26 November 2024 (*)

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

In Case T‑455/24 R,

Advanz Pharma Ltd, established in Dublin (Ireland), represented by J. Bourgeois and M. Meulenbelt, lawyers,

applicant,

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

defendant,

having regard to the order of 4 September 2024, Advanz Pharma v Commission (T‑455/24 R, not published),

makes the following

By its application under Articles 278 and 279 TFEU, the applicant, Advanz Pharma Ltd, seeks suspension of the 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 – obeticholic acid’, an orphan medicinal product for human use (‘the contested decision’).

Background to the dispute and forms of order sought by the parties

The applicant is a pharmaceutical company established in Ireland.

Since 16 December 2022, the applicant has been the holder of the conditional marketing authorisation 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.

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

On 12 October 2023, the European Commission initiated the review procedure provided for in Article 20 of 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), 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 marketing authorisation for Ocaliva should be maintained, varied, suspended or revoked’.

While the review procedure was still ongoing, on 21 May 2024 the applicant submitted an application for renewal of the conditional marketing authorisation for Ocaliva pursuant to Article 6(2) of Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation No 726/2004 (OJ 2006 L 92, p. 6).

Following 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. Therefore, the CHMP was of the opinion, by consensus, that the marketing authorisation for Ocaliva should be revoked.

By letter of 7 August 2024, the Commission informed the applicant that, in view of the developments in the review procedure, the procedure for the renewal of the conditional marketing authorisation for Ocaliva had become devoid of object.

On 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 contested decision, revoking the conditional marketing authorisation for Ocaliva.

By application lodged at the Court Registry on 3 September 2024, the applicant brought an action for annulment of the contested decision.

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

–order the immediate and temporary suspension of operation of the contested decision until a final order in the interim proceedings;

–order the suspension of operation of the contested decision until final judgment is reached in the main proceedings;

–reserve the costs pending the outcome of the main proceedings.

In its observations on the application for interim measures, lodged at the Court Registry on 18 September 2024, the Commission contends that the President of the General Court should:

–set aside the order of 4 September 2024, Advanz Pharma v Commission (T‑455/24 R, not published);

–dismiss the application for interim measures;

–order the applicant to pay the costs.

On 20 September 2024, the applicant lodged its observations on the Commission’s observations.

On 27 September 2024, the Commission lodged a letter concerning the applicant’s observations on the Commission’s observations.

Law

General considerations

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).

The first sentence of Article 156(4) of the Rules of Procedure provides that applications for interim relief 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 measure applied for’.

The judge hearing an application for interim measures may order the 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 damage 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 measures 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).

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 specific circumstances of the case, the manner and order in which those various conditions are to be examined, there being no rule of law imposing a pre-established scheme of analysis within which the need to order interim measures must be assessed (see order of 19 July 2012, Akhras v Council, C‑110/12 P(R), not published, EU:C:2012:507, paragraph 23 and the case-law cited).

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.

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

The condition relating to urgency

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 of an interlocutory order to avoid serious and irreparable damage to the party requesting the interim protection. 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).

Furthermore, in accordance with the second sentence of Article 156(4) of the Rules of Procedure, applications for interim relief are to ‘contain all the evidence and offers of evidence available to justify the grant of interim measures’.

It is in the light of those criteria that it must be examined whether the applicant has succeeded in demonstrating urgency.

In the present case, in the first place, the applicant alleges that there are circumstances giving rise to extreme urgency.

In that regard, first, the applicant asserts that, as a result of the revocation of the conditional marketing authorisation, wholesalers and pharmacies are, in principle, no longer allowed to distribute or dispense Ocaliva.

Second, the applicant submits [confidential]. (1)

Third, the applicant submits [confidential].

Fourth, the applicant claims that the Commission did not respond to its request of 30 August 2024 for a voluntary suspension of the contested decision.

In the second place, the applicant relies on six specific circumstances giving rise to urgency.

In that context, first, the applicant states that the effects of the contested decision are irreversible and that that is due to the Commission’s decision to superimpose the review procedure upon the renewal procedure. It refers in particular to the Commission’s position that the revocation of the conditional marketing authorisation for Ocaliva rendered the renewal procedure ‘devoid of object’.

Second, the applicant claims that it will irreversibly lose its market share if it has to await the outcome of the main proceedings, since two rival medicinal products for the second-line treatment of primary biliary cholangitis are in development and could obtain market authorisation and capture the entirety of the market before the Court has had the opportunity to rule in the main proceedings.

