Norbrook Laboratories Ltd v Ministry of Agriculture, Fisheries and Food.
Date: 1998-04-02
89 The question must nevertheless be asked whether those provisions themselves are in conformity with the principle of proportionality.  As the Court has held, in order to establish whether a provision of Community law complies with the principle of proportionality, it must be ascertained whether the means which it employs are suitable for the purpose of achieving the desired objective and whether they do not go beyond what is necessary to achieve it (see, in particular, Case C-84/94 United Kingdom v Council [1996] ECR I-5755, paragraph 57).
90 In a sphere in which the Community legislature is called on to undertake complex assessments based on technical and scientific information which is liable to change rapidly, judicial review of the exercise of its powers must be limited to examining whether it has been vitiated by a manifest error of assessment or a misuse of powers or whether the legislature has manifestly exceeded the limits of its discretion (see, in particular, United Kingdom v Council, cited above, paragraph 58).
103 Nor can any obligation to state the reasons on which a request for further information is based be inferred from any general principle of Community law.  It is true that Community law imposes an obligation to state the reasons for national decisions affecting the exercise of a fundamental right conferred on individuals by the Treaty (see, in particular, Case 222/86 Unectef v Heylens [1987] ECR 4097, paragraphs 14 and 15).  However, in view of its aim, that obligation does not extend to measures such as the one at issue in this case, relating to the examination of an application, by which the competent authority asks an applicant for marketing authorisation to provide further information.  In the event of authorisation being withheld on the ground that the applicant has failed to comply with the request for further information, the competent authority is in any event required to state the reasons on which its decision is based.
106 It must be remembered, first, that, as the Court has held repeatedly, the principle of State liability for loss and damage caused to individuals as a result of breaches of Community law for which the State can be held responsible is inherent in the system of the Treaty (Joined Cases C-6/90 and C-9/90 Francovich and Others v Italian Republic [1991] ECR I-5357, paragraph 35; Joined Cases C-46/93 and C-48/93 Brasserie du Pêcheur and Factortame [1996] ECR I-1029, paragraph 31; Case C-392/93 The Queen v H.M. Treasury, ex parte British Telecommunications [1996] I-1631, paragraph 38; Case C-5/94 The Queen v MAFF, ex parte Hedley Lomas [1996] ECR I-2553, paragraph 24; and Joined Cases C-178/94, C-179/94, C-188/94, C-189/94 and C-190/94 Dillenkofer and Others v Germany [1996] ECR I-4845, paragraph 20).
107 It is clear from the above case-law that three conditions must be satisfied for a Member State to be required to compensate for damage thus caused: the rule of law infringed must have been intended to confer rights on individuals; the breach must be sufficiently serious; and there must be a direct causal link between the breach of the obligation resting on the State and the damage sustained by the injured parties (Brasserie du Pêcheur and Factortame, paragraph 51;  British Telecommunications, paragraph 39; Hedley Lomas, paragraph 25; and Dillenkofer and Others, paragraph 24, all cited above).
109 As regards the second condition, the Court has held, first, that a breach is sufficiently serious where a Member State, in the exercise of its legislative powers, has manifestly and gravely disregarded the limits on its powers (see Brasserie du Pêcheur and Factortame, paragraph 55; British Telecommunications, paragraph 42; and Dillenkofer and Others, paragraph 25, all cited above) and, second, that where, at the time when it committed the infringement, the Member State in question 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 (see Hedley Lomas, paragraph 28, and Dillenkofer and Others, paragraph 25, both cited above).
111 Finally, it has been settled case-law since the judgment in Francovich and Others, cited above (paragraphs 41 to 43), that, subject to the existence of a right to obtain reparation which is founded directly on Community law where the three conditions mentioned above are met, it is on the basis of rules of national law on liability that the State must make reparation for the consequences of the loss and damage caused, with the proviso that the conditions for reparation of loss and damage laid down by the national legislation must not be less favourable than those relating to similar domestic claims and must not be so framed as to make it in practice impossible or excessively difficult to obtain reparation.