Keywords

Summary



Keywords

1. Application for interim measures — Suspension of operation of a measure — Conditions for granting — Prima facie case — Prima facie examination of the pleas in law put forward in support of the main action — Jurisdiction of the court hearing the application for interim relief — Limits — Action against a decision of the EMA granting a third party access to information submitted by an undertaking in the context of its application for authorisation to market a medicinal product — Plea revealing the existence of complex legal questions — Plea not prima facie lacking in foundation

(Art. 278 TFEU; Rules of Procedure of the General Court, Art. 156(3); European Parliament and Council Regulation No 1049/2001)

2. Application for interim measures — Suspension of operation of a measure — Conditions for granting — Balancing of all the interests involved — Suspension of operation of a decision of the EMA granting a third party access to information submitted by an undertaking in the context of its application for authorisation to market a medicinal product — Need to maintain the effectiveness of the decision of the General Court in the action in the main proceedings

(Arts 15(3) TFEU and 278 TFEU; Charter of Fundamental Rights of the European Union, Art. 47; Rules of Procedure of the General Court, Art. 156(3); European Parliament and Council Regulation No 1049/2001)

3. Application for interim measures — Suspension of operation of a measure — Interim measures — Conditions for granting — Serious and irreparable damage — Damage resulting from the disclosure of allegedly confidential information — Assessment of the seriousness of the damage by the court hearing the application for interim measures

(Arts 278 TFEU and 279 TFEU; Rules of Procedure of the General Court, Art. 156(3))

4. Application for interim measures — Suspension of operation of a measure — Conditions for granting — Urgency — Serious and irreparable damage — Financial loss — Assessment in accordance with the circumstances of the case — Damage linked to the disclosure of information covered by business secrecy — Criteria for assessment — Importance of the information for the undertaking concerned and usefulness of it for other undertakings

(Art. 278 TFEU; Rules of Procedure of the General Court, Art. 156(3); European Parliament and Council Regulation No 1049/2001, Art. 6(1))

5. Application for interim measures — Suspension of operation of a measure — Interim measures — Conditions for granting — Urgency — Assessment in litigation on the protection of confidential information — Serious and irreparable damage — Sufficient where probability of that damage is shown

(Arts 278 TFEU and 279 TFEU; Rules of Procedure of the General Court, Art. 156(3))

6. Application for interim measures — Suspension of operation of a measure — Interim measures — Conditions for granting — Urgency — Serious and irreparable damage — Decision of the EMA granting a third party access to information submitted by an undertaking in the context of its application for authorisation to market a medicinal product — No jurisdiction for the court hearing the application for interim relief to authorise partial access

(Arts 278 TFEU and 279 TFEU; Rules of Procedure of the General Court, Art. 156(3))

Summary

1. In interlocutory matters, the condition that there must be a prima facie case is satisfied where at least one of the pleas in law put forward by the applicant for interim measures in support of the main action appears, prima facie, not unfounded. That is the case, inter alia, where one of the pleas relied on reveals the existence of difficult legal issues the solution to which is not immediately obvious and therefore calls for a detailed examination that cannot be carried out by the court hearing the application for interim measures but must be the subject of the main proceedings, or where the discussion of issues by the parties reveals that there is a major legal disagreement whose resolution is not immediately obvious. In that context, it must be borne in mind that the interim relief procedure, which is based on a prima facie examination, is not designed to establish the truth of complex and much debated facts. The court hearing an application for interim measures does not have the means necessary in order to carry out such examinations and in numerous instances would have difficulty doing so in sufficient time.

In that regard, concerning an application for suspension of operation of a decision of the European Medicines Agency (EMA) to disclose reports lodged in the context of an application for authorisation to market a medicinal product, the existence of a prima facie case is recognised where the question has arisen whether the fact that the applicant compiled scientific data known to the public and added secret scientific data in order to produce a body of complex information which, as such, is not readily accessible may justify treating that body of information as confidential. That question also raises issues which cannot be immediately resolved in the context of proceedings for interim measures. In that regard, there is no case-law that would make it possible to give a ready answer to the questions of confidentiality that fall to be decided in the present case by the future judgment on the substance. They are novel questions of principle which cannot be resolved, for the first time, by the court hearing an application for interim measures; rather they require thorough examination within the main proceedings

