Space Policy
George Freeman Excerpts(8 years, 4 months ago)
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Dr Philippa Whitford (Central Ayrshire) (SNP)
I beg to move,
That this House notes the scientific, cultural and technological opportunities arising from exploration of outer space and the significant contribution the space industry makes to the UK economy; further notes the increased public interest in space exploration resulting from Major Tim Peake’s mission to the International Space Station (ISS); welcomes the global co-operation that has led to the development of the ISS over the last forty years; takes note of the shortlist of airports and aerodromes that could host a UK spaceport published by the UK Government in March 2015; and calls on the Government to bring forward further advice and support for organisations considering developing such facilities so that they might be operational by the Government’s target date of 2018.
If hon. Members read the motion, they will see that it covers the incredible breadth and depth of the space industry and its amazing potential. I hope that that will be covered during the debate by Members from different parts of the United Kingdom. Some people are likely to stoop to using some fairly poor puns. At this point I would like to register the fact that I accept no responsibility for that. I lay the blame at the feet of the Prime Minister, who has stooped to using some pretty shocking puns at Question Time recently, something for which he needs to be penitent.
Some people who follow the media will be aware that our former First Minister, my right hon. Friend the Member for Gordon (Alex Salmond), has used as a travelling pseudonym the name of that famous captain of the USS Enterprise, but for a debate as important as this, I felt we should contact the real McCoy. I therefore have a message to the House of Commons from William Shatner:
“Space is one of the last known frontiers, mostly untouched by mankind and his politics. In opening a debate on this subject my hope is you take the tenets of Star Trek’s prime directive to universally and peacefully share in the exploration of it. I wish you all a wonderful debate. My best, Bill”.
As some people will have seen, we have also had a message on Twitter from George Takei—otherwise known as Mr Sulu—wishing us luck as we venture to the stars.
This is not a debate about fictional astronauts. We tried to get the debate on this day to honour a real astronaut, Major Tim Peake, who is currently in the international space station. We sought it today because tomorrow he will be making a spacewalk. Contrary to some slightly sloppy journalism, he is not actually the first British astronaut. That honour fell to Dr Helen Sharman from Yorkshire a quarter of a century ago, in 1991. I find it incredibly appropriate that, prior to that, she was a research chemist for Mars. [Laughter.] It’ll get worse.
However, Major Tim Peake is our first astronaut through an increased engagement with the European Space Agency. While Helen Sharman was on the Mir station, he is in the international space station, and tomorrow he will certainly be taking part in the very first British spacewalk. It will start, hopefully, at 11.30 GMT tomorrow morning. I would encourage all schools, children and youngsters of all ages to log on to principia.org or NASA TV on the internet, where it will be shown, as it truly is an historic moment. He has been tasked with changing regulators on the solar panels. As they are high-voltage regulators, the walk has to be carried out entirely on the dark side.
I am a member of the parliamentary space committee. We had the great opportunity to have a private tour of the “Cosmonauts” exhibition in the Science Museum, which I would recommend to anyone. The museum spent four years negotiating with Russia to bring incredible artefacts to this country—the space capsule of Tereshkova, uniforms of Gagarin and all sorts of pieces of hardware that even people in Russia did not know existed. What struck me as we went round the museum was the fact that, during points of incredible friction between Russia and the US and across the world, back channels always remained open. Co-operation always continued on the international space station. We have seen that in these few years of setting up the exhibition, during which we have had the Ukrainian crisis, Crimea and friction over Syria. If we can work so well together in space, it would be great if we could work a little bit better here on earth.
Any Members who were in the Chamber when I made my maiden speech will remember that I referred to Prestwick in my constituency as being on the shortlist for consideration as a space port. I remember that whenever I talked to anyone about that during the election, they would always just laugh, because in this country we think that space is for other people—the big boys: north America, Russia and maybe even China, but not us. That is something we have to change. We need to believe in what we can do, and I think Major Tim Peake’s mission will achieve that. We see the interest of school children and the Science Museum was packed on the day of the launch, and we had Members in this place watching it live on screen. We hope it will lead to an interest in STEM subjects—science, technology, engineering and maths—and an absolute belief in the space industry here in the United Kingdom.
The space industry is new, but the UK has a proud aviation history, which includes Rolls-Royce and supersonic flight. We need to take the next step and grasp that opportunity. The industry has changed over the past five years, and I applaud the decisions taken in 2010 that led to the formation of the UK Space Agency. It is now an industry with a turnover of £11.5 billion. It employs 35,000 people, three quarters of them in graduate jobs, and a third of its production is exports, but the vision of the Department for Business, Innovation and Skills is that it should grow to become a £40 billion industry. For that, we really need to take action.
If it was not a political decision, there should not really be any great doubt that the choice should be Prestwick. We already have almost everything that is needed. We have a runway that is touching 3 km. We are in a coastal position, to allow start-off over the sea. We have the northern air traffic control centre in our campus, which allows the planning of what will be some pretty clever management of airspace, and obviously we have relatively empty airspace. We are close to Glasgow University and Strathclyde technology catapults and we have, uniquely, an aerospace cluster on the airport campus. It contains BAE Systems, Spirit AeroSystems and many others, all of whom are interested in the idea of a space port.
Up the road from us is Clyde Space, which makes small CubeSats that are only a litre in size. Early communication satellites were weighed in tonnes and were the size of a double-decker bus, but the UK, through Surrey Satellite Technology, has led since the ’80s in producing satellites that are about the size of a fridge. That is a step change. It has been shown that if the cost of getting a satellite into space gets down to the tens of thousands, everyone is going to want one. We will have to look at regulating that, otherwise space will be full of junk, but it enables all sorts of possibilities. However, we do not have a domestic launch site. That is why the aim is to have a UK space port by 2018.
As well as all the physical attributes of Prestwick, 20 years of Met Office data show that, despite preconceptions, it has the clearest weather, compared with Newquay, which people would presume is the closest contender. Low cloud is suffered by Newquay 31% of the time and only 11% of the time at Prestwick. Less than 5 km visibility is suffered by Newquay 15% of the time and only 4% of the time at Prestwick. I live in Troon, which is next door, and I can vouch for the fact that we have a weird little weather system, locally known as the Prestwick hole. People can fly into it, drive into it or walk into it. They can be surrounded by thick cloud, but they will look up and see a large hole of pure blue sky. That is what has made Prestwick the clear weather airport for the United Kingdom for decades.
I call on the Minister to look not just at having one space port. I think this is an industry that will mushroom. We need to accept that all sorts of sectors will develop that we have not even thought about. It will diversify. This is a real industry. It is not about saying, “Beam me up, Scotty,” or fretting about the dilithium crystals that we see on the telly; it is a multi-billion pound industry. I call on the Minister to be imaginative, to be brave and to be boldly going where no Minister has gone before. [Hon. Members: “Ooh!”] Nearly done.
Dr Whitford
Oh, I am sure the Minister will have about two hours more.
Prestwick was Scotland’s first ever passenger airport and it was founded by Group Captain David McIntyre, the first man to fly over Everest. That is the kind of imagination and drive we need. I call on the Minister to please be imaginative and to support the industry across the entire UK so that it can live long and prosper.
The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
I thank you, Madam Deputy Speaker, and the Speaker’s Office for granting the debate, and congratulate the Backbench Business Committee on securing it. I think it shows the House at its very best, capturing the mood of the nation and setting out an inspiring and challenging vision of how in the years ahead this country can do so much more in this exciting field.
As many hon. Members have said, the debate is timely. Major Tim Peake floats in orbit above us, looking down, and tomorrow he will conduct the historic and serious spacewalk. He is the first British European Space Agency astronaut and the first British astronaut to enter the international space station. The debate is also timely because of the sad passing of the iconic David Bowie, whose lyrics in so many ways provided a backdrop to my generation’s childhood and captured, at the time of the Apollo missions, the existential challenge and opportunity of pushing the boundaries of space, time and culture. That provides a rather extraordinary and unpredictable but moving backdrop to this moment in space.
Bob Stewart
I rise as the Member for the coolest constituency in the country. David Bowie lived and played in my constituency, and we are hoping that the bandstand where he played will be saved and restored properly. That is not happening at the moment.
George Freeman
I am glad that my hon. Friend the Member for Beckenham (Bob Stewart), David Bowie’s constituency, rose to speak at that moment.
This debate and story is about more than the space endeavour alone. It is about business—the UK space industry is an £11.8 billion industry, employing 35,000 highly skilled people. It is about extraordinary technology in optics, communications, rocketry and engineering. It is about an activist industrial policy and strategy, for which I am delighted to confirm our support, to encourage leading technologies and industry. I pay tribute to the work done by Paul Drayson and by my great friend and colleague David Willetts, now a Member of the other place, who in 2012 was instrumental with the Chancellor in securing the £80 million for the international space station, which was crucial to securing Tim Peake’s role in it, and in securing the money for the reaction engines programme, on which this country is leading.
This debate is also about science, not just in space, but solar and earth science. Taking in rocketry, engineering, climatology, optics and communications, this is a deep science project to inspire all. It is about women in science, as others have said. Dr Helen Sharman was the first British woman in space, and the Italian Samantha Cristoforetti was the first European Space Agency woman astronaut; she did inspiring work and has become something of a legend and a role model for girls and women in science. It is also about our perception and consciousness of our environment. The “Earth dawn” photo changed perceptions of the fragility of the Earth’s ecosystem.
The debate on space is also about geopolitics. Who, in the appallingly dark days of the cold war and intercontinental ballistic missile threats in which many of us grew up, could have imagined that we would now have an international space station in which Americans, Russians and people from across the world work together for the good of all? It is about defining a new common space for all and a new approach to our defence and security through common leadership. It is not a subject I get to speak much about at the Dispatch Box, but today’s debate makes it possible to talk about mankind’s destiny—the questing spirit deep in us all and in society to inquire, discover, imagine, explore and make possible whole new worlds and opportunities.
This debate is also about the power of ambitious, positive, global, purposive and internationalist leadership to inspire and unite to produce a better politics from us all. No one spoke better on that than JFK, in his inspiring inaugural address in 1960, when he famously said, on a frosty morning in Washington at the very height of the cold war,
“my fellow Americans: ask not what your country can do for you, ask what you can do for your country.”
He launched America on a mission of internationalism, and two years later, in his Apollo speech, announced that America chose to go to the moon not because it was easy, but because it was hard. He did so in the spirit of internationalism and of appeal to the best instincts of mankind. It is a beautiful thing, I think, that on the moon is left an inscription stating that mankind came to the moon in a spirit of freedom and peace. That mission captures so much that is best about our society and what we want to achieve.
It is for those reasons that the Prime Minister asked that we harness the inspirational power of Major Peake’s mission to inspire the next generation of scientists and engineers and to bring the country together. All of us found it difficult to avoid the excitement associated with the launch and arrival of the first British ESA astronaut at the international space station. We held celebration events in Edinburgh, London, Cardiff and Belfast, at discovery centres throughout the UK, and here in Parliament. The Science Museum in London attracted almost 11,000 visitors, and if the sheer exhilaration of the 5,000-plus primary schoolchildren at the museum translates into an increase in future sciences, Tim Peake’s mission will already have achieved its goal. In all, 35% of the viewing public watched the launch, and a further 3.8 million people watched the Soyuz spaceship dock with the international space station that evening.
Our Government are providing £3 million of support to the education and engagement programme associated with Tim Peake’s mission, and we have been lauded by the ESA as the country doing the most to invest in and promote educational outreach. We will measure whether the excitement inspires young people to take up STEM subjects—several Members rightly commented on that—and increases public understanding of and engagement with science through an evaluation study being undertaken by York University. It is the first such research since the Apollo effect study in the 1970s.
The Peake mission is possible because of a decision made at the 2012 European Space Agency Council of Ministers meeting by the then Science Minister, David Willetts, which resulted in the UK joining the international space station and the related European programme for life and physical sciences—ELIPS. The UK made a further investment at the Council of Ministers in 2014. The total investment, which exceeded £80 million, provides substantial value for money, giving UK scientists access to a laboratory that has cost others up to $100 billion and is testament to international collaboration in science. The three man crew on the Soyuz, which launched on 15 December, comprised Tim Peake, the American Tim Kopra and the Russian commander Yuri Malenchenko. It is early days, and evaluation of UK involvement is ongoing, but the current results are incredibly exciting.
Experiments for the ELIPS and subsequent experiments undertaken on the space station are selected on the basis of science excellence, which plays to UK strengths. We sometimes forget that this is a massive international set of experiments up in space. In the most recent competition, the UK won more than 10% of awards for experiments, although UK involvement in the space station is at about 5% of costs, so we are punching above our weight. About 40 to 80 scientists across the UK are involved.
Space is not just about national exploration; it is about critical national infrastructure and services, such as weather forecasting, satellite navigation and satellite television. Space-based technologies are used for tackling many global challenges. Satellites can assist with tackling illegal fishing, efficient urban and rural land use, resource management, safe implementation of autonomous vehicles, and myriad further uses underpinning new technologies and new markets. For example, over half the essential climate variables needed to understand climate change derive from our satellite observations.
The UK space sector is undoubtedly a massive and growing success story. There are real prospects for the young people inspired by Tim Peake and the Rosetta mission to work in our very strong and vibrant space economy in the future. It is currently worth more than £11.8 billion to the UK economy. That is growing at about 8% a year, which is three times faster than the average non-finance sector. It is characterised by an incredibly highly skilled workforce of more than 37,000 people, half of whom hold at least a first degree. Those direct jobs each support more than two jobs in the wider economy. The sector has a general value added per job of £140,000, three times higher than the UK average.
To reflect the strategic and economic importance of the sector, my right hon. Friend the Secretary of State for Business, Innovation and Skills launched the national space policy on 13 December to coincide with the Peake mission. It showcases how deeply space now impacts on our daily lives, not least in the field of satellite data and information. It describes how the sector is a unique, strategic national capability which delivers science and innovation, national security, essential public services and prosperity. The policy spells out how the UK Space Agency has brought together the roles and responsibilities of 17 different Government organisations and other partners, such as research councils and Innovate UK which are involved with space.
Space-based activity is a long-term endeavour with international collaboration, industrial co-investment, skills development and considerable planning at its heart. Stability and certainty are important, and the national space policy is the Government’s expression of our long-term commitment to seeing it through and to putting in place a policy landscape to support that investment.
The UK’s involvement in space ranges from fundamental underpinning research into the origins of the universe, to understanding and protecting our planet, through to supporting the research that leads to UK companies launching entirely new multimillion-pound telecommunication satellites. Some 25% of the world’s telecommunication satellites are substantially built here in the UK. Satellites operated under the disaster charter and earth observation data procured commercially were critical to effectively targeting the response efforts on the ground in the recent floods.
This is an exciting time for space. In 2016 the UK will be building the main experiment on the Plato mission that will search for new earths orbiting other stars, in pursuit of answers to the profound question about life elsewhere in the universe, and will precipitate key contracts for UK companies. We look forward to a major European Space Agency Council of Ministers meeting in November/December 2016, where we will negotiate to ensure that the UK continues to play an influential part and benefits fully from European Space Agency programmes. The programmes that we are looking forward to in particular include the UK-led biomass experiment that will calculate the capacity of the world’s forests to store carbon. As well as improving our ability to control climate change, this offers a considerable opportunity as UK companies are poised to win contracts to provide the craft that will host the experiment in orbit.
2017 will see the launch of the joint European-Japanese BepiColombo mission which will set out on a voyage to Mercury, using a very efficient ion drive electric propulsion engine manufactured by UK firm Qinetiq.
In the field of space flight, through companies such as Clyde Space and SSTL, the UK has become a leader in the manufacture of smaller satellites and has largely secured cost-effective launch by arranging “piggy-back” launches with larger satellites in a competitive launcher market which is not yet sustainable but is growing fast. This is connected to the growth of commercial constellations of tens or even hundreds of low-cost small mass-produced satellites that can provide ubiquitous communications across the globe or near real-time imagery from low earth orbits.
Indeed, we believe that commercial space flight is a market which, when combined with the emerging trend to use large constellations of small satellites, could provide a cumulative economic benefit to the UK of £20 billion by 2030. This will provide new and long-term manufacturing and service jobs and will stimulate high tech growth. This includes exciting developments such as single-stage to orbit launchers, the engines for which are being pioneered by Reaction Engines, a rapidly growing company in Oxfordshire.
This is the context for the UK to explore having a launch capability. We believe there is at least a two-stage process to achieving it. The first part of our ambition is for the UK to become the European hub for commercial space flight and related space sector technologies. The initial focus is on creating the necessary legislative and regulatory framework that will enable commercial suborbital space flights alongside existing civilian and military airspace operations. Alongside this, it is the Government’s intention to select a preferred location for a UK spaceport that will be capable of operating horizontal commercial spaceplanes. We are closely examining what this process will look like, to ensure that it is fair, transparent and robust.
We will seek to draw on established Government approaches to appraisal and will ensure that the preferred location meets a number of key criteria—that it can deliver a spaceport technically capable of operating horizontal commercial spaceplanes, that it will be commercially viable, that it can ensure the safety of the uninvolved public, and that it takes into account the potential environmental impacts of the spaceport and will deliver local and national economic growth. These criteria are likely to form the core of any selection process, though we have not settled on the final criteria.
Drew Hendry
The Minister is outlining an exciting programme of opportunities and economic development. He has heard from a number of Members today about the need to encourage girls and young women to get involved in the industry. Will he take that message away to the Government and do something practical to promote that?
George Freeman
Yes, I certainly will. There are a number of initiatives in place which I have not had time this afternoon to set out, but I will happily take that point on board. We are seized of the importance of promoting women in the sector.
Developing a UK spaceport and a commercial suborbital operation are crucial steps to building the capability and credibility for a UK launch capability, with the aim of launching small satellites from the UK.
I shall touch on some of the key points that hon. Members made. I congratulate the hon. Member for Central Ayrshire (Dr Whitford), whose introductory speech set the scene beautifully. I was delighted that she referred to me as a Minister prepared to boldly go where no Minister has gone before. I pay tribute to my hon. Friend the Member for Bracknell (Dr Lee) who, in his maiden speech, was quick on to this subject and has been a leading advocate and vice-chairman of the space committee. It is great to see the cross-party support for this project.
