Abstract
Most parents and many paediatricians are not aware that medicines for children are often not tested, labelled, or approved for their prescribed use. In 1997, the Food and Drug Administration developed incentives for pharmaceutical companies to perform paediatric research in medications. The European Commission brought out its proposal for paediatric incentives after in-depth internal reflection. Now it should be adapted quickly to boost pharmaceutical paediatric research in the EU as soon as possible. Conclusion:The proposal must be balanced and aware that both incentives and requirements are mandatory in order to maintain and stimulate paediatric research on medicines in Europe.
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References
Boos J (2003) Editorial. Off label use—label of use? Ann Oncol 14: 1–5
Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products (1992). Official Journal of the European Communities L182, pp 1–5
Council resolution of 14 December 2000 on paediatric medicinal products (2001/c 17/01) (2001). Official Journal of the European communities 19.1.2001, pp C17/1
European Commission (2002) Pharmaceuticals: regulatory framework and market authorizations. Better medicines for children—proposed regulatory action on paediatric medicinal products. Consultation document, February 28th http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2002/feb/cd_pediatrics_en.pdf (accessed January 26, 2004)
European Commission (2003) Directorate-General for Research. Towards a European Research Area Science, Technology and Innovation. Key Figures 2003–2004, pp 43–44
European Commission (2004) Commission consultation on a draft proposal for a European Parliament and Council Regulation (EC) on medicinal products for paediatric use, March, 8th http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2004/mar/Paediatric%20consultation%20document%20final%208%20March%2004.pdf (accessed April 13, 2004)
Gregg (2003) Pediatric Research Equity Act of June 27 (legislative day, June 26), from the Committee on Health, Education, Labor, and Pensions. US Senate report 108–84, p 3 http://frwebgate.access.gpo.gov/cgi-in/getdoc.cgi?dbname=108_cong_reports&docid=f:sr084.108.pdf (accessed January 26, 2004)
Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (2000) Official Journal of the European Communities L18, pp 1–5
Smith, RN (2002) 5th EMEA/IFAPP Conference. Meeting report: clinical studies at extremes of age. Int J Pharm Med 16: 49–56
The Pediatric Exclusivity Provision (2001) Status Report to Congress—Department of Health and Human. January Services—US Food and Drug Administration, p 12 http://www.fda.gov/cder/pediatric/reportcong01.pdf (accessed January 26, 2004)
US Food and Drug Administration (2003) Center for Drug Evaluation and Research. Paediatric Exclusivity Labelling Changes as of August 22 http://www.fda.gov/cder/pediatric/labelchange.htm (accessed January 26, 2004)
US Food and Drug Administration (2003) Department of Health and Human Services. FDA Statement. Statement of the FDA Commissioner Mark B. McClellan, M.D., Ph.D., on the signing of the Pediatric Research Equity Act of December 3 http://www.fda.gov/bbs/topics/NEWS/2003/NEW00989.html (accessed January 26, 2004)
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Ramet, J. What the paediatricians need—the launch of paediatric research in Europe. Eur J Pediatr 164, 263–265 (2005). https://doi.org/10.1007/s00431-005-1633-z
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DOI: https://doi.org/10.1007/s00431-005-1633-z