THE ESICM AND THE EU DIRECTIVES ON CLINICAL TRIALSEUROPEAN LEGISLATIONOn the 4th of April 2001, the European Council and the European Parliament adopted the Directive 2001/20/CE, on "the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use".This Directive must be transposed in the European member States' national laws by the 1st of May 2003 and applied from the 1st of May 2004. This Directive poses however a problem to the intensive care community, as it might hinder research on incompetent patients. See the following comments and reactions to the Directive:
(2002) 28 :660
Academics and investigators from the public organisations have voiced their concerns and the EU started taking into account the specific constraints of these investigators. In June 2006, the European Commission published a draft guidance on “specific modalities” for non-commercial clinical trials referred to in the Commission Directive 2005/28/EC laying down the principles and detailed guidelines for good clinical practice. The document was open for consultation in early autumn 2006. The ESICM took part in this consultation process and underlined the positive evolution of the EU regulation. |