Memorandum by the Department of Health
(MT 1)
CONTENTS
1. Introduction.
2. Government policy objectives.
3. Context for change.
4. Meeting the challenge of change.
5. The Healthcare Industries Task Force (HITF)
and its recommendations.
6. The utilisation of telemedicine (including
telecare) and its future potential for improving services.
7. The speed of and barriers to the introduction
of new technology.
8. The effectiveness and cost benefit of new
technologies.
ANNEXES
A. — Sector definition, metrics and
performance indicators.
B. — Competitiveness analysis
of six key sub-sectors of the UK medical devices industry: interim
findings.
C. — DH research—Health Technology
Assessment (HTA) findings and applications.
D. — Healthcare Industries Task Force
(HITF) Terms of Reference.
E. — Examples of telemedicine and telecare
applications.
1. INTRODUCTION
1.1 The term "new medical technologies"
embraces a wide range of products, systems and techniques used
in health and social care. There is no readily accessible definition
of this term—it is usually applied to new and emerging technologies
in any field which may be have a medical application. Examples
of technologies that offer potential for better healthcare solutions
include digitalisation, tissue engineering, nanotechnology (particularly
bionanotechnology), robotics, information and communication technologies
(ICTs), materials engineering, pharmacogenetics and pharmacogenomics
and point of care testing devices (miniaturisation). Technological
advances in these areas are being utilised to develop higher quality
imaging equipment, tissue implants and wound management products,
tumour destruction techniques, precision surgery, genetic screening
tests, tests to predict adverse drug reactions, and more rapid
turnaround times for a variety of pathology tests, moving diagnostics
closer to patients.
1.2 The producers of these medical technologies
are loosely grouped together according to the technology within
the healthcare industries sector. Further information, compiled
by the Department of Trade and Industry (DTI), about the scope
of the UK-based sector and its characteristics is at Annexes A
and B.
1.3 Technology has never evolved more quickly
than at the present time and it is increasingly at the centre
of innovation in the field of human health, as well as in other
industrial and social areas. The medical technology industry operating
in the UK is highly diversified and innovative. It is a significant
component of the national economy and has considerable potential
for growth. It also has the capability of transforming the way
in which health and social care services are delivered.
1.4 For all these reasons, Government is
pleased to note the Committee's interest in this area.
2. GOVERNMENT
POLICY OBJECTIVES
2.1 The Government's policy objective in
relation to the use of new medical technologies is to harness
the benefits that they can bring to all stakeholders. This means
provision of improved healthcare for patients and service users,
whilst continuing to safeguard public health, and fostering a
vibrant commercial environment in which the industry can grow,
increase its competitiveness and its contribution to the UK economy.
3. CONTEXT FOR
CHANGE
3.1 The Wanless report[2]
stated that the NHS was a "late and slow adopter of medical
technology". Since its publication in April 2002 DH has been
considering the reasons for this and developing ways of improving
patient access to new technologies. Up to 2003-04 expenditure
on the NHS has increased by an average of 6.2% in real terms each
year since 1997 and is set to further increase by an average of
7.2% in real terms over the period from 2003-04 to 2007-08. This
investment is resulting in increases in workforce numbers and
NHS capacity, new and better treatments for patients, shorter
waiting times and greater choice. By 2008 there will be increases
above the September 2001 staffing figures of 15,000 more consultants
and GPs, 35,000 more nurses, midwives and health visitors, and
30,000 more therapists and scientists.
3.2 The changing demographic profile is
another significant factor which influences health and social
care needs. People are living longer and surviving some previously
life-threatening illnesses, due in part to advances in medical
science. The proportion of older people is growing and they need
a different range of services eg to help manage long term conditions
and to support independent living.
3.3 DH is also in the process of developing
policies to ensure that patients and services users are at the
heart of the health and social care system. Strategies are underway
to devolve NHS decision-making, budgets and commissioning of services
to front-line staff and to drive forward a programme of service
modernisation eg increasing the number Foundation Trusts, integrating
health and social care services, introducing specialist Independent
Treatment Centres (ITCs), decreasing waiting times for some operations
through the establishment of local day surgery units, extending
the role of pharmacists in the community, etc. Combined with other
central and local initiatives, the aim is to deliver responsive,
patient-centred services within a flexible framework capable of
providing speedy, convenient and modern healthcare solutions.
3.4 Changes to central structures are also
necessary to reflect the new balance of power. The DH review of
its Arm's Length Bodies (ALBs) [3]which
is already starting to take effect, will ensure that the Departmental
structure reflects and supports the new roles and ways of working
centrally, in the remaining ALBs and in the NHS.
3.5 Alongside developments in public policies
and structures, an explosion is taking place of new technologies
which have considerable potential in the medical field to improve
treatments. Information and Communications Technology (ICT) already
has many recognised medical applications and continues to evolve
as further advances are made. Similarly, tissue engineering promises
to bring improved therapies in a range of medical conditions,
as do breakthroughs in pharmacogentics, nanotechnology, robotics
and new device/drug combinations. It is necessary to keep up-to-date
with all these developments to help ensure that patients have
access to better treatments.
4. MEETING THE
CHALLENGE OF
CHANGE
4.1 The Government aims to meet its objectives
in optimising the benefits of new technologies for all stakeholders
via a number of processes and initiatives.
4.1.1 DH research in the NHS
The DH budget for NHS research and development
is over £600 million in 2004-05, of which £480 million
is allocated to NHS providers. Some 75% of the money from these
allocations meets the service costs to the NHS of research funded
by research councils and charities.
Research is fundamental to the introduction
of new products, technologies and services to the health and social
care system. DH funds research specifically to support policy
initiatives through its Policy Research Programme, and provide
the evidence needed to underpin quality improvement and service
development in the NHS through three main national programmes:
— New and Emerging Applications of
Technology (NEAT).
— Health Technology Assessment (HTA).
— Service Delivery and Organisation.
Both the HTA and NEAT programmes have commissioned
work of relevance to the Committee's Inquiry.
Policy Research Programme
The Policy Research Programme aims to underpin
policy development by commissioning high quality research-based
evidence. Its remit extends across the full range of DH's responsibilities,
including health and social care services, healthy living and
well-being, disease prevention, the role of the environment in
health, the organisation of the NHS and strategies for treating
particular diseases and conditions.
Horizon scanning reviews of both telemedicine
and telecare were commissioned in 1997 and 1998, and these informed
a developing research agenda within DH. This built upon earlier
involvement in European research programmes (Technology Initiative
for Disabled and Elderly People, and Advanced Informatics in Medicine),
and was closely linked to policy making in a number of areas,
including the potential for the technologies to support elderly
and disabled people. In 2000 DH commissioned a report on The
Use of Information and Communication Technologies (ICTs) in Assistive
Technology.[4]
Further research is being planned that will
provide evidence in relation to the most cost-effective approaches.
