n the March 2006 Budget, Gordon Brown announced plans to allocate £1 billion for funding UK health research through a new Single Fund, which would replace the streams running through the Medical Research Council (MRC) and NHS Research & Development (R&D).
The Government commissioned an independent review, chaired by Sir David Cooksey (founder of Advent Venture Partners), to examine the arrangements and implementation of the new single fund. Cooksey published his report in December and the Chancellor accepted the findings.
Last Thursday (15 March) the House of Commons Science and Technology Committee published its response. While recognising the benefits offered by “a coherent strategy to maximise the health benefits from UK research,” the committee had several reservations, some of which impact on the pharmaceutical sector.
For example, the Committee argued that the review focused on pharmaceuticals and played less attention to other interventions. They comment: “Whilst the pharmaceutical sector is clearly of great importance to the UK’s health research output, the Committee is concerned that allied health research sectors such as medical engineering and technology, preventive and public health research should not be overlooked.” The Committee suggested that the Department of Trade and Industry, and Department of Health must ensure the representation of these sectors within the Office for Strategic Co-ordination of Health Research (OSCHR) and the Translational Medicine Funding Board (TMFB), which will administer the single fund.
The Committee also expressed concerns over the impact of increased funding for clinical and translational research (bench to bedside or experimental medicine), which is increasingly important in the R&D strategies of many pharmaceutical and biotech companies. This reflects concerns that the balance excessively favours basic research. He recommended increasing the funding of translational research, while keeping funding for basic research at current levels. “This suggests that any future funding increase to translational and clinical research may be at the expense of basic research,” the committee writes. “We acknowledge and support the importance of translational and clinical research. However, it is essential that the new proposals do not result in decreased funding for basic research”.
The Royal Society is also worried about any possible threat to basic science as funding aims to develop a “more balanced portfolio”. Commenting on the committee’s report, David Read, Vice President of the Royal Society and Professor of Plant Sciences at the University of Sheffield said: “The Society is particularly concerned that action is taken to safeguard basic research, which is an essential foundation to develop future treatments for patients. We will continue to monitor the situation to seek reassurance on this.”
Cooksey also recommends the OSCHR will set UK health research priorities and identify those public and private sector projects that address unmet health needs. Such projects could benefit from “institutional and procedural advantages”, such as faster clinical trial approval. The Royal Society told the committee that that a top-down approach to setting health priorities targets might divert attention from “more readily soluble and innovative research”. The committee concluded: “We support the setting of priorities, but we expect OSCHR to ensure that the best research in all fields is funded and that research outside the priorities is adequately supported”. They called for performance monitoring without rigid targets.
Cooksey highlighted three main barriers that hinder the pharmaceutical sector’s ability to deliver new medicines, diagnostics and devices “at prices that reward innovation and are affordable to health systems (in the UK and abroad)”. Firstly, the NHS culture is cautious with respect to innovation. Secondly, regulation has not kept pace with advances in drug development science and technology. Thirdly, the NHS Health Technology Assessment (HTA) limits uptake of new drugs.
To lower these barriers, the Review proposed that OSCHR would identify Priority Health Research Projects early in development, which could then run on a fast track to market. For example, such agents could receive ‘conditional licensing’ allowing more rapid assessment in clinical trials and faster marketing, facilitated by earlier NICE involvement. However, the Association of UK University Hospitals told the committee that, at present, “there is no way that any clinical research can be fast tracked. The administrative burden on the investigator and the Trust is enormous when performing this work. As yet, there is no sign that these burdens will be reduced or simplified; this must happen before any fast track system can be developed.” Against this background, the committee concluded: “We support the principles behind fast-tracking crucial research. However, we remain somewhat sceptical about the ability of the current structures to respond to the demands this would make on them”. They plan to monitor developments in this area.
The Royal Society shares many of the concerns expressed by the committee. “We hope that this report, which reinforces the concerns voiced by a number of organisations, galvanises the newly established Office for Strategic Coordination of Health Research, together with the Department of Health and Department of Trade and Industry to take action to address these issues,” said Professor Read. “We believe that a single health fund offers the potential to vastly improve the coordination of health research funding in the UK if implemented and resourced effectively. In considering this, it is crucial that the MRC continues to have strong leadership to see it through this period of change and ensure that fundamental research across the spectrum of the medical sciences continues to benefit human health.” By Mark Greener