A number of colleagues, particularly from Scotland, spoke about the importance of the Scottish cluster. In this field as well as in other technology areas, Scotland has a powerful cluster. Despite a number of powerful bids being made from Scotland, Wales and Cornwall, hon. Members would not expect me today to pre-empt the process of selecting appropriate sites, but I can assure them that we will conduct that process fairly, openly and against proper criteria. All their bids have been heard clearly today.
Let me address some of the key questions that have been raised. There was a question about our priorities. I hope my comments setting out our commitment and the commitments set out in the recently launched space strategy go some way to clarifying that. I was asked about research funding. In the autumn statement the Chancellor announced the historic ring-fenced increased commitment to science capital and revenue, and the Government are in the process of working through with the research councils how that science funding will be allocated to various projects. We will shortly make announcements on how we see that being taken forward.
There were questions about growth and what we are doing to ensure a joined-up strategy for the sector. We are working widely with industry to identify the key markets that we see delivering the main growth. The Space Leadership Council, jointly chaired by my hon. Friend the Minister for Universities and Science and the president of the UK space trade association, is actively working to develop a set of policies, and the blueprint for growth which was set out in our recently published national space policy sets out the framework that we intend to follow.
On the timing of the announcement of the spaceport location, as hon. Members know, this is an entirely new market. It is moving quickly, but there are complex issues to be dealt with in relation to regulations and the legal basis for safe flights that we need to get right. That work is ongoing, and I hope that my comments today have reassured Members that it is being taken seriously. The Government expect to be able to announce how we proceed as soon as we can in 2016.
Important questions were asked about space debris and regulation. This area is governed by the Outer Space Act 1986. No licence is issued to operators of space assets unless they can show that they are compliant and safe, and minimising space debris is part of that process. Technical failures do occur, but we remain vigilant. The strategic defence and security review set up a cross-governmental committee, chaired by my hon. Friend the Minister for Universities and Science, to further ensure security in space, particularly in relation to space debris.
A number of hon. Members asked about careers in STEM. We have allocated £3 million to support education programmes to help young people benefit from Tim Peake’s mission, and reaching out to girls and women is an important part of that. The European Space Agency has acknowledged that the UK is doing more to support that work than any other nation in the project. We are providing practical tools for teachers and lecturers.
There was a question about the University of Glasgow and how the Government are engaging with cutting-edge research facilities. Through the work of the Engineering and Physical Sciences Research Council, the Natural Environment Research Council and the Science and Technology Facilities Council, we are actively looking at how we can use those research centres to support this project.
The hon. Member for Strangford (Jim Shannon)—on a previous occasion he described himself as a stalker of mine, because we appear to speak in all the same debates —made a powerful plug for Northern Ireland. The Government fully recognise the benefit that Northern Ireland’s space industry and universities play in our space policy. That is why we were delighted to convene and take part in an event held in Belfast to mark Tim Peake’s launch.
My hon. Friend the Member for a bit of Cornwall—the precise part escapes my memory right now. [Interruption.] My hon. Friend the Member for South East Cornwall (Mrs Murray) raised the important issue of Newquay airport. My right hon. Friend the Prime Minister has said previously from the Dispatch Box that he recognises the importance of Newquay in this and in the wider Cornish economy. As I have said, we will look at all bids in time.
We have heard a lot of quotes in today’s debate—some more original than others—not least from David Bowie. I wanted to close with one that we have not heard. In “An Occasional Dream” he sang about
“tomorrows of rich surprise… Some things we could do”
He sang:
“We can be heroes, just for one day”.
I think that this debate, and indeed this whole topic, captures the sense in which good politics can bring people together to achieve the very highest goals. I am grateful to colleagues for raising it and pleased to be part of a Department that is committed to this sector and to achieving everything that this country can do in this very exciting race.
Pharmaceutical Price Regulation Scheme
George Freeman Excerpts(8 years, 4 months ago)
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The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
My hon. Friend the Parliamentary Under-Secretary of State (Lord Prior of Brampton) made the following written statement on 21 December 2015.
I am announcing today the level of payment due from members of the Pharmaceutical Price Regulation Scheme (PPRS) in 2016 to keep health service spend on branded medicines within the levels agreed under the Scheme. The PPRS payment percentage for 2016 will be 7.80%.
The PPRS allows patients access to the medicines they need while maintaining affordability for the NHS and providing stability for industry in support of the Government’s innovation and growth agenda. There is an agreed, fixed limit on the majority of NHS spend on branded medicines with additional expenditure above this level paid for by the pharmaceutical companies. The agreed growth limit in both 2014 and 2015 was 0%. Annual growth will be limited to 1.8% in 2016,1.8% in 2017 and 1.9% in 2018. Small companies with less than £5 million of sales a year to the health service are exempted.
The Government welcome the pharmaceutical industry’s agreement to increase its payments to the Department of Health in 2016 compared to the amount agreed in the amendment to the Pharmaceutical Price Regulation Scheme (PPRS) published in August 2015. This supports the Government’s NHS funding commitment made at the spending review to deliver the Five Year Forward View. This represents a payment of monies that would have been due in 2017 and 2018 under the PPRS and will support industry and Government efforts to improve patient access to new clinically and cost-effective medicines.
The Department has published a document setting out further details entitled “Pharmaceutical Price Regulation Scheme 2014: revised forecasts and profile of payment percentages at December 2015”.
It is also available online at: http://www.parliament.uk/writtenstatements.
[HCWS447]
Oral Answers to Questions
George Freeman Excerpts(8 years, 4 months ago)
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Christian Matheson (City of Chester) (Lab)
5. What assessment he has made of the effect of changes to social care budgets on A&E attendances.
The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
Our health and care system is under extraordinary rising demand from an ageing society. There are a million more pensioners this year than there were at the beginning of the previous Parliament, and there will be another million by the end of this Parliament. The number of adults needing care in the next 10 years will rise from 180,000 to 264,000. That is why integration of health and care is so important, and it is why I am delighted that my right hon. Friend the Chancellor announced in the autumn statement £3.5 billion for social care by 2020 through the new adult precept and extra funding for the NHS five-year forward view.
Christian Matheson
In any given week at the Countess of Chester hospital, 70-plus elderly patients pitch up and cannot be discharged because care is not available elsewhere. We know that the Government broke their promise before the election to sort out funding for long-term care, and the King’s Fund recently said that the settlement to which the Minister refers will put
“even more pressure on … the NHS to pick up the pieces when there’s a breakdown in … care”.
Will the Minister now accept that that continuing neglect and those broken promises are the key cause of the crisis in our A&E departments?
George Freeman
Well—happy new year! Only Labour could take a £3.5 billion commitment to fund social care as “more pressure”. We are leading the way in integration—not before time, after 14 years in which Labour did nothing. We are leading the way on integration and putting in the extra money. I am delighted to say that, through the £3.8 billion for this coming year and the £10 billion funding for the NHS Five Year Forward View for transformation, it is the Conservative party that is investing in a 21st-century NHS. Labour seems to want to take us back to “Call the Midwife”.
Andrew Bridgen (North West Leicestershire) (Con)
Does my hon. Friend agree that it is an important step to devolve powers to local authorities, as they are best placed to commission care services for local populations?
George Freeman
My hon. Friend makes an excellent point. The key is, of course, more funding and more integration, but crucially more local leadership too, and we are actively making it easier through the devolution programme for local authorities and local health leaders to plan the integrated services that are appropriate for their area. Not all areas are the same.
Jenny Chapman (Darlington) (Lab)
17. Having listened to what the Minister has to say, people in my constituency will be disbelieving. The number of days that patients are stuck in hospital, not because they are sick but because there is nowhere to move them, has doubled under his Government. He has to acknowledge that that is due to the neglect of local government and adult social care specifically.
George Freeman
It is true that in different areas there are different pressures. In my own area of Norfolk there are pressures. Let me remind the hon. Lady that A&E spending has gone up dramatically over the past decade, from £900 million in 2001 to £2.4 billion. The early evidence from the better care fund, which we launched only this year to tackle this very issue, is 85,000 fewer delayed transfers, 12,000 more older people at home within three months of discharge, and nearly 3,000 people supported to live independently. Through more funding, greater freedoms and local devolution, we are supporting health leaders and council leaders to bring together health and care.
David T. C. Davies (Monmouth) (Con)
Despite the pressures, is it not excellent that 95% of patients who present at A&E in England are seen within the target time, unlike in Wales, where the figure is only 81%, as a result of the fact that the NHS is run by members of the Labour party?
George Freeman
My hon. Friend makes an excellent point. We hear very little from the Labour party about Wales, where it is responsible for the health service, and an awful lot of questions about England, where fortunately it is not responsible. If we want to get pressure on A&E down, we need to integrate and invest as we are doing in prevention and in keeping people out of unnecessary A&E admission.
Norman Lamb (North Norfolk) (LD)
23. The Health Foundation estimates that the gap in social care funding by 2020 will be £6 billion, not taking into account the increase in the minimum wage, so although the spending review narrows the gap, it still leaves an enormous gap which will result in further cuts in social care. How will the Government avoid the totally unacceptable situation in which those with money will still get good care and those without money will get substandard care or no care at all?
George Freeman
I pay tribute to the right hon. Gentleman. He is a Norfolk colleague and as Minister did a lot of work in this area. He raises an important point that as a society we need to think profoundly about how we integrate health and social care. As I say, the Government have made a £3.5 billion commitment from the new precept and the better care fund is a significant commitment, but he is right—we will have to go further. Through the devolution programme and the integration programme, we will have to develop more powers so that local health leaders and care council leaders can better integrate services to reduce unnecessary pressure.
Dr Philippa Whitford (Central Ayrshire) (SNP)
In Scotland, A&E performance is published weekly, but since June that in England has been published only every month and now after a six-week delay. Since that time, the performance in Scotland has risen and 96% of people were seen within four hours in Christmas week, which is a huge challenge, whereas the last data published for England were for October and show a figure below 90%. Do the Minister and the Secretary of State accept that to improve performance we need to return to more timeous and frequent analysis and publication?
George Freeman
I share the hon. Lady’s interest in data and in proper information. We need to be a little careful about Scottish figures. Over winter, England publishes three times more A&E performance measures than Scotland every week. We publish quality rankings on hospitals, care homes and GP surgeries, which Scotland does not. What we do not hear about in Scotland is A&E closures, A&E diverts, emergency admissions, general and acute beds—I could go on. It is dangerous to compare data that were not prepared on the same basis, but I share the hon. Lady’s enthusiasm, as does the Secretary of State, for information.
Dr Whitford
I am aware that the renewed strike call from junior doctors has actually been called in order to meet the new rules created by the Government’s own union laws and that negotiations are ongoing. To avoid an impact on hospital waiting times, what will the Secretary of State bring to the negotiating table to try to reassure junior doctors?
George Freeman
I am delighted to be able to announce—the hon. Lady might already have heard this—that the Secretary of State has appointed Sir David Dalton from Salford Royal to lead on that. I repeat the offer that the Secretary of State made this morning: we are very close to an agreement, so the right approach is not to strike, but to come to the table and reach it.
Barbara Keeley (Worsley and Eccles South) (Lab)
Three hundred thousand fewer older people have publicly funded care packages than in 2010, and nearly half the current record level of hospital delayed discharges are due to waiting for a care package, and that will get worse as winter pressures mount. It is risky that the proposed increases in the better care fund are back-loaded; they do not reach £1.5 billion until 2019-20. The social care precept funding is uncertain because it will raise only £1.6 billion by 2020 if every single council decides to raise the maximum possible. Social care is in crisis now. Can the Minister explain why the Government are proposing risky, uncertain and late funding?
George Freeman
This is the most extraordinary welcome for one of the most important announcements in the autumn statement. Having come under pressure to raise more money for social care, the Chancellor and the Secretary of State announced £3.5 billion extra for social care, from the new adult social care precept and the better care fund. The Opposition say that it is not enough and that it will fail, but the data do not support that. If we look at the early data from the better care fund, which was introduced by this Government early last year, we see 85,000 fewer delayed transfers, 12,500 more older people at home within three months of discharge and 3,000 people supported to live independently. We are making real progress.
John Stevenson (Carlisle) (Con)
6. What progress his Department has made on improving the performance of hospital trusts in special measures.
Mr Peter Bone (Wellingborough) (Con)
8. What his policy is on making docetaxel available as a treatment for prostate cancer.
The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
Docetaxel is routinely available in England for the treatment of metastatic prostate cancer, where the disease has not responded to hormone treatment. It is not at the moment licensed for use alongside hormone treatment and has not been appraised by the National Institute for Health and Care Excellence for that indication. In the absence of NICE guidance, NHS commissioners are free to make funding decisions on the best available evidence.
Mr Bone
I thank the Minister for stating the current practice. A constituent of mine has prostate cancer. His doctor, consultant and oncologist all say that he would benefit from taking docetaxel, but it is not available in Northamptonshire, although it is available in parts of the rest of the country. He has been told that if he goes down the road to the private hospital, he can have it at £2,700 a cycle. Is that not unacceptable? Should he not get the treatment on the NHS and should he not get refunded the monies paid for private treatment?
George Freeman
I congratulate my hon. Friend on being a diligent advocate for his constituent Mr Vann. I am delighted to tell him that the result of the STAMPEDE clinical trial has now been published. Today NICE is publishing an evidence review. NHS England will shortly be publishing its interim commissioning policy based on that evidence. That is very encouraging.
Daniel Kawczynski (Shrewsbury and Atcham) (Con)
9. What assessment his Department has made of the need for wi-fi infrastructure in hospitals to facilitate use of developing healthcare technologies.
The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
Digitalisation of healthcare is absolutely essential for the 21st-century NHS—for individual care, for system performance and safety, and for research. Wi-fi is an important part of that, with benefits for doctors, nurses, hospital management and patients. That is why I am delighted that my right hon. Friend the Secretary of State secured the necessary funding in the comprehensive spending review to fund fully the NHS’s plans for digitalisation and transformation. We have announced that we are implementing Baroness Martha Lane Fox’s recommendation of free wi-fi in all NHS hospitals.
Daniel Kawczynski
I am grateful for that answer. The new chief executive of the Royal Shrewsbury hospital informed me that people can receive wi-fi in only half of the hospital area. Can the Minister give me an assurance that everything will be done to ensure that wi-fi is available throughout the Royal Shrewsbury hospital?
George Freeman
That is an important point. It is up to each hospital to implement digitalisation in its own way, but we are putting in place a series of steps to make sure that all parts of the NHS are supported and encouraged in the drive for delivery of a paperless NHS by 2020. In the new year, we are requiring the clinical commissioning group digital index, which will measure the digitalisation of all health economies, and we are launching a review of best practice. We are absolutely committed to driving digitalisation so that the 21st-century NHS is not running on paper and cardboard.
Anne Marie Morris (Newton Abbot) (Con)
10. What plans he has to publish a rural healthcare strategy.
ACCESS TO MEDICAL TREATMENTS (INNOVATION) BILL
George Freeman Excerpts(8 years, 5 months ago)
Public Bill CommitteesRead Full debate Read Hansard Text Read Debate Ministerial Extracts
Justin Madders
It is always a pleasure to serve under your chairmanship, Mr Streeter. I congratulate the hon. Member for Daventry on successfully progressing his Bill to Committee. I have not been in this place long, but I am aware that many private Members’ Bills fall well before this stage, so he deserves credit for clearing the hurdles placed in front of him so far. I also thank the hon. Gentleman for taking the time to meet me yesterday to discuss the Bill. I know from our conversation that he has put a huge amount of work into the Bill, and I am sure that even those who oppose it will have welcomed the opportunity that he has given to all the interested bodies to discuss it with him.
As I made clear during the debate on the money resolution, and as the shadow Secretary of State for Health, my hon. Friend the Member for Lewisham East (Heidi Alexander), set out in detail on Second Reading, Opposition Members believe that the Bill has been presented by the hon. Gentleman with the best of intentions, but we have serious reservations about some aspects of it. I will set those out in relation to our amendments 1 and 2, which we intend to press to a vote.
As I am sure the hon. Gentleman has been reminded on many occasions, the breadth of opposition to the Bill is extraordinary. It unites a huge number of professional bodies, royal colleges, charities and patients’ bodies. That opposition has been particularly strong in relation to clause 3 onwards, and we share the concerns about those clauses.
Our first two amendments relate to the introductory comments in clause 1, which sets out the purpose of the Bill. Amendment 1 would remove the words
“promote access to innovative medical treatments by… providing”
in lines 3 to 5 on page 1 and insert instead in line 5 the word “provide”. Amendment 2 would delete entirely lines 8 and 9. When combined together, and subject to what else is agreed today, those amendments would, we hope, remove entirely the provision in the Bill relating to what is described as “responsible innovation.” In our view, that provision is at best unnecessary, possibly counterproductive and at worst potentially dangerous. It is unnecessary because to date no evidence has been provided to suggest that the threat of litigation acts as an inhibitor on doctors innovating. A number of bodies have spoken on that point, as indeed have hon. Members at previous stages of the Bill.
I will give a few examples. The British Medical Association said:
“We are not aware of any evidence to suggest that the threat of litigation inhibits innovation or that confusion exists amongst doctors over the circumstances under which they can deviate from standard practice.”
The Academy of Medical Royal Colleges said that
“the Bill rests on the false assumption that it is fear of litigation that is holding back innovation by doctors. There is simply no evidence that this is the case”.
The Royal College of Surgeons said that
“there is no evidence that doctors are deterred from innovating due to the threat of legal action.”
Even Sir Robert Francis, QC, said:
“The law of negligence does not prevent responsible innovation and never has.”
As the hon. Member for Daventry will know, many have also made the same point that the current law is not an impediment to innovation, so this part of the Bill seeks to address a problem that we say simply does not exist. I am aware that some clinicians said in response to the Government consultation that that was a problem, but even the Minister conceded that very few saw it as the principal problem. If we are looking to break down barriers to innovation, a great many other factors mentioned in responses to that consultation could address the problem and are not set out in the Bill.
