Court of Justice of the European Communities (including Court of First Instance Decisions)

ORDER OF THE PRESIDENT OF THE GENERAL COURT

19 August 2019(*)

(Interim measures — Medicinal product — Marketing authorisation — Omega-3 acid ethyl esters — No urgency)

In Case T‑472/19 R,

BASF AS, established in Oslo (Norway), represented by E. Wright, A. Rusanov and H. Boland, lawyers,

applicant,

v

European Commission, represented by L. Haasbeek and A. Sipos, acting as Agents,

defendant,

APPLICATION pursuant to Articles 278 and 279 TFEU for the grant of interim measures to suspend the operation of the Commission Implementing Decision of 6 June 2019 concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations of medicinal products for human use containing ‘Omega-3 acid ethyl esters’ for oral use in secondary prevention after myocardial infarction (C(2019) 4336 final),

THE PRESIDENT OF THE GENERAL COURT

makes the following

Order

 Background to the dispute, procedure and forms of order sought

1        The applicant, BASF AS, is part of BASF, a global group of chemical companies.

2        According to the applicant, it is the marketing authorisation holder for, inter alia, the omega-3-acid ethyl ester medicinal products Omacor and Zodin.

3        Omacor was approved in 1995. The therapeutic indication relating to the treatment in secondary prevention after myocardial infarction was approved in 2001.

4        In 2003, a marketing authorisation was granted for the medicinal product Zodin, which is identical in all aspects to Omacor.

5        On 15 March 2018, the Kingdom of Sweden initiated a procedure pursuant to Article 31 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67).

6        That procedure resulted in the Commission Implementing Decision of 6 June 2019 concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations of medicinal products for human use containing ‘Omega-3 acid ethyl esters’ for oral use in secondary prevention after myocardial infarction (C(2019) 4336 final; ‘the contested decision’).

7        By virtue of the contested decision, Member States are, in essence, required to remove, from the existing marketing authorisations for medicinal products such as Omacor and Zodin, the therapeutic indication of use in secondary prevention after myocardial infarction.

8        By application lodged at the Court Registry on 9 July 2019, the applicant brought an action for annulment of the contested decision.

9        By a separate document lodged at the Court Registry on the same day, the applicant brought the present application for interim measures, in which it claims, in essence, that the President of the General Court should:

–        suspend the operation of the contested decision in its entirety or in so far as the applicant is affected;

–        order the Commission to pay the costs.

10      In its observations on the application for interim measures, lodged at the Court Registry on 29 July 2019, the Commission contends that the President of the General Court should:

–        dismiss the application for interim measures;

–        order the applicant to pay the costs.

 Law

11      It is apparent from reading Articles 278 and 279 TFEU together with Article 256(1) TFEU that the judge hearing an application for interim measures may, if he considers that the circumstances so require, order that the operation of a measure challenged before the General Court be suspended or prescribe any necessary interim measures, pursuant to Article 156 of the Rules of Procedure of the General Court. Nevertheless, Article 278 TFEU establishes the principle that actions do not have suspensory effect, since acts adopted by the institutions of the European Union are presumed to be lawful. It is therefore only exceptionally that the judge hearing an application for interim measures may order the suspension of operation of an act challenged before the General Court or prescribe any interim measures (order of 19 July 2016, Belgium v Commission, T‑131/16 R, EU:T:2016:427, paragraph 12).

12      The first sentence of Article 156(4) of the Rules of Procedure requires applications for interim measures to state ‘the subject matter of the proceedings, the circumstances giving rise to urgency and the pleas of fact and law establishing a prima facie case for the interim measure applied for’.

13      Accordingly, the judge hearing an application for interim relief may order suspension of operation of an act and other interim measures, if it is established that such an order is justified, prima facie, in fact and in law, and that it is urgent in so far as, in order to avoid serious and irreparable harm to the applicant’s interests, it must be made and produce its effects before a decision is reached in the main action. Those conditions are cumulative, and consequently an application for interim measures must be dismissed if any one of them is not satisfied. The judge hearing an application for interim relief is also to undertake, when necessary, a weighing of the competing interests (see order of 2 March 2016, Evonik Degussa v Commission, C‑162/15 P-R, EU:C:2016:142, paragraph 21 and the case-law cited).

14      In the context of that overall examination, the judge hearing the application has a wide discretion and is free to determine, having regard to the specific circumstances of the case, the manner and order in which those various conditions are to be examined, there being no rule of law imposing a pre-established scheme of analysis within which the need to order interim measures must be assessed (see order of 19 July 2012, Akhras v Council, C‑110/12 P(R), not published, EU:C:2012:507, paragraph 23 and the case-law cited).

15      Having regard to the material in the case file, the judge hearing the application considers that he has all the information needed to rule on the present application for interim measures without there being any need first to hear oral argument from the parties.

16      In the circumstances of the present case, it is appropriate to examine first whether the condition relating to urgency is satisfied.

17      In order to determine whether the interim measures sought are urgent, it should be borne in mind that the purpose of the procedure for interim relief is to guarantee the full effectiveness of the future final decision, in order to prevent a lacuna in the legal protection afforded by the EU judicature. To attain that objective, urgency must be assessed in the light of the need for an interlocutory order to avoid serious and irreparable damage to the party requesting the interim measure. That party must demonstrate that it cannot await the outcome of the main proceedings without suffering serious and irreparable damage (see order of 14 January 2016, AGC Glass Europe and Others v Commission, C‑517/15 P-R, EU:C:2016:21, paragraph 27 and the case-law cited).

