ORDER OF THE PRESIDENT OF THE GENERAL COURT
18 October 2022 (*)
(Interim relief – Medicinal products for human use – Directive 2001/83/EC – Marketing authorisations for medicinal products containing the active substance ‘hydroxyethyl starch (HES), solutions for infusion’ – Application for suspension of operation of a measure – No urgency)
In Case T‑416/22 R,
Fresenius Kabi Austria GmbH, established in Graz (Austria), and the other applicants whose names are listed in the annex, (1) represented by W. Rehmann and A. Knierim, lawyers,
applicants,
v
European Commission, represented by M. Escobar Gómez and K. Mifsud-Bonnici, acting as Agents,
defendant,
THE PRESIDENT OF THE GENERAL COURT
makes the following
Order
1 By their application under Articles 278 and 279 TFEU, the applicants, Fresenius Kabi Austria GmbH and the other legal persons whose names are listed in the annex, seek the suspension of operation of European Commission Implementing Decision C(2022) 3591 final of 24 May 2022 concerning, in the framework of Article 107p of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations of medicinal products for human use which contain the active substance ‘hydroxyethyl starch (HES), solutions for infusion’ following an assessment of a post authorisation safety study (‘the contested decision’).
Background to the dispute and forms of order sought
2 The applicants are part of the Fresenius Kabi Group, a global company belonging to the Fresenius Group, which specialises in healthcare and which manufactures and distributes, inter alia, medicinal products containing hydroxyethyl starch as the active substance.
3 Hydroxyethyl starch solutions for infusion are used to replace plasma volume following a sudden and acute loss of blood, where treatment with alternative products called ‘crystalloids’ is not sufficient by itself.
4 On 17 October 2017, in accordance with a request from the Swedish National Competent Authority, a procedure was opened under Article 107i 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).
5 On 17 July 2018, the Commission adopted Implementing Decision C(2018) 4832 final concerning, in the framework of Article 107i of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations of medicinal products for human use which contain the active substance ‘hydroxyethyl starch (HES), solutions for infusion’. By that decision, addressed to the Member States, the Commission decided that the Member States concerned should amend the national marketing authorisations for the medicinal products at issue on the basis of the scientific conclusions of the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), a body representing the EU Member States which is responsible for ensuring harmonised safety standards for medicines authorised under national procedures across the European Union. In its scientific conclusions, the CMDh stated that solutions for infusion containing hydroxyethyl starch could remain on the market provided that a series of supplementary risk minimisation measures were adopted to ensure that those medicinal products would not be used in patients at risk of serious harm to their health.
6 On 10 February 2022, the Pharmacovigilance Risk Assessment Committee (‘the PRAC’), the European Medicines Agency’s (EMA) committee responsible for assessing the safety of medicinal products for human use, adopted an assessment report in which it found that solutions for infusion containing hydroxyethyl starch continued to be used in populations that were contraindicated and therefore at greater risk of serious harm to their health, including mortality, and that overall, the benefit-risk balance of products containing hydroxyethyl starch was negative. Consequently, the PRAC recommended the suspension of the marketing authorisations for those medicinal products.
7 On 23 February 2022, the CMDh, on the basis of the PRAC’s recommendation and the attached scientific conclusions, concluded in a majority decision that the marketing authorisations for those medicinal products should be suspended.
8 On 24 May 2022, the Commission adopted the contested decision, addressed to the Member States, by which it decided that the Member States concerned should suspend the national marketing authorisations of the medicinal products at issue on the basis of the scientific conclusions of the relevant competent bodies.
9 By application lodged at the Court Registry on 1 July 2022, the applicants brought an action for annulment of the contested decision.
10 By separate document lodged at the Court Registry on 19 July 2022, the applicants brought the present application for interim measures, in which they claim that the President of the General Court should:
– order the suspension of operation of the contested decision, in so far as it orders the EU Member States to suspend the national marketing authorisations for the medicinal products referred to in Annex I to that decision;
– in the alternative, as a precautionary measure, order the suspension of operation of the contested decision in so far as it orders the EU Member States to suspend the national marketing authorisations for the medicinal products which the applicants market and which are referred to in Annex I to that decision;
– order the Commission to pay the costs.
