(AGENPARL) – gio 14 marzo 2024 PRESS RELEASE No 46/24
Luxembourg, 14 March 2024
Judgment of the Court in Case C-291/22 P | D & A Pharma v Commission and EMA
Marketing authorisations for medicinal products: the European Medicines
Agency (EMA) must ensure that the experts it consults do not have a
conflict of interest
The EMA cannot avoid this obligation of objective impartiality by requiring the applicant to prove the bias of
the committee member concerned
The laboratory D & A Pharma filed an application with the European Medicines Agency (EMA) for marketing
authorisation for Hopveus, a medicinal product derived from sodium oxybate. That active substance is indicated to
combat alcohol dependence in the medium and long term.
Following a negative opinion from the Committee for Medicinal Products for Human Use (CHMP – which is part of
the EMA), D & A Pharma requested re-examination of its application, proposing in particular that the therapeutic
indications of the medicinal product be revised and that a scientific advisory group on psychiatry (the SAG on
Psychiatry) be convened. That request for re-examination also resulted in a negative opinion, which led the
European Commission to refuse, in July 2020, the marketing authorisation for Hopveus.
Criticising, among other things, the lack of impartiality of the experts consulted (who allegedly had a conflict of
interest) as well as a breach of the principle of adversarial examination, D & A Pharma requested the General Court
of the European Union to annul the decision of the Commission. That action having been dismissed 1, the laboratory
then turned to the Court of Justice.
The Court sets aside the judgment of the General Court and annuls the decision of the Commission refusing
the application for marketing authorisation for Hopveus.
In its judgment, the Court first pointed out that a member of the expert group consulted by the CHMP had a
conflict of interest, substantially vitiating the procedure. It then found that the judgment of the General Court was
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.
Finally, taking the view that the state of the proceedings permits final judgment to be given, the Court added that
the decision to convene an ad hoc expert group instead of the SAG on Psychiatry constitutes a defect vitiating the
procedure for adopting the opinion of the EMA, which in turn affects the procedure undertaken by the
Commission to adopt that decision. The EMA is required to undertake that the CHMP will systematically consult a
SAG when the applicant for re-examination requests such consultation in good time and in a duly reasoned way.
NOTE: An appeal, on a point or points of law only, may be brought before the Court of Justice against a judgment or
order of the General Court. In principle, the appeal does not have suspensive effect. If the appeal is admissible and
Communications Directorate
Press and Information Unit
curia.europa.eu
well founded, the Court of Justice sets aside the judgment of the General Court. Where the state of the proceedings
so permits, the Court of Justice may itself give final judgment in the case. Otherwise, it refers the case back to the
General Court, which is bound by the decision given by the Court of Justice on the appeal.
Unofficial document for media use, not binding on the Court of Justice.
The full text and, as the case may be, the abstract of the judgment is published on the CURIA website on the day of
delivery.
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Judgment of 2 March 2022, D & A Pharma v Commission and EMA, T-556/20.
Communications Directorate