10.12.2018

EN

Official Journal of the European Union

C 445/18

(Case T-594/18)

(2018/C 445/24)

Language of the case: English

Parties

Applicant: Pharma Mar, SA (Colmenar Viejo, Spain) (represented by: M. Merola and V. Salvatore, lawyers)

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:

—annul Commission Implementing Decision C(2018) 4831 final of 17 July 2018, refusing marketing authorisation under Regulation (EC) No 726/2004 (1) for ‘Aplidin — plitidepsin’, a medicinal product for human use;

—order the defendant to pay the costs.

Pleas in law and main arguments

In support of the action, the applicant relies on five pleas in law.

1.First plea in law, alleging the lack of impartiality of the scientific advisory group on oncology and of their appointment process.

—The applicant argues that the duty to examine all relevant aspects of a case carefully and impartially has been breached given that the contested decision is based on an opinion issued by experts who are not impartial.

—The breach of the duty to carry out an impartial examination alleged by the applicant also relates to the appointment of experts by the European Medicines Agency (EMA) in a manner that unduly reduced the plurality of views, which should be considered a precondition for an impartial assessment.

2.Second plea in law, alleging breach of the principle of good administration.

—The applicant refers to the appointment of experts by the EMA in a manner that unduly reduced the plurality of views and claims that this can be regarded as a breach of the principle of good administration.

3.Third plea in law, alleging infringement of Article 12 of Regulation (EC) No 726/2004 and the principle of equal treatment.

—The applicant argues that the Commission committed a manifest error of appraisal and wrongly concluded that the efficacy of Aplidin was not properly and sufficiently demonstrated, thereby infringing the said Article 12.

—In the examination procedure before the EMA, part of the scientific evidence submitted in support of the efficacy of Aplidin was disregarded due to the methodologies applied by the applicant, which is inconsistent with an opinion delivered by an expert working group of the EMA.

—The methodologies applied in the present case are the same as those accepted by the EMA in a similar case concerning the marketing authorisation procedure of another medicinal product, which indicates that the principle of equal treatment has been breached.

4.Fourth plea in law, alleging infringement of the requirement to provide a statement of reasons.

—The applicant argues that no statement of reasons has been provided for the decision to disregard the scientific evidence submitted in support of the efficacy of Aplidin, in particular as regards the reasons for departing from the opinion delivered by an expert working group of the EMA.

5.Fifth plea in law, alleging infringement of the right of defence.

—The applicant argues that it was prevented from effectively exercising its right of defence in relation to a subject-matter that was crucial to assessing Aplidin’s efficacy, in particular due to the limited time allowed to prepare for oral explanation meetings.

* Language of the case: English.

Regulation 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).