Court of Justice of the European Communities (including Court of First Instance Decisions)

JUDGMENT OF THE GENERAL COURT (Fifth Chamber)

4 July 2012 (*)

(Medicinal products for human use - Marketing authorisation for the medicinal product Orphacol - Letter informing the applicant of the Commission's intention to refuse authorisation - Application for a declaration of failure to act - Definition of position by the Commission - Inadmissibility - Application for annulment - Adoption of a new decision - No need to adjudicate)

In Case T-12/12,

Laboratoires CTRS, established in Boulogne-Billancourt (France), represented by K. Bacon, Barrister, M. Utges Manley and M. Barnden, Solicitors,

applicant,

supported by

Czech Republic, represented by M. Smolek and D. Hadroušek, acting as Agents,

by

French Republic, represented by G. de Bergues, acting as Agent,

and by

United Kingdom of Great Britain and Northern Ireland, represented by E. Jenkinson and S. Ossowski, and subsequently by E. Jenkinson and H. Walker, acting as Agents, and by J. Holmes, Barrister,

interveners,

v

European Commission, represented by E. White and L. Banciella, acting as Agents,

defendant,

APPLICATION for a declaration that the Commission failed to act in unlawfully failing to adopt a final decision in relation to the applicant's application for a marketing authorisation for the medicinal product Orphacol, and, in the alternative, for annulment of the decision, allegedly contained in the Commission's letter of 5 December 2011, not to grant that authorisation to the applicant,

THE GENERAL COURT (Fifth Chamber),

composed of S. Papasavvas, President, V. Vadapalas (Rapporteur) and K. O'Higgins, Judges,

Registrar: N. Rosner, Administrator,

having regard to the written procedure and further to the hearing on 24 April 2012,

gives the following

Judgment

Facts, procedure and forms of order sought

1 The applicant, Laboratoires CTRS, developed the medicinal product Orphacol, which is used to treat two rare but very serious liver disorders. Those disorders, if not properly treated within the first weeks or months of life, can lead to death.

2 On 30 October 2009, the applicant applied for a marketing authorisation ('MA') for this medicinal product under the procedure provided for by 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), as amended by Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation No 726/2004 (OJ 2006 L 378, p. 1).

3 On 16 December 2010, the Committee for Medicinal Products for Human Use, which comes under the European Medicines Agency ('EMA'), adopted a positive opinion recommending that an MA be granted for that medicinal product. On 14 April 2011, following requests for clarification by the European Commission, that Committee adopted a revised opinion, which was also positive.

4 On 7 July 2011, the Commission submitted to the Standing Committee on Medicinal Products for Human Use (the 'Standing Committee') a draft decision refusing to grant to the applicant an MA for the medicinal product Orphacol. The reasons given in the annex to that draft decision were essentially as follows. Firstly, the conditions for the granting of an MA under Article 10a of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67), as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83 (OJ 2004 L 136, p. 34), had not been met. According to the Commission, there had been a failure to demonstrate well-established medicinal use within the European Union for at least 10 years, which would exempt an applicant for an MA from the requirement of providing the results of pre-clinical and clinical trials, and comprehensive data establishing the efficacy and safety of the active substance had not been provided. The Commission held that the grant of an MA for Orphacol, despite those two defects, would have amounted to a circumvention of Regulation No 1901/2006. Secondly, where an MA is applied for on the basis of a well-established medicinal use, within the meaning of Article 10a of Directive 2001/83, the application cannot rely on the 'exceptional circumstances' provided for in Article 14(8) of Regulation No 726/2004.

5 On 13 September 2011, the Standing Committee discussed the draft Commission decision refusing to grant the MA, but did not proceed to a vote and postponed the discussion until its next meeting.

6 On 13 October 2011, the Standing Committee delivered a negative opinion on the draft Commission decision refusing to grant the MA.

7 On 24 October 2011, the Commission submitted to the Appeal Committee the draft decision refusing to grant the MA.

8 On 8 November 2011, the Appeal Committee also delivered a negative opinion on the draft Commission decision refusing to grant the MA.

9 On 11 November 2011, the applicant sent a letter to Mr D., the Commission Member responsible for matters relating to health and consumer policy, in which it called on the Commission to adopt a decision granting it an MA for Orphacol without further delay.

10 On 14 November 2011, the applicant sent a further letter to Mr D., supplementing its previous letter, as well as a letter to the President of the Commission, accompanied by a copy of the letter sent on that same day to Mr D.

11 On 5 December 2011, Mr D. sent a letter to the applicant stating that, for the reasons set out in the annex to the draft decision refusing the MA, the Commission took the view that the conditions for granting that MA had not been met.

12 On the same day, the applicant sent an e-mail to Mr D. asking him whether it could expect to receive further correspondence in response to its letters of 11 and 14 November 2011, and stating its intention to bring proceedings before the General Court within two months on the basis of the Commission's refusal to act.

