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

(Case C-16/21 P)

Language of the case: Estonian


Appellant: Republic of Estonia (represented by: N. Grünberg)

Other parties to the proceedings: Pharma Mar, SA (represented by: M. Merola and V. Salvatore), European Commission (represented by: L. Haasbeek and A. Sipos)

Form of order sought

The appellant claims that the Court should:

set aside the judgment of the General Court of 28 October 2020;

order each of the parties to bear their own costs incurred in the appeal proceedings.

Pleas in law and main arguments

The Republic of Estonia puts forward the following arguments:

1.    The General Court misconstrued the requirement of impartiality laid down in Article 63 of Regulation (EC) No 726/2004 1 by finding that, in respect of experts who participate in the work of a scientific advisory group (SAG), owing to the mere fact that they are in an employment relationship with a university hospital, any legitimate doubt as to possible bias that may exist in respect of their impartiality cannot be excluded.

2.    First, when examining the principle of impartiality within the meaning of Article 63 of Regulation (EC) No 726/2004, the General Court erred in finding that a university hospital can, as a whole, be equated with a pharmaceutical company.

3.    Second, when examining the principle of impartiality the General Court made a manifest error of assessment in the evaluation of the rival medicinal product and the connection between the expert and the manufacture of the ‘rival medicinal product’.

4.    Third, when examining the principle of impartiality the General Court erred by failing properly to assess the connection between the experts concerned and the cell therapy centre and the experts’ influence on the SAG’s decisions.


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).