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Problems in applying EU rules aimed at protecting the health of children

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  • Case: 2575/2009/(TS)(TN)RA
    Opened on 19 Jan 2010 - Recommendation on 11 May 2012 - Decision on 22 Jul 2013
  • Institution(s) concerned: European Medicines Agency
  • Field(s) of law: Environment, consumers and health protection
  • Types of maladministration alleged – (i) breach of, or (ii) breach of duties relating to: Lawfulness (incorrect application of substantive and/or procedural rules) [Article 4 ECGAB],Absence of discrimination [Article 5 ECGAB],Duty to state the grounds of decisions and the possibilities of appeal [Articles 18 and 19 ECGAB]
  • Subject matter(s): Institutional and policy matters
Several kids around pill printed on open book
Author: Luis Molinero Martínez
Copyright: Stocklib © Luis Molinero Martínez

Summary of the decision on complaint 2575/2009/(TS)(TN)RA against the European Medicines Agency

This case concerns the European Medicines Agency's procedures for deciding whether pharmaceutical companies should be obliged to carry out studies to investigate whether and how their product could be used to treat children. These procedures, which are derived from the EU's Paediatric Regulation, aim to improve the availability of medicinal products for children. While the Regulation establishes a general rule that pharmaceutical companies must carry out studies to determine whether and how their product could be used to treat children, it allows the Agency to waive this obligation in certain cases.

The complainants argued that the Agency was wrong to reject their application for a waiver for their drug (candesartan), which is used to treat heart failure. They noted that the Agency had granted a waiver to two similar products (losartan and valsartan) and alleged that the refusal to grant them a waiver infringed the principle of equal treatment, was not objective or fair, and was not reasoned.

The Ombudsman concluded that the Agency was entitled to deny a waiver to candesartan. However, he found that the Agency (i) failed to ensure adequate transparency of the process through which it reached its decisions and as a result (ii) failed to provide adequate reasons for those decisions.

To avoid similar problems in the future, the Ombudsman made a draft recommendation, calling on the Agency to adopt measures to make its work in this area more transparent. The Agency agreed, setting out the initiatives it had already taken and those that are in the pipeline. The Ombudsman welcomed these measures, which should help to avoid similar problems reoccurring and to instill even greater trust of citizens in the Agency's work.