29 April 2025 (*)

( Appeal – Interim relief – Medicinal products for human use – Orphan medicinal product for human use Ocaliva – Revocation of a conditional marketing authorisation – Application for suspension of operation of a measure – No urgency )

In Case C‑859/24 P(R),

APPEAL under the second paragraph of Article 57 of the Statute of the Court of Justice of the European Union, brought on 12 December 2024,

Advanz Pharma Ltd,

established in Dublin (Ireland), represented initially by J. Bourgeois, avocat, and M. Meulenbelt, advocaat, and subsequently by B. Baum, Rechtsanwältin, O. Beghin, avocat, and M. Meulenbelt and A. Vermulst, advocaten,

appellant,

the other party to the proceedings being:

European Commission,

represented by R. Lindenthal, E. Mathieu and A. Spina, acting as Agents,

defendant at first instance,

THE VICE-PRESIDENT OF THE COURT,

after hearing the Advocate General, M. Szpunar,

makes the following

1By its appeal, Advanz Pharma Ltd seeks to have set aside the order of the President of the General Court of the European Union of 26 November 2024, Advanz Pharma v Commission (T‑455/24 R, EU:T:2024:863; ‘the order under appeal’), by which he dismissed its application for interim measures, seeking an immediate and temporary suspension of operation of Commission Implementing Decision C(2024) 6281 final of 30 August 2024 revoking, under Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council, the conditional marketing authorisation, granted by Implementing Decision C(2016) 8685 final, for Ocaliva, an orphan medicinal product for human use (‘the decision at issue’).

Legal context

2Directive 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), as amended by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 (OJ 2011 L 174, p. 74 and corrigendum OJ 2009 L 87, p. 174) (‘Directive 2001/83’), provides, in Article 5(1):

‘A Member State may, in accordance with legislation in force and to fulfil special needs, exclude from the provisions of this Directive medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised healthcare professional and for use by an individual patient under his direct personal responsibility.’

3Article 6(1) of that directive provides:

‘No medicinal product may be placed on the market of a Member State unless a marketing authorisation [(MA)] has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted 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)] …’

4In accordance with Article 77(1) to (3) of the directive:

‘1. Member States shall take all appropriate measures to ensure that the wholesale distribution of medicinal products is subject to the possession of an authorisation to engage in activity as a wholesaler in medicinal products, stating the premises located on their territory for which it is valid.

3. Possession of a manufacturing authorisation shall include authorisation to distribute by wholesale the medicinal products covered by that authorisation. Possession of an authorisation to engage in activity as a wholesaler in medicinal products shall not give dispensation from the obligation to possess a manufacturing authorisation and to comply with the conditions set out in that respect, even where the manufacturing or import business is secondary.’

5Point (c) of the first paragraph of Article 80 of that directive states:

‘Holders of the distribution authorisation must fulfil the following minimum requirements:

…

(c) they must supply medicinal products only to persons who are themselves in possession of the distribution authorisation or who are authorised or entitled to supply medicinal products to the public in the Member State concerned; …’

6Article 117(1)(b) of Directive 2001/83 provides:

‘… Member States shall take all appropriate steps to ensure that the supply of the medicinal product is prohibited and the medicinal product withdrawn from the market, if the view is taken that:

…

(b) it lacks therapeutic efficacy …’

Background to the dispute

7The background to the dispute is set out in paragraphs 2 to 9 of the order under appeal and may be summarised as follows for the purpose of the present proceedings.

8Advanz Pharma is a pharmaceutical company established in Ireland.

9Since 16 December 2022, the appellant has been the holder of the conditional MA for the orphan medicinal product Ocaliva – obeticholic acid (‘Ocaliva’), initially granted by Commission Implementing Decision C(2016) 8685 final of 12 December 2016 granting a conditional marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for ‘OCALIVA – obeticholic acid’, an orphan medicinal product for human use.

10Ocaliva, the active substance of which is obeticholic acid, is a medicinal product intended for the treatment of a liver disease, primary biliary cholangitis (PBC).

