Safe in our hands?Professor Lord Ara Darzi talks to Clinical Discovery magazine about the issues facing the UK life sciences industry and the government’s commitment to safeguarding its future
What is your view of the current environment for life science research in the UK?
There are of course challenges, not least pharma’s trend to externalise more of its R&D with consequent job losses for internal R&D teams, but there are opportunities for other players including biotech, SMEs, contract research organisations and universities. Some of these issues will be examined as part of the government’s Growth Review.
The Spending Review outcome was a great result for science funding, and agreement on funding of the UK Centre for Medical Research and Innovation (UKCMRI) is fantastic news as it will focus on the basic biology underlying human health – finding ways to prevent and treat the most significant diseases affecting people today.
The UK has a world-leading life sciences industry and the government is committed to
ensuring we build on this. Chris Brinsmead’s appointment as life sciences business adviser – to support close and collaborative working on life sciences across government and with key partners – reflects this as it recognises that government policy impacts all stages of the life sciences value chain, from investment in the research base, through to enterprise, innovation and finance policy, through regulation and standards, to skills and access to the NHS market.
What is needed to make sure that recent initiatives to stimulate life science research in the UK, such as the Therapeutic Capability Clusters programme or the multi-stakeholder platform for stratified medicine, translate into innovative products as well as benefits for patients and the UK economy?
There are many issues at play here, but the proposed Patent Box is an important step to ensuring that IP generated in the UK (and life sciences is an IP rich sector) is translated (including manufacturing) in the UK and contributes to UK growth.
The Patent Box will be designed to encourage companies to locate the high-value jobs
and activity associated with the development, manufacture and exploitation of
patents in the UK. It will also enhance the competitiveness of the UK tax system for
high-tech companies that obtain profits from patents.
Many initiatives to streamline, harmonise and facilitate the infrastructure and procedures for clinical trials in the UK have been slow to take root and the trend towards lower-cost markets with large, often treatment-naive, patient populations continues apace. Is it all too little too late?
The government remains committed to building the UK’s reputation as an
international location for clinical trials by increasing their reliability and cost
effectiveness. Much has been achieved through the infrastructure improvements of the National Institute for Health Research (NIHR). Indeed, the NIHR Clinical Research Network’s NW Exemplar Programme is demonstrating the improvements that this has made possible. Work to strengthen NHS Trust R&D departments continues unabated through the NIHR research support services.
Have the new procedures administered by NIHR and others genuinely
made it easier to plan, launch and manage clinical trials in the UK or have they
merely added another layer of bureaucracy?
NIHR’s progress over the past four years has been remarkable. Its approach has
generated widespread support from the NHS, academia and industry. These achievements include:
• Increasing the attractiveness of the UK as a site for life science industry investment
– through NIHR Biomedical Research Centres, Units and Clinical Research
• Speeding up the translation of advances in basic science into tangible benefits for
patients – through NIHR Clinical Research Facilities (CRFs)
• Increasing the capacity and the capability of the NHS to support research funded
by research councils and charities – through NIHR Clinical Research Networks
• Reversing the decline in clinical academic careers – through the NIHR Integrated
Academic Training programme
• Increasing the quality and volume of applied health research focused on the needs
of patients and the public – through NIHR Research Programmes
• Transforming the health research system so it is transparent, competitive, and
based on quality and relevance – by embedding research as a core function of the
The practical issues hampering clinical research in the NHS, such as cost-effectiveness and patient recruitment, are well documented, but aren’t the real problems to do with resourcing, incentives and leadership? How should these be addressed?
The NIHR recently issued a standards framework for local NHS research management
that will enable NHS trusts’ R&D offices to offer a consistent, streamlined and risk-proportionate service to support research in the NHS in England.
As regards bureaucratic barriers to research, the independent review by the Academy
of Medical Sciences of the regulation and governance of medical research will report
soon. When it does, the government will look at the legislation and bureaucracy that
affects medical research and radically simplify it. The government is considering a
national research regulator and expects the Academy’s working group to make detailed
recommendations about that.
What do you feel is the most significant obstacle to attracting more clinical trials
into the NHS and the UK? Should we stop trying to compete with other markets on
cost/cost-effectiveness and recruitment speed and instead try to accentuate USPs such as oncology and stem cell research?
There are a number of government initiatives to both improve the UK as an environment for clinical trials and to boost the UK’s strength in particular areas of cutting edge research. For example, the Stratified Medicines Innovation Platform is designed to place the UK at the centre of a new era of molecular-based healthcare by catalysing the commercial application of new technologies for diagnosing and treating disease. It will also help the pharma industry to develop greater numbers of more effective drugs targeted at smaller patient groups, the diagnostics industry to develop further the companion diagnostic tests that underpin this, and the healthcare providers to improve their cost effectiveness.
The new programme will oversee an investment of more than £50 million of government
funding in innovative R&D in areas such as tumour profiling to improve cancer care and develop biomarkers for more effective drugs. The first competitions, worth up to £11 million, open in January 2011. The focus will initially be on the two specific areas of tumour profiling in cancer – with an initial focus on breast, lung, colorectal, prostate, ovarian and skin cancers and associated technologies; and biomarker implementation that will provide validated tests for predicting responses to marketed drugs, or drugs in development, in health conditions of clinical and commercial importance to the UK.
Is the planned revision of the EU’s Clinical Trial Directive likely to improve research conditions in the UK?
As well as considering a revision of the Directive for the long term, the EU could do a
lot now by encouraging a more flexible interpretation of the rules in practice. Inspectors should be allowed to take a proportionate approach to trials that present no more risk than normal patient care. There is a strong public interest in gathering better evidence about medicines and other treatments in use, whether the research is done by academics or by industry to comply with conditions of licensing.
There have been suggestions from Lilly that negotiations on value-based pricing (VBP) could put up bureaucratic obstacles that will delay product launches and discourage R&D investment in the UK. Do you feel VBP will offer a genuine premium for innovation?
This is a global market and companies will locate where they can find the best science
base at a reasonable cost, taking into account other supply side factors such as tax, flexible labour markets, economic stability generally, etc. Through the Ministerial Industry Strategy Group the government has been working with the industry to ensure the UK remains an attractive environment for investment.
Value-based pricing should better recognise and reward innovation that delivers step
changes in benefits for patients, incentivising a focus towards genuine breakthrough
drugs that address areas of significant unmet need. Value-based pricing will reward
medicines that innovate in ways that improve health outcomes.
The government’s proposals to ensure that licensed and effective drugs are available
to NHS clinicians and patients are set out in the consultation document. A new value-based approach to the pricing of branded medicines was published on Thursday 16
December and is available at:
What impact do you feel the market access concessions already made within the
PPRS, such as flexible pricing, the innovation pass, patient access schemes and less
rigorous QALYS for end-of-life therapies, have had in encouraging clinical research in the UK?
Measures such as flexible pricing, patient access schemes and NICE’s end-of-life
flexibilities are primarily intended to enable and improve patient access. While Patient Access Schemes have increased access to innovative drugs for NHS patients and have featured in 11 positive NICE appraisals, they are not a panacea. That is why the government is committed to reforming the way the NHS pays for drugs, so that drug manufacturers are paid according to the value of their new treatments.
Ministers suspended the Innovation Pass in July 2010 after it became apparent
there was a high degree of overlap between drugs potentially covered by the Cancer
Drugs Fund and possible candidates for the Pass.