11 In its observations on the application for interim measures, lodged at the Court Registry on 1 September 2022, the Commission contends that the President of the General Court should:
– dismiss the application for interim relief as inadmissible or, in the alternative, as unfounded;
– order the applicants to pay the costs.
Law
General considerations
12 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 or she 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).
13 The first sentence of Article 156(4) of the Rules of Procedure provides that applications for interim measures are 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’.
14 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).
15 In the context of that overall examination, the court hearing the application for interim measures enjoys a broad discretion and is free to determine, having regard to the particular 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).
16 Having regard to the material in the file, the President of the General Court considers that he has all the information necessary to rule on the present application for interim measures, without there being any need first to hear oral argument from the parties.
17 In the circumstances of this case, and without it being necessary to rule on the admissibility of the present application for interim measures, it is appropriate to examine first of all whether the condition relating to urgency is satisfied.
The condition relating to urgency
18 In order to determine whether the interim measures sought are urgent, it should be noted 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 generally 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).
19 In addition, under the second sentence of Article 156(4) of the Rules of Procedure, applications for interim measures ‘shall contain all the evidence and offers of evidence available to justify the grant of interim measures’.
20 Accordingly, an application for interim measures must by itself enable the defendant to prepare its observations and the judge hearing the application to rule on it, as 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 settled case-law that, in order to determine whether all the conditions referred to in paragraph 18 above are fulfilled, the judge hearing the application for interim measures must have specific and precise information, supported by detailed, certified documentary evidence, which shows the situation in which the party seeking the interim measures finds itself and enables the probable consequences, should the measures sought not be granted, to be assessed. It follows that that party, in particular when it relies on the occurrence of financial damage, must produce, with supporting documentation, an accurate overall picture of its financial situation (see 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 It is in the light of those criteria that the Court must examine whether the applicant has succeeded in demonstrating urgency.
23 In the present case, the applicants submit that they will suffer serious and irreparable damage consisting of a substantial loss of market share, a direct loss of profit caused by the halt to the distribution of the medicinal products amounting to EUR 2 million per month and, above all, a loss of reputation owing to the fact that the contested decision, as published, suggests to the healthcare professionals concerned and the competent authorities of other countries which are not part of the European Union that the medicinal products in question are not safe.
24 In particular, as regards the alleged financial damage, the applicants claim that that damage cannot be compensated for by the group to which they belong since all 15 companies in that group are affected.
25 In that context, the applicants add that regaining a significant proportion of the market share, in particular by appropriate publicity measures, would be highly unlikely owing to obstacles of a structural and legal nature.
26 Furthermore, the applicants argue that it is highly improbable that they would succeed in an action for damages if the contested decision is annulled since, in so far as the Commission relies on the scientific conclusions of the PRAC and the CMDh, it would be difficult for them to show that the Commission has manifestly and significantly exceeded the limits set on its discretion.
27 In addition, the applicants assert that they face similar measures by the competent authorities of certain non-EU countries. Their medicinal products would thus no longer have access to the markets and could not be introduced again.
28 Consequently, if the operation of the contested decision is not suspended, the applicants claim that they would de facto be deprived of their right to effective judicial protection. The infringement of that right cannot be balanced by the public interest since the medicinal products concerned are safe, patient safety is not under threat and there is no public interest that justifies the suspension of the marketing authorisations.
29 In that respect, in the first place, as regards the applicants’ argument that they will suffer serious and irreparable damage consisting of a substantial loss of market share and a loss of profit resulting from the halt to the distribution of the medicinal products, it must be held that that damage has to be considered as being purely financial in nature.
