ENVI Committee discusses and votes Clinical Trials report

On 29 May, the European Parliament Committee on Health and Consumer Affairs (ENVI) met to discuss its report on the new Directive on Clinical Trials. The Committee adopted the text unanimously. The purpose of the Directive is to formulate simpler and more uniform rules that will encourage research while keeping patients safe.

The new text, makes specific provision for low-risk trials, clarifies the duties of ethics committees and details how to obtain informed consent from patients. Specific rules would also apply to clinical trials on pregnant or breastfeeding women, on persons deprived of liberty and on people with specific needs

EuGMS has actively worked with the Rapporteur, Glenis Willmott MEP, to insert specific references to older people in the text. The final voted text is not available yet, but it looks like the amendments reflecting these references have indeed been adopted by the Committee. 

Willmott has now received a mandate to negotiate an agreement with EU ministers. 

For more information: http://www.europarl.europa.eu/meetdocs/2009_2014/organes/envi/envi_20130529_0900.ht