Memorandum 7
Submission from the Association of British
Healthcare Industries
1. BACKGROUND
Sir Derek Wanless' first report referred to
the NHS as a "late" and "slow" adopter of
new technology. Against that background, the Healthcare Industries
Task Force (HITF) was launched in October 2003 as a year-long
initiative of industry and government "to identify opportunities
where closer co-operation would bring about benefits for patients
and service users, the NHS and social care, whilst also helping
to improve the industry's performance". Its report was published
in November 2004, and work has gone ahead since then on the systematic
translation of its recommendations into practice.
The healthcare industries include manufacturers
of medical devices, which are all kinds of products other than
medicines used in diagnosis, prevention, monitoring or treatment
of illness or handicap in humans, and regulated by the European
Medical Devices Directives.
— There are estimated to be in excess
of 2,000 companies engaged in medical device manufacture in the
UK.
— Of these, 85% are very small companies,
with a turnover around £5 million. Very few truly large companies
are domiciled in the UK.
— The industry employs over 50,000
people, the second largest employer in Europe after Germany in
this sector.
— UK manufacturers' sales were £4.7
billion in 2004 according to ONS figures. The trade balance in
2004 remained positive, having fallen quite rapidly over a five
year period, at £83 million.
— In comparison with the pharmaceutical
industry, the sector has relatively short product development
cycles and draws on innovation from a wider range of sources.
— The market is globalised and increasingly
consolidated, requiring continuous investment in skills, knowledge
and specialised infrastructure.
— In the UK, the industry's close relationship
with its market is an important strength, together with the ability
to create technical solutions which address strategically important
goals (laparoscopic instrumentation has enabled day surgery, for
example).
— Domestic strengths are particularly
in R&D and are especially important in advanced wound care,
diagnostics and orthopaedics.
— Improvements in the commercial clinical
trials environment have been identified as significant for the
competitiveness of the UK's medical device sector and for R&D
activities in particular.
— The NHS' approach to procurement
has an impact on the competitiveness of domestic firms and particularly
on the development of SMEs.
2. BALANCE OF
EMPHASIS BETWEEN
MEDTECH
AND THE
BIOTECH
AND PHARMACEUTICAL
SECTORS
The HITF report recognised the importance of
the MedTech sector to both the health of patients and the UK economy.
However, there is an implicit bias throughout the review towards
the needs of the pharmaceutical and biotechnology sectors. Failure
to maintain a correct balance to support a healthy MedTech sector
would be a major potential loss for the UK economy.
1. What arrangements should be made to ensure
that the governing board of OSCHR will have sufficient awareness
of the issues relating to the Med Tech industry, and not just
those of biotech and pharma?
2. Chapter 8 provides an entire section on
a new drug development pathway: the MedTech sector needs a similar
focus. How will this be achieved?
3. VISIONING
The Cooksey review recognises the essential
element of Visioning in underpinning all research and policy development,
as laid out in the Haldane principles. The essential element which
the Wanless review introduced was the shared and publicly debatable
nature of such a report: we recognise that the Department of Health
has always undertaken such activities, but that their outcomes
have traditionally been kept relatively private. We also believe
that the generation of such visioning research should be reasonably
independent of the MRC and NIHR who will deliver against the priorities
it establishes.
3. Will there be an explicit "visioning"
activity as part of OSCHR's remit (ie to make sure we have an
up to date version of Wanless etc which all stakeholders can use
and debate the implications of)? There is some lack of clarity
in the relevant sections of the review on this matter (paras 4.6.1
and 5.71).
4. TRANSLATIONAL
MEDICINE FUNDING
BOARD
This is an area of real importance to all healthcare
industries.
4. Can Sir David give reassurance that the
definition of "Medicine" in "the Translational
Medicine Funding Board" will be based on its broad definition
(ie "Medicine is the branch of health science and the sector
of public life concerned with maintaining or restoring human health
through the study, diagnosis and treatment of disease and injury.")
rather than the narrow pharmaceutical based definition?
5. SBRI ROLE
The industry was encouraged to see the comments
relating to the potential value of the SBRI. The report "SECRETS"
OF THE WORLD'S LARGEST SEED CAPITAL FUND: How the United States
Government Uses its Small Business Innovation Research (SBIR)
Programme and Procurement Budgets to Support Small Technology
Firms' by David Connell of the Centre for Business Research, University
of Cambridge suggested that this could be a very productive approach
to fomenting innovation in UK.
5. Can Sir David enlarge on the role he sees
for SBRI in improving the procurement of resulting products and
services, and not just research, from healthcare industry SMEs?
(paras 7.24 to 7.28)
6. PROCUREMENT
The industry was very encouraged to see the
excellent grasp of the issues involved in Procurement and Innovation
(paras 6.61 to 6.64). However, the following recommendation (6.64)
was not strong.
6. Can Sir David explain what steps he feels
should be taken to ensure procurement mechanisms are supportive
of good innovations; and send appropriate signals to risk takers
and developers of new technologies?
7. ROLE OF
HEALTH TECHNOLOGY
ASSESSMENT (HTA) IN
THE TRANSLATION
PATHWAY
The review notes that HTA "arguably happens
too late in the development process". A new approach is proposed
in Chart 7.1 relating to the second gap in translation. The industry
has a concern that this is unduly optimistic of the HTA programme
in terms of its ability to provide prospective evidence of value.
If this is to happen, we must ensure that HTA will have the methodologies
and capacity to be able to deliver this new role, as opposed to
that of providing an evidence base on the relative effectiveness
of existing health technologies which has been its traditional
role: this may involve significant changes. Alternatively, there
is a more creative solution which could be based on the developers
of new technologies working in partnership with potential users
in assessing value: this is hinted at in paras 7.49 and 6.63.
HITF proposed the development of "nationally
accepted methodologies and toolkits for device evaluation that
can be used locally to ensure consistency of approach whilst facilitating
decision-making at an appropriate level". This would better
reflect the diverse nature of medical devices and the continuous
iterative nature of development. Centralised HTA activity is unlikely
ever to have the capacity to address all developments in technology
or to reflect the variety of opportunities for incorporation of
that technology into patient care. A decentralised approach will
be needed to complement central HTA processes that may be appropriate
for high impact technologies.
7. Can Sir David comment on the changes he
feels may be required to make HTA fit for this new purpose?
8. Can Sir David comment on the importance
and methods necessary to ensure that HTA assesses the full economic
impact of disease and innovative treatments on the UK economy,
and does not simply focus on the cost effectiveness of providing
treatment etc (cf para 5.71)?
January 2007
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