THE IMPARTIALITY AND THE CONFLICT OF INTEREST WITH THE PHARMACEUTICAL INDUSTRY OF THE EXPERTS OF THE EUROPEAN MEDICINES AGENCY: COMMENT ON THE CJEU, APLIDIN CASE, 22 JUNE 2023 (Joined Cases C-6/21 P and C-16/21 P)

The CJEU judgment of 22 June 2023 (joined cases C-6/21 and C-16/21) on the assessment of an alleged conflict of interest in two experts of the European Medicines Agency provides an opportunity to delimit the scope of application of impartiality in authorization procedures for orphan medicinal products. In its ruling, the CJEU states that a university hospital should be exempted from qualifying as a pharmaceutical company, even if it houses a drug production unit that qualifies as such. Consequently, the employment of the two experts at the university hospital is not likely to undermine the right to a diligent and impartial marketing authorization procedure, and therefore no conflict of interest can be discerned. This commentary is intended to provide an approximation of the reasons for the legal conflict between the right to a sound administration of justice within the EMA and the obligation to have the best scientific expertise available when making opinions for the marketing authorization of medicinal products.

Automated summary

The CJEU judgment determines that a university hospital is exempt from being classified as a pharmaceutical company, even if it houses a drug production unit. Therefore, the employment of two experts at the university hospital does not amount to a conflict of interest.