We also think that the Bill is counterproductive. Even were it accepted that there was a problem, the Bill could increase litigation and uncertainty among doctors. On that point, Earl Howe said in response to a similar provision in the Medical Innovation Bill that it may be that overall litigation claims increase slightly as the legislation is tested. This Bill adds an extra layer of complexity that the law does not warrant. I would be interested to know whether the Minister has any views on the potential for extra litigation arising from the Bill. As we know, the law on medical negligence has been developed over many years, and I am not persuaded that the perceived benefits of the Bill are worth upsetting the certainty and stability that the settled law has brought.
Most significantly, we consider the clause to be potentially dangerous. That is not an attempt to cast aspersions on the hon. Member for Daventry, as I know he is genuinely trying to do his best, but we all know about roads paved with good intentions. To give an example, because “innovative treatments” is not defined in the Bill, it applies to all decisions to treat that are outside the range of accepted treatments. It therefore includes treatments that would currently be considered negligent, because negligent treatments are by definition outside the range of accepted treatments. That by itself is concerning.
The Bill requires the agreement of two doctors that a treatment decision would be supported by a responsible body of medical opinion, but it does not tell us how that agreement is to be reached. Is it a chat over a pint at the golf club? On any analysis, that is in no way comparable to a court finding on the basis of expert evidence that there was a responsible body of opinion that would have supported the treatment and that the treatment was rational and reasonable in all circumstances.
“Treatment” is defined in clause 5 to include “inaction”. For example, a patient might suffer from complications after bowel surgery. The patient having a fever and abdominal pain, the surgeon decides not to return them to theatre, but to continue with treatment of antibiotics and monitoring. In fact, the patient has a bowel perforation caused by the surgery and sadly dies. Under the current law, the court would find that no responsible body of surgeons would have delayed taking the patient to surgery within 24 hours. Had the surgeon done so, the patient’s perforated bowel could have been repaired and they would have survived. The court would find that the surgeon was negligent and that the negligence caused the patient’s death. The patient’s family would in those circumstances be compensated.
If the Bill becomes law, the surgeon might have a defence where there is none currently. Suppose he had consulted a colleague and asked whether he thought a responsible body of surgeons would not take the patient back to theatre, but would adopt a “wait and see” approach. If the colleague agrees, the surgeon could say that he had weighed up all the advantages and disadvantages, that he had the agreement of the patient to wait and see, rather than to go back to theatre, that he had gone through all the right steps under the Bill and that it was just that the decision was a bad one, which in fact no reasonable body of surgeons would condone. The Bill would give him a defence in such circumstances. If he had gone through the right steps under the Bill, by definition he could not be found negligent.
I am worried that the Bill will muddy the waters on the legal route for doctors who wish to innovate. I am worried that it will reduce patient participation in clinical trials. If patients are faced with the choice of guaranteed access to treatment or participation in a trial in which there is a 50:50 chance that they will not be part of the group receiving innovative treatment, why would they choose to be part of the trial? I am worried about the potential removal of legal redress for a patient with a genuine negligence claim. I am worried that unsafe treatments could be used on dying patients. Clause 1 should be amended to remove that provision from the Bill.
I will speak briefly to the other two amendments in the group. Amendment 3 replaces a paragraph that reads:
“the results of such treatments”,
and is intended to make it clear that we expect negative as well as positive results to be reported to prevent unsuccessful innovations being repeated, which would cause unnecessary suffering.
Amendment 4 would ensure that the information recorded on the database is as comprehensive as possible. In order to be a comprehensive record of the treatment, patient experiences need to be included. It may well be that the hon. Member for Daventry intends the Bill to be fairly general in its description of the database at this stage, in which case he may say that it is not necessary to have this level of prescription in the Bill. However, we believe that these are important details that should be set out now and included at this stage.
The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
It is a pleasure to serve under your chairmanship, Mr Streeter. As the hon. Member for Ellesmere Port and Neston has just said, this is one of those Bills that has aroused a lot of interest. We have a number of issues to deal with in Committee and outside this room in further conversations.
I know that we are discussing specific amendments, but let me say briefly that I agree with much of what the hon. Gentleman said. Everybody accepts that the ambition of the Bill is noble: to promote innovation. Everybody in the health system accepts that innovation has been the lifeblood of medicine and of the NHS, and of this country’s leadership in medicine. The point of difference we need to focus on is the one he eloquently raised: identifying the barriers to adoption of innovation and the extent to which fear of negligence is one of them. If it is not, what is the barrier?
The hon. Gentleman made an important point about the risk of even well-intentioned attempts to clarify having an inadvertent effect of generating a festival for lawyers, to debate whether or not the Bill could potentially have any effects other than those that Parliament intended. I certainly agree with him that if that were to happen it would be unhelpful.
The point of the clause, as I understand it, is to clarify for those who fear that the existing protections on negligence create a burden of proof that is unclear in law and thus create a de facto barrier to innovation, a clear process that in no way changes the current provisions of medical negligence law. I can confirm that one of my main preoccupations has been to ensure that we in no way inadvertently or deliberately change that protection. We have had counsel look at that very carefully, and we have been advised that this would in no way change the basis of medical negligence law.
The Bill simply seeks to create a procedure that would provide clinicians with comfort that by pursuing that they are simply pursuing what is currently best practice under existing medical negligence provisions. I take the hon. Gentleman’s point that, if it creates any significant uncertainty and thus inadvertently creates confusion, it will have the opposite effect to that it was seeking, which is to clarify the process.
The hon. Gentleman touched on the importance of need, and I will return to that point later because it goes to the heart of where the Committee ought to help get the Bill. He also touched on safety. I want to address that profoundly, because my No. 1 concern as a Health Minister is patient safety. I join him in paying tribute to my hon. Friend the Member for Daventry for taking the wide interest of the House in the subject and seeking to come up with a measure that can satisfy all parties. He has done a magnificent job of moving us on.
As I have said on the record at the Dispatch Box on more than one occasion, if the Bill, despite its best intentions, undermined patient safety or significantly created the perception that patient safety had been undermined, that would be very damaging for the UK and for the NHS. As the Minster responsible for getting more medical and clinical research into the UK, I cherish this country’s hard-won reputation for setting the highest standards in research medicine. I would be concerned if the Bill specifically, deliberately or inadvertently harmed that.
The chief medical officer has said that she supports the Bill. From a safety point of view, I take a lot of comfort from that. Sir Bruce Keogh has said that he is absolutely sure that the Bill is safe in terms of patient safety, which has been our No. 1 criterion. I think that it would be fair to say that although Sir Bruce Keogh says that the Bill is safe, he does not necessarily lie awake at night longing for it to be passed. He shares some of our concerns about the avoidable but none the less quite predictable outcome of the Bill having the opposite effect to the one intended. From a safety point of view, I am absolutely sure, as a Minister, that the Bill will in no way interfere with current medical negligence practice and that it is merely an attempt to clarify the existing protections available to patients and clinicians.
Chris Leslie (Nottingham East) (Lab/Co-op)
You’ve started, so you should finish.
George Freeman
As the hon. Gentleman says, I have started so I had better finish. Let me wrap up a lifetime’s work by saying that there are many barriers to the uptake of innovation in the system. It is clear from pretty substantial anecdotal evidence from people on the frontline that latterly, the fear of unreasonable charges of negligent practice features in their consideration. Some institutions—partly for other reasons to do with tightening up commissioning processes and clarifying and rationalising—have given clinicians instructions such as, “We don’t want you to do anything other than these things; by the way, if you did, you might put us in a difficult position and we’d have to make sure we could defend possible litigation claims.” That is often used, anecdotally and apocryphally, to support a more general presumption about sticking to what we know works and what we have always done.
My hon. Friend the Member for Daventry is partly trying to tackle a culture that is rather difficult to prove and ill-evidenced, but that we none the less picked up in the consultation. In my 15-year career, clinicians said to me, “We used to have a culture that was a bit more conducive to innovation, but we’re all now slightly treading on eggshells and worried about any attempt being misconstrued.” I do not want to suggest that such fear is the No. 1 issue or the most important priority. This is a private Member’s Bill. If I were introducing a Government Bill on access to innovative medicine, I would have measures on a number of other issues before that one, but I respect that there is a cultural fear that innovative practice is less encouraged, promoted and supported, which we picked up in the consultation.
That is one thing that I, as a Minister, am keen to tackle through our work at the Department of Health to sponsor the National Institute for Health Research. The Prime Minister and I have set out a strategic objective: every hospital a research hospital, and every patient a research patient. We do not mean that every patient should be experimented on; we mean that, in an intelligent health system, we should be learning from every moment that we treat patients in the NHS.
I do not think fear of litigation is the No. 1 barrier to innovation, but equally, in an open democracy, Members are free to promote legislation on their own account. I have supported the attempt of my hon. Friend the Member for Daventry to have a debate and find a way of accelerating the uptake of innovation because it is a noble purpose.
I hope that what I have said is helpful and clarifies where I think the barriers are and are not. The bigger barriers are siloed funding, strict and specific commissioning structures, organisational barriers between people who diagnose and people who treat and a lack of integrated funding—all the things we spend our time trying to tackle. It is important that the chief medical officer supports the Bill and that Sir Bruce Keogh has said he is absolutely sure that it is safe; he has advised the Secretary of State and I to that effect.
The Bill was in some ways preceded by a different one: Lord Saatchi’s Bill in the House of Lords, which generated a lot of attention and interest. This is a very different Bill. Lord Saatchi’s Bill set out provisions for a registry, which came late in the process of Lords scrutiny of that Bill, with the thinking being, “Oh, we’d better keep a register of innovations that flow as a result of this Bill.”
If I understand it correctly, my hon. Friend’s purpose is different, and I support him strongly in it, because this is another passion of mine. It is not about creating conditions in which every medic is exhorted and encouraged to experiment and record that in a database—that is absolutely not the right approach or what the Bill seeks to do. Importantly, the wording of the preamble in the opening clause focuses the Bill on something quite different, which I support: the provision of information to clinicians on innovative medicines coming on stream that are either in research trials, which doctors might want to enrolling their patents in, or off-label uses of drugs. No clinician can be expected to keep in their head 24/7 information about all the innovative medicines out there or, indeed, unlicensed medicines that might be available through the early access to medicines scheme that I launched. That wording intends to clarify that the Bill is different from Lord Saatchi’s Bill, with a focus on giving clinicians access to information about treatments that they consider their patient might be eligible for. For me, that is the best bit of the Bill, and I would strongly support the Committee in continuing to debate it.
The hon. Member for Torfaen proposed a Bill, which did not get a Second Reading, that sought to promote off-label use of medicines. A database for clinicians that gave them, at the click of a mouse, access on their desktop to information about innovative medicines that are available—or, indeed, about off-label, innovative uses of existing medicines—would be a powerful tool to help promote innovation.
Chris Leslie
I am focused on the amendments. Will the Minister give us his view on whether he supports amendments 1 to 4? That would help.
George Freeman
I do not. I am politely winding my way round to saying that. However, the reasons are important. It is not that I object to amendments at all—I hope the Bill will be heavily amended in Committee to reach that nirvana of all the parties—but, because the clause is important and helps to clarify the Bill’s intention, I suggest that the amendments should not be pressed. However, we might work on a package of amendments on Report that tackle giving clinicians access to information about innovative medicines and the important points made by the hon. Gentleman.
Dr Philippa Whitford (Central Ayrshire) (SNP)
My concern about the Bill is that it seems to create a parallel system for something that we already have. We already have clear structures around litigation, defence and informed consent, which the Bill seems to bypass. If a doctor finds one other doctor who agrees with them, they can do what they like to somebody—they can go out and clip their privet hedge and give it to them: they are at the end of life and desperate, so they will try anything. That is really concerning.
The database would create a second information system that is not just about people reporting something. Someone might go to it in desperation, read about privet hedges and try that. That creates a separate system from the research system that has been developed over many years.
When I was a young doctor—sadly that was quite a long time ago—there was a paternalistic approach, in which the patient did exactly what the doctor told them. The thing is, when people are at the end of life or suffering from something for which we do not have an easy treatment, they are incredibly vulnerable, so we have a duty to protect them.
Part of the problem with the Bill is that it would create separate systems. Why should a doctor go through the entire system of pre-clinical research phases 1, 2 and 3, getting permission and getting things passed when, whatever their idea is, they can talk some wee lady into it and give it to them without any cover? That is quite frightening and would undermine our trials process.
There are things that could be improved. I agree with the Minister that some institutions have become rigid and defensive, thinking, “We don’t want you using that for anything else.” Out of the Bill we could get, as the Minister said, a database that talks about research that is going on that we could collaborate in, and what the findings and trial results are. Busy, front-line clinicians are often unaware of trials. In Scotland, we have the Scottish Breast Cancer Trials Group so that we flag up trials to people. There could be merit in that, but the idea that putting on a database something that I do to a patient, just randomly, somehow gives it credence is actually quite frightening.
We have Bolam. We have a system and a definition of negligence and litigation. Creating these two parallels undermines the patient. How can they give informed consent if we are talking about something that has no work-up, no safety profile and no phase 1 trials? How do we ensure that we are not encouraging people to do that across the country? There are things that could be done with the Bill but, as it stands, I have grave concerns, as many other doctors do.
Justin Madders
Yes, my hon. Friend is absolutely correct. That is why we spent some time talking about those issues. They are really at the heart of the concerns.
George Freeman
Before the hon. Gentleman decides how he wants to proceed, I wanted to welcome the commitment my hon. Friend the Member for Daventry made to withdraw if we cannot reach agreement and to second my offer to sit down and work with members of the Committee and others to see whether we can get a package of amendments. I am rather less worried about other bits of the Bill from a Government point of view, but this bit is in many ways the best bit of the Bill. This is a very different Bill from the original Saatchi Bill, in that it focuses—perhaps not strongly enough for the hon. Gentleman—on getting information to clinicians on the innovative medicines that are out there. Funnily enough, it is the bit of the Bill I would most like us to keep. I reiterate that I am happy to work with members of the Committee, and to get officials to help us try to get the Bill into a better place, if that helps us to avoid an unnecessary Division.
George Freeman
I thank and pay tribute to the hon. Member for Torfaen for his persistence and patience in working with all parties on this matter. Similar to the Bill we are discussing, his Bill touched on an ambition shared by colleagues across the House to promote greater off-label use of medicines. I have encouraged him and my hon. Friend the Member for Daventry has welcomed his commitment to try to work through this Bill to see whether we might be able to tackle some of the same objectives, which is an ambition I strongly support.
In this Bill, my hon. Friend the Member for Daventry has repositioned a much stronger focus on the database being a registry not for capturing innovations that medics might or might not think are reasonable to record, but for the provision of information to clinicians on licensed, unlicensed and off-label uses for innovative medicines that are currently being developed. That represents a powerful opportunity for us to strike a blow for getting clinicians access to drugs that are in development, in trials or in an early access to medicine scheme and to off-label drugs currently in use of which clinicians might be unaware.
I dream of the day when a clinician can talk to a patient, click on their electronic medical records to see their history, click on available treatments for patients of that profile and see, at the click of a mouse, what clinicians around the country are doing, including the numbers. That could then be used to help intelligent prescribing, using their best clinical judgment and their knowledge of the patient. There is an interesting opportunity for us to do something here.
Let me turn to the amendments. Amendment 7 seeks to make it explicit in the Bill that “treatments” includes access to off-patent drugs. I actually support that ambition. Lawyers at the Department of Health will tell me that it is otiose—a legal term meaning that it is not strictly necessary—but, as a pure democrat, I think that it would be helpful if we could find a way to make it clear that that is specifically what we want to achieve. I can list the reasons why a lawyer might say it is not a good use of legislation because it is already covered by the existing definition, which it is. I think it would be helpful to send a message that we explicitly want the database to promote off-label use. As the Minister responsible, I would happily take instruction in whatever mechanism from the House to go away and come back with a proposal on it.
Amendment 8 seeks to provide for the establishment of an arm’s length body to assist those seeking regulatory approval for off-patent drugs in a new indication. As the hon. Member for Torfaen is aware, we have talked about that at length. Although I understand the thinking behind it, I do not accept it. For those colleagues who have not been following this debate closely, the thinking is broadly that because an off-label indication does not have an applicant company with a patent and a commercial interest, there is nobody to promote its case, and to put together the data package, lobby for it and advocate for it through the system, and to ask NICE to look at it. Word has got round that, because of that absence of a commercial interest, those uses are not being properly looked into, and that if it had a licence clinicians would use those off-label indications.
I understand it, but I think that the logic is profoundly flawed for two or three reasons. First, the evidence is that even where off-label indications are well evidenced and even recommended by NICE, in which case there is clearly no barrier, uptake is patchy and in some places slow. That is not because of the absence of recommendations and data. In the example of the use of Tamoxifen as a preventative treatment for cancer, in fact, patients and clinicians decide not to use it, in many cases because of the side effects or because women prefer to have surgery. It is not due to the lack of a licence; it is because it is an off-label use and has different impacts on different patients, and patients always want to reserve the right. It is the same with the use of bisphosphonates. There are off-label treatments that are well evidenced and well supported and recommended by NICE. It is not about the absence of a licence.
Most profoundly, I worry that if we expected all off-label uses to have a licence we would inadvertently create a situation in which those off-label uses that did not have a licence would suddenly become questionable. I totally understand that is not the intention of the hon. Member for Torfaen. We might actually undermine our objective and end up in a situation in which we have to license every single off-label use in order to keep it legitimate, which would be the complete opposite of what my hon. Friend the Member for Daventry wants to achieve. I will come later to why the Secretary of State and I do not want to become the licensors of medicines.
Dr Whitford
I accept the Minister’s point about Tamoxifen. There are certainly other reasons why patients do not take it. As we move into an era of more and more non-medical prescribers—nurses and professions allied to medicine—those people are going to be a lot less comfortable prescribing unlicensed drugs that are not in the “British National Formulary”. Those people are made to sign a liability form and they are simply not going to do that. We are moving patients out into the community. The idea that they will come to a specialist every eight weeks for a prescription is not practical.
