T-637/25

ORDER OF THE PRESIDENT OF THE GENERAL COURT 12 December 2025 (*) ( Interim relief – Medicinal products for human use – Marketing authorisation for MAVENCLAD - cladribine – Request for administrative assistance concerning the scope and extent of the marketing authorisation – Application for suspension of operation of a measure – No urgency ) In Case T‑637/25 R, Merck Europe BV, established in Amsterdam (Netherlands), represented by P. Bogaert and Z. Bertrand, lawyers, applicant, v European Commission, represented by E. Mathieu and A. Spina, acting as Agents, defendant, THE PRESIDENT OF THE GENERAL COURT makes the following Order 1        By its application under Articles 278 and 279 TFEU, the applicant, Merck Europe BV, seeks suspension of the operation of the letter sent by the European Commission to the Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices, Germany; ‘the BfArM’) on 11 July 2025 headed ‘Request for administrative assistance concerning the scope and extent of the marketing authorisation for MAVENCLAD (Cladribine)’ (‘the contested measure’).  Background to the dispute and forms of order sought by the parties 2        The applicant is a subsidiary of the Merck KGaA group. 3        On 22 August 2017, the Commission adopted Implementing Decision C(2017) 5888 final granting the applicant authorisation to place MAVENCLAD – cladribine (‘Mavenclad’), a medicinal product for human use, on the Union market, in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1) (‘the marketing authorisation’). 4        Mavenclad is a medicinal product indicated for the treatment of adults with highly active relapsing multiple sclerosis (MS), as defined by clinical or imaging features. 5        MS is a chronic, inflammatory and demyelinating disease of the central nervous system that can result in neurological impairment and severe disability. 6        On 5 April 2022, the applicant notified the BfArM of a study which it classified as a non-interventional study, that is to say, a clinical study other than a clinical trial, within the meaning of Article 2(2)(4) of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use and repealing Directive 2001/20/EC (OJ 2014 L 158, p. 1), aimed at observing patients who had been treated with Mavenclad after completion of the first four-year treatment cycle (‘the CLIP-5 study’). 7        On 5 August 2022, following an exchange between the Clinical Trials department of the BfArM and the applicant, which included a submission of educational materials approved by the BfArM, the CLIP-5 study was classified by the BfArM as non-interventional. 8        On 22 November 2023, the applicant submitted an application to vary the terms of the marketing authorisation, in which it requested, inter alia, the addition of the following wording in section 4.2 of the summary of product characteristics: ‘following completion of the first 4-year treatment period, treatment may be continued in year 5 or later at the discretion of the treating physician’. 9        On 1 February 2024, in the course of the assessment procedure for the requested amendment, the Rapporteur of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) raised an objection to the proposed addition to section 4.2 of the summary of product characteristics. 10      Based on that preliminary scientific assessment by the Rapporteur of EMA’s CHMP, the applicant withdrew its application to amend section 4.2 of the summary of product characteristics. 11      On 17 March 2025, the BfArM sent the Commission a request for administrative assistance, explaining that it had to take a decision as to whether a ‘research project’ required authorisation as a ‘clinical trial’ within the meaning of Article 2(2)(2) of Regulation No 536/2014 and asked the Commission to clarify whether the continuation of treatment with the medicinal product Mavenclad by repeated administration from the fifth year onward was covered by the marketing authorisation. 12      On 11 July 2025, after consulting EMA, the Commission sent the contested measure to the BfArM, confirming that, in accordance with the summary of product characteristics, the use of Mavenclad beyond year four after the initial treatment is not covered by the terms of the marketing authorisation. 13      By application lodged at the Registry of the General Court on 21 September 2025, the applicant brought an action for the annulment of the contested measure. 14      By separate document lodged at the Court Registry on the same day, the applicant lodged the present application for interim measures, in which it claims that the President of the General Court should: –        suspend the operation of the contested measure until a final judgment is reached in the main proceedings; –        order the Commission to pay the costs. 15      In its observations on the application for interim measures, which were lodged at the Court Registry on 6 October 2025, 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  General considerations 16      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 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 a measure 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). 