Checks and Balances in the EU: The Role of the European Ombudsman, with a Focus on the Paediatric Regulation

Abstract

The European Ombudsman is an independent and impartial body that holds the EU administration to account. The Ombudsman deals with complaints lodged against the European Medicines Agency, most of which concern lack of transparency. In dealing with these complaints, the Ombudsman has underlined the importance of ensuring that European citizens trust the Agency and have confidence in the important work it carries out on their behalf.

During the course of 2012, the European Ombudsman issued a draft recommendation to the Agency in relation to the latter’s application of the EU’s Paediatric Regulation. Specifically, the case concerned the Agency’s procedures for deciding whether pharmaceutical companies should be obliged to carry out studies to investigate whether a pharmaceutical product could be used to treat children. The case is a useful illustration of the Ombudsman’s essential role in holding the European Medicines Agency to account. More generally, it helps demonstrate that the Union has inbuilt checks and balances that seek to ensure that its institutions act legally, in full respect of fundamental rights, and in accordance with principles of good administration.

The points made, and any possible errors, in this chapter are solely attributable to the author. The views expressed are not necessarily supported by the Ombudsman.