EU directive blocking trusts from clinical trials, says Confed

The NHS Confederation has told the European Commission that trusts’ efforts to participate in global clinical trials and research are being hampered by excessive bureaucracy.

A revision of the EU clinical trials directive is currently under discussion. The NHS Confederation is calling for a more risk-based approach to reduce the burden on trials of drugs for well-used treatments for illnesses other than those they are officially approved to treat.

Currently, such treatments are often expected to go through the same regulatory processes as new drugs, irrespective of the risk of the research.

The confederation’s European Office has been stressing to the Commission that there is an “urgent need” for change.

Figures from the Department of Health show that UK involvement in global clinical trials has been in decline since the introduction of the directive in 2004.

Since then, the number of EU products in clinical trials that are developed in the UK has almost halved from 46 per cent in 2002 to just 24 per cent in 2007.

The number of mid-stage, late-stage and post-approval clinical trials - which test potential treatments on humans to see if they should be approved for wider use in the general population - fell from 728 in 2008 to 470 in 2009, the lowest level in the past decade.

The importance of UK involvement in clinical trials has been highlighted by the government, which announced in this year’s budget that it wanted to make clinical research a major part of making the UK a more attractive place to do business.

But director of the NHS Confederation’s European office Elisabetta Zanon said: “The rules as they stand are not clear enough. They do not provide NHS organisations with enough clarity about what processes they do. What we are calling for is a system that is easier to navigate and gets the balance right.” 

NHS Confederation chief executive Mike Farrar added: “This revision of the rules is an opportunity to achieve the government’s ambitions to make clinical research a primary driver of national economic growth.”

There have been some examples, such as in the North West, where NHS organisations have worked within the current rules and managed to increase the numbers of trials being carried out. But the confederation stressed this was an exception and not the rule.

Mr Farrar, who was involved in the North West case, said: “It has been a challenge for NHS trusts to establish themselves as real players in the market. But given a better context, we know how committed and successful [trusts] could be in delivering improvements to the speed and reliability of clinical trials. “