Genomic Medicine: S&T Committee Report

Earl Howe Excerpts

Wednesday 9th June 2010 Lords Chamber

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)]

My Lords, I join other noble Lords in thanking the noble Lord, Lord Patel, for his excellent introduction to this debate, which was of particularly high quality and which was crowned by the coruscating contribution that we have just heard from the noble Lord, Lord Winston. It provides the new Government with the chance to hear, first hand, your Lordships’ views on this important area of science—one that offers so much potential to improve the health of our nation, as we have heard.

The United Kingdom has a well deserved worldwide reputation for its work in the field of genetics—the study of individual genes—and now genomics, which is the study of the interaction between genes: if genomics is like a garden, genetics is like a single plant. It is now more than half a century since Watson and Crick published their research on the double helix, while this year marks the 10th anniversary of the human genome project. The sequencing of the human genome has not only revolutionised the way in which we view ourselves as human beings, but it has led to many practical benefits, including new medicines and diagnostic tools. Throughout, British scientists have been at the forefront of this groundbreaking technology. It is a technology that increasingly brings economic benefits, as well as important improvements in healthcare.

The inquiry by your Lordships’ committee was thorough in its investigation and forthright in its conclusion, which was that this reputation, and the benefits that the science could bring, would be at risk if action were not taken to ensure that we remained at the forefront of genetic technology. The benefits are real—for patients, business and society. That is why the government response was a joint one from the Department of Health and the Department for Business, Innovation and Skills. That collaboration continues, ensuring that the UK is a place where technology and enterprise can flourish within a transparent, facilitating regulatory environment that encourages, not stifles, innovation. This includes eliminating obsolete and inefficient regulation. We want regulation to complement, not complicate, the way in which people work—not, incidentally, just in the UK but also at a European level. We will work with the EU to improve current guidelines and ensure that initiatives on research and regulation meet UK objectives.

As your Lordships’ committee rightly said, the 2003 genetics White Paper recognised the potential impact of genetics and the genome project, as well as the importance of preparing the NHS to take advantage of these developments. These were laudable aspirations, and some advances were made in the diagnosis and treatment of rare single gene disorders, yet the accompanying strategy has proved incapable of keeping pace with the speed of change in this field—a point well made by a number of noble Lords. This inability to respond to a rapidly changing landscape means, as the committee rightly concluded, that doctors, nurses and other healthcare specialists are unable fully to exploit these developments for the benefit of their patients. Clearly, this Government want NHS patients to be able to access the best medical advances that genomics will bring.

As many noble Lords mentioned, the Human Genomics Strategy Group has already been established under the chairmanship of Professor Sir John Bell. Its remit is to develop strategic options for genomics in the NHS—that is, to work with the objective of ensuring enhanced patient services through the better use of advances in research and technology. We are fully supportive of the work of that group. The noble Lord, Lord Sutherland, made various proposals for the group’s remit and I shall see that that remit and the development plan for the group are shared with the Science and Technology Committee. I will invite him to share his thoughts on both documents with the chair, Sir John Bell. He may like to know that the group had its inaugural meeting on 25 May.

The noble Lord, Lord Taverne, asked about the funding of the group and I think that the noble Lord, Lord Warner, expressed a few fears on that front. I agree that we need to ensure that the group is properly supported. That is why we provided this support through the Department of Health, which I trust will continue.

As the noble Lord, Lord Patel, and many other noble Lords pointed out, we are already seeing some important developments in relation to patients with diseases such as cancer and diabetes. Scientists are finding new genetic mutations that can help to define alternative treatments. We can identify patients who respond better or who suffer more severe side effects from a particular drug, helping to ensure that it is appropriately prescribed. The development of these stratified medicines has the potential to improve patient outcomes without increasing the cost to the NHS.

In laboratories, the new DNA sequencing machines have increased capacity so that a single laboratory can sequence more data in one day than was achieved during the entire human genome project. Utilising this capacity effectively across all branches of medicine will save the NHS millions. We are linking DNA sequencing with advanced IT to diagnose children born with severe congenital problems and to help guide their treatment and care. All these achievements are opening up a new world of healthcare that can be tailored more effectively and efficiently towards individual patients.

