# C_2016279EN.01003802.xml

| 1.8.2016 | EN | Official Journal of the European Union | C 279/38 |
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1.8.2016

EN

Official Journal of the European Union

C 279/38

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Action brought on 6 June 2016 — SymbioPharm v EMA

(Case T-295/16)

(2016/C 279/54)

Language of the case: German

Parties

Parties

Applicant: SymbioPharm GmbH (Herborn, Germany) (represented by: A. Sander, lawyer)

Applicant:

Defendant: European Medicines Agency

Defendant:

Form of order sought

Form of order sought

The applicant claims that the Court should:

| — | Annul the decision of the EMA of 1 April 2016, which was delivered on 7 April 2016, to initiate a referral procedure under Article 31 of Directive 2001/83/EC with respect to the medicinal product Symbioflor 2 and similarly named medicinal products of the company SymbioPharm GmbH; |
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Annul the decision of the EMA of 1 April 2016, which was delivered on 7 April 2016, to initiate a referral procedure under Article 31 of Directive 2001/83/EC with respect to the medicinal product Symbioflor 2 and similarly named medicinal products of the company SymbioPharm GmbH;

| — | Order the EMA to pay the costs of the proceedings. |
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Order the EMA to pay the costs of the proceedings.

Pleas in law and main arguments

Pleas in law and main arguments

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

| 1. | First plea in law: Infringement of Article 31 of Directive 2001/83/EC (1)

  The applicant submits that the referral procedure was initiated although no ‘specific case where the interests of the European Union are involved’ is set out in the notification of the German authorisations authority and that no such specific case, moreover, exists. |
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1.

First plea in law: Infringement of Article 31 of Directive 2001/83/EC (1)

1

The applicant submits that the referral procedure was initiated although no ‘specific case where the interests of the European Union are involved’ is set out in the notification of the German authorisations authority and that no such specific case, moreover, exists.

| 2. | Second plea in law: Infringement of Article 29 of Directive 2001/83/EC
  The applicant maintains that the German authorisations authority did not, in relation to the medicinal product for human use Symbioflor 2, set out the ‘risk to public health’, which is a precondition for the initiation of a procedure, and submits that, what is more, there is clearly no such risk. |
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2.

Second plea in law: Infringement of Article 29 of Directive 2001/83/EC

The applicant maintains that the German authorisations authority did not, in relation to the medicinal product for human use Symbioflor 2, set out the ‘risk to public health’, which is a precondition for the initiation of a procedure, and submits that, what is more, there is clearly no such risk.

| 3. | Third plea in law: Infringement of Articles 116 and 117 of Directive 2001/83/EC
  The applicant submits that the German authorisations authority has not made a case for the existence of an unfavourable benefit-risk balance with regard to the medicinal product for human use Symbioflor 2 and submits that there is clearly no such unfavourable benefit-risk balance. |
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3.

Third plea in law: Infringement of Articles 116 and 117 of Directive 2001/83/EC

The applicant submits that the German authorisations authority has not made a case for the existence of an unfavourable benefit-risk balance with regard to the medicinal product for human use Symbioflor 2 and submits that there is clearly no such unfavourable benefit-risk balance.

| 4. | Fourth plea in law: Infringement of Article 22a of Directive 2001/83/EC, of the principle of proportionality and of the right to be heard
  The applicant submits that there is infringement of Article 22a of Directive 2001/83/EC and of the principle of proportionality because the German authorisations authority did not make use of the possibility of ordering an efficacy study to be conducted (failure to exercise a discretion). It maintains that that is also shown by the express refusal of the German authorisations authority to organise a hearing in the form of a discussion on that subject with the ombudsman, as requested by the applicant. |
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4.

Fourth plea in law: Infringement of Article 22a of Directive 2001/83/EC, of the principle of proportionality and of the right to be heard

The applicant submits that there is infringement of Article 22a of Directive 2001/83/EC and of the principle of proportionality because the German authorisations authority did not make use of the possibility of ordering an efficacy study to be conducted (failure to exercise a discretion). It maintains that that is also shown by the express refusal of the German authorisations authority to organise a hearing in the form of a discussion on that subject with the ombudsman, as requested by the applicant.

| 5. | Fifth plea in law: Infringement of the principles of the rule of law
  Here the applicant submits that it is contrary to principles of the rule of law to initiate a referral procedure whilst national court proceedings in respect of the same subject-matter are pending. |
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5.

Fifth plea in law: Infringement of the principles of the rule of law

Here the applicant submits that it is contrary to principles of the rule of law to initiate a referral procedure whilst national court proceedings in respect of the same subject-matter are pending.

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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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