Third, the applicant estimates [confidential].

Fourth, the applicant submits [confidential].

Fifth, the applicant claims that if the contested decision is not suspended and Ocaliva remains off the market until the judgment on the merits, the confidence of patients and medical professionals in Ocaliva risks being irreversibly affected.

Sixth, the applicant claims that it was deprived of essential procedural guarantees during the procedure leading to the adoption of the contested decision. According to the applicant, there exist serious doubts as to the impartiality of the expert review and the European Medicines Agency failed to take into account all the evidence submitted to it.

Furthermore, the applicant submits that the procedure concerning the contested decision was not initiated in response to new safety concerns but due to the inconclusive outcome of one analysis carried out in one clinical study.

The Commission disputes the applicant’s arguments.

In that regard, in the first place, as regards the circumstances giving rise to extreme urgency, first, the applicant asserts that wholesalers and pharmacies are, in principle, no longer allowed to distribute or dispense Ocaliva.

That argument must be rejected in so far as 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 and cannot therefore justify urgency, let alone extreme urgency.

According to settled case-law, the party seeking interim measures may not, in order to establish urgency, rely on damage caused to the rights of third parties or to the general interest (see order of 26 September 2017, António Conde & Companhia v Commission, T‑443/17 R, not published, EU:T:2017:671, paragraph 35 and the case-law cited).

According to settled case-law, in order to prove that the condition relating to urgency is satisfied, an applicant is required to show that suspension of the operation of a measure or other interim measures sought are necessary in order to protect its own interests. However, in order to establish urgency, an applicant cannot plead damage to an interest which is not personal to it, such as damage to a general interest or to the rights of third parties, be they individuals or a State. Such interests may be taken into consideration only when the Court comes to weigh up the interests at stake (see order of 10 November 2004, Wam v Commission, T‑316/04 R, EU:T:2004:333, paragraph 28 and the case-law cited).

Thus, that party must show that the damage alleged is likely to entail – for itself – serious and irreparable personal damage (see order of 25 October 2018, Antonakopoulos v Parliament, T‑590/18 R, not published, EU:T:2018:727, paragraph 17 and the case-law cited).

Second, as regards the argument that the competent national authorities could require a recall of the medicinal product or take a decision in order to ensure the supply of Ocaliva to patients, such actions are hypothetical and would be attributable to third parties, but do not appear to be a necessary consequence of the contested decision itself. The same is true of the applicant’s argument that Ocaliva will be removed as a matter of law from the various lists of reimbursed medicinal products and, if the contested decision is annulled, it will have to initiate fresh reimbursement negotiations in each Member State concerned.

Moreover, it must be stated, as noted by the Commission, that the applicant does not explain what serious and irreparable damage the removal of Ocaliva from the list of reimbursed medicinal products would entail specifically for it. However, even assuming that the competent authorities remove Ocaliva from their respective lists and that that removal is considered to be serious damage to the applicant, it would not in any event be irreparable, since the applicant does not substantiate its claim that, if the contested decision is annulled, it would be impossible or excessively difficult for it to have Ocaliva reinstated on the list of reimbursed medicinal products.

Third, as regards the applicant’s argument that [confidential], that argument will be assessed in paragraphs 65 and 66 below, in connection with the specific circumstances on which the applicant relies in order to demonstrate urgency. That argument is identical to the one concerning urgency and there is no additional evidence to support it in connection with extreme urgency.

Fourth, as regards the applicant’s argument that the Commission did not respond to its request of 30 August 2024 for a voluntary suspension of the contested decision, it must be observed that the Commission had no reason to suspend or interest in suspending the contested decision immediately after adopting it, since it deemed it to be lawful and justified.

In the second place, as regards the specific circumstances giving rise to urgency, first, the applicant states that the effects of the contested decision are irreversible, since the Commission decided to superimpose the review procedure upon the renewal procedure.

48In that regard, it must be acknowledged, as the Commission acknowledged, that the contested decision has an effect on the renewal procedure, since that procedure became devoid of object as soon as the contested decision revoked the conditional marketing authorisation for Ocaliva on completion of the review procedure. However, contrary to the applicant’s claims, any subsequent annulment of the contested decision would not be deprived of any effectiveness. If the contested decision is annulled, it will be necessary for the Commission to place itself on the date on which the illegality found by the Court occurred. The conditional marketing authorisation could therefore become valid again until the adoption by the Commission of a decision under the renewal procedure.