George Freeman
The hon. Lady makes an excellent point, with the benefit of her front-line experience. It goes to the heart of why this Bill and that of the hon. Member for Torfaen mesh together. As she says, there are now clinicians on the frontline, nurses and others, making decisions and they need guidance. My only point of dispute is that a licence is a very heavy-handed form of guidance. I want to signal that I am actively and enthusiastically looking at ways of ensuring that front-line clinicians get the right guidance without creating a structure that requires the Department and Ministers to become the licensors of every off-label use. That is not least through the accelerated access review, about which I will be specific in a minute.
Nick Thomas-Symonds
That has been the difference between myself and the Minister in this debate for a number of months. The aim surely has to be to get consistency both across different medical sectors and prescribers in terms of off-label use. The big problem, as the Minister is aware, has been inconsistency.
There is an argument, and the Under-Secretary of State for Life Sciences made the point, about licences being heavy-handed. However, there would at least be consistency. We must find a way through that provides such consistency.
George Freeman
The hon. Gentleman makes a good point, up to a point, because one needs to preserve clinical freedoms and clinicians need to be free to make the right decision for their patient. However, I appreciate that the point he is making, principally, is that we do not want pockets of enlightened use of off-label drugs, perhaps because a group of clinicians has access to the information or works in a research hospital, for example. We want patients to have access across the whole system. That is why the ambition to use, and the possibility of using, the database in the Bill could be powerful.
Amendment 8 seeks to provide for the establishment of an arm’s length body to assist those seeking regulatory approval for off-patent drugs in a new indication. The Government do not support the amendment. As I have said, we support the objective, but we do not support that mechanism. The Medicines and Healthcare Products Regulatory Agency, for which I am responsible, already provides advice to people who want to apply for marketing authorisations.
We have no plans to fund an additional arm’s length body, and I do not believe that it would be helpful. However, I am happy to ask the accelerated access review team to look specifically at the question of how we could promote the use of off-label medicines, and to give recommendations to that effect, and, if that is not possible in the next few weeks, as the team finalises its recommendations, to take action as a review and come back on that specifically.
I would happily sit down with the hon. Member for Torfaen and the promoter of the Bill to see whether we can agree a form of words. I am signalling my willingness to amend the Bill to make the ambition very clear, but I cannot accept the amendment. I do not want to go back to the Secretary of State tonight and tell him, “Great news, Secretary of State! You and I have now become the licensors of off-label medicines and will be putting together regulatory and litigation packages. We are going to set up a pre-clinical office.” It is not what he and I are here for, mainly because we are here to drive and protect patient safety.
It is for others to bring forward drugs and for us to regulate them. It would be a profound and fundamental conflict of interest if we were to take that on. Off-label use of medicines is widespread in the system today, particularly in paediatrics, without the need for licences. I do not accept that licensing is the right mechanism, but I happily accept that we should put into the Bill the fundamental objective of promoting off-label use.
Nick Thomas-Symonds
The Minister is entirely right on paediatrics. There is also quite widespread off-label use in anaesthetics, but of course that shows the problem, because there is pretty consistent use in those two areas but not in other medical specialisms, which is of course the point.
George Freeman
It is a point well made by the hon. Gentleman.
It could be argued that strictly speaking the wording of the Bill makes amendment 9 unnecessary, but I have quite a lot of sympathy with it, in the spirit of my response to amendment 7. Again, I wanted to offer the possibility of sitting down with the hon. Gentleman and officials to see whether we could reach a wording to bring before hon. Members to capture the ambition of giving effect to greater off-label use.
Currently, all innovative treatment falls within the scope of the Bill, including not only innovative medicines but the innovative use of existing medicines. However, given the level of interest in and the particular challenge with off-label drugs—the subject elicits particular interest, not least with some patient groups—it could be powerful to make that more explicit.
With regard to new clause 1, I reiterate that, as the licensing authority for the United Kingdom, the Secretary of State cannot become a routine applicant for licences. Neither would it be appropriate for the Government to take on responsibility for bringing medicines to market, which is a requirement of marketing authorisation holders. If my right hon. Friend the Secretary of State was responsible for nominating a body to undertake the role, that would still place him in far too close a proximity to the state of being a licence applicant, and would conflict with his responsibility to oversee and ensure the quality of the system. I encourage the hon. Gentleman not to press the new clause, but I am very open to seeing whether we can put a package together on Report.
The Secretary of State already has the power—a power he delegates to me, for this purpose—to direct NICE to carry out a technology appraisal where appropriate, but new clause 2 would turn that freedom into a binding obligation for NICE to carry out an appraisal where the use of an off-patent drug might be better addressed by a different NICE product. I understand the ambition behind the new clause, and I am happy to work on the wording of the Bill, but that mechanism is too restrictive and too binding. It would put the Secretary of State and me in a difficult situation.
Justin Madders
I will be briefer on these amendments.
The clause deals with the creation of the database, which we consider unnecessary, because the Secretary of State already has the relevant power under section 254 of the Health and Social Care Act 2012. Even if there is a difference of opinion and the clause remains in the Bill, we want to broaden the number of bodies that the Secretary of State must consult. We think the list in the amendment is comprehensive, whereas, as the Bill stands, to make regulations under clause 2, the Secretary of State need consult only the Health and Social Care Information Centre. The explanatory notes to the Bill state:
“The detailed design of the database would be consulted upon with professional bodies and organisations”,
from which we take some comfort, but we feel that it is better to be clear in the Bill about the wider range of bodies to be consulted.
Amendment 6 would insert a proposed new subsection (6A) requiring the Secretary of State to seek approval for regulations from the bodies on the same list, in essence, as in amendment 5, but with the addition of the HSCIC. It is about having approval in principle, as well as the details and mechanics of the database.
We are not making a complicated point, but we are putting on record our wish for a broader selection of groups to be consulted.
George Freeman
I will be brief. Following our earlier conversation about the database provisions, I emphasise that they are the part of the Bill that the Government most strongly support. The database is not envisaged as it was in the predecessor Bill—if I may call it that—as a registry for recording ad hoc innovations by clinicians, but as a fundamental database to give all clinicians access to information on innovative medicines, including off-label uses of medicines and medicines that are either unlicensed but in use, as in the early access to medicines scheme, or in clinical trials, in which a patient might be eligible to enrol. The clause gives the Secretary of State the power to make regulations conferring functions on the HSCIC, the body that develops and puts into place databases such as the one we are discussing, in connection with the establishment, maintenance and operation of the database for innovative medical treatments.
I am pleased that my hon. Friend the Member for Daventry proposed the database for recording such treatments and for getting information on them out to clinicians. The measure is important in the promotion of innovation. Crucially, the measure would give doctors the ability to search the database for innovations, so the position is very different from that under the Bill introduced in the House of Lords last year, which proposed a database as a registry on which innovative doctors could log what they had done. The database proposed in this Bill is completely different, which is why I strongly support it.
The database could result in better care and health outcomes for patients and a faster uptake of new treatments, and it could support our work to make Britain a world-leading centre for innovative medicines. The pace of progress in genomics and informatics is profoundly changing the way in which new drugs are developed, but our databases and systems information have not kept up, so that is among the things that are being considered under the accelerated access review. While the Secretary of State might already have the legal power to create a database, the Bill helpfully sets out that provision may be made to give instructions to HSCIC to create a specific database, which I would welcome. If the Bill does not, for whatever reason, reach the statute book, I would happily proceed towards establishing such a database, but it would be helpful if the provision were set out clearly in legislation.
The Government do not support amendment 5 because it is not exhaustive. Although it represents a helpful list of consultees, such a provision would need to include many more organisations. While I understand the intention behind the amendment, restricting the process would not be helpful, but I would be happy to write to members of the Committee about our approach. I undertake to write to all the relevant organisations and to ensure that they are consulted, but I am old enough and ugly enough to know that well-intentioned lists of statutory consultees can quickly become out of date. They can create weird anomalies whereby parties that really have nothing to say are statutory consultees, yet those who have a lot to say are not. I am happy to discuss what other steps we can take to ensure that those who, rightly, need to be informed about the Bill and the mechanisms it proposes are properly informed.
The Government do not support amendment 6 for the same reason—because the list is not exhaustive—but I will be happy to put in a place an alternative mechanism to ensure that those parties listed the amendment and others are properly informed. I would not want to put in law a list of consultees that we might well need to amend quite quickly. I, for one, do not want to find myself back in Committee considering a statutory instrument to amend a list of statutory consultees established by a well-intentioned proposal, so I hope that the hon. Member for Ellesmere Port and Neston will withdraw the amendment.
Chris Heaton-Harris
Obviously, I agree with the Minister, and I have discussed the matter with the shadow Minister. I know from my consultation on the Bill with stakeholders that we would need longer lists than those in the amendments. I hope that the hon. Member for Ellesmere Port and Neston will agree to the Minister’s generous offer and therefore withdraw the amendment.
Justin Madders
Our debate has shown that a well-intentioned proposal might have unintended consequences, so I accept what the Minister and the hon. Member for Daventry say about the need for comprehensive lists. I think that the lists in the amendments are pretty comprehensive, but I accept that other bodies might emerge or feel that they should be included. I am happy to work with the hon. Gentlemen to ensure that we reflect the intention behind the amendments, yet do not create additional work a few years down the line because we have to amend the legislation. I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Clause 2 ordered to stand part of the Bill.
Clauses 3 to 5 ordered to stand part of the Bill.
Clause 6
Extent, commencement and short title
Question proposed, That the clause stand part of the Bill.
George Freeman
On a point of order, Mr Streeter. This may be a point of order, although I stand to be corrected.
The Chair
If you want to say something nice about the Committee, let us do that after clause 6.
George Freeman
I just wanted to repeat the offer I made earlier. Although we are skittling through these clauses, let me say, in the spirit of co-operation between all Members, that, if Members felt it appropriate, I would happily convene a round table before Report and Third Reading. There is obviously a bit of work to be done between the hon. Member for Torfaen and my hon. Friend the Member for Daventry. I will happily put my office at the disposal of that work and convene a meeting to try to prepare some amendments that might be tabled on Report. If you think it appropriate, Mr Streeter, we could circulate them among the members of this Committee, and, if it were possible to say, “These amendment are in the spirit of the Committee deliberations and are agreed”—albeit possibly not unanimously—I happily suggest that as something we might do.
Chris Heaton-Harris
Thank you, Mr Streeter. What a wise Chairman you are—one of the best Committee Chairmen ever.
I thank all members of the Committee for their forbearance, especially those who have distinct issues with parts of the Bill. The offers I made are real, and, if I cannot get the controversial parts in clauses 3 and 4 into the right place quickly, I intend to table amendments to delete them, as I said to the hon. Member for Torfaen, so that there is absolute clarity. I look forward to working with anybody who wants to work with me on getting all the other provisions in the Bill into the right place.
I thank you very much, Mr Streeter, and would like to wish a very merry Christmas to every member of the Committee and staff, especially the departmental staff. There is a gentleman called Mr Peter Knight who helped convene a workshop last week for me to explain to interested organisations what the database could look like and how the consultation on it might proceed, which shed a lot of light on this issue and clarified things.
George Freeman
I would like briefly to add my thanks to you, Mr Streeter, for chairing the Committee.
We have had a constructive discussion with all parties represented on the Committee, with some front-line advice from clinicians. I thank my hon. Friend the Member for Daventry for his clear offer. I pay tribute to him for the clarity of that offer. The Government are concerned that this Bill, with the noblest of intentions, is still not in a place where it has widespread support from all parties. A Bill that elicits concerns and opposition from both industry and charities, patient groups, lawyers and the General Medical Council is a Bill whose nobility of purpose is not yet reflected in unanimity of support.
I am grateful to my hon. Friend, and I know that he is keen to get the Bill to a point where it can be distinguished from a predecessor Bill that generated a lot of heat and some opposition. I genuinely believe he is trying to get to that point, particularly on the database provisions. I urge him to keep his foot to the pedal, particularly on the negligence provisions, on which we have a bit more work to do. I repeat that if a well-intentioned Bill has the inadvertent effect of undermining patient and public trust in the world-class status of our research medicine and clinical trials, it will be self-defeating and I would find it impossible to support. However, we have a chance to avoid that.
I thank you for your excellent chairmanship of the Committee, Mr Streeter, and add my thanks to the officials sitting on both sides of you, who have guided us through this process. I hope we can get to a point where we can go back to the House on Report and say that this Committee has managed to rescue a noble cause and, with the help of my hon. Friend the Member for Daventry, put forward a proposal we can all support.
Justin Madders
May I start by thanking you, Mr Streeter, for your chairmanship of the Committee? I hope that this is the first of many times we will meet in such a situation. I also thank the Minister and the hon. Member for Daventry for the open way in which they took on board our concerns. I, along with my hon. Friend the Member for Torfaen, will be pleased to accept any offers to help get the Bill into a shape where it has the support of not only Members of all parties, but, most importantly, the greater medical community. The hon. Member for Daventry is a beacon of optimism in that respect, given the level of concern that remains, but we shall try. The Minister is right that we do not want to put into law something about which there is such widespread concern, but we shall see where we get to on Report.
Question put and agreed to.
Bill accordingly to be reported, without amendment.
Specialist Neuromuscular Care and Treatments
George Freeman Excerpts(8 years, 5 months ago)
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Mrs Gillan
Thank you very much, Mr Brady. I was not sure whether you were going to say something more from the Chair before I spoke again. May I welcome you warmly to the Chair? Perhaps we will get through this debate together without knowing too many details about the procedure.
I also welcome the Minister to his position. When one is a Minister, one sometimes finds oneself in debates where it is déjà vu all over again, as they say. I am afraid that this is probably going to be one of those debates, but it is no less serious than the debate that we had last week on this subject, and I am grateful for the opportunity that the House has given me to reinforce that debate, by allowing this debate today. I see colleagues in the Chamber who were also here last week, and they will know how passionately I feel about this subject; indeed, many of my colleagues, from all parties in the House, feel passionately about it.
I really am delighted to have an opportunity to speak about this subject, because as I think we all know, there are more than 60 different types of muscular dystrophy and related neuromuscular conditions. It is now widely accepted that approximately 1,000 children and adults for every 1 million of the population in the UK are affected by these muscle-wasting conditions, and it is estimated that some 70,000 people right across the UK are affected.
I appreciate that there are other areas that we could discuss under this topic, and I am sure that we will hear from colleagues about them. However, I will use this opportunity to concentrate on muscular dystrophies such as Duchenne muscular dystrophy, on which I have been working hard with my constituents, the Hill family, in order to gain access to a drug called Translarna.
Around 2,500 children and adults in the UK have Duchenne and almost all of them are male. The condition is caused by the lack of a vital muscle protein called dystrophin. It leads to muscles weakening and wasting over time, and to increasingly severe disability. The vital heart and breathing muscles are affected, which often causes devastating cardiac and respiratory difficulties. In older patients, assisted ventilation can be required, which necessitates 24-hour care. Some patients have to undergo a tracheostomy procedure and, sadly, few people live with this condition past their 30th birthday.
Duchenne has a huge impact on families and on the individuals who suffer from it. Only about 100 boys are diagnosed with it every year in the UK, but it is hard to overstate the devastation to the individual and the surrounding family that it causes. The diagnosis is really hard to come to terms with, and the family must deal with huge challenges as the condition progresses and the patient grows older. It usually leads to full-time wheelchair use, surgery for scoliosis, which often involves inserting iron rods into the patient’s back, and the use of full-time assisted ventilation.
As the Minister knows, there is a very brave little boy who is my constituent. He is called Archie Hill and his parents, Gary and Louisa Hill, together with his brother, Leyton, have campaigned tirelessly for access to Translarna. To put things in context for my colleagues who are here for this debate, I can do no better than to use the words, once again, of Gary and Louisa Hill, which I hope will help people to understand the devastation that this condition causes:
“Being told your child will probably die before you, has to be the most devastating thing you can tell anyone. Archie was diagnosed in 2008. Over the next couple of years we became very reclusive, barely getting out the car at school drop off, sometimes not even answering the phone...we wanted to grieve on our own (grieving is not too strong a word). We’re angry, we look at other families and wonder why us?”
They wonder why it has happened to their beautiful child. They blame themselves, even though they know it is not their fault.
The emotional effect on siblings is really apparent, although I have to say that, having met Leyton, I know he is a fantastic support to his brother and to his mother and father. He is an integral part of this team and should be equally praised for his courage and perseverance. I know that he struggles with his concentration, and that he is deeply affected by his brother’s condition, but he is also a very brave little boy coping with this in his family.
Archie faces huge day-to-day challenges. His parents say:
“He is taken out of lessons for physio on a daily basis. He suffers from…mood swings”.
I find that hardly surprising. They go on:
“Every so often he will ask us questions about his condition; does it only affect my legs? Do I always have to take this medicine? Why do I have to wear the night splints?”
He asks all the sorts of questions that a child of his age would ask their parents when they knew that they were suffering from this condition.
Despite that, Archie has great stamina, and he has spent whole days here campaigning, marching up to Downing Street and telling the Prime Minister what he wants and what the Prime Minister should do about it. Quite frankly, he is one of the pluckiest little spirits that I have ever met in my life.
The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
indicated assent.
Mrs Gillan
I see the Minister nodding his head; I know that he agrees; anybody who has met Archie will know that what I am saying is true.
It is not just Archie who is affected by this condition. Sue Barnley, whose son Harry would benefit from Translarna, says:
“If Harry could get Translarna now whilst he is the best he is ever going to get, ie not gaining any more skills, only deteriorating then this will enable us to have more fun on a day to day basis. We gain a lot of support from our family and friends already, this will only increase as time goes on.”
She goes on to say:
“It seems cruel that the drug is there to make a massive difference in our lives, yet it is totally out of reach. Living with Duchenne is like living under a very dark cloud, we as parents know what Harry’s…future holds, to have some extra time living for the ‘here and now’ would make a BIG BIG difference, time to make and treasure some extra memories before our lives become totally engulfed by this awful disease.”