11On 12 October 2023, the European Commission initiated a review procedure, as provided for in Article 20 of Regulation No 726/2004 (‘the review procedure’), requesting the Committee for Medicinal Products for Human Use (‘the CHMP’) of the European Medicines Agency (EMA) to ‘give its opinion by June 2024 on whether the [MA] for Ocaliva should be maintained, varied, suspended or revoked’.

12While the review procedure was still ongoing, Advanz Pharma submitted an application on 21 May 2024 for renewal of the conditional MA for Ocaliva.

13Following the assessment conducted under the review procedure, the CHMP concluded, in its opinion of 27 June 2024, that Ocaliva lacked therapeutic efficacy and that the risk-benefit balance was not favourable. The CHMP was therefore of the opinion, by consensus, that the MA for Ocaliva should be revoked.

14By letter of 7 August 2024, the Commission informed Advanz Pharma that, in view of the developments in the review procedure, the procedure for the renewal of the conditional MA for Ocaliva had become devoid of object.

15On 30 August 2024, on the basis of the conclusions and recommendation of the CHMP set out in its opinion of 27 June 2024 during the review procedure, the Commission adopted the decision at issue, revoking the conditional MA for Ocaliva.

The proceedings before the General Court and the order under appeal

16By application lodged at the Registry of the General Court on 3 September 2024, Advanz Pharma brought an action for annulment of the decision at issue.

17By separate document, lodged at the Court Registry on the same day, Advanz Pharma brought an application for interim measures, in which it claimed, in essence, that the President of the General Court should order the immediate and temporary suspension of operation of the decision at issue until a final order in the interim proceedings and order the suspension of operation of the decision at issue until final judgment in the main proceedings.

18By order of 4 September 2024, Advanz Pharma v Commission (T‑455/24 R), the President of the General Court granted the application to order the immediate and temporary suspension of operation of the decision at issue.

19By the order under appeal, the President of the General Court cancelled the order of 4 September 2024, Advanz Pharma v Commission (T‑455/24 R) and dismissed the application for interim measures.

20To that end, the President of the General Court found in paragraph 73 of the order under appeal that Advanz Pharma had not established that the condition relating to urgency had been satisfied, such that the application for interim measures had to be dismissed, without it being necessary to rule on whether there was a prima facie case or to weigh up the interests involved.

21He found, in particular, in paragraphs 38 to 42 of the order under appeal that Advanz Pharma’s argument that wholesalers and pharmacies were, in principle, no longer allowed to distribute or dispense Ocaliva had to be rejected since the situation of distributors of Ocaliva and the need of patients to receive that medicinal product were not covered by Advanz Pharma’s personal interest.

22In paragraph 43 of the order under appeal, the President of the General Court held that the recall of the medicinal product by the authorities or its removal from the lists of reimbursed medicinal products were actions that were hypothetical and attributable to third parties, and would not constitute a necessary consequence of the decision at issue itself.

23In paragraphs 49 to 51 of the order under appeal, the President of the General Court found, inter alia, that it was not certain that competitors which could obtain MAs for medicinal products that could serve as alternatives to Ocaliva could capture the market share that Advanz Pharma feared losing as a result of the decision at issue. Moreover, according to the President of the General Court, that company had not explained the nature of the obstacles that would prevent it from recovering that market share if the decision at issue were annulled.

24In paragraphs 55 to 60 of the order under appeal, the President of the General Court concluded that Advanz Pharma had not established the seriousness of the harm which it feared that it would suffer. In particular, although it had provided an estimate of its losses in the overall turnover of the group to which it belongs, it had not provided any information on the composition of that group or on the economic and financial situation of its shareholders. In any event, according to the President of the General Court, it was for Advanz Pharma, if it was not to bear itself the loss resulting from the withdrawal of the conditional MA for Ocaliva, which was an eventuality that could arise further to scientific progress and evolving understanding, to protect itself against such an eventuality by adopting an appropriate policy.

25In paragraph 67 of the order under appeal, the President of the General Court observed, inter alia, as regards the applicant’s argument that the confidence of patients and medical professionals in Ocaliva risked being irreversibly affected, that, in the highly regulated sector of the EU’s pharmaceuticals market, the suspension of an MA for a product is an eventuality that may arise further to scientific progress and evolving understanding.