13 On 19 December 2011, Mr D. stated, in response to that e-mail, that an MA could not be granted for the reasons set out in the annex to the Commission's draft refusal decision, but that the Commission could also not adopt a formal decision refusing the MA because of the negative opinion delivered by the Appeal Committee.

14 By application lodged at the Registry of the General Court on 12 January 2012, the applicant brought the present action.

15 By a separate document lodged at the Registry of the Court on the same day, the applicant applied for an expedited procedure pursuant to Article 76a of the Court's Rules of Procedure.

16 By decision of 8 February 2012, the Court (Fifth Chamber) granted that request.

17 Following the report of the Judge-Rapporteur, the Court decided to open the oral procedure and, by way of measures of organisation of procedure under Article 64 of its Rules of Procedure, on 12 March 2012 asked the Commission to reply to a written question prior to the hearing. The Commission replied to that question within the period prescribed.

18 On 28 March, 4 April and 6 April 2012, respectively, the Czech Republic, the United Kingdom of Great Britain and Northern Ireland and the French Republic applied for leave to intervene in support of the form of order sought by the applicant. Those applications for leave to intervene were notified to the parties, which submitted their observations within the prescribed period, with the exception of the Commission (in respect of the last two applications). The applications for leave to intervene were granted by order of the President of the Fifth Chamber of the Court of 18 April 2012.

19 On 20 April 2012 Asklepion Pharmaceuticals sought leave to intervene in support of the form of order sought by the Commission. By order of the President of the Fifth Chamber of the Court of 23 April 2012, that application was rejected.

20 On 23 April 2012, the Commission informed the Court that the Standing Committee would meet on 8 May 2012 to discuss a new draft Commission decision refusing the MA for the medicinal product Orphacol.

21 The parties presented oral argument and replied to the Court's oral questions at the hearing on 24 April 2012.

22 By letter from the Court Registry of 22 May 2012, the parties were informed that the judgment was to be delivered on 7 June 2012.

23 By letter of 25 May 2012, the Commission informed the Court that it had adopted a decision refusing to grant the MA for the medicinal product Orphacol on that same day. That decision states that the Standing Committee examined the new draft decision on 8 May 2012, but that the committee did not deliver an opinion.

24 By order of 4 June 2012, the Court decided to order that the oral procedure be reopened, in accordance with Article 62 of the Rules of Procedure, in order to allow the parties to define their position in regard to that new element.

25 By letter from the Court Registry of the same day, the parties were thus requested to set out their views on the consequences to be drawn from the Commission's adoption of the decision of 25 May 2012.

26 All of the parties replied within the periods prescribed, with the exception of the French Republic.

27 By decision of 19 June 2012, the General Court again closed the oral procedure.

28 The applicant, supported by the Czech Republic, the French Republic, and the United Kingdom, claims that the Court should:

- declare that the Commission has unlawfully failed to adopt a final decision on its application for the grant of an MA for the medicinal product Orphacol;

- in the alternative, annul the decision refusing an MA for the medicinal product Orphacol, contained in the Commission's letter of 5 December 2011;

- order the Commission to pay the costs.

29 In response to the question raised by the Court on 4 June 2012, the applicant stated, by letter of 14 June 2012, that it was maintaining both the application for a declaration of failure to act and the alternative application for annulment.

30 The Commission contends that the Court should:

- dismiss the application for a declaration of failure to act as inadmissible or, in the alternative, as unfounded;

- dismiss the application for annulment as inadmissible or devoid of purpose;

- order the applicant to pay the costs.

31 In response to the question raised by the Court on 4 June 2012, the Commission submitted, by letter of 15 June 2012, that both the application for a declaration of failure to act and the application for annulment had become devoid of purpose.

Law

The application for a declaration of failure to act

32 According to the applicant, since Article 10(2) of Regulation No 726/2004 provides that the Commission is to take a final decision within 15 days after the end of the examination procedure provided for by Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ 2011 L 55, p. 13), which repeals Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (OJ 1999 L 184, p. 23), the Commission was under an obligation to take a final decision in accordance with that procedure, that is to say, a decision which has received a positive or neutral opinion from the Standing Committee, or a positive or neutral opinion from the Appeal Committee.

33 The applicant submits that, by letter of 11 November 2011, it formally called upon the Commission to take action in that respect, in accordance with the second paragraph of Article 265 TFEU, and that the two-month period provided for by that provision expired on 11 January 2012, by which date the Commission had not adopted a final decision in accordance with the examination procedure.