As the Minister knows, I have worked quite closely with Muscular Dystrophy UK and I have nothing but praise for that organisation, because it goes the extra mile for the people it represents. In my experience, the way that it deals with parliamentarians, offering them briefs and helping them, is second to none. It is an organisation that I trust, and I believe that it gives us the right information at the right time. It says that for older boys and men who have this condition, the respiratory function is compromised and the challenges get even greater for them and their families, because they have to engage with and face what many find to be truly frightening aspects of the condition.
One mother with whom Muscular Dystrophy UK works closely was called out to her son’s residential home at 2 am one weekend in September due to an emergency incident. Although her son was not hospitalised long term, he was experiencing increasing difficulties, and his mother told us that
“he is very conscious of his own mortality.”
Other young men are hospitalised frequently and often for long periods of time due to chest infections, which are very difficult to shift and are life-threatening. The current time of year is a frightening time for young men with Duchenne, because as we all know, respiratory infections abound, but in their case, hospitalisation is much more likely than it is for other people.
The Minister knows that Translarna is available from a company called PTC Therapeutics. We should put the benefits of Translarna in the context of a very short life. The early loss of the ability to walk is associated with a faster progression of the disease, and the later stages, as I have just described, are frightening and absolutely devastating. In a short life, the main goal is to spend as much of that life as possible in the best state of health and with the best quality of life. The National Institute for Health and Care Excellence—we are waiting for its decision on Translarna—must apply significant weight to any benefits that can be obtained through the use of Translarna in the context of that short and limited life. A delay in any of the devastating consequences of the disease, no matter how short, contributes to quality of life.
While Translarna is not yet licensed for use as an end-of-life medicine—it is still to be tested in clinical trials with older patients—evidence from existing trials shows that it delays the progression of the disease during a significant stage of a boy’s life. The trials also indicate that it is likely to delay the end of life, as a proxy measure. NICE has to give special consideration to the limited life expectancy of these boys when it is looking at this issue.
Translarna was the first licensed drug to tackle the underlying genetic cause of Duchenne and to keep boys walking for longer. Boys with the specific nonsense mutation of Duchenne, such as my constituent Archie Hill, have been waiting a year and a half since the European Medicines Agency approval in May 2014 for a decision on whether Translarna will be approved in England. It was a conditional approval, but the rubber stamp with it meant that the drug was then available in such countries as France, Spain, Italy, Germany and Denmark. That prompts the obvious question: if a European citizen can travel to any of those countries and get Translarna, why can they not get Translarna here in England?
I appreciate that there is a process that has to be gone through, and that due process needs to be followed, but it seems a cruel and unusual punishment that we have been waiting for more than a year and a half to see whether the drug can be made available to children in our country. As things stand, families face the prospect of a further agonising delay to NICE’s decision over Christmas. If I have stressed it once, I have stressed it over and over again: every day counts as those boys lose ambulation and become ineligible for Translarna.
Boosting clinical trial capacity for Duchenne muscular dystrophy is important. As Translarna becomes available for treatment, as I hope it will, it will apply only to 10% to 15% of boys with Duchenne. Other treatments are beginning to emerge. With the growth in clinical trials for Duchenne, specialist muscle centres—that is where the studies are conducted—are reporting that they are having to turn studies away due to a lack of resources and capacity. As part of a new initiative by Duchenne charities to address those concerns, Muscular Dystrophy UK has conducted an audit of clinical trial capacity and submitted that to the accelerated access review as evidence confirming that worrying picture. If the issue is not addressed, as the Minister knows—he is nodding his head in agreement—there is a risk that the promising drugs for Duchenne that are in the pipeline and in clinical trial will not continue to improve and meet their potential, hampering the search for effective treatments.
Muscular Dystrophy UK’s audit also found an excessively high clinical workload being placed on small and overstretched teams, which means that they are unable to participate in clinical trials through, for example, recruiting patients. That also means that children affected by Duchenne are unable to enrol in trials where they could access a new therapy. To aid the development of clinical trials, it is important that standards of NHS care for Duchenne patients are high across the country to ensure that patients on clinical trials are generally in the same state of health and physical shape. While there are some centres of excellence, such as Newcastle and Great Ormond Street, other parts of the country have much less developed services, and essential therapies, such as specialist physiotherapy, are not regularly provided.
Centres have also expressed concern that excess treatment costs—the additional costs of treating patients enrolled in research—are not being reimbursed to centres by clinical commissioning groups. That is a clear point of friction, and it limits the centres’ ability to take part in research. NHS England recently issued guidance on the issue, but it is not yet clear whether that will be enforced in practice.
Turning to the NICE guidelines on uncommon neurological conditions, a huge problem faces families and health professionals because there is no NICE guideline for any muscular dystrophies or neuromuscular conditions, which is why NHS England has asked NICE to develop clinical guidance on the assessment, diagnosis and referral of uncommon neurological problems. Muscular Dystrophy UK attended the initial scoping workshop on 11 November and will be participating in the consultation, which I understand has already started. While muscular dystrophies and neuromuscular conditions were listed as among the many conditions covered by the guideline and despite past assurances from NICE, there is concern that the focus on muscle-wasting conditions might be minimal unless the complexities of the conditions are highlighted. Given the internationally recognised standards of care for Duchenne and spinal muscular atrophy, it is disappointing that the NICE guidelines that are being developed are far more generic than the original guideline proposed by NICE to cover uncommon neuromuscular conditions in a letter to Muscular Dystrophy UK in November 2013.
Muscular Dystrophy UK has proposed that the guidelines should address the following: paediatric neuromuscular services specifically for Duchenne muscular dystrophy, in conjunction with current guidelines; the use of steroids as effective therapy in terms of the age when the optimal effect can be achieved, whether there should be a continuous or intermittent dosing regime, and how to manage the side effects; spinal surgery to correct or prevent scoliosis, with evidence regarding the optimum age and management pre and post surgery; and respiratory support, with a comparison of the evidence regarding invasive and non-invasive interventions, including comparisons with experiences in Denmark, where evidence suggests that men with Duchenne are living into their 40s because of the relatively high standard of respiratory support. So far as adult neuromuscular services are concerned, the guidelines need to address: diagnosis and the importance of GPs recognising the conditions, making early referrals and ensuring effective links from primary into tertiary care; respiratory support, as I have talked about before; and cardiac support, including regular monitoring to detect and address the deterioration of the heart through the progression of muscle-wasting conditions.
High costs can be involved in unplanned emergency admissions due to Duchenne and other muscle-wasting conditions, and in living with such conditions. There is a cost attached to not taking action to implement preventative care. Access to specialist multidisciplinary care, including access to respiratory, cardiac and physiotherapy support, can contribute to reducing avoidable, unplanned emergency admissions to hospital. A clinical audit of emergency hospital admissions that was led by Professor Mike Hanna revealed in June 2012 that 40% of these costly admissions could have been prevented if patients had been able to access expert tertiary care, specialist physiotherapy and—this is the worst finding of all—vital medical equipment. It has been estimated that addressing those issues could save the NHS more than £32 million a year as the appropriate proportion of NHS spending on neuromuscular services.
The cost of living with Duchenne is enormous. In the first study of its kind, academics found that the overall care for each patient with Duchenne cost the UK economy about £71,000 a year, giving a national total of £120 million. That survey was led by Newcastle University and a team in Sweden. Some 770 patients and their primary caregivers in the UK, Germany, Italy and the US were asked to complete a questionnaire on their experience of living with Duchenne and its impact on their need to access medical care, employment, leisure time and quality of life. The direct cost of the illness across all countries was at least eight times higher than the average health expenditure per person, and the figure for the UK was 16 times higher. The overall figures included medical treatment as well as the cost associated with the loss of employment among caregivers. In the UK, nearly half of caregivers reduced their working hours or stopped working completely owing to their relatives’ Duchenne muscular dystrophy. I therefore have several questions that I hope the Minister will answer during his winding-up speech.
When we discussed access to medicines last week in Westminster Hall, the Minister mentioned that he had made contact with NICE about both Translarna and Vimizin. I hope he feels that he may have reached a point with NICE such that he can talk about those drugs. I understand that they are used in similar situations, so if there is good news about Vimizin, we hope there will be good news about Translarna, and vice-versa.
Will the Minister provide more details on ensuring standards of care for muscular dystrophy and neuromuscular conditions? I really hope that clinical trials will be developed, so will he say a little more about that? I also want him to ensure that NICE gives more prominence to muscular dystrophy and neuromuscular conditions in the development of the uncommon neurological conditions guidelines, as was outlined in the original proposal.
Lastly, I hope the Minister will join me in congratulating Muscular Dystrophy UK on its work to develop information and resources for people with muscle-wasting conditions and to support health professionals through its “Bridging the Gap” project. More than 400 GPs and 150 physiotherapists completed the online learning modules about muscular dystrophy. The charity has sent out 4,500 alert cards for specific muscle-wasting conditions and 300 care plans, which is a positive step forward to improve how we treat and look after our patients with Duchenne.
I finish with a plea to the Minister. When I asked for this debate, as he knows, it was entirely based on trying to get Translarna cleared for Archie Hill. The Hill family went on holiday today, I think shortly before the debate began. I do not know what the Minister can do to speed the process along but, for the Hill family and Archie, and for all the other children and their parents at this time of year, if the Minister could ask NICE to bring forward a positive decision on Translarna, it would be the best Christmas present that any parent or child could get.
The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
It is a pleasure to serve under your chairmanship, Mr Brady. I am left with 10 minutes in which to try to deliver my speech and the answers that I have carefully prepared while listening to colleagues’ comments. If I run short of time, I will undertake to write to everyone in the Chamber with answers to the points raised.
I start by paying tribute to my right hon. Friend the Member for Chesham and Amersham (Mrs Gillan) for securing the debate. She is a tenacious advocate on this issue, as on others. I join her in paying tribute to Archie and his family. I have met patients who suffer from these diseases and their families, and one’s heart goes out to them. One wants to pay tribute to the bravery with which they deal with their conditions. As is so often the case in the history of medical progress, the families, patients and carers are those who advocate and, in the end, win through to make their point heard, with the help of colleagues from across the House. My right hon. Friend eloquently paid tribute to the families of children with these disorders and diseases who, in many ways, suffer every bit as much as the patients who show such incredible fortitude. She asked me last week whether I would give her an A grade for effort and persistence. I will happily give her an A-plus in this end-of-term summary, but the people to whom we really want to give an A-plus are NICE and NHS England.
I want to touch on some of the excellent points that were raised. My right hon. Friend raised Vimizim and Translarna, so I will say something in detail about the timing of those decisions in a minute. She also made an important point about standards of care across the NHS in clinical trials, which was mentioned by numerous colleagues, and the importance of NICE giving more prominence to the time aspect of these conditions, which are unusual because they can deteriorate with every week’s delay in getting treatment.
The hon. Member for York Central (Rachael Maskell) gave us the benefit of her front-line clinical expertise. In case I run short of time, I shall say now that I will happily convene a meeting at the Department of Health with officials from my Department and NHS England, to which I invite colleagues from all parties who want to discuss the issues she and others raised about front-line care, because a range of practical issues about such care has been raised, in addition to access to drugs, and giving colleagues the chance to raise such points on behalf of their constituents would represent a powerful opportunity. The hon. Lady talked in particular about training and the interface of paediatric and specialist services, which I come across in connection with numerous different specialist conditions.
My hon. Friend the Member for Romsey and Southampton North (Caroline Nokes) spoke passionately about James, Jules and Jagger Curtis, and the importance of expediting those particular decisions and quicker assessment, as well as adoption in general. That is a passion of mine, which was why I launched the accelerated access review to look systemically at what we can do to expedite getting new medicines into the service. She also touched on the importance of wheelchair access.
The hon. Member for South Down (Ms Ritchie) talked eloquently about Michaela and the importance of specialist, multidisciplinary teams. The hon. Member for Strangford (Jim Shannon), who gets the prize for appearing in more debates with me than any other Member of the House, which is a tribute to his activism as the Democratic Unionist party’s spokesman on these issues, highlighted the importance of Belfast as a hub of research and regional strategies in Northern Ireland and spoke about his constituents. This is a devolved matter, and while I pay tribute to the work of researchers and medics in Northern Ireland, it is important that the devolved Administration in Northern Ireland put in place a similarly enlightened commissioning process.
The hon. Member for Bridgend (Mrs Moon) raised the broader issues of Parkinson’s and neurological disorders, while the hon. Member for Dumfries and Galloway (Richard Arkless) spoke passionately about his mother’s suffering. Before I came to Parliament, I worked in Scotland and, as he highlighted, in this area, as in several others, Scotland pioneers some of the clinical commissioning work. The supreme irony of the debate was brought to light by his request that we depoliticise the NHS. For me, one of the greatest steps following the Health and Social Care Act 2012 was the separation of the NHS from the Department of Health. NHS England now operates under its own arm’s length management, subject to a mandate from Ministers
We do not control the NHS—believe me that if, for one afternoon, I could do that, I wish it was now. I would love nothing more than to pull the lever and give all these children the drugs that we all want them to get before Christmas, but that is not in my gift, and I suggest that it is in all our interests that it is not. It is right that such decisions are taken by NHS England and clinical professionals, advised by the very best people at NICE.
Barbara Keeley
It is important that the NHS mandate covers these conditions because at the moment it does not. Something must be done to make sure that they are covered.
George Freeman
In the few minutes I have available, let me say a few things about the main issues raised. I pay tribute to Muscular Dystrophy UK, Robert Meadowcroft, Emily Crossley, the Duchenne Children’s Trust, Action Duchenne and all the other organisations that work so hard in this area, and specifically on the two or three key drugs.
I remind the House that the decision from NICE on Vimizim is due before the end of the year. Without breaching due process, I have asked that, if that decision is in the pipeline, it can be made as quickly as possible, ideally before we all break up for the Christmas holidays. That is not in my gift, but I made that request. Similarly, I have requested that the Translarna decision, which I believe is due in February, is similarly expedited. However, again, that is not in my gift, and while during the year the Prime Minister and I have urged NICE and NHS England to do everything they can to expedite their decision making on those drugs, we do not have the power—rightly, in my view—to step in and breach process. It is fair to all patients in the NHS that decisions are taken properly.
Mrs Gillan
The Minister has given us a sympathetic hearing and I know that he has done everything in his power to try to bring forward that decision. Quite rightly, it is not his decision to make, but, through him, may I appeal to the men and women who are making that decision? If they have any humanity about them, they ought to make a positive announcement before Christmas.
George Freeman
My right hon. Friend made the point more powerfully that I could. On Vimizim, I am delighted that BioMarin, the company concerned, has, following exhortation from me and others, sat down with NHS England and gone through pricing flexibilities. I have been able to grant an access agreement. The drugs are incredibly expensive, which is what makes NICE’s work difficult, so if anyone from PTC Therapeutics, the company responsible for making Translarna, is watching, I urge them to sit down with NHS England and adopt a similar approach.
On specialist commissioning, we lived through and focused on difficult decisions, and this summer NHS England agreed to 23 new treatments, including Duodopa, which controls the symptoms of patients with Parkinson’s disease, wider access to proton beam therapy, and extending treatment with ivacaftor for cystic fibrosis involving G551D mutations.
We live in an age of extraordinary biomedical progress, but budgets struggle to keep up with the rate of progress that our scientists and researchers make. I know that this is of little comfort to my right hon. Friend and to Archie and his family, but I hope that hon. Members agree that, in deciding which treatments should be procured on behalf of us all, due process must apply. However, I share their frustration, which was why I launched the accelerated access review, which will report independently to me in the spring. That substantial piece of work is examining whether we can do more to embrace breakthroughs in genomics and informatics to give NICE and NHS England new flexibilities to speed up how innovations for patients are assessed, as well as to explore new pathways and flexibilities for different models of reimbursement to get innovation through quicker.
I want to pick up the point that was made about specialist neuromuscular care. The truth is that there are few curative treatments for most of these diseases, so we are talking about the importance of routine care for people that is provided by local primary and secondary care services via local CCGs. However, a number of specialist services have been designated among the 146 that NHS England is responsible for commissioning nationally, which are set out in legislation and commissioned directly by NHS England through 10 area teams. Twenty-five specialised neurological treatment centres across England ensure that patients can access high-quality neurological care where they live.
As I said, I will be happy to convene a meeting in the Department with officials and NHS England to talk about how we can address some of the practical issues raised when providing front-line, integrated services. I fear that the clock is against my being able to go through the 22 questions for which I had answers prepared, so I close by saying that while we all would want to pull a lever to make this happen quickly, the truth is that we need a system that is rigorous, robust and evidence-based, but quicker, in recognition of the effects on these patients.
Motion lapsed (Standing Order No. 10(6)).
Anti-TNF Drugs
George Freeman Excerpts(8 years, 5 months ago)
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The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
May I start by thanking and congratulating the hon. Member for Leeds North East (Fabian Hamilton) on securing the debate? I am grateful to him for giving me advance notice of the issues he has raised. We serve our constituents best in debates such as this when there is a spirit of non-partisan co-operation, and he is the very embodiment of that.
The hon. Gentleman spoke incredibly fluently on behalf of his constituent, Samara Ullmann. He and I have discussed this issue, and he has raised it with the Department in recent months. I pay tribute to his work on his constituent’s behalf and, most of all, to Samara and all of those who suffer with this condition. One of my privileges in this ministerial role is to see the extraordinary patience, fortitude, courage and force of life spirit with which so many people with ill-met or unmet conditions survive. It drives me on in my work to try to accelerate the landscape and get innovate medicines and treatments to those people more quickly.
I will say something about the condition and then try to address the points raised by the hon. Gentleman. As most Members here will perhaps know, uveitis, or inflammation of the uveal tract, is the term used to describe inflammation of any structure within the eye that, when very severe, may cause visual loss. It can lead to blindness through either direct damage to the light-sensitive retina or secondary complications such as glaucoma. Uveitis is uncommon. It is estimated that two to five in every 10,000 people will be affected by it in the UK every year. It usually affects people aged 20 to 59, but can also occur in children. Despite being uncommon, it is a leading cause of visual impairment in the UK.
Dr Mathias
Just for information, the other problem with uveitis, apart from blindness, is intense pain.
George Freeman
My hon. Friend makes an excellent point. Patients experience a whole range of associated conditions.