Forms of order sought

26Advanz Pharma claims that the Court of Justice should:

–order the immediate and temporary suspension of the order under appeal until a final order in the present appeal proceedings;

–set aside the order under appeal;

–order the immediate and temporary suspension of operation of the decision at issue;

–in the alternative, refer the case back to the President of the General Court, and

–reserve the decision on the costs at first instance and on appeal until final judgment by the General Court.

27The Commission contends that the Court of Justice should:

–dismiss the appeal, and

–order Advanz Pharma to pay the costs.

The application for immediate and temporary suspension of operation of the order under appeal

28In its appeal, Advanz Pharma seeks the immediate and temporary suspension of the order under appeal.

29Pursuant to Article 160(4) of the Rules of Procedure of the Court of Justice, read in conjunction with Article 190(1) thereof and with Articles 39 and 57 of the Statute of the Court of Justice of the European Union, an application for interim measures in the context of an appeal concerning interim measures must be made by a separate document.

30It follows that that application, since it was made in the appeal, is inadmissible (see, to that effect, order of 22 November 2018, Hércules Club de Fútbol v Commission, C‑334/18 P(R) and C‑334/18 P(R)-R, EU:C:2018:952, paragraph 23 and the case-law cited).

The appeal

31In support of its appeal, Advanz Pharma relies on three grounds of appeal.

32The first ground of appeal alleges, first, an error of law, in that the President of the General Court, in paragraphs 49 and 50 of the order under appeal, required that Advanz Pharma show a ‘certain’ loss of market share rather than a ‘foreseeably likely’ loss, and, second, an infringement of the obligation to state reasons, in that the President of the General Court failed to state reasons concerning the evidence provided by Advanz Pharma with a view to demonstrating the imminent loss of market share and the market barriers that would prevent Advanz Pharma from regaining the market share lost as a consequence of the decision at issue.

33The second ground of appeal alleges an error of law and a distortion of the evidence in that the President of the General Court concluded, in paragraph 39 of the order under appeal, that the impact of the decision at issue on Advanz Pharma’s own distribution network did not concern a personal interest.

34The third ground of appeal alleges an error of law and a distortion of the evidence in that the President of the General Court, in paragraph 43 of the order under appeal, concluded that a recall of Ocaliva, its removal from national reimbursement lists and the need to obtain national approvals in order to continue deliveries are ‘hypothetical’ and irrelevant since they are ‘attributable to third parties’.

The first ground of appeal

35The first ground of appeal concerns paragraphs 49 and 50 of the order under appeal and consists of two parts, the first part alleging an error of law and the second a failure to state reasons.

The first part

–Arguments

36According to Advanz Pharma, the President of the General Court, by requiring that it show a ‘certain’ loss of market share, rather than a ‘foreseeably likely’ loss of market share, and therefore by rejecting the argument that an expected loss of market share would result in a foreseeable likelihood of serious and irreparable harm, imposed a probatio diabolica and incorrectly departed from the case-law of the General Court and the Court of Justice according to which, first, where the harm is of a financial nature, urgency is established if market share is likely to be affected substantially, taking into account, inter alia, the size and turnover of the undertaking of the party concerned, the characteristics of the group to which it belongs and the relevant market characteristics. It refers in that regard to the 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).

37Second, according to the order of 10 November 2004, Wam v Commission (T‑316/04 R, EU:T:2004:333, paragraph 27), the imminence of the damage does not have to be demonstrated with absolute certainty, but the applicant must show that the occurrence of such serious and irreparable harm may be foreseen ‘with a sufficient degree of probability’, as stated in the order of 27 September 2023, Amazon Services Europe v Commission (T‑367/23 R, EU:T:2023:589, paragraph 41).

38In that regard, Advanz Pharma asserts that it provided not only detailed evidence showing that its current market share for second-line therapy for the treatment of PBC is between 46 and 76% in different Member States, but also evidence that two competing products, Iqirvo and Livdelzi, were in development and that they were likely to obtain an MA.

39It reiterates that given that the first of those products was awarded an MA – of which the President of the General Court was informed well before the order under appeal was made – and the likelihood of an MA for the second of those products, it is inevitable that Advanz Pharma will lose most or even all of its market share in the European Economic Area (EEA), since it is unimaginable that patients affected by PBC would be left with no medical treatment.

