Memorandum 1
Submission from Guy's
and St Thomas' NHS Foundation Trust, South London and Maudsley
NHS Trust, and King's College London
As a partnership between health service and
academe, we welcome the Cooksey Review, as an opportunity to create
a funding environment which will enhance our ability to create
seamless pathways which link the most basic scientific research
to improvements in health care delivery.
We support the Chancellor's ambition to create
a single ring-fenced budget to support health research as a means
of achieving this goal. A single budget, if properly managed,
should reduce bureaucracy and erode the artificial separation
between the research agendas of Universities and their partner
NHS Trusts. It would encourage collaboration between the two entities
and incentivise NHS staff to undertake research, and University
staff to think about the applications of their research to patient
care.
HOW FUNDS
SHOULD BE
ALLOCATED
Under the present system, there are significant
differences in the two funding regimes which will need to be reconciled.
MRC funds are earned on the basis of research excellence, as judged
by rigorous peer review, and measured against national and international
priorities aligned with the MRC's mission to "encourage and
support high-quality research with the aim of improving human
health". Funding awarded to Universities by Research Councils
and other external funders of research is ring-fenced and cannot
be used for any other purpose. On the other hand, the majority
of NHS R&D funds are allocated formulaically for research
infrastructure, although it is often difficult to trace this income
stream to specific R&D support. This is the rationale behind
the "Best Research for Best Health" initiative, which
is designed to ring-fence R&D funds for R&D in NHS Trusts.
Redistribution of funds under BRBH poses a substantial
financial risk to NHS Trusts that are research-active—and
perversely, the more research-active a Trust has been, the more
it stands to lose. Even if Trusts are able to regain income equivalent
to their current R&D levies through various BRBH schemes,
the new income will be ring-fenced for specific research initiatives,
leaving an underlying deficit in their budgets which could seriously
destabilise clinical services. For this reason we believe that
it would be preferable to create the £500 million DOH contribution
to the joint fund by redirecting this amount into R&D from
the planned growth in funding (£4 billion pa for the next
two years[1])
in the NHS.
It should be noted that if it is the case that
not all of the £700 million attributed to NHS R&D is
being used for research purposes, then the total amount of research
that could be funded out of a combined £1 billion fund should
be substantially greater, which would be of benefit to the UK.
The Higher Education sector is well advanced
in developing methodologies for full economic costing of research.
Any new system should take advantage of the work that has already
been done in this regard and extend the principles across the
fund as a whole.
It will be important to re-evaluate the entire
range of research interests and methodologies that exist along
the biomedical research pathway from basic discovery to applied
research to ensure that an appropriate proportion of spend is
allocated across the spectrum. These changes are necessary to
support the translational research agenda, which has come to the
fore over the past few years, as research breakthroughs in basic
research are beginning to be applied to clinical questions. It
may be necessary to provide considerable funding at the applied
end of the spectrum for training and incentives to ensure that
the expertise exists to support excellent research in areas such
as statistics, epidemiology, health economics, and health policy,
and to attract health care professionals other than doctors into
research activities.
The single fund should also consider setting
aside funds for infrastructure development in areas such at IT
and clinical research facilities, to support seamless working
across partner organisations.
WHAT SORT
OF ORGANISATION
SHOULD MANAGE
THE FUND
There is considerable collaboration amongst
the various Research Councils. Research activities undertaken
outside the MRC's remit but with important consequences for health
are co-ordinated and sometimes co-funded, in areas such as the
physical sciences, bioinformatics, maths and social sciences.
There are also strong relationships between the MRC, the DOH and
the medical charity sector (for example, the Joint Infrastructure
Fund and more recently, the Clinical Research Facility initiative).
Any new funding regime must take care not to disrupt these important
connections and collaborations.
In order to maintain its leading international
position in biomedical and health research, second only to the
USA, the UK funding regime must allocate resource on the basis
of excellence, which is best determined through a rigorous peer-review
system. The MRC has vast experience of managing such a system
and is recognised throughout the world as an organisation that
funds the best science through fair and equitable mechanisms driven
by strategic goals. We believe that the new single funding body
should be based on these principles.
GOVERNANCE ISSUES
We believe that a novel governance model is
needed which draws on the best features of the two current schemes
and acknowledges the interdependence of the NHS and its academic
partners. All key stakeholders should be involved—government
departments, research councils, universities, the NHS, medical
charities, industry and patient groups.
Two models are possible. One is that, as proposed,
there is a single budget which relies on a single resource allocation
methodology. The advantages of this model as we see them have
been discussed above. There are potential difficulties which would
have to be resolved in order for a single budget to work effectively.
Principle amongst these would be to agree the appropriate proportion
of the fund to be distributed to different elements of activity.
Without careful management, basic research could benefit at the
expense of more applied research simply because the metrics are
more easily defined for laboratory-based research. It will also
be difficult, we suspect, to resolve the "ownership"
of a single fund in a way that both partners in the scheme felt
was equitable and aimed at achieving the right set of goals.
An alternative model might be to combine the
funds under a single governance arrangement with a single Board
Chairman, but with two discrete funding streams, each with its
own Director. One of these would be drawn from the DOH and would
be responsible for building capacity in the NHS, funding research
infrastructure and applied research. The other would be drawn
from academe and would be responsible for funding those activities
currently under the remit of the MRC. In order for this model
to be successful, there would have to be a single strategic vision
across the two arms of the structure. The diagram on page 3 of
the Academy of Medical Sciences/Royal Society response to this
consultation provides a model which we would support.
