# C_2020371EN.01001901.xml

| 3.11.2020 | EN | Official Journal of the European Union | C 371/19 |
| --- | --- | --- | --- |

3.11.2020

EN

Official Journal of the European Union

C 371/19

---

Action brought on 4 September 2020 — D&A Pharma v Commission and EMA

(Case T-556/20)

(2020/C 371/22)

Language of the case: French

Parties

Applicant: Debregeas et associés Pharma (D&A Pharma) (Paris, France) (represented by: N. Viguié and D. Krzisch, lawyers)

Defendants: European Commission and European Medicines Agency

Form of order sought

The applicant claims that the General Court should:

| — | annul the Commission’s Implementing Decision of 6 July 2020 refusing marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for ‘Hopveus — sodium oxybate’, a medicinal product for human use; |
| --- | --- |

—

annul the Commission’s Implementing Decision of 6 July 2020 refusing marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for ‘Hopveus — sodium oxybate’, a medicinal product for human use;

| — | order the European Commission and the EMA to pay all the costs of the present proceedings. |
| --- | --- |

—

order the European Commission and the EMA to pay all the costs of the present proceedings.

Pleas in law and main arguments

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

| 1. | First plea in law, alleging infringement, first, of Article 62(1) of 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 and, secondly, of Article 11 of the Rules of Procedure of the Standing Committee on Medicinal Products for Human Use (‘the CHMP’). The applicant submits that the procedure that led to the CHMP opinion was irregular in so far as the CHMP was required to consult the Scientific Advisory Group on Psychiatry, a competent and independent body, given that it was asked to do so in the context of the procedure for re-examining the application for a marketing authorisation (‘MA’) for Hopveus. However, the CHMP did not do so. |
| --- | --- |

1.

First plea in law, alleging infringement, first, of Article 62(1) of 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 and, secondly, of Article 11 of the Rules of Procedure of the Standing Committee on Medicinal Products for Human Use (‘the CHMP’). The applicant submits that the procedure that led to the CHMP opinion was irregular in so far as the CHMP was required to consult the Scientific Advisory Group on Psychiatry, a competent and independent body, given that it was asked to do so in the context of the procedure for re-examining the application for a marketing authorisation (‘MA’) for Hopveus. However, the CHMP did not do so.

| 2. | Second plea in law, alleging infringement of Article 63(2) of Regulation No 726/2004 in so far as that the procedure before the CHMP was vitiated by a lack of impartiality owing to conflicts of interest on the part of certain experts on the ad hoc committee convened by the CHMP. The applicant claims that experts who work, in particular, as advisors to pharmaceutical companies in the development of treatments that may be in competition with Hopveus may not participate in ad hoc expert groups. Accordingly, their participation failed to comply with the principle of objective impartiality, as defined by the Courts of the European Union and the European Court of Human Rights, and gave rise to reasonable doubt as to whether the applicant’s application for a conditional MA was carried out in a neutral and objective manner. |
| --- | --- |

2.

Second plea in law, alleging infringement of Article 63(2) of Regulation No 726/2004 in so far as that the procedure before the CHMP was vitiated by a lack of impartiality owing to conflicts of interest on the part of certain experts on the ad hoc committee convened by the CHMP. The applicant claims that experts who work, in particular, as advisors to pharmaceutical companies in the development of treatments that may be in competition with Hopveus may not participate in ad hoc expert groups. Accordingly, their participation failed to comply with the principle of objective impartiality, as defined by the Courts of the European Union and the European Court of Human Rights, and gave rise to reasonable doubt as to whether the applicant’s application for a conditional MA was carried out in a neutral and objective manner.

| 3. | Third plea in law, alleging that the minutes of the ad hoc committee meeting of 6 April 2020 do not comply with the provisions of Article 3.7 of the EMA document ‘Mandate, objectives and rules of procedure of the Scientific Advisory Groups (SAGs) and ad hoc expert groups’. |
| --- | --- |

3.

