Life Sciences

Andy Burnham Excerpts

Monday 5th December 2011 Commons Chamber

[The Secretary of State for Health (Mr Andrew Lansley)]

With permission, Mr Speaker, I would like to make a statement about the strategy for UK life sciences that the Prime Minister is launching this afternoon at a leading life sciences conference. The life sciences industry is one of the most promising areas for growth in the UK economy. It has consistently shown stronger growth than the United Kingdom as a whole, and it accounts for 165,000 UK jobs and totals more than £50 billion in turnover. Pharmaceuticals alone account for more than a quarter of our total industrial research and development spend. Global pharmaceutical sales are predicted to grow by up to 6% a year in the coming years, and in emerging economies medical technology is achieving growth rates of more than 12%. A flourishing life sciences sector is essential if we want to build a more outward-looking, export-driven economy. The partnership between industry, the NHS and our outstanding universities is not just essential to economic growth; it will benefit millions of future and current NHS patients, fuelling the more rapid development of cutting-edge treatments and earlier access to those treatments for NHS patients.

Like many industries, the life sciences industry is undergoing rapid change. The old “big pharma” model of having thousands of highly-paid researchers working on a pipeline of blockbuster drugs is declining. A new model has emerged—one that is more about collaboration, the outsourcing of research and early clinical trials on patients. Excessive regulation can mean that the uptake of new treatments and technology is slow. That is a challenge felt acutely by an industry that sometimes feels that the return is not there quickly enough to satisfy investors. It is felt even more acutely by patients, who understandably expect that they should be able to access the latest and most effective treatments, and that new innovations in care should be adopted rapidly by the NHS.

We have a leading science base, four of the world’s top 10 universities and a national health service that is uniquely capable of understanding population health characteristics, but those strengths alone are not enough to keep pace with what is happening. We must radically change the way we innovate and the way we collaborate.

The life sciences strategy we launch today, alongside the NHS chief executive’s review on innovation, health and wealth, sets out how we will support closer collaboration between the NHS, industry and our universities, driving growth in the economy and improvements in the NHS. All the documents have been placed in the Library.

Among other key measures, we will set up a new programme between the Medical Research Council and the Technology Strategy Board to bring medical discoveries closer to commercialisation and use in the NHS. There are many medical products being developed to treat patients and the cost of developing them is high because they take a long time to develop and test. Investors want to see at least some evidence that the products might work in people and robust validation of the quality of the research and development work being undertaken, as well as of the capability of the company to bring the product to market, before they will finance the development of the products. That means that some of the best medical innovations are not making it through to patients. We are already providing investment to address that, but we believe that we can do more to support the development of these products across funding organisations and the successive stages of product development, which will support the development of promising innovations and help to increase the number of treatments made available to patients. We are therefore introducing a £180 million catalyst fund for the most promising medical treatments.

It can take more than 20 years from the first discovery of a drug until patients can be prescribed it by their doctor and we have already taken steps to address that. Through the National Institute for Health Research, we are investing £800 million in new research centres and two major translational research partnerships that will help cut the time between the development of new treatments and their application in the NHS—from the bench to the bedside.

Now, we are going further. As part of a major drive to improve innovation and access to medicines in the NHS, we are announcing proposals on a new early access scheme that could allow thousands of the most seriously ill patients to access new cutting-edge drugs up to a year earlier than they can now. Through the early access scheme, the medicines regulator, the Medicines and Healthcare products Regulatory Agency, would provide a scientific opinion on the emerging benefits and risks of very promising new drugs to treat patients with life-threatening or debilitating conditions for whom there are no satisfactory treatment options. That will mean that seriously ill patients of any age who have no other hope of being treated or having their life extended could benefit from drugs more quickly, around a year before they are licensed.

We must also ensure that we make better use of our unique NHS data capability. It is often said that the NHS is data-rich but information-poor. As a national health service, it contains more data about health than any other comparable health system in the world, but neither the NHS nor scientists developing new drugs and treatments have always been able consistently to make good use of the data or to use them to drive further scientific breakthroughs.

We have seen how powerful the release of data can be. For example, South London and Maudsley NHS Trust and the Institute of Psychiatry now have access to a database covering 250,000 patients. It includes their brain scans, medical records and notes—a wealth of information, all consented to and all anonymised, that is helping them find new answers in the fight against dementia.

We need powerful data-handling capacity and the skills to write the software to mine them. That is why we are investing in e-infrastructure, which will provide secure data services to researchers. The clinical practice research datalink is being introduced by the MHRA in partnership with the NIHR and will provide a specialised service to the research and life sciences communities. Let me reassure the House that we will take all necessary steps to ensure safeguards for patient confidentiality.

We will also make sure that more UK patients get the opportunity to take part in national and international clinical trials and play a much greater role in the development of cutting-edge treatments. We believe that patients should have the right to access new treatments and be involved in research to develop new medicines.

