APPENDIX 23
Memorandum submitted by the Association
of the British Pharmaceutical Industry (ABPI)
SUMMARY
Since providing our written evidence to the
original inquiry in March 2000 there have been a number of important
developments outlined in the detailed comments in our response.
These include:
— Industry representation on the newly
formed National Cancer Research Institute
— New processes for speedier approval
of clinical trials as set out in the conclusions of the Pharmaceutical
Industry Competitiveness Task Force Report published in March
2001
— The publication of the EU Clinical
Trials Directive in May 2001 with implementation due by May 2004
and providing for a maximum 60 day timeline for regulatory authorities
and ethics committees to consider clinical trial protocols
— The development of Cancer Research
Networks
— A number of positive appraisals of
cancer medicines by NICE
However there are some potential negatives and
they include:
— A potential threat to cancer registries
through the Data Protection provisions
— Failure of local hospital trusts
and primary care trusts to adequately implement NICE guidance
A number of the new developments including the
NCRI, Cancer Research Networks and the rules for ethics committees
are in their infancy and the ABPI believes that it is too soon
to judge what effect they will have on cancer management in the
UK. Therefore we believe that this review by the Select Committee
should be the first of a series and that regular reviews of cancer
management in the UK should be undertaken. The ABPI would be delighted
to continue to provide evidence both written and oral to the Committee.
Our detailed comments are as follows:
THE RESEARCH
BASE, REVIEW
AND FUNDING
OF THE
NHS CANCER PLAN
AND ITS
DELIVERY TO
DATE
In our evidence to the Select Committee Inquiry
into Cancer Research, we highlighted the problems in the UK of
getting clinical trials started. As a result of the agreements
within the Clinical Research Workstream of the Pharmaceutical
Industry Competitiveness Task Force (PICTF) set up by the Government
in April 2000, we are pleased to report that systems are in place
to considerably reduce the timelines in getting clinical trials
started. However as the new systems are currently being instituted,
it is too early to comment on whether they have been successful.
This process will also potentially be helped by the introduction
of the EU Directive on Clinical Trials which essentially requires
a decision to be made on whether a trial can start by the regulatory
authority and the relevant ethics committees within 60 days. The
Directive will be implemented in the UK by May 2004. The Medicines
Control Agency (MCA) have indicated that they wish the regulatory
process to remain as efficient as it currently is and therefore
this should benefit sponsored clinical research in the UK.
With regard to the NHS Cancer Plan, we believe
that it is too early to come to any concrete conclusions on whether
it is delivering it targets. We believe that the awaited report
from the Commission for Health Improvement (CHI) on the NHS uptake
of the Calman-Hine report will provide evidence as to whether
Health Authorities and Trusts are taking the management of cancer
seriously enough. However there can be no doubt that the appointment
of a "Cancer Czar" has had a beneficial effect on cancer
services and it was clear from Dr Richards' presentation at the
All Party Cancer Group Conference on 31 October that over the
next year or so, there should be considerable developments in
the management of cancer in the UK.
PROGRESS IN
DEVELOPING THE
VIRTUAL NATIONAL
CANCER RESEARCH
INSTITUTE
The ABPI welcomes the fact that the newly instituted
National Cancer Research Institute (NCRI) has an industry member
in the person of Dr John Patterson of AstraZeneca. As we indicated
in our oral evidence to the Select Committee, it was a considerable
disappointment that the industry had not been invited to take
part in the Cancer Research Funder's Forum. The ABPI has formed
a Cancer Working Group to support Dr Patterson and it met with
Dr Liam O'Toole, the manager of the NCRI recently. As yet it is
too early to comment on whether the NCRI will transform cancer
research in the UK or just be a talking shop, although we recognise
that it is Dr O'Toole's intention that it will be much more positive
than a talking shop.
The ABPI fully supports the development of a
National Tissue Bank to be used by researchers involved in cancer
research and involving all the safeguards laid down in the report
of the Alder Hey Inquiry.
CANCER REGISTRATION
AND ITS
IMPLICATIONS FOR
DATA PROTECTION
The UK is one of the leading countries in the
world in the field of cancer epidemiology. There are two major
reasons for this, firstly we have a National Health Service which
enables data to be collected fairly easily on patients with cancer
and for their disease path to be followed and secondly our strong
tradition in evidence-based medicine. It is of vital importance
that the cancer registries are not lost but improved and increased.
Of course it is also vital that individual patient data be protected
as much as possible but particularly in the field of cancer, the
ABPI believes that societal requirements must outweigh individual
requirements. We believe that judicious use of Clause 60 of the
Health and Social Care Act will enable cancer registries to develop
whilst at the same time protecting individual patient data as
much as possible. Researchers in the cancer field will need access
to these registries but they will not require identifiable patient
data. However there must be some mechanism for the keyholder of
anonymised information to obtain further information in an anonymised
form where required. We believe that this will be an important
role for the Patient Information Advisory Group (PIAG), which
has been set up under Clause 61 of the Health and Social Care
Act. The ABPI is disappointed that none of its four nominees to
PIAG have been appointed and we hope that its membership will
include some researchers who will understand the need for access
to suitably anonymised individual patient data in diseases like
cancer.
THE NEW
CANCER RESEARCH
NETWORKS
Experience with the new cancer research networks
has so far been positive. Both the national lead, Professor Peter
Selby, and some of the regional leads are happy to work and collaborate
with industry and we view this as a positive step. The networks
are in their infancy and more time is required before we will
be able to judge just how effective they are but the signs are
good.
OTHER FACTORS
The ABPI recognises that the Health Select Committee
will be holding a short inquiry into the National Institute for
Clinical Excellence (NICE) early in 2002, but we believe it is
appropriate to comment on the implementation of NICE decisions
on cancer therapies. Although there have been a number of positive
appraisals on cancer medicines made by NICE the only one that
has so far led to a significant increase in prescribing was the
appraisal of taxanes for ovarian and breast cancer and even this
increase is £14 million short of the predicted £25 million
from Government. The ABPI is concerned that the results of the
recently published survey from CancerBACUP (www.cancerbacup.org.uk),
which shows that "fewer than half the health authorities
in England and Wales have a policy for monitoring local compliance
with NICE guidance". Also we are concerned that "guidance
on a wide range of treatments for other types of cancer is not
being followed in all parts of the country eg only 15 per cent
of respondents to the survey said that specific funds are available
to implement NICE guidance on lung cancer". This means that
there are too many patients not receiving medicines given a positive
appraisal by NICE who might well benefit.
However with all the above comments in mind,
the ABPI welcomes Lord Hunt's statement at the Annual NICE Conference
on 5 December. He announced that the Government will meet its
commitment to ensure that patients receive drugs and treatment
recommended by NICE if deemed appropriate by their clinician.
There will be statutory obligations on Health Authorities and
Primary Care Trusts to provide appropriate funding for recommended
treatments, although we have difficulty in assessing from where
the extra funding will come. This announcement will undoubtedly
benefit cancer patients in England and we hope that similar announcements
will be forthcoming from the Welsh Assembly and Scottish Parliament.
For instance we do understand that in Dundee funding for lung
cancer therapy recommended by NICE is unavailable.
If the uptake of cancer medicines increases
as a result of the Government announcement then this should increase
the UK oncology market and may lead to an increase in sponsored
clinical research in new cancer medicines in the UK.
6 December 2001
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