NHS Confederation applauds proposed bureaucracy-cutting changes to EU clinical trials law

17/07/2012

Proposed changes to EU law, put forward today (Tuesday) will reduce the tangle of bureaucracy that has caused a rapid decline in the number of clinical trials carried out in the UK, the NHS Confederation’s European Office says.

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."

Notes to Editors

1. Since the introduction of the EU Clinical Trials Directive there has been a dramatic drop in the number of clinical trials with EU, and UK, involvement. The European Commission's own figures show that from 2007 to 2011, the number of applications to carry out clinical trials in the EU fell by 25 per cent, while costs have increased significantly and the delays for launching a clinical trial have risen by 90 per cent.

2. The European Commission's proposed Regulation will now pass to the European Parliament and the Council of Ministers for negotiations before an agreement can be reached. Negotiations are expected to last for several months.

3. The existing Clinical Trials Directive foresees that each trial should have a sponsor (i.e. an organisation responsible for the conduct of the trial). While the vast majority of EU Member States have interpreted the Directive as requiring a single sponsor for each trial, UK legislation allows co-sponsorship, whereby the sponsor’s responsibilities and liabilities may be shared between two or more organisations. This model is widely used by NHS trusts who often lead clinical trials in partnership with universities.

4. The requirements of the existing Directive are not proportionate to the degree of risk for the participants in a trial. The new EU proposal seeks to address this lack of proportionality and attempts to adjust the regulatory burden for 'low-intervention clinical trials'. This means that low-risk trials would be subject to a lighter regime.

5. The full text of the proposed European Commission Regulation can be found here.

6. The NHS European Office represents the NHS in EU affairs and influences EU developments in the interest of the NHS. It is part of the NHS Confederation and funded by the strategic health authorities in England. More information on the NHS European Office and its work on clinical trials can be found at: www.nhsconfed.org/europe

7. The NHS Confederation represents all organisations that commission and provide NHS services. It is the only membership body to bring together and speak on behalf of the whole of the NHS. We help the NHS to guarantee high standards of care for patients and best value for taxpayers by representing our members and working together with our health and social care partners.

8. Contact Georgie Agass on 020 7074 3304. For out of hours media enquiries, please call the Duty Press Officer on 07880 500726.

Contacts

Georgie Agass
020 7799 8637
Georgie.Agass@nhsconfed.org

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NHS Confederation applauds proposed bureaucracy-cutting changes to EU clinical trials law

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