Case C‑296/15

Medisanus d.o.o.

v

Splošna Bolnišnica Murska Sobota

(Request for a preliminary ruling from the
Državna revizijska komisija za revizijo postopkov oddaje javnih naročil)

(Reference for a preliminary ruling — Public procurement — Medicinal products for human use — Directive 2004/18/EC — Article 2 and Article 23(2) and (8) — Articles 34 and 36 TFEU — Public contract for supplying a hospital — National legislation requiring that hospitals are to be supplied as a matter of priority with medicinal products obtained from national plasma — Principle of equal treatment)

Summary — Judgment of the Court (Third Chamber), 8 June 2017

1. Questions referred for a preliminary ruling—Reference to the Court—National court or tribunal for the purposes of Article 267 TFEU—Definition—Državna revizijska komisija za revizijo postopkov oddaje javnih naročil (State Public Procurement Tribunal, Slovenia)—Included

   (Art. 267 TFEU)

2. Free movement of goods—Goods—Definition—Medicinal products derived from human plasma or blood—Included

   (Art. 34 TFEU)

3. Approximation of laws—Procedures for the award of public works contracts, public supply contracts and public service contracts—Directive 2004/18—Scope—Public supply contracts—Meaning—Public contract for the supply of medicinal products derived from human blood or plasma—Included

   (European Parliament and Council Directive 2004/18, Art. 1(2)(a) and (c))

4. Free movement of goods—Quantitative restrictions—Measures having equivalent effect—Concept—National legislation requiring that hospitals are to be supplied as a matter of priority with medicinal products obtained from national plasma—Included

   (Arts 18 TFEU and 34 TFEU)

5. Approximation of laws—Procedures for the award of public works contracts, public supply contracts and public service contracts—Directive 2004/18—Public supply contracts—Public contract for supplying a hospital with medicinal products obtained from plasma—Introduction in the tender specifications of a national origin requirement for the plasma—Not permissible—Justification—Protection of public health—None—Breach of principle of proportionality

   (Arts 34 TFEU and 36 TFEU; European Parliament and Council Directive 2004/18, Arts 2 and 23(2) and (8))

6. Approximation of laws—Procedures for the award of public works contracts, public supply contracts and public service contracts—Directive 2004/18—Public supply contracts—Definition of the needs of the contracting authority—Establishment of a requirement to supply a product from a specific source—Lawfulness—Conditions—Limits

   (European Parliament and Council Directive 2004/18, Arts 2 and 23(2) and (8))

1.  See the text of the decision.

   (see paras 33-38)

2.  See the text of the decision.

   (see para. 53)

3.  See the text of the decision.

   (see para. 54)

4.  See the text of the decision.

   (see paras 62-64)

5.  Article 2 and Article 23(2) and (8) of 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, and Article 34 TFEU read in conjunction with Article 36 TFEU, must be interpreted as precluding a clause in the tender specifications for a public contract which, in accordance with the law of the Member State to which the contracting authority belongs, requires medicinal products derived from plasma, which are the subject matter of the public procurement at issue, to be obtained from plasma collected in that Member State.

   In that respect, the Court notes that, as the Advocate General observed in point 94 of his Opinion, Directive 2004/18 does not bring about exhaustive harmonisation of the aspects relating to the free movement of goods. It follows that, with regard to both the discriminatory obstacles to the free movement of goods and the grounds for their justification, examination of the national origin requirement at issue in the main proceedings, according to which medicinal products derived from plasma must be obtained from plasma collected in Slovenia, cannot be limited to an assessment under Directive 2004/18; it must also take the provisions of primary law into account.

   In the present case, clearly, the national origin requirement is inherently discriminatory. Indeed, the requirement that supplies must be obtained as a matter of priority from medicinal products derived from Slovenian plasma precludes any undertaking with medicinal products derived from plasma collected in another Member State of the European Union from tendering effectively in response to calls for tenders such as that issued by the hospital. In the present case, since the national origin requirement is discriminatory, as established in paragraph 68 of the present judgment, the Slovenian legislation can be justified only on one of the grounds listed in Article 36 TFEU (see, inter alia, by analogy, judgments of 17 June 1981, Commission v Ireland, 113/80, EU:C:1981:139, paragraphs 7, 8, 10 and 11, and of 30 November 1995, Gebhard, C‑55/94, EU:C:1995:411, paragraph 37). Encouraging voluntary unpaid blood donations is a way of addressing public health concerns such as those referred to in Article 36 TFEU. Therefore, that objective is, in principle, capable of justifying a restriction on the free movement of goods (see, to that effect, judgment of 9 December 2010, Humanplasma, C‑421/09, EU:C:2010:760, paragraph 33). Since the intended objective of ensuring EU self-sufficiency in the supply of blood products is to protect public health, its scope must be interpreted broadly. Consequently, national legislation such as that at issue in the main proceedings pursues legitimate objectives of public health protection.

   In that regard, the material before the Court clearly does not lead to the conclusion that the priority supply principle for medicinal products manufactured industrially from Slovenian plasma collected from Slovenian hospitals contributes decisively to encouraging the Slovenian population to make voluntary unpaid blood donations. Accordingly, inasmuch as (a) the blood donors’ motivation is the same in other Member States as in Slovenia and (b) all donors in the Member States have objectively concurring interests with regard to the manufacture and use of products derived from human blood and human plasma coming from such voluntary unpaid donations, there is no reason to consider, as the Slovenian Government claims, that conditions based on a purely national concept of solidarity are the only ones liable to have a major impact, in Slovenia, on the quantities of human blood and blood components collected and, thus, on the quantities of blood products derived from such donations. It is not therefore evident that the objective of encouraging and maintaining a high level of voluntary unpaid blood donations necessarily requires recourse to the national origin requirement at issue in the main proceedings. In those circumstances, the Court finds that the priority supply principle is disproportionate.

   (see paras 68, 69, 72, 80, 87, 92, 93, 96-98, 104, operative part)

6.  See the text of the decision.

   (see para. 76)