Letter from Lord Warner to the Chairman
of the Health Committee (LW 1)
At the Health Select Committee hearing on 4
March 2004 I promised to write with more detail on a number of
issues. These are covered in the paper attached to this letter.
The Committee asked for the following additional
information:
1. Mr Simon Burns MP asked for clarification
on the response given by the Parliamentary Under Secretary of
State for Community in his evidence to the Committee regarding
the collection and publication of statistics by age-related groups
and the specific case of the performance indicator on emergency
readmission for over-75 year olds.
2. Mr Keith Bradley MP asked about the timetable
for the review of NHS Foundation Trusts and the timeframe for
further waves of proposals on Foundation Trusts.
3. Mr Paul Burstow MP asked for more information
about work in train in conjunction with the Commission for Healthcare
Audit and Inspection on the impact of its work on patient choice.
4. Dr Richard Taylor MP requested further
information on the complaints procedure.
5. I agreed to provide further information
on NICE's work in conjunction with the pharmaceutical industry
to ensure the publication of information.
6. Mr Paul Burstow MP requested further
information on the rationale for the decision regarding NHS funding
of one In vitro fertilisation (IVF) cycle, following the
recent NICE guidance on IVF treatment.
7. Dr Richard Taylor MP asked whether the
Department of Health had seen a decrease in the number of letters
concerning postcode rationing since the introduction of NICE.
8. Mr Jim Dowd MP asked for more information
on whether women were being sufficiently served by pharmaceutical
research.
9. I agreed to clarify the role of the Health
Development Agency with regard to health education.
10. Mr Paul Burstow MP asked for further
information on the Department of Health's approach to the commissioning
of research.
I hope that the attached response meets your requirements
and I look forward to working with you and other members of the
Health Committee in the future.
16 March 2004
Annex 1
Responsibilities of Parliamentary Under-Secretary
of State for Health, Lord Warner Follow-up Information
1. COLLECTION
AND PUBLICATION
OF STATISTICS
BY AGE-RELATED
GROUPS AND
THE SPECIFIC
CASE OF
THE PERFORMANCE
INDICATOR ON
READMISSION FOR
OVER-75 YEAR
OLDS
The Committee asked me why it is considered
ageist to collect data for readmissions of patients over 75 years
old as a performance indicator, but not ageist to collect other
data, such as smoking cessation, by age group. My colleague, the
Parliamentary Under Secretary of State for Community, answered
this question in his evidence to the Committee and has subsequently
written on the subject to both Mr Burns and Mr Burstow.
In short, when the only data collected as a
performance indicator for readmissions were for readmissions of
over 75s and the target was to reduce that rate, there was a potential
incentive for hospitals not to readmit those over 75 even when
it was appropriate for them to do so. We now have a performance
indicator of readmissions of patients of all ages, so there is
no possibility that a patient may be denied services on the basis
of age. Collecting data by age group on smoking cessation or genito-urinary
medicine does not run the risk that frail older people will be
denied services which they need in order to meet performance targets.
Dr Ladyman has offered Mr Burns and Mr Burstow
the possibility of providing an age based analysis of hospital
episode statistics, which are not used for performance management,
if they would specify the analysis in which they would be interested.
2. THE REVIEW
OF NHS FOUNDATION
TRUSTS
The review of NHS Foundation Trusts is to be
undertaken by the Commission for Health Audit and Inspection (CHAI),
in conjunction with the Office of the Independent Regulator for
NHS Foundation Trusts. Department of Health officials are currently
working with CHAI, and the Regulator to develop proposed terms
of reference for the Review. We expect to make an announcement
about this and about the timing of the next wave of NHSFT authorisations
soon.
3. THE IMPACT
OF THE
WORK OF
THE COMMISSION
FOR HEALTHCARE
AUDIT AND
INSPECTION ON
PATIENT CHOICE
So far as CHAI and patient choice is concerned,
CHAI has been established to offer authoritative independent commentary
on the quality of healthcare. The information that CHAI makes
available will, as it grows in extent and sophistication, help
patients and the public (and those working in healthcare) to exercise
informed choices.
CHAI will also be charged with carrying out
reviews that take account of the standards on which the Department
of Health is currently consulting. Within the "accessible
and responsive care" domain of these standards are standards
about maximising patient choice and about ensuring access to services
through a range of providers and routes of access.
This is in line with Building on the Best that
we issued last year following an extensive consultation with patients
and public to ask them what would do most to improve the experience
of health care for patients, users and carers. One of the six
immediate priorities set out in Building on the Best is the need
for patients to have information to help share decisions about
their healthcare and exercise choice.
4. COMPLAINTS
PROCEDURE
Under the proposed, revised complaints procedure,
and the draft regulations are the subject of three months formal
consultation process, referral to CHAI replaces the current Independent
Review Process. A complainant would have a right to request that
CHAI consider the complaint where:
— he or she is not satisfied with the
result of an investigation at local level;
— investigation of the complaint has
not been completed within six months; or
— the complaint was not investigated
locally because it was not originally made within the time limit.
