Keywords

Summary



Keywords

1. Applications for interim measures - Conditions governing admissibility - Admissibility of the main application - Irrelevance - Limits

(Arts 242 EC and 243 EC; Rules of Procedure of the Court of First Instance, Art. 104(1))

2. Applications for interim measures - Suspension of operation of a measure - Interim measures - Conditions for granting - Serious and irreparable damage - Burden of proof - Balancing of all the interests involved

(Arts 242 EC and 243 EC; Rules of Procedure of the Court of First Instance, Art. 104(1) and (2))

3. Applications for interim measures - Suspension of operation of a measure - Interim measures - Conditions for granting - Urgency - Balancing of the interests involved - Protection of public health - Examination as a matter of urgency - Condition

(Arts 242 EC and 243 EC; Rules of Procedure of the Court of First Instance, Art. 104(1) and (2))

4. Applications for interim measures - Suspension of operation - Suspension of operation of a decision authorising a medicinal product to be placed on the market - Conditions for granting - Balancing of all of the interests involved

(Art. 242 EC; Rules of Procedure of the Court of First Instance, Art. 104(1))

Summary

1. Although the issue of the admissibility of the main action should not, in principle, be examined in proceedings for interim relief, so as not to prejudge the Court's decision on the substance of the case, it may nevertheless be necessary, where it is contended that the main action to which the application for interim measures relates is manifestly inadmissible, to establish whether there are any grounds for concluding prima facie that such an action is admissible.

( see para. 59 )

2. The urgency of an application for interim measures must be assessed in relation to the necessity for an interim order to prevent serious and irreparable damage to the party applying for those measures. It is for that party to prove that it cannot wait for the outcome of the main proceedings without suffering damage of that kind. However, in order to determine whether the applicant has proved the need for the suspension sought, it is necessary for the judge dealing with the application for interim measures to analyse the alleged harm in the light of all the interests involved.

( see paras 126 and 137 )

3. In an application for interim measures, although damage which may be caused to third parties or to the environment, invoked by a party applying for such measures, may be taken into account only in the balancing of the interests involved in an application for the suspension of operation of a Commission decision concerning the placing of a medicinal product on the market, the applicant, by reason of her particular position as investigator in the clinical trials recorded in the reports attached to the application for authorisation, which involves her signing those reports, cannot be denied the possibility of satisfying the condition for urgency by invoking the danger to human health which could result from a lack of efficacy and from toxicity of the medicinal product authorised.

( see para. 135 )

4. In the case of an application for the suspension of operation of a Commission decision authorising a medicinal product to be placed on the market, where the applicant has failed to prove in a sufficiently convincing manner that there is no need for the active ingredient in that medicinal product, which would arise if a therapeutic solution to replace the pharmacological treatment actually existed, the judge dealing with the application for interim measures cannot substitute his assessment for that of the Commission in regard to the balancing of the advantages and risks which the authorised medicinal product presents for the patients concerned.

( see paras 144 and 145 )