Further supplementary submission submitted
by the Department of Health
QUESTIONS ON
GOVERNMENT RESPONSES
TO SELECT
COMMITTEE REPORTS
1. The Department responded to our concerns about
the extent and cost of drug-induced illness by focusing specifically
on the problem of medication errors (when patients are given the
wrong prescription). Drug-induced illness extends far beyond this.
Should we infer from your response that the Department feels unable
or unwilling to assess the extent and cost of medicalisation?
There are two causes of drug induced illness, medication
errors and adverse drug reactions (ADRs). The Government response
to recommendation 29 covers the work the Department has taken
forward in both of these areas.
I understand that your reference to "medicalisation"
refers to the Committee's conclusion that there appears to be
a pill for every problem. I would first like to clarify that the
Government's position is made clear in the public health white
paper Choosing Health, where we have emphasised the need for the
NHS to become a health improvement and prevention service. What
we are doing is explained in more detail in the Government response
to recommendation 31. It is important to remember however, that
a patient's treatment is decided by a trained clinician, and is
based on clinical judgement. The clinician will discuss with the
patient the best course of treatment before deciding the most
appropriate intervention.
The focus of all Department of Health (DH) research
programmes is to enable the NHS to improve health outcomes for
patients, and we recognise that this is much broader than providing
pharmaceutical solutions. For example, in the area of mental health,
cognitive behavioural therapy may be a better option than pharmaceutical
intervention. In the prevention of coronary artery disease, public
health initiatives to reduce smoking and improve diet could have
a greater impact than improving drug treatments. The general approach
of DH Research and Development is to commission research based
on the best advice available from carefully selected clinical
experts. Our experience is that they are the best people to decide
which approach is most likely to deliver benefits for their patients,
and that they are very willing to explore alternatives to drug
treatments. One result of this approach has been that our portfolio
of directly funded research includes a number of projects that
cover different aspects of the range of alternatives to drug treatment.
2. The response to the New Medical Technologies
inquiry details extensive additional training across the board
in the use of new medical devices. No changes are proposed in
the response to our inquiry into the Influence of the Pharmaceutical
Industry regarding better training for doctors in the use of drugs
and in evaluating drug safety and efficacy, at undergraduate or
post-graduate level, despite recent events involving Vioxx and
continuing questions on Seroxat. Why do you think "doctor
knows best" when it comes to drugs but not devices?
The Government does recognise the need to influence
the curricula for undergraduate and postgraduate training but
is satisfied that the mechanisms in place for ongoing training
and education are fit for purpose (as set out in the response
to recommendation 21).
Training and education in the use of new medical
technologies is regarded by both Government and industry as key
to facilitating adoption of useful innovation by the NHS and social
care services. The pace of product development is rapid in this
field, and the technology new and complex. There is often close
collaboration between companies and professional users during
the development of innovative health technologies because of their
specialist application. The roll-out of training for staff involved
in using these when they are brought to market is therefore essential
to successful introduction. This needs to keep pace with medical
advances and competencies need to be kept up-to-date so that staff
have the necessary skills to use innovative products and technologies
competently and safely. The Healthcare Industries Task Force recognized
the importance of training and education in this highly specialised
and fast moving area, and has therefore initiated a project to
identify ways of strengthening this aspect.
The curricula for undergraduate medical education
are the responsibility of the regulatory body, the GMC and in
the case of postgraduate medical education the Postgraduate Medical
Education and Training Board is the competent authority. Both
bodies have lay as well as medical membership. Trainees at various
levels receive training in drugs and devices as determined by
the curricula. However, there is also much local training and
development activity where it is for the judgement of individual
NHS organisations as to how clinicians are kept up to date.
It is important that prescribers are kept up to date
on new medicines entering the market. They receive independent
advice on medicines from the National Prescribing Centre, and
through the British National Formulary and the Drug and Therapeutic
Bulletin, both of which are purchased for the NHS by the Department.
3. We have heard a lot about Herceptin recently.
Do you see a way in which medicines that appear to benefit many
patients can be made available quickly, while ensuring effective
post-marketing surveillance to avoid the problems caused by drugs
such as Vioxx and the SSRIs?
On allowing early access to new medicines, the Government
recognises that there is a need to strike a balance between speedy
access to potentially life saving therapies and protecting the
public from medicines where the risks may outweigh any benefit.
Under the recent review of EU medicines legislation
there is a new provision allowing for an accelerated assessment
procedure on grounds that the product is of major interest from
the point of view of public health, and in particular represents
a therapeutic innovation. A separate provision introduced in the
review (compassionate use) permits products either in clinical
trials or in the process of being authorised to be given to certain
groups of patients. These are patients with a chronically or seriously
debilitating disease or whose disease is considered to be life
threatening. Whether the means of accessing new medicines is through
accelerated authorisation, compassionate use or off-label use,
it is vital that data on emerging safety data to inform the risk
benefit assessment is captured. The strengthening of the pharmacovigilance
provisions, including the introduction of risk management plans,
the initiatives of the European Risk Management Strategy, are
central to this process.