30 In that context, it should be borne in mind that where the harm referred to is of a financial nature, the interim measures sought are justified where, in the absence of those measures, the party seeking them would be in a position that would imperil its financial viability before final judgment is given in the main action, or where its market share would be affected substantially in the light, inter alia, of the size and turnover of its undertaking and, where relevant, the characteristics of the group to which it belongs (see order of 12 June 2014, Commission v Rusal Armenal, C‑21/14 P‑R, EU:C:2014:1749, paragraph 46 and the case-law cited). Since imminent disappearance from the market does constitute damage that is both irreparable and serious, adoption of the interim measure sought appears justified in such a situation (order of 9 June 2010, Colt Télécommunications France v Commission, T‑79/10 R, not published, EU:T:2010:228, paragraph 37).
31 Furthermore, in accordance with settled case-law, damage of a pecuniary nature cannot, otherwise than in exceptional circumstances, be regarded as irreparable since, as a general rule, pecuniary compensation is capable of restoring the aggrieved person to the situation that obtained before that person suffered the damage. Any such damage could be recouped by the applicant’s bringing an action for compensation on the basis of Articles 268 TFEU and 340 TFEU (see order of 23 April 2015, Commission v Vanbreda Risk & Benefits, C‑35/15 P(R), EU:C:2015:275, paragraph 24 and the case-law cited).
32 While, in the case-law, account has also been taken of the fact that, if the measure sought were not granted, the applicant’s market share would be irremediably affected, it must be pointed out that this situation can be placed on an equal footing with that of the risk of disappearance from the market and justify adoption of the interim measure sought only if the irremediable effect on market share is also of a serious nature. It is therefore not sufficient that a market share may be irremediably lost by an undertaking; rather, it is necessary for that market share to be sufficiently large in the light of, in particular, the size of that undertaking, regard being had to the characteristics of the group to which it belongs through its shareholders. A party seeking interim measures which invokes the loss of such a market share must demonstrate, furthermore, that regaining a significant proportion of that share is impossible by reason of obstacles of a structural or legal nature (see order of 28 April 2009, United Phosphorus v Commission, T‑95/09 R, not published, EU:T:2009:124, paragraph 35 and the case-law cited).
33 It is in the light of those considerations that the Court must examine the evidence put forward by the applicants in order to establish that they would suffer serious and irreparable damage of a financial nature if suspension of the operation of the contested decision were not ordered.
34 In the present case, first, the applicants neither establish nor even claim that they are in a position that would imperil their financial viability before final judgment is given in the main action, in the light of the size, turnover and characteristics of the group to which they belong.
35 The only quantitative evidence advanced by the applicants is apparent from the claim that the loss of profit resulting from the halt to the distribution of the medicinal products at issue amounts to EUR 2 million per month.
36 Apart from that claim, the applicants provide no figures, from accounts or otherwise, capable of substantiating the existence of serious and irreparable damage.
37 The applicants merely assert that their financial damage cannot be compensated by the Fresenius Kabi Group, to which they belong, since all of the group’s 15 companies are affected.
38 However, it should be observed that, in accordance with the case-law referred to in paragraph 21 above, in order to demonstrate a risk to their financial viability, the applicants should have produced, with supporting documentation, an accurate overall picture of their financial situation.
39 Since the applicants have not provided any additional information or any certified evidence concerning their financial situation and the financial situation of the Fresenius Group, to which the Fresenius Kabi Group belongs, it must be found that they merely make assertions that are not supported by evidence.
40 Accordingly, the judge hearing the application for interim measures is not able to establish an accurate overall picture of the applicants’ financial situation, in accordance with the case-law cited in paragraph 21 above.
41 Secondly, as regards the alleged damage caused by the substantial loss of market share, first of all, it must be held that the loss of market share claimed also amounts to damage of a purely financial nature in that it consists of the loss of the income from sales of the medicinal products at issue.
42 According to settled case-law, the market share held by a company indicates only the percentage of all the products present on the market in question which were sold by that company to customers over the course of a specified reference period. Consequently, the loss of that market share consists in the loss of the profits liable to be realised in the future on sales of the product in question. A market share can thus clearly be represented in financial terms, as the holder of that market share can benefit from it only in so far as it generates profit for that holder (see order of 30 April 2010, Xeda International v Commission, T‑71/10 R, not published, EU:T:2010:173, paragraph 41 and the case-law cited).
