Memorandum 12
Submission from GlaxoSmithKline
SUMMARY
The interests of patients, industry and the
UK economy are served by an environment that supports the research
and development of innovative medicines that add value. The Cooksey
Review identifies environmental factors that would make a difference
in the UK and makes a number of very constructive suggestions
to achieve this goal. GSK supports the premise on which the Cooksey
Review was initiated in that healthcare research is failing to
realise its full potential in the UK.
In terms of the recommendations, GSK welcomes
the establishment of a single health research fund to help with
the translation of basic biomedical research outputs into clinical
application. In this regard, biomedical research should be viewed
as a continuum; support for the UK's excellent basic biomedical
research base and the continued generation of our talent pool
should not therefore be neglected. To ensure improved benefits
to patients, the high standard of large late stage clinical trials
conducted in the UK needs must also be maintained and should remain
focussed on national and international objectives.
The proposals on prioritisation of diseases,
focusing government health funding on research that will aid the
discovery of new medicines and earlier signalling of what medical
advances will be valued by payers could also deliver real progress.
The proposals to bring new medicines to patients more quickly
and provide fairer reward for medicines that deliver value to
patients and society are also welcome.
GSK would support the research fund being used
to establish a clinical research cadre, with a medical workforce
that recognises the benefits of clinical research early in their
training and effective incentives being introduced to encourage
institutions and physicians to engage in such research. Increasing
flexibility of movement of scientific staff between academia/NHS
and Industry should be a key objective in building a research
cadre and would benefit all parties.
GSK has an open mind on the concept of conditional
regulatory approval for new medicines, with additional post-approval
monitoring once the medicine is used in clinical practice. A real
opportunity to assess the scientific validity of this proposal
and to accelerate change could be developed in the UK through
the development of real-life pharmacovigilance, facilitated by
a research-focused NHS National Programme for IT, being delivered
through Connecting for Health (CfH). The recognition given in
the Review to the importance of the establishment, through CfH,
of a national integrated electronic healthcare information system
that will give full consideration to the needs of researchers
in industry, academia and public health is very welcome. In addition
to the above benefits, this will be a major enabler of clinical
research in the UK.
The concept of earlier dialogue between NICE
and the industry to inform the development of new medicines is
welcome. What is needed is advice that allows the flexibility
needed in a global clinical development plan. GSK looks forward
to working with NICE, the Department of Health and other stakeholders
to further refine this proposal.
Industry, Government, Regulators and Academia
must now work together to turn these ambitious proposals into
reality, recognising the need to balance a strategy for the UK
with wider European regulatory requirements and the realities
of global medicine development programmes. GSK hopes to play a
key role in this process and also that, over the next five years,
the Cooksey Review will encourage other bolder initiatives for
the establishment of a research-based culture in the UK and the
expansion of a research infrastructure through effective training
and career incentives, both in clinical research and other related
fields.
INTRODUCTION
GSK is one of the world's leading research-based
pharmaceutical and healthcare companies. We are involved in the
research, development, manufacture and commercialisation of prescription
pharmaceuticals, vaccines, over-the-counter medicines, and health-related
consumer products. In 2005, GSK invested £3.1 billion in
R&D globally with £1.3 billion of this being spent in
the UK. GSK's R&D organisation employs almost 15,000 people,
with 6,400 of those employed in the UK, where we have nine R&D
sites.
GSK welcomed the announcement that a single,
ring-fenced budget, worth at least £1 billion per annum,
was to be established to support the health research funded by
the Medical Research Council and the NHS R&D Programme. It
is very positive that this funding has been confirmed and that
a strong oversight mechanism will be established to develop clear
accountabilities, thus ensuring that this investment delivers
innovation in health care.
