On Thursday 22 June , the Court of Justice of the European Union (CJEU) annulled the decision of the General Court of the European Union, (Joined Cases 6/21 P and C-16/21 P) which had found that the experts of theEuropean Medicines Agency (EMA) could have been impartial in the negative opinion issued on the marketing authorisation application by Pharma Mar for the orphan drug ‘Aplidin’.
In July 2018, the Commission had relied on an EMA opinion to refuse to grant marketing authorisation for this drug developed to treat severe bone marrow cancer. The opinion was based on the work of several experts, two of whom had been employed by a university hospital that controlled a cell therapy centre. The latter fulfilled the criteria of a ‘pharmaceutical undertaking’ within the meaning of EMA rules. Employment in such a company is, in principle, incompatible with participation in EMA activities.
Just over two years later, on 28 October 2020, following an appeal lodged by Pharma Mar, the Court of First Instance annulled this decision, ruling that the procedure that led to the refusal did not offer sufficient guarantees to exclude any legitimate doubt as to the possible bias of the experts involved in the assessment of the drug.
In its judgment, the Court held that the Court of First Instance had erred in considering that the university hospital constituted a ‘pharmaceutical undertaking’ solely because it controlled the cell therapy centre in question.
“To consider that all the staff of a university hospital are employed by a ‘pharmaceutical undertaking’ would be contrary to European Union law”, the Court stated, taking the view that a blanket exclusion of this kind could lead to a shortage of experts with sufficient medical knowledge to assess medicines.
In addition, the Court points out, the EU’s centralised authorisation procedure also applies to orphan medicines, with a view to harmonising the single market.
See the judgment: https://aeur.eu/f/7na (Original version in French by Thomas Mangin)