06 June

HEALTHCARE

The EU Court of Justice decides on the obligation of impartiality: it is not necessary to prove the lack of impartiality, a legitimate doubt that cannot be dispelled is sufficient

06/06/2019

"EU institutions and bodies are required to respect the fundamental rights of the European Union, which include the right to good administration enshrined in Article 41 of the Charter" [of fundamental rights], which, in paragraph 1, establishes that every person has the right to have his or her affairs handled impartially.

The requirement of impartiality aims to guarantee equal treatment, which is a basic principle of European law, in order to avoid situations of potential conflict of interest for officials acting on behalf of institutions. Given the fundamental importance of guaranteeing independence and integrity as regards both internal operation and the external image of EU institutions, this requirement of impartiality must cover all of the circumstances that an official called upon to comment on a case must reasonably understand as likely to appear, in the eyes of third parties, as capable of influencing independence in the matter.

Consequently, the requirement of impartiality must be ensured both from a subjective point of view, in the sense that none of the members of the institution concerned must express preconceived opinions or personal prejudices, as well as from an objective point of view, in the sense that the institution is bound to offer sufficient guarantees to exclude any legitimate doubt as regards potential prejudice.

On the basis of these principles, in annulling the judgement of the first instance, the EU Court of Justice declared the decision adopted by the European Commission on the renewal of the marketing authorisation of a medicinal product to be illegitimate. The decision was adopted on the basis of the opinion given by the Committee for Medicinal Products for Human Use (CHMP) of the EMA, whose main rapporteur was an employee of the national authority that had previously issued a decision refusing the renewal of the marketing authorisation for said medicinal product. Furthermore, the employee had defended the aforementioned authority in the appeal against the decision before national judges, and initiated the procedure before the Committee itself (EU Court of Justice, judgment of 27 March 2019, in case C-680/16P).