17      The first sentence of Article 156(4) of the Rules of Procedure provides that applications for interim measures must ‘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 measures applied for’. 18      Accordingly, the judge hearing an application for interim relief may order suspension of operation of a measure, or 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 party seeking interim relief, 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. Where appropriate, the judge hearing an application for interim relief must also weigh 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). 19      In the context of that overall examination, the judge 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). 20      Thus, it is not excluded that the judge hearing an application for interim measures may, where he considers it appropriate to do so, take into consideration the relative strength of the pleas in law relied on in order to establish a prima facie case when assessing urgency and, where appropriate, when weighing up the interests involved (see order of 7 March 2013, EDF v Commission, C‑551/12 P(R), EU:C:2013:157, paragraph 23 and the case-law cited). 21      However, while the relative strength of the prima facie case is not without influence on the assessment of urgency, it remains true that, in accordance with Article 156(4) of the Rules of Procedure of the General Court, two distinct conditions govern the obtaining of a suspension of operation of measures, and accordingly the applicant remains bound also to demonstrate the imminent threat of serious and irreparable harm (see orders of 31 January 2011, Commission v Éditions Odile Jacob, C‑404/10 P-R, not published, EU:C:2011:37, paragraph 27, and of 19 July 2012, Akhras v Council, C‑110/12 P(R), not published, EU:C:2012:507, paragraph 26). 22      Having regard to the material in the case file, the President of the General Court 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. 23      In order to assess whether the cumulative conditions necessary for the grant of interim measures are satisfied in the present case and without it being necessary to rule on the admissibility of the present application for interim measures, it is appropriate to begin by examining whether the condition relating to urgency is satisfied.  The condition relating to urgency 24      In order to determine whether the interim measures sought are urgent, it should be recalled 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. For the purpose of attaining that objective, urgency must generally be assessed in the light of the need for an interlocutory order so as to avoid serious and irreparable damage to the party seeking the interim relief. 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). 25      Moreover, according to the second sentence of Article 156(4) of the Rules of Procedure, an application for interim measures ‘shall contain all the evidence and offers of evidence available to justify the grant of interim measures’. 26      It is in the light of those criteria that it is necessary to examine whether the applicant has succeeded in demonstrating urgency. 27      In the present case, in the first place, the applicant submits that the contested measure is manifestly unlawful, with the result that interim measures should be granted without it being necessary to examine the condition relating to urgency. The applicant also claims that, in any event, the contested measure is vitiated by a particularly serious illegality and the seriousness of that illegality should be taken into account when examining the condition relating to urgency. 28      In the second place, the applicant argues that the contested measure is directly relevant to the conduct of the CLIP-5 study. In that context, the applicant claims that the CLIP-5 study was classified as non-interventional, referring to the BfArM’s opinion that the treatment of patients beyond year four was covered by the terms of the marketing authorisation. 29      In particular, to demonstrate the serious and irreparable nature of the harm, the applicant submits that the contested measure risks resulting in a situation where the CLIP-5 study cannot be continued and completed as planned because of non-compliance with the requirements set out in Regulation No 536/2014, specifically the lack of authorisation as a clinical trial. If the study is suspended even temporarily, it will not be possible to continue monitoring the already treated patients in accordance with the CLIP-5 study protocol, and the study will therefore lose its reliability. 30      Thus, the applicant submits that it is reasonably foreseeable that that will result in the loss of crucial information regarding the safety and effectiveness of the re-initiation of Mavenclad therapy after year four as well as clinical considerations influencing the decision to continue treatment during year five. First, the discontinuance or even temporary suspension of the CLIP-5 study would result in an irretrievable loss of data, since any new study would necessarily recruit different patients and would be undertaken against the background of a different treatment environment. Second, it would not be possible to repair the damage suffered through financial compensation. If the CLIP-5 study is stopped or seriously jeopardised before its full completion, it will not be able to prove what value the data would have had in case of proper completion of the study. A claim for financial compensation would unavoidably remain hypothetical. 