Some of the more sophisticated electronic technology options will
be studied further within a wider programme of research currently
out to tender and aimed at investigating technological support
for chronic disease management, for self-care and for healthy
living. The invitation to tender has been timed to coincide with
the latest call by the DTI in their Technology Programme, and
we are encouraging joint proposals to the DH call and to the pervasive
computing section of the DTI call. The Department has also been
discussing with the Engineering and Physical Sciences Research
Council and Economic and Social Research Council their interest
in joint research in this area.
NEAT
The HITF report Better health through partnership:
a programme for action (see also section 5) recognised that
an NHS aiming to innovate should capture the benefits of emerging
technologies and, in so doing, provide an engine for industrial
development based on the knowledge economy. NEAT aims to promote
this concept by supporting applied research and development that
will apply recent advances in fundamental knowledge and technology
to the development of new products and interventions for improved
health and social care or for disease prevention and treatment.
The NEAT programme provides funding for applied
research and development in all areas of the medical sciences
where new or innovative technological approaches can be used to
enhance the quality, efficiency and effectiveness of health and
social care. The research is strategic and applied in nature,
and has the potential (although not necessarily the direct aim)
for generating both intellectual property and cost reducing products
and interventions. Its outputs are general; they have wide applicability
and are capable of exploitation.
Projects supported by NEAT have for example
been concerned with the use of new technology in quantitative
3-D ultrasound breast imaging, speech recognition for people with
severe dysarthria, and the development of a practical recycling
device to permit cost effective application of Xenon anaesthesia.
The NEAT programme has been in operation for
some five years and has an annual budget of approximately £1.5
million. As indicated in the HITF report, this commitment is to
be increased by DH through the UK Clinical Research Collaboration
(UKCRC) (see paragraph 5.5.4). The NEAT programme is open to all
research providers in the academic and NHS communities. It aims
to overcome the funding gap for research that is basic in nature
and fundable by the Research Councils, and that which is towards
market and driven by industry along commercial lines. The NEAT
programme helps to fill this gap and support speculative applied
research which may have benefit to the NHS but which does not
have immediate commercial application and return.
HTA
The aim of the HTA programme is to ensure that
high quality information on costs, effectiveness and broader health
impact of health technologies is produced in the most effective
way and is bought to the attention of those who use, manage and
work in the NHS. The HTA programme considers the effectiveness
and appropriateness of technologies by asking four fundamental
questions:
— does the technology work?
— how does it compare to alternatives?
Examples of HTA findings and the uses to which
they have been put are given in Annex C.
LINK collaborative research
The Department has used the LINK collaborative
research scheme (formerly overseen by the Office of Science and
Technology) as a means of sponsoring the pre-commercial or strategic
development and assessment of new technology. The MedLINK programme,
which ran from 1996 to 2001, supported projects with the potential
to lead to new medical devices for prevention, diagnosis, monitoring
or treatment of illness or injury. A total of 48 projects received
Government support of £15 million.
The LINK Health Technology Devices programme
is currently supporting the research into innovative healthcare
technologies needed to develop new medical devices. A further
£15 million of government funding will be available throughout
the programme to support collaborative R&D projects involving
industry, universities and the NHS. Public investment will be
matched by industry. As well as medical devices, the programme
covers healthcare devices for use in the community and the home.
National Horizon Scanning Centre (NHSC)
The NHSC, funded through the NHS R&D Programme,
aims to provide advance notice to DH of new and emerging health
technologies likely to impact on the NHS. Where such technologies
require evaluation, including consideration of clinical and cost
effectiveness, they are passed to the Health Technology Assessment
Programme for prioritisation. Where there are implications for
the development or modification of clinical guidance, topics are
referred to NICE.
Assistive technology
A report on Research and Development Work Relating
to Assistive Technology is prepared annually for Parliament under
Section 22 of the Chronically Sick and Disabled Persons Act 1970.
The report is funded by DH and currently prepared by the Foundation
for Assistive Technology, whose database of research projects
is used both to highlight gaps and to identify funding sources.
4.1.2 The National Institute for Clinical
Excellence (NICE)
NICE has made a positive contribution to improving
NHS understanding of the clinical and cost effectiveness of new
medical technologies and has led to faster uptake where there
is evidence of benefits. DH recognises that more needs to be done
to improve implementation of NICE guidance and work is ongoing
to address this. (See also section 8.)
4.1.3 Regulation of medical devices
The regulations and controls on medical devices
provide a stable framework for product development and use. They
derive largely from EU legislation.
European Directives
A series of five European Directives regulating
the marketing of medical devices throughout the EU started to
come into effect from 1 January 1993:
— the Active Implantable Medical Devices
Directive (AIMD) covers powered implants (such as pacemakers)
or partial implants which are left in the body. This Directive
was transposed into UK law by the Active Implantable Medical Devices
Regulations (SI 1992 No 3146, as amended), subsequently consolidated
into The Medical Device Regulations (SI 2002 No 618);
— the Medical Devices Directive (MDD)
covers a broad range of products from sticking plasters to X-ray
machines and was transposed into UK law by the Medical Devices
Regulations (SI 1994 No 3017, as amended), subsequently consolidated
into The Medical Devices Regulations (SI 2002 No 618);
— the In Vitro Diagnostic (IVD) Medical
Devices Directive covers test kits and instruments used in vitro
for examining specimens taken from the human body (eg blood grouping
reagents, pregnancy and Hepatitis B test kits). It was transposed
into UK law by the In Vitro Medical Devices Regulations (SI 2000
No 1315), subsequently consolidated into The Medical Devices Regulations
(SI 2002 No 618); and
— the Directive amending the MDD to
include medical devices which incorporate stable derivatives of
human blood or human plasma (eg albumin, thrombin, fibrinogenor
immunoglobulin) which can be incorporated into medical devices
such as stents, leads, heart valves, vascular grafts, catheters,
filters and haemostats) was transposed into UK law by the Medical
Devices Regulations 2002 (SI 2002 No 618).
These Directives are single market measures
designed to remove technical barriers to trade by harmonising
safety and performance requirements for medical devices. The Directives
replace former national controls of Member States. The CE mark
is applied to devices to denote conformity with the requirements
of the Directives and manufacturers may then market their products
freely throughout the European Community without having to abide
by any further national controls.
Key features
— the Competent Authority (CA) in each
Member State must ensure effective implementation. In the UK,
the CA is the Secretary of State for Health acting through the
Medicines and Healthcare products Regulatory Agency (MHRA). The
main responsibilities of the CA involve enforcing compliance with
the implementing regulations, maintaining a register of manufacturers,
assessing notifications for clinical investigations, monitoring
and designating Notified Bodies (NBs) (independent organisations
responsible for assessing the conformity of certain classes of
devices) and authorising use of non-CE marked medical devices
on humanitarian grounds;
— the Directives seek to match the
level of control to the perceived risk associated with the product.