Of course, this does not necessarily mean that
CHAI will investigate. It may, having assessed the nature and
substance of the complaint, decide to take no further action.
Nonetheless, the right would exist for a complaint to invite CHAI
to undertake that assessment.
5. NICE AND THE
PUBLICATION OF
INFORMATION
In the technology appraisal programme, NICE
negotiates with companies to minimise the amount of data classified
as commercial in confidence and regularly secures agreement from
manufacturers to lift their restrictions. NICE does not keep records
that allow this to be quantified precisely but it should be noted
that many recent appraisals have very little or no commercial
in confidence data in the evidence base. The Institute is finalising
an agreement with the Association of British Pharmaceutical Industries
on handling commercial in confidence data in technology appraisals.
The clinical guidelines programme does not accept
commercial in confidence data.
6. NICE GUIDANCE
ON IVF TREATMENT
NICE publishes a cost impact assessment as part
of its guidance on each technology appraisal. In addition, NICE
is currently piloting a cost impact assessment on three of its
clinical guidelines. The first of these was for the infertility
guideline (Clinical Guideline No 11: Fertility: assessment
and treatment for people with fertility problems) and was
published with the guideline on NICE's website on 25 February
2004. NICE has also developed a template for use locally by health
economies, and the template for the infertility guideline was
published on 1 March 2004. It is planned that the cost impact
analysis should become a standard feature of NICE's guidance on
clinical guidelines.
7. CORRESPONDENCE
CONCERNING POSTCODE
RATIONING
Unfortunately it is not possible to tell from
the Department of Health's correspondence database whether the
complaints around postcode rationing have decreased since NICE
implementation. Correspondence is categorised by subject or policy
keyword, and we do not have one on postcode rationing. Unfortunately,
it would require us to go through thousands of letters to be more
precise on this issue. Anecdotally, however, officials who have
been drafting correspondence for a number of years confirm that
postcode rationing is not the issue it used to before NICE, although
there are still a number of letters relating to particular treatments
in particular areas. These are referred to the relevant Strategic
Health Authority for action, as indicated by Lord Warner in response
to question 51.
8. WOMEN AND
PHARMACEUTICAL RESEARCH
The Committee suggested that women were among
the "vulnerable groups" identified by the recent King's
Fund report as not being best served by the current arrangements
for research and development of new medicines. In fact, the King's
Fund report does not itself include women in this category—it
highlights only children and older people. As Lord Warner said
to the Committee, a large number of drugs have been developed
particularly for older people, who of course are also major users
of medicines developed for conditions such as coronary heart disease
and cancer.
The Department is not aware of any convincing
evidence that women's health needs are neglected in medicines
research, and products for treating conditions suffered mainly
by women are well represented among new medicines coming to the
market. Equally, clinical trials of drugs for conditions suffered
both by men and women need to contain a representative sample
of the two sexes. Before a Marketing Authorisation is granted
for a new medicinal product, the Medicines and Healthcare products
Regulatory Agency (MHRA) ensures that data submitted within an
application including the population randomised into clinical
trials is sufficient to justify the use in the ultimate target
population in terms of age, gender and ethnicity. Where drugs
are intended to treat conditions that affect both men and women,
clinical trials data must include a sufficiently representative
sample in this population.
9. THE ROLE
OF THE
HEALTH DEVELOPMENT
AGENCY
The health education and health promotion activities
previously carried out by the Health Education Authority do not
form part of the Health Development Agency's (HDA) remit. The
HDA does, however, continue the Health Education Authority's (HEA)
lead role for the National Healthy Schools Standard on behalf
of the Department of Health and Department for Education and Skills.
10. COMMISSIONING
RESEARCH
An additional note is attached on this subject
at Annex 2.
Annex 2
Department of Health—Research &
Development
1. SUPPORTING
THE SCIENCE
BASE IN
HEALTH AND
SOCIAL CARE
1.1 In March 2000, Research and Development
for a First Class Service: R&D funding in the new NHS set
out the Government's plans to develop a clearer and fairer system
of NHS funding for R&D. It announced two streams of funding:
NHS Support for Science; and NHS Priorities and Needs Funding.
The latter provides funding for research of direct relevance to
the NHS. NHS Support for Science meets the NHS costs of hosting
R&D supported by eligible research funders, such as clinical
trials sponsored by the Medical Research Council. The new system
is designed to improve the efficiency with which these resources
are allocated and clarify access to them. The NHS will meet these
costs where agreed standards of strategic direction, mutual influence,
open access and quality assurance are maintained by non-commercial
research funders. A key element in the new funding system is to
strengthen NHS-university partnerships.