40Advanz Pharma submits in addition that it set out the structural barriers present in the market for treatments for progressive diseases that will prevent it from regaining its current market share if the decision at issue is ultimately annulled.

41According to Advanz Pharma, the President of the General Court, by finding that it had failed to explain the nature of the barriers that would prevent it from recovering any lost market share, ignored facts which are generally accepted in the scientific community, namely, in particular, that a chronically ill patient whose condition has stabilised should not be treated with a different medicinal product.

42The Commission contends that the first part of the first ground of appeal is ineffective and in any event unfounded.

–Assessment

43According to settled case-law, the purpose of the procedure for interim relief is to guarantee the full effectiveness of the future final decision, in order to ensure that there is no lacuna in the legal protection provided by the Court. It is for the purpose of attaining that objective that urgency must be assessed in the light of the need for an interlocutory order to avoid serious and irreparable damage to the party seeking the interim relief. It is for that party to prove that it cannot await the outcome of the main proceedings without suffering such damage (order of the Vice-President of the Court of 21 March 2025, Nuctech Warsaw Company Limited and InsTech Netherlands v Commission, C‑720/24 P(R), EU:C:2025:205, paragraph 30 and the case-law cited).

44While it is true that, in order to establish the existence of serious and irreparable damage, it is not necessary for the occurrence and imminence 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 party seeking interim measures is nevertheless required to prove the facts forming the basis of its claim that serious and irreparable damage is likely (order of the Vice-President of the Court of 24 May 2022, Puigdemont i Casamajó and Others v Parliament and Spain, C‑629/21 P(R), EU:C:2022:413, paragraph 75 and the case-law cited).

45Furthermore, the court hearing the application for interim relief must have concrete and precise indications, supported by detailed documents which demonstrate the situation of the party seeking the interim measures and enable the precise effects which would probably follow if the measures sought were not granted to be examined. That party is therefore required to provide, with supporting documentation, evidence and information allowing an accurate overall picture of its financial situation to be established (order of the Vice-President of the Court of 16 July 2021, Symrise v ECHA, C‑282/21 P(R), EU:C:2021:631, paragraph 41 and the case-law cited).

46Those requirements apply in particular where the damage alleged is damage of a financial nature which cannot, other 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 prevailed before he or she suffered the damage. Any such damage could be remedied by the applicant’s bringing an action for compensation on the basis of Articles 268 and 340 TFEU (order of the Vice-President of the Court of 16 July 2021, Symrise v ECHA, C‑282/21 P(R), EU:C:2021:631, paragraph 42 and the case-law cited).

47Accordingly, where the harm referred to is of a financial nature, the interim measures sought are justified where, in the absence of those measures, the applicant 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 the characteristics of the group to which it belongs (order of the Vice-President of the Court of 25 February 2025, Webgroup Czech Republic v Commission, C‑620/24 P(R), EU:C:2025:136, paragraph 17).

48In the present case, as regards, first, the irreparable nature of the alleged damage, it should be found that the assertion that the President of the General Court required, in paragraph 49 of the order under appeal, that the irreparable character of the damage be ‘certain’, is based on a misreading of that paragraph, which does not reflect the logical sequence of the considerations set out therein.

49In fact, the reference to the term ‘certain’ in paragraph 49 of the order under appeal is only after the statement on the possible entry on the market of competing medicinal products that may serve as alternatives to Ocaliva. Accordingly, that reference relates not to the degree of probability of the alleged irreversible loss of market share, as Advanz Pharma claims, but to the extent of the share of that loss that would actually be attributable solely to the decision at issue.

50Furthermore, paragraph 49 of the order under appeal must be read in the light of the information provided by Advanz Pharma on the state of its market share before the adoption of the decision at issue, referred to in paragraph 38 of the present judgment, from which it is apparent that competitors that could obtain MAs for medicinal products that could serve as alternatives to Ocaliva are capable of capturing market share which is not held by Advanz Pharma.

51Advanz Pharma is therefore wrong when it criticises the President of the General Court for having imposed a higher standard of proof than that required by settled case-law.

52It follows that the first complaint of the first part of the first ground of appeal is unfounded.

