European Parliament:

On 11 March, in a meeting of the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI), discussions focused on the transparency of clinical trial results. The draft Clinical Trials regulation, presented last July, repeals the current Directive 2001/20/EC as this has led to regulatory overload. The aim of the draft regulation is to stimulate clinical research in the EU by simplifying procedures and by differentiating between trials according to risks.

 

NGOs are calling for total transparency in clinical trial results, in order to show what laboratories are eager to hide, as well as to avoid redundant research. Pharmaceutical companies argue that they have to protect their commercial data and the patients’ private data. MEPs are calling for total transparency (so that academics can verify and compare results) and for communication of the results in a way that is understandable to the wider public.

Meanwhile, rapporteur Glenis Willmott (S&D, UK) has over 700 amendments to consider and to find compromise amendments with the other political groups. The vote is scheduled for 24-25 April.

EuGMS has worked actively with several Members of the European Parliament (including Mrs. Willmott) to ensure references to the need to include older and frail people in clinical trials as well. Several amendments have been tabled to this effect.

For the draft Parliament report: http://www.europarl.europa.eu/meetdocs/2009_2014/organes/envi/envi_20130320_0900.htm