Judgment;Abstract — ECLI:EU:T:2019:624
Date: 2019-09-19
Language of the case: English
Court formation: Fourth Chamber
Subject matter: Approximation of laws;Public health
Procedure: Action for annulment - unfounded

Summary — Order of the President of the General Court, 11 July 2018 1. Application for interim measures — Suspension of operation of a measure — Conditions for granting — Urgency — Serious and irreparable harm — Financial loss — Commission decision suspending the marketing authorisation for a product — Reliance on the adoption of measures suspending authorisations for the product at issue by third States — Harm not serious in nature (Art. 278 TFEU) 2. Application for interim measures — Suspension of operation of a measure — Interim measures — Conditions for granting — Urgency — Serious and irreparable harm — Financial loss — Serious nature of harm — Assessment in the absence of information concerning the size of the undertaking concerned — Lack of information making it necessary for the judge hearing the application for interim measures to determine the existence of particular circumstances, specific to the case at issue, such as to justify urgency — Harm not serious in nature — Existence of contracts allowing the undertaking to reduce the scale of the harm (Arts 278 TFEU and 279 TFEU) 3. Application for interim measures — Suspension of operation of a measure — Conditions for granting — Urgency — Serious and irreparable harm — Financial loss — Irreparable alteration in market share — Commission decision suspending the marketing authorisation for a product — Reliance on difficulties in participating in tendering processes that require a full range of products in the field in question — Marketing authorisation held by the applicant for another product which may, to a certain extent, be substituted for the product covered by the suspension decision — No urgency (Art. 278 TFEU) 1. As regards an application for suspension of operation of a Commission decision suspending the marketing authorisation for a product, the applicant’s assertion that third States have adopted measures suspending authorisations for the product at issue cannot constitute particular circumstances from which the seriousness of the harm may be inferred. Even if that allegation were to prove to be founded, that would not call into question the fact that those decisions were adopted by independent authorities and that it falls to the applicant potentially to bring the appropriate actions in those legal systems in order to challenge the lawfulness of those decisions. (see paras 49, 50) 2. As regards an application for suspension of operation of a Commission decision suspending the marketing authorisation for a product, the condition of urgency is not met where the applicant fails to provide the judge hearing the application for interim measures with the essential elements enabling him to examine the seriousness of the alleged effects so far as concerns the contractual obligations to which the applicant is subject and the costs resulting from the need to replace the banned product, whilst merely making general assertions without stating, for example, the size of the contracts at issue in the light of its activity as a whole, the estimated amount of the costs attributable to the substitution of the banned product or the penalty incurred on account of the possible failure to perform those contracts. In that connection, although the lack of information concerning the substitution costs generated by the contractual obligations referred to by the applicant does not allow the increase in the alleged harm to be assessed, the existence of the contracts at issue nevertheless suggests that, to a certain extent, the applicant has a means of reducing the scale of that harm and preserving the market share that it fears it will lose on the markets for similar products in the Member States concerned and outside the European Union. In that context, it may be observed that, in the light of the average duration of proceedings before the General Court, the judgment on the substance in the present case will probably be delivered within two years. Consequently, depending on the term of those contracts, the applicant may potentially know where it stands on the lawfulness of the contested decision before their expiry. (see paras 52, 53) 3. As regards an application for suspension of operation of a Commission decision suspending the marketing authorisation for a product, the applicant cannot validly invoke as a particular circumstance establishing urgency the circumstance that the contested decision prevents it from participating in tendering processes that require a full range of products in the field in question, where the applicant holds a marketing authorisation within the European Union for another product, the marketing of which is unaffected by that decision, and which, without being an exact substitute for the former product, could nevertheless reduce the impact of the disadvantages feared by the applicant. (see para. 54)