It is widely recognised that information relating to the use of medicines in children is sorely lacking, causing substantial ‘off-label use’ of adult medicines in paediatric populations. Attempts have been made to address this shortfall in the USA through the introduction of specific legislation. The EU also intends to put forward legislation, but whether, or how much, EU law should reflect that of the USA is a matter of some considerable analysis and debate.
ConroyS.ChoonaraI.ImpicciatoreP. (2000) ‘Survey of unlicensed and off label drug use in paediatric wards in European countries’British Medical JournalVol. 320, pp. 79–82.
2.
ChoonaraI. (2000) ‘Clinical trials of medicines in children’British Medical JournalVol. 321, pp. 1093–1094.
3.
Directive 2001/20/EC of the European Parliament and of the Council of 4th April, 2001, on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
4.
Note for Guidance CPMP/ICH/2711/99, ICH Topic E11, ‘Clinical Investigation of Medicinal Products in the Pediatric Population’, 27th July, 2000.
5.
McElnayProfessor J., Queens University Belfast. Reported in BBC News, 29th August, 2002, available at http://news.bbc.co.uk.
6.
Ben Peck presentation in European Parliament Workshop, 18th February, 2003, US consumer group ‘Public Citizen's Congress Watch’.
Commission Consultation on a draft proposal for a European Parliament and Council Regulation (EC) on medicinal products for paediatric use, March 2004.
Regulation (EC) No. 141/2000 of the European Parliament and Council of 16th December, 1999, on orphan medicinal products, and Commission Regulation (EC) No. 847/2000 of 27th April, 2000, laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts 'similar medicinal product’ and ‘clinical superiority’.
16.
Anon (2002) ‘ISDB and the proposed regulation for medicines in children’, available at http://www.isdbweb.org.
17.
Anon (2003) ‘Medicines for mankind — Medicines for children’, EFPIA publication, Brussels, May.
18.
EFPIA position papers ‘Better medicines for children’ (April 2002) and ‘Considerations in support of an effective proposal for medicinal products for paediatric use’ (April 2003).
19.
Commercial data obtained by the EGA.These studies may be carried out in one or a number of countries. Although the cost of studies can vary between countries, the fact that these are the best possible rates is inherent in the commercial nature of the figures in a competitive market.
