ORDER OF THE PRESIDENT OF THE FIFTH CHAMBER OF THE GENERAL COURT
14 March 2025 (*)
( Intervention – Association for the protection of health – Direct and existing interest in the result of the case )
In Case T‑455/24,
Advanz Pharma Ltd, established in Dublin (Ireland), represented by M. Meulenbelt, B. Baum, O. Beghin and A. Vermulst, lawyers,
applicant,
v
European Commission, represented by R. Lindenthal, E. Mathieu and A. Spina, acting as Agents,
defendant,
THE PRESIDENT OF THE FIFTH CHAMBER OF THE GENERAL COURT
makes the following
Order
1        By its action under Article 263 TFEU, the applicant, Advanz Pharma Ltd, seeks the annulment 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 Decision C(2016) 8685 final, for ‘Ocaliva – obeticholic acid’, an orphan medicinal product for human use (‘the contested decision’).
Facts and procedure
2        The applicant is a pharmaceutical company established in Ireland.
3        Since 16 December 2022, the applicant has been the holder of a conditional marketing authorisation (‘CMA’) 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.
4        Ocaliva, the active substance of which is obeticholic acid, is a medicinal product intended for the treatment of a liver disease, primary biliary cholangitis.
5        On 30 August 2024, on the basis of the conclusions and recommendation of the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA), set out in its opinion of 27 June 2024 during 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 Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1), the European Commission adopted the contested decision, revoking the CMA for Ocaliva.
6        By application lodged at the Registry of the General Court on 3 September 2024, the applicant brought an action for annulment of the contested decision.
7        By document lodged at the Court Registry on 26 December 2024, CBP Portugal, a non-profit association established in Azabucho – Pousos, Leiria (Portugal), sought leave to intervene in the present proceedings in support of the form of order sought by the applicant.
8        The application to intervene was served on the main parties in accordance with Article 144(1) of the Rules of Procedure of the General Court.
9        The applicant submitted that CBP Portugal’s application to intervene should be granted. The Commission, however, contended that that application should be refused.
Law
10      Under the second paragraph of Article 40 of the Statute of the Court of Justice of the European Union, applicable to proceedings before the General Court in accordance with the first paragraph of Article 53 of that statute, any person which can establish an interest in the result of a case other than a case between Member States, between institutions of the European Union or between Member States and institutions of the European Union, may intervene in that case.
11      It is apparent from settled case-law that the concept of ‘an interest in the result of a case’, within the meaning of that provision, must be defined in the light of the precise subject matter of the case and be understood as meaning a direct, existing interest in the ruling on the form of order sought, and not as an interest in relation to the pleas in law put forward. The words ‘result of a case’ refer to the final decision sought, as set out in the operative part of the future decision (order of the President of the Court of 7 February 2019, Bayer CropScience and Bayer v Commission, C‑499/18 P, not published, EU:C:2019:107, paragraph 5 and the case-law cited).
12      As regards, more specifically, applications to intervene lodged by health protection organisations, the requirement of a direct, existing interest in the result of the case presupposes, first, that the field of activity of those organisations, as is apparent from their purpose, enshrined as the case may be in their statutes, has a direct link with the subject matter of that case and, secondly, that that case raises questions of principle liable to affect the interests defended by the organisations in question (order of the President of the Court of 7 February 2019, Bayer CropScience and Bayer v Commission, C‑499/18 P, not published, EU:C:2019:107, paragraph 6, and order of 16 January 2015, Deza v ECHA, T‑189/14, not published, EU:T:2015:63, paragraph 20 and the case-law cited).
13      In that regard, as with environmental protection organisations, the requirement for health protection associations to have a direct and existing interest in the result of the case requires either that the remit of those organisations coincides with the sector concerned by the act being challenged or, where their remit is wider, they must be actively involved in activities relating to the sector concerned, the viability of which may be jeopardised by the adoption or annulment of the contested measure (see, to that effect, order of 20 January 2025, End the Cage Age v Commission, T‑151/24, not published, EU:T:2025:61, paragraph 13 and the case-law cited).
14      In the present case, CBP Portugal submits that it satisfies the conditions for leave to intervene laid down in the second paragraph of Article 40 of the Statute of the Court of Justice of the European Union.