In the MDD, this is achieved by a classification system whereby
devices are grouped into one of three classes according to a series
of rules. Class I covers products generally regarded as low risk
such as spectacles, bandages and non-invasive products. Manufacturers
of these devices are required to assess themselves that they comply,
make a declaration to this effect and register their details with
the CA. For medium risk products (Class II a and b), eg contraceptive
devices, contact lens care products and for high risk products
(Class III), eg intra-uterine contraceptive devices and devices
combined with a medicinal product, the manufacturer must apply
to an NB to assess conformity. Only when the NB certifies that
the manufacturing processes or the products meet the requirements
may the manufacturer CE-mark these devices and place them on the
market. A similar system based on risk applies in the IVD Directive
which groups IVDs into four categories reflecting an increasing
risk. These are general IVDs; those intended for self-testing,
that is for use by lay people; Annex II List B—which amongst
others includes test kits for German measles, toxoplasmosis and
phenylketonuria test kits as well as self-test kits for blood
glucose; and Annex II List A—which includes test kits for
HIV, HTLV I and II, most hepatitis viruses, and some blood grouping
products, including those used to test donated blood. As the risk
increases through these categories, so too does the involvement
of the NB in ensuring that the devices have met the relevant requirements
of the Directive before they are placed on the market. All devices
covered by the AIMD are regarded as being high risk and subject
to the highest conformity assessment controls. All devices covered
by the AIMD are regarded as being high risk and subject to the
highest conformity assessment controls; and
— a vigilance system which requires
serious adverse incidents to be reported to the relevant CA where
they are evaluated and, if appropriate, the results communicated
to other Member States and the European Commission to help prevent
similar incidents from occurring elsewhere in the Community.
The medical devices Directives do not include
controls on advertising.
MHRA
In the UK, the MHRA is responsible for ensuring
manufacturers comply with the Regulations. It investigates all
allegations of non-compliance received and carries out a pro-active
compliance exercise on selected manufacturers from the Class I
Register and on focussed projects selected because of some safety
concern. Member States have the power to withdraw from the market
any device which it considers is a danger to public health.
Clinical investigations
To place their product on the market in the
EU, manufacturers must demonstrate that it complies with relevant
Essential Safety Requirements. To demonstrate such compliance,
it will sometimes be necessary to carry out a specifically designed
clinical investigation. The clinical investigation must be designed
to establish that the performance claims of the manufacturer can
be adequately demonstrated, and that the device may be judged
safe to use on a patient, taking into account any risks associated
with its use when weighed against the expected benefits.
Before a clinical trial can be held, the manufacturer
must notify the CA of his intention and submit a detailed trial
protocol. The CA has 60 days to assess the notification and raise
any objections on grounds of public health or policy. In the absence
of a formal objection from the CA, the trial may be held.
4.1.4 Procurement
Part of the wider Government agenda includes
ensuring efficient public procurement which also allows for innovation.
Relevant reports include DTI's Innovation Review Competing
in the Global Economy: The Innovation Challenge[5]
published in December 2003, the Office of Government Commerce
(OGC) report Capturing Innovation: Nurturing Suppliers' Ideas
in the Public Sector published in May 2004,[6]
Sir Peter Gershon's Efficiency Review of the Public Sector[7]
published in July 2004, OGC's report to the Chancellor of the
Exchequer Increasing Competition and Improving Long-term Capacity
Planning in the Government Market Place published in December
2003[8]
and the OGC and Cabinet Office report Making a Difference—Reducing
Bureaucracy in Central Civil Government Procurement published
in December 2003.[9]
NHS procurement is being brought into line with
Government policy with the aim of ensuring the purchase of high-value
products that perform effectively. The sharing of best practice
between local purchasers and commissioners is improving the quality
of decision-making, and the development of regional procurement
hubs is enabling better value-for-money procurement. Centrally-managed
procurement of high investment medical equipment continues to
ensure that the NHS benefits from such programmes.
To underpin this more professional approach
to procurement, NHS budgeting arrangements are being reformed
so that funding is directly linked to the treatment provided to
the patient. The new system is designed to take account of the
costs and savings throughout the complete care programme, wherever
they occur.
4.2 Most recently, bringing many of these
streams of activity together and initiating new collaborative
work, government and industry have published the Healthcare Industries
Task Force (HITF) report (see section 5 below).
4.3 Following on from the HITF report and
as a result of the DH ALB Review, the NHS University (NHSU) and
the Modernisation Agency are to be merged to create a new NHS
Institute of Learning, Skills and Innovation (NILSI). This new
organisation will manage the Innovation Centre proposed under
HITF.
4.3.1 NHS Institute of Learning, Skills and
Innovation (NILSI)
NILSI will promote excellence and innovation
across the health and social care system. It will enhance service
delivery in the NHS by focusing on innovation, learning and leadership
development in an integrated and efficient manner.
The institute will assume a leadership role
in the implementation and delivery of change in the NHS and manage
the new Innovation Centre. It will aim to engender a culture of
innovation within front line staff by developing linked training
and modernisation programmes for new medical technologies.
An advisory board, under the Chairmanship of
Sir David Brown (Chairman of Motorola), has been established to
support the development of this new organisation. This board is
to be advised by a Transition Team, who will manage the process
of developing, reconstructing and merging the three entities into
a single operational body by July 2005.
5. HEALTHCARE
INDUSTRIES TASK
FORCE (HITF) AND
ITS RECOMMENDATIONS
Background to HITF
5.1 HITF was the first venture of its kind
in this country at a strategic level between Government and the
healthcare industries. It was a year-long initiative which was
launched in October 2003 by the co-chairmen, Lord Warner, Under
Secretary of State at DH, and Sir Christopher O'Donnell, Chief
Executive of Smith & Nephew plc. Task Force members included
Lord Sainsbury, Minister for Science and Innovation at the Department
of Trade and Industry (DTI), Mike O'Brien (later succeeded by
Douglas Alexander), Minister of State for Trade & Investment
and Foreign Affairs, senior public policy makers and leading executives
from the healthcare industries. The terms of reference are at
Annex D, and the industry sector and products covered are defined
in Annex A.
5.2 The broad aim was to develop a better
understanding of how Government and the industry interact and
to identify opportunities where closer co-operation would benefit
all stakeholders. Its agenda was wide-ranging and complex, but
the key issue was how to improve patient access to healthcare
products, particularly beneficial new medical technologies. The
Task Force recognised that solving this particular issue would
unlock ways forward in other areas of mutual interest—developing
practical measures to stimulate more innovation in the industry
and in the NHS, and modernising NHS procurement would underpin
the central objective.
The HITF process
5.3 The Task Force established four Working
Groups to study the areas identified in the terms of reference:
— R&D and the industrial base;
5.4 The Working Groups comprised representatives
from industry, government and its agencies, the NHS, academia,
patient groups and other key stakeholders. They identified the
issues and barriers in each of the four areas, and in June 2004
put forward over 50 recommendations to the Task Force.