Attached to this response is an annexe, from
South London and Maudsley NHS Trust, giving specific examples
of the possible impact on mental health research of the proposed
changes.
January 2007
South London & Maudsley
NHS Trust and Institute of Psychiatry, King's College London (KCL)
RESPONSE TO COOKSEY CONSULTATION
FUNDING RESEARCH
ON THE
DEVELOPMENT AND
EVALUATION OF
INNOVATIVE THERAPIES
As a supplement to the main KCL submission with
its associated NHS Trusts to the Cooksey consultation, this paper
addresses the need to establish an effective system for the allocation
of the excess treatment costs necessary to allow the scientific
investigation of innovative therapeutic interventions to take
place. This response has been prepared by senior clinical academics
representing core mental health disciplines with internationally
recognised expertise in developing new treatments for psychiatric
conditions, including psychological therapies for anxiety disorders,
bipolar disorder, schizophrenia, obsessive-compulsive disorder,
eating disorders, psychosomatic problems, and conduct problems
in childhood—and in evaluating these treatments in large-scale
multi-site randomised controlled trials with funding from sources
including the Medical Research Council, the Wellcome Trust and
other NHS recognized medical charities, and the Department of
Health.
1. Over the last 25 years, the UK has been
a world leader in the development of new and effective treatments
for mental illness, including innovatory psychological and social
therapies. Many of these psychological treatments, for example,
are now recommended as treatments of choice by review bodies such
as NICE, to be used either in conjunction with pharmacological
treatments or for many conditions as the preferred treatment on
grounds of effectiveness, cost and patient preference. Much development
and evaluation work remains to be done, again as highlighted by
NICE.
2. However, current central funding arrangements
threaten to undermine and weaken this work and the UK's pre-eminence
because the allocation of the excess treatment costs necessary
for such clinical investigations is complex and does not operate
effectively. Definitions of treatment, and excess treatment, costs
are set out in: The Department of Health Guidance Document "Attributing
revenue costs of externally-funded non-commercial research in
the NHS (ARCO)" (Gateway reference: 5956) of December 2005,
which states:
"Treatment Costs are the patient care costs
which would continue to be incurred if the patient care service
in question continued to be provided after the R&D activity
had stopped. Where patient care is provided that is either an
experimental treatment or a service in a different location from
where it would normally be given and it differs from the normal,
standard treatment for that condition, the difference between
the total Treatment Costs and the costs of the standard treatment
(if any) is called Excess Treatment Costs. These costs are nonetheless
part of the Treatment Costs, not an NHS Support or Research Cost.
The term Treatment Costs covers all types of patient care services,
including diagnostic, preventive, continuing-care and rehabilitative-care
services, and health promotion."
3. The normal expectation by the Department
of Health is that these excess treatment costs, which fall outside
the NHS R&D budget, are sought through commissioning arrangements
via PCTs. Exceptionally it has been possible for those conducting
clinical trials and other clinical studies to seek excess treatment
costs from central Department of Health subvention. More recently,
however, central subvention for the excess treatment costs relating
to research has become more variable and increasingly difficult
to establish. This threatens the capacity to run large-scale trials,
such as those of psychological therapies, because:
(a) Local NHS commissioners will usually
only fund existing treatments. They are often understandably reluctant
to fund new therapies until they have been shown to be effective
and better than those that are already available in the NHS.
(b) New therapies need to be delivered by
clinicians who are fully trained in the innovative procedures.
This is realisable with a centrally funded expert therapeutic
teams, but difficult to achieve with routine NHS clinicians who
are temporarily seconded to a project and have many competing
clinical demands. In mental health care the treatment cost issue
applies particularly to innovative psychological and social treatments,
where individual and specifically trained therapists are required
to provide the complex treatments, whereas pharmacological trials
can normally be conducted by arranging for the usual clinical
staff to prescribe and administer the intervention.
(c) Multi-centre trials are often needed
to provide a definitive evaluation of a new treatment. Separate
negotiation of therapist costs from multiple local NHS organisations
is bureaucratically cumbersome, and can engender substantial delays
before projects can start. Absence of central funding also undermines
consistency and control of therapy delivery across sites.
4. We also wish to emphasise the need for
the single fund allocation system to distribute funds in such
a way that recognises different clinical environments that incur
different costs. In particular, we emphasise that much mental
health service provision takes place in the community and thus
associated research costs need to reflect the high level of contact
with community mental health teams, which are generally higher
than the costs of inpatient/outpatient hospital oriented research.
There are also additional costs associated with recruitment of
some hard to reach participants, particularly within mental health
services.
5. These points pose severe current threats
to the development and evaluation of innovative treatments, including
novel psychological and social therapies, with adverse implications
for the UK's international position in this area as well as for
the NHS. It is therefore to be hoped that new funding arrangements
will address the need for combined funding of therapy provision
and evaluation costs to ensure that high quality studies of new
treatments that are expected to have a substantial impact on the
NHS can take place.
Prepared by:
Professor Derek Bolton, Professor Trudi Chalder,
Professor David Clark, Dr Ivan Eisler, Professor Philippa Garety,
Professor Elizabeth Kuipers, Professor Robin Murray, Professor
Paul Salkovskis, Dr Ulrike Schmidt, Professor Jan Scott, Dr Stephen
Scott, Professor Graham Thornicroft, Dr David Veale, Professor
Simon Wessely.
Signed on behalf of the South London and Maudsley
NHS Trust:
Mr Stuart Bell, Chief Executive
Signed on behalf of the Institute of Psychiatry,
King's College London:
Dr George Szmukler, Dean
1 Based 6% of £70 billion growth in NHS budget
for next two years. Back
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