Dáil Éireann díospóireacht -
Thursday, 7 Dec 2000

Vol. 527 No. 5

Written Answers. - Medicines Suitability.

Liam Burke

Ceist:

43 Mr. L. Burke asked the Minister for Health and Children if his attention has been drawn to the fact that about 75% of medicines administered to children are not evaluated as to their suitability for children; and if he will support moves to have the EU adopt a scheme to encourage Europe's pharmaceutical companies to develop drugs that are specifically suitable for children as advocated by the French Government. [28948/00]

Minister for Health and Children (Mr. Martin)

I am aware that the French EU Presidency outlined, in a draft memorandum on paediatric drugs – SN 3195/00 – of 14 June 2000, proposals to foster research and clinical trials for medicinal products provided for children. This subsequently became the basis for a draft Council resolution on paediatric medicines – document 13187/00 SAN 115 – which is currently being considered by the member states.

The resolution observes that medicinal products intended for children necessitate appropriate pharmaceutical presentation, to ensure easy and safe administration and also points out that a large number of the medicinal products administered to children may not have been evaluated specifically for paediatric use.

To alleviate this situation, the introduction of some form of incentive, regulatory or other supportive measures is proposed to promote clinical research and development in this area. Special and innovative action is required if these issues are to be addressed. Ireland welcomes this initiative and supports the adoption of the EU resolution to promote wider options to ensure that new medicinal products for children and products already on the market are fully adapted to the specific needs of children. The resolution also recognises that any such developments would have to take into account internationally acknowledged standards for the protection of minors with regard to medical scientific research.