EU red tape blamed for decline in UK clinical trials
pharmafile | June 10, 2011 | News story | Research and Development | UK clinical research, clinical trials
Medical and pharma groups have blamed European Union red tape for the decline in the UK as a location for clinical trials.
The fault, according to the NHS Confederation, lies with the EU Clinical Trials Directive, introduced in the UK in 2004 to promote good clinical practice and harmonise clinical trial activity across Europe.
In a submission to the European Commission, the confederation is calling for a “more streamlined ‘one-stop-shop’ approach for organisations taking part in clinical trials”.
It wants a faster approval process and fewer variations in the way guidelines are interpreted in different countries. “The rules as they stand are not clear enough,” said Elisabetta Zanon, director of the NHS Confederation’s European Office.
“They do not provide NHS organisations with enough clarity about what processes they do and do not need to follow when applying to participate in a clinical trial. As a result the UK’s involvement in the global development of new medicines and technologies has stalled,” she added.
In the four years from 2004, the numbers of global drugs trials with UK involvement fell from 6% to 2%. Across Europe in 2002, 46% of EU products in clinical trials were being developed in the UK – but this had nearly halved to 24% by 2007.
Department of Health figures also show mid-stage, late-stage and post-approval clinical trials fell from 728 in 2008 to 470 in 2009, the lowest level in the past decade. Early stage trials fell to 210 in 2009, the lowest in five years.
“This means that everyone in the UK – including the NHS, its patients, and taxpayers – is losing out,” concluded Zanon. “What we are calling for is a system that is easier to navigate and gets the balance right.”
UK industry body the ABPI is supporting the NHS Confederation’s call to arms, saying that more UK trials mean “better healthcare for NHS patients, more highly-skilled jobs, and growth for the UK economy”.
“If research and development companies carry out the clinical trial process in the UK, they are more likely to launch the medicine in the UK,” explained Dr Allison Jeynes-Ellis, ABPI medical and innovation director. “This means NHS patients have access to the medicine earlier.”
In its budget this year, the government suggested it wanted to make the UK a more attractive place to conduct clinical research and “radically reduce” the time it takes to get approval for trials.
NHS Confederation chief executive Mike Farrar pointed to the North West Clinical Trials Exemplar – which takes best practice from 20 industry-sponsored trials adopted by the National Institute for Health Research Clinical Research Network – as showcasing what the UK can offer.
Adam Hill
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