34 The applicant adds that Mr D.'s letter of 5 December 2011, in response to the formal request of 11 November 2011, is not a decision delivered in accordance with the examination procedure required by Article 10(2) of Regulation No 726/2004, and hence cannot be a final decision within the meaning of that provision. In its form, that letter could not 'express' such a decision. In its substance, the position expressed in that letter, namely, the refusal to grant an MA on the basis of the reasons set out in the draft Commission decision refusing the MA, which was rejected by both the Standing Committee and the Appeal Committee, is prohibited by Regulation No 182/2011.

35 The Commission claims, without formally raising an objection of inadmissibility, that the application for a declaration of failure to act must be declared inadmissible because of the absence of a reference to Article 265 TFEU in the applicant's 'correspondence'.

36 The Commission also contends that, contrary to the applicant's claims, it has not failed to fulfil its obligations by not adopting a final decision. It argues that it fulfilled its obligations, in accordance with Regulation No 726/2004, by submitting, on 7 July 2011, a draft decision to the Member States and to the applicant, with explanations annexed as to why it took the view that an MA for the medicinal product Orphacol had to be refused. It claims that the fact that it did not adopt a final decision within 15 days following the end of the procedure referred to in Article 87(3) of Regulation No 726/2004 is because it identified the need to obtain further clarifications from the EMA. Hence, the examination of the application for an MA remains ongoing and will continue to be conducted in accordance with Regulations No 726/2004 and No 182/2011.

37 Finally, the Commission submits that, as set out in Article 265 TFEU, an action for a declaration of failure to act can be brought only to establish an 'unlawful omission'. However, it goes on, the fact that it has not granted the MA requested despite the EMA's recommendation and the Standing Committee's negative opinion on the draft Commission decision is not unlawful and some of the reasons for its view that the grant of the requested MA would be unlawful are contained in the annex to the draft Commission decision refusing the MA. Those reasons, however, are still subject to revision.

38 According to settled case-law, under the second paragraph of Article 265 TFEU, an action for a declaration of failure to act is admissible only if the institution concerned has first been called upon to act. Giving the institution formal notice is an essential procedural requirement, the effects of which are, firstly, to set in motion the two-month period within which the institution is required to define its position and, secondly, to delimit any action that might be brought should the institution fail to define its position. Whilst there is no particular requirement as to form, the notice must, none the less, be sufficiently clear and precise to enable the Commission to ascertain in specific terms the content of the decision which it is being asked to adopt and it must make clear that its purpose is to compel the Commission to state its position (Joined Cases 81/85 and 119/85 Usinor v Commission [1986] ECR 1777, paragraph 15; order in Case T-311/97 Pescados Congelados Jogamar v Commission [1999] ECR II-1407, paragraph 35; and Case T-17/96 TF1 v Commission [1999] ECR II-1757, paragraph 41).

39 It should be noted that the applicant, by its letter to Mr D. of 11 November 2011, requested that the Commission adopt a decision granting the MA for the medicinal product Orphacol without further delay.

40 In the light of the terms used, it must be held that that letter, taken as a whole, was sufficiently clear and precise to enable the Commission to ascertain in specific terms the content of the decision which the applicant was asking it to adopt and also made clear that its purpose was to compel the Commission to state its position. Hence, it must be found that the Commission was being called upon to act, in accordance with the second paragraph of Article 265 TFEU. The fact, referred to by the Commission, that that letter does not expressly refer to the second paragraph of Article 265 TFEU is irrelevant in this regard, since that provision does not require such a formal condition.

41 By his letter of 5 December 2011, Mr D. replied that, for the reasons set out in the annex to the draft Commission decision refusing the MA, the Commission took the view that the conditions for granting an MA had not been met in the present case.

42 Thus, Mr D. indicated very clearly that the Commission did not intend to grant the applicant the requested MA (see, to that effect, order of the President of the Court in Case T-34/05 R Makhteshim-Agan Holding BV and Others v Commission [2005] ECR II-1465, paragraph 64).

43 It must therefore be held that Mr D.'s letter of 5 December 2011 constitutes a definition of position within the meaning of the second paragraph of Article 265 TFEU, bringing to an end the Commission's alleged failure to act (see, to that effect, order in Case T-3/02 Schlüsselverlag J. S. Moser and Others v Commission [2002] ECR II-1473, paragraph 21).

44 In that respect, first, as regards the applicant's argument that that letter could not, due to its form, 'express' the Commission's decision to refuse to grant the requested MA, Regulation No 726/2004 does not impose on the Commission any particular form in drafting the decision that it must take following the opinion delivered by the Appeal Committee.

45 Secondly, the applicant's argument that the position expressed in the letter of 5 December 2011 is prohibited by Regulation No 182/2011 relates to the lawfulness of the decision refusing to grant the requested MA contained in that letter and can therefore be dealt with only in the context of the examination of the application for annulment.

46 Accordingly, as Mr D.'s letter of 5 December 2011 constitutes a definition of position within the meaning of the second paragraph of Article 265 TFEU, the application for a declaration of failure to act must be declared inadmissible.

