Proposed new EU regulation covering paediatric medicines could further delay improvements to research and availability of medicines for children, warned the Association of the British Pharmaceutical Industry today (Monday).
The UK pharmaceutical industry has led the way in improving the provision of medicines for children and supports the need for new legislation to encourage further research. But Dr Richard Tiner, ABPI's Director of Medicine, said the association, which represents more than 70 pharmaceutical companies and 20 contract research organisations in the UK, regretted that EU proposals were unlikely to be finalised for at least another 18 months.
"This will introduce further delay in the development of paediatric uses for medicines in Europe. However, we are pleased that paediatric development will not delay the authorisation of medicines for adults," said Dr Tiner.
"Our biggest disappointment relates to the failure of the Commission to recommend a transition period whilst the discussions on the Regulation take place in the Parliament and Council. Companies should be encouraged to develop paediatric data as soon as possible and not have to wait for 18 months or more due to the Parliamentary process. This would definitely benefit the children of Europe and partially alleviate the outcomes of the continuing delays in the introduction of final legislation," said Dr Tiner.
"We are also disappointed that there will need to be further legislation introduced to promote the Community programme - Medicines Investigation for the Children of Europe (MICE) - as we believe this further delays research into much older medicines which are frequently used in children, and is work that is unlikely to be taken up by the industry."
The ABPI has led the way in European discussions over extending clinical trials to include children but this work can only be carried out where it is ethically safe to do so. It believes the new regulatory framework established by the new legislation must reflect this.
For further information, please contact: ABPI Press Office 020 7747 1410