HITF recommendations
5.5 The Task Force focused on nine key areas
for action to optimise their impact across HITF's agenda:
5.5.1 Development of an enhanced Device Evaluation
Service (DES)
To provide independent, expert guidance on performance
of devices and their value to purchasers. The existing service
is to be transferred from MHRA to NHS Purchasing and Supply Agency
(PASA) with effect from 1 April 2005, subject to any necessary
amendments to legislation, where links to procurement will be
strengthened. The new DES will establish a consistent "once-only"
approach to evaluation, will be more responsive to industry and
public health needs, disseminate expert advice to purchasers,
be supported by strengthened horizon scanning so that it knows
what developments are in the offing and in what area useful new
medical applications are likely to appear. The new DES will be
at the hub of a wide-ranging network, joining industry with NHS
clinicians and purchasers, with access to expertise in the field,
paving the way for patient access to modern healthcare solutions.
The Task Force considered this new departure
to be the cornerstone of its outputs, connecting NHS purchasers
more closely to informed evaluations of novel products and medical
technologies on the market and helping to promote the uptake of
innovation.
5.5.2 Innovation Centre
To stimulate innovation in the NHS and in the
global industry, this new institution will be developed to provide
a pathway into the NHS and the social care system for beneficial
new products and ways of working. It will cover more than medical
devices and technologies, and promote a more entrepreneurial culture
in the NHS. It will co-ordinate the work programmes of the NHS
Innovations Hubs, stimulate innovation within the NHS as well
as the global industry, and develop a brokerage service and a
"route-map" to signpost the pathway for successful product
development. It will also work towards building up a fund for
translational research to fill what is currently a gap in funding
streams and why a number of useful ideas are not progressed. The
Innovation Centre will be a visible portal to the NHS with expertise
to advise NHS staff and private companies on how best to proceed
with their inventions.
5.5.3 Procurement processes
Ensuring that procurement of healthcare products
in the NHS is modern and based on informed advice, will help ensure
that patients get faster access to better treatments. Procurement
processes are already being modernised in line with HITF outputs,
DH and wider Government policies on procurement, developing a
regional focus to reduce market entry points, a professional approach
including significant clinician involvement so that health professionals'
needs are taken into account, more transparent procedures to help
overcome bureaucracy and improve understanding. Decisions will
be informed by device evaluations from the new DES, and more interaction
with suppliers is taking place, eg consultation on procurement
plans, the development of National Service Frameworks (NSFs),
development of best practice models, and the new NHS budgeting
arrangements Payment by Results (PbR) which is currently being
phased in. The aim of the latter initiative is that hospitals
receive an agreed sum for a particular course of treatment, rather
than via a broad service agreement which may not appropriately
reflect the level of activity. The result is that funds follow
the patient, incentivising better patient care and underpinning
implementation of patient choice. This combined with a DES assessment
of the value of a product, will help overcome "silo budgeting".
5.5.4 Building R&D capacity
The UK Clinical Research Collaboration (UKCRC)[10]
will encompass new medical technologies within its programme.
Embedding research on medical devices and technologies into the
UKCRC networks will help increase the number of clinical trials
with medical devices, make the NHS more accessible, and exploit
its potential to help generate high quality clinical data on safety
and performance. UKCRC will promote a better understanding of
the conditions needed for the conduct of clinical trials with
new medical technologies and help create more opportunities for
trialling innovative products and procedures. Unlike medicines,
development of new healthcare products and technologies is generally
a continuous process involving incremental enhancements. Therefore,
the products have relatively short life-cycle. It is important
that the environment for clinical investigations and device evaluation
are responsive to this (whilst continuing to protect patient safety)
ie uses rapid, simple procedures supported by effective dissemination
networks. UKCRC will facilitate this approach and co-ordinate
efforts to streamline approval processes.
5.5.5 Development of Healthcare Technology
Co-operatives (HTCs)
The Task Force appreciated the need to develop
academic specialist centres, bringing government, universities
and industry together to pioneer and test out new medical techniques
and products. A pilot is to be designed to inform the future development
of this project. The NHS working in partnership with other stakeholders
in the field of innovation and trialling new products will help
overcome barriers of resistance to adopting new technologies and
will provide another means of support for product development.
5.5.6 UK as the regulatory lead in the EU
and internationally
Maintaining and building on the UK's high standing
in regulatory matters will be important in ensuring that future
legislation for new and emerging technologies is appropriate,
so that patients safety is paramount whilst innovation is not
unnecessarily stifled.
5.5.7 International trade
Exports are important to this sector and agreements
were struck on how to focus government support to improve performance
in overseas markets. Part of the solution lies in ensuring that
the NHS is a showcase for leading-edge technology and innovation,
and the other HITF outputs will clearly contribute to helping
companies to sell their products abroad.
5.5.8 Communication with patients/public to
improve understanding of benefits and risks of medical devices
Educating patients and the public about the
important part medical devices play in their daily lives, communicating
their risk:benefit profile and the regulatory system that governs
them will help promote their safe use within our health and social
care system.
5.5.9 Training and education
Improvements in the training and education of
NHS and social care staff in the use of medical devices are to
be made via the development of learning programmes and tools to
expand opportunities for professionals to acquire practical skills
and competences. This will facilitate career development and improvements
to training records systems will help ensure that workforce skills
are kept up-to-date. These initiatives will underpin the introduction
of new medical technologies and be an essential element in speeding
up patient access to modern treatments.
5.6 HITF agreed two further actions to improve
understanding of the dynamics of UK-based industry, given its
scope to help the NHS with innovation and its industrial potential
:
— The complex nature and fragmentation
of the industry has made it difficult to gather accurate and consistent
data in the past. To address this the Government decided to undertake
a regular data collection exercise. DTI reviewed existing statistical
data on the sector and reached a consensus with DH and the industry
on what statistical indicators should be collected on the industry
in future years (see Annex A). This exercise will ensure that
a clearer picture of the sector and its performance is made available
on a regular basis.
— DTI also commissioned an independent
sector competitiveness analysis of six key sub-sectors of the
industry. The sub-sectors were chosen on the basis that they would
offer in-depth insight into a range of high-technology and fast-moving
disciplines, and provide the opportunity to assess UK strengths
and weaknesses in each case. The study is currently being finalised
and the report will be published in the early part of 2005. More
information about the interim findings is at Annex B.
Implementation plans
5.7 The process of developing implementation
plans was started once there was a consensus in principle on the
nine key HITF outputs and, where possible, set in train. This
involved identifying the necessary resources, and preparing the
ground for establishing new structures and procedures. The nine
key recommendations, together with an update on implementation
strategies, were presented to the Task Force at its final meeting
in October 2004. The Task Force gave its full backing to the recommendations
and framework for action. An account of the work of the Task Force
and its conclusions are detailed in its final report Better health
through partnership: a programme for action[11]
published on 17 November 2004.
