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Recommendations on Drug Therapy in Childhood (2005)

In 2005 an Ad-hoc commission published recommendations concerning the issue of “Drug Therapy in Childhood”. The work of the commission followed a conference regarding “Problems and Perspectives of Drug Therapy in Childhood and Adolescence” held by the Paul-Martini-Stiftung and the German National Academy of Sciences Leopoldina in Berlin.



Recommendations on Drug Therapy in Childhood
Children require special protection due to the circumstances of their age and development. This is also necessary because important prerequisites for later life are established in childhood, so it bears a high social value for the future.In the opinion of the Presidium of the Leopoldina, the German Academy of Natural Scientists, it has to be ensured that children are neither endangered by treatment with untested medicines nor exposed to medically or ethically unjustifiable stress in clinical tests.With this recommendation, the Presidium of the Leopoldina calls upon thoseresponsible in politics and society to commit themselves to implement the following action programme to protect children and optimise preventive measures at all ages:

1. The support for the EU Commission’s Proposal for a Regulation on MedicinalProducts for Paediatric Use aimed at developing and testing drugs for childrenand adolescents.

2. The immediate establishment of an infrastructure for developing and testing drugs for paediatric use in clinical medicine.

3. The obligatory integration of reports by paediatricians and other medical experts when compiling and assessing research reports on tests of paediatric medicinal products.

4. The implementation of an interdisciplinary working group on “Drug Therapyin Childhood”, e.g. within the licensing authorities, which would address the medical and social science aspects to a large degree.

5. The paediatric centres already established at six Co-ordinating Centres forClinical Studies (KKS) have to be extended and ensured secure funding on a long-term basis.

In addition to enhancing public welfare, this action programme could also provide an innovative boost for the pharmaceutical industry, both with regard to largescale industry involved in research and small and medium-sized enterprises.


Elmar König

Head of Department Science – Policy – Society, Head of Berlin Office

Phone 030 203 8997 - 865
E-Mail elmar.koenig (at)leopoldina.org