The NHS Confederation has called for a halt in the decline of UK-based clinical trials, sending a statement to the European Commission that highlights an ‘urgent need’ to address the drop since the EU Clinical Trials Directive was introduced in the UK in 2004.
According to the Confederation, which represents providers and commissioners of NHS services in England, the number of global drug trials with UK involvement dropped from six per cent in 2004 to two per cent in 2008.
The percentage of EU products in clinical trials developed in the UK has also decreased in recent years, falling from 46 per cent in 2002 to 24 per cent by 2007.
Elisabetta Zanon, director of the NHS Confederation’s European Office, said that the rules contained in the Directive, which aims to encourage good practice in clinical trials and to encourage the sharing of information across the EU, were not clear enough about the process NHS organisations need to follow when applying to participate in a clinical trial.
“This means that everyone in the UK – including the NHS, its patients, and taxpayers – is losing out,” said Zanon. “What we are calling for is a system that is easier to navigate and gets the balance right.”
In a blog post response to the NHS Confederation’s statement, Dr Allison Jeynes-Ellis, medical and innovation director at the Association of the British Pharmaceutical Industry (ABPI), backed up the need to simplify and speed up the regulatory process for clinical trials.
“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,” said Jeynes-Ellis. “This means NHS patients have access to the medicine earlier – something which can make a huge difference to people’s lives, not just patients, but their families and their carers.”
The post also highlighted the UK government’s ‘growth review’ that calls on business and industry to challenge government departments on decisions made concerning the private sector, with the intention of ‘removing barriers that are preventing them from performing to their full potential’.
In the March 2011 budget announcement following the review, the government confirmed the formation of a new health research regulatory agency. The body was recommended by the UK’s Academy of Medical Sciences as part of changes to the way medical research is regulated, with potential advancements affected by the bureaucracy of the current system.
Also in March, the Department of Health (DH) announced £775m of funding over five years for translational research as part of a £4bn investment into research and development in the UK up to March 2015.