31      In the third place, the applicant claims that the contested measure causes immediate and irreparable reputational harm. 32      According to the applicant, the reputation of a marketing authorisation holder is inseparably linked to trust in the regulatory environment. In the pharmaceutical sector, credibility with regulators, reimbursement authorities and prescribing health professionals is fundamental for market access. Unlike companies operating in consumer-facing industries, marketing authorisation holders of a prescription-only medicinal product build their reputation with patients on regulatory compliance rather than on advertising. Their credibility depends on full compliance with the terms of that authorisation and the associated requirements of EU pharmaceutical legislation. 33      However, according to the applicant, the contested measure, in practice, presents the applicant as being non-compliant with the terms of the marketing authorisation and the provisions of EU legislation on non-interventional studies. 34      In addition, the applicant states that the contested measure fails to record that the BfArM had both endorsed educational materials for health professionals allowing the use of Mavenclad beyond year four and authorised the conduct of the CLIP-5 study as a non-interventional study, namely, as a study relating to a patient population that comes under the terms of the marketing authorisation. According to the applicant, the Commission’s failure to refer to those two facts in the contested measure worsens the harm to its reputation, as it paints the applicant as an operator that has failed to engage with the competent national authority, in particular for the purposes of the conduct of the non-interventional study. 35      The Commission disputes the applicant’s arguments. 36      In that regard, in the first place, it follows from the Court’s case-law that the relative strength of the prima facie case is not without influence on the assessment of urgency. The urgency that may be pleaded by an applicant must thus be taken into consideration by the judge hearing the application for interim measures all the more if the prima facie case raised by the pleas and arguments relied on appears particularly serious (see order of 12 October 2022, Juvin v Parliament, C‑544/22 P(R), not published, EU:C:2022:798, paragraph 68 and the case-law cited). 37      The fact remains that, as mentioned in paragraph 21 above, in accordance with Article 156(4) of the Rules of Procedure, the conditions relating to a prima facie case and to urgency are distinct and cumulative, so that the party seeking interim measures still needs to prove the imminence of serious and irreparable damage (see order of 12 October 2022, Juvin v Parliament, C‑544/22 P(R), not published, EU:C:2022:798, paragraph 69 and the case-law cited). 38      Nevertheless, where a decision appears, having regard to the nature of the complaints made against it, to lack even the appearance of legality, the judge hearing the application for interim measures must suspend its operation forthwith, without the need for the party seeking interim protection to show that that protection must be granted to that party in order to avoid the occurrence of serious and irreparable damage (see order of 12 October 2022, Juvin v Parliament, C‑544/22 P(R), not published, EU:C:2022:798, paragraph 70 and the case-law cited). 39      It follows from that case-law that only exceptionally serious illegality may warrant an order for suspension of operation of a decision without the risk of the occurrence of serious and irreparable damage being established, and that it is therefore not sufficient in that regard to show a particularly strong prime facie case (see order of 12 October 2022, Juvin v Parliament, C‑544/22 P(R), not published, EU:C:2022:798, paragraph 71 and the case-law cited). 40      According to well-established case-law, the possible infringement of a rule of law by a measure cannot, in principle, suffice, in itself, to establish the seriousness and irreparable nature of any damage caused by that infringement. Consequently, it is not sufficient for the party seeking interim measures to plead a manifest infringement of rules of law in order to prove that the conditions relating to urgency, namely the serious and irreparable nature of the harm which might result from that infringement, are satisfied, since that party is required to prove the facts forming the basis of its claim that serious and irreparable damage is likely (see, to that effect, order of 30 September 2011, Gollnisch v Parliament, T‑346/11 R, not published, EU:T:2011:553, paragraph 18 and the case-law cited). 41      In the present case, the documents before the Court do not, prima facie, indicate that the illegality alleged is manifest. 