The application for annulment

47 The applicant claims that, if the Court should regard Mr D.'s letter of 5 December 2011, whether on its own or read together with the subsequent correspondence, as, in substance, a decision, the Court must annul that decision, which, it claims, is prohibited by Regulation No 182/2011, and which must also be annulled on the basis of fundamental errors of law and/or insufficiency of reasoning contrary to Article 296 TFEU.

48 In that respect, it must be pointed out that, according to settled case-law, an application for annulment brought by a natural or legal person is admissible only in so far as that person has an interest in the annulment of the contested measure (see order of 25 January 2012 in Case T-330/11 Mastercard and Others v Council, not published in the ECR, paragraph 25 and the case-law cited).

49 An applicant's interest in bringing proceedings must, considered in the light of the purpose of the application for annulment, exist at the stage of lodging the application, failing which the application will be inadmissible (see order in Mastercard and Others v Council, paragraph 26 and the case-law cited).

50 In the present case, subsequent to the letter of 5 December 2011, which contained the decision refusing the MA, the Commission submitted to the Standing Committee a new draft decision refusing the MA requested by the applicant. Following the examination of 8 May 2012, the Standing Committee did not deliver an opinion and the Commission adopted that draft decision on 25 May 2012.

51 As the present application for annulment is directed against the decision contained in the letter of 5 December 2011, the applicant had an interest in bringing proceedings on the date on which the application was lodged, and the application was admissible.

52 However, the interest in bringing proceedings must continue until delivery of the Court's decision, failing which there will be no need to adjudicate. That presupposes that the application must be capable, if successful, of procuring a benefit for the party bringing it (see order in Mastercard and Others v Council, paragraph 28 and the case-law cited).

53 If the applicant's interest in bringing proceedings disappears in the course of the proceedings, a decision of the Court on the merits cannot confer any benefit on it (see order in Mastercard and Others v Council, paragraph 29 and the case-law cited).

54 It must be stated that the decision of 25 May 2012 replaces the decision refusing the MA contained in the letter of 5 December 2011.

55 It must therefore be held that there is no longer any need to adjudicate on the action in so far as it seeks the annulment of the decision contained in the Commission's letter of 5 December 2011, as the applicant no longer has any interest in challenging that decision because of the adoption of the decision of 25 May 2012, and because the applicant has not requested leave to amend the form of order sought with a view to requesting annulment of the decision of 25 May 2012.

56 The applicant's argument, advanced in its reply to the Court of 14 June 2012, according to which the adoption of the decision of 25 May 2012 does not mean that the decision contained in the Commission's letter of 5 December 2011 can no longer be annulled, cannot call into question the foregoing findings. By reason of the adoption, by the Commission, of the decision of 25 May 2012, that annulment would not be capable of procuring any benefit for the applicant, because the refusal to grant the MA, which adversely affects the applicant, would continue on the basis of that decision.

57 Accordingly, in that situation, it inevitably follows that there is no longer any need to adjudicate on the application for annulment, submitted by the applicant in the alternative.

Costs

58 Under Article 87(3) of the Rules of Procedure, where each party succeeds on some and fails on other heads, or where the circumstances are exceptional, the General Court may order that the costs be shared or that each party bear its own costs.

59 Moreover, under Article 87(6) of the Rules of Procedure, where a case does not proceed to judgment, the costs are to be in the discretion of the General Court.

60 In the present case, it must be stressed that the Commission adopted a decision refusing an MA on 25 May 2012, thereby replacing the decision contained in the letter of 5 December 2011. It must also be stressed that the Commission adopted that decision of 25 May 2012 three days after it had been informed by the Registry of the General Court that delivery of the judgment was scheduled for 7 June 2012 (see paragraphs 22 and 23 above).

61 That being so, in the light of the exceptional circumstances of the present case, it is appropriate to order the Commission to bear its own costs and to pay those incurred by the applicant.

62 Finally, pursuant to the first subparagraph of Article 87(4) of the Rules of Procedure, the Member States which have intervened in the proceedings are to bear their own costs.

63 Accordingly, the Czech Republic, the French Republic and the United Kingdom must be ordered to bear their own costs.

On those grounds,

THE GENERAL COURT (Fifth Chamber)

hereby:

1. Dismisses the application for a declaration of failure to act as inadmissible;

2. Rules that there is no longer any need to adjudicate on the application for annulment submitted in the alternative;

3. Orders the European Commission to bear its own costs and to pay those incurred by Laboratoires CTRS;

4. Orders the Czech Republic, the French Republic and the United Kingdom of Great Britain and Northern Ireland to bear their own respective costs.

Delivered in open court in Luxembourg on 4 July 2012.

[Signatures]

* Language of the case: English.

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