5.8 Work is continuing to refine the HITF
outputs and implementation plans. Resources in some areas still
need to be identified, eg to identify funding for the development
of the new DES, the Innovation Centre and the pilot HTC. Government
is committed to meeting its HITF undertakings and is working with
other stakeholders to complete its action plans. In addition,
DH and industry are in the process of establishing a new strategic
group to monitor implementation of HITF outputs. The new group
is to be led by the former HITF co-chairmen, Lord Warner and Sir
Christopher O'Donnell, and its members will be key players from
both government and industry who will champion the delivery of
the commitments given under HITF.
Conclusion
5.9 Taken together, the key HITF outputs
constitute a coherent action plan which, once the various elements
are brought into operation, should significantly increase NHS
uptake of useful new medical technologies. The new joint group
being formed will oversee implementation and address any unforeseen
issues that arise from this. HITF has also provided a platform
for the development of constructive relationships between manufacturers
representatives and government at all levels. This is seen as
a very important legacy—one which will provide mechanisms
for ongoing communication so that policy makers, clinicians and
innovators can share their knowledge and harness the industry's
capability for innovation to meet the health needs of the nation.
5.10 The HITF report has been received enthusiastically
by interested parties, both in the UK and overseas. As the issues
addressed are common to other countries, it is hoped that HITF
and its ongoing work will provide a model for others to follow.
6. THE UTILISATION
OF TELEMEDICINE
(INCLUDING TELECARE)
AND ITS
FUTURE POTENTIAL
FOR IMPROVING
SERVICES
6.1 Two of the technologies which can have
a significant effect on a wide range of care environments are
telemedicine and telecare.
What are telemedicine and telecare?
6.2 Telemedicine and telecare have a long
history. In 1906 the Indonesian-born Dutch cardiologist Willem
Einthoven experimented with using telephones to try and send early
electrocardiogram recordings as the first attempt at exchanging
information at a distance. The first specific references to "telemedicine"
start in 1959, at the University of Nebraska, where microwave
video links were used for medical consultations and continuing
education.[12]
6.3 It may be helpful to make some distinctions
between the terms "telehealth", "telemedicine",
"telemonitoring" and "telecare", although
they overlap conceptually and, as technology advances, they will
overlap in reality.
"Telehealth" is a generic term used
to cover both "telemedicine" and "telehealth monitoring
(telemonitoring)".
"Telemedicine" covers systems that
help doctors and other health professionals to diagnose and treat
patients over a distance, typically linking geographically remote
health premises such as a GP surgery and a hospital. As well as
being able to provide more convenient access to patients, there
is significant value for healthcare professionals in terms of
continuing professional development and providing expert support
when dealing with complex or less common conditions.
"Telemonitoring" covers equipment
that allows remote monitoring of symptoms, such as heart functions
and blood oxygen. A more accurate record of variations in a patient's
condition can be created, improving the ability to spot changes
in conditions, and unnecessary clinic visits are avoided. These
systems are best if located in the patients' homes, possibly sharing
communications infrastructure with telecare devices. Other future
developments could see help for improved patient compliance with
medication regimes.
"Telecare" includes systems that incorporate
electronic devices (eg movement sensors, fall alarms, monitors
for unlit gas) that can alert the occupant of a house, or a care
response system, on the occurrence or non-occurrence of predetermined
events, such as the fridge not being opened for a long time. By
better managing the "risk" of letting disabled and older
people live independently at home, telecare systems have the potential
to enhance the lives of individuals and to postpone admission
to residential care and to hospital.
6.4 Examples of telemedicine and telecare
currently in operation are given in Annex E.
DH policy
6.5 DH's policy on telemedicine and telecare
covers relevant health and social care services.
6.5.1 Telemedicine
Telemedicine is referenced in both the NHS Plan
and the NHS Improvement Plan. The underlying principle of using
Information and Communications Technology (ICT) to support and
transform the delivery of healthcare by connecting delivery of
the NHS Plan with the capabilities of modern information technologies
is at the heart of the Government's vision for the NHS in the
21st century. Under the National Programme for IT in the NHS for
England a national broadband network is being implemented across
the NHS in England which will support the capability for telemedicine
and telecare, including the transfer of medical images. Future
possibilities include telemedicine in GP surgeries for electrocardiograms
and skin disease, ambulance telemonitoring in emergency response
vehicles, and home telecare.
6.5.2 Telecare
Modern, responsive electronic community alarm-type
devices can do much more than alert a carer or call centre to
an event that needs investigation to ensure that a person is safe.
They may, for example, remind the person of things they should
do. This allows them to stay in control of their lives for longer
and gives them and their carers reassurance owing to reduced risk
of untoward events. In time, technologies for the remote monitoring
of health conditions could share the same infrastructure as telecare
technologies, and many people would benefit from both types of
monitoring. Technical advances mean that the devices are easy
to install and that they are relatively unobtrusive.
As well as the improvements in quality of life,
efficiency gains to the health and social care systems are possible
because "just-in-case" admissions of older people to
hospital and residential care are still common. Telecare and related
health technologies can therefore contribute to a number of important
agendas such as:
— avoidance of unnecessary hospital
admission and timely discharge;
— falls prevention strategies;
— saving lives through more reliable
fire/smoke detection for older people;
— timely information to inform people's
care package reviews;
— improving quality of life and reducing
care costs for people with long term conditions and with strokes;
and
— better monitoring of people with
chronic obstructive pulmonary disease (COPD) and diabetes which
can alert to changes in condition and significantly reduce out-patient
attendances.
A number of influential publications referenced
research in this area and influenced policy development by the
Government. The Audit Commission's Fully Equipped reports
in 2000 and 2002, followed by Older People—Independence
and Well-being (February 2004) and particularly the sub-report
on assistive technology, are notable examples.
Telecare enables older and disabled people to
remain in their own homes—rather than in hospital or residential
care—with increased safety and reassurance. It gives reassurance
to the service user that help can be summoned quickly; to the
informal carer that their friend or relative is safe and that
they will be called in the event of an emergency; and to the professional
that there is cover when they are not present. Telecare may most
usefully be provided as part of a care package.
Community equipment services play an important
part in helping people to develop their full potential and to
maintain their health and independence. A wide range of equipment
and adaptations can now be provided from 138 services in England
with the majority of items being provided within seven days of
a professional decision being made.
The Government has set out to increase the number
of people benefiting by this integrated approach to meeting their
needs. It is making a significant investment in modernising and
expanding these services. The NHS Plan and National Service Framework
for Older People set out the main targets.
In July 2004, as part of the 2004 Spending Review,
The Chancellor announced £80 million funding for a social
services' Preventative Technologies Grant over two years from
April 2006. This is to extend the benefits of new technology community
alarms (telecare), with the aim of reducing the number of avoidable
admissions to residential care and to hospital.
These funds will be distributed through social
services' baseline funding which means that councils and their
PCT partners will need to have in place before April 2006 plans
to take forward the implementation of the Government's policy
to expand the uptake of these technologies.