53As regards, second, the finding in paragraph 50 of the order under appeal that Advanz Pharma did not explain the nature of the obstacles that would prevent it from recovering lost market share if the decision at issue were annulled, it should be observed that Advanz Pharma does not formally allege distortion, the only situation in which the assessment of the facts and evidence constitutes a question of law which is subject, as such, to review by the Court of Justice in an appeal (see, to that effect, order of 5 February 2025, Dakem v Commission, C‑308/24 P, EU:C:2025:55, paragraph 30 and the case-law cited).

54Consequently, the complaint alleging that the President of the General Court ignored those obstacles, as described by Advanz Pharma in paragraph 53 of the application for interim measures, will be examined in the assessment of the second part of the first ground of appeal, alleging a failure to state reasons.

The second part

–Arguments

55According to Advanz Pharma, the assertion that it does not explain the nature of the obstacles that would prevent it from recovering lost market share if the General Court were to annul the decision at issue constitutes at least a failure to state reasons since it does not permit it to understand the reasoning followed by the President of the General Court or to allow the Court of Justice to exercise its power of review.

56Specifically, not only did the President of the General Court not take into account the grant of an MA for Iqirvo, but he also incorrectly stated that Advanz Pharma had not explained the nature of the obstacles that would prevent it from recovering any lost market share.

57According to the Commission, the second part of the first ground of appeal is unfounded.

–Assessment

58It should be noted, first, that, in the context of an appeal, the purpose of review by the Court of Justice is, inter alia, to ascertain whether the General Court addressed, to the requisite legal standard, all the arguments raised by the appellant and, secondly, that the plea alleging that the General Court failed to rule on arguments relied on at first instance amounts essentially to relying on a breach of the obligation to state reasons, which derives from Article 36 of the Statute of the Court of Justice of the European Union, applicable to the General Court by virtue of the first paragraph of Article 53 of that statute, and from Article 117 of the Rules of Procedure of the General Court (order of the Vice-President of the Court of Justice of 2 February 2024, Zentiva and Zentiva Pharma v Commission, C‑609/23 P(R), EU:C:2024:114, paragraph 28 and the case-law cited).

59According to settled case-law, the statement of the reasons on which an order of the President of the General Court is based must clearly and unequivocally disclose his or her thinking, so that the persons concerned can be apprised of the justification for the decision taken and the Court of Justice can exercise its power of review (order of the Vice-President of the Court of 25 February 2025, Webgroup Czech Republic v Commission, C‑620/24 P(R), EU:C:2025:136, paragraph 29).

60Furthermore, it can be seen from that case-law that the President of the General Court’s duty to state reasons does not require him or her to provide an account which follows exhaustively and one by one all the arguments put forward by the parties to the case, and that the President of the General Court’s reasoning may therefore be implicit, on condition that it enables the persons concerned to know why he or she has not upheld their arguments and provides the Court of Justice with sufficient material for it to exercise its power of review (order of the Vice-President of the Court of 25 February 2025, Webgroup Czech Republic v Commission, C‑620/24 P(R), EU:C:2025:136, paragraph 30).

61In the present case, it should first of all be observed that the question of whether the President of the General Court did in fact, in his examination of the application for interim measures, take account of the grant of an MA for Iqirvo, is no longer relevant since, as is apparent from paragraph 49 above, the entry of competing medicinal products on the market does not affect the probability of an irreversible loss of market share owing to the decision at issue, but only the extent of that loss.

62As regards, next, the description in paragraph 53 of the application for interim measures of the obstacles that would prevent Advanz Pharma from regaining lost market share if the General Court were to annul the decision at issue, it should be observed that the President of the General Court responded in detail, in paragraph 67 of the order under appeal, to the argument based on a loss of confidence in Ocaliva in the relevant circles due to the withdrawal of its MA.

63By contrast, the order under appeal does not rule specifically on the argument, made in the aforementioned paragraph 53 and accompanied by a reference to a scientific study, which states that, in the light of the main purpose of the treatment of PBC, which is to stabilise the slow, progressive illness, patients are unlikely to change treatment if their illness is considered to have been stabilised.

