EMA (Order) [2016] EUECJ C-550/15

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(Appeal — Access to documents — Regulation (EC) No 1049/2001 — Documents held by the European Medicines Agency and produced in connection with proceedings concerning an application for a marketing authorisation for a medicinal product — Decision to grant a third party access to those documents — Suspension of operation of that decision — Interest in bringing proceedings — No need to adjudicate)

APPEAL under the second paragraph of Article 57 of the Statute of the Court of Justice of the European Union, brought on 23 October 2015,

European Medicines Agency (EMA), represented by S. Marino, A. Spina, A. Rusanov, T. Jabłoński and N. Rampal Olmedo, acting as Agents,

Pari Pharma GmbH, established in Starnberg (Germany), represented by M. Epping and W. Rehmann, Rechtsanwälte,

Novartis Europharm Ltd, established in Camberley (United Kingdom), represented by C. Schoonderbeek, Advocaat,

1 By its appeal, the European Medicines Agency (EMA) seeks the setting aside of the order of the President of the General Court of the European Union of 1 September 2015 in Pari Pharma v EMA (T‑235/15 R, not published, EU:T:2015:587) (‘the order under appeal’), by which that court decided to suspend the operation of Decision EMA/271043/2015 of the EMA of 24 April 2015, in so far as that decision grants a third party access, pursuant to Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ 2001 L 145, p. 43), to the assessment report (EMA/CHMP/702525/2014) concerning the similarity of Vantobra [to] Cayston and TOBI Podhaler and the assessment report (EMA/CHMP/778270/2014) concerning the clinical superiority of Vantobra over TOBI Podhaler, and ordered the EMA not to disclose those reports (‘the decision at issue’).

Background to the dispute, procedure before the judge hearing the application for interim relief, and the order under appeal

2 The main task of the EMA, established 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), is ensuring the protection and promotion of public and animal health through the evaluation and supervision of medicinal products for human and veterinary use.

3 To that end, the EMA is responsible for the scientific evaluation of applications for European Union marketing authorisations (‘MAs’) for medicinal products. Under the first subparagraph of Article 57(1) of Regulation No 726/2004, the EMA is to provide the Member States and the institutions of the European Union with the best possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human or veterinary use which is referred to it.

4 Regulation No 726/2004 provides that certain categories of medicinal products must be approved under a centralised procedure pursuant to that regulation. That procedure entails the submission, by the pharmaceutical company concerned, of an application for an MA, which the EMA then examines and issues an opinion on, and the adoption by the European Commission of a decision regarding that MA. Exclusive responsibility for preparing the EMA’s opinions on all questions relating to medicinal products for human use is vested in a Committee for Medicinal Products for Human Use (‘the CHMP’).

5 Novartis Europharm Ltd is the holder of an MA granted by the Commission on 20 July 2011, pursuant to Regulation No 726/2004, for the medicinal product TOBI Podhaler.

6 TOBI Podhaler was classified as an ‘orphan medicinal product’ within the meaning of Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ 2000 L 18, p. 1), that is to say, medicinal products intended for the diagnosis, prevention or treatment of rare conditions. In order to promote the development of effective treatments for patients affected by rare conditions, that regulation introduces a system of incentives to encourage pharmaceutical undertakings to invest in the research, development and placing on the market of orphan medicinal products. According to recital 8 of Regulation No 141/2000, the strongest incentive for those purposes is the prospect of obtaining market exclusivity for a certain number of years during which part of the investment might be recovered.

7 In that regard, Article 8(1) of Regulation No 141/2000 provides that orphan medicinal products in respect of which an MA has been granted enjoy market exclusivity, in that ‘the Community and the Member States shall not, for a period of 10 years, accept another application for [an MA], or grant [an MA] or accept an application to extend an existing [MA], for the same therapeutic indication, in respect of a similar medicinal product’.

8 Under that provision, TOBI Podhaler therefore enjoys a period of market exclusivity which, following the grant of a two-year extension, will not expire until 20 July 2023.

