3 Difficulties facing the pharmaceutical
36. As PICTF indicated, the UK-based pharmaceutical
industry is faced with a number of difficulties in conducting
research and operating successfully. The cost of conducting medical
research in the UK is second only to the US.
Extra security is needed because of threats from animal rights
protesters, for instance. Novartis UK has spent an extra £1
million on security measures at its UK sites in the last two years
alone. The cost of
research programmes run within NHS hospitals are elevated because
of 'overheads', which vary from 30% to 100% extra, depending on
the hospital. According
to the Department of Health, it has "paid close attention
to creating a safe and positive environment for both publicly
funded medical research and commercial contract research",
and "it is Government policy that Industry must meet the
full costs of work that the NHS undertakes for industry under
37. Authorisation to conduct early stage trials in
animals has to be obtained from the Animals Procedures Committee
of the Home Office and it is more difficult to obtain permission
to conduct animal experimentation in the UK than in any other
This may place an additional constraint on the conduct of research.
Cancer Research UK stated:
An example of such constraint is the requirement
for primate research for certain types of pre-clinical assessment.
If the costs and barriers for drug development continue to increase,
fewer new drugs will comes to market, thus stifling innovation
and, more importantly, potential patient benefit.
38. The "fragmented and customer un-friendly
nature of academic units and clinical services" was highlighted
by the Royal College of General Practitioners (RCGP). The College
also mentioned the "multiple layers of Research Ethics approval"
that may be required and a "disparate, and sometimes competing,
collection of clinical and academic teams" that may need
to be brought together to achieve sufficient mass for large-scale
39. Many large-scale Phase II and III trials are
currently being carried out in Eastern Europe and elsewhere as
a result of high costs imposed here.
Dr Malcolm Boyce, who runs a London-based Contract Research Organisation
A strong pound sterling makes matters worse for overseas
companies. For those reasons, companies are increasingly placing
their Phase II and III trials outside the UK, in low cost areas
such as Eastern Europe, Russia and India.
40. There are not enough trained medical researchers
in the UK. This means
there are too few individuals who can organise clinical trials
or take part in a reviewing or implementation capacity. Prof Patrick
Vallance, from University College London (UCL), told us:
There is a shortage of appropriately trained clinical
investigators in the UK, and this reflects lack of investment
in clinical research and problems with clinical training pathways.
41. Specialist facilities are also lacking. There
are very few centres in which paediatric clinical trials may be
effectively conducted, for example. This will become more relevant
following the introduction of a new European Regulation on Paediatric
Medicines in 2006, which will require more medicines to be licensed
for use in children.
42. Witnesses pointed out that the NHS does not have
a coherent approach to industry-sponsored clinical trials and
lacks the staff and specialist facilities in which to conduct
them. This partly explains why a very low percentage of patients
are enrolled in clinical trials in the UK; experience shows that
recruitment can be increased substantially provided suitable policies
and other measures are in place.
For example, the National Cancer Research Network (NCRN) provides
the NHS with the 'infrastructure' to support cancer clinical trials
in England. It was established by the Department of Health in
April 2001. Since that date the number of patients taking part
in cancer clinical trials in the UK has doubled. All results from
NCRN trials are scrutinised by an Independent Data Monitoring
Committee, which is the only body to see unblinded data. All
results emerging from trials approved by the Clinical Trials Awards
and Advisory Committee are published.
43. A flourishing UK pharmaceutical industry is of
great importance for healthcare as well as having economic benefits.
To achieve this, it is most important for the industry to be able
to undertake research effectively. The success of the NCRN shows
that it is possible to provide the infrastructure within the NHS
that the industry requires. Similar systems need to be put in
place throughout the NHS as a matter of urgency. The
industry's ability to compete internationally requires a legislative
and organisational framework for research that protects the interests
of all stakeholders - patients, researchers and pharmaceutical
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