18      Furthermore, following settled case-law, there is urgency only if the serious and irreparable harm feared by the party requesting the interim measures is so imminent that its occurrence can be foreseen with a sufficient degree of probability. That party remains, in any event, required to prove the facts that form the basis of its claim that such harm is likely, it being clear that purely hypothetical harm, based on future and uncertain events, cannot justify the granting of interim measures (see order of 16 February 2017, Gollnisch v Parliament, T‑624/16 R, not published, EU:T:2017:94, paragraph 25 and the case-law cited).

19      Furthermore, under the second sentence of Article 156(4) of the Rules of Procedure, an application for interim measures must ‘contain all the evidence and offers of evidence available to justify the grant of interim measures’.

20      Thus, an application for interim measures must, of itself, enable the defendant to prepare its observations and the judge hearing the application to rule on it, if necessary without any other supporting information, since the essential elements of fact and law on which the application is based must be found in the actual text of that application (see order of 6 September 2016, Inclusion Alliance for Europe v Commission, C‑378/16 P-R, not published, EU:C:2016:668, paragraph 17 and the case-law cited).

21      It is also established case-law that, in order to determine whether all the conditions set out in paragraphs 17 and 18 above are met, the judge hearing the application for interim measures must have hard and precise information, supported by detailed and certified documents showing the situation of the party seeking interim relief and making it possible to examine the actual consequences which would be likely to result if the measures sought were not granted. It follows that that party, especially where it alleges harm of a financial nature, must provide, with supporting documentation, an accurate and comprehensive picture of its financial situation (see, to that effect, order of 29 February 2016, ICA Laboratories and Others v Commission, T‑732/15 R, not published, EU:T:2016:129, paragraph 39 and the case-law cited).

22      Lastly, while the application for interim measures may be supplemented on specific points by references to documents annexed to the application, those documents cannot compensate for the failure to set out the essential elements of that application. It is not the task of the judge hearing the application for interim measures to seek, in place of the party concerned, the information that may be found in the annexes to the application for interim measures, in the main application or in the annexes to that application, which is liable to substantiate the application for interim measures. To impose such an obligation on the judge hearing the application for interim measures would also be likely to deprive of any effect Article 156(5) of the Rules of Procedure, under which the application for interim measures must be made by separate document (see, to that effect, order of 20 June 2014, Wilders v Parliament and Others, T‑410/14 R, not published, EU:T:2014:564, paragraph 16 and the case-law cited).

23      It is in the light of those criteria that it is necessary to examine whether the applicant has succeeded in demonstrating the imminence of serious and irreparable harm.

24      In the present case, the applicant maintains, in the first place, that suspension of the operation of the contested decision is required so as to avoid serious and irreparable harm to patients who suffered myocardial infarction and who could no longer be treated with the applicant’s medicinal products.

25      The applicant acknowledges that, in accordance with settled case-law, as recalled in paragraph 17 above, urgency must be assessed in the light of the need for an interlocutory order to avoid serious and irreparable harm to the party requesting the interim measure.

26      However, the applicant submits that the fact that the serious and irreparable harm is not suffered by the applicant itself but by the patients being treated with the applicant’s medicinal products may not exclude the granting of interim measures. On the one hand, Articles 278 and 279 TFEU and Article 156 of the Rules of Procedure do not prescribe that the serious and irreparable harm must be suffered personally by the applicant. On the other, imposing such a requirement would deprive those articles of their purpose and meaning.

27      That plea cannot succeed.

28      In that respect, it must be recalled, first, that the disputed requirement was confirmed only recently by the Grand Chamber of the Court of Justice, in paragraph 43 of the order of 20 November 2017, Commission v Poland (C‑441/17 R, EU:C:2017:877).

29      Second, as a rule and as recalled in paragraph 11 above, actions do not have suspensory effect.

30      As is clear from paragraph 17 above, the purpose of the procedure for interim relief is to guarantee the full effectiveness of the future final decision in order to prevent a lacuna in the legal protection afforded by the EU judicature.

31      Accordingly, only if the applicant requesting interim relief can demonstrate that it cannot await the outcome of the main proceedings without suffering serious and irreparable damage does a situation exist in which there could be a lacuna in its legal protection if no interim measures were accorded.

32      Third, according to the settled case-law, harm to a general interest or the rights of third parties is not entirely devoid of relevance, since it can be taken into account, where appropriate, in the examination of the balance of the interests involved (see, to that effect, order of 2 August 2006, Aughinish Alumina v Commission, T‑69/06 R, not published, EU:T:2006:225, paragraph 80 and the case-law cited).

33      Accordingly, the applicant’s argument cannot succeed, since the disputed requirement is inherent in the logic of the system of interim relief and cannot be regarded as rendering the procedure for interim measures devoid of purpose or meaningless.

34      In the second place, the applicant submits that it would suffer damage to its reputation. In that respect, it argues, in essence, that it is possible for the patients using the medicinal products in question to be unaware of the contested decision and to hold the applicant responsible for the fact that the medicinal products in question are no longer available for treatment in secondary prevention after myocardial infarction.

35      Nor can that plea establish urgency.

36      First, it must be pointed out that the damage to reputation claimed appears to be highly speculative.

37      Second, the applicant does not claim that it is prevented from explaining to patients currently being treated with the medicinal products in question that the removal from the marketing authorisation of the therapeutic indication of use in secondary prevention after myocardial infarction is not of its own deliberate making but is the result of the contested decision.

38      It follows from all the foregoing considerations that the application for interim measures must be dismissed, since the applicant has failed to establish urgency, without it being necessary to rule on the prima facie case or to strike a balance between the interests at issue.

39      In accordance with Article 158(5) of the Rules of Procedure, the costs must be reserved.

On those grounds,

THE PRESIDENT OF THE GENERAL COURT

hereby orders:

1.      The application for interim measures is dismissed.

2.      The costs are reserved.

Luxembourg, 19 August 2019.

*      Language of the case: English.

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