Draft EU Clinical Trials Regulation lacks ambition
Compromise text is a progress but does not secure patients’ access to innovative treatments.
20 December 2013, Brussels
EuropaBio welcomes the political agreementon the draft Clinical Trials Regulation by the EU Committee of Permanent Representatives (COREPER) today, thus paving the way for the adoption of the Regulation by the co-legislators, the European Parliament and the Council, in 2014. The Clinical Trials Regulation however must reflect a balanced approach with regards to competitive assessment timelines and the disclosure of clinical trial data.
A quick adoption and considered implementation of the Regulation will contribute to achieving greater harmonisation and efficiency in the regulatory framework for clinical trials, whilst maintaining high standards of patient safety and robustness of clinical data.
Nevertheless, we believe that the compromise text agreed by Member States today is not ambitious enough to meet the objective of securing timely patient access to innovative treatments and improving the attractiveness of Europe in terms of clinical research, and thus contributing to the growth objective of the Europe 2020 Strategy.
According to the agreement backed by Member States today, national authorities would grant clinical trial approval at 60 days; however, the timeline could be extended by 50 days for advanced therapy medicinal products. EuropaBio fears that these extended timelines lack ambition and signal that there is little commitment to restoring a competitive environment for conducting clinical research in Europe.
Including the timelines for questions and assessment of responses, the total assessment timelines would actually be nearer to or in many cases exceeding 100 days.Noting that Member States such as Belgium and the UK have put in place shorter timelines of around 30 days, such aproposal would bring little or no improvement to the current situation in many European countries. At best, it would speed up approvals in countries that currently have longer timelines.
Access to clinical trials data
EuropaBio recognises the scientific and public interest in access to clinical trial data and supports measures to achieve this. We believe that a balanced approach on data transparency measures will support Europe’s attractiveness for clinical research; however, the measures agreed today raise a number of technical questions that will need to be addressed.
Miriam Gargesi, Director of Healthcare at EuropaBio stated: “Whilst we welcome the revision of the Clinical Trials Directive as a commitment to stimulate clinical research in Europe, we are concerned that the proposal adopted today in the EU Committee of Permanent Representatives may not fully achieve the intended objective to provide a harmonised and efficient framework for clinical research in the EU. In particular, the Regulation should be carefully implemented so as not to jeopardise companies’ innovation potential and as patients’ timely access to innovative medicines.”