Article 41 - Right to good administration
Article 47 - Right to an effective remedy and to a fair trial
Article 51 - Field of application
Article 52 - Scope and interpretation
Key facts of the case:
Appeal – Medicinal products for human use – Application for marketing authorisation – Independence of experts consulted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) – Article 41 of the Charter of Fundamental Rights of the European Union – Right to good administration – Requirement of objective impartiality – Criteria for verifying the absence of conflict of interest – EMA’s policy on competing interests – Activities as a principal researcher, consultant or strategic adviser for the pharmaceutical industry – Rival products – Re-examination procedure – Regulation (EC) No 726/2004 – Article 56, Article 62, Article 63 – EMA Guidelines – Consultation of a scientific advisory group (SAG) or an ad hoc expert group.
Outcome of the case:
On those grounds, the Court (Fourth Chamber) hereby:
1. Sets aside the judgment of the General Court of the European Union of 2 March 2022, D & A Pharma v Commission and EMA (T‑556/20, EU:T:2022:111), except in so far as it declared the action inadmissible to the extent that it was directed against the European Medicines Agency (EMA).
2. Annuls the Commission implementing decision of 6 July 2020 refusing the marketing authorisation application for the medicinal product for human use Hopveus – sodium oxybate pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency, as amended by Regulation (EU) No 2019/5 of the European Parliament and of the Council of 11 December 2018.
3. Dismisses the action as to the remainder.
4. Orders Debrégeas et associés Pharma SAS (D & A Pharma) to pay the costs incurred by the European Medicines Agency (EMA) relating to the proceedings before the General Court of the European Union.
5. Orders the European Commission to bear its own costs, relating to both the proceedings before the General Court of the European Union and to the appeal proceedings, and to pay those incurred by Debrégeas et associés Pharma SAS (D & A Pharma) in those two sets of proceedings.
6. Orders the European Medicines Agency (EMA) to bear its own costs relating to the appeal proceedings.
49 Accordingly, the President of the Fourth Chamber of the Court decided that the request to reopen the written part of the procedure should be rejected, without having to examine the question, raised by the appellant in its request for such reopening, of whether the non-applicability of Article 128(2) of the Rules of Procedure in appeal proceedings may, in certain circumstances, be contrary to the right to an effective remedy enshrined in Article 47 of the Charter of Fundamental Rights of the European Union (‘the Charter’).
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55 According to the second part of the ground of appeal, that error of law, which constitutes an infringement of the right to good administration enshrined in Article 41 of the Charter, was coupled with an error in the legal characterisation of the facts, since the General Court wrongly held that Experts A and B were not in a situation of conflict of interest.
60 In the appellant’s view, if the policy on competing interests were, as the General Court held, to be understood as meaning that the principal investigator for a product may participate in the panel of experts which assesses the suitability of a rival product to be granted marketing authorisation, it would have to be concluded that that policy is contrary to the requirement of objective impartiality as derived from Article 41 of the Charter. The General Court’s interpretation of that policy cannot, therefore, be upheld.
61 The Commission and the EMA submit that the requirement of impartiality, enshrined in Article 41 of the Charter, is reflected in Article 63(2) of Regulation No 726/2004 and in the EMA Code of Conduct, adopted pursuant to the latter provision. The decision of the EU legislature to empower the EMA to implement Article 63(2) expresses the fact that that agency is the body best placed to assess the interests involved. The EMA struck a very detailed balance between the need for impartiality and the need for a high level of expertise. That balancing operation is expressed in Annex I to the policy on competing interests.
72 In that regard, it must be borne in mind that the fundamental right to good administration, set out in Article 41 of the Charter, includes, under paragraph 1 of that provision, the right to have one’s affairs handled impartially by the institutions, bodies, offices and agencies of the European Union.
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82 It must be stated, however, that the abovementioned paragraphs 130 to 133 of the judgment under appeal, which are vitiated by the errors of law relied on by the appellant in the first part of the second ground of appeal, constitute only one of the two grounds on which the General Court’s reasoning is based. The General Court held, in paragraphs 99 to 129 of that judgment, that Experts A and B were not, in accordance with the policy on competing interests, in a situation of conflict of interest when they participated in the discussions and deliberations of the ad hoc expert committee consulted by the CHMP in the context of the re-examination of the MA application for Hopveus, and that that policy was sufficient to ensure compliance with the requirement of objective impartiality, as follows from Article 41 of the Charter.
87 However, notwithstanding the existence of that broad discretion and the importance of the public interest referred to above, the EMA is required, in the exercise of its powers, under Article 51(1) of the Charter, to respect the rights and principles mentioned therein.
88 That agency is, in particular, bound by the requirements of Article 52(1) of the Charter. That provision states that any limitation on the exercise of the rights and freedoms recognised by the Charter must be provided for by law and respect the essence of those rights and freedoms, and that, subject to the principle of proportionality, limitations may be made only if they are necessary and genuinely meet objectives of general interest recognised by the European Union or the need to protect the rights and freedoms of others.
111 Those findings of the General Court must be read in conjunction with paragraphs 127 to 129 of the judgment under appeal, according to which the compliance of the policy on competing interests with the principle of objective impartiality, as it follows from Article 41 of the Charter, should not be called into question since the EMA carried out a detailed examination of all the situations of conflicts of interest likely to arise, and the appellant had not raised a plea of illegality in respect of that policy under Article 277 TFEU.
112 While the General Court was entitled to hold that, since the appellant did not claim that it was unlawful, there was no need to examine the lawfulness of the policy on competing interests, it could not have been unaware that the EMA is bound, when exercising its powers, by the Charter and must therefore, in any event, interpret and apply its policy in a manner consistent with it.
115 It follows that paragraph 104 of the judgment under appeal is vitiated by an error of law, in that the General Court’s interpretation of the policy on competing interests is incompatible with the principle of objective impartiality, as set out in Article 41(1) of the Charter.