9 However, under Article 8(3) of Regulation No 141/2000, by way of derogation from paragraph 1 of that article, ‘[an MA] may be granted, for the same therapeutic indication, to a similar medicinal product if:

(c) the second applicant can establish in the application that the second medicinal product, although similar to the orphan medicinal product already authorised, is safer, more effective or otherwise clinically superior.’

10 It was on the basis of that provision that Pari Pharma GmbH sought an MA in respect of the medicinal product Vantobra, which is the subject-matter of the present proceedings.

11 The Commission granted that request on 18 March 2015 following a centralised authorisation procedure pursuant to Regulation No 726/2004. On the basis of the additional compilation of clinical trial data and related calculations provided by Pari Pharma, the CHMP concluded on 22 January 2015 that Pari Pharma’s claim that Vantobra was clinically superior to other medicinal products by reason of its greater safety for a significant part of the target population had been substantiated by sufficient evidence and that an MA should therefore be granted for Vantobra.

12 That favourable opinion is based on two CHMP reports issued on the same day, namely the assessment report (EMA/CHMP/702525/2014) concerning the similarity of Vantobra [to] Cayston and TOBI Podhaler and the assessment report (EMA/CHMP/778270/2014) concerning the clinical superiority of Vantobra over TOBI Podhaler (collectively, ‘the reports at issue’).

13 The first paragraph of Article 73 of Regulation No 726/2004 states that Regulation No 1049/2001 is applicable to documents held by the EMA.

14 On 13 April 2015 the EMA informed Pari Pharma that it had received a request for access to documents including the reports at issue, submitted on the basis of the latter regulation, concerning the medicinal product Vantobra. It emerged in the course of the procedure that the person requesting access was Novartis Europharm. The EMA informed Pari Pharma of its intention to disclose those documents with a few redactions concerning personal data, while setting that company a deadline for requesting additional redactions. On 20 April 2015, Pari Pharma asked the EMA not to disclose the reports at issue. As a precautionary measure, it also asked that additional redactions be made to the documents in question if they were to be communicated.

15 By the decision at issue, Novartis Europharm obtained disclosure of the documents in question.

16 By application lodged at the Registry of the General Court on 15 May 2015, Pari Pharma brought an action seeking, in essence, annulment of the decision at issue in so far as it granted a third party access to the reports at issue.

17 By separate document, lodged at the Court Registry on the same day, Pari Pharma submitted an application for interim relief, in which it asked the President of the General Court to suspend the operation of the decision at issue in so far as it granted that access, to order the EMA not to disclose the reports at issue or, in the alternative, if those reports should however be disclosed, to make additional redactions thereto.

18 In its observations on that application, lodged at the Court Registry on 1 June 2015, the EMA asked the President of the General Court to dismiss the application and to order Pari Pharma to pay the costs relating to the proceedings for interim relief.

19 By order of 22 June 2015, the President of the General Court granted Novartis Europharm leave to intervene in the proceedings for interim relief in support of the form of order sought by the EMA. The main parties having requested that certain documents in the file be regarded as confidential and having produced, for the purpose of communication to Novartis Europharm, a non-confidential version of the documents in question, the President of the General Court ordered that the notification to that party of the procedural documents served or to be served on the main parties be restricted to that non-confidential version, stating that a decision as to whether the request for confidential treatment was well founded would be taken at a later stage in the light of any objections raised by Novartis Europharm in that regard.

20 By written submission of 26 June 2015, Novartis Europharm expressed objections with regard to most of the documents that had provisionally been classified as confidential in the order of 22 June 2015. Nevertheless, it lodged a statement in intervention on 30 June 2015, in which it asked the President of the General Court to dismiss the application for interim relief and to order Pari Pharma to pay all the costs.

21 By the order under appeal, the President of the General Court suspended the operation of the decision at issue, ordered the EMA not to disclose the reports at issue, reserved the costs and dismissed the remainder of the application.

