The European Parliament's Environment and Public Health Committee voted in Brussels this week on a new EU Regulation to replace the controversial Clinical Trials Directive, introduced in the UK in 2004. Aimed at harmonising clinical trials activity and promoting good clinical practice across the EU, the Directive resulted in a 25 per cent fall in the number of trials across the EU, with the time taken to launch a clinical trial almost doubling.

The full European Parliament will vote on the text of the draft Regulation in October during which time the EU Institutions will try and achieve agreement.

Welcoming the vote, the NHS Confederation’s European Office is now calling for the EU decision-makers to reach agreement rapidly, to 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 are missing out on vital opportunities to benefit from the development of life-changing medicines.

“This is an important step in the process, but we must maintain the pressure. 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 Parliament 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 text voted-for in the European Parliament also shows that the NHS continues 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.”

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.

The European Commission's proposed Regulation needs agreement by both the European Parliament and the Council of Ministers before it can become EU law.

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.

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

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

The NHS European Office represents the NHS in EU affairs and influences EU developments in the interest of the NHS. The office is part of the NHS Confederation. More information on the NHS European Office and its work on clinical trials can be found at: www.nhsconfed.org/europe

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.

Contact the NHS Confederation media centre 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