42      As regards the first of the two pleas relied on by the applicant as demonstrating sufficiently manifest infringements of EU law, namely the plea alleging a lack of legal basis for the contested measure, which, in the applicant’s view, constitutes a restriction of the terms of the marketing authorisation, it should be noted that, prima facie, an initial examination of the contested measure, in the light of its heading, structure and content, shows that that measure is a reply from a Head of Unit of the Commission to a request from the competent German authority concerning the interpretation of the marketing authorisation. The heading of the contested measure explicitly states that it is a response to a request for ‘administrative assistance’. Moreover, pursuant to the principle of sincere cooperation enshrined in the Treaties, the Commission was required, pursuant to Article 4(3) TEU, to reply to a request for assistance made by the competent authority of a Member State. Since the contested measure is not one capable of amending or restricting the terms of the marketing authorisation, it is intended solely to respond to a request for administrative assistance from the German competent authority and merely supplies the clarification requested as to whether the use of Mavenclad beyond the four-year treatment cycle should be considered as already covered by the terms of the summary of product characteristics. 43      The terms of a marketing authorisation for a medicinal product cannot be altered by way of letter. A Union marketing authorisation granted under Regulation No 726/2004 may be varied or restricted only by means of legal acts adopted following a procedure for variation, in accordance with that regulation and Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products (OJ 2008 L 334, p. 7). 44      Furthermore, the applicant itself appears to be of that view, in so far as it submitted, on 22 November 2023, an application to vary the marketing authorisation. 45      As regards the second plea relied on by the applicant as demonstrating a sufficiently manifest infringement of EU law, alleging infringement of the right to be heard, it must be held that the contested measure is not addressed to the applicant, but forms part of correspondence between administrative authorities. It does not appear, prima facie, that the Commission was required to include the applicant in correspondence of that nature. 46      Similarly, as regards the applicant’s claim that the Commission should have informed it that an ‘administrative procedure’ was underway, it should be noted that, prima facie, the request submitted by the competent German authority related to ‘administrative assistance’ and that the rights conferred by Article 41 of the Charter of Fundamental Rights of the European Union do not appear, prima facie, to impose on the EU institutions an obligation to inform third parties of their exchanges with the competent authorities of the Member States under the principle of sincere cooperation. 47      Accordingly, even if the adoption of the contested measure did constitute an illegality, it must be held that such an illegality would not be of such an exceptional nature and seriousness as to demonstrate that the condition relating to urgency is satisfied in the present case. 48      It follows that the applicant’s argument cannot succeed. 49      In the second place, as regards the applicant’s argument that the contested measure risks resulting in a situation where the CLIP-5 study cannot be continued and completed as planned because of non-compliance with the requirements set out in Regulation No 536/2014, specifically the lack of authorisation as a clinical trial, which, in the applicant’s view, would result in an irretrievable loss of data and financial loss which cannot be compensated, it must be stated that, in accordance with well-established case-law, there is urgency only if the serious and irreparable harm feared by the party seeking 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 damage is likely, it being clear that purely hypothetical damage, based on future and uncertain events, cannot justify the grant of interim measures (see order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 24 and the case-law cited). 50      In circumstances such as those of the present case, under Article 5 of Regulation No 536/2014, applications for clinical trials are to be submitted to the competent authorities of the Member States. In addition, under the first paragraph of Article 4 of Regulation No 536/2014, the obligation to submit an application for authorisation arises only where the proposed study may be considered a clinical trial within the meaning of Article 2(2)(2) of that regulation, whereas non-interventional studies are merely notified to the national competent authority. According to Article 2(2)(4) of Regulation No 536/2014, a ‘non-interventional study’ means ‘a clinical study other than a clinical trial’. In the light of those provisions and where none of the conditions laid down in Article 2(2)(2) of Regulation No 536/2014 is satisfied, a study may be considered a non-interventional study and therefore falls outside the scope of that regulation. 