The service implications
6.6 The use of ICT offers significant opportunities
to improve the quality of care and meet patient expectations:
— efficiency and streamlining the work
of professionals;
— monitoring, performance management
(clinical and non clinical) and clinical governance, dissemination
of evidence based best-practice;
— joined-up working throughout the
NHS and social care; and
— reduction in human errors (eg computerised
checking of dispensed medicines).
6.7 ICT enables the separation of location
between patient and professional and between professional and
hospital. Telemedicine and telecare will enable patients to be
treated outside hospital settings, and support GPs and Primary
Care teams in providing much greater opportunity for independent
living for the elderly and chronically ill. ICT has tremendous
potential to help transform the way healthcare is delivered and
realise the vision of care tailored to patients' needs and responsive
to their wishes and that of their carers. It is important however
to remember that technology is only part of the solution.
6.8 Substantial investment will be required
in training and IT skills for all staff, as well as investment
in infrastructure and system design. This will need to place the
patient at the centre of IT system design to ensure that technology
developments enhance the patient experience of care.
6.9 Confidentiality and security are recurrent
issues. ICT can enable and facilitate (for example) home telecare
and home telemonitoring and alert care teams to a health problem
with a patient—but that has to be balanced against patients'
rights to privacy.
6.10 While there are clear benefits to the
use of telemedicine, formal studies have indicated that it is
by no means a panacea. For example, one study in the NHS into
telemedicine in an Accident and Emergency setting in East Gloucestershire
looked at the safety and clinical effectiveness of a telemedical
system and its cost-effectiveness. The telemedicine system was
formally evaluated through a prospective, randomised and blinded
study, and a wide range of data, incorporating clinical, financial
and satisfaction outcomes were collected. The results showed that
telemedicine enjoys an acceptable safety profile, with overall
clinical outcomes similar to conventional practice. However it
also found that telemedicine is more expensive than conventional
alternatives, and that there are a number of important process
issues that must be adequately addressed if telemedicine is to
succeed.
6.11 This view is reinforced by a study[13]
into the perceptions of general practitioners (GPs) towards teledermatology,
that demonstrated the importance of linking the use of telemedicine
effectively into the clinical process. There was a general perception
that teledermatology would result in quicker diagnosis and treatment,
decreased referral rates and improved medical education and training.
The study also indicated that unless the telemedicine system was
quick, easy to use, efficient and reliable, and crucially, did
not increase GPs' workloads, it would be unlikely to find widespread
acceptance.
Key issues
6.12 The introduction of telemedicine and
telecare into mainstream delivery of health and care services
has been limited by the need to understand the key issues that
distinguish them from more traditional approaches, and the implications
for patient healthcare outcomes and service organisation. Valuable
lessons can be learnt from the demonstration and pilot projects
that have taken place to date and generalisations made about the
principles and practicalities of implementing telemedicine and
telecare services in line with Government policies.
6.13 Telemedicine and telecare should be
implemented only as part of an integrated package developed in
conjunction with appropriate business process re-engineering.
Clinical engagement is essential to ensure that there is robust
adherence to the highest clinical standards and that there are
no compromises affecting patient safety. Above all, telemedicine
and telecare facilities must be seen as complementing, not replacing,
more traditional forms of healthcare delivery.
6.14 Legal and ethical issues that need
to be addressed include:
— Who is responsible for telemedicine
and telecare interventions ? Is it the clinician or agency directly
interacting with the patient, or the remote clinician or agency,
and how is the responsibility shared? Where services are provided
across national boundaries there may additionally be jurisdictional
issues.
— Does the concept of "consent"
in a telemedicine/telecare context differ from a face-to-face
context? If so, how is this to be managed so that patients understand
what it is they may be consenting to and the implications of that.
For example, there is a fundamental tension between the application
of telemonitoring and a citizen's right to privacy.
— Protocols for use of telemedicine
and telecare—have they been clinically proven? In a telemedicine/telecare
context, what impact does the intervention of ICT equipment have
on the clinical judgement of clinicians ? What are the implications
of malfunction or misoperation of equipment being used in a clinical
context for which it was never designed and may not have been
formally certified as a "medical device"?
— A fundamental principle of the NHS
is that healthcare provision should be on the basis of clinical
need, and that, in general, the same levels and types of service
should be available nationally. The implications of providing
telemedicine and telecare services, that, by definition, are not
locality based, has far-reaching implications for NHS service
organisation, which traditionally has been focussed on serving
the needs of local communities.
— Does professional training for telemedicine
and telecare differ from traditional clinical practice? If so,
how does this get integrated into health and social care training?
What the future holds
6.15 Developments in medical technology
will continue as will the convergence between medical devices
and traditional ICT systems. An increasing number of medical devices,
particularly diagnostic devices, will have ICT capability and
will be configured for connection to networks as part of the standard
manufacturing process. All of this will facilitate their inclusion
in telemedicine and telecare applications as well as raising the
expectations that they can be used for this purpose. All administrations
across the UK have strategies in place to implement comprehensive
Electronic Health Care Records which will be used in all health
care interventions. As the use of electronic records becomes the
norm, the necessity for the patient to be physically present on
all occasions will diminish. Coupled with advances in telemedicine
technology generally, this combination of events will open up
many new possibilities to exploit telemedicine and telecare for
the better delivery of health services.
6.16 Looking further ahead, "intelligent
technologies", medical devices that can self-monitor and
call upon expert/professional help automatically will play an
increasing role in care. Miniaturisation of diagnostic and monitoring
tools is likely to be significant, making these available in local
or home settings. Professionals could be making much greater use
of "intelligent devices" expert systems software to
support clinical decision making, for example. There will be increased
use of "data mining" and systems that can infer "rules"
based on experience of previous events. Techniques such as "teleimmersion"—enabling
users in different locations to collaborate in a shared, simulated
environment as if they were in the same physical space; and "telepresence"—using
remote sensors and manipulators to enable operations to be controlled
in real-time from a distance, and virtual reality tools will increasingly
make the physical location of services less important. Patients
will be able to interact with and discuss their case specialist
consultants from their homes or GP practice supported by their
local GP. (Early pilots are already taking place, eg Chorleywood,
NHS Digital TV referred to in Annex E.)
Conclusion
6.17 Health technologies are a rapidly developing
area. The aim of developing health technologies is to improve
the quality of care by promoting cost-effective technology and
to protect the patient from less effective or less convenient
health interventions. Failure to respond to new opportunities
may result in the persistence of ineffective and obsolescent technologies
to the detriment of the patient or client and possibly greater
expense to the healthcare system.
6.18 The past two decades have seen a rapid
rate of development in information and communications technologies
as evidenced primarily by the arrival of the internet. The developments
in the communications technologies in particular have generated
a flurry of activity in many industry sectors. The potential for
such as services as internet banking and on-line shopping are
well understood and are being widely exploited. The potential
of technologies which facilitate the delivery of health and medical
services at a distance—telemedicine and telecare—are
similar.
