The EU Clinical Trials Directive (Directive 2001/20/EC) was implemented in 2004, with the aim of simplifying and harmonising the administrative requirements for clinical trials across the EU, whilst ensuring the safety of clinical trial participants, the ethical soundness of trials and the reliability and robustness of data generated.
Whilst it is widely accepted that the Directive has improved the safety and ethical soundness of trials across the EU, a number of issues have also emerged which have contributed to making the EU a much less attractive location to carry out clinical trials.
The European Commission launched a consultation paper late last year, which included a detailed discussion of how the Directive is working, and considered various options for remedying shortcomings and unintended consequences that have become apparent since the implementation of the Directive. Through the consultation, the European Commission sought evidence of the strengths and weaknesses of the current legal framework, as well as views on the issues highlighted and ideas on how to address them.
In particular, the consultation considers a number of specific issues, including:
- Measures to streamline procedures for multinational trials
- Mechanisms to address weaknesses with regards the reporting of serious adverse events
- How to develop a more risk-based approach to clinical trials
Many of the issues covered in the consultation were of interest to NHS organisations and their partners involved in medical research and innovation in healthcare, and our briefing explored some of these in more detail.
Next steps
The NHS European Office responded to the consultation based on your input, and will be keeping NHS organisations abreast of future developments in this area. For more information please contact:
jenny-lee.spencer@nhsconfed.org or helena.bowden@nhsconfed.org.