European Medicines Agency (EMA) v MSD Animal Health Innovation GmbH and Intervet international BV.

• Jurisdiction: European Union
• ECLI: ECLI:EU:C:2017:149
• Court: Court of Justice (European Union)
• Date: 01 March 2017
• Docket Number: C-512/16
• Procedure Type: Recurso de casación - infundado
• Celex Number: 62016CO0512

Provisional text

ORDER OF THE VICE-PRESIDENT OF THE COURT

1 March 2017 (*)

(Appeal — Order for interim measures — Access to documents — Regulation (EC) No 1049/2001 — Directive 2001/82/EC — Regulation (EC) No 726/2004 — Documents held by the European Medicines Agency (EMA) submitted in connection with an application for marketing authorisation for a veterinary medicinal product — Decision to grant a third party access to the documents — Suspension of operation of that decision — Prima facie case — Urgency — Balancing of interests)

In Case C‑512/16 P(R),

APPEAL under the second paragraph of Article 57 of the Statute of the Court of Justice of the European Union, brought on 29 September 2016,

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

appellant,

the other parties to the proceedings being:

MSD Animal Health Innovation GmbH, established in Schwabenheim (Germany),

Intervet international BV, established in Boxmeer (Netherlands),

represented by J. Stratford QC, C. Thomas, Barrister, P. Bogaert, advocaat, and by B. Kelly and H. Billson, Solicitors,

applicants at first instance,

THE VICE-PRESIDENT OF THE COURT OF JUSTICE,

after hearing the Advocate General, M. Wathelet,

makes the following

Order

1 By its appeal, the European Medicines Agency (EMA) seeks to have set aside the order of the President of the General Court of the European Union of 20 July 2016, MSD Animal Health Innovation and Intervet International v EMA (T‑729/15 R, not published, ‘the order under appeal’, EU:T:2016:435), by which it ordered the suspension of the operation of Decision EMA/785809/2015 of the EMA of 25 November 2015 granting to a third party, 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), access to certain documents submitted in connection with an application for marketing authorisation for the veterinary medicinal product Bravecto (‘the decision at issue’).

Background to the dispute and the order under appeal

2 Article 5 of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ 2001 L 311, p.1), as amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 (OJ 2009 L 188, p.14) (‘Directive 2001/82’), provides that no veterinary medicinal product may be placed on the market of a Member State unless a marketing authorisation (‘MA’) has been granted by the competent authorities of that Member State in accordance with that directive or by the European Commission pursuant to the centralised procedure laid down in 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 (EU) No 1027/2012 of the European Parliament and of the Council of 25 October 2012 (OJ 2012 L 316, p. 38) (‘Regulation No 726/2004’).

3 The latter procedure entails the submission, by the pharmaceutical company concerned, of an MA application, upon which an opinion is given by the EMA, then a decision by the European Commission.

4 In accordance with the combined provisions of Article 31 of Regulation No 726/2004 and Article 12 of Directive 2001/82, that application must contain, in particular, a quality dossier including particulars on product composition and a description of the manufacturing processes, and the results of non-clinical tests, safety tests — including toxicological tests —, residue tests and clinical and preclinical trials in support of the intended therapeutic use of the medicinal product.

5 Under Article 38(3) of Regulation No 726/2004, the EMA, after examining the MA application, is to publish the European Public Assessment Report on the medicinal product for veterinary use (‘the EPAR’), containing a summary of the product’s characteristics that is understandable to the public, and the reasons for its opinion, after deletion of any information of a commercially confidential nature.

6 The first paragraph of Article 73 of Regulation No 726/2004 states that Regulation No 1049/2001 applies to documents held by the EMA. Article 80 of Regulation No 726/2004 provides, moreover, that the EMA is to adopt rules to ensure the availability to the public of regulatory, scientific or technical information concerning the authorisation or supervision of medicinal products which is not of a confidential nature. Therefore, in December 2006, the EMA adopted rules for the implementation of Regulation No 1049/2001.

