Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts (OJ 2004 L 134, p. 114 and corrigendum OJ 2004 L 351, p. 44), as amended by Commission Regulation (EU) No 1251/2011 of 30 November 2011 (OJ 2011 L 319, p. 43) (‘Directive 2004/18’), contains the following definitions in Article 1(2) and (5):

‘2.(a) “Public contracts” are contracts for pecuniary interest concluded in writing between one or more economic operators and one or more contracting authorities and having as their object the execution of works, the supply of products or the provision of services within the meaning of this Directive.

...

(d)“Public service contracts” are public contracts other than public works or supply contracts having as their object the provision of services referred to in Annex II. 

... 5.A “framework agreement” is an agreement between one or more contracting authorities and one or more economic operators, the purpose of which is to establish the terms governing contracts to be awarded during a given period, in particular with regard to price and, where appropriate, the quantity envisaged.’

The applicability of Directive 2004/18 to the award of public service contracts is subject to various conditions, in particular as regards the value of those contracts and the kind of services concerned.

Thus, first, in accordance with the first and third indents of Article 7(b), Directive 2004/18 applies, inter alia, to public service contracts with a value of EUR 200 000 or more (before value added tax) which have as their object the services listed in Annex II A to that directive awarded by contracting authorities other than the central government authorities listed in Annex IV of that directive or which have as their object the services listed in Annex II B thereto. Under Article 9(9) of that directive, the value to be taken into consideration in respect of framework agreements is the maximum estimated value of all the contracts envisaged for the total term of the framework agreement concerned. According to Article 9(8)(b)(ii) of Directive 2004/18, in the case of contracts without a fixed term, the value to be taken into consideration is limited to the monthly value of such a contract multiplied by 48.

Secondly, under Articles 20 and 21 of Directive 2004/18, contracts which have as their object services listed in Annex II A of that directive are to be awarded in accordance with Articles 23 to 55 thereof, whereas contracts which have as their object services listed in Annex II B of that directive are to be awarded in accordance with Articles 23 and 35(4) only thereof, which concern, respectively, the technical specifications and the notice of the results of the procurement procedure. In accordance with Article 22 of Directive 2004/18, contracts which have as their object services listed both in Annex II A and in Annex II B of that directive are to be awarded in accordance with Articles 23 to 55 thereof where the value of the services listed in Annex II A is greater than the value of the services listed in Annex II B, or, in other cases, in accordance only with Articles 23 and 35(4) of that directive.

Category 2 in Annex II A to Directive 2004/18 concerns land transport services, including armoured car services and courier services, except transport of mail. Category 25 in Annex II B to that directive covers health and social services.

Finally, in accordance with Article 32(2) of Directive 2004/18, the conclusion of a framework agreement means that contracting authorities are to follow the rules of procedure laid down by that directive in all the phases of that agreement up to the award of contracts based on it.

In accordance with the principle of solidarity laid down in Article 2 of the Constitution of the Italian Republic and the principle of subsidiarity guaranteed by Article 118 thereof, both national and regional Italian law attribute an active role in providing health services to voluntary associations, characterised by the absence of profit-making, the prevalence of services supplied in voluntary form and the marginal nature of commercial or production activities.

Accordingly, Articles 1 and 45 of Law No 833 on the establishment of the national health service (legge n. 833 — Istituzione del servizio sanitario nazionale) of 23 December 1978 (Ordinary supplement to GURI No 360 of 28 December 1978) recognise the role, in the functioning of the national health service, of voluntary associations and benevolent institutions whose object it is to contribute to the attaining of the institutional objectives of that service. It provides that that contribution is to take the form of agreements concluded with the local health bodies in accordance with planning and legislation laid down at regional level.

The voluntary nature of such participation is regulated at national level by Law No 266 setting out a framework on voluntary work (legge No 266 — Legge-quadro sul volontariato) of 11 August 1991 (GURI No 196, of 22 August 1991, ‘Law No 266/1991’). Article 1 thereof sets out the principle of the recognition of voluntary work in the following terms: ‘The Italian Republic recognises the social value and function of voluntary work as an expression of solidarity and pluralism, fosters its development while preserving its independence and encourages individual contributions in the pursuit of social, civil and cultural objectives set by the State, the Regions, the Autonomous Provinces of Trentino and Bolzano and the local authorities.’

