/25 
 
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Service shall be subject, respectively, to the issuance of the authorisations referred 
to in Article 8-ter, the institutional accreditation referred to in Article 8-quarter, 
and to the conclusion of the contractual agreements referred to in Article 8-
quinquies. This provision shall also apply to social healthcare facilities and 
activities’; 
Article 8-ter, which concerns the authorisation for the establishment and operation 
of healthcare facilities, in order to prevent facilities which do not meet the 
essential requirements as regards habitability, hygiene and professionalism being 
opened and becoming operational; 
Article 8-quarter, which concerns the accreditation of healthcare facilities, in 
order to ensure that the patient has the right to freely choose the doctor or facility 
by which to be treated, albeit within the limitation of healthcare services the costs 
of which may, in principle, be borne by the National Health Service; 
Article 8-quinquies, as amended by Article 15(1)(b) of legge n. 118 (Law No 118) 
of 2022, on so-called ‘contractual arrangements’, paragraph 1-bis, under which 
the private entities with whom to conclude a contractual arrangement ‘shall be 
identified, for the purposes of concluding contractual agreements, by means of 
transparent, fair and non-discriminatory procedures, following publication by the 
regions of a notice containing objective selection criteria, which give priority to 
the quality of the specific healthcare service to be provided. The selection of those 
entities must be carried out periodically, taking into account regional healthcare 
planning and on the basis of verifying the potential need to streamline the network 
of contractual arrangements and, for entities that already have contractual 
agreements, the activity performed; for those purposes, the updating of the 
fascicolo sanitario elettronico (FSE) (the electronic health record) in practice on a 
continuous and timely basis shall also be taken into account […], as well as the 
results of control, surveillance and monitoring activities in relation to the 
evaluation of the activities provided, the procedures for which shall be established 
by the decree referred to in Article 8-quarter, paragraph 7’. 
Legge n. 449 (Law No 449) of 27 December 1997; in particular: Article 32(8), 
which governs the principle of necessary healthcare planning by the regions, in 
advance, for each public or private healthcare institution, by determining the 
annual limits for costs borne by the Fondo sanitario nazionale (the National Health 
Fund, Italy), the annual budgets for healthcare provision, guidelines and 
procedures for negotiations. 
Decreto legislativo n. 59 (Legislative Decree No 59) of 26 March 2010 
implementing Directive 2006/123/EC on services in the internal market; in 
particular Article 7(1)(b), according to which the provisions of that decree are not 
applicable ‘to healthcare services and pharmaceutical services provided directly 
for therapeutic purposes in the exercise of healthcare professions, irrespective of 
whether or not they are provided in healthcare facilities, and regardless of the 
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ways in which they are organised and financed, and whether they are public or 
private’. 
Decreto del Ministero della Salute (Decree of the Ministry of Health) of 
19 December 2022; in particular, Article 3: ‘In identifying private entities for the 
purposes of concluding contractual agreements, each region and autonomous 
province shall take into account the provisions laid down in Article 8-quinquies, 
paragraph 1-bis, of Legislative Decree No 502 of 1992, which require the 
publication of a notice containing objective selection criteria, which give priority 
to the quality and minimum volumes of the specific services to be provided. The 
selection of those entities shall be carried out periodically, taking into account 
organisational specifications and, in line with regional planning, any need to 
streamline the network of contractual arrangements, the activity performed by 
entities that already have contractual agreements, the updating of the electronic 
health record in practice on a continuous and timely basis, and the results of 
control, surveillance and monitoring activities in relation to the evaluation of the 
activities provided, carried out on the basis of the elements set out in Annex B of 
this decree’. 
Legge n. 193 (Law No 193) of 16 December 2024; in particular Article 36(1), 
which, in order to carry out a comprehensive review of the rules on institutional 
accreditation and contractual arrangements, suspended, until 31 December 2026, 
the effect of paragraph 1-bis of Article 8-quinquies of Legislative Decree 
No 502/1992, in the version cited above, and of the Decree of the Ministry of 
Health of 19 December 2022. 
