EFPIA Calls on EU Policy-makers to Set in Place a Strong and Attractive Paediatric Framework for the Benefit of Children

April 27, 2005

Applied Clinical Trials

Taking part in a lunch debate organised by the European Parliament on the theme "Better Medicines for Children - The currently debated legislative proposal", Brian Ager, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA), today called on EU policy-makers to quickly adopt the Commission's proposal for a Regulation on Medicinal Products for Paediatric Use.

Brussels, 27 April 2005 - Taking part in a lunch debate organised by the European Parliament on the theme "Better Medicines for Children - The currently debated legislative proposal", Brian Ager, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA), today called on EU policy-makers to quickly adopt the Commission's proposal for a Regulation on Medicinal Products for Paediatric Use.

"The European-based pharmaceutical companies that invest in high value-creating R&D support this long-awaited EU initiative, said Brian Ager. Measures to be introduced at Community level must include simple and effective incentives to stimulate paediatric R&D in Europe".

Sharing EFPIA's views with high-level representatives of the European Parliament, the Presidency of the EU Council, the European Commission and various stakeholders, Brian Ager stressed that:

  • so far progress has been achieved in numerous paediatric therapeutic fields, thanks to medicines that provide cure or relief from many childhood diseases;
  • but pharmaceutical research in children presented a series of scientific, technical, practical and ethical challenges of importance;
  • industry, regulators, patient groups, doctors, paediatric societies and EU researchers all had a role to play - the goal was to foster paediatric research in Europe for the benefit of children.

The adoption of the Commission's proposal by the European Parliament and the European Council and subsequently its implementation without delay by all EU-25 Member States is a key opportunity to improve children's health. It should also allow Europe to catch up with other world regions where paediatric research has been incentivised as a means to develop medicines adapted to the needs of children.

"Our children must be able to benefit from medicines tailored to their special needs. This must be achieved by restoring a strong pharmaceutical research and development presence for Europe", concluded Brian Ager.

EFPIA's views on the European Commission's Proposal for a Regulation on Medicinal Products for Paediatric use are available on-line on the EFPIA website at: http://www.efpia.org/4_pos/paediatrics0405.pdf