Wijziging van de Wet medisch-wetenschappelijk onderzoek met mensen in verband met de evaluatie van deze wet en herstel van onvolledige implementatie van richtlijn nr. 2001/20/EG

This Dutch bill amends the Medical Research Involving Human Subjects Act (WMO), which sets the rules for medical research on people in the Netherlands. The bill has two aims: to reflect the findings of the evaluation of the current law, and to correct gaps in how the Netherlands implemented EU Directive 2001/20/EC on clinical trials. The directive aims to protect trial participants and to harmonise trial rules across the EU. Researchers, research institutions, research ethics committees, and sponsors of clinical trials in the Netherlands would be most directly affected by the changes. Trial participants would also benefit from any stronger safeguards. Based on the metadata alone, the exact provisions cannot be confirmed.