In accordance with Article 3 of Law No 266/1991, a voluntary association is any organisation set up with the aim of undertaking voluntary activities having overall and primary recourse to the individual, voluntary and unpaid services of its members, the same article authorising such an organisation to use employed or self-employed workers only to the extent necessary for its day-to-day functioning or having regard to the type or specialisation of the activity. That article also provides that voluntary associations pursue their activity either through their own infrastructures or by means of public facilities or infrastructures that have entered an agreement with those public facilities.

Article 5 of Law No 266/1991 lists the means by which voluntary associations may be financed. These include payments made on the basis of agreements concluded with public bodies and income received from marginal commercial or production activities.

Finally, Article 7 of that Law governs the conclusion of such agreements with public bodies, which must regulate the activities of the associations as regards, inter alia, the quality of the services, and must also make provision for the manner in which expenses incurred are to be repaid.

That regulatory framework is set out and implemented in the Region of Piedmont by Regional Law No 38 on the enhancement and promotion of voluntary work (legge regionale n. 38 — Valorizzazione e promozione del volontariato) of 29 August 1994. Article 9 of that law provides, inter alia, that contracts concluded between that region, local authorities or other public authorities established in its territory, on the one hand, and voluntary organisations, on the other, must identify user categories, the services to be provided and the arrangements for providing those services, as well as the arrangements for reimbursing the costs of insurance cover and documented costs incurred by the contracting organisation in carrying on the activity covered by the contract, together with the arrangements for checking implementation of the contract, including through regular meetings between the heads of public services and the operational heads of that organisation.

By its first question, the referring court asks, in essence, whether the rules of EU law on public procurement must be interpreted as precluding national legislation which, like that at issue in the main proceedings, allows local authorities to entrust the provision of medical transport services by direct award, without any form of advertising, to voluntary associations which, for the provision of those services, receive only reimbursement of the expenditure actually incurred for that purpose.

It should at the outset be noted that a contract cannot fall outside the concept of public contract merely because the remuneration is limited to reimbursement of the expenditure incurred to provide the agreed service or because the contract is concluded with a non-profit-making body (see, to that effect, judgment in Azienda sanitaria locale No 5 ‘Spezzino’ and Others, C‑113/13, EU:C:2014:2440, paragraphs 36 and 37 and the case-law cited).

However, the answer to the question referred depends on whether Directive 2004/18 is fully applicable or, instead, the general principles of transparency and equal treatment flowing from Articles 49 TFEU and 56 TFEU must be taken into account.

In the first case, it should be considered that Directive 2004/18 precludes national legislation, such as that at issue in the main proceedings, which allows local authorities to entrust the provision of medical transport services by direct award, without any form of advertising, to voluntary bodies (see, to that effect, judgment in Azienda sanitaria locale No 5 ‘Spezzino’ and Others, C‑113/13, EU:C:2014:2440, paragraph 44).

In the second case, it must be noted, first, that EU law on public procurement, in so far as it concerns, inter alia, public service contracts, is intended to ensure the free movement of services and the opening-up to competition in the Member States which is undistorted and as wide as possible and, secondly, it must be found that the application of national legislation such as that at issue in the main proceedings leads to a result contrary to those objectives, since it excludes for-profit entities from the markets concerned (see, to that effect, judgment in Azienda sanitaria locale No 5 ‘Spezzino’ and Others, C‑113/13, EU:C:2014:2440, paragraphs 51 and 52).

The award, in the absence of any transparency, of a contract to an undertaking located in the same Member State as the contracting authority amounts to a difference in treatment to the detriment of undertakings which might be interested in that contract but are established in another Member State. Unless it is justified by objective circumstances, such a difference in treatment, which, by excluding all undertakings established in another Member State, operates mainly to the detriment of the latter undertakings, amounts to indirect discrimination on the basis of nationality, prohibited under Articles 49 TFEU and 56 TFEU (judgment in Azienda sanitaria locale No 5 ‘Spezzino’ and Others, C‑113/13, EU:C:2014:2440, paragraph 52 and the case-law cited).

However, it follows from all these considerations, namely the national legal framework, the nature of the services concerned, which fall within the context of the national health service, the findings of the referring court regarding the positive budgetary impact of contracts such as those at issue in the main proceedings and the fact that, by their very nature, the associations that are signatories to such contracts are voluntary, that the use of those associations in the organisation of the medical transport service is likely to be grounded in the principles of universality, the good of the community and in reasons of economic efficiency and suitability, in so far as it allows that public service to be provided in an economically balanced manner for budgetary purposes, by bodies constituted, essentially, for the purpose of public service.