43 Next, it must be held that the applicants have not demonstrated, to the requisite legal standard, the existence of obstacles of a structural or legal nature preventing them from regaining a significant proportion of their market share, in accordance with the case-law cited in paragraph 32 above.
44 As is apparent from the applicants’ pleadings, in particular from paragraph 84 of the application for interim measures, the market for the medicinal products at issue in Europe is shared by only two competing companies and the EU market share of the companies belonging to the Fresenius Kabi Group amounts to approximately 81%. Accordingly, it must be observed, as the Commission has done, that the applicants and their sole competitor, as holder of a marketing authorisation for the medicinal products at issue, are both affected by the contested decision in exactly the same manner. Consequently, their competitor will not be able to gain market share from the applicants.
45 It follows that the alleged loss of market share is evidently not irreversible. On the contrary, that share would be recovered automatically if the contested decision were to be annulled at the conclusion of the main proceedings.
46 As regards, in the second place, the applicants’ argument that the contested decision causes serious damage to their reputation since it suggests to the healthcare professionals concerned and to the competent authorities of other countries which are not part of the European Union that the medicinal products in question are not safe, it must be pointed out that, in accordance with settled case-law, the damage to the applicants’ reputation, on the assumption that it is proved, would already have been caused by the contested decision and would last until such time as that decision is annulled by the judgment in the main proceedings. The purpose of proceedings for interim relief is not to ensure compensation for damage already suffered. In addition, the applicants cannot reasonably claim, in order to establish that they have suffered serious and irreparable damage, that only suspension of the operation of the contested decision would allow damage to their reputation to be avoided. Annulment of the contested decision on conclusion of the main proceedings would provide sufficient reparation for the alleged non-material damage (see, to that effect, order of 24 March 2021, The Floow v Commission, T‑765/20 R, not published, EU:T:2021:167, paragraph 34 and the case-law cited).
47 In the third place, as regards the applicants’ claim that it is highly improbable that they would succeed in an action for damages in the event that the contested decision is annulled, it should be borne in mind, in that regard, that it has already been held 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 within the meaning of the case-law. At the interlocutory stage, the possibility of subsequently obtaining compensation for pecuniary damage if an action for damages is brought following annulment of the contested measure is necessarily uncertain. 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 (in this case an action for annulment), to which the interlocutory proceedings are an adjunct (see order of 28 November 2013, EMA v InterMune UK and Others, C‑390/13 P(R), EU:C:2013:795, paragraph 50 and the case-law cited).
48 In the fourth place, as regards the applicants’ argument that they face similar measures by the competent authorities of certain non-EU countries, meaning their medicinal products would thus no longer have access to the markets and could not be introduced again, it must be held that the applicants have not established that the suspension of operation of the contested decision, assuming that it is granted, would prevent the authorities of non-EU countries from adopting measures similar to the specific conditions laid down in the contested decision. As a result, they have not shown that suspension of operation of the contested decision would be such as to prevent the alleged harm caused, where relevant, on the market in non-EU countries (see, to that effect, order of 25 October 2021, Troy Chemical Company and Troy v Commission, T‑297/21 R, not published, EU:T:2021:733, paragraph 46 and the case-law cited).
49 In addition, it should be observed that the possible suspension of the marketing authorisations of the medicinal products at issue in certain third countries because those countries allegedly mirror EU rules cannot be taken into account in the assessment of the seriousness of the alleged harm, as such measures would be the direct consequence, not of the contested decision, but of a decision taken by the authorities of each third country in the exercise of their absolute discretion (see, to that effect, order of 11 July 2018, GE Healthcare v Commission, T‑783/17 R, EU:T:2018:503, paragraph 46 and the case-law cited).
50 It follows from all of the foregoing that the application for interim measures must be dismissed since the applicants have failed to prove that the condition relating to urgency is satisfied, without it being necessary to rule on whether there is a prima facie case or to carry out a weighing of interests.
51 Pursuant to Article 158(5) of the Rules of Procedure, the costs should 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, 18 October 2022.
E. Coulon | | M. van der Woude |