In submitting our original comments to the review
by Sir David Cooksey we welcomed the fact that the review would
consider the full spectrum of research, from basic biomedical
science through to later stage clinical studies and improvements
to patient outcomes. Key factors influencing GSK's continued long-term
investment in the UK include the strength of the UK's basic biomedical
research in universities and research institutes and the quality
of its skills base and talent pool. Maintaining the quality of
the basic biomedical sciences base is important for the development
of individuals with key skills, research output, effective collaborative
research, knowledge transfer and the recruitment of talent.
GSK agrees with the Review's findings that both
the translation of basic research into a clinical context and
healthcare research in general has been failing to realise its
potential in the UK. We welcome therefore the Review's focus on
the need to strengthen the UK's expertise in translating the outputs
from its basic research base into clinical practice. However,
it must be appreciated that translational research is not a one
way process, but a bi-directional flow requiring a strong clinical
science base to understand disease processes. This means that,
in addition to supporting a wider group of clinicians engaged
in research and trials, the pool of clinical scientists must also
be strengthened. Whilst recognising the demands of NHS service
work, attention is needed to ensure that the importance of clinical
work research is also appropriately recognised.
GSK COMMENTS ON
THE RECOMMENDATIONS
OF THE
COOKSEY REVIEW
OF UK HEALTH
RESEARCH FUNDING
Establishment of the Office for Strategic Coordination
of Health Research (OSCHR) and the NHS National Institute of Health
Research (NIHR) as an Executive Agency
For the results of basic research to be translated
more efficiently and rapidly into new methods of diagnosis and
treatment and improved patient benefit, the establishment of a
stronger culture of joint working between all funders of biomedical
research including industry and the medical charities is required.
GSK is very supportive therefore of the Review's proposals for
the encouragement of stronger partnerships between Government,
health industries and charities.
We support the establishment of the OSCHR which
could bring the best elements of the MRC—rigour of peer
review and science quality—together with those of NHS R&D—immediate
engagement with clinical problems of importance—into a common
governance framework. We would ask however that further consideration
be given to the notion that some aspects of the new research strategic
umbrella should be extended over other research councils, such
as the EPSRC, to help drive innovation. This could well support
the excellent work that the EPSRC is doing in promoting interdisciplinary
research and training and assist it to overcome the difficulties
it faces in finding effective ways for medics and engineers to
work together and therefore bring the best technology to problems
quickly.
The Cooksey Review recommends that the MRC should
continue to operate independently. As the recommendations of the
Review are implemented, it is of vital importance that funding
is continued to maintain excellence in the UK's basic biomedical
research base and the development and generation of the UK's talent
pool. The new arrangements being introduced should not negatively
impact the basic sciences budget due to the focus on current health
care priorities.
The creation of the virtual National Institute
for Health Research is a relatively recent development and it
is therefore too early to assess the impact of making the NIHR
a real, rather than a virtual, institute, separated from the Department
of Health as an executive agency. If this protects the ring-fencing
of the research budget of the Agency and contributes to a new
pro-research culture in the NHS, then it is to be supported.
GSK would welcome the communication of the government's
health priorities to industry. We support the concept of identifying
and badging priority projects and providing them with procedural
benefits, such as faster clinical trial approval or quicker NICE
review. It remains to be seen how this will occur and how priorities
will be agreed. Implementation and the decision-making processes
to agree priorities will require careful consideration with all
stakeholders.
The Creation of a Translational Medicine Funding
Board
GSK supports the creation and proposed goals
of the joint MRC-NIHR Translational Medicine Funding Board and
particularly welcomes that industry will form a key part of the
Board. The Board will contribute to the creation of a stronger
research culture in the NHS, but its remit should be crisply defined
as should an effective strategic direction for funding. Progress
towards achieving goals should also be periodically reviewed.
Any new Health Research fund should focus its
funding on where it can add most benefit to the UK in the longer
term. It is to be welcomed therefore that the MRC-NIHR Board will
seek to direct funding towards projects that promise health and
economic benefits.