64It is true that the succinct presentation of that argument means that it is not possible to assess the extent to which the specific purpose of that treatment of PBC is capable of differentiating it from the treatment of other illnesses. However, such an assessment is necessary in order to prevent a situation where the difficulties caused by the switch from one medicinal product to another are, as a matter of principle, regarded as preventing a pharmaceutical company from regaining market share that is lost owing to the fact that it has had an MA withdrawn.

65That being the case, it must be held that the lack of any response to that argument in the order under appeal constitutes a failure to state reasons.

66Nevertheless, it should be observed that the findings set out in paragraphs 49 and 50 of the order under appeal relate only to the irreparable nature of the alleged damage, whereas the second of the two cumulative conditions justifying urgency, namely the seriousness of that damage, is dismissed in paragraphs 55 to 60 of that order, without Advanz Pharma having contested, in its appeal, the findings set out in those latter paragraphs.

67It follows that the second part of the first ground of appeal must be rejected as ineffective and that that ground of appeal must therefore be rejected in its entirety.

The second ground of appeal

Arguments

68Advanz Pharma submits that the President of the General Court distorted the evidence and erred in law by finding, in paragraph 39 of the order under appeal, that the situation of distributors of Ocaliva and the need of patients to receive that medicinal product are not covered by the applicant’s personal interest.

69The inability of wholesalers and pharmacies to sell Ocaliva obviously affects Advanz Pharma because it can no longer sell them that medical product since, pursuant to Article 80 of Directive 2001/83, the holders of an MA, even where they have a wholesale distribution network of their own, can sell medicinal products only to wholesalers or pharmacists and not directly to patients. Consequently, Advance Pharma’s arguments describing the inability of distributors to sell Ocaliva is obviously a reference to its own interests.

70According to the Commission, this ground of appeal is unfounded. First, Advanz Pharma does not point precisely to the evidence that was submitted to the General Court that was distorted. It merely refers in fact to its arguments made in the application for interim measures that were assessed by the President of the General Court and not to any evidence presented in that application.

71Second, even if there had been distortion of the evidence by the President of the General Court, it would have to be obvious distortion, which is not the case.

72Third, the President of the General Court was right to hold in paragraph 39 of the order under appeal that the situation of distributors of Ocaliva and the need for patients to receive that medicinal product do not concern Advanz Pharma’s personal interest.

Assessment

73According to settled case-law, the party seeking the grant of interim measures is required to provide proof that it cannot await the conclusion of the main action without personally suffering damage which would have serious and irreparable effects for it (order of the Vice-President of the Court of 2 February 2024, Zentiva and Zentiva Pharma v Commission, C‑609/23 P(R), EU:C:2024:114, paragraph 89 and the case-law cited).

74According to the President of the General Court, Advanz Pharma was therefore unable to rely, in order to establish urgency, on the fact that wholesalers and pharmacies are in principle no longer authorised to distribute or supply Ocaliva.

75Without it being necessary to examine Advanz Pharma’s complaint of distortion of the evidence, it should be observed that, according to its reading of Article 80(c) of Directive 2001/83, which is not disputed by the Commission, Advanz Pharma is authorised to supply medicinal products only to persons who are themselves in possession of a distribution authorisation or who are authorised or entitled to supply medicinal products to the public in the Member State concerned.

76In those circumstances, the fact that wholesalers and pharmacies are unable to sell Ocaliva, as pleaded by Advanz Pharma, cannot be understood as referring to any interests other than its own.

77The President of the General Court therefore erred in law in finding that Advanz Pharma was relying on an interest that was not personal to it.

78Nevertheless, it should be observed that the findings relating to Advanz Pharma’s interest, in paragraph 39 of the order under appeal, are part of the overall assessment of the consequences which, according to Advanz Pharma, the withdrawal of the MA for Ocaliva will have on that company, which was carried out by the President of the General Court despite the rejection of the argument examined in paragraph 39 in respect of both urgency and extreme urgency. In any case, the present ground of appeal does not call into question the President of the General Court’s assessment of the second of the cumulative conditions required to establish urgency, namely the seriousness of the alleged damage, as set out in paragraphs 55 to 60 of that order.

79It follows that the second ground of appeal must be rejected as ineffective.

