The Queen, on the application of Synthon BV v Licensing Authority of the Department of Health.
Date: 2008-10-16
32. As the Advocate General stated in points 100 and 101 of his Opinion, not only would such an interpretation run counter to the very wording of Articles 28 and 29 of Directive 2001/83, but it would render those provisions redundant. If a Member State which was asked to recognise an authorisation already granted by another Member State could make that recognition subject to a second assessment of all or part of the application for authorisation, that would deprive the mutual recognition procedure established by the Community legislature of all meaning and seriously compromise the attainment of the objectives of Directive 2001/83 such as, in particular, the free movement of medicinal products in the internal market, referred to in paragraph 25 above.
35. In that regard, it should be borne in mind that, according to settled case-law (see, inter alia, Brasserie du Pêcheur and Factortame , paragraph 51; Case C-5/94 Hedley Lomas [1996] ECR I-2553, paragraph 25; and Case C-278/05 Robins and Others [2007] ECR I-1053, paragraph 69), for a Member State to incur liability for damage caused to individuals by a breach of Community law it is necessary that:
– the rule of law infringed should be intended to confer rights on individuals;
– the breach should be sufficiently serious;
– there should be a direct causal link between the breach of the obligation incumbent on the State and the damage sustained by the injured parties.
36. Although, in principle, it is for the national courts to determine whether the conditions for State liability for breach of Community law are met, the Court of Justice may nevertheless indicate certain circumstances which the national courts may take into account in their evaluation (Case C-150/99 Stockholm Lindöpark  [2001] ECR I-493, paragraph 38).
37. As regards the condition requiring a sufficiently serious breach of Community law, on which the referring court asks the Court for a preliminary ruling, the Court has had occasion to make clear that such a breach is established where it implies manifest and grave disregard by the Member State for the limits set on its discretion, the factors to be taken into consideration in this connection being, inter alia, the degree of clarity and precision of the rule infringed and the measure of discretion left by that rule to the national authorities ( Brasserie du Pêcheur and Factortame , paragraphs 55 and 56, and Robins and Others , paragraph 70).
38. If, however, the Member State was not called upon to make any legislative choices and had only considerably reduced, or even no, discretion, the mere infringement of Community law may be sufficient to establish the existence of a sufficiently serious breach ( Hedley Lomas , paragraph 28, and Robins and Others , paragraph 71).
39. It follows that the Member State’s discretion, which is broadly dependent on the degree of clarity and precision of the rule infringed, constitutes an important criterion in determining whether there has been a sufficiently serious breach of Community law (see, to that effect, Robins and Others , paragraphs 72 and 73).
43. In those circumstances, a breach of Article 28 of that directive, such as that committed by the Licensing Authority in the main proceedings, is enough to establish a sufficiently serious breach of Community law (see, by analogy, inter alia, Stockholm Lindöpark , paragraph 42, and Case C‑470/03 AGM-COS.MET  [2007] ECR I-2749, paragraph 86).