Case T-718/15 R: Order of the President of the General Court of 20 July 2016 — PTC Therapeutics International Ltd v EMA (Application for interim measures — Access to documents — Regulation (EC) No 1049/2001 — Documents held by the EMA concerning information submitted by an undertaking as part of its application for authorisation to place a medicinal product on the market — Decision to grant a third party access to the documents — Application for suspension of operation of a measure — Urgency — Prima facie case — Weighing up of interests)
Date: 2016-07-20
Institutions: General Court
Subjects: access to EU information, confidentiality, disclosure of information, market approval, medicinal product, provision of documents, trade information








C_2016326EN.01002701.xml










5.9.2016   


EN


Official Journal of the European Union


C 326/27





Order of the President of the General Court of 20 July 2016 — PTC Therapeutics International Ltd v EMA
(Case T-718/15 R)
((Application for interim measures - Access to documents - Regulation (EC) No 1049/2001 - Documents held by the EMA concerning information submitted by an undertaking as part of its application for authorisation to place a medicinal product on the market - Decision to grant a third party access to the documents - Application for suspension of operation of a measure - Urgency - Prima facie case - Weighing up of interests))
(2016/C 326/48)
Language of the case: English

Parties


Applicant: PTC Therapeutics International Ltd (Dublin, Ireland) (represented by: G. Castle, B. Kelly, H. Billson, Solicitors, M. Demetriou, QC, and C. Thomas, Barrister)

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

Intervener in support of the applicant: European Confederation of Pharmaceutical Entrepreneurs (Eucope) (Brussels, Belgium) (represented by: S. Cowlishaw, Solicitor, and D. Scannell, Barrister)

Re:

Application pursuant to Articles 278 TFEU and 279 TFEU for, in essence, the suspension of operation of Decision EMA/722323/2015 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 containing information submitted in the context of an application for marketing authorisation for the medicinal product Translarna.

Operative part of the order







1.


The operation of Decision EMA/722323/2015 of the European Medicines Agency (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, access to Clinical Study Report ‘Ataluren (PTC124) PTC124-GD-007-DMD’ on a Phase 2B efficacy and safety study of Ataluren in subjects with nonsense-mutation-mediated Duchenne and Becker muscular dystrophy, is suspended.










2.


The EMA shall not disclose the report referred to in point 1.










3.


Costs are reserved.