15      In that regard, it states that it defends the interests of patients with primary biliary cholangitis.
16      However, due to the fact that the contested decision and the subsequent decision of the Portuguese health authorities revoked the CMA for the orphan medicinal product ‘Ocaliva’, patients with primary biliary cholangitis can only access that medicinal product at the cost of a highly uncertain procedure for exceptional permission from those authorities even though, for certain intolerant patients, Ocaliva constitutes the sole alternative to the only other medicinal product for treatment of primary biliary cholangitis.
17      The Commission submits, on the contrary, that the interest that CBP Portugal invokes is not sufficiently direct since the contested decision produces legal effects only in respect of the applicant and the Member States.
18      According to the Commission, the contested decision is not capable of affecting the legal interests of patients with primary biliary cholangitis, since the decisions of the national health authorities, adopted after that decision and concerning the use of Ocaliva, do not depend only on the existence of a CMA.
19      Furthermore, the Commission submits that, in so far as CBP Portugal seems to root its request in its status as an association representative of its members, it has not demonstrated that it is representative of patients with primary biliary cholangitis, or that the present case raises questions of principle.
20      On that last point, however, it must be stated that, to establish its interest in the outcome of the case, CBP Portugal relies not on any status as a representative professional association, but on its statutory objectives, which it is apparent include, inter alia, supporting and defending the interests of patients with primary biliary cholangitis and their families, and promoting and expressing the rights of those patients.
21      It follows that CBP Portugal’s remit coincides with the sector concerned by the proceedings before the Court, namely that of treatments for primary biliary cholangitis, of which, until the adoption of the contested decision, Ocaliva constituted one of the two treatments available (see, by analogy, as regards an association of beekeepers granted leave to intervene in a case in which an implementing regulation amending the conditions of approval of certain active substances and prohibiting the use and sale of seeds treated with plant protection products containing those active substances was at issue, order of 20 October 2014, Syngenta Crop Protection and Others v Commission, T‑451/13, not published, EU:T:2014:951, paragraphs 100 and 101).
22      That finding is confirmed by the various events, actions and communications directly connected to primary biliary cholangitis which CBP Portugal has carried out since January 2024 and which the Commission does not dispute.
23      Accordingly, CBP Portugal must be regarded as having established to the requisite legal standard that it has a direct, existing interest in the outcome of the applicant’s claim for annulment of the contested decision and, consequently, an interest in the result of Case T‑455/24, as provided for in the second paragraph of Article 40 of the Statute of the Court of Justice of the European Union.
24      That conclusion is not called into question by the Commission’s argument alleging that the contested decision has no legal effect on patients with primary biliary cholangitis, whose rights CBP Portugal seeks to promote.
25      It should be noted that, under Article 3(1) of Regulation No 726/2004, read in conjunction with point 4 of Annex I to that regulation, no orphan medicinal product may be placed on the market within the European Union unless a CMA has been granted by the European Union in accordance with the provisions of that regulation.
26      Consequently, notwithstanding the case-law referred to by the Commission, according to which the grant of a CMA is capable of producing legal effects only vis-à-vis the company that requested that authorisation and the Member States, the fact remains that the contested decision, which revokes the CMA for Ocaliva, deprives patients who use that medicinal product of the possibility of obtaining it, or at least of obtaining it as easily as when that medicinal product was covered by a CMA (see, by analogy, order of the President of the Court of 11 April 2001, Commission v Schuck, C‑476/00 P(R), EU:C:2001:221, paragraph 100), which CBP Portugal has demonstrated and the Commission does not dispute.
27      Accordingly, annulment by the Court of the contested decision would be likely to safeguard the interests of the patients whom CBP Portugal seeks to support and defend.
28      In those circumstances, CBP Portugal must be granted leave to intervene in the present case in support of the form of order sought by the applicant.
On those grounds,
THE PRESIDENT OF THE FIFTH CHAMBER OF THE GENERAL COURT
hereby orders:
1.      CBP Portugal is granted leave to intervene in Case T‑455/24 in support of the form of order sought by Advanz Pharma.
2.      The Registrar shall send to CBP Portugal a copy of all the procedural documents served on the main parties.
3.      A time limit shall be prescribed within which CBP Portugal may submit a statement in intervention.
4.      The costs are reserved.
Luxembourg, 14 March 2025.
V. Di Bucci
J. Svenningsen
Registrar
President
*      Language of the case: English.