Better medicines for children - From concept to reality
Tonio Borg, Commissioner for Health and Consumer Policy said: 'The Paediatric Regulation was adopted to address a very serious gap in healthcare. Despite the fact that children make up over 20 % of the population, many of the medicines prescribed to them were not specifically studied and authorised for use in children. I am pleased to see that in five years, progress has been made on research and the safety of children's medicines, and I hope that this marks the beginning of a much needed paradigm shift.'
Better Medicines for Children’ was a consultation paper from February 2002, in which the European Commission presented its vision for regulatory actions on paediatric medicinal products. At that time, many of the medicinal products used in children were not specifically studied or authorised for children. Instead, doctors often used products authorised for adults, sometimes in different dosages, with the associated risks of inefficacy and/or adverse reactions.
In 2010 around 21% of Europeans were children, representing more than 100 million people. Children represent a vulnerable population group with developmental, physiological and psychological differences from adults. They are not merely ‘small adults’. Age and development related research, and the availability of suitable medicinal products, is
consequently particularly important.
This consultation paper led to the adoption of the Paediatric Regulation some five years later, in December 2006.
In brief, the key objectives of the Regulation are:
• to ensure high-quality research into the development of medicines for children
• to ensure, over time, that the majority of medicines used by children are specifically
authorised for such use with appropriate forms and formulations
• to ensure the availability of high-quality information about medicines used by children
Five years on, since the Regulation came into force, DG SANCO has published a progress report on medicines for children. This preliminary snapshot shows:
• improvements in the paediatric medicines landscape
• better and safer research
• more medicines for children on the EU market
• more information for parents and health professionals
Some concrete examples of how much progress has actually been made are:
• an increase of new paediatric uses authorised for existing medicines and new pharmaceutical forms adapted for children
• EU funding of 16 research projects on off-patents medicines
• 18 000 study reports on paediatric population submitted by companies to the competent authorities
This report does not yet provide comprehensive answers, 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. Although it is on the whole very positive.