Keywords

Summary



Keywords

1. Non-contractual liability – Conditions – Sufficiently serious breach of Community law

(Art. 288, second para., EC)

2. Non-contractual liability – Conditions – Sufficiently serious breach of Community law

(Art. 288, second para., EC)

3. Approximation of laws – Proprietary medicinal products – Marketing authorisation – Conditions for the suspension or withdrawal of the authorisation

(Council Directive 65/65, Art. 11)

Summary

1. As regards the condition for the non-contractual liability of the Community, in considering whether the breach of Community law is sufficiently serious, the determining factor is whether the institution concerned manifestly and gravely disregarded the limits of its discretion. It follows that the general or individual nature of a measure is irrelevant when examining the condition that the institution’s conduct be unlawful. The nature of the measure is not conclusive in identifying the limits of the institution’s discretion.

In that connection, it must be recalled that the requirement of a sufficiently serious breach of Community law seeks, whatever the unlawful nature of the measure in question, to avoid the situation where the risk of having to bear the losses alleged by the persons concerned hinders the ability of the institution to fully exercise its competences in the general interest, both in the context of its activities that are regulatory or involve economic policy choices and in the sphere of its administrative competence, without thereby leaving third parties to bear the consequences of flagrant and inexcusable misconduct.

(see paras 52-55)

2. In matters relating to the non-contractual liability of the Community, where the institution in question has only a considerably reduced discretion, or none at all, the mere infringement of Community law may be sufficient to establish the existence of a sufficiently serious breach. However, there is no automatic link between lack of discretion of the institution concerned, on one hand, and classification of a sufficiently serious breach of Community law on the other. Although the extent of the discretion of the institution concerned is a determining factor, it is not an exclusive criterion. Only the finding that an irregularity would not have been committed in similar circumstances by an administrative authority exercising ordinary care and diligence enables the liability of the Community to be established. It is therefore for the Community judicature, after determining, first of all, whether the institution concerned had a margin of discretion, to then take account of the complexity of the situation to be regulated, the difficulties in the application or interpretation of the legislation, the clarity and precision of the rule infringed, and whether the error of law made was inexcusable or intentional.

(see paras 58-60, 62)

3. Although the Commission has a wide measure of discretion in the application of Article 11 of Directive 65/65 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products, where it is called on to make complex evaluations, particularly in cases of scientific uncertainty, in compliance with the principle that precedence must be given to the requirements of the protection of public health and the precautionary principle, it is, none the less, bound by the conditions for the suspension or withdrawal of a marketing authorisation defined in Article 11. If one of those alternative conditions is satisfied, it must suspend or withdraw the marketing authorisation. Conversely, if the Commission does not establish that one of the conditions has been satisfied, the marketing authorisation must be maintained.

Thus where the application of a new scientific criterion for assessing the efficacy of the substance concerned is not based on any new scientific data or information and no new potential risk has been identified, Article 11 of Directive 65/65 does not authorise the Commission to order the withdrawal of marketing authorisations.

In a case where the finding of fact that the new scientific criterion applied in the final opinion of the Committee for Proprietary Medicinal Products (CPMP) is not based on the identification of new scientific data or information follows necessarily from the examination of that final opinion and the various relevant scientific reports and documents available to the Commission, such a finding does not mean, therefore, despite the complexity of such an examination, that there is a margin of discretion. The same is true with respect to the finding that the alleged change in the scientific criterion applied does not emerge from the guidelines relied on by the CPMP. It follows that, in such circumstances, the Commission does not have any discretion in the application of the substantive criteria for the suspension or withdrawal of a marketing authorisation laid down by Article 11 of Directive 65/65.

In the absence of a margin of discretion on the part of the Commission, it is therefore for the Community judicature to examine the legal and factual complexity of the situation, taking account, in particular, of the pre-eminence of the public health objectives pursued and the particular constraints on the Commission in the pursuit of those objectives, in order to establish whether the error of law committed by the Commission is an irregularity which would not have been made by an administration exercising ordinary care and diligence in similar circumstances.

(see paras 97, 103-104, 107, 111)