(see paras 38, 39, 52, 62, 63)

2. In interlocutory matters, the weighing up of interests requires the court hearing an application for interim measures to determine whether or not the applicant’s interest in obtaining the measures sought outweighs the interest in the immediate application of the contested measure, by examining, more specifically, whether the possible annulment of that measure by the Court when ruling on the main application would allow the situation that would have been brought about by its immediate operation to be reversed and, conversely, whether suspension of operation of the measure would prevent it from being fully effective in the event of the main application being dismissed. As regards more particularly the condition that the legal situation created by an interim relief order must be reversible, it must be recalled that the purpose of the procedure for interim relief is to guarantee the full effectiveness of the future decision on the main action. Consequently, that procedure is merely ancillary to the main action to which it is an adjunct, and accordingly the decision made by the court hearing an application for interim relief must be provisional in the sense that it cannot either prejudge the future decision on the substance of the case or render it illusory by depriving it of practical effect. It necessarily follows that the interest defended by a party to interim relief proceedings does not merit protection where that party’s request is that the judge hearing the application should adopt a decision which, far from being a merely interim measure, would serve to prejudge the future decision on the main action and to render it illusory by depriving it of practical effect.

In that regard, concerning an application to suspend the operation of a decision of the European Medicines Agency (EMA) dismissing an application for confidentiality in respect of reports submitted by the applicant in the context of an application for authorisation to market a medicinal product and manifesting its intention to disclose those reports to a third party, in order to preserve the effectiveness of a judgment annulling the said decision, the applicant must be able to ensure that the EMA does not unlawfully disclose those reports. A judgment ordering annulment would be rendered illusory and deprived of practical effect if the application for interim measures were to be dismissed, since the EMA would then be free to disclose the reports at issue immediately, thereby effectively prejudging the future decision in the main action, namely that the action for annulment would be dismissed. It follows that the interest defended by the applicant must prevail over the EMA’s interest in the dismissal of the application for interim measures, a fortiori since the grant of the interim measures requested would amount to no more than maintaining the status quo for a limited period, while the EMA, far from alleging that disclosure of the reports at issue is necessary to meet an overriding need to protect public health, merely invokes, inter alia, the general principle of transparency.

As regards the interest of an intervener, which has requested the EMA to disclose the reports at issue, it is true that it may invoke a right of access to the documents of the European Union’s institutions, bodies, offices and agencies under Article 15(3) TFEU. However, the exercise of that right would merely be delayed if the interim measures were granted; that would entail a temporal restriction on the exercise of that right, whilst the applicant’s right to protection of the confidentiality of those reports would be reduced to nothing if the application for interim relief were dismissed. In that regard, in so far as the intervener invokes its right to an effective remedy, laid down in Article 47 of the Charter of Fundamental Rights, maintaining that it must have access to the reports at issue in order to be able to support its action for annulment of the decision to grant marketing authorisation to the applicant, it is for the intervener to request access to those documents and for the Court deciding on the substance to assess whether it would be appropriate to grant the access sought, in order to respect the intervener’s right to an effective remedy, the assumption being that, if the intervener were granted access to those reports, it could not use them for any inappropriate purpose, since it would be entitled to use them only for the purpose of defending its interests in the case in question and for no other purpose.

(see paras 64-71)

3. In interlocutory matters, where damage is alleged resulting from the disclosure of information claimed to be confidential, for the purpose of assessing the existence of serious and irreparable damage, the court hearing an application for interim measures is necessarily required to start from the premiss that the information alleged to be confidential is in fact confidential, as claimed by the applicant in proceedings for interim relief. Information of an economic nature is classified as confidential only if its disclosure is liable to cause serious damage to the commercial and financial interests of the holder of that information. It follows that the assessment of whether disclosure of the reports at issue would cause the applicant ‘ordinary’ or ‘serious’ damage cannot be separated from the thorough examination to be carried out by the Court when ruling on the main action. In view of its ancillary role vis-à-vis that of the Court adjudicating on the substance, the court hearing an application for interim measures is therefore, in any event, required to assume, for the purposes of the interim proceedings, not only that the information at issue is confidential, but also that the damage that may be caused to the applicant by disclosure of that information is serious.

