Official Journal of the European Union

EN

C series

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C/2024/6443

(Case T-455/24)

(C/2024/6443)

Language of the case: English

Parties

Applicant: Advanz Pharma Ltd (Dublin, Ireland) (represented by: J. Bourgeois and M. Meulenbelt, lawyers)

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:

—annul Commission Implementing Decision C(2024)6281final of 30 August 2024, revoking, under Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council, (1) the conditional marketing authorisation, granted by Decision C(2016)8685(final), for ‘Ocaliva – obeticholic acid’, an orphan medicinal product for human use (‘the contested Decision’); and

—order the Commission to pay the costs.

Pleas in law and main arguments

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

1.First plea in law, alleging that by voiding the ongoing renewal procedure under Article 6(3) of Commission Regulation (EC) No 507/2006, (2) the contested Decision infringes the applicant’s right to an effective remedy under Article 47 of the Charter of Fundamental Rights of the European Union (‘the Charter’) and violates Article 6(4) of Regulation No 507/2006.

2.Second plea in law, alleging that the assessment procedure underpinning the contested Decision infringes the right to good administration under Article 41 of the Charter, in particular regarding the Ad-Hoc Expert Group process, which was affected by expert bias, conflicts of interest, and insufficient preparation time.

3.Third plea in law, alleging that by asserting a lack of efficacy without assessing the possibilities to obtain therapeutic results with Ocaliva, the contested Decision infringes Article 116, first paragraph, of Directive 2001/83/EC of the European Parliament and of the Council (3) and the principle of good administration.

4.Fourth plea in law, alleging that the contested Decision infringes the principle of scientific excellence by basing the negative benefit-risk assessment on a single inconclusive analysis from one study without assessing its robustness and suitability as the sole basis for the assessment; and by discarding all other studies and analyses favouring Ocaliva from the benefit-risk assessment, without substantiating assertions of absolute invalidity and relative invalidity of such other studies and analyses, and without a comparative assessment of the robustness of the inconclusive analysis on the one hand, and all other evidence, on the other hand.

5.Fifth plea in law, alleging errors in law and fact and the infringement of the principles of proportionality and legitimate expectations and the violation of Article 57 of Regulation No 726/2004, by proceeding directly to the revocation of the conditional marketing authorisation, without consideration or assessment of the alternative study programme and the modification of the specific obligations proposed by the marketing authorisation holder.

(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) Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ 2006 L 92, p. 6).

(3) 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).

ELI: http://data.europa.eu/eli/C/2024/6443/oj

ISSN 1977-091X (electronic edition)

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