The government has commissioned an independent review of the regulation and governance of medical research in the UK, addressing concerns that the sector is being “jeopardised by a complex legal and regulatory framework”.

The “rapid independent review” requested from the Academy of Medical Sciences is an acknowledgment that the string of initiatives, taken from the Cooksey report onwards, to galvanise the UK’s translational research base in the life sciences still lacks traction at ground level.

Clinical trials have been a particular sore point, aggravated by the cost efficiencies available in emerging markets and a perception that trials through the National Health Service are hampered by procedural complexities and slow patient recruitment. Figures from the Department of Health showed that last year the volume of Phase II-IV trials approved in the UK fell to 470 from 728 in 2008, the lowest level in the past decade.

“In view of the particular problems for clinical trials”, the Academy’s review “will have a specific focus in this area”, noted the Department for Business Innovation and Skills (BIS). It will be chaired by Sir Michael Rawlins, senior fellow of the Academy of Medical Sciences and better known as chairman of the National Institute for Health and Clinical Excellence (NICE).

According to the government, the legal and regulatory framework for medical research in the UK is “having a negative impact on the health and wealth of the country. It is affecting both the UK’s competitiveness as a site for industry-funded research and the speed with which advances in basic science can be turned into benefits for patients”.

Health Secretary Andy Burnham said it was “becoming increasingly clear that medical research is getting tied up in red tape. For research to flourish and provide the huge benefit it can give to the health and wealth of the country, it needs freedom from unnecessary bureaucracy and interference”.

UKCMRI funding

The review was announced in tandem with a number of related initiatives, including £250 million of investment in 2010/11 for the UK Centre for Medical Research and Innovation (UKCMRI).

The Centre, which is envisaged as a counterpart to other global hubs of scientific and medical excellence, such as Singapore’s Biopolis, The Allston Initiative at Harvard University in the US and the Shanghai Science-based Industrial Park in China, will be established at St Pancras in London through a partnership between the Medical Research Council, Cancer Research UK, The Wellcome Trust and University College London.

The funding announced last week will be delivered by the Medical Research Council from the Department for Business, Innovation & Skills, subject to approval of the relevant business case later this year. The UKCMRI partners are currently finalising the project agreements and the government’s commitment “will provide more certainty and give full confidence to the partners to enable them to commit their funding”, it said.

The plan is that the centre will start operations in 2015-16, with capacity for around 1,200 researchers. This timetable, and the government’s comments about partner confidence, suggest the project has faltered somewhat. In December 2007, when the government cleared a space for the UKCMRI by agreeing to sell a plot of land next to the British Library and the Eurostar terminal at St Pancreas, the Centre was expected to open its doors by the end of 2013.

Also announced by Business Secretary Lord Mandelson were plans to appoint the UK’s first Minister for Life Sciences, a move that has been welcomed by the country’s four life sciences trade associations.

Lord Mandelson said Prime Minister Gordon Brown was “minded in the next Parliament to appoint for the first time a Minister for Life Sciences to report to both the Secretaries of State for Business and Health”. This would build on last year’s creation of an Office for Life Sciences in the UK and subsequent initiatives such as the Patent Box and the Life Sciences Super Cluster.

“But having listened to the sector, and fully to realise the potential of our life sciences industries, we need to go further in ensuring improved co-ordination across government and in committing to a sustainable future for the Office,” Lord Mandleson added.