Clinical trials
Clinical trials are “Investigations in humans intended to discover or verify the effects of one or more investigational medicinal products (IMPs)”. Trials conducted in the European Union (EU) are currently governed by Directive 2001/20/EC (the Clinical Trials Directive, CTD) but these guidelines have been implemented differently across member states, thereby failing to reduce red tape and increasing costs. Consequently, in July 2012, the Commission published its proposal for a revision of the CTD and its replacement with the Clinical Trials Regulation (CTR).
In the EU/EEA, approximately 4,400 clinical trials are applied for every year. Approximately 60 per cent of clinical trials are sponsored by the pharmaceutical industry and 40 per cent by other stakeholders, such as academics. Directive 2001/20/EC has brought about important improvements in the safety and ethical soundness of clinical trials in the EU and in the reliability of clinical trials data. However, it is arguably the most heavily criticised piece of EU-legislation in the area of pharmaceuticals. Since its introduction, the number of applications for clinical trials has fallen, the cost of conducting trials has increased and the average delay for launching trials has increased by 90 per cent . As a result, the Commission launched a revision of the CTD in July 2012.
The CTR is going through the ordinary legislative procedure and is currently awaiting a first reading by the Parliament. The responsible committee is ENVI and the Rapporteur is Glenis Willmott (S&D, UK). Opinions are expected to be given by IMCO (Rapporteur Cristian Silviu Busoi, ALDE, Romania) and ITRE (Rapporteur Michele Rivasi, Greens/EFA, France). The Committee vote is scheduled for 29 May 2013 and the plenary session is forecast for 10 June 2013.
EPHA Policy Tracker Article (updated on 30 April 2013)
I. Background
II. Tracking the legislative procedure (past, present, future)
III. Contact Data of relevant Actors (MEPs, assistants, experts, attachés, industry, NGOs)
V. MEP questions and COM answers
(FULL UPDATE) Clinical Trials – new Regulation – Proposal for the Clinical Trials Regulation (CTD)
————
EPHA Policy Tracker is a new intelligence feed produced by EPHA Secretariat to report developments to public health policy.
– You can find the list of all EPHA Policy Tracker articles here
————————