On 22 June 2023, the Court of Justice of the EU (“the Court”) set aside a judgment of the General Court regarding the impartiality of experts involved in the scientific assessment of a marketing authorisation application submitted before the European Medicines Agency (EMA).
The case stems from the Commission’s decision to refuse the granting of a marketing authorisation for an orphan designated product intended to treat multiple myeloma. The applicant challenged the refusal before the General Court who in turn annulled the Commission’s decision based on a conflict of interest of two scientific experts, members of the Oncology Scientific Advisory Group (SAG), involved in the scientific assessment of the application.
In particular, the General Court considered the two experts had a possible bias to the extent that they had been employees of a university hospital that controlled a cell therapy centre which itself satisfied the criteria of the ‘pharmaceutical company’, as defined in EMA’s Policy on the handling of competing interests of scientific committees’ members and experts.
Following an appeal from Germany and Estonia, the Court overruled the General Court’s judgment and concluded that university hospitals must be treated as research organisations and not as pharmaceutical companies when interpreting EMA’s policy on the handling of competing interests of scientific committees’ members and experts.
According to the Court, the exclusion of these hospitals from the concept of pharmaceutical company helps to strike a balance between the requirement of impartiality and the need for scientific advice of the highest possible standard. To achieve that balance, EMA must be entitled to appoint individuals belonging to the staff of university hospitals as experts.
The Court goes on to argue that an overall exclusion of all university hospital experts from participation in the EMA’s scientific assessment on the ground that such hospitals have, within them, one or more entities capable of constituting pharmaceutical companies, would risk creating a shortage of experts with detailed medical knowledge in certain scientific fields, especially in relation to orphan medicinal products or advanced therapies. Only individuals employed by entities which themselves satisfy the criteria of a ‘pharmaceutical company’ should be excluded from participating in the scientific assessment of marketing authorisation applications.
The judgment is good news to EMA, given that -as noted in the judgment- staff of universities and university hospitals represent the most important part of the network of experts in which EMA relies on when evaluating applications for marketing authorisation of a medicinal product.
