Commission of the European Communities v CEVA Santé Animale SA and Pfizer Enterprises Sàrl.
Date: 2005-07-12
50. While it is for the Court of First Instance alone to assess the value to be attached to the items of evidence adduced before it, and while it cannot be required to give express reasons for its assessment of the value of each piece of evidence presented to it, in particular where it considers that evidence to be unimportant or irrelevant to the outcome of the dispute (Case C-237/98 P Dorsch Consult  v Council and Commission [2000] ECR I‑4549, paragraphs 50 and 51), the Court of First Instance is none the less obligated to provide reasons which will allow the Court to exercise its judicial review.  Those reasons must make it possible for the Court to review any distortion of the evidence submitted to the Court of First Instance.
62. The system of rules which the Court has worked out with regard to that provision takes into account, inter alia, the complexity of the situations to be regulated, difficulties in the application or interpretation of the texts and, more particularly, the margin of discretion available to the author of the act in question (Joined Cases C-46/93 and C-48/93 Brasserie du Pêcheur and Factortame  [1996] ECR I‑1029, paragraph 43; Case C-352/98 P Bergaderm and Goupil  v Commission  [2000] ECR I‑5291, paragraph 40; Case C-312/00 P Commission  v Camar and Tico  [2002] ECR I‑11355, paragraph 52; and Case C-472/00 P Commission  v Fresh Marine  [2003] ECR I‑7541, paragraph 24).
63. The Court has ruled that Community law confers a right to reparation where three conditions are met: the rule of law infringed must be intended to confer rights on individuals; the breach must be sufficiently serious; and, finally, there must be a direct causal link between the breach of the obligation devolving on the institution and the damage sustained by the injured parties ( Brasserie du Pêcheur and Factortame , paragraph 51; Bergaderm and Goupil  v Commission , paragraphs 41 and 42; Commission  v Camar and Tico , paragraph 53; and Commission  v Fresh Marine , paragraph 25, all cited above).
64. With regard to the second condition, the Court has stated that the decisive test for determining whether a breach of Community law is sufficiently serious is whether the Community institution concerned manifestly and gravely disregarded the limits on its discretion ( Brasserie du Pêcheur and Factortame , paragraph 55; Bergaderm and Goupil  v Commission , paragraph 43; Commission  v Camar and Tico , paragraph 54; and Commission  v Fresh Marine , paragraph 26).
65. Where that institution has only a considerably reduced, or even no, discretion, the mere infringement of Community law may be sufficient to establish the existence of a sufficiently serious breach ( Bergaderm and Goupil v Commission , paragraph 44; Commission  v Camar and Tico , paragraph 54; and Commission  v Fresh Marine , paragraph 26).
66. The determining factor in deciding whether there has been such an infringement is therefore the discretion available to the institution concerned ( Bergaderm and Goupil v Commission , paragraph 46; Commission  v Camar and Tico , paragraph 55; and Commission  v Fresh Ma rine , paragraph 27).
75. It must be remembered in this regard that the Court, ruling in relation to a legal procedure similar to that provided for under Regulation No 2377/90, held that, in delicate and controversial cases, the Commission must have a sufficiently broad discretion and enough time to submit for re-examination the scientific questions which determine its decision (see Bergaderm and Goupil  v Commission , paragraph 66).
80. It follows that the Commission must be given a discretion which is sufficient to allow it to determine, on a fully informed basis, the measures that are necessary and appropriate for the protection of public health.
81. As the Court of First Instance properly recognised in paragraph 100 of the judgment under appeal, the progesterone file is one that is particularly complex.
82. That complexity is attributable, inter alia, to the facts, as noted by the Court of First Instance in paragraph 100 of the judgment under appeal, that progesterone is an endogenous substance and that there are at present no reliable analytical methods by which to check abuse of that substance.  It is apparent from the documents before the Court of First Instance that, although an application to have an MRL established for progesterone had been before it since 1993, the Commission found itself facing a situation of continuing scientific uncertainty characterised by divergences between the scientific opinions adopted between 1996 and 1999 by the CVMP, on the one hand, and, on the other, the SCVPH and other international scientific bodies, which the Commission, in accordance with the third recital in the preamble to Regulation No 2377/90, takes into account.
83. In those circumstances, the Commission was entitled to seek an additional opinion from the CVMP (Case C-151/98 P Pharos  v Commission  [1999] ECR I‑8157, paragraph 26), as the Court of First Instance, moreover, recognised in paragraph 99 of the judgment under appeal.
87. That position on the maintenance of the use of progesterone for therapeutic or zootechnical purposes constituted a stage which necessarily had to precede the taking of a position on the establishment of an MRL for that substance, since an MRL may be established for a pharmacologically active substance only if that substance is intended to be placed on the market (Case C‑248/99 P France  v Monsanto and Commission  [2002] ECR I‑1, paragraph 80).