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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