The Government are determined to develop a patient-led NHS that delivers better health outcomes. It is clear that genetics and genomics have an important role to play in achieving this aim. However, before moving forward, we must ensure that we are getting the most from the investment already made. Services should be commissioned by those best placed to make the decisions—doctors in consultation with patients who are free to make confident choices about their own healthcare, and better manage it as well. To make that happen we need a commissioning system that is consistent and provides appropriate services to NHS patients and their families. The UK genetic testing network is already working with specialised commissioners to determine how these services can be improved.

While we need to ensure that the NHS benefits from advances in genomic medicine we must also make sure that existing services are fit for purpose and are accessible. As the report rightly pointed out, ensuring that NHS staff have the necessary skills to use genetic testing effectively is a vital component of providing better services. We want to see that addressed as soon as possible so that the roughly 400 types of genetic tests already available are better used by NHS staff. That is why we support the work of the GMC’s Tomorrow’s Doctors programme, which sets out the requirements for the knowledge, skill and behaviours that undergraduate medical students should learn. It includes a requirement on medical schools to cover genetics in their curricula and provides flexibility on how best to cover its application and its place in diagnosis.

Reducing the budget deficit is the main priority of the Government but even if that were not the case the public still have the right to expect NHS services to be provided in the most cost-effective way possible. We have a duty to identify any practice that is not providing value for money and to take action to remedy the situation. That is why the Department of Health is pushing ahead with the recommendations of the Carter review on modernising pathology services, as mentioned by the noble Lord, Lord Warner. They deliver the highest volume of genetic testing services by far. This will see the services rationalised and reconfigured to increase the quality, productivity, efficiency and effectiveness of pathology services. I say to the noble Lord, Lord Warner, that the size and importance of these services mean that we have a duty to ensure that they are as effective and efficient as possible. The Carter review estimated that the reconfiguration of services could improve quality and realise £250 million to £500 million efficiency savings annually. It is our challenge to realise that potential.

The public have a right to hold us accountable for the way in which we invest in the NHS and to be confident that its primary focus is to improve outcomes. The Government will ensure that these principles are applied across all genetics testing services available to the NHS. The noble Lord, Lord Patel, spoke about clinical trials. Currently, the Department of Health, the MHRA and the MRC are considering what the obstacles are to the initiation and conduct of clinical trials in the UK and how these might be addressed. The MHRA is also working with European colleagues to identify any issues at a European level. The Government consult all interested parties when considering changes to legislation.

The noble Lord also raised the issue of inconsistencies in access to the provision of genetic services. Clearly articulated commissioning competences will ensure that commissioners can incorporate new scientific developments into their commissioning decisions and deal with unacceptable variations in access to care and treatment. As the noble Lord, Lord Kakkar, rightly pointed out, one of the keys to this is education. That function is currently provided by the National Genetics Education and Development Centre based at Birmingham Women’s NHS Foundation Trust. We have agreed a work programme for 2010-11 with the trust. It is agreed to target key professional groups for the programme. Future provision will be further considered through the work of the strategy group and in consultation with the trust and the centre.

The National Genetics Education and Development Centre has already made good progress in raising the need for genetics to be part of the curricular and CIPD programmes across the medical professions, but we recognise that this conversation must be had with the royal colleges and the GMC, which are best placed to advise on curricular content for the professions that they represent.

My noble friend Lord Selborne, whose speech on bioinformatics I listened to with close attention, asked a number of questions. It is still very unclear what type of bioinformatics will be needed for genetic testing, and what their true role will be in supporting genetic services. Work is already under way at Manchester National Genetics Reference Laboratory, and the NHS chair on pharmacogenetics based at the University of Liverpool is carrying out further research into how this new technology can best be utilised.

The noble Lord, Lord Patel, and my noble friend Lord Selborne asked whether the Government intend to establish an institute for bioinformatics. The Government’s main priority is to reduce the budget deficit and so I cannot give a commitment now on this matter. However, the Human Genomics Strategy Group will lead on giving this issue further consideration as it looks at how best we might take forward issues such as the proposed institute.