49Second, as regards the alleged damage caused by the irreversible loss of market share, it must be stated that that loss would be due, at least in part, to the possible entry of two new competitors who would obtain marketing authorisations for medicinal products that could serve as alternatives to Ocaliva. However, it is not certain that those competitors will be able to capture the market share that the applicant fears it will lose as a result of the contested decision.

50Moreover, the applicant does not explain the nature of the obstacles that would prevent it from recovering that market share if the Court were to annul the contested decision.

51It is apparent from the case-law of the Court of Justice that, where the party applying for interim relief claims loss of its market share, it must demonstrate that obstacles of a structural or legal nature prevent it from regaining a significant proportion of that market share (order of 24 March 2009, Cheminova and Others v Commission, C‑60/08 P(R), not published, EU:C:2009:181, paragraph 64).

52Third, as regards the applicant’s argument that its financial situation is imperilled due to a likely serious and irreversible loss of turnover, it is settled case-law that the interim measure sought will be justified only if it appears that, without such a measure, the party seeking it would be in a position that could imperil its existence before the final decision in the main action (see order of 21 January 2019, Agrochem-Maks v Commission, T‑574/18 R, EU:T:2019:25, paragraph 33 and the case-law cited).

53In that regard, it is settled case-law that the assessment of the serious nature of such damage is carried out in the light of, inter alia, the size and turnover of the undertaking and the characteristics of the group to which it belongs (see order of 21 January 2019, Agrochem-Maks v Commission, T‑574/18 R, EU:T:2019:25, paragraph 34 and the case-law cited).

54Moreover, it must be recalled that, also according to settled case-law, it has been found that, on the one hand, with regard to a loss corresponding to less than 10% of turnover of undertakings active in highly regulated markets, the financial difficulties which those undertakings risked suffering did not appear to be such as to threaten their very existence, and, on the other, regarding a loss representing almost two thirds of the turnover of those undertakings, while acknowledging that the financial difficulties they underwent could have been such as to threaten their very existence, it has nevertheless been underlined that, in a highly regulated sector where major investment is often required and the competent authorities may be led to intervene when public health risks become apparent, for reasons which cannot always be foreseen by the undertakings concerned, it was for those undertakings, if they were not to bear themselves the loss resulting from such intervention, to protect themselves against its consequences by adopting an appropriate policy (see order of 21 January 2019, Agrochem-Maks v Commission, T‑574/18 R, EU:T:2019:25, paragraph 35 and the case-law cited).

55In the present case, the applicant estimates [confidential].

56First of all, it must be held that the applicant does not establish that it is in a position that would imperil its financial viability before final judgment is given in the main action, in the light of its size, its turnover and the characteristics of the group to which it belongs.

57It merely states that the impact of losing Ocaliva is significant to the applicant’s business because of its impact on future cash flows.

58Next, although the applicant estimates its losses at [confidential] of the overall turnover of the group to which it belongs, it does not provide any information on the composition of that group or on the economic and financial situation of its shareholders.

59Last, even assuming that the applicant has established, to the requisite legal standard, a loss of [confidential] of the turnover of the group to which it belongs, it should be borne in mind that, according to the case-law referred to in paragraph 54 above, for undertakings active on a highly regulated market, regarding a loss representing almost two thirds of the turnover of those undertakings, while acknowledging that the financial difficulties they underwent could have been such as to threaten their very existence, in a highly regulated sector where major investment is often required and the competent authorities may be led to intervene when public health risks become apparent, for reasons which cannot always be foreseen by the undertakings concerned, it was for those undertakings, if they were not to bear themselves the loss resulting from such intervention, to protect themselves against its consequences by adopting an appropriate policy.

60It should be noted that in the highly regulated sector of the EU’s pharmaceuticals market, the revocation of a conditional marketing authorisation is an eventuality that may arise further to scientific progress and evolving understanding (see, to that effect, order of 11 July 2018, GE Healthcare v Commission, T‑783/17 R, EU:T:2018:503, paragraph 62 (not published)).

61The applicant submits that the case-law referred to in paragraph 54 above cannot reasonably be relied on against it. It justifies that claim by alleging that it was deprived of essential procedural guarantees during the procedure provided for in Article 20 of Regulation No 726/2004 and by stating that that case-law applies only where a regulatory measure is adopted when public health risks become apparent, which is not the case here, since the contested decision was taken only because of an alleged lack of therapeutic efficacy.

62In that regard, it should be pointed out, first of all, that the claim that the applicant was deprived of essential procedural guarantees falls within the scope of the condition relating to a prima facie case and appears to be irrelevant to the assessment of the condition relating to urgency.

