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.

 

 

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.

 

 

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.

 

 

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

Networks

• 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

NHS.

 

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.

 

 

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.

 

 

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.

 

 

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:

http://www.dh.gov.uk/en/Consultations/Liveconsultations/DH_122760

 

 

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.