Such objectives are taken into consideration by EU law.

In that connection, it must be recalled, in the first place, that EU law does not detract from the power of the Member States to organise their public health and social security systems (judgment in Azienda sanitaria locale No 5 ‘Spezzino’ and Others, C‑113/13, EU:C:2014:2440, paragraph 55 and the case-law cited).

Admittedly, in the exercise of that power the Member States may not introduce or maintain unjustified restrictions on the exercise of fundamental freedoms in the area of health care. However, in the assessment of compliance with that prohibition, account must be taken of the fact that the health and life of humans rank foremost among the assets or interests protected by the Treaty and it is for the Member States, which have a discretion in the matter, to decide on the degree of protection which they wish to afford to public health and on the way in which that degree of protection is to be achieved (judgment in Azienda sanitaria locale No 5 ‘Spezzino’ and Others, C‑113/13, EU:C:2014:2440, paragraph 56 and the case-law cited).

Furthermore, not only the risk of seriously undermining the financial balance of a social security system may constitute per se an overriding reason in the general interest capable of justifying an obstacle to the freedom to provide services, but also the objective of maintaining, on grounds of public health, a balanced medical and hospital service open to all may also fall within one of the derogations, on grounds of public health in so far as it contributes to the attainment of a high level of health protection. Thus, measures which aim, first, to meet the objective of guaranteeing in the territory of the Member State concerned sufficient and permanent access to a balanced range of high-quality medical treatment and, secondly, assist in ensuring the desired control of costs and prevention, as far as possible, of any wastage of financial, technical and human resources are also covered (judgment in Azienda sanitaria locale No 5 ‘Spezzino’ and Others, C‑113/13, EU:C:2014:2440, paragraph 57 and the case-law cited).

In the second place, a Member State, in the context of its discretion to decide the level of protection of public health and to organise its social security system, may take the view that recourse to voluntary associations is consistent with the social purpose of a medical transport service and may help to control costs relating to that service (see, to that effect, judgment in Azienda sanitaria locale No 5 ‘Spezzino’ and Others, C‑113/13, EU:C:2014:2440, paragraph 59).

However, a system of organisation of a medical transport service such as that at issue in the main proceedings, which enables the competent authorities to use voluntary associations, must actually contribute to the social purpose and the pursuit of the objectives of the good of the community and budgetary efficiency on which that system is based (judgment in Azienda sanitaria locale No 5 ‘Spezzino’ and Others, C‑113/13, EU:C:2014:2440, paragraph 60).

In that connection, it is essential that, where they act in that context, the voluntary associations do not pursue objectives other than those mentioned in the previous paragraph of the present judgment, do not make any profit as a result of their services, apart from the reimbursement of the variable, fixed and on-going expenditure necessary to provide them, and do not procure any profit for their members. Furthermore, although it is permissible to maintain a workforce, for it would, without one, be almost impossible for those associations to act effectively in numerous domains in which the principle of the good of the community may naturally be implemented, the activities of those associations must strictly comply with the requirements laid down by national law (judgment in Azienda sanitaria locale No 5 ‘Spezzino’ and Others, C‑113/13, EU:C:2014:2440, paragraph 61).

Having regard to the general principle of EU law on the prohibition of abuse of rights, the application of that legislation cannot be extended to cover the wrongful practices of voluntary associations or their members. Thus, the activities of voluntary associations may be carried out by the workforce only within the limits necessary for their proper functioning. As regards the reimbursement of costs, it must be ensured that profit making, even indirect, cannot be pursued under the cover of a voluntary activity and that volunteers may be reimbursed only for expenditure actually incurred for the activity performed, within the limits laid down in advance by the associations themselves (judgment in Azienda sanitaria locale No 5 ‘Spezzino’ and Others, C‑113/13, EU:C:2014:2440, paragraph 62).

In the eventuality referred to in paragraph 55 of the present judgment, it is for the national court to carry out all the assessments required in order to verify whether the contract and, where relevant, the framework agreement at issue in the main proceedings, as regulated by the applicable legislation, actually contribute to the social purpose and the pursuit of the objectives of the good of the community and budgetary efficiency.

