The Ailing Clinical Trials Directive

Author:Mr Alan McBride
Profession:Howrey LLP

The European Commission has started to consider whether Directive 2001/ 20/EC, better known as the Clinical Trials Directive (the Directive), needs to be revised. The aim of the Directive is to protect the rights, safety and well-being of patients taking part in clinical trials. Although some of those aims have been achieved, the Directive has been subject to constant criticism by industry, academics and clinicians alike. Now the European Commission is planning to look at concerns about the failings of the current legislative framework and decide if it is time that the Directive was changed.

What Is the Problem?

Implementation of the Directive has not been as smooth as the legislators and regulators had hoped. The Medical and Healthcare products Regulatory Agency (MHRA) has been carrying out regular inspections of sponsors and investigators in the UK since May 2004 to assess compliance with the Directive. The MHRA's published findings covering the period May 2004 to February 2006 illustrate multiple failures over many areas of the regulatory regime. The failures include the following:

Lack of robust pharmacovigilance systems, including lack of awareness of legislative requirements and unclear procedures for out-of-hours emergency contacts;

Lack of ethics approval for study advertising;

Trials not conducted in accordance with MHRA approval;

Lack of good clinical practice training; and

Missing and/or fraudulent documentation.


Aside from these issues, it now appears that EU Member States have implemented and interpreted the Directive's provisions in different ways, especially in relation to good manufacturing practice, information to be provided in a clinical trial approval application and approval timelines. A particularly contentious issue concerns the definition of the term "investigational medicinal product" (IMP). A common understanding of the definition of an IMP is necessary to facilitate clinical trials, especially multi-centre trials carried out in more than one EU Member State.

The current definition of an IMP is linked to the definition of "medicinal product", the intended use of the medicinal product and the definition of a "clinical trial". It's not surprising that Member States have been interpreting this rather cumbersome definition in different ways. For example, academic research often involves using a novel drug together with one more established medicine. Some Member States have been defining the new drug as...

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