In severe cases, treatment to try to prevent sight loss requires drugs that suppress immune cells. The drugs in standard use across the world include prednisolone and immunosuppressant drugs, which work in over 60% of patients. For the remainder, the drugs do not work or the patients suffer serious side effects that prevent the drugs from being used to their full potential. The next step in treatment is the use of a group of drugs known as biologics. As the hon. Member for Leeds North East said, those drugs are very specialised and designed to focus on specific molecules released during inflammation from cells, suppressing the inflammation in doing so.
TNF inhibitors are biologic drugs that suppress the physiologic response to tumour necrosis factor, which is part of the inflammatory response. Humira and Remicade are two anti-TNF alpha treatments that are licensed and NICE-approved for the treatment of adults with a range of conditions, including rheumatoid and psoriatic arthritis, ankylosing spondylitis and inflammatory bowel diseases, including Crohn’s disease and ulcerative colitis. In terms of the latter, I understand that the hon. Gentleman has been supporting his constituents by raising awareness for those living with a debilitating bowel disease by supporting Crohn’s and colitis awareness week, which has just ended. NICE has not yet appraised any anti-TNF drugs for the treatment of uveitis. I shall say more about that in a moment.
Decisions about funding for new treatments and drugs that are for rarer conditions, such as uveitis, and which have not been considered by NICE are made by NHS England as part of its specialised commissioning function. NHS England operates a horizon-scanning process to identify new treatments, and its clinical reference groups advise on the development of services for patients and keep published evidence under review. When NICE is not considering a therapy, NHS England can examine the evidence base and may propose commissioning treatments through its commissioning policy development process.
Turning to clinical experts, my hon. Friend the Member for Twickenham (Dr Mathias) made a really important point. Much as I would like to be able to pull a lever and accelerate treatments in response to very eloquent advocacy in this House, it is completely appropriate—I can see the hon. Member for Leeds North East nodding—that such decisions are made by the patients, clinicians and clinical experts, advised by NICE on the basis of the very best evidence available. Sometimes the collection of that evidence and the processing of those appraisals can be frustratingly slow, not least for the patients, but it is important that the process is done well.
The clinical experts at NHS England have considered the use of Humira and Remicade as treatment options for adult patients with severe refractory uveitis. NHS England concluded that there was insufficient evidence to support the routine commissioning of those treatments. NHS England is, however, awaiting publication of the Visual clinical trial report in order to consider revising its commissioning policy in the light of the study’s outcomes. The trial report is expected to be published in a peer review journal in early 2016, at which stage NHS England will consider submitting a revised policy as an in-year service development.
The use of Remicade for children with severe refractory uveitis has also been considered by NHS England. Again, NHS England concluded that there was, as yet, insufficient evidence to support its routine commissioning at this time. That decision will be reviewed in April 2017.
On 11 November, NHS England published an interim clinical commissioning policy on the use of Humira for children with severe refractory uveitis with onset in childhood. Its use is recommended in children aged two to 18 who meet the clinical criteria set out in the policy. The policy, which has been developed by NHS England’s clinical reference group for specialised ophthalmology services with support from clinicians and patient representatives, will benefit children whose sight is threatened by the condition, and for whom other treatments have proven ineffective. That is on an interim basis pending further evidence from the Sycamore clinical trial. The interim policy will be reviewed in 2016, once the full Sycamore trial data have been published. Humira for severe refractory uveitis in children is being commissioned and funded by NHS England through specialist regional centres.
I want to mention individual funding requests, which are important in this context. All treatments for uveitis up to and including the use of immunosuppressants remain funded by clinical commissioning groups. As hon. Members know, the NHS is legally required to fund treatments recommended in NICE technology appraisal guidance. In the absence of such guidance, any funding decisions should be made by NHS commissioners, including NHS England in respect of specialised services, based on an assessment of all the available evidence and an individual patient’s clinical circumstances.
Oliver Dowden (Hertsmere) (Con)
The Minister talks about need. In a similar vein to other Members, I would like to highlight the need of a constituent of mine—a young lady called Olivia, aged 15, who is totally reliant on self-funded anti-TNF treatments to retain her eyesight. She is very concerned that when she reaches adulthood, she may no longer have access to that, which is why her parents, also constituents, have created a charity called Olivia’s Vision. Again, I ask—
Mrs Anne Main (in the Chair)
Order. Interventions must be brief. I call the Minister.
George Freeman
My hon. Friend has eloquently raised his point. I am happy to look into that with him afterwards.
NHS England will consider individual funding requests for treatments not recommended by NICE to treat individuals whose clinician can demonstrate clinical exception. The NHS constitution states that patients have the right to expect local decisions on the funding of drugs and treatments
“to be made rationally following a proper consideration of the evidence.”
If an NHS commissioner decides not to fund a drug, it has a duty to explain that decision to the constituents of the hon. Member for Leeds North East and others.
I want to turn quickly to the hon. Gentleman’s specific questions and then deal with a couple of questions that really sit under this whole debate. Let me respond to his four questions. I completely agree that time is of the essence to anyone in danger of losing their eyesight and, yes, people should have the chance to have a family and we need to make sure that we are supporting patients in the appropriate way. We are working to speed up the process, so that effective medicines get to patients much more quickly, but we need to know that they work and to make sure that the benefits they bring to patients are commensurate with their cost to the NHS, which is why we have NICE, a world-leading expert in health economics.
I must clarify that NICE is not currently appraising either adalimumab or infliximab for uveitis. However, it is consulting stakeholders on a proposal to include adalimumab within the scope of the technology appraisal guidance that it is developing on its two other drugs for the treatment of uveitis. A final decision on referral will be taken once NICE has concluded that consultation. I am aware that evidence is emerging on the use of these drugs on the treatment of uveitis in adults. When the full evidence is available, both NICE and NHS England will be able to take that into account when considering whether anti-TNF treatments should be made routinely available on the NHS.
In the remaining moments, I want to touch on the underlying issues that this debate has helpfully flagged up. The pace of change in the biomedical space, the rate at which new drugs are being discovered and the power of genomics and informatics, giving us a new insight into diagnosis and treatment, is putting pressure on our traditional methods of assessing drugs. Traditionally, NICE has worked on a one-size-fits-all, health benefit, “yes or no”, quality-adjusted life-year basis. I have launched the accelerated access review partly to look at how we can better use the genomics and informatics in our health system and give NICE more freedoms to be able to fast-track treatments to the patients who we know will benefit.
That touches on the question of off-label use of drugs. When there is a proven benefit outside of an on-label indication, we need to be much better at getting that information to clinicians, so that they can prescribe drugs in an off-label indication more quickly. The burden of proof needs to be not only right, but appropriately set, so that where there is clear evidence, the system can respond more quickly.
The hon. Gentleman made an important point about the cost of benefits. The system at the moment is not great at measuring the full cost of a condition downstream, which is partly why we are putting such efforts into the digitalisation of the health service and into being able to measure the cost of treatment and a disease condition. When we have a benchmark of what the cost is to society after a diagnosis, we will have a much better benchmark for rewarding innovation.
I will happily deal with any other questions offline. We have had a very short amount of time, but I hope I have tackled the hon. Gentleman’s specific questions. I am grateful to him for raising the issue, and I hope I have given some signal as to where in the coming weeks and months we may be able to expect some helpful progress.
Question put and agreed to.
Cystic Fibrosis
George Freeman Excerpts(8 years, 5 months ago)
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The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
It is a pleasure to serve under your chairmanship, Sir Edward. I congratulate the hon. Member for Dudley North (Ian Austin) and other hon. Members from across the House who have spoken. This timely debate has been incredibly powerful—not that there has been much disagreement in it. It has been an opportunity to raise important issues that I am dealing with, and I am grateful to colleagues for acknowledging that.
The debate is particularly timely because I am convenor of a major summit today on accelerated access for faster cures. There is a precision medicine summit in London and the Association of Medical Research Charities has just held its annual conference, at which I exhorted members to come to my table with ideas about how to accelerate novel treatments and give the charities more of a voice. A powerful and helpful debate is going on.
I pay tribute to the work of the Cystic Fibrosis Trust, which is among a number of charities that lead the debate on innovative treatments and medicines. Its leader Ed Owen in particular plays an important role in that; but so do Carly, Lorraine, Michael, Kelly and the other people who have been mentioned. Many of the charities do extraordinary work to articulate the experience of patients who suffer from disease and bring it to the policy table in a powerful way. It is a change in policy making that I am keen to accelerate.
The debate goes to the heart of the challenge and opportunity that precision medicines represent for our system and the landscape of assessment, testing, approvals and reimbursement, as well as the growing role of charities and the patient voice. Those things are passions of mine and I want to discuss why, in the next few months and the years ahead, there will be dramatic progress.
The Government and I wholeheartedly support the cystic fibrosis campaign’s central aim of ensuring that as many people with CF as possible will have access to personalised medicines by 2020. That sets an inspiring and clear goal and I relish the attempt to deliver it. I want to make some remarks about the condition, about what NHS England and the NHS in Scotland and Northern Ireland are doing about treatment today, about the rare diseases and precision medicine landscape, and about the reforms that I am pushing to try to deal with the issues that have been raised.
I have had a career in biomedical research, so it is an extraordinary privilege to have been given my role by the Prime Minister, who has personal experience of the tragic consequences of genetic disorders affecting children. I am delighted to share with the House the fact that my passion to lead in this field, and unleash the power of the NHS and our research expertise in a new landscape for accelerated access, is exceeded only by the Prime Minister’s.
As hon. Members know, cystic fibrosis is the most common life-limiting inherited condition in the UK. It affects about 10,500 people in England—and more, of course, in Scotland, Northern Ireland and Wales—more than half of whom are adults. Cystic fibrosis is one of the UK’s commonest life-threatening inherited diseases. It is caused by a single defective gene. As a result, the internal organs and especially the lungs and digestive system become clogged. That results in chronic infections, inflammation in the lungs and difficulty digesting food.
The number of adults living with CF is gradually increasing over time, because of improvements in diagnosis from newborn screening and new treatments. The condition affects everyone differently—that is an important point—but for many it involves a rigorous daily treatment regime including physiotherapy, oral, nebulised and occasionally intravenous antibiotics, and taking enzyme tablets with food. For those who are very ill with cystic fibrosis and who have very poor lung function, daily life can be a struggle as basic tasks can leave them breathless. Some patients use a wheelchair to get around, and use oxygen to help them breathe.
For patients and their families, managing the condition is extremely challenging. That is made worse by the absence of an effective treatment or cure—or, as several colleagues have explained today, by the tantalising presence of a possible treatment or cure that cannot yet be administered to them or their suffering loved ones. I pay tribute to patients who grapple with the disease day in, day out, and who have done so for years, for their patience as we try to bring new solutions to the table. Current treatments generally target the complications rather than the cause of the condition. Treatments can be broadly classified as nutritional support, relief of airway obstruction, treatment of airway infection and, ultimately, lung transplantation.
What are the Government doing? I want first to talk about what the NHS is doing in England and in Scotland and the other devolved areas, and then to say something about what we are doing more strategically to tackle the new landscape.
Since April 2013 NHS England has been responsible for securing high-quality outcomes for patients with cystic fibrosis as part of its remit to deliver specialised services. Its service specifications for cystic fibrosis—one for adults and one for children—set out what providers must have in place to offer high-quality care and support equity of access to services for patients with cystic fibrosis, wherever they live. The NHS England cystic fibrosis clinical reference group has developed a number of clinical policies for the treatment of patients with cystic fibrosis and it reviews outcomes with the Cystic Fibrosis Trust and with patients and charities.
As we have heard, Scotland, leading within the United Kingdom—and it is not the first time—has launched a dedicated fund worth £40 million this year to give patients greater access to new medicines, as the Scottish Health Secretary, Alex Neil, has announced today. The £40 million new medicines fund expands and replaces the rare conditions medicines fund established in March 2013, giving health boards access to greater resources. In 2013-14 the rare conditions medicines fund supported the cost of 45 different medicines, benefiting more than 200 patients, including ivacaftor for cystic fibrosis as well as other treatments for related rare diseases.
NHS England is investing significant resources into the provision of new medications that work directly on the genes causing cystic fibrosis. Since 2013, it has routinely commissioned ivacaftor or Kalydeco for the treatment of cystic fibrosis in those with a certain gene mutation affecting only 5% of the CF population. Earlier in 2015, that indication was extended to an additional eight mutations for patients aged six years and above. NHS England is considering a policy proposition for extending the use of ivacaftor for the same gene mutations to children aged two to five years. It will consider the evidence base and be included with other therapies requiring investment as part of NHS England’s prioritisation process for specialised services for 2016-17.
Several colleagues raised the matter of Orkambi. Some drugs for cystic fibrosis will be considered by NICE through its technology appraisal process, including Orkambi, which, as many will know, is lumacaftor in combination with ivacaftor. NICE is currently developing technology appraisal guidance on the use of Orkambi for the treatment of patients with cystic fibrosis. It currently expects to issue final guidance in July 2016. NHS England will commission drugs where there is a positive NICE technology appraisal, and I will say something about the changes that we envisage in the landscape in that respect.
NHS England operates a horizon-scanning process to identify new treatments and the cystic fibrosis clinical reference group advises on the development of services for patients and keeps relevant published literature under review. Where NICE is not considering a therapy, NHS England can consider the evidence base and may propose commissioning treatments through its policy development process. I shall say something shortly about changes that we are considering in the way NHS specialist commissioning might embrace the new freedoms in the accelerated access review to accelerate the commissioning of rare disease treatments.
In fact, ivacaftor is something of a mild success story. NHS England commissioned it earlier than might otherwise have been expected, having agreed, in discussion with the company that makes it, a flexible pricing model. We want to see more of that sort of innovation.
I am grateful to the hon. Member for Denton and Reddish (Andrew Gwynne) for giving me some time to answer the various questions asked, which I will try to do in some detail. First, I want to set the scene in terms of why this debate is happening and why this landscape is under such pressure. The truth is that breakthroughs in genomics and informatics—our ability to understand patients’ genetic predisposition to different diseases and to respond to different drugs, as well as the availability of large-scale data sets, including individualised patient treatment histories and anonymised cohort studies—are transforming the traditional pathway for drug R and D, which normally takes years. It now takes roughly 15 years and $2 billion to bring the average drug to patients.
Genomics and informatics, particularly for some of the rare genetic diseases, allow us to take time, cost and risk out of the development pathway in a profound way. That is driving opportunity and challenge in our system; the Prime Minister created this post and put me in it to ensure we respond to that challenge with ambition.
Julian Sturdy
My hon. Friend the Minister is absolutely right to say that the medical landscape is changing hugely at the moment, but does he feel that the wider implications of new medicines are being fully explored by NHS England and NICE? We have heard about the huge consequences of cystic fibrosis for not only the sufferer but their wider family and the NHS. Does he feel that those wider consequences are being fully explored?
George Freeman
My hon. Friend raises an important point. Over the past few decades, the NHS across the UK has played an inspiring role in leading a lot of the breakthroughs in new treatments, but we have become latterly a slower adopter of the very treatments we often helped to discover. That is partly because the pressure of an ageing society and the rising cost for the health system today of just treating existing conditions are extremely challenging. In some areas, that has made innovations appear a cost to the system, when in fact good innovations may come with a cost spike on day one but generally lead to downstream savings in years 2, 3 and 4.
My hon. Friend puts his finger on a profound challenge at the heart of this landscape: in order really to assess the impact of innovative treatments, we need a much better handle on the existing costs, many of which are hidden, that come with a diagnosis. For that reason, I am spearheading work in the Department of Health to drive through a system of per-patient costing, so that we can begin to get a much clearer handle on what a CF diagnosis means on day one for both the patient and the health economy. That will allow NICE and NHS England to develop much more intelligent systems for assessing whether an innovation really represents good value.
Genomics and informatics are changing the landscape; for that reason the Prime Minister has created my post and we have launched a series of initiatives. On genomics, we have launched a groundbreaking £300 million initiative to sequence the genomes from 100,000 NHS patients of cancer and rare diseases. We have also launched 11 genomic medicine centres across the NHS, so that genomics is fundamentally embedded in our health system. On informatics, we have released huge amounts of cohort data to drive research, and we just announced in the comprehensive spending review a major £3.5 billion programme to invest in NHS digital infrastructure to support that.
We have launched precision medicine and cell therapy catapult centres with the Medical Research Council and industry partners to lead in both understanding causal mechanisms of rare diseases and developing and accelerating new treatments. We continue to fund the excellent National Institute for Health Research, for which it is my privilege to be responsible, to the tune of £1 billion a year, and we committed this year in the CSR to fund it throughout this Parliament, at a cost of £5 billion. We have funded the £700 million Francis Crick Institute, and roughly £2 billion of the drugs budget is allocated to new medicines and new treatments in this Parliament.
There is a major commitment, in terms of science and funding, to trying to tackle this issue, but crucially we need policy reforms to ensure that breakthroughs in science can be harnessed for much quicker benefits for patients. That is what the accelerated access review and a number of other initiatives, such as the test bed programme and the vanguards I am running with NHS England, are about—trying to ensure we can change the pathways for getting innovation into our health system for much quicker patient benefit.
I want to say something about the accelerated access review and the specialist commissioning reforms that NHS England is putting in place. I know all Members here take an interest in this subject, so I hope they will be aware that I have launched the independent AAR to ask and answer one big question: what can we better do to harness the extraordinary infrastructure here in the UK in terms of our deep science research base, our NHS-NIHR research base and our NHS daily treatment platform?
The NHS is the fifth biggest organisation in the world, making millions of diagnoses and carrying out millions of treatments every day. Its original founding mission was to be a research organisation, but unless we better capture the data on those interventions, we are still practising, in many cases, blind medicine; we are not harnessing that intelligence enough to inform treatment.
I have asked that the AAR tackles three big questions. First, what can we do to allow the innovators—the developers of new drugs and innovations—quicker access to patients, to reach the all-important moment of proving an innovation works in patients? Secondly, what can we do to harness our leadership in genomics and informatics in order to create a more intelligent system for NICE and NHS England, with more flexibilities, so that they can assess, adopt, approve and reimburse innovations using real-time data about real patients? That will allow us to develop a more flexible set of pathways and adaptive tools with which to embrace this revolution.