Having regard to all of the foregoing considerations, the answer to the first question is that Articles 49 TFEU and 56 TFEU must be interpreted as meaning that they do not preclude national legislation, such as that at issue in the main proceedings, which allows local authorities to entrust the provision of medical transport services by direct award, without any form of advertising, to voluntary associations, provided that the legal and contractual framework in which the activity of those associations is carried out actually contributes to the social purpose and the pursuit of the objectives of the good of the community and budgetary efficiency.

By its second question, based on the assumption that Directive 2004/18 is not applicable to a contract such as that at issue in the main proceedings, the referring court asks essentially whether, where a Member State allows the public authorities to have direct recourse to voluntary associations to carry out certain tasks, in accordance with the conditions laid down in that regard by EU law, a public authority that intends to conclude contracts with such associations is required to compare, in advance, the proposals of various associations in order to avoid any unnecessary costs.

In that regard, it should be noted that, in accordance with the operative part of the judgment in Azienda sanitaria locale No 5 ‘Spezzino’ and Others (C‑113/13, EU:C:2014:2440) and with paragraph 67 of the present judgment, when all conditions are met which, under EU law, allow a Member State to provide for the use of voluntary associations, the provision of medical transport services may be entrusted to those associations by direct award, without any form of advertising.

The absence of any advertising requirement means that public authorities that make use of voluntary associations, under those conditions, are not required under EU law to organise a comparison between voluntary bodies.

Nevertheless, it must be noted that, as pointed out in paragraph 60 of the judgment in Azienda sanitaria locale No 5 ‘Spezzino’ and Others (C‑113/13, EU:C:2014:2440) and in paragraph 63 of the present judgment, the lawfulness of the use of voluntary associations is subject, in particular, to the condition that such use actually contributes to the objective of budgetary efficiency. Therefore, the arrangements for implementing that use, such as those laid down in the contracts concluded with those associations and in any framework agreement, must also contribute to the achievement of that objective. Furthermore, as pointed out in paragraph 62 of the judgment in Azienda sanitaria locale No 5 ‘Spezzino’ and Others (C‑113/13, EU:C:2014:2440) and in paragraph 65 of the present judgment, the general principle of the prohibition of abuse of rights applies with regard to the reimbursement of expenses incurred by voluntary associations.

Consequently, the answer to the second question is that, where a Member State allows public authorities to make direct use of voluntary associations to carry out certain tasks, a public authority that intends to conclude contracts with such associations is not required, under EU law, to compare the proposals of various associations beforehand.

By its third question, based on the assumption that Directive 2004/18 is not applicable to a contract such as that at issue in the main proceedings, the referring court essentially asks whether, where a Member State, which allows public authorities to make direct use of voluntary associations to carry out certain tasks, in accordance with the conditions laid down in that regard by EU law, authorises those associations to engage in certain commercial activities, that Member State must establish, in that regard, precise limits, expressed as a percentage of the activity or resources of those associations.

At the outset, with regard to the principle of a non-profit organisation engaging in an activity on the market, it follows from paragraph 48 of the judgment in CoNISMa (C‑305/08, EU:C:2009:807) that that question falls within the competence of a national legislature.

Furthermore, in accordance with paragraph 61 of the judgment in Azienda sanitaria locale No 5 ‘Spezzino’ and Others (C‑113/13, EU:C:2014:2440) and paragraph 64 of the present judgment, the activities of voluntary associations must strictly comply with the requirements laid down by national law that are applicable to them. Thus, the Court found that, within the limits set by that judgment, the regulatory framework of the activities of those associations falls within the competence of Member States.

Consequently, it is for the national legislature which, while allowing public authorities to use voluntary associations to carry out certain tasks, opted to allow those associations to pursue a commercial activity on the market, to decide whether it is preferable to regulate that activity by establishing a numerical limit or by otherwise defining that activity.

Observing the limits set out in paragraphs 60 to 62 of the judgment in Azienda sanitaria locale No 5 ‘Spezzino’ and Others (C‑113/13, EU:C:2014:2440), noted in paragraphs 63 to 65 of the present judgment, however, fundamentally entails respecting the very nature of those voluntary associations.

It follows that any commercial activity carried out by such associations on the market must be marginal and support the pursuit of their voluntary activity.

Consequently, the answer to the third question is that, where a Member State, which allows public authorities to make direct use of voluntary associations to carry out certain tasks, authorises those associations to engage in certain commercial activities, that Member State must establish the limits within which those activities may be carried out. Those limits must nevertheless ensure that those commercial activities are marginal, having regard to all the activities of such associations, and must support the pursuit of their voluntary activity.