We have responded to calls from research charities and clinicians for Government to get patients more involved in supporting research. 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 and, in addition, 72% would like to be offered opportunities to be involved in research trials. We will therefore consult on changing the NHS constitution so that there is an assumption, with the ability to opt out, that data collected during a patient’s care by the NHS may be used for approved research.

That would make it clear that researchers and companies with new and potentially life-saving medicines could access the data of patients and could approach patients whom they feel could benefit in order to discuss their involvement in research studies. This would encourage growth in the life sciences industry as more people and more detailed data would be available for the important trials and research needed to get breakthrough treatments used more widely.

Additionally, we have set out actions to improve incentives for investment in innovation and to reduce regulatory bureaucracy. With the creation of the Health Research Authority, we will streamline regulation and improve the cost-effectiveness of clinical trials. As the NHS chief executive’s review of innovation has shown, the NHS needs to be quicker and smarter in adopting new technologies and approaches to care that can both save more lives and cut costs.

Sometimes, it is a question of evidence. Until recently, we could not say with certainty that telehealth could keep people out of hospital and save lives, and there was understandable reluctance among parts of the NHS and councils to invest in untried technology. However, as early results from the whole system demonstrator pilots show, the potential of telehealth is nothing short of remarkable, with dramatic reductions in mortality, in hospital admissions, in emergency visits and in the number of hospital bed days. To make the most of this, we will support the NHS and work in partnership with industry and councils dramatically to spread the use of telehealth over the next five years. In doing so, we are looking to transform the lives of 3 million people in this country.

We will become a global leader in the management of chronic and long-term conditions, generating massive opportunities for UK companies developing this technology. It will be innovation in practice and we will foster other proven innovations such as fluid management technology techniques that were developed for use in high-risk surgery and critical care to help clinicians administer fluids and drugs safely. In March 2011, the National Institute for Health and Clinical Excellence published guidance recommending that this technology should be used for patients undergoing major or high-risk surgery. Currently, it is used for fewer than 5% of applicable patients despite evidence showing that it could benefit 800,000 patients and save the NHS £400 million. We will launch a national drive to make sure that fluid management technology is used in appropriate settings across the NHS. That is one example of many.

The innovation review sets out how we will address all the barriers to innovation in the NHS, whether they involve culture, leadership, training, use of information or lack of incentives and investment. We will also introduce a NICE compliance regime that will mean that medicines approved by NICE will be available on the NHS much more quickly. The plans set out in today’s strategies will help to drive the development of new technologies to diagnose and treat the most complex diseases in this country for the benefit of NHS patients. This is a strong package of measures that will support economic growth and innovation in the NHS and will drive significant improvements in patient care. I commend this statement to the House.

[Andy Burnham (Leigh) (Lab)]

May I thank the right hon. Gentleman for his statement and start by setting out two points of common ground with the Government? First, we too have pride in Britain’s life sciences industry and its strength. We agree that the industry needs Government support and focus if its potential to contribute to the country’s industrial future is to be maximised. Secondly, we agree that there are huge potential benefits to British patients from closer collaboration between the NHS and the industry. We all want patients to have the quickest possible access to the latest life-saving and life-enhancing treatments.

It was for those two principal reasons that Labour, when in government, prioritised the life sciences sector and established the Office for Life Sciences. In Lord Drayson, we created a life sciences Minister who was a contact point for the industry—someone of huge experience and with real personal commitment to the industry. One of our criticisms of this Government is that they have allowed the momentum that Labour had established in promoting the industry to fall away. Progress has stalled because of the Government’s failure to understand that economic growth needs a proper partnership between the public and private sector and because of the combined effect of a number of their policies. Such policies include: damaging 15% real-terms cuts to the science budget; the loss of the regional developments agencies, many of which were heavily involved in this area; cuts to regional investment; and the destabilising effect of the unnecessary reorganisation of the NHS, particularly the disintegration of the strategic health authorities, which played a role in promoting research. The unexpected closure of Pfizer earlier this year exposed a Government asleep at the wheel and was a wake-up call, and now we see a Government playing catch-up.

Although we welcome their belated recognition of the importance of the sector, there are sensitive issues involved and Ministers need to tread carefully so as not to undermine public trust. What they are fond of calling red tape are, to others, essential safeguards. Some areas will always need proper regulation and the use of patient data is most certainly one of them. As we have heard from patients groups today, some have been caused real anxiety by this media-briefed statement from the Government and the lack of accompanying detail.

Ministers need to be aware that people with terminal illnesses and long-term conditions will react differently from others to a statement of this kind, so for them we seek direct assurances today from the Secretary of State that he failed to give in his statement. Will all patients have the ability to opt out of the sharing of their data, even in anonymised form? Surely that fundamental principle of consent should form the bedrock of any new system, and that control of data should be possible in today’s information age. If the Secretary of State cannot give that assurance, why not? How can he justify that?