7 In November 2010, the EMA amended its policy on access to its documents in order to enhance the transparency of its operations. That new policy provided, in particular, that documents submitted to the EMA in connection with an MA application may be disclosed from the time when the decision-making process regarding the application was finalised.

8 Intervet international BV (‘Intervet’) holds an MA, issued by the Commission on 11 February 2014, for Bravecto chewable tablets, a veterinary medicinal product used to treat tick and flea infestations in dogs. In its application for an MA, Intervet submitted to the EMA, in the form of detailed non-clinical study reports, five toxicology studies sponsored by MSD Animal Health Innovation GmbH (‘MSD’), which is part of the same group of companies as Intervet.

9 In August 2015, the EMA informed MSD that it had received a request from a pharmaceutical company seeking access to those five toxicology study reports on the basis of Regulation No 1049/2001. Since it intended to disclose three of those reports (‘the reports at issue’), the EMA invited MSD to provide it with any proposed redactions in those documents. In response, while taking the view that each of the reports at issue was legally protected in its entirety by a general presumption of confidentiality, MSD redacted the passages which it considered to be confidential. The EMA informed MSD that it accepted some of the proposed redactions, but rejected the vast majority of them on the ground that MSD had failed to show that disclosure of those reports would undermine its economic interests, competitive position or decision-making process and there was therefore a general presumption in favour of such disclosure.

10 Consequently, on 25 November 2015, the EMA, by the decision at issue, granted the third party applicant access to the reports at issue in their entirety, removing only certain passages relating, inter alia, to details on the concentration range of the active substances, details on the internal reference standard used for analytical tests and references to future development plans of MSD and Intervet.

11 By application lodged at the Registry of the General Court on 17 December 2015, MSD and Intervet brought an action for annulment of that decision.

12 By separate document, lodged at the Registry of the General Court on the same day, MSD and Intervet also lodged an application for interim measures in which they claimed, in essence, that the President of the General Court should suspend the operation of the decision at issue and order the EMA to abstain from any form of disclosure of the reports at issue.

13 The EMA claimed that the President of the General Court should reject that application.

14 By the order under appeal, the President of the General Court ordered that the operation of the decision at issue be suspended and the EMA not to disclose those reports.

15 The President of the General Court considered, in the first place, that it was not obvious that the reports at issue, taken as a whole, were not confidential and that it was therefore necessary to find that there was a prima facie case as regards the plea alleging confidentiality and infringement of Article 339 TFEU, Article 7 of the Charter of Fundamental Rights of the European Union (‘the Charter’) and of the first indent of Article 4(2) of Regulation No 1049/2001. In the second place, the President found that the balance of the interests in the case weighed in favour of granting the interim measures sought, since the public interest in transparency raised by the EMA would be sufficiently satisfied, pending a ruling on the substance, by publication of the summary of the characteristics of Bravecto, the user information leaflet and the EPAR. In the third place, the President of the General Court held, having regard to the harm that disclosure of the reports at issue would cause MSD and Intervet, that the condition relating to urgency was also met.

Procedure before the Court of Justice and forms of order sought

16 By its appeal, the EMA claims, in essence that the Court should:

– set aside the order under appeal;

– dismiss the application for interim measures seeking the suspension of the operation of the decision at issue; and

– order MSD and Intervet to pay the costs, including those relating to the proceedings before the General Court.

17 MSD and Intervet contend that the Court should dismiss the appeal and order the EMA to pay the costs.

The appeal

18 The EMA raises two grounds of appeal. The first alleges several manifest errors in the assessment of the facts and the second alleges errors of law in the assessment of whether there was a prima facie case, of urgency and of the condition requiring a balance of interests.

The first ground of appeal

Arguments of the parties

19 Even though the appeal application is very difficult to read, it can be inferred that the EMA raises, in essence, three arguments in support of its first ground of appeal.

20 In the first place, it submits that paragraphs 51 and 52 of the order...