The Swiss regulatory framework for pædiatric health research


Autoria(s): Junod, V.
Data(s)

2008

Identificador

https://serval.unil.ch/notice/serval:BIB_59893923B739

Idioma(s)

eng

Fonte

European Journal of Health Law152183-195

Tipo

info:eu-repo/semantics/article

article

Resumo

Medical research on minors entails both risks and benefits. Under Swiss law, clinical trials on children, including nontherapeutic drug trials, are permissible. However, ethics committees must systematically verify that all clinical studies have a favorable risk-benefit profile. Additional safeguards are designed to ensure that children are not unnecessarily involved in research and that proper consent is always obtained. Federal Swiss law is undergoing revision to extend these protections beyond clinical trials to a broad array of health research. The Swiss drug agency also seeks to improve the incentives for pharmaceutical firms to develop new paediatric drugs and relevant paediatric drug labels.

Palavras-Chave #Pharmaceutical regulation; Ethics committees; Data protection; Swiss law; Paediatric studies; Clinical trials; Drug research