Brussels, 5 February 2013

In a joint analysis, the Association Internationale de la Mutualité, the Medicines in Europe Forum, the International Society of Drug Bulletins and Wemos argue that, with its proposed new Regulation on clinical trials, the European Commission has overlooked important improvements provided by Directive 2001/20/EC for the protection of subjects enrolled in clinical trials. Most notably, the proposed Regulation could seriously undermine Member States' subsidiarity on ethical matters.

> Click here to download the joint analysis (pdf, 332 Ko)

Contents of the joint analysis:

• Introduction
  • Directive 2001 versus proposed new Regulation: throwing out the baby with the bathwater?
• Deregulation under the guise of "simplification"
  • Dangerous change to the definition of a clinical trial
  • "Low-intervention clinical trials": caution is needed
  • "Substantial modification": wiggle room for scientific misconduct
• Member States' subsidiarity on ethics at risk of being seriously undermined
  • ‘Disappearance' of ethics committees
  • A single assessment for all Member States concerned, with very few possibilities to "opt-out"
  • Untenable timelines and "tacit authorisation" by default
  • Make-believe "ethics assessments" by Member States (Part II): more or less limited to informed consent, and restricted to "own territory"
• A revision offering major opportunities to improve healthcare
  • Requiring comparative clinical trials against the ‘best current proven intervention'
  • Improving citizens' access to information
  • Reporting of adverse drug reactions: do not let ‘the fox guard the henhouse'
• To conclude: several major improvements are needed

©AIM, MiEF, ISDB, Wemos February 2013