22 In parallel to Pari Pharma’s action as mentioned in paragraph 16 above, on 28 May 2015 Novartis Europharm brought an action before the General Court seeking annulment of the decision of 18 March 2015 by which the Commission had granted the MA for Vantobra, on the ground that that decision infringed the market exclusivity which it enjoyed, pursuant to Article 8(1) of Regulation No 141/2000, in respect of its medicinal product TOBI Podhaler. That action was registered as Case T‑269/15.

23 By application lodged on 23 October 2015, the EMA claims that the Court should set aside the order under appeal, dismiss the request for interim measures seeking suspension of operation of the decision at issue, and order Pari Pharma to pay the costs incurred in the proceedings at first instance and on appeal.

24 By a response lodged on 23 November 2015, Pari Pharma contends that the Court should dismiss the appeal and order the EMA to pay the costs of the proceedings at first instance and on appeal. The reports at issue are included in the annexes to that response.

26 On 24 November 2015, the response lodged by Pari Pharma and the annexes thereto were notified to the other parties to the appeal proceedings in accordance with the second paragraph of Article 20 of the Statute of the Court of Justice of the European Union.

27 On 25 November 2015, Pari Pharma submitted a request for confidential treatment in order that certain documents appended to its response, including the reports at issue, should not be notified to Novartis Europharm.

28 Because that request for confidential treatment was submitted out of time, those appended documents were notified as they stood. Consequently, by letter lodged at the Registry of the Court on 3 December 2015, Pari Pharma asked the Court — provided it had a legal basis for doing so — to order Novartis Europharm to keep the documents confidential and not to notify those documents to any third parties.

29 In addition, Pari Pharma informed the Court that it had succeeded in concluding an agreement in principle with Novartis Europharm under which the latter company had undertaken, in any event, to keep the documents in question confidential and not to communicate them to third parties. Novartis Europharm would not be authorised to use those documents except in connection with the case pending between it and the Commission, registered with the General Court as Case T‑269/15.

30 Lastly, Pari Pharma added that it still has an interest both in the substantive proceedings before the General Court and in the present appeal proceedings.

31 By a letter from the Court Registry of 3 December 2015, the EMA was asked to clarify whether, given the circumstances, it considered that there was still any need to adjudicate on its appeal. It replied in the affirmative, stating that its interest in bringing proceedings in the present appeal proceedings was based on the following facts.

32 In the first place, despite the agreement in principle concluded with Pari Pharma, Novartis Europharm has not withdrawn its request, submitted pursuant to Regulation No 1049/2001, for access to the documents in question.

33 In the second place, a decision granting access to documents has an effect erga omnes, so that any person requesting access is entitled to obtain the documents in question. Given that several other requests for access to those documents have already been submitted, the EMA is unsure how to respond to those requests, in particular in view of the considerations expressed by the President of the General Court in the order under appeal.

34 In the third place, that order is contrary to the case-law of the Court relating to the assessment that must be carried out by the General Court of whether there exists a risk of serious and irreparable harm such as to justify granting suspension of operation. Thus, that order, by allowing, according to the appellant, the systematic suspension of any decision authorising the disclosure of documents to third parties owing to the fact that proceedings for interim relief have been brought seeking the suspension of that decision, raises a question of principle as regards the effective application of Regulation No 1049/2001.

35 In view of the circumstances of the present case, it is necessary to begin by examining whether the EMA still has a legal interest in bringing proceedings in connection with the present appeal.

36 In that regard, it should be borne in mind that for a person to have an interest in bringing appeal proceedings the appeal must be capable, if successful, of procuring an advantage for that party (order of the President of the Court of 27 February 2002 in Reisebank v Commission, C‑477/01 P(R), EU:C:2002:126, paragraph 21 and the case-law cited).

38 Indeed, the fact that Novartis Europharm now has access to the reports at issue clearly deprives the interim measures obtained by Pari Pharma through the order under appeal of all effect.