6.19 Geographical location will not necessarily
imply health and social isolation. Delivery of appropriate care
services through a variety of electronically enabled support mechanisms,
thus sometimes avoiding the need to visit the GP surgery or local
hospital, will be possible. In adopting even a small range of
telemedicine and telecare initiatives, opportunities such as changing
skill mixes of staff to deliver services more effectively thus
giving more meaningful and rewarding work will also be possible.
6.20 Telemedicine and telecare offers the
potential for a wider range of safe, effective, high-quality care
to be offered and opens up a new range of possibilities for localised
services. This includes increasingly sophisticated day surgery,
exploring networking between hospitals, including the potential
of telemedicine, and exploring new ways of providing services
at night, for example as at the Princess of Wales Hospital in
Grimsby where telemedicine technology enables links to be made
between the Grimsby radiology department, Hull and Scunthorpe
hospitals, consultants' homes and other external sites. At any
time of day or night, consultant radiologists can diagnose remotely
from their home.
6.21 The UK is taking a leading role in
the use of ICT to support the delivery of healthcare. In England
the National Programme for IT, one of the world's largest IT projects,
is putting in place a national information infrastructure which
will support telemedicine and telecare, help change the way the
NHS works and improve the experience for both healthcare professionals
and patients. The health services in the other UK countries (which
are the responsibility of the devolved and Northern Ireland administrations)
are also fully committed to making full use of ICT.
6.22 The electronic NHS in the 21st century
will help deliver better, safer and higher quality care. The opportunities
offered by new information technology, telemedicine and other
new technologies that are coming on stream will enable the design
of modern services.
7. THE SPEED
OF AND
BARRIERS TO
THE INTRODUCTION
OF NEW
TECHNOLOGIES
Barriers
7.1 The barriers to the speedy uptake of
useful new medical devices and technologies were identified as
part of the HITF process (see section 5 above). The main ones
were :
— multi-entry points to the NHS for
companies marketing products
— no formal mechanism to disseminate
device evaluation advice and guidance, or to share experience
and best practice amongst purchasers—leads to risk-averse
purchasing decisions
— insufficient data available to purchasers
about cost and value of new products and technologies
— NHS budgeting arrangements can act
as a disincentive to uptake of innovation where initial costs
are high/higher than existing products and encourage a risk-averse
approach to innovative ideas, particularly where the benefits
of new technology do not fall into the budget holder's domain
— not enough sharing of information
between purchasers/clinicians/industry, which can result in ill-informed
purchasing decisions
— NHS culture is not entrepreneurial
enough—needs to be a driver of innovation
— lack of financial and technical support
for companies in translating promising new ideas into marketable
products
— bureaucracy around procurement procedures
and instigating clinical trials in the NHS
— reluctance/difficulty in changing
the current configuration of health and social care services inhibits
the introduction of disruptive technologies
— NHS staff need to be better trained
in the use of new medical technologies and products
7.2 A lot of these issues are interlinked.
The Task Force therefore concentrated on finding practical ways
to overcome or reduce the most important barriers and weaving
these into an integrated strategy that would impact on all the
key areas. The specific measures agreed by Task Force are covered
under section 5.
Role of healthcare scientists
7.3 In addition to the range of measures
proposed under HITF, the introduction of a range of new technologies
into the NHS and the continual evaluation of performance are integral
to the function of many healthcare scientists working in the constituent
disciplines of the NHS workforce and associated organisations
such as the National Blood Service and the Health Protection Agency
(Life sciences and Genetics; Physiological Sciences; Clinical
Engineering and Physical Sciences). Most of this is achieved as
part of routine scientific service provision, rather than as part
of formalised and funded R&D studies, and is part of the usual
process of developing and improving scientific services. In some
instances, equipment manufacturers and other diagnostic and therapeutic
manufacturers may provide kits/equipment for trial and evaluation
(alongside the current service provision) which often leads to
purchase and introduction into the NHS as part of the usual capital
replacement programmes or service improvement business planning
processes. Additionally, some healthcare scientists will as part
of their NHS function work with industry at the developmental
stage of new technologies in a partnership approach.
7.4 Healthcare scientists within the life
science disciplines (pathology, genetic and embryology) would
routinely be introducing new in vitro diagnostic testing kits
which can, for example, take what has been a research tool into
a full NHS diagnostic service which includes the measurement of
new parameters (eg BNP—a cardiac protein which is an important
marker in heart failure). Within the field of applied molecular
genetics (which is an integral part of many life science disciplines),
there is an ongoing adoption of new technologies, especially those
that can speed up processes or provide greater accuracy. Equipment
in the Life science disciplines is evolving rapidly and recently
robotic platforms have been introduced for the rapid processing
of blood samples for biochemistry, haematology and for immunology,
an extended range of point of care testing devices (eg for blood
glucose monitoring), state of the art tandem mass spectrometry
and the introduction of liquid based cytology.
7.5 Within the physiological science disciplines
where tests and investigations are made directly on patients,
a range of new equipment and technologies has been adopted that
includes those to introduce new techniques or ways of measuring
function (eg using sound waves to detect changes in airflow) or
to make it easier for patients to comply with the measurement
requirements. A wide selection of more portable and sometimes
hand-held devices has been introduced that has enabled measurements
to be provided in a range of healthcare settings, including primary
care (variety of cardiac monitors eg echo machines, ECG event
monitoring, spirometers, hand-held blood gas analysis, hand-held
vascular scanners) and in some instances to enable patients to
make the measurements themselves at home and transmit via telemetry.
In addition, new technology has been introduced that has enabled
improved treatment (DH investment in digital hearing aids, local
funding of improved domiciliary nasal ventilation systems, cardiac
defibrillators) or improved screening (DH investment in digital
cameras to support diabetic retinal screening).
7.6 Within the clinical engineering and
physical science disciplines many scientists have a key role in
equipment evaluation prior to procurement. Clinical engineers
and physicists play a key role in designing and introducing a
range of new technologies not only to support imaging, but rehabilitation,
clinical measurement and in radiotherapy. Other scientists working
in maxillofacial prosthetics would have a key role in introducing
new biomaterials to support reconstructive approaches. Some healthcare
scientists are employed in specialist units where they evaluate
equipment and software to support, for example, the introduction
of advanced imaging technologies into the NHS.
7.6.1 Supporting education and training
Part of the training and education requirements
to support regulation of practice of healthcare scientists (currently
regulated or the aspirant professions where regulation will be
extended in 2005-06) includes:
— an understanding of the principles
of measurement;
— application within the health sector;
— evaluation, review and implementation
of new technologies and techniques based on comparative research
methodology (including reviewing the evidence base and ensuring
that they measure what they are supposed to measure, to the degree
of accuracy and precision etc).