51      Thus, as the Commission submits, the fact that, in the context of a clinical study, a medicinal product is being used in accordance with the terms or outside the terms of the marketing authorisation is not sufficient to establish whether a study is a ‘clinical trial’ or a ‘non-interventional study’. As can be seen from the definition of clinical trial in Article 2(2)(2) of Regulation No 536/2014, the mere fact that a study concerns the use of a medicinal product without marketing authorisation does not, in itself, trigger the application of that regulation. 52      It follows from the foregoing that responsibility for any decision concerning the conduct of a clinical study remains with the responsible competent authority of the Member State, and cannot depend on the content of a letter sent by the Commission to that authority clarifying the scope of a marketing authorisation. 53      Consequently, the contested measure cannot be considered capable of causing the serious and irreparable harm alleged. 54      That conclusion cannot be called into question by the position expressed by the BfArM in its request for administrative assistance of 17 March 2025, according to which it is crucial to determine whether the continuation of treatment with the medicinal product Mavenclad by repeated administration from the fifth year onward was covered by the marketing authorisation. 55      The interpretation provided in the contested measure is only one factor, among others, which the BfArM may take into consideration when adopting its decision on the conduct of a clinical study, and that factor in no way detracts from that national authority’s own responsibility. It is therefore clear that the BfArM’s decision will be attributable to that authority itself and will not derive from the contested measure. 56      As regards the applicant’s argument that the discontinuance or even temporary suspension of the CLIP-5 study would result in an irretrievable loss of data, it should be observed that, for the reason set out in paragraph 55, that possible loss of data could not be attributable to the contested measure. 57      Lastly, as regards the applicant’s argument that it would be unable to obtain financial compensation in the event of a loss of data on the ground that it would not be able to prove the resulting financial loss, it must be held, even if that loss could be attributable to the contested measure, that the applicant has not identified or explained the financial loss which it might suffer if the CLIP-5 study were discontinued. 58      In those circumstances, it must be concluded that the applicant has not succeeded in demonstrating that the condition relating to urgency was satisfied on the basis of the purely financial damage relied on. 59      In the third place, first of all, as regards the applicant’s argument that the contested measure causes immediate and irreparable harm to its reputation, in so far as that measure presents the applicant as being non-compliant with the terms of the marketing authorisation and the provisions of the EU legislation on non-interventional studies, it should be pointed out that that measure was sent to the BfArM following a request for clarification concerning the terms and conditions of the marketing authorisation, as provided for in the authorisation decision. That measure was not addressed to healthcare professionals or to patients. 60      Consequently, it must be concluded that a letter responding to a request from a competent national authority is not capable of having the effect of harming the reputation of a manufacturer of medicinal products with patients as regards regulatory compliance. 61      Next, as regards the applicant’s argument that, when the contested measure is implemented by the BfArM and other competent national authorities across the European Union, the harm to its reputation will start materialising, it must be stated that the applicant’s claim merely rests on hypothetical and lapidary statements. 62      Lastly, as regards the applicant’s argument that the omission of certain facts from the contested measure worsens the harm to its reputation, as it paints the applicant as an operator that has failed to engage with the competent national authority, in particular for the purposes of the conduct of the non-interventional study, it should be noted, as the Commission has done, that those factual and contextual elements have no bearing on and do not alter the non-binding nature of the contested measure. Furthermore, it should be emphasised that those factors did not play a decisive role in the sending of the contested measure, unlike the facts at issue in the case which gave rise to the judicial decision cited by the applicant in that regard. 63      It follows from all of the foregoing that the application for interim measures must be dismissed as the applicant has failed to establish urgency, without it being necessary to rule on whether there is a prima facie case or to weigh up the interests involved. 64      In accordance with Article 158(5) of the Rules of Procedure, the costs are to 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, 12 December 2025. V. Di Bucci   M. van der Woude Registrar   President *      Language of the case: English.