“Substantial” progress has already been made towards implementing Sir David Cooksey’s recommendations for health research funding in the UK, according to Lord Hunt, minister of state for quality at the Department of Health.

As Lord Hunt noted at a conference in London last week, the health department has worked with the Department of Trade and Industry to establish the new Office for Strategic Coordination of Health Research under the interim leadership of Professor John Bell, president of the Academy of Medical Sciences.

This ‘light-touch’ organisation will serve as an umbrella agency for the Medical Research Council and the DH’s National Institute for Health Research, setting both the UK’s health research strategy and the budget needed to deliver it under the single, ring-fenced fund announced in the March 2006 Budget. It was a key recommendation of the wide-ranging review published early last December by Sir David Cooksey, founder of Advent Venture Partners.

Speaking at the conference on ‘Healthcare Innovations: The Next Frontier’, organised jointly by the MRC, the NIHR and the Association of the British Pharmaceutical Industry, Lord Hunt said plans were also rapidly taking shape for the Translational Medicine Funding Board, another crucial component of Sir David’s proposals.

Moreover, the Ministerial Industry Strategy Group, the high-level forum set up to take the recommendations of the UK’s Pharmaceutical Industry Competitiveness Task Force forward, has been entrusted with overseeing the implementation of the new drug development pathway set out in Chapter 8 of the Cooksey report.

Faster approval for trials, expedited NICE review

One of the recommendations of the Cooksey review was that the OCHR should designate Priority Health Research Projects addressing an unmet national health need. These might bring advantages such as faster approval for clinical trials of qualifying medicines and an expedited route through the assessment procedure of the National Institute for Health and Clinical Excellence.

Clearly, though, these potential benefits remain some way down the line. “The PHRP (Priority Health Research Project) recommendations are contingent on the establishment of health research priorities, which in turn are contingent on the identification and agreement of health priorities,” the DH told PharmaTimes. “Implementation is therefore still at a very early stage.”

The Translational Medicine Funding Board is envisaged in the Cooksey review as a joint initiative between the MRC and the NIHR, with representation from these bodies as well as the healthcare industries, the DH, the DTI and the devolved administrations in Wales and Scotland. It would take the lead on developing a translational research strategy to maximise the health and economic benefits of innovation. According to the DH, setting up the Translational Medicine Board is an “immediate priority” and the OSCHR’s Interim Oversight Group is currently discussing details of its structure and functions.

In the interim, the ‘Funding’ part of the Board’s name appears to have been quietly dropped. There have been reports that the OSCHR is thinking of removing the Board’s funding role and leaving budgets for translational research in the hands of the MCR and the NIHR. That might help to quell some of the unease researchers have voiced about clinical and translational work being funded at the expense of basic research.

Drug development pathway

Proposals on taking forward the recommendations for a new drug development pathway in Chapter 8 of the Cooksey report – which could include faster uptake of new medicines in the NHS, conditional licensing of products at the end of Phase II trials and earlier engagement by NICE in the drug development process – will be put to the MISG at its next meeting on 1 May, the DH said.

As Lord Hunt noted, the MISG is already addressing some of these issues through its Long-Term Leadership Strategy, while both John Bell of the OSCHR and Professor Sally Davies, director general of research and development at the DH, are part of the Group.

The health department also had some evidence that measures already been applied to improve the climate for pharmaceutical R&D in the UK, against a backdrop of stiff competition from emerging economies such as China and India, continue to bear fruit. The NIHR is implementing a substantial number of changes in this respect, including the research networks established under the UK Clinical Research Collaboration, the revised model Clinical Trials Agreement and a ‘passport’ system for researcher approval.

The number of industry industry-sponsored clinical trials (all of them Phases II to IV) adopted by the UKCRC’s topic-specific network has now reached 45, with many more under negotiation. Of the total adopted, 19 have gone through the Cancer Research Network, 11 through the Diabetes network, seven are for Dementia/Neurodegenerative Diseases (the DeNDRoN network), four are Medicines for Children, three are for Stroke and one for Mental Health.

As to whether proposals from the Office of Fair Trading to overhaul the Pharmaceutical Price Regulation Scheme could end up undoing some of this good work by undermining the operating stability that has attracted R&D investment to the UK, the DH commented: “We are studying the OFT recommendations carefully. It is important that we have fair prices which give value for money to the taxpayer. However, we recognise the importance of the pharmaceutical industry to healthcare and the development of medical advances, and it is in all of our interests to encourage research and reward innovation.”