(see paras 84, 90)

4. In interlocutory matters, the question of the extent to which the disclosure of allegedly confidential information causes serious and irreparable damage depends on a combination of circumstances, such as, inter alia, the professional and commercial importance of the information for the undertaking seeking its protection and the utility of that information for other market participants which are liable to examine and use it subsequently. As regards more specifically damage caused by publication on the internet of allegedly confidential information contained in reports of clinical and non-clinical trials of a medicinal product submitted to the EMA for the purposes of obtaining marketing authorisation, where financial damage which is objectively considerable, or even not insignificant, may be considered serious, without it being necessary in every case to relate that damage to the turnover of the undertaking concerned, those reports constitute an intangible asset that may be used for competitive purposes, whose value could be seriously reduced, or even eliminated, if the reports did not remain secret.

As regards the irreparable nature of the damage alleged, disclosure of the reports at issue to the third party which made a request to that effect to the EMA pursuant to Regulation No 1049/2001, namely the intervener, would place the applicant in a vulnerable situation as least as threatening as that in which information is disclosed on the internet. The applicant for access would immediately take cognisance of those reports and could use them straightaway for any purpose it deemed useful, since Article 6(1) of Regulation No 1049/2001 does not require the party requesting access to give reasons explaining that request. The applicant would thus have to expect that the disclosure of those reports would be liable to weaken its competitive position. It would therefore be in a vulnerable situation which would entail, for it, a risk of damage. Moreover, the disclosure of a document, under Regulation No 1049/2001, has an erga omnes effect in that the document may be communicated to other applicants for access and any person has the right to access it. The aforementioned erga omnes effect would even allow the EMA to publish the reports at issue on its website.

Once the reports at issue are disclosed, it is highly likely that current or potential competitors of the applicant with a genuine interest in exploiting those reports would attempt to obtain them, in order to use them for their own scientific and commercial needs, particularly with a view to producing a similar medicinal product and obtaining authorisation to market that product on many different markets within or outside the European Union. Consequently, the possibility of the applicant sustaining financial damage as a result of such future exploitation of the reports at issue by its competitors cannot be characterised as purely hypothetical. Rather, it is foreseeable with a sufficient degree of probability that the vulnerable situation in which the applicant would be placed in the event of disclosure of those reports would become one entailing financial damage to it.

(see paras 87-89, 95-98)

5. Having regard to the particular features of proceedings for the protection of allegedly confidential information, the applicant, in the context of interim proceedings having established to a sufficient legal standard the probable occurrence, for that applicant, of serious and irreparable damage in the event of disclosure of such information, is not required to establish, in addition, that it would be in a position that would imperil its financial viability or that its market shares would be seriously and irreparably affected if the measures applied for were not granted.

(see para. 102)

6. In interlocutory matters, even if the damage alleged by the applicant, in the context of an application to suspend the operation of a decision of an EU agency to disclose allegedly confidential information, could not be classified as irreparable, the court hearing the application for interim measures could not examine the confidentiality of each individual piece of data with a view to possibly upholding the application for interim measures only in part, which would amount to protecting only certain pieces of information, while allowing access to others. If the dispatch required in interim proceedings is not in itself such as to preclude such an individual examination, it must be concluded that it is not only that need for dispatch, but above all the purely ancillary, and therefore limited, nature of his powers, which prevents the court hearing an application for interim measures from carrying out such an examination in the context of its assessment of the condition relating to urgency. Thus, if the Court adjudicating on the main action accepted that the reports at issue were covered by a general principle of confidentiality, those reports would not be subject to an obligation of partial disclosure. The court hearing an application for interim measures, given its purely ancillary powers — which remain largely less extensive than those entailed by the far more autonomous role granted to some national courts by their respective domestic law —, cannot therefore authorise partial access without depriving the judgment on the substance of practical effect.

Lastly, the court hearing an application for interim measures must not apply mechanically and rigidly the condition relating to the irreparable nature of the financial damage pleaded. Rather, it must take account of the factual and legal circumstances specific to each case, particularly since that condition, which arises solely from the case-law and is set out in neither the Treaties nor the Rules of Procedure, must not be applied if it is irreconcilable with the need to provide effective provisional protection. Article 278 TFEU and Article 279 TFEU, which are primary law provisions, authorise the court hearing an application for interim measures to order the suspension of operation of a measure if it considers that circumstances so require and to prescribe any necessary interim measures.

(see paras 103, 104, 109, 110)