The right reverend Prelate the Bishop of Newcastle and my noble friend Lord Colwyn referred to predictive genetic testing. My noble friend rightly said that there is a moratorium on predictive genetic test results until 2014—certainly by insurance companies. We are due to review the concordat and moratorium in 2011 and we believe that that is the right time to review the Select Committee’s recommendation. We will specifically examine the question about whether a long-term agreement about the use of genetic testing for insurance purposes is appropriate.

The noble Baroness, Lady Finlay, asked whether the Department of Health had commissioned NICE to develop and manage a single evaluation pathway specifically for diagnostic technologies. Good progress has been made. NICE’s evaluation pathway programme for medical technologies and diagnostic assessment programme are already helping the NHS to adopt effective and cost-effective medical devices and diagnostics more rapidly and consistently. She asked about the role of value-based pricing and perhaps I may write to her on that. It is a matter slightly for the medium term, but I will write to her on that even though our thoughts are not yet fully worked out.

The noble Baroness also raised the issue of BIS working with the Department of Health to ensure that the intellectual property system supports diagnostic test development. Intellectual property issues will be considered as part of the innovation sub-group of the Human Genomics Strategy Group and BIS is fully engaged with the department in taking that matter forward. She also spoke about single-gene testing for sudden cardiac death. As she knows, the taking of human tissue for any scientific or medical purposes is governed by the Human Tissue Act, which is essentially based on consent. However, I would like to provide the noble Baroness with a fuller answer and so I will take this issue away and ask my officials to supply more detailed information.

My noble friend Lord Colwyn spoke about genetic testing kits sold to the general public and expressed his worry about that. Often, the answer proposed is that there should be some form of regulation. We have thought about that carefully, but we cannot see that compulsory regulation would be effective, given the cross-border nature of the market delivered by the internet. The Human Genetics Commission’s common framework of principles provides what we see as a proportionate and effective response, given the support that it has received from the international industry and other interested parties.

The noble Lord, Lord Warner, asked whether NICE was evaluating genomic tests for common diseases. Good progress has been made. NICE’s new medical technology advisory committee has been appointed and NICE’s evaluation pathway programme for medical technologies and diagnostics assessment is already helping the NHS to adopt effective and cost-effective medical devices more rapidly. The noble Lord referred to the excellent and interesting report by the PHG Foundation, a copy of which I have. We have noted that report with considerable interest. The Human Genomics Strategy Group has been asked to note the recommendations in that report as part of its work to develop a strategic vision.

The noble Lord spoke about the commissioning of genetic testing in the NHS, which was a subject raised by several noble Lords. The UK Genetic Testing Network is part of the national specialised commissioning team in the London NHS. It currently offers more than 400 genetic tests for single gene disorders. Those are available across the NHS. It is held up as an excellent template for the evaluation and commissioning of genetic tests. It is widely admired and copied across the world.

Several noble Lords, not least the noble Lord, Lord Patel, have put the $64,000 question to me about the possibility of a White Paper. I have to disappoint the noble Lord, because we do not believe that there is compelling evidence for a White Paper on genomic medicine at the moment. The point of a White Paper would be to address a perceived lack of strategic direction. I hope that I have shown that that is not an issue, not least because of Sir John Bell’s strategy group. That is particularly true because the White Paper of 2003 was reviewed in 2008; several initiatives were refreshed, including the strengthening of specialised genetic services, building genetics into mainstream services, spreading knowledge across the NHS and generating new applications. That is clearly a matter that we will have to keep under review.

Like your Lordships’ committee, we want a future strategy for these services. That strategy must be clear, patient-led and deliver better health outcomes at a time when the national finances are in a mess. We look to Sir John Bell to provide us with that road map. We need to look at what we have already achieved and ensure that the system is delivering what the NHS needs. If not, we must be committed to making the necessary changes to make it work. Finally, we must be creative in how we deliver to ensure that we not only maintain our reputation for the science in this area but translate that science into services for NHS patients.

It is my hope, as it is the Government’s, that Members of this House, especially the noble Lord, Lord Patel, will continue to provide us with the benefit of their knowledge in this area and that they will remain at the forefront of this debate over the years ahead.