When a drug comes to us with a genomic biomarker and we know that it will work for a certain sub-cohort of patients, that profoundly changes the risk dynamic of a traditional pharmaceutical clinical trials programme and should allow us to accelerate adoption for particular patient groups.
Rachael Maskell
Within those considerations, will the Minister also look at international evidence, so that we are looking at not only our own clinical trials but those on a global scale? Clearly, developments are global rather than just national.
George Freeman
The hon. Lady makes an important point. I have been to Washington three times and to Berlin, Paris and Brussels to highlight that while the UK is leading in this field, we need a transatlantic—European and American—agreement on how we move things forward. That is why I am convening and chairing a summit this afternoon with the Washington-based FasterCures campaign, which is a cross-party group on the Hill pushing for innovations in this space. I have been talking to the Commission about the European framework. I want the UK to be the best entry point into the European market, but I also want the European regulatory framework to be consistent and coherent; that is an important point.
The second question I have asked the AAR to look at is: what freedoms, flexibilities and new pathways can we envisage giving NICE and NHS England, particularly in the field of specialist commissioning? For CF, the decision to purchase ivacaftor is a national one, made by an NHS England specialist commissioning unit. I would like that unit to work much more closely with the Department of Health pricing team, so that where we can offer a company faster access to a key patient cohort, data and genomic information, we are able to do a much better deal with the company.
At the moment, we are operating the Translarna and Vimizim programme in the existing landscape. I share colleagues’ frustration, but it is important we go through due process. I do not think anyone wants a world in which Ministers decide what drugs come through on the basis of political pressure, tempting though it may be. I have done everything I can this year to expedite the existing process.
Following the positive news on Vimizim, I am hopeful about Translarna—a similar drug. NICE has been consulting on the process, and I believe the company has been engaging with NICE on pricing. I am hopeful that there will be a decision in the next few months to parallel the one on Vimizim, but that decision is not in my gift: it is up to NICE, which is rightly working on the basis of the very best clinical evidence.
George Freeman
I had better crack on; I will come to the questions that my right hon. Friend the Member for Chesham and Amersham (Mrs Gillan) asked later, if I may.
Hon. Members have raised a number of questions and I want to deal with them all. The hon. Member for Dudley North asked about timings for the accelerated access review. We have had an interim report. I have asked for final recommendations in the spring—in March or April—and also that the review considers whether the process should go on. I want recommendations that we can implement quickly, but equally these discussions are complex and we may well need to go on to look at other bits of the landscape. I would be delighted to meet the Cystic Fibrosis Trust—in fact, that is already arranged; we are meeting this afternoon at the summit that I have organised.
The hon. Gentleman also asked about safeguards, which is a very important point. Although all of us share a recognition of the need to accelerate access, nothing in what is happening must in any way undermine patient trust and confidence in safety and protections. That is an important balance to strike. Nothing in what we are doing in any way looks at changing the legal basis in terms of negligence, consent or the clinical trials framework. The issue is about ensuring that our systems have the flexibilities to embrace the very latest science, and particularly, in this case, genomic biomarkers.
The hon. Gentleman asked about amending the NICE appraisal process to weight wider societal costs. At this point, the review is not specifically looking at the internal mechanics of NICE’s current high-technology appraisal process, but we are looking at giving it, with its new flexibilities and freedoms, a suite of different types of innovation that might come through. We are particularly looking at where that can be ring-fenced and targeted at particular patient groups.
The hon. Gentleman asked about a ring-fenced fund. As I said, we are looking at the allocation that we have had from the Treasury, which is about £4 billion extra on drugs in this Parliament, £2 billion of which is more or less the existing demand driven by demographic change. There is about a £2 billion allocation in there for new medicines. The difficulty is that the drugs that we might consider now to be most worthy of ring-fencing and accelerating may not be the ones that in five years’ time, on the basis of the clinical evidence, we look back on and say, “Why did we not accelerate that?”
We want to make sure, through the AAR, that we are putting in place a system that gives us the flexibilities to pull through those drugs that have the most transformational effect. But let me be clear: we are looking at wanting to build in, over the next few years, a wider understanding of the real costs to our health economies—local and national—of different forms of disease. That is why the Secretary of State and I are leading on per-patient costing so that, in due course, we can develop a more intelligent system to reflect that.
The hon. Gentleman asked about the NIHR and specialist muscle centres. This debate covers a number of different disease areas, and it is a tribute to the NIHR’s research network that more and more charities are now wanting to build centres of excellence. In the forthcoming NIHR five-year funding cycle, looking at the biomedical research centres and the biomedical research units, I am keen to make sure we consider where we can bring funding in from charities to complement that core research network.
Finally, the hon. Gentleman asked about the accelerated access review and the powers that we are looking at for NICE and NHS England. I do not want to pre-empt the findings of that independent review, but I have asked that the review looks precisely at how we can make it easier for NICE and NHS England to work more closely together. Specialist commissioning would be an obvious place to start to share those data and look at how we can get a better deal for everybody—for patients, the system and the economy.
My right hon. Friend the Member for Chesham and Amersham asked about Translarna and Vimizim and how quickly we may be able to get good news for Archie. I pay tribute to my right hon. Friend; she has been a very doughty campaigner on this matter during the last year. I share her frustration that in the existing system, due process has to be gone through and that, although we have expedited this as much as we can, it has taken a long time. I pay tribute, as she has, to Archie. He, like so many of these patients, is an inspiring example of the very best of this sector and of this country. They are people who have the most reason to complain, but tend to be the least likely to and the most inspiring, given their generosity about the system and their demand that we take their suffering and use it to make sure that others do not have to suffer.
I have touched on the timetable. I am very hopeful that we should get a decision from NICE on the basis of the secondary consultation early in the new year.
Mrs Gillan
I thank the Minister for the way in which he is still pursuing this matter on behalf of my constituent and the other boys. However, does he share my frustration? I know we have to go through due process, but why does due process have to take so long? Every day matters to these children and to their quality of life. I cannot impress enough on the Minister, NICE and anybody else watching this debate, that due process must be executed in a more timely fashion. This is nothing short of torture for these boys and these families. I know that the Minister has tried very hard, but I just hope that the people at NICE will be listening to this. I appeal to them directly through him to make a positive decision on this before Christmas; it would be the best Christmas present that these boys and their families could have.
George Freeman
My right hon. Friend makes her point as powerfully as ever. I shall not add to it; it has been put on the record very clearly.
My right hon. Friend asked about contact with the company. It is not for Ministers to get actively involved—much as, at times, I would like to—in negotiating these deals, but I have made contact with the company, both on Vimizim and Translarna, to urge it to be as flexible as it can in discussions. I can only say that I am hopeful that it will have been able to reach a point where NICE feels able to make a recommendation.
Part of the reason why due process is important is that when NICE makes a recommendation, NHS England is bound in law to provide the drug in perpetuity, so it is a major cost undertaking. In some cases, these drugs cost £200,000 or £300,000 a year, so it is a commitment of several hundred million pounds from NHS England. Other patients would say, “We must make sure that when you make a decision like that, it is done properly.” However, I share my right hon. Friend’s frustration that a lot of these breakthroughs scientifically mean that we ought to be able to speed things up.
My right hon. Friend asked whether the Prime Minister is holding my feet to the fire. She need not worry; I am as passionate about this as ever and very impatient to make sure that the AAR is landed with some good recommendations.
My right hon. Friend made an excellent point about NIHR staffing. I am working with the chief medical officer and the NIHR on that at the moment. A number of our clinical research facilities could, with a few more staff, turn over more and do more trials work. There is an opportunity for us to get more people internationally to enrol in NIHR training—in clinical trials and translational research training—which would give us more capacity and allow us to move things along faster.
The hon. Member for York Central (Rachael Maskell) raised an important point about cost. I have touched on the work that we are doing on per-patient costing to try and make sure that we develop a system that more intelligently captures the real cost of disease.
I am grateful to the hon. Member for Denton and Reddish, the Opposition spokesman, for his comments. I congratulate him on the by-election victory. He asked about NICE reform, which I have touched on, through the AAR. We do not want to interfere with or undermine NICE’s independence and their “gold standard” reputation, but we want to create a place in which the accelerated access review gives them the freedoms that they are, indeed, helping to shape.
In conclusion, this debate has highlighted not only the challenges from the rising costs of new drug discovery—£200,000 to £400,000 a year for patients in the rare disease space—and the pressure on the one-size-fits-all model of assessment, but the opportunities for us to unleash our leadership in genomics and informatics to create a new landscape. That is why this week, the Association of Medical Research Charities conference and my summit this afternoon, and the accelerated access review work is creating momentum for a new landscape for accelerated pathways for patient-led innovation.
I think we will look back in two or three years at this as a crucial turning point at which the system that was set up to assess a very one-size-fits-all, 20th-century model was rapidly adapted, creating new opportunities for patient-led innovations and charities such as the CF Trust to bring through innovations that benefit their patients more quickly.
Adult Skills Budgets: Enfield
George Freeman Excerpts(8 years, 5 months ago)
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The Parliamentary Under-Secretary of State for Business, Innovation and Skills (George Freeman)
It is a pleasure to respond to the right hon. Member for Enfield North (Joan Ryan) in this Adjournment debate. I pay tribute to her advocacy of the further education sector generally and the colleges in her constituency; she is an effective and outspoken advocate, as we have witnessed during this debate. The right hon. Lady may be surprised at the extent to which the Secretary of State and I sympathise with and support the points that she makes.
Since 2008, we have all heard much about the value of adult learning as a driver of economic recovery and renewed business growth, and rightly so. It continues to be a major part of the Government’s long-term economic plan and of our commitment to help get more people back to work and support our economy in its recovery.
Further education has been a crucial part of our education system as far back as its roots in Victorian times, and it is a powerful catalyst for and supporter of the promotion of people’s aspiration and achievement. That applies particularly to young people whose early education experiences may not have been entirely positive. FE gives so many people the chance to get the skills, education and training that they need to go on and flourish in their lives and careers. I shall come in a minute to the specific points relating to the excellent colleges in the right hon. Lady’s constituency.
It is also true that FE continues to fire the interest of older people, often through more informal learning opportunities. Furthermore, it promotes the integration of recent arrivals into communities, offering crucial courses in English as a second language—an issue that the right hon. Lady has raised before, and which is ever more important today given the issues of cultural integration and assimilation. Nevertheless, at times it has been popular not only to describe but to treat further education, and the wide range of differing local needs that it serves, as the poor relation of a system dominated by the needs of mainstream schools and universities. However, I sincerely believe that that is not the case today. Notwithstanding the very difficult funding decisions that the Government have had to take, I believe that within the Department and across Government more generally, and through the work of the Chancellor of the Exchequer, we are deeply committed to supporting FE, not just through the apprenticeship programme but more generally.
The experience in the previous Parliament and the contribution that more than 2.5 million new apprentices are already making to a fairer, more prosperous Britain and to our economic recovery has been much discussed. We went further and promised that by 2020 at least another 3 million apprentices will have begun learning on the job, spreading aspiration, opportunity and employment further across our society. Colleges in London have a crucial role to play in this. Figures published in The Times Educational Supplement only last week show that colleges in London currently spend less of their general adult skills funding on providing apprenticeships than those in any other region—a mere 12% of the total.
The right hon. Lady spoke of the extra funds required for the further education sector to function, and that is indeed an important consideration, but, as I am sure she agrees, funding is not the only consideration. Also important are the organisation of the network and the need to remove duplication, to support best practice and centres of excellence, and to make sure that our FE college infrastructure is operating at peak efficiency. The proper measure of education is not how much is spent on it but how well or otherwise it meets the needs of those who depend on it. The two are linked—I am not suggesting they are not—but the organisation and structure of the network is important.
These colleges and the people who depend on them, whether employers, trainers, learners or families, need to be brought inside the tent rather than left outside, as they have sometimes tended to be. Their voice in this matters, and that is what we are endeavouring to achieve. That includes, notably, prioritising the provision of apprenticeships to exploit the proven benefits that they bring to young people’s prospects and lifetime earning potential, and involving employers and their representatives closely in the design of the training courses that their firms and sectors will rely on and put to use. I am proud that the involvement of approximately 1,000 employers in our trailblazers scheme to design new apprenticeship standards is already proof of the success of that approach.
Before I turn to the specific points that the right hon. Lady made in connection with her constituency, let me put this in context. We spend £1.7 billion a year on FE, the bulk of that—£770 million—now on apprenticeships, and the rest on classroom learning and some loan funding. There are 240 FE colleges in the UK and 2.7 million learners going through the system. As she knows, they are all independent charitable institutions regulated by the Business Secretary. Between 2010-11 and 2015-16, we have indeed seen a change in the way in which that funding has worked, with a significant increase in funding for apprenticeships from £360 million to £700 million, and £1.3 billion for classroom learning and an additional £490 million available from the Treasury. Any independent observer would say that over the course of this Government’s stewardship of the economy we have made a significant commitment to the apprenticeships programme and to continuing to fund further education, for the reasons I have set out. It is equally true that in times of straitened public spending in which everybody is having to work out how to deliver more for less, the FE sector must play its part in that.
Let me turn to the points that the right hon. Lady made about the three colleges in her constituency—Barnet and Southgate, CONEL, and Capel Manor. They are all excellent colleges, grade 2 Ofsted rated and doing more of the sort of work that we want to see, including in apprenticeships. She raised three particular issues that I want to touch on. Time is limited, and if I do not deal with them all I will happily write to her to do so in more detail.
First, on the impact of the funding reductions, I am not going to pretend that the rebalancing of the spend and the reductions we have had to make do not have an impact: they clearly do, and many colleges are dealing with that. To some extent, that can be absorbed by rationalisation, consolidation and concentration of skills in the right centres. Generally speaking, the right hon. Lady’s colleges are not being affected any worse than those elsewhere. I will come to the ESOL and Capel Manor issues in a moment.
Secondly, on ESOL funding, it is true that Barnet and Southgate has been hit hard by the decision that has had to be made to reduce ESOL funding, and particularly by the suddenness of the decision. That is partly because this was an election year and the normal process of longer term funding, under the three-year comprehensive spending review, did not apply. I acknowledge that the decision has come pretty quickly and the college has not had a lot of time to adjust to it. However, as the right hon. Lady has highlighted, the management and those behind this and the other colleges are first class. I anticipate that they will be able to make the necessary adjustments, but I do not for a minute pretend that that will be straightforward or easy.
Thirdly, I wanted to pick up the right hon. Lady’s point about Capel Manor. I join her in paying tribute to the great work of the team there. The Ministers in the Department very much sympathise with the need for the specialist provision at the college to be reflected properly in the ongoing area reviews. She will have noticed—indeed, she has helped to ensure this—that the Mayor has taken a strong interest and role in making sure there is a proper strategic view of specialist provision London-wide. I assure her that the area reviews will take into account the nature of the specialist centres in the London-wide context, and we intend to make sure that the specialist provision at Capel Manor is properly reflected in the London-wide strategy.
The right hon. Lady asked about the comprehensive spending review. Mr Deputy Speaker, you will have noticed that I am not the Chancellor of the Exchequer. I would love to be able to give her the reassurance she wants, but the Chancellor will shortly be on his feet to tell the House the details of the spending review, and it would be quite inappropriate, as I am sure she understands, for me to do so, even if I knew the detail of the allocation. I can however reassure her that the points she has made eloquently this afternoon and elsewhere about the importance of FE are very well taken, and Ministers will make sure that they are taken into account in the London-wide area review.
George Freeman
We are very short of time. Perhaps I can undertake to take away the right hon. Lady’s points and get back to her on the detail in writing, but I will take one quick intervention and then I must wrap up.
George Freeman
That is an incredibly kind invitation. Perhaps I may pass it on to the Minister for Skills—he has responsibility for further education—who I know will appreciate it. If I am ever passing nearby, I will gladly come and have a look.
I will take away and address the right hon. Lady’s specific points. I hope that there will be some good news through the area reviews. We will see how we may be able to help post the comprehensive spending review.
Question put and agreed to.
Oral Answers to Questions
George Freeman Excerpts(8 years, 6 months ago)
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Maggie Throup (Erewash) (Con)
3. What steps the Government are taking to improve diagnostic testing in primary care.
The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
The Government are determined to improve and invest in diagnostic testing in primary care. Diagnostics and breakthroughs in innovative diagnostics are key to a 21st-century NHS. That is why we have set up the medical technology strategy group, which I chair, to look at accelerating diagnostics into the system; the cancer strategy taskforce; the Prime Minister’s GP access fund; the new models of care programme; and the accelerated access review, which is looking to accelerate those diagnostics with particular value to patients and the system. We have also introduced the new guidelines for the National Institute for Health and Care Excellence, and, through the genomics programme, we are investing in 21st-century molecular diagnostics, which will come to shape the future.
Maggie Throup
C-reactive protein point-of-care testing could reduce the number of prescriptions for antibiotics, contribute to the UK’s anti-microbial resistance strategy, and save the NHS millions of pounds each year. Ahead of my Adjournment debate on this issue next Monday, will the Minister agree to look at this type of testing as a way of saving the NHS money and providing appropriate patient treatments?
George Freeman
My hon. Friend makes an excellent point. We are completely committed to tackling anti-microbial resistance, and reducing the volume of antibiotics prescribing is vital to that. We are a world leader in this field in tackling AMR. We have an expert group looking at how to improve diagnostic services in relation to AMR, and it has already identified what diagnostics are currently in use and what new technologies are on the horizon, including C-reactive protein point-of-care testing. The group is currently formulating conclusions. The public health Minister, my hon. Friend the Member for Battersea (Jane Ellison), is looking forward to responding to my hon. Friend’s debate on Monday to set out more of the detail.
Mr John Baron (Basildon and Billericay) (Con)
The Government have done a very good job in getting one-year cancer survival rates into the DNA of the NHS as a means of encouraging clinical commissioning groups to promote earlier diagnosis—cancer’s magic key. Does the Minister agree that we all need to ensure that we keep the CCGs’ feet close to the fire as regards these one-year figures so that we do not just improve diagnostic testing in primary care, but improve screening rates, GP referral rates and awareness campaigns as a means of ensuring that we save the thousands of lives that are needlessly lost through late diagnosis?