This is reflected to some extent within both
undergraduate and postgraduate programmes and in professional
body examinations.
The National Occupational Standards Project
in Healthcare science has produced a clear set of occupational
standards based on competences for introducing new technologies
and techniques into the health sector covering all elements of
the function at all levels of practice from early evaluation,
through to comparative studies, introduction, review, procurement
etc. In addition, standards have been developed to define the
competent performance for the quality assurance of measurements,
calibration of equipment, protocols and procedures for undertaking
the measurement which is an integral part of any introduction
of new technologies and techniques. These standards define what
needs to be demonstrated in terms of skill and knowledge requirements,
with assessment criteria to determine competent performance are
being built into pre and post registration programmes and into
award and qualification frameworks.
The contribution of healthcare scientists to
training and education will be included in HITF considerations
on how to improve training and education needs, taking into account
the services also provided by industry in this area (see paragraph
5.5.9).
Conclusion
7.7 Taken together, all these measures are
designed to stimulate appropriate innovation and provide mechanisms
for more rapid uptake of beneficial new medical technologies by
the NHS. HITF produced its report in November 2004 and work to
deliver the outputs has already started. The first milestone will
be the transfer of DES from 1 April 2005 to PASA. Other initiatives
are already underway eg the creation of NILSI which will manage
the new Innovation Centre, improvements to procurement processes,
development of UKCRC's programme including medical devices, regular
regulatory dialogue between MHRA and industry. Some issues have
still to be settled, including more detailed plans and funding
arrangements for the new DES, the Innovation Centre within the
wider context of NILSI and the development of a pilot HTC. Co-ordinating
and supporting the work on improved training and education will
also be taken forward. The new strategic group to be led by Lord
Warner and Sir Christopher O"Donnell will oversee progress
and ensure timely delivery of the HITF outputs.
8. THE EFFECTIVENESS
AND COST
BENEFIT OF
NEW TECHNOLOGIES
Development of DES
8.1 HITF addressed the issue of how to assess
the effectiveness and cost benefit of new technologies. The Task
Force concluded that existing mechanisms, with some re-focusing,
would be the best way to provide this information. Development
of DES, currently part of MHRA, is at the centre of HITF proposals
to help ensure that new technologies are taken up by the NHS.
A key component is the provision of authoritative advice to purchasers
on performance and value. The current service provided by DES
does not take account of costs, but this will become an additional
responsibility as the new service is developed under NHS PASA.
8.2 DES has strong links with NICE, particularly
in relation to NICE's role in evaluating significant new medical
technologies. The new DES will continue to work closely with NICE
on areas of common interest.
NICE
8.3 Established in April 1999, NICE plays
an important role in advising the NHS on clinical and cost effectiveness
of new and existing health technologies, and in promoting uptake
where technologies are demonstrated to be clinically and cost
effective. NICE develops three forms of guidance: clinical guidelines
(management of particular clinical conditions), appraisal guidance
(guidance on specific health interventions, including pharmaceuticals),
and guidance on the safety and efficacy of interventional procedures.
8.3.1 Topic selection processes
The NICE technology appraisal and clinical guideline
work programmes are jointly set by the Department of Health and
the Welsh Assembly Government. Topics for referral include both
new and emerging health technologies and those drugs, devices
and procedures currently in use in the NHS where there is variation
in practice.
New medical technologies are chosen for referral
to NICE by the Department of Health topic selection process. Information
on these topics is provided by bodies commissioned by the Department
of Health to track the progress of new medical technologies (whether
they are drugs, devices or procedures). Information may also be
submitted directly to the Department of Health by interested parties.
8.3.2 Clinical guidelines and technology appraisals
In its first five years NICE has published 86
technology appraisals giving guidance on 159 pharmaceuticals,
21 procedures, 17 diagnostics, one Health Promotion and 106 devices
(as of December 2004).
The first NICE-commissioned guideline, covering
the management of schizophrenia, was published in December 2002.
Up to December 2004, NICE had published 23 clinical guidelines,
six cancer service guidelines and eight inherited guidelines.
NICE also has 44 guidelines and 53 technology appraisals in simultaneous
preparation, making it the largest programme in any country.
8.3.3 Interventional procedures
NICE's Interventional Procedures Programme (IPP)
provides guidance about whether interventional procedures used
for diagnosis or treatment are safe enough and work well enough
for routine use. Referrals can be made at any time directly to
the Institute itself. Since the launch of the IPP in February
2003, 96 guidance documents have been produced (up to December
2004).
8.3.4 Implementation of NICE guidance
There is clear evidence now emerging that, while
overall NICE guidance has led to faster uptake of recommended
treatments and some narrowing of variations between different
parts of England and Wales, there are still significant and unacceptable
variations. Ministers announced on 14 June 2004 a broad programme
of action to aid faster uptake of NICE guidance. Action to support
the implementation of NICE guidance does not fall to any single
body. There is a broad partnership to ensure that patients get
ready access to the quality of care recommended by NICE.
Conclusion
8.4 DH fully recognises that a major element
of improving patients' access to new medical technologies is via
evaluation of their effectiveness and benefits, and is already
taking steps to address this issue.
2 Securing our Future Health: Taking a Long-Term
View written by Sir Derek Wanless for HM Treasury, examined
future health trends and the resources necessary to run a publicly
funded, comprehensive and high-quality health service over the
next 20 years (accessible on www.hm-treasury.gov.uk). Back
3
Reconfiguring the Department of Health's Arm's Length Bodies
(July 2004) and An Implementation Framework for Reconfiguring
the DH Arm's Length Bodies (November 2004)- www.dh.gov.uk/publicationsandstatistics/publications/pulicationspolicy. Back
4
"Assistive technology" is a term generally used to
describe aids for the disabled eg in the home, to help mobility
etc. Back
5
www.dti.gov.uk/innovationreport/index.htm. Back
6
www.ogc.gov.uk/embedded_object.asp?docid=1001717. Back
7
Releasing Resources to the Frontline: Independent Review of the
Public Sector-www.hm-treasury.gov.uk. Back
8
www.ogc.gov.uk/embedded_object.asp?docid=10013941. Back
9
www.ogc.gov.uk/embedded_object.asp?docid=1001426. Back
10
UKCRC is tasked with speeding up the development of new medicines
and treatments from the laboratory to the patient by expanding
the number and range of clinical trials. Its aim is to help bring
together clinical teams, primary care trusts, the voluntary sector
and industry to increase the number of patients participating
in clinical trials. Its work will initially be targeted on five
therapeutic areas. It is chaired by the Director of DH R&D
and the Board comprises representatives of the main UK funding
bodies for clinical research. Back
11
www.advisory.bodies@doh.gov.uk/hitf. Back
12
Centre for Health Informatics Aberystwyth. Back
13
K Collins et al. GPs' perceptions of asynchronous teledermatology;
Journal of Telemedicine and Telecare 2004; 10: 94-98. Back
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