39 In that regard, it should be noted that the assessment of an applicant’s interest in obtaining the measures sought takes on particular importance in proceedings on an application for interim relief. The judge hearing an application for interim relief may order suspension of operation of an act or other interim measures only if it is established, inter alia, that such an order is urgent inasmuch as, in order to prevent serious and irreparable harm to the applicant’s interests, it must be made and produce its effects before a decision is reached in the main action. Interim measures which would no longer serve to prevent the serious and irreparable harm feared by the applicant cannot, a fortiori, be necessary for that purpose (see, in particular, order of the President of the Court of 27 February 2002 in Reisebank v Commission, C‑477/01 P(R), EU:C:2002:126, paragraphs 22 and 23 and the case-law cited).

40 Regardless of the assessments which could be carried out by the President of the General Court concerning the possibility of cancelling or modifying the order under appeal upon application by one of the parties to that effect pursuant to Article 159 of the Rules of Procedure of the General Court, it must be held that the fact that those interim measures serve no purpose also deprives the EMA of any interest in bringing proceedings in the present appeal proceedings.

41 Indeed, whatever the outcome of the present proceedings, no advantage will be procured for the EMA. In particular, if the appeal were to be upheld and the EMA could therefore implement the decision at issue, the sole effect thereof would be to enable the EMA to communicate to Novartis Europharm the reports at issue which it already holds. If, by contrast, the appeal were to be dismissed, the EMA would, admittedly, not be entitled to communicate those reports to Novartis Europharm. However, the fact that Novartis Europharm has in any event obtained access to those documents means that the EMA is deprived of any interest in the immediate implementation of the decision at issue.

42 That assessment is not called in question by the EMA’s arguments seeking to establish that it has an interest in bringing proceedings in the present appeal proceedings.

43 First, the fact that Novartis Europharm has maintained its request for access has no effect on the need to adjudicate on the present appeal. Although the withdrawal of that request is in fact capable of affecting Pari Pharma’s interest in bringing proceedings at first instance, the fact that the request has been maintained does not in itself require, in view of the circumstances of the present case, a ruling on the present appeal.

44 Next, it is true that the EMA’s interest as regards the outcome of the processing of other requests for access is legitimate and well founded, but it does not concern the resolution of the present dispute and is not connected to the form of order sought in its appeal.

45 Lastly, regarding the answer to the question of principle raised by the present appeal, it must be held that it can no longer procure an advantage for the EMA in the present case, and may only be raised in the future, in cases similar to that which gave rise to the present appeal. That cannot suffice to justify the appeal proceeding to judgment (see, to that effect, order of the President of the Court of 18 May 2011 in Council v Zhejiang Xinan Chemical Industrial Group, C‑337/09 P-R, not published, EU:C:2011:314, paragraph 44).

46 In those circumstances, given that the appellant has, in the course of the proceedings, lost its interest in pursuing the proceedings for interim relief, there is no longer any need to adjudicate on its appeal (see, to that effect, order of 5 March 2009 in Commission v Provincia di Imperia, C‑183/08 P, not published, EU:C:2009:136, paragraph 31).

47 Regarding Pari Pharma’s request that Novartis Europharm be ordered not to disclose the reports at issue, it should be pointed out that the Court manifestly has no jurisdiction, in the context of an appeal, to adopt interim measures connected with the action for annulment pending before the General Court, because only the President of the General Court has that jurisdiction, pursuant to Articles 158 and, perhaps, 159 of that court’s Rules of Procedure.

48 Under Article 149 of the Rules of Procedure of the Court of Justice, applicable to appeal proceedings pursuant to Article 190 of those Rules, where a case does not proceed to judgment, the Court is to give a decision as to costs.

49 Article 142 of the Rules of Procedure, applicable to appeal proceedings pursuant to Article 184 of those Rules, provides that, in such a case, the costs are to be in the discretion of the Court.

50 Because the fact that there is no need to adjudicate in the present case is the result of Pari Pharma’s submitting its request for confidential treatment out of time, Pari Pharma must be ordered to bear its own costs and to pay those incurred by the EMA and by Novartis Europharm in the present appeal proceedings.

2. Pari Pharma GmbH is to bear its own costs and to pay those incurred by the European Medicines Agency (EMA) and by Novartis Europharm Ltd in connection with the appeal proceedings.

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