Complex regulation and governance of clinical research in the UK has held back research with no evidence of improved patient safety, concludes a report by the country's Academy of Medical Sciences (AMS).

The AMS was commissioned by the UK government in March 2010 to review the regulation of clinical and health research. The review, released on 10 January, recommends the establishment of an independent Health Research Agency (HRA) to simplify approval processes that currently differ across the UK. The authors also recommend the establishment of a National Research Governance Service within the HRA to accelerate approval of multicenter studies. The branch would take responsibility for certain approvals of multicenter trials; the current system requires multiple approvals carried out by different units within the country's National Health Service.

According to the report, “nearly a quarter of the world's top 100 medicines” were developed in the UK. Antibody therapies, first developed in the UK, constitute a third of all new drugs for major diseases, including cancer and arthritis, and this sector of the market is projected to grow to over $43 billion by 2012. But whereas 46% of EU products in clinical trials were developed in the UK in 2002, this fell to 24% by 2007.

The report's authors say that even though the country's Medicines and Healthcare Products Regulatory Agency (MHRA) provides timely authorization of clinical trials, the EU Clinical Trials Directive is hampering scientific work and discouraging academic and commercial health research sponsors in the UK.

“The European Clinical Trials directive has been a disaster,” the chair of the AMS working group that prepared the report, Sir Michael Rawlins, told Nature Medicine. “Within Europe the number of patients on clinical trials has dropped by about a third in the last nine years which, considering that elsewhere in the world it's increasing, is not good.” The bureaucracy is “horrid,” he added, “the time taken in countries like Britain makes it just completely unattractive.”

The UK government welcomed the recommendations, but organizations including the BioIndustry Association (BIA) voiced concerns about yet another layer of regulation.

“The BIA continues to believe that it would be more efficient and effective to build upon and expand existing competencies within MHRA rather than create a new body to oversee the regulation and governance of health research, as recommended by the AMS report,” says Alan Morrison, chairman of the BIA's Regulatory Affairs Advisory Committee.