Case C‑390/13 P(R)

European Medicines Agency (EMA)

v

InterMune UK Ltd and Others

‛Appeal — Order for interim measures — Regulation (EC) No 1049/2001 — Access to documents of the institutions — Documents held by the European Medicines Agency in the context of an application for authorisation to place a medicinal product on the market — Decision to grant a third party access to the documents — Information not available to the public — Serious and irreparable damage — Evidence’

Summary — Order of the Vice-president of the Court, 28 November 2013

Application for interim measures — Suspension of operation of a measure — Interim measures — Conditions for granting — Serious and irreparable damage — Burden of proof on the party seeking the interim measure — Risk of a breach of fundamental rights — Insufficient to constitute serious damage — Assessment in the circumstances of the present case — Harm linked to the disclosure of information covered by the obligation of professional secrecy — Criteria for assessment — Importance of the information for the undertaking concerned and the utility of that information for other undertakings

See the text of the decision. (see para. 36)

The purpose of interlocutory proceedings is to guarantee the full effectiveness of the definitive future decision, in order to ensure that there is no lacuna in the legal protection provided by the Court of Justice. It is for the purpose of attaining that objective that urgency must be assessed in the light of the need for an interlocutory order in order to avoid serious and irreparable damage to the party seeking the interim relief. It is for that party to prove that it cannot wait for the outcome of the main proceedings without suffering damage of that kind. Although it is correct that in order to establish the existence of serious and irreparable damage it is not necessary for the occurrence of the damage to be demonstrated with absolute certainty, it being sufficient to show that damage is foreseeable with a sufficient degree of probability, the applicant is still required to prove the facts forming the basis of its claim that such serious and irreparable damage is likely. (see paras 37, 38)

The argument that harm is, by definition, irreparable because it falls within the scope of fundamental freedoms cannot be accepted since it is not sufficient to allege infringement of fundamental rights in the abstract for the purpose of establishing that the harm which could result would necessarily be irreparable. It is true that the infringement of certain fundamental rights, such as the prohibition of torture and inhuman or degrading treatment or punishment, enshrined in Article 4 of the Charter of Fundamental Rights of the European Union, is liable, because of the very nature of the right infringed, to give rise by itself to serious and irreparable harm. Nevertheless, it is still for the party seeking an interim measure to set forth and establish the likelihood of such harm occurring in its particular case. Such harm cannot be inferred from the premiss that the information redacted in the edited version of the documents to which access has been requested are indeed confidential, as claimed by the companies opposing that access. It cannot be held that the alleged infringement of those companies’ fundamental right to the protection of their business secrets, enshrined in Article 339 TFEU, in Article 8 of the ECHR, and in Article 7 of the Charter, and of their right to an effective remedy, enshrined in Article 6 of the ECRH and Article 47 of the Charter, was sufficient in itself to establish the risk of serious and irreparable harm. However, the extent to which the disclosure of such information causes serious and irreparable harm depends on a combination of circumstances, such as, inter alia, the professional and commercial importance of the information for the undertaking which provides it and the utility of that information for other undertakings which are liable to examine and use it subsequently. (see paras 40, 42-45)

Damage of a pecuniary nature cannot be regarded as irreparable, otherwise than in exceptional circumstances, since as a general rule pecuniary compensation is capable of restoring the aggrieved person to the situation that obtained before he suffered the damage. In particular, such damage could be recouped via an action for compensation. Nevertheless, harm of a financial nature may, inter alia, be considered to be serious and irreparable if the harm, even when it occurs, cannot be quantified. It is true that the uncertainty of obtaining compensation for pecuniary damage if an action for damages is brought cannot in itself be regarded as a factor capable of establishing that such damage is irreparable. Interlocutory proceedings are not intended to act as a substitute for an action for damages in order to remove that uncertainty, since their purpose is only to guarantee the full effectiveness of the final future decision that will be made in the main action. On the other hand, the situation is different where it is already clear, when the assessment is carried out by the judge hearing the application for interim measures, that, in view of its nature and the manner in which it will foreseeably occur, the harm alleged, should it occur, may not be adequately identified or quantified and that, in practice, it will not therefore be possible to make good that harm by bringing an action for damages. (see paras 48-51)