Did patients’ representatives walk away from the Department of Health working group on these important matters and, if so, why? One representative said on the radio this morning that the whole process “stinks”. Does the Secretary of State not accept that he and his Department will need to do better than this to uphold public confidence in the process or risk undermining trust in the whole principle? What safeguards will there be to ensure that patient data are stored securely? Does he not need to articulate a more positive statement of patients’ rights in this important area, rather than the loose opt-out he proposes in the NHS constitution?

Is it the case that the anonymity of data cannot always be guaranteed? If so, what are those circumstances and, again, why not? Even within anonymised datasets, particularly dealing with small numbers of very specific conditions, it is possible to identify individual patients. What steps are being taken to guard against those risks? Will the Secretary of State give a categorical assurance that data cannot be used for purposes other than research—passed on to third parties or used by the same company to target people for other products and services?

Today’s announcement also needs to be considered in the context of the Government’s reorganisation of the NHS. Does not a more market-based health system with a greater number of private providers create much greater challenges for the control of data? I had many dealings with senior figures in the pharmaceutical industry in my time as a Minister. They were clear that it was the national structure of the NHS, and the ability to collaborate and share information across a whole health system, that was a huge attraction to the industry and a competitive strength for this country.

Does not the Secretary of State’s Health and Social Care Bill risk turning the NHS into a competitive market, where collaboration is discouraged in an any-qualified-provider free-for-all? So how can he guarantee that that competitive strength will be there in the future and will continue to be used by the pharmaceutical industry? Although he will not admit it today, were not many of the measures he has announced, particularly the expansion of telecare, made possible by the steps that we took to invest and modernise NHS IT?

More broadly, this announcement raises questions about the Government’s policy on the involvement of the private sector in the NHS. The Government need to set out what, if any, limit they see on the involvement of the private sector in the NHS. The Prime Minister has said that he wants the NHS to be a fantastic business. Let me quote from a recent leaked document on NHS commissioning, “Towards Service Excellence”. It says:

“The NHS sector . . . needs to make the transition from statutory function to freestanding enterprise.”

It is no wonder that, on the back of these worrying words, the British Medical Association has adopted a position of outright opposition to the Secretary of State’s Bill. Our worry is that, in their desperation to develop a credible industrial strategy, Ministers seem ready to put large chunks of the NHS up for sale.

Patient data are not the Secretary of State’s to give away. The NHS is not his to sell. The truth is that the Government are running huge risks with patient confidentiality and patient safety by opening up the NHS to the private sector and reorganising at a time of financial stress, but we do not yet know the full scale of those risks.

[Mr Speaker]

Order. I am pretty sure that the shadow Secretary of State is on his last sentence, which is almost certainly a short one.

[Andy Burnham]

It is.

The great irony is this: while Ministers are happy to offer up other people’s data, they continue to withhold the NHS risk register, which shows the risk they are running with our NHS. Is that not why people are increasingly asking what the Secretary of State has to hide?

[Mr Lansley]

I am afraid that the last sentence was not really worth it, Mr Speaker. The right hon. Gentleman, while talking about things that were completely irrelevant to my statement, asked a number of questions. Will patients be able to opt out? Yes. It is clear that they will be able to opt out, as I have said. Are there risks relating to a small number of patients being identified? No. As he should know, and as has been done in relation to the general practice research database, where there are small populations of patients in which it might be possible to indentify individuals, or where a small number of patients have very specific sub-sets of conditions and there is a risk of identification, it is perfectly possible to ensure that that information cannot be accessed through the database. We have made it clear that data would be not only anonymised—in fact, it would be double anonymised—in order to ensure that it cannot be recreated, but viewed in such a way that will make it impossible to identify from the circumstances of the data where the patient comes from.

The right hon. Gentleman asked whether the database must be used for approved research or could be used for other purposes. It must be used for approved research and cannot be used for other purposes. It is not a database that people, whoever they may be, whether from universities or pharmaceutical research companies, can simply access in order to go mining for information; they must do so only through the MHRA and for approved research purposes.

Finally, the right hon. Gentleman asked—frankly, I think it is irrelevant—about the extent of the private sector’s role. Unlike his predecessor, Patricia Hewitt, who was Secretary of State when he was a Health Minister, and who said that she was aiming for 10% or 15% private sector involvement, we are not looking for a specific level of private sector involvement or creating a free market in the NHS. It will continue to be a national health service with the national characteristics that we would expect, funded through taxation and available to all based on need, not ability to pay, and in this context it will continue to be a national NHS. The simple fact that, among other measures in the life sciences strategy, we are able to show how we can bring data sets together, including the general practice database, the hospital episodes statistics, the cancer registries and so on, in order to show the power of data across the whole NHS to support research for new treatments is a complete vindication of the fact that it will be a national health service—that it will change in that respect and that patients will benefit from both the national health service and the research that comes with it.