63Next, it should be borne in mind that the marketing authorisation for Ocaliva is conditional and, therefore, temporary in nature. The applicant was aware of the conditions for maintaining that authorisation, inter alia those relating to the two studies that it had to provide.

64Last, as the Commission confirms, the contested decision was taken following the CHMP’s scientific conclusions of 27 June 2024 to the effect that Ocaliva no longer presented a favourable risk-benefit balance. The revocation of the conditional marketing authorisation for Ocaliva by means of that decision was therefore justified by the desire to protect public health, by ensuring that patients were not exposed to a medicinal product with a negative risk-benefit balance, in accordance with the conditions established by the case-law referred to in paragraph 54 above.

65Fourth, as regards the applicant’s argument relating to [confidential].

66In addition, it should be observed that [confidential].

67Fifth, as regards the applicant’s argument that the confidence of patients and medical professionals in Ocaliva risks being irreversibly affected, it must be noted that, in the highly regulated sector of the EU’s pharmaceuticals market, the suspension of a marketing authorisation for a product is an eventuality that may arise further to scientific progress and evolving understanding. It is common knowledge that many undertakings operating on that type of market have already had their products withdrawn from the market, without it being possible to say that those undertakings or their products were stigmatised as a result. The regulatory authorities and businesses in the sector concerned, which are familiar with the regulatory framework, tend rather to view that type of decision as a normal part of the regulatory process. Such a decision may in fact be seen as being simply the result of scientific developments and improvement in research methods (see, to that effect, order of 11 July 2018, GE Healthcare v Commission, T‑783/17 R, EU:T:2018:503, paragraph 62 (not published)).

68In the present case, the risk of damage to reputation is even significantly reduced, since the risk of a negative decision in the case of a conditional marketing authorisation is greater than in the case of a marketing authorisation, because the initial conditional marketing authorisation is based on a limited set of data and the data submitted after authorisation are examined to confirm or invalidate the positive benefit/risk balance.

69In addition, it should be noted that, if the applicant’s reputation has in fact suffered, that damage would already have been caused by the adoption of the CHMP’s negative opinion published on 27 June 2024 or, at the very least, by the adoption of the contested decision itself.

70The purpose of interim proceedings is not to secure reparation of damage that has already occurred (order of 8 May 2024, Lattanzio KIBS and Others v Commission, T‑113/24 R, not published, EU:T:2024:306, paragraph 24), since such damage can no longer be avoided by granting the interim measures sought.

71Given that the contested decision was adopted on completion of a complex administrative procedure, in which scientific experts and professionals from the sector concerned were involved, a suspension of operation of that decision, ordered by the President of the General Court purely on an interim basis and in summary proceedings, would scarcely be such as to restore the applicant’s reputation (see, to that effect, order of 15 November 2011, Xeda International v Commission, T‑269/11 R, not published, EU:T:2011:665, paragraph 42 and the case-law cited).

72Even if the applicant’s reputation were in fact compromised by the contested decision, it is settled case-law that annulment of that decision on conclusion of the main proceedings would provide, in principle, sufficient reparation for the alleged non-material damage (see, to that effect, orders of 25 March 1999, Willeme v Commission, C‑65/99 P(R), EU:C:1999:176, paragraphs 14, 61 and 62; of 22 July 2010, H v Council and Others, T‑271/10 R, not published, EU:T:2010:315, paragraph 36; and of 18 November 2011, EMA v Commission, T‑116/11 R, not published, EU:T:2011:681, paragraph 21).

73Since the applicant has not established that the condition relating to urgency has been satisfied, the application for interim measures must be dismissed, without it being necessary to rule on whether there is a prima facie case or to weigh up the interests involved.

74Since the present order closes the proceedings for interim measures, the order of 4 September 2024, Advanz Pharma v Commission (T‑455/24 R, not published), adopted on the basis of Article 157(2) of the Rules of Procedure, pursuant to which the Commission was ordered to suspend the operation of the contested decision until the date of the order terminating the present proceedings, must be cancelled.

75Under Article 158(5) of the Rules of Procedure, the costs must be reserved.

On those grounds,

hereby orders:

1.The application for interim measures is dismissed.

2.The order of 4 September 2024, Advanz Pharma v Commission (T‑455/24 R), is cancelled.

3.The costs are reserved.

Luxembourg, 26 November 2024.

Registrar

—

Language of the case: English.

Confidential information redacted.