UK Regulations Are Too Complex

January 14, 2011
Stephanie Sutton
Pharmaceutical Technology Europe

Urgent changes are required in the UK's regulation and governance of health research because medical advances are currently being stifled by unnecessary delays, bureaucracy and complexity.

Urgent changes are required in the UK’s regulation and governance of health research because medical advances are currently being stifled by unnecessary delays, bureaucracy and complexity. Acknowledging these issues, a report from the Academy of Medical Sciences has set out a new regulatory and governance pathway.

“We have found unequivocal evidence that health research in this country is being jeopardized by a regulatory and governance framework that has become unnecessarily complex and burdensome,” Professor Sir Michael Rawlins, Chair of the Academy of Medical Sciences working group that prepared the report, said in a press statement. “Further, we received no evidence that this increased regulatory and governance burden has led to enhanced safeguards for participants in the research.”

The report recommends establishing a new independent Health Research Agency (HRA) that brings together existing approval processes. The HRA would work with regulatory and governance bodies across the developed nations to develop an integrated UK approvals system. Additionally, the report recommends establishing a National research Governance Service that can facilitate rapid approval of research studies in single or multiple UK National Health Service (NHS) sites.

“The delay in obtaining NHS permissions is a major failure of the current pathway and is the biggest single barrier to all types of health research studies. There is a highly inefficient emphasis on process rather than outcomes, which has led to delays of over a year to gain permissions for simple studies,” said Rawlins.

The report’s publication has been welcomed by the BioIndustry Association (BIA), which described the report’s recommendations as a “step in the right direction”; however, the BIA also believes that there may be a more effective solution than establishing a new HRA.

“The BIA continues to believe that it would be more efficient and effective to build upon and expand existing competencies within the Medicines and Healthcare products Regulation Agency (MHRA) rather than create a new body,” Alan Morrison, Chair of the BIA’s Regulatory Affairs Advisory Committee, explained in a BIA press statement.

The UK has created nearly a quarter of the world’s top 100 medicines, but recent data has shown a decline in the country’s share of clinical research activity. According to the Academy of Medical Sciences, there has been widespread agreement that the regulatory and governance framework is one of the main contributing factors to this decline.

www.acmedsci.ac.uk