The European Commission has today published draft revised legislation, which would amend the controversial EU Clinical Trials Directive, introduced in the UK in 2004. Aimed at harmonising clinical trial activity across the EU and promoting good clinical practice, the Directive resulted in a 25 per cent drop in the number of trials across the EU and the time taken to launch a clinical trial almost doubling.
Welcoming the proposal, the NHS Confederation’s European Office is now calling for EU decision-makers to rapidly agree the changes, which could reduce the onerous bureaucracy currently surrounding clinical trials.
Director of the NHS Confederation’s European Office, Elisabetta Zanon, said:
“The current Directive places a huge bureaucratic burden on NHS organisations that want to get involved in clinical trials. This is wholly disproportionate, particularly for trials which are low risk. Not only is the UK economy losing out, but UK patients miss out on vital opportunities to benefit from the development of life-changing medicines.
“We have long been pressing for changes to the existing Directive, and for an approach which gets right the balance between risk and safety. We are pleased that the European Commission has listened to the concerns we have voiced on behalf of the NHS. In particular, it has recognised the need for a more risk-proportionate approach and the need to help speed up and simplify the authorisation process which has contributed to excessive delays.
“The proposal will also enable the NHS to continue to share responsibilities and liabilities for trials with academic partners, a model widely used by NHS trusts and one which we fought hard to maintain.
"More than 95 per cent of NHS trusts now take part in clinical research, a key component of the UK's growing life-sciences agenda. We want the NHS to continue to play a pioneering role in the development of new treatments. This will bring real improvements to the lives of patients and will be fighting to ensure the final agreement is good for the NHS, patients and the economy.
"We hope that the changes put forward in the EU proposal are a start to allowing us to do that."