Appeal brought on 20 February by PP Nature-Balance Lizenz GmbH against the judgment of the General Court (Fifth Chamber) of 11 December 2014 in Case T-189/13 PP Nature-Balance Lizenz GmbH v European Commission

(Case C-82/15 P)

(2015/C 127/18)

Language of the case: German

Parties

Appellant: PP Nature-Balance Lizenz GmbH (represented by: M. Ambrosius, Rechtsanwalt)

Other party to the proceedings: European Commission

Form of order sought

The appellant claims that the Court should:

Pleas in law and main arguments

The appellant relies upon five grounds of appeal.

First ground of appeal: infringement of Article 116 of Directive 2001/83/EC (1) read in conjunction with the precautionary principle.

The General Court invokes the precautionary principle in order to raise serious doubts as to the benefit of the medicinal product. The precautionary principle is, however, aimed at the evaluation of risks, rather than the efficacy, of a pharmaceutical product.

Second ground of appeal: infringement of Article 116 of Directive 2001/83/EC in so far as the General Court accepted four studies as new information

New information which can be taken into account for the purposes of Article 31 of Directive 2001/83/EC includes only that which is available post-authorisation, such as at the time of the first extension. The General Court was, however, of the opinion that the evaluation undertaken by the Committee for Medicinal Products for Human Use (CHMP) was independent from that undertaken by the national authorities. As a result, any information would prima facie be new whenever a matter had not yet been referred to the Committee.

Third ground of appeal: infringement of Article 116 of Directive 2001/83/EC with regard to the consideration of the criterion of the unproven efficacy of the medicinal product

The General Court adopted the view that the existence of studies which are not suitable for proving efficacy was per se sufficient to find that a medicinal product is not beneficial or less beneficial than previously considered to be the case. In fact, the General Court should have found in this context that the grounds which led to the failure of a study ought to be taken into consideration.

Fourth ground of appeal: distortion of the evidence

The General Court distorted evidence in that it found there to be no contradiction between the risk assessment of hypersensitive reactions, undertaken by the rapporteur, co-rapporteur and SAG-N, and the evaluation of the CHMP.

Fifth ground of appeal: infringement of Article 10(a) of and the Annex to Directive 2001/83/EC

The General Court infringed Article 10(a) of and the Annex to Directive 2001/83/EC in so far as it held that this provision is only applicable in the event of first marketing authorisation procedures. In addition, the General Court infringed Article 10(a) of Directive 2001/83/EC in that it approved the fact that the CHMP concentrated on the assessment of merely four studies, whereas there are over eighty studies in total on tolperisone.

(1)  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67).