Appeal brought on 7 January 2021 by Federal Republic of Germany against the judgment of the General Court (Sixth Chamber) delivered on 28 October 2020 in Case T-594/18, Pharma Mar v Commission

(Case C-6/21 P)

Language of the case: English

Parties

Appellant: Federal Republic of Germany (represented by: S. Heimerl, J. Möller, Agents)

Other parties to the proceedings: Pharma Mar, SA, European Commission

Form of order sought

The appellant claims that the Court should:

set aside the judgment of the General Court of the European Union of 28 October 2020 in Case T-594/18, Pharma Mar v Commission;

uphold Commission Implementing Decision C(2018) 4831 final of 17 July 2018 refusing marketing authorisation under Regulation (EC) No 726/20041 of the European Parliament and of the Council for "Aplidin - plitidepsin", a medicinal product for human use and dismiss the action;

in the alternative, refer the case back to the General Court; and

order the applicant to bear the costs before the Court of Justice and the General Court.

Pleas in law and main arguments

The appellant considers that the General Court erred in law, first, by misinterpreting and misapplying Section 3.2.2. of the EMA policy on the handling of competing interests of 6 October 20162 (‘the EMA Policy’). In so doing, the General Court wrongly proceeded on the assumption that the university hospital where the two experts were employed was a pharmaceutical company within the meaning of Section 3.2.2. of the EMA policy.

Second, the court wrongly appraised the allocation of the burden of proof. In particular, it is erroneous to assume that it was for the Commission to adduce evidence proving that the cell therapy centre is a separate entity within the university hospital, and is therefore not under its control, in order to remove the doubt thus created. Rather, the applicant should have proved that the cell therapy centre is in fact under the control of the university hospital.

Third, the General Court erred in law by misinterpreting and misapplying Section 4.2.1.2. of the EMA policy on so-called rival products. On the one hand, the General Court erred in law in taking into account the activities of the second expert in relation to certain rival products and, on the other hand, it wrongly found, in the context of its erroneous appraisal of the evidence, that there are few, if any, alternative medicinal products for the treatment of multiple myeloma on the market.

Fourth, the General Court erred in law in failing to recognise that the second expert’s participation in the Scientific Advisory Group for Oncology did not have a decisive impact on the conduct or outcome of the procedure.

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1 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).

2 EMA, European Medicines Agency policy on the handling of competing interests of scientific committees’ members and experts, 6 October 2016, EMA/626261/2014,Rev. 1.