# C_2019305EN.01005601.xml

| 9.9.2019 | EN | Official Journal of the European Union | C 305/56 |
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9.9.2019

EN

Official Journal of the European Union

C 305/56

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Action brought on 9 July 2019 — BASF v Commission

(Case T-472/19)

(2019/C 305/67)

Language of the case: English

Parties

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; |
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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. |
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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.

| 1. | 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) |
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1.

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

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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; |
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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. |
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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.

| 2. | 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; |
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2.

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

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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. |
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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.

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(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).

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