The Ministerial Industry Strategy Group referred
to the Government response (to recommendation 6) will also be
considering how to enhance the safety of the introduction of new
medicines as one area of study within the overall work stream.
In addition, the Government is aware of the concerns
over the delay in providing the NHS with authoritative advice
on the clinical and cost effectiveness of important new drugs
once they have received a license. In an effort to address these
concerns, the Health Secretary Patricia Hewitt announced on 3 November
that proposed changes to enable the National Institute for Health
and Clinical Excellence (NICE) to produce faster guidance on individual
drugs will go ahead immediately.
NICE will launch a new, rapid process for assessing
drugs and other treatments to sit alongside its standard process.
The Single Technology Appraisal (STA) process will be used initially
to produce faster guidance on certain potentially life-saving
drugs which have already been licensed and on new medicines already
referred to NICE. The STA process could mean that for some new
drugs guidance is issued as soon as 8 weeks after licensing. Herceptin
is amongst the first five products to be appraised under the new
process.
4. The Government has not addressed several of
the recommendations made in the pharmaceutical industry inquiry,
in particular that regarding the need for greater alignment between
the industry's research priorities and NHS public health aims.
Could you tell us now whether any discussions will take place
to address our concerns in this area?
The Government agrees with the Committee's conclusion
that there should be formal discussions between Government and
industry on the key health challenges ahead, and this will allow
industry to plan which disease areas to carry out research in.
Paragraph 15 of the Government response responds to the Committee's
conclusion, and we have asked the UK Clinical Research Collaboration
(UKCRC) to hold a Futures Forum to bring together key stakeholders
to advise ministers on priority areas for innovation in healthcare.
The UKCRC has indicated that it intends to hold the first Futures
Forum in 2006. This will be informed by the results of its strategic
analysis of current research funding by its Partner organisations,
which include the pharmaceutical industry, due to be available
next spring.
5. The Government's response to the Committee's
report on NHS Continuing Care indicated that many of the
issues we raised will be addressed in the forthcoming national
framework. Can you up-date the Committee on the progress of that
work? When is the framework likely to be available and what is
the implementation timetable?
Development of the national eligibility criteria
and assessment tools is well advanced. In the past months, the
Department has conducted several stakeholder workshops with health
and social care colleagues and patient and user representatives,
to debate the format and principles of the national framework.
These events produced a broad consensus on the way forward, as
well as marked enthusiasm for the Department's commitment to consultation.
Final development of a consultation document on the national eligibility
criteria is underway and will be completed within weeks. The date
for formal consultation will be confirmed as soon as possible,
though legal advice indicates that this may not take place until
the New Year, taking into account other related events such as
the forthcoming White Paper, NHS reorganisation and ongoing litigation.
A national assessment process, including a bespoke
decision-support tool, is in development based on existing models
in use across the country. The tool will be subject to benchmarking,
including a specific stakeholder event for this purpose in December
2005. Following completion of the formal public consultation,
the national framework will be published.
6. The Committee also raised concerns about compensation
for people wrongly denied continuing care. In your response it
was stated that "the Department is working with the Ombudsman's
Office on this issue". Can you tell us what developments
have occurred and whether there is any progress on the question
of compensation (as opposed to merely restitution)?
The Department has remained in close contact with
the Ombudsman's Office on this issue, and we expect to receive
proposals within the next month on the subject of compensation
payments. The Department will then need to consider its response
to those proposals.
7. Recommendation 11 in our report on the Use
of New Medical Technologies was about the unstructured adoption
on new technologies (a theme that informed the whole Select Committee
report). What are "the different strategies" that are
mentioned in the last paragraph of the Government's response?
How are they to be implemented?
Innovation in medical technologies can present in
a number of different ways. Medical devices often follow an evolutionary
development pathway, with a series of enhancements following in
relatively rapid succession. The original product and its subsequent
adaptations could all be innovative, and once in use, innovation
is therefore adopted in an incremental way.
However, introducing a new technology which challenges
existing service provision, is more expensive, requires new competencies,
or looks promising but needs more supporting evidence of effective
performance and value for money, requires a different approach
to adoption. The NHS Institute for Innovation and Improvement,
established on 1 July 2005, will help to identify (through the
National Innovation Centre set up under HITF recommendations)
such technologies. Through its service transformation function,
the Institute can investigate the impact of disruptive technologies
on current services and support any necessary organisational change
where there is a financial and clinical case. Additionally, where
new technologies appear to have the potential for high impact
on care, introduction through piloting to secure more evidence
of performance and benefits, particularly where these are realised
longer term, can be considered, and more data produced on the
risk:benefit ratio and cost implications.
The Institute also has a learning function which
will support the development of appropriate skills in healthcare
professionals so that skills are kept up-to-date with advances
in medical science and NHS staff can work effectively and safely
with new technologies.
13 December 2005
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