Making the NHS more research and innovation-friendly
A number of proposals are made in the Review
that would make the NHS more innovation-friendly. GSK supports
the suggestions made and in particular the recommendations to
develop incentives for innovation that will drive better healthcare
and the establishment of a systematic approach to adopting new
technologies. The incentivisation of physicians and NHS Trusts
to become more involved in research will be a priority and increased
funding for research training and enhanced clinical research career
development opportunities should also be pursued.
The Cooksey Review does not adequately address
how a clinical research cadre can be developed in an environment
in which the rewards of private medicine are high, the demands
on NHS appointees (with significant NHS service commitments) are
significant and university support for clinical academic posts
is not increasing. Major cultural and behavioural changes within
the NHS and research community are needed in order to achieve
this goal. Neither is the problem simply related to money, time
and management practice are also contributing factors. Ground-breaking
world-class clinical research will not be delivered by clinical
researchers who spend only a small portion of their working time
on R&D. We believe this warrants further thought.
Although progress has already been made, the
excessive bureaucracy that restricts clinical research in the
UK must be removed if the benefits of the single health research
fund are to be achieved. Through the UK Clinical Research Collaboration
and the Department of Health's R&D strategy "Best Research
for Best Health", significant effort has been put into increasing
the competitiveness of the UK clinical trial environment, but
further work is needed. The lack of sufficient infrastructure
in the UK research community to efficiently comply with the demands
of safe and compliant clinical research should also be a priority
as the Review is implemented.
Enhancing medicine development and the uptake
of clinically- and cost-effective new technologies
The Review recognises the need to support a
more pro-active approach in the NHS to the adoption of cost-effective
new ideas, process improvements and technologies. This is positive
as this is a significant driver of research and development as
is market uptake of the products of research. GSK particularly
welcomes the fact that a clearer process will be developed for
ensuring that the initial assessments and recommendations made
by NICE are implemented.
GSK supports greater resourcing for NICE and
would welcome a focus on developing a mechanism by which advice
was provided to companies to inform development planning. Pragmatism
will be needed to ensure that the expectation is not generated
that ever increasing quantities of data would be created prior
to launch, especially as that would further add to the cost of
developing a new medicine. Industry and NICE should also work
together to agree how to deal more effectively with new medicines
where there is insufficient data available at launch for NICE
to recommend use in the NHS.
The Review recommends that a new partnership
should be created between government, regulators and industry
to pilot a new drug development "pathway". We understand
this to mean that certain medicines might be released for community
use earlier, with a reduced clinical trial dataset, and that patients
taking these medicines would be monitored closely for efficacy,
safety and outcome parameters. The data collected from these "early
users" could also increase the volume of "real life"
data available at the point in time when the approval would have
been given under current approval regimes.
This concept is scientifically sound, but difficult
to realise. It would be most relevant for diseases where there
is high unmet medical need and these diseases may provide the
basis for such a pilot.
The research potential of Connecting for Health
Many of the organisational and cultural issues
in the NHS and academia identified by Sir David Cooksey need to
be addressed before the benefits of Connecting of Health could
be achieved. The development of the research applications of the
National Programme for IT would certainly have a major impact
upon clinical research in the UK: access by researchers to a national
integrated healthcare information system of linked, anonymised,
electronic primary and secondary healthcare records would improve
the efficiency of recruitment of patients into clinical trials
and will also make a significant impact on large-scale epidemiological
studies and in improving patient safety through enhanced pharmacovigilance
and the monitoring of real-life data.
Additional funding for clinical research to be
considered in the Comprehensive Spending Review (CSR)
A number of proposals have been made for additional
funding to be considered in the Comprehensive Spending Review
in 2007. This would be extremely positive, particularly the creation
of a sustained capital budget for NHS R&D. The fact that funding
is to be allocated to support the establishment of the NHS R&D's
"Best Research for Best Health" Centres of Biomedical
Research excellence, the first tranche of which have recently
been announced, is also to be welcomed. It is important though
that future funding be flexible so that other developing institutions
are encouraged to improve the quality of their research and to
benefit accordingly.
January 2007
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