Select Committee on Science and Technology Third Report

6  The pharmaceutical sector and a new drug development pathway

17. The private sector, in particular the pharmaceutical sector, is a major investor in health research in the UK. Cooksey identified the challenges faced by the industry to ensure that their investment delivers new medicines, diagnostics and devices at prices that reward innovation and are affordable to health systems (in the UK and abroad). The Review highlighted three main barriers in the UK to achieving these objectives:

a)  a cautious NHS culture with respect to innovation;

b)  regulatory barriers which have not kept pace with the science and technology associated with the drug development process;

c)  uptake of new medicines and technologies has been limited by the NHS Health Technology Assessment (HTA) which assess their clinical and cost-effectiveness.

18. To lower these barriers, the Review proposed that OSCHR's UK Priority Health Research Projects would be identified at an early stage of drug development and benefit from 'conditional licensing' so that they could be assessed more quickly through clinical trials and thus be brought to market more quickly. This will be facilitated by earlier involvement from the National Institute for Health and Clinical Excellence (NICE). The Report also recommends that increased public funds should be invested in the conduct of more translational medicine (largely in the form of clinical trials) in the UK.

19. In evidence, Sir David outlined the new mechanism he has proposed to involve NICE and the HTA in Phase III of clinical trials in order to make drugs available to more patients and provide better data that NICE can use to reach decisions on whether to allow a drug to be used within the NHS.[23] However, the Association of UK University Hospitals told us 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."[24] 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. This is an area in which we will monitor developments.

23   Q 48 Back

24   Ev 16 Back

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Prepared 15 March 2007