Succinct presentation of the facts and procedure in the main proceedings  
1 In relation to an action brought by the AGCM, the TAR Sicily, by judgment 
No 2967 of 22 December 2020 (‘the TAR judgment’), upheld the action and 
annulled Decree No 2087 of the Regional Department of Health, of 9 November 
2018, which allocated public resources for specialised healthcare services 
provided by private entities, for 2018, solely on the basis of the criterion of so-
called ‘historical expenditure’ and, for 2019, in the amount of 95% on the basis of 
‘historical expenditure’, thereby infringing the principles of equality and the 
protection of competition. In particular, that annulment did not have retroactive 
effect for 2018, whereas it did have retroactive effect for 2019. 
2 By judgment No 994/2021, the Consiglio di giustizia amministrativa per la 
Regione siciliana (Council of Administrative Justice for the Region of Sicily, 
Italy; ‘the Council of Administrative Justice’) upheld the appeal brought by the 
Regional Department of Health against the TAR judgment and declared, also for 
2019, the non-retroactivity of the effects of the annulment which it had ordered. 
3 Subsequently, the AGCM, taking the view that the Regional Department of Health 
continued to fail to fulfil its obligation to allocate those public resources on the 
basis of criteria and parameters capable of ensuring effective competition and 
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equality between operators in the field, brought an action for compliance before 
the Council of Administrative Justice, seeking the full enforcement of the TAR 
judgment. 
4 Sanicam Palermo – Ambulatorio Polispecialistico SpA, which supported the 
request for enforcement of the TAR judgment, and the Regional Department of 
Health, which, by contrast, claimed that it had already fully complied with that 
judgment by issuing several decrees (‘the Regional Department of Health decrees 
at issue’), appeared before the Council of Administrative Justice. The AGCM 
submitted that those decrees were contrary to the TAR judgment. 
5 The TAR Sicily, before which the proceedings were resumed on the ground that it 
had ‘functional’ competence to rule on the AGCM’s action, dismissed the latter 
action by judgment No 2341/2023, taking the view that the Regional Department 
of Health had complied with the TAR judgment, since it had gradually abandoned 
the criterion of historical expenditure. 
6 By an appeal lodged on 16 November 2023, the AGCM challenged that judgment 
before the Council of Administrative Justice, the referring court. 
The essential arguments of the parties in the main proceedings  
7 In support of its appeal, the AGCM submits that the Regional Department of 
Health, by means of the Regional Department of Health decrees at issue, 
continues to maintain a certain rigidity in its allocation of public resources to 
specialised healthcare services provided by private entities, thereby favouring 
entities that are already operating in that market. 
8 First, for the two-year period 2020-2021, the Regional Department of Health did 
not adopt measures to avoid distortion of competition, having allocated, for 2020, 
an individual budget identical to that of 2019, with the mere addition of a one-off 
bonus, and, for 2021, an individual budget corresponding to the value of the 
services actually provided, a value which does not always correspond, however, to 
a more efficient organisation of the activity or better patient care. 
9 Secondly, for the two-year period 2022-2023, the Regional Department of 
Health’s choices were completely ineffective, since an individual budget made up 
of 50% of the budget allocated to the same facility in 2019 and 50% of another 
parameter - equal for all the facilities, calculated by dividing the total amount 
assigned in 2019 to each Azienda Sanitaria Provinciale (Provincial Health 
Authority, Italy) by the number of accredited facilities operating in it - was 
allocated. A ‘maximum fluctuation band’ was also provided for in order to 
prevent the budget actually granted to each facility from being reduced by more 
than 15% or increasing by more than 50% in relation to the lower value between 
the 2019 budget and 2019 production. In that way, according to the AGCM, half 
of that allocation still operates on the basis of the criterion of historical 
expenditure and the other half on an inflexible parameter, namely, that of the 
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allocation to each facility of the same amount, which is not capable of restoring 
competitive dynamics. 
Succinct presentation of the reasoning in the request for a preliminary ruling 
10 The Italian National Health Service model introduced on the basis of Legislative 
Decree No 502/1992 is intended to reconcile the principle of freedom of the user 
to choose the trusted facility, whether public or private, in which to receive 
healthcare services, with that of planning of services provided at the expense of 
the public service. In particular, under Article 32(8) of Law No 449/1997, the 
regions are to adopt an annual plan to identify, in advance, for each public and 
private healthcare institution, the maximum annual limits on expenditure that may 
be borne by the National Health Fund, as well as the annual budgets for healthcare 
provision. 
