Revision of the EU Clinical Trials Directive: Light at the end of the tunnel?

The end of the lengthy revision of the EU Clinical Trials Directive is finally in sight. The Directive, which delineates the legal requirements for conducting clinical studies in Europe, has come under fire several times since it was started in 2004. The main criticisms are “(1) the divergent application of the Clinical Trials Directive in the Member States; (2) the increased administrative burden for clinical trials in view of regulatory requirements which do not take into account practical necessities and constraints; and (3) the fact that clinical trial regulation does not sufficiently take into account the increasingly global scale of clinical trials."

drugsIn view of increased criticism, the European Commission issued a communication on “Safe, Innovative and Accessible Medicines: a Renewed Vision for the Pharmaceutical Sector” in order to carry out an assessment of the current directive. The findings of this assessment gave birth to a ‘roadmap' or a ‘legislative proposal on a Regulation/Directive amending the Clinical Trials Directive 2001/20/EC'.

The main objectives of this roadmap include a regulatory framework that takes into account the current research environment and pharmaceutical sector without compromising the needs of clinical trials’ patients and practical requirements. In addition, the defined policy options to meet these objectives include clarification of certain provisions of the current clinical trials directive, revision of guidelines for trials and procedures and replacing part of the directive with measures of Community law that require no further implementation by national Member States. It is also proposed to increase scrutiny of trials conducted in non-EU countries and to simplify and streamline the clinical trials’ authorisation process.

ConsultationAs part of this proposal to amend the Directive, EURORDIS submitted a contribution in May 2011. “In a nutshell, rare disease patients would greatly benefit from accelerated procedure for multi-centred clinical trials for rare diseases," says Flaminia Macchia, Director of European Public Affairs at EURORDIS. “Our contribution goes in the same direction as the European Commission’s desire to coordinate the procedures at the EU level, so that it is less cumbersome and costly for sponsors willing to initiate a clinical trial. Especially in the rare disease field which is complex enough by nature. However, we question the statement affirming ‘ethical issues clearly follow within the remit of Member States and should remain there’. There is a need to streamline ethical standards, as well as administrative and safety standards, at EU level.”

Recently EURORDIS put forward a spirited view at a workshop at the European Parliament, hosted by Philippe Juvin (French MEP, EPP), criticising the uneven application of ethical considerations amongst Member States. “We don’t think it is ethical to have different ethical assessments in different countries of the same trial. Either an argument is medically valid and therefore has to protect patients everywhere or it is not medically valid and should not be a barrier to authorising clinical trials in some countries or regions.”

EURORDIS’ presentation focused on the basis of three fundamental principles of research in humans (benevolence/non malevolence, autonomy/respect of the person and universalism/distributive justice). “We believe that asking sponsors to apply once for authorisation (Single Submission) will lower costs, and that the widening of the scope of the Common Assessment Procedure in order to include ethical aspects, are essential elements to secure justice and equality throughout the EU” highlights EURORDIS Chief Executive Officer Yann Le Cam.

EURORDIS’s view is shared by many who feel that the directive imposes too many hurdles to the population it is supposed to serve and protect. Several researchers are also worried that the costs involved in initiating a trial in Europe will be only affordable to big pharmaceutical companies and keep out academic research and SMEs. And there is real fear amongst some decision-makers that the Directive is driving medical research out of the EU.

“The current legislation could be amended or an entirely new regulation could be introduced,” explains Yann Le Cam. “With the particular challenges and cost concerns of the average rare disease clinical study, the revamping of the Clinical Trials Directive is an affair to follow closely.”

More information:
EURORDIS Contribution to the European Commission Public Consultation on the revision of the Clinical Trials Directive
News article: “Patients Lose Patience”


This article was first published in the March 2012 issue of the EURORDIS newsletter
Author: Paloma Tejada
Photo credits: © EURORDIS

Page created: 21/02/2012
Page last updated: 02/04/2012
 
 
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