Exciting day for medical research today - David Cameron has just launched a new life sciences strategy in a speech this afternoon. Also published were new initiatives to support innovation in the NHS – following David Nicholson’s review of this.
The announcements brought together lots of existing initiatives and made a few new announcements including a planned consultation on changes to open up patient data for research while protecting the individual’s right to opt-out.
These announcements have been warmly welcomed across the science community and the pharmaceutical sector.
The Office for Life Sciences have been gathering evidence since the summer to identify measures they can take to support and grow life sciences in the UK. They have developed a new strategy for life sciences which was published today Strategy for UK Life Sciences: Building a life sciences ecosystem
Also David Nicholson, chief executive of the NHS, has been reviewing how the NHS supports and takes up new innovations. He has published his recommendations aimed at improving innovation in the NHS today Innovation Health and Wealth: Accelerating adoption and diffusion in the NHS.
A quick summary of some of the big announcements today:
There was a lot of mention of existing initiatives that together all help support life sciences in the UK. But some new announcements too:
£180 million Biomedical Catalyst Fund – to support the development of promising early-stage drugs into new treatments. Because they cost a lot to test and develop and there is no guarantee they will be successful, there are concerns that many promising drugs fall into a “valley of death” where no-one invests in them and their development is stalled. Universities and small or medium enterprises (SMEs) will be able to apply for this funding.
An agreement between MRC and AstraZeneca giving academia access to 22 compounds developed by AstraZeneca. These are all compounds which have the potential to treat or prevent a specific disease which have not yet been developed further. http://www.astrazeneca.com/Media/Press-releases/Article/20110512-groundbreaking-scientific-collaboration-and-uk-academia
Early access scheme – the government are going to consult on a new scheme involving the Medicines and Healthcare products Regulatory Agency (MHRA) working with industry and charities to identify where new treatments could potentially be given conditional authorisation, their assessment could be accelerated or it could even be licensed early – the aim being that drugs can be developed faster and patients can benefit from them sooner.
Two new Life Sciences Champions – Chris Brinsmead and John Bell – and an independent Life Sciences Advisory Board, led by one of the Life Sciences Champion and comprising of representatives from industry, academia, NHS, MRC, TSB, NIHR and government departments – strangely no mention of charity involvement here. But as major members of the sector we have a key role to play in the board’s delivery plans.
The use of patient data for research - The government also confirmed their plan to establish a secure Clinical Practice Research Datalink - effectively a secure data service which will link up datasets from GP and hospital care so that it will be possible for researchers to access data about a patients entire journey through the care system. This was announced previously and mentioned in last week’s autumn statement. This has attracted controversy today as the implications of making this data available to all investors in research in the NHS, including the pharmaceutical industry, has been discussed. Check out this leaflet which explains how patient data is used for research while safely and securely protecting both patients and researchers: http://policyblog.amrc.org.uk/2011/11/21/a-new-leaflet-to-explain-to-patients-the-value-of-their-health-records/. Medical research charities strongly support the development of a safe and secure system to enable the use of patient data for research as it has huge potential to help us understand disease better and develop new preventions and treatments. But this has to be developed taking patients concerns on board to ensure this is a system that both they and researchers can be confident in.
The government also announced a new consultation on the use of patient records for research, exploring whether we should move to a system where anonymous data collected during a patients care in the NHS may be routinely used for research unless the patient has asked to opt out, with a goal of increasing the opportunities for patients to be involved in research.
…in response to calls from charities we will consult on changes to make it easier for patients to be involved in research, with patient data being opened up as the default, but protecting the individual’s right to opt-out.
This is partly in response to concerns we have been raising during the course of the Health & Social Care Bill that we need to develop safe and secure systems to enable researchers to access both anonymous and identifiable patient information for research, while protecting patients and research. And announcing this Andrew Lansley also referenced the overwhelming public support for opportunities to be involved in research shown by our MORI poll back in June.
In response to calls from research charities and clinicians, for government to get patients more involved in supporting the research agenda. A recent IPSOS MORI poll in June found that 97% of people believed it is important that the NHS should support research into new treatments. In addition, 72% would like to be offered opportunities to be involved in research trials. Therefore, we will consult on changing the NHS Constitution so there is an assumption - with the ability to opt out - that data collected during a patients care by the NHS may be used for approved research.
There has been a broad welcome across the science community for today’s announcements.
Check out Cancer Research UK's blog which also gives a bit more detail on their thoughts on the value to patients and research of enabling earlier access to drugs.
AMRC's chief exec, Sharmila Nebhrajani, has responded:
Charities invest over £1bn each year into health research – that’s approximately a third of the total UK public investment. Today’s measures supporting the development of promising early stage drugs and making it easier for trials of new treatments to get off the ground will help to accelerate the clinical benefits of research and make each research pound donated by the public go further, improving healthcare for patients.
NHS patient records are a valuable resource for health researchers and we welcome steps to develop the system, allowing researchers to access anonymous patient data safely and securely. Patients also recognise the value of their data and want to support research; in our recent survey 80% of the public told us they would like to consider allowing a researcher confidential access to their medical records. We need now to develop a system which is safe and secure so they can be confident in doing so.
Charities are funded by the public and thus are a crucial part of the research ecosystem. They fund both basic scientific research and the development of new drugs and treatments of therapeutic value to patients and their carers. This really is the patient voice in research and the new Life Sciences Advisory Board should work with us to deliver a new system that works for patients and researchers.
Well next on my list is to go through all today's announcements in detail to identify exactly what this means for medical research charities and where we can feed into the implementation. We’ll also be gearing up to respond to the planned consultations announced today.