11 Legislative Decree No 502/1992 then provides that, in order to be able to exercise 
healthcare activities at the expense of the National Health Service, a private 
healthcare facility must have the authorisation provided for in Article 8-ter 
thereof, be accredited in accordance with Article 8-quarter thereof and conclude 
specific contractual agreements with the public health authority (so-called 
‘contractual arrangements’) pursuant to Article 8-quinquies thereof. Those 
agreements give rise to the right on the part of the private healthcare facility, 
within the limits of the budget allocated to it, to remuneration for the healthcare 
services provided. 
12 The referring court notes that, according to the settled case-law of the Italian 
administrative courts, the Italian healthcare system, based on horizontal 
subsidiarity between accredited public and private healthcare operators, is subject 
to the competition rules applicable to any sector of the market, requiring the 
assessment of new operators entering the market, the periodic review of operators 
already accredited and, consequently, the potential examination of the level of and 
desirable improvements to the healthcare services offered to citizens. 
13 In accordance with that case-law and numerous opinions of the AGCM, 
provisions, such as those based on the use of the criterion of historical 
expenditure, which hinder the conclusion of contracts with new accredited entities 
by favouring entities that already have contractual arrangements and referring 
exclusively, by way of justification, to the saturation of supply, are therefore 
unlawful. Although that criterion ensures the stability of relationships and enables 
private entities to make medium and long-term investments, it actually creates 
advantageous positions on the market. 
14 In that context, the referring court asks, in the first place, whether or not the 
exclusion of healthcare services provided for by Directive 2006/123/EC has an 
effect on the full implementation of the principles of the protection of competition 
in the specific field of access of accredited private entities to the contractual 
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arrangements provided for in Article 8-quinquies of Legislative Decree 
No 502/1992. 
15 In the second place, if those principles are applicable in that specific field, it asks 
whether the criterion of historical expenditure, applied by a region exclusively or 
predominantly or, in any event, in a preponderant way, adversely affects 
competition between undertakings (which may not even be Sicilian or Italian) that 
are accredited and, therefore, theoretically entitled to provide healthcare services 
at the expense of the National Health Service. According to the referring court, 
that criterion favours economic operators already present on the market by making 
access difficult for new entrants (‘newcomers’) or those that, even if already 
present on the market, have had lower turnover. 
16 In that regard, the referring court states that the criterion of historical expenditure 
applied in an predominant way refers to the situation in which, as appears to be 
the case in the Regional Department of Health decrees at issue, the criterion of 
historical expenditure is used to determine more than half of the budget allocated 
to each private healthcare facility, whereas, the criterion of historical expenditure 
applied in a [preponderant] way, means the situation in which that criterion is used 
to determine an otherwise very high percentage of that budget. 
17 In the third place, as regards the allocation, provided for in the Regional 
Department of Health decrees at issue as from 2022, of a fixed entry budget in 
favour of all accredited private entities with whom an arrangement is to be 
concluded pursuant to Article 8-quinquies above, the referring court asks whether 
such an allocation is contrary to the principles of the protection of competition and 
the free market. That budget does not take into account, inter alia, criteria such as 
the efficiency or capacity of the entity providing services, the location of the 
services to be provided on the territory, and the specific needs of patients. 
18 In the fourth place, in the event that that allocation is held to be compatible with 
those principles, the referring court asks whether that compatibility depends on the 
value of the entry budget determined in advance by the region, a budget which 
may be considered in absolute terms or in relation to the value of the budgets 
allocated to other private entities already accredited and subject to contractual 
arrangements in the same sector. 
19 The referring court considers that it is necessary to make a reference to the Court 
of Justice for a preliminary ruling, since it is only if the first question is answered 
in the negative that the principles of the protection of free competition can be 
regarded as applicable to the market for the provision of medical care provided by 
accredited private entities under the National Health Service regime, that is to say, 
with costs borne by public funds. In that situation, as it is an actual market subject 
to the European rules, all the provisions that preclude the conclusion of contracts 
with new accredited entities or that favour accredited entities already operating on 
that market would be unlawful because they are contrary to EU law.