1.2 The Department of Health plays a major
role in the science base for medical and health related research
by funding support for R&D in NHS bodies and providers of
NHS services. As well as providing for some directly managed research
in the NHS, the support funding meets the costs to the NHS of
providing the setting for high quality research led by the Research
Councils and medical research charities. In medical/health research
there is in effect a "triple support" system, with the
Department providing the research infrastructure in the NHS for
science alongside HEFCE, which provides the infrastructure funding
for universities, and Research Councils who provide project funding.
The Department therefore has a major stake in promoting synergy
between the NHS and the science base.
1.3 The Department places great emphasis
on the need to work with other research funders to ensure that
the science base for health and social care is adequately supported
and the research agenda is effectively addressed, avoiding unnecessary
duplication. These partnerships have been formalised through a
range of agreements including concordats with all the grant-awarding
Research Councils, bilateral agreements between the Department
of Health and non-commercial sponsors of R&D and a strategic
Alliance with HEFCE.
2. KNOWLEDGE
GENERATION FOR
HEALTH AND
SOCIAL CARE
2.1 The Department of Health needs research
to ensure that policy and practice in public health, health care
and social care is based on reliable evidence of needs and of
what works best to meet those needs. The Department draws widely
on national and international research to inform policy and practice.
It also invests in research to support its objectives, and priorities
within the research agenda are driven by policy and service priorities.
2.2 The research programmes and initiatives
taken forward by the Department reflect a mix of priorities and
needs identified by the Department of Health through a number
of routes including horizon scanning and consultation exercises
with external stakeholders. The Department works in a number of
ways to ensure that research is available to address priorities
and needs. Methods include:
— accessing national and international
research;
— working in partnerships with and
influencing other funders;
— running directly commissioned research
programmes;
— supporting high quality research
programmes in NHS providers; and
— research supported through Non-Departmental
Public Bodies.
Working in partnerships with other funders
2.3 Where the research needs identified
are likely to require more basic scientific input, the Department
looks to the Research Councils to take work forward. The Health
Departments' Concordats with the Research Councils formalise this
relationship. Interactions of this kind occur most often with
the Medical Research Council and to reflect this there is a formal
framework for recording Department of Health (and other Health
Departments') priorities for MRC research. In some cases the Department
asks the MRC to take research forward proactively, for example
in Creutzfeldt Jakob Disease, and sometimes do so with Department
of Health R&D funding, for example on HIV/AIDS epidemiology.
Directly commissioned research programmes
2.4 Though there are a number of other research
funders in health and social care, they operate largely in responsive
mode and may not necessarily reflect policy requirements identified
by the Department of Health. While such work is essential to our
wider knowledge base for health and social care, many of the research
needs identified for policy and practice have to be met directly
by the Department. The Department of Health has therefore developed
a number of generic programmes through which research is delivered
to meet research needs. Overall the Department of Health spends
over £100 million per annum in total on directly commissioned
research programmes.
2.5 The Department supports National NHS
R&D Programmes through which NHS research priorities and needs
are met. The principal programmes are:
— the Health Technology Assessment
(HTA) Programme, which meets the need for high quality research
information on the costs, effectiveness, and broader impact of
health technologies, and which has strong international links;
and
— the Service Delivery and Organisation
(SDO) Programme, which focuses on the organisation and delivery
of services to improve patient care.
2.6 The Department also funds a Policy Research
Programme to support its work across the whole range of Secretary
of State's responsibilities in public health, health services
and social care. The programme supports a mix of longer-term programmes
in research units, initiatives on specific themes, individual
projects and reviews. Sufficient flexibility is retained within
the budget to enable urgent in-year research needs to be taken
forward. Criteria for prioritising calls on the budget are:
— relevance to the priorities, aims
and objectives of the Department of Health in improving the health
and social welfare of the population and reducing inequalities;
— size and importance of the problem
to be addressed in terms of actual or potential burden of disease
or social condition;
— well-defined plans for introducing
research results into current policy activity or the formulation
of future policy;
— feasibility of research;
— likely return on the investment in
research in terms of impact on health, and other benefits; and
— appropriateness and availability
of other research budgets, for example, those of Non-Departmental
Public Bodies, Research Councils, NHS R&D.
2.7 The Department also manages a number
of other smaller research budgets either on specific programmes
eg Radiation Protection Research, or on an ad hoc basis. A number
of the Department's agencies also have R&D programmes, eg
NHS Estates.
High quality research programmes in NHS providers
2.8 Much of the research needed for better
health and social care services is carried out in the NHS. As
well as funding and setting the overall strategic direction for
research, the Department has a responsibility to ensure that the
NHS works effectively to deliver high quality research.
2.9 As part of the new NHS Priorities and
Needs funding arrangements, we are promoting research partnerships
and networks between the NHS, researchers and consumers, to meet
the needs for health and health care research. Programmes of research
in NHS and partner research organisations are supported directly.
The Department may specify such programmes in detail or may agree
a strategic direction for the organisation, collaboration or network
with delegated authority to determine how best to deliver the
desired outcomes.
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