The third ground of appeal

Arguments

80Advanz Pharma submits that the President of the General Court erred in law and distorted the evidence by finding in paragraph 43 of the order under appeal that a recall of Ocaliva, its removal from national lists of reimbursed medicinal products and the need to obtain national approvals to continue to supply that product are hypothetical and irrelevant since they are attributable to third parties.

81First, Advanz Pharma asserts that it demonstrated in its application for suspension of operation that recalls of Ocaliva were likely in view of the legal provisions requiring an MA in order to be able to distribute a medicinal product and obtain its inclusion on the lists of reimbursed medicinal products.

Second, it states that decisions to include a medicinal product on lists of reimbursed medicinal products require that the medicinal product concerned have a valid MA.

83Third, it argues that the need for decisions by Member States is not hypothetical but is laid down in Articles 5 and 117 of Directive 2001/83. Consequently, the President of the General Court erred in law.

84Fourth, the President of the General Court errs in asserting in paragraph 43 of the order under appeal that the recall of Ocaliva is ‘attributable to third parties’ and does not appear to be a consequence of the decision at issue, inasmuch as most of the situations recognised in the case-law as establishing urgency involve acts or omissions by third parties.

85The Commission replies that Advanz Pharma did not submit any evidence in its application for interim measures that Ocaliva itself had been subjected to recalls and was wrong to claim that the removal of Ocaliva from the lists of reimbursed medicinal products would occur by law.

–Assessment

86Under Article 117(1) of Directive 2001/83, Member States are to take all appropriate steps to ensure that the supply of a medicinal product is prohibited and the medicinal product is withdrawn from the market if, inter alia, it lacks therapeutic efficacy.

87In the present case, as is apparent from the CHMP opinion of 27 June 2024, the conditional MA for Ocaliva was withdrawn on the ground that it lacked therapeutic efficacy.

88In those circumstances, and despite the fact that Advanz Pharma was unable to specify a decision to withdraw Ocaliva from the market on the date of applying for interim measures, such a withdrawal cannot, without disregarding the wording of Article 117(1), be regarded as ‘hypothetical’.

89The same is true of the assertion in paragraph 43 of the order under appeal that the recall of Ocaliva is an action that is attributable to third parties, since decisions to prohibit and withdraw a product from the market cannot be taken by the holder of an MA itself.

90It follows, without there being any need to examine the complaint of distortion of the evidence, that the President of the General Court committed an error in law.

91As regards, by contrast, the approval or otherwise, by the competent national authorities, of personal supply under Article 5(1) of Directive 2001/83, it must be held that that provision merely gives those authorities an option. Since the optional nature of such supply has not been rebutted by Advanz Pharma in its application for interim measures, it must be held that there has been neither an error of law nor distortion in that latter respect.

92Although it is apparent from paragraphs 89 and 90 above that Advanz Pharma has, in its third ground of appeal, correctly identified an error of law in paragraph 43 of the order under appeal, that ground of appeal must nevertheless be rejected as ineffective for the same reasons as those set out in paragraphs 66 and 67 and 78 and 79 above, namely that, in the light of the statement of reasons for the order under appeal, the ground of appeal in question is not capable of leading to the order being set aside.

93Indeed, since the President of the General Court specifically rejected the arguments and evidence submitted in order to establish the seriousness of the alleged damage, the fact that Advanz Pharma has not contested the findings made to that end in paragraphs 55 to 60 of the order under appeal means that the third ground of appeal, which relates to the irreparable nature of the damage, is not capable of resulting in the order being set aside.

94It follows that the third ground of appeal must be rejected as ineffective.

95The appeal must therefore be dismissed in its entirety.

Costs

96In accordance with Article 184(2) of the Rules of Procedure of the Court of Justice, where the appeal is unfounded, the Court is to make a decision as to costs.

97Under Article 138(1) of the Rules of Procedure of the Court of Justice, which are applicable to the procedure on appeal by virtue of Article 184(1) thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.

98Since Advanz Pharma has been unsuccessful, it must be ordered to pay the costs, in accordance with the form of order sought by the Commission.

On those grounds, the Vice-President of the Court hereby orders:

1.The appeal is dismissed.

2.Advanz Pharma Ltd shall bear its own costs and pay those incurred by the European Commission.

Luxembourg, 29 April 2025.

Registrar

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Language of the case: English.