# C_2014439EN.01003101.xml

| 8.12.2014 | EN | Official Journal of the European Union | C 439/31 |
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Action brought on 19 September 2014 — August Wolff and Remedia v Commission

(Case T-672/14)

(2014/C 439/42)

Language of the case: German

Parties

Applicants: Dr. August Wolff GmbH & Co. KG Arzneimittel (Bielefeld, Germany), Remedia d.o.o. (Zagreb, Croatia) (represented by: P. Klappich, C. Schmidt and P. Arbeiter, lawyers)

Defendant: European Commission

Form of order sought

The applicants claims that the Court should:

| — | annul Commission Implementing Decision C(2014) 6030 final of 19 August 2014 concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations for high concentration of estradiol containing human medicinal products for topical use in so far as it requires Member States to comply with the obligations imposed in the implementing decision for the medicinal products listed in Annex I to the implementing decision and those not listed with 0,01 % estradiol by weight for topical use, with the exception of the restriction that the medicinal products named in Annex I to the implementing decision with 0,01 % estradiol by weight for topical use may be administered only intravaginally; |
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| — | order the European Commission to pay the costs. |
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Pleas in law and main arguments

In support of the action, the applicants rely on three pleas in law.

| 1. | First plea in law: Infringement of Article 31 et seq. of Directive 2001/83/EC( 1 )
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It is submitted in this connection that the contested implementing decision is based on a procedure which was initiated and conducted in a procedurally unlawful manner. In this regard, the applicants state inter alia that, contrary to the first sentence of the first paragraph of Article 31 of Directive 2001/83/EC, the procedure was initiated not before, but only after a decision on a request for renewal of the medicinal product was made and that, in addition, there was no specific case of Union interest. Furthermore, with regard to the first applicant, the initiation of the procedure entails a circumvention of the rules existing in the Member State of Germany on the renewal of medicinal products. —
Furthermore, the applicants argue that the appropriate Scientific Risk Assessment Committee was not involved in the procedure and that, in addition, a biased member was appointed as rapporteur in the Scientific Committee on Medicinal Products involved in the procedure. —
In addition, the first applicant claims that it was not properly consulted on an essential aspect within the framework of the expert opinion review procedure. | — | It is submitted in this connection that the contested implementing decision is based on a procedure which was initiated and conducted in a procedurally unlawful manner. In this regard, the applicants state inter alia that, contrary to the first sentence of the first paragraph of Article 31 of Directive 2001/83/EC, the procedure was initiated not before, but only after a decision on a request for renewal of the medicinal product was made and that, in addition, there was no specific case of Union interest. Furthermore, with regard to the first applicant, the initiation of the procedure entails a circumvention of the rules existing in the Member State of Germany on the renewal of medicinal products. | — | Furthermore, the applicants argue that the appropriate Scientific Risk Assessment Committee was not involved in the procedure and that, in addition, a biased member was appointed as rapporteur in the Scientific Committee on Medicinal Products involved in the procedure. | — | In addition, the first applicant claims that it was not properly consulted on an essential aspect within the framework of the expert opinion review procedure. |
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| — | It is submitted in this connection that the contested implementing decision is based on a procedure which was initiated and conducted in a procedurally unlawful manner. In this regard, the applicants state inter alia that, contrary to the first sentence of the first paragraph of Article 31 of Directive 2001/83/EC, the procedure was initiated not before, but only after a decision on a request for renewal of the medicinal product was made and that, in addition, there was no specific case of Union interest. Furthermore, with regard to the first applicant, the initiation of the procedure entails a circumvention of the rules existing in the Member State of Germany on the renewal of medicinal products. | | | | | | |
| — | Furthermore, the applicants argue that the appropriate Scientific Risk Assessment Committee was not involved in the procedure and that, in addition, a biased member was appointed as rapporteur in the Scientific Committee on Medicinal Products involved in the procedure. | | | | | | |
| — | In addition, the first applicant claims that it was not properly consulted on an essential aspect within the framework of the expert opinion review procedure. | | | | | | |

| 2. | Second plea in law: Infringement of the first sentence of Article 116 and the first sentence of Article 126 of Directive 2001/83/EC
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In this context, the applicants submit that the implementing decision is based on an incorrect assessment of the benefit-risk balance of the medicinal product. In particular, it disregards the fact that, over a more than 45-year market presence, no reports of serious risks arising from the use of the medicinal product with 0,01 % estradiol by weight had been submitted to the first applicant. —
In addition, the Commission — which in this respect bears the burden of presentation and proof — did not put forward any new scientific data and information from which a new risk arising from the use of the medicinal product emerges. | — | In this context, the applicants submit that the implementing decision is based on an incorrect assessment of the benefit-risk balance of the medicinal product. In particular, it disregards the fact that, over a more than 45-year market presence, no reports of serious risks arising from the use of the medicinal product with 0,01 % estradiol by weight had been submitted to the first applicant. | — | In addition, the Commission — which in this respect bears the burden of presentation and proof — did not put forward any new scientific data and information from which a new risk arising from the use of the medicinal product emerges. |
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| — | In this context, the applicants submit that the implementing decision is based on an incorrect assessment of the benefit-risk balance of the medicinal product. In particular, it disregards the fact that, over a more than 45-year market presence, no reports of serious risks arising from the use of the medicinal product with 0,01 % estradiol by weight had been submitted to the first applicant. | | | | |
| — | In addition, the Commission — which in this respect bears the burden of presentation and proof — did not put forward any new scientific data and information from which a new risk arising from the use of the medicinal product emerges. | | | | |

| 3. | Third plea in law: Infringement of the principles of proportionality and equal treatment
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In respect of the third plea, the applicants argue that the warnings in the product information, which are provided for in the implementing decision, the further restrictions included in the marketing authorisation for the medicinal product and the obligations based thereon are disproportionate and infringe the principle of equal treatment. In particular, a restriction on the period of use whilst at the same time precluding repeated use of the medicinal product, in addition to the proposed amendments to the product information, is disproportionate. In any event, instead of restricting the period of use — whilst at the same time precluding repeated use — and the obligations based thereon, a less stringent means of examining the alleged safety concerns would have been to order the carrying out of a study. | — | In respect of the third plea, the applicants argue that the warnings in the product information, which are provided for in the implementing decision, the further restrictions included in the marketing authorisation for the medicinal product and the obligations based thereon are disproportionate and infringe the principle of equal treatment. In particular, a restriction on the period of use whilst at the same time precluding repeated use of the medicinal product, in addition to the proposed amendments to the product information, is disproportionate. In any event, instead of restricting the period of use — whilst at the same time precluding repeated use — and the obligations based thereon, a less stringent means of examining the alleged safety concerns would have been to order the carrying out of a study. |
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| — | In respect of the third plea, the applicants argue that the warnings in the product information, which are provided for in the implementing decision, the further restrictions included in the marketing authorisation for the medicinal product and the obligations based thereon are disproportionate and infringe the principle of equal treatment. In particular, a restriction on the period of use whilst at the same time precluding repeated use of the medicinal product, in addition to the proposed amendments to the product information, is disproportionate. In any event, instead of restricting the period of use — whilst at the same time precluding repeated use — and the obligations based thereon, a less stringent means of examining the alleged safety concerns would have been to order the carrying out of a study. | | |

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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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