Action brought on 9 July 2019 – BASF v Commission

(Case T-472/19)

Language of the case: English


Applicant: BASF AS (Oslo, Norway) (represented by: E. Wright, Barrister-at-law, A. Rusanov and H. Boland, lawyers)

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:

annul, in its entirety, or insofar as it affects the applicant, Commission Implementing Decision C(2019) 4336 final of 6 June 2019 concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations of medicinal products for human use containing ‘Omega-3 acid ethyl esters’ for oral use in secondary prevention after myocardial infarction;

order the defendant to pay the costs.

Pleas in law and main arguments

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

First plea in law, alleging that the contested decision has no valid legal basis.

The applicant argues that, by adopting the contested decision, the European Commission failed to respect and fulfil the obligations imposed on the institution by Article 116 of Directive 2001/83/EC; 1

More specifically, the applicant states that the defendant failed to demonstrate that the medicinal product Omacor is harmful, lacks therapeutic efficacy, that the risk-benefit balance is not favourable, or that its qualitative and quantitative composition is not as declared;

The contested decision, it is further argued, disregards the principle established by the case-law of the Court of Justice that the favourable risk-benefit balance and efficacy of Omacor are presumed and that it is for the European Commission to demonstrate that the available clinical data supports the reversal of this presumption.

Second plea in law, alleging that, by adopting the contested decision, the defendant disregarded the general principle of proportionality under EU law.

It is argued again, under this plea, that the defendant failed to demonstrate that Omacor lacks therapeutic efficacy or that the risk-benefit balance of Omacor is no longer favourable. Moreover, the applicant maintains that the contested decision manifestly fails to respect the principle of proportionality;

Even if, quod non, there had been substantiated concerns regarding the efficacy or risk-benefit balance of Omacor, the defendant would have been required to consider measures that could address these concerns and which are less restrictive than the contested decision.


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).