Report from the Commission to the European Parliament and the Council. Better medicines for children – from concept to reality. General report on experience acquired as a result of the application of Regulation (EC) No 1901/2006 on medicinal products for paediatric use

‘Better Medicines for Children’ was the ambitious title of a consultation paper of February 2002, in which the European Commission presented its vision for regulatory actions on paediatric medicinal products. At that time, many of the products used in children were not specifically studied or authorised in children. Instead, doctors often used products authorised for adults, sometimes in different dosages, with the associated risks of inefficacy and/or adverse reactions.

The consultation paper built on a 5-year discussion process that started in 1997 with a round table meeting at the premises of the European Medicines Agency (EMA) and was the blueprint for the subsequent legislative act. It outlined many of the measures that are to be found in the Paediatric Regulation (Regulation (EC) No 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use).

The Regulation was adopted some five years after the consultation paper, on 12 December 2006. It entered into force on 26 January 2007 and its main provisions were applicable from 26 July 2008 (Article 7) and 26 January 2009 (Article 8), respectively. Five years on, it is time to take stock of developments and report to the European Parliament and the Council on the experience acquired as a result of the Regulation. Are we already seeing the emergence of ‘better medicines for children’?

This report does not yet provide comprehensive answer, as it is subject to certain limitations; it should therefore be regarded as an interim report that presents a first impression of the experience gained. In view of the development cycles of medicinal products, it will take at least 10 years to gain a full understanding of the impact of the legislation. This factor has already been accounted for in the legislation which requires the Commission to provide a second, more comprehensive report in 2017 which must include an analysis of the economic impact of the rewards and incentives, together with an analysis of the Regulation’s implications for public health, with a view to proposing any necessary amendments. However at this stage, some analyses and interim conclusions can be made.

EUR-Lex: COM(2013)443: Follow the progress of this report through the decision-making procedure http://eur-lex.europa.eu/legal-content/EN/HIS/?uri=COM:2013:443:FIN

ESO: Background information: Medicines for children: more research, more availability and more information compared with 5 years ago http://www.europeansources.info/record/press-release-medicines-for-children-more-research-more-availability-and-more-information-compared-with-5-years-ago/

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