Third plea in law, alleging that the minutes of the ad hoc committee meeting of 6 April 2020 do not comply with the provisions of Article 3.7 of the EMA document ‘Mandate, objectives and rules of procedure of the Scientific Advisory Groups (SAGs) and ad hoc expert groups’.

| 4. | Fourth plea, alleging that by refusing to grant a conditional MA on the ground that ‘the benefit-risk balance of Hopveus [was] not favourable’, the European Commission failed to comply with the framework laid down by Commission Regulation 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 and thereby vitiated the contested decision by breaching the principle of equal treatment and non-discrimination. According to the applicant, that conclusion is based on an error of law and a manifest error of assessment, since Regulation No 507/2006 does not make the grant of a conditional MA on the submission by the applicant of exhaustive clinical data free of methodological limitations. Conditional MAs ‘are based on data that is less complete than that normally required and are subject to specific obligations’. In the present case, those studies were even reviewed by the Pharmacovigilance Risk Assessment Committee (‘the PRAC’) and by the CHMP in the context of the annual evaluation of sodium oxybate based medicines and their validity was confirmed by that evaluation and by the European Commission in relation to the bioequivalent medicine Alcover. The applicant claims that the EMA could not therefore consider that the limitations of the studies submitted by the applicant, some of which were validated in a 2010 scientific opinion, were major and decisive as regards a conditional MA when similar criticisms had not been made in the context of unconditional MAs granted to competitors. |
| --- | --- |

4.

Fourth plea, alleging that by refusing to grant a conditional MA on the ground that ‘the benefit-risk balance of Hopveus [was] not favourable’, the European Commission failed to comply with the framework laid down by Commission Regulation 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 and thereby vitiated the contested decision by breaching the principle of equal treatment and non-discrimination. According to the applicant, that conclusion is based on an error of law and a manifest error of assessment, since Regulation No 507/2006 does not make the grant of a conditional MA on the submission by the applicant of exhaustive clinical data free of methodological limitations. Conditional MAs ‘are based on data that is less complete than that normally required and are subject to specific obligations’. In the present case, those studies were even reviewed by the Pharmacovigilance Risk Assessment Committee (‘the PRAC’) and by the CHMP in the context of the annual evaluation of sodium oxybate based medicines and their validity was confirmed by that evaluation and by the European Commission in relation to the bioequivalent medicine Alcover. The applicant claims that the EMA could not therefore consider that the limitations of the studies submitted by the applicant, some of which were validated in a 2010 scientific opinion, were major and decisive as regards a conditional MA when similar criticisms had not been made in the context of unconditional MAs granted to competitors.

| 5. | Fifth plea in law, alleging that, by refusing to grant the conditional MA on the ground that ‘the benefit-risk balance of Hopveus [was] not favourable’, the European Commission vitiated its decision by breaching the principle of equal treatment and non-discrimination, combined with a manifest error of assessment and a breach of Article 16 of Regulation No 726/2004. The applicant claims that the EMA entities (CHMP and PRAC) issued contrary opinions on the respective benefit-risk balances of Alcover and Hopveus, despite the fact that the bioequivalence of these medicines is recognised and that they are both intended to treat the same pathology. Those differing opinions cannot be explained by any objective difference, in particular with regard to the objectives of European legislation on medicinal products. Furthermore, the benefit-risk balance cannot differ between pre-marketing and post-marketing analysis. |
| --- | --- |

5.

Fifth plea in law, alleging that, by refusing to grant the conditional MA on the ground that ‘the benefit-risk balance of Hopveus [was] not favourable’, the European Commission vitiated its decision by breaching the principle of equal treatment and non-discrimination, combined with a manifest error of assessment and a breach of Article 16 of Regulation No 726/2004. The applicant claims that the EMA entities (CHMP and PRAC) issued contrary opinions on the respective benefit-risk balances of Alcover and Hopveus, despite the fact that the bioequivalence of these medicines is recognised and that they are both intended to treat the same pathology. Those differing opinions cannot be explained by any objective difference, in particular with regard to the objectives of European legislation on medicinal products. Furthermore, the benefit-risk balance cannot differ between pre-marketing and post-marketing analysis.

| 6. | Sixth plea in law, alleging that the contested decision infringed the principles of equal treatment and consistency between the opinions of the EMA entities, and the principle of good administration, since the CHMP and the PRAC constantly issued contradictory opinions concerning the outpatient and inpatient administration of Hopveus and Alcover. |
| --- | --- |

6.

Sixth plea in law, alleging that the contested decision infringed the principles of equal treatment and consistency between the opinions of the EMA entities, and the principle of good administration, since the CHMP and the PRAC constantly issued contradictory opinions concerning the outpatient and inpatient administration of Hopveus and Alcover.

---