George Freeman
My hon. Friend is absolutely right. I pay tribute to his work on this through the independent cancer taskforce. The aim is to save 30,000 more lives a year by 2020. We are working with Harpal Kumar and Cancer Research UK on implementing its recommendations. NICE has set out new guidelines on clear ambitions and standards on how quickly patients should be referred for diagnostics. There is good news in that in 2014-15, compared with 2009-10, over 4.3 million more imaging and endoscopy tests were commonly used to diagnose cancers, but I agree that we have much more still to do.
Simon Danczuk (Rochdale) (Lab)
4. What steps he is taking to reduce suicide rates.
Jo Churchill (Bury St Edmunds) (Con)
7. What progress has been made by Genomics England in making the UK the world leader in genomic medicine.
The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
The Genomics England project, which was launched by my right hon. Friend the Prime Minister, has electrified the global life and health science community. We are the first nation on earth to commit to sequencing 100,000 entire genomes of NHS patients, which will be combined with patient records to unlock NHS and UK leadership in the fast-emerging field of genomic medicine, focusing initially on rare diseases and cancer. I am delighted to report that we have the genomes of 5,000 patients fully sequenced and that 11 genomic medicine centres have been set up. We have identified first diagnostics and treatments for some rare diseases; 2,500 researchers are involved in the project; the cost of sequencing a genome has fallen from £5,000 to £1,000; and, importantly, NHS England is setting the international standard on ethics and patient consent in genomic medicine.
Jo Churchill
Does the Minister agree that the world-leading Genomics England will deliver a personalised and patient-centred revolution in modern healthcare by combining the talent of global companies such as AstraZeneca with that of UK-based companies such as Congenica in my region, to the benefit of patients with cancer and other rare diseases, the vitality of our NHS and, through jobs and innovation, the strength of our economy?
George Freeman
My hon. Friend makes a great point. I pay tribute to Congenica, a small company in Cambridge that is doing extraordinary work. I recently went to open Illumina’s global research and development headquarters, which is a £160-million commitment. As well as the significant investment in technology and research in the UK, NHS England is leading genomic medicine across the UK, not just in the Oxford-Cambridge-London triangle, but through 11 genomic medicine centres across the country, which are bringing genomic diagnostics to the benefit of us all.
John Pugh (Southport) (LD)
The Minister will know of the case of one-year-old Layla Richards, who was saved from leukaemia by genome editing at Great Ormond Street hospital. What specific help does he give for such hands-on pioneering work?
George Freeman
The hon. Gentleman makes an excellent point. Genome editing is the latest in a suite of technologies that is rapidly emerging in genomics. Through the Genomics England programme, we are actively supporting those tools and intermediate technologies, and through the accelerated access review that I have launched, we are looking to harness those breakthroughs to support new treatments and new flexibilities for the National Institute for Health and Care Excellence and NHS England on targeted treatments.
Oliver Colvile (Plymouth, Sutton and Devonport) (Con)
8. What progress he has made on implementing a new contract for junior doctors; and if he will make a statement.
Access to Medical Treatments (Innovation) Bill (Money)
George Freeman Excerpts(8 years, 6 months ago)
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The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
I beg to move,
That, for the purposes of any Act resulting from the Access to Medical Treatments (Innovation) Bill, it is expedient to authorise the payment out of money provided by Parliament of any increase attributable to the Act in the sums payable under any other Act out of money so provided.
The House debated the Access to Medical Treatments (Innovation) Bill on Friday 16 October, when it received its Second Reading. I pay tribute to my hon. Friend the Member for Daventry (Chris Heaton-Harris) for the huge amount of work that he put in to get the Bill to a point where it can enjoy majority support in this House and the other place, and for his open approach to dealing with all the stakeholders with an interest in it.
I want to reiterate what I said on Second Reading. Although the Government support the intention behind the Bill to promote access to medical innovation—an intention which sits four-square within my ministerial responsibilities—the mechanisms of any Bill need to be considered on their merits. We are neither supporting nor opposing this Bill, but working with those with an interest in it and the sponsors to do what we can to help to get it to a place where it could contribute to the landscape for medical innovation that we are putting in place.
This money resolution is not a signal of Government support or otherwise for the Bill; it is merely a convention of the House once a Bill has received its Second Reading. We have brought forward this resolution to allow the Bill to progress to Committee stage, reflecting that convention, and the will of the House for further debate.
Dr Sarah Wollaston (Totnes) (Con)
On a point of order, Madam Deputy Speaker. Is it in order for the Government to be neutral on a Bill if the payroll vote is whipped for that vote?
Madam Deputy Speaker (Natascha Engel)
That is a matter for the Government, rather than for the Chair.
George Freeman
The debate on Second Reading raised a large number of issues, which clearly need to be addressed and I have no doubt will be addressed in Committee. We cannot second-guess where that Committee will get to or the shape of any Bill that might subsequently return to the Floor of the House.
The costs associated with this Bill, were it to be implemented in its current shape, arise from the establishment and maintenance of a database by the Health and Social Care Information Centre. Early discussions on costing with the HSCIC, which is leading on the construction of a number of databases and data streams crucial to the operation of the NHS, have provided an indicative costing of between £5 million and £15 million for developing the database of innovative medicines that the Bill anticipates.
Mr John Baron (Basildon and Billericay) (Con)
My hon. Friend has implied broad Government support for the Bill. Can he provide any evidence to suggest that litigation is preventing doctors from innovating in medical science and practice generally? That is the premise on which the Bill is based.
George Freeman
My hon. Friend makes a good point. That is the premise on which the Bill introduced by Lord Saatchi in the other place earlier in the year in the previous Parliament was predicated. My hon. Friend is right that it is a controversial proposition that fear of litigation for medical negligence is putting clinicians off innovating. The evidence that the Government received through the consultation was that some clinicians do feel that that is a problem, but very few saw it as the principal problem or the principal obstacle. A number of clinicians made the point that several factors have acted in recent decades to slow down the rate of innovative prescribing and other procedures in surgery and elsewhere, not least increasing central control of procurement from NHS England, which puts in place very tight procurement guidelines, as well as a general sense of an increasingly litigious society, which is just one of a number of factors cited in an extensive range of barriers to innovation.
Dr Philippa Whitford (Central Ayrshire) (SNP)
Does the Minister not recognise the concern of the Association of Medical Research Charities and many within the profession about what the Bill opens up? The position when I started 30-odd years ago was that doctors could do what they liked. We have spent decades protecting people, slimming down the ethics paperwork to run trials, and I do not see that the Bill is necessary. I think it is dangerous. The problem is that people think it is about access to new drugs. It is not. Any drug that is licensed we can prescribe. This says that doctors can try what they like. That is quite scary.
George Freeman
The hon. Lady makes a series of interesting points. Her criticisms would perhaps apply more to the Bill introduced by Lord Saatchi in the other House. Let me confirm that this Bill has nothing at all to do with clinical research. It is to do with clarifying the freedoms that she is right to say that clinicians enjoy today. Clinicians are free to prescribe any treatment for their patients that they feel is appropriate on the basis of the clinical evidence.
The specific problem that the Government recognise, whether or not this Bill is the appropriate mechanism to deal with it, is that in order for clinicians to feel confident in making an innovative prescription or adopting an innovative procedure, the biggest barrier is the lack of information on what innovative procedures are out there already and being used by other clinicians. It was with that in mind that the registry was originally proposed in the Bill introduced by Lord Saatchi. It was originally intended as a registry of innovative practices that clinicians adopted under the procedures in the Bill, which merely clarify the existing protections already afforded by medical negligence law. It was felt that that registry would be a helpful innovation in itself.
The Government’s view is that, as we build an infrastructure for the provision of information to clinicians to support off-label use of medicines and access to the latest information on innovative treatments, that registry could provide a much more interesting function of providing to clinicians, at the click of a mouse, an up-to-date registry of innovative medicines that are available and off-label and other treatments that other clinicians are already using. I want to stress that this Bill, which has a very different structure from the original Bill introduced by Lord Saatchi, has nothing to do with research at all. It is purely to do with supporting innovative prescribing by clinicians by providing them with information on innovations that they might consider.
Dr Whitford
Does not this undermine our existing structures of clinical research? Those protect the patient through ethics and research being reviewed, whereas this allows a couple of doctors to say, “We’re going to give you liquorice for your cancer”, and that can get put on to a database. Many in the profession are anxious about this.
George Freeman
I want to make two things absolutely clear. First, this Bill, in law, would have no impact at all on clinical research. We in the Department have been very clear about that. If it in any way changed the basis on which clinical research is regulated, it would be a very serious matter, because we lead the world in terms of our ethical and regulatory controls on research, and it is vital that we do not affect that.
Secondly, it would be a matter of very serious concern if this Bill were to undermine patient or public trust and confidence in our NHS, our research medicine and our clinical trials infrastructure. I flagged up on Second Reading the fact that I do have some concerns. Some of those relate to the way in which this debate is conducted, although I am not making any comment about the hon. Lady’s intervention. It is very important that we explain to people what this Bill does and does not do. If we mislead them, it is not surprising that we will get a lot of unnecessary fear. It is very important that we clarify that this has nothing to do with clinical research.
Dr Wollaston
Does the Minister accept, however, that the Association of Medical Research Charities, the Academy of Royal Medical Colleges, the British Medical Association, and an A to Z of other organisations involved with medical research are very clear that this does undermine participation in medical research? He should listen to those concerns and acknowledge that they are genuine.
George Freeman
Yes, indeed; I have listened. I acknowledged those concerns on Second Reading and said I was concerned about them. This is merely a debate about the Bill—there is no change in the law—and it is only this debate that is upsetting people at the moment. It is therefore very important that we carry it out in a way that makes it clear to them what this Bill does and does not achieve.
I am concerned that the passage of the Bill, the conduct of the debate, and any legislation that may survive the process of parliamentary scrutiny do not in any way undermine public or patient trust and confidence in clinical research or mainstream medicine. Were it to do so, I would be very concerned and the Government would be unable to support it. I have made it very clear to my hon. Friend the Member for Daventry that that is the No. 1 consideration, and as this is his private Member’s Bill, it is his task to get it to a point at which the Government would feel able to support it. Public trust and confidence in our NHS and in our clinical research infrastructure is crucial.
Mr Baron
May I add to the voice of my hon. Friend the Member for Totnes (Dr Wollaston) and suggest that not just the bodies she mentioned but many of the cancer bodies, charities and communities are very concerned about this Bill? Let me bring the Minister back to the issue of evidence. The pursuit of justice starts with evidence, and there is no evidence that litigation is deterring doctors from innovating. This Bill, in many respects, addresses a non-existent problem. If it is not necessary to legislate, it is necessary not to legislate.
George Freeman
As my hon. Friend knows, I have a lot of respect for his logic and his position, so let me be very clear again. As I tried to explain, I accept that if one were setting out a list of the biggest barriers to the uptake of innovation, fear of negligence would not be No. 1 on the list. However, it is equally true, as has been put to us during the consultation on this Bill, that it is a consideration. It is very important that the mechanism is proportionate to that obstacle. I think that that is the point he is really making, and I could not agree more. I signalled on Second Reading, and signal again now, that for the Government the most interesting part of this Bill is about access to information on innovative medicines and treatments for clinicians, who already have the freedom to innovate.
The second part of the Bill, as we understand it—we have taken substantial legal advice—does not in any way change the law on medical negligence; we would struggle if it did. Rather, it sets out a clear pathway for doctors seeking to enjoy the freedoms that are already in law to make it very clear what the procedure would be. People might say that these are fairly marginal improvements and ask whether they really merit the time of the House, but it is not for me to judge what is or is not an appropriate use of Parliament’s time. However, I do understand that my hon. Friend the Member for Daventry is trying to tackle, through a small measure, something that we all have an interest in, which is increasing access to innovative medicine.
The focus on provision of information that is reflected in the Bill’s new title and structure has the potential for an interesting mechanism. That is why we have looked at what the costs might be of putting such a database together. The figure that I have given is based on the understanding that further significant scoping work would be required were the Bill to become law, including consideration of the modification of existing coding systems to capture an innovation in medical notes, the data flow and the searching capability before the information centre—the HSCIC—was able to provide a robustly costed solution. Until proposed options and variables undergo additional policy refinement, including the development of a proper specification, it is not possible to offer a further estimate of supporting costs. The affordability of any specific proposal and future investment in technology more generally will also need to be considered in the light of the forthcoming spending review settlement, and the work of the National Information Board, which is putting in place a broader framework for the flow of information in the NHS.
Medical practitioners are already required to comply with the General Medical Council and BMA guidance on record keeping, and the recording of an innovation for front-line staff is therefore based on existing practice. Thus no additional costs are foreseen for medical practitioners or their own organisation. Officials in the Department of Health are currently drafting an impact assessment to examine the estimated impact of the Bill and to understand better the likely costs and benefits of the proposals.
The database proposed by the Bill—should it survive parliamentary scrutiny—may ultimately improve the flow of information to clinicians on the range of innovative treatments that are already available. Those treatments might include off-label uses of medicines, about which the House is interested in connection with another Bill. In our view, the biggest barrier to the flow of information through the system is the lack of incentives or proper reward for innovation. That is to do with how we reward patterns of activity, rather than the promotion of health and healthcare. The lack of availability of data and information is one of the biggest barriers. Subject to whatever scrutiny and changes the Bill may undergo in Committee, we think that there is a potential prize worth winning, but I appreciate that the Committee will need to go through the Bill in some detail.
Justin Madders (Ellesmere Port and Neston) (Lab)
I will not detain the House for long, as my hon. Friend the shadow Health Secretary set out in detail our concerns about the Bill on Second Reading. I will say in summary that the Opposition believe the Bill to be at best unnecessary, and at worst a danger to patients.
The Bill is strongly opposed by a number of medical royal colleges, including the Royal College of Surgeons, the Royal College of Pathologists and the Royal College of Paediatrics and Child Health. There is strong opposition from several medical research charities, including Cancer Research UK, Alzheimer’s Research UK and the British Heart Foundation. There is also strong opposition from bodies such as the Wellcome Trust, the Patients Association and Action against Medical Accidents.
Given the range and depth of concern, I do not understand how the Minister can be so comfortable in supporting the Bill, even though he contends that he is not supporting it. I ask him to reconsider the Government’s position. We will see very shortly whether the point made by the hon. Member for Totnes (Dr Wollaston) is correct, and whether the Government are as neutral on the Bill as they state.
George Freeman
The hon. Gentleman will be familiar with the procedures of the House, but I just want to confirm that once the House has given a private Member’s Bill a Second Reading, the convention is that the Government, even when they robustly oppose it, always table a money resolution so that the Committee need not concern itself with that matter. Doing so is not a signal of Government support; it is absolutely in line with the convention of the House with all private Members’ Bills, whether we oppose or support them.
Justin Madders
I am grateful to the Minister for his clarification. As I say, we shall see very shortly whether that is the case.
I understand that the part of the Bill to which the money resolution primarily relates will give the Secretary of State the power to set up a database. As the shadow Secretary of State set out on Second Reading, we consider that unnecessary because, under section 254 of the Health and Social Care Act 2012, the Secretary of State and NHS England have the power to direct the Health and Social Care Information Centre to establish and operate a system for the collection or analysis of information. I note that, in a recent letter to the shadow Health Secretary, the Minister said:
“Under section 254 of the Health and Social Care Act the Secretary of State has the power to direct the Health and Social Care Information Centre to establish and operate a system for the collection or analysis of information of a description specified in the direction.”
I understand that the Minister’s argument is that he thinks it is appropriate to give the Secretary of State an express power, but I am not convinced by that and neither are many in the medical profession, including the Royal College of Surgeons.
We believe that the Bill attempts to address a problem, namely the fear of litigation, that simply does not exist and for which the profession has provided no evidence. There is a risk that it will undermine the methodical and reasoned approach to research that already exists. In the context of the £30 billion challenge that the NHS faces and the financial problems that are taxing us all, we note that the Bill may prove to be a step in the wrong direction. We will vote against the money resolution for the Bill, and we will no doubt see what the Government make of it when they have considered their research on the costs.
George Freeman
It is not for me to defend this private Member’s Bill, promoted by my hon. Friend the Member for Daventry (Chris Heaton-Harris), but I want to deal with two or three points that have been raised in connection with the Government’s view of clinical research and patient safety, both of which are very important.
The hon. Member for Central Ayrshire (Dr Whitford) made an impassioned plea that patient safety not be undermined. I reiterate that the Bill will in no way have any impact on our clinical research approvals and ethical regulatory infrastructure, which are world-class and a much prized jewel in our crown. The Bill merely—by saying merely, I do not mean to undermine its potential impact—deals with freedoms to prescribe innovatively, which already exist and are enjoyed by clinicians. It is important that everyone understands that doctors are already free to prescribe medicines. They have sovereignty in prescribing treatment to their patients where they believe there is good clinical evidence.
The hon. Lady made a point about the importance of evidence. The part of the Bill that the Government think is of particular interest is the mechanism for accelerating the giving of evidence to clinicians on currently available innovations—both innovative medicines and the off-label innovative use of existing medicines. It is worth bearing in mind the House’s interest in accelerating off-label use through the provision of information. Patient safety and patient protection are absolutely key, and we will do nothing, and allow nothing, that undermines that.
My hon. Friend the Member for Totnes (Dr Wollaston) raised a range of concerns. They are all legitimate, but I think the place to address them is in Committee. I reiterate that nothing in the Bill will interfere in any way with UK clinical research infrastructure.
In response to the point that the hon. Member for Ellesmere Port and Neston (Justin Madders) made about whether the Government support the Bill, let me be very clear: the Government neither oppose nor support the Bill. We are prepared to work with the Bill’s sponsors to get it to a place where it supports the environment that we want to see.
On testing the will of the House, I can assure the hon. Gentleman that the Government always support money resolutions, even on Bills to which they are blatantly opposed. That is the convention, so he will be testing and proving nothing other than that we will stick to the convention of always supporting the money resolution to a Bill.
Question put.