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Ethical principles and legal requirements for pediatric research in the EU: an analysis of the European normative and legal framework surrounding pediatric clinical trials

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Abstract

The involvement of minors in clinical research is inevitable to catch up with the lack of drugs labeled for pediatric use. To encourage the responsible conduct of pediatric clinical trials in the EU, an extensive legal framework has been developed over the past decade in which the practical, ethical, legal, social, and commercial issues in pediatric research are addressed. In this article, the European legal framework surrounding pediatric clinical trials is analyzed from the perspective of the major ethical concerns in pediatric research. The four principles of biomedical ethics will be used as a conceptual framework (1) to map the ethical issues addressed in the European legal framework, (2) to study how these issues are commonly handled in competent adults, (3) to detect workability problems of these paradigmatic approaches in the specific setting of pediatric research, and (4) to illustrate the strong urge to differentiate, specify, or adjust these paradigmatic approaches to guarantee their successful operation in pediatric research. In addition, a concise comparative analysis of the European regulation will be made. To conclude our analysis, we integrate our findings in the existing ethical discussions on issues specific to pediatric clinical research.

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Notes

  1. A list of countries that signed and/or ratified the convention can be consulted at http://conventions.coe.int/Treaty/Commun/ChercheSig.asp?NT=164&CM=&DF=&CL=ENG.

  2. Similar to the Pediatric Regulation, US Legislation offers (already since 1997) a 6-month extension of marketing exclusivity as a reward for the conduct of pediatric clinical trials. A study of the economic return of the Pediatric Exclusivity Program in the US shows that the economic return of the 6-month exclusivity extension is highly variable with net return-to-cost ratios ranging from −0.84 (i.e., a loss of $11,088,214) to 73.63 (i.e., a profit of $507,899,374) (see Li et al. [23]).

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Acknowledgement

The research for this publication was supported by the EuroCareCF Coordination Action (FP6—contract no. LSHM-CT-2005-18932).

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Authors and Affiliations

  1. Centre for Biomedical Ethics and Law, K.U.Leuven, Kapucijnenvoer 35, 3000, Leuven, Belgium

    Wim Pinxten, Kris Dierickx & Herman Nys

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  1. Wim Pinxten
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  2. Kris Dierickx
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  3. Herman Nys
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Correspondence to Wim Pinxten.

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Pinxten, W., Dierickx, K. & Nys, H. Ethical principles and legal requirements for pediatric research in the EU: an analysis of the European normative and legal framework surrounding pediatric clinical trials. Eur J Pediatr 168, 1225–1234 (2009). https://doi.org/10.1007/s00431-008-0915-7

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  • DOI: https://doi.org/10.1007/s00431-008-0915-7

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