Oral Answers to Questions

Daniel Zeichner Excerpts

Tuesday 29th October 2019 Commons Chamber

[Matt Hancock]

I can assure my hon. Friend, who has campaigned long and hard on the issue of access to Kuvan, that we are working on that as well. I hope very much that we can come to a positive conclusion.

[Daniel Zeichner (Cambridge) (Lab)]

The system did finally work, but did it not take far too long, and is it not time to introduce transparency into this opaque system, particularly when the Americans are waiting to pounce on our pharmaceutical industry?

[Matt Hancock]

The NHS is off the table in trade talks and pharmaceutical pricing is off the table. Transparency over pharmaceutical pricing would not benefit this country at all because we get the best deals in the world because we can keep them confidential, so it is a slight surprise to hear a Labour Member argue for what would effectively lead to higher prices for drugs in the NHS. Instead, we will protect the NHS.

Artificial Intelligence in Healthcare

Daniel Zeichner Excerpts

Thursday 5th September 2019 Westminster Hall

[Daniel Zeichner (Cambridge) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Paisley. I congratulate the hon. Member for Crawley (Henry Smith) not only on securing the debate but on his thoughtful and comprehensive introduction to an extraordinarily complicated subject that I suspect will require much more debate in this place in future. I chair the all-party parliamentary group on data analytics and represent a constituency that is, of course, well known for its health services, innovation and tech cluster, not just in the city but around it.

The issue is therefore close to my heart. When I was elected as the Member of Parliament for Cambridge, I never imagined that I would spend quite so much time on such issues, but there are many jobs involved and huge opportunities available, exactly as the hon. Gentleman said. However, I suspect that I will be slightly less optimistic than him, because as I have begun to look at the issue more closely, it has struck me, as he said, that the only way that we will make it work is by maintaining the trust of patients, which is difficult—particularly given the behaviour of some of the major tech companies. It is not a lost cause, in my view, but we are going to need a qualitative change in regulation and protection if we are to secure some of the benefits that have already been referenced. Every day in Cambridge, I hear about new innovations and developments that convince me and, I think, many others that we really are on the cusp of a technological revolution across a range of sectors. Everywhere one goes in Cambridge, one sees people working on the most extraordinary things, and the gains are potentially huge, not just for our citizens but across the world.

It is hard to explain a lot of this to the public. I feel that I am in a privileged position going around Cambridge; I sometimes feel that I am the only person who is seeing all the various things that are going on, and one of my challenges is to try to spread the word about all the stuff that is happening. My worry is that often it is poorly communicated and poorly understood, and that misunderstanding can easily lead to a public backlash. I read with great interest the report from the all-party parliamentary group on heart and circulatory diseases; a very distinguished panel of people was behind it, and I will highlight some of the crucial points.

Ensuring that artificial intelligence really does enhance patient healthcare—and that it does not, as some of us fear could easily happen, get diverted on to a profit-seeking route—requires the following key elements: stakeholder engagement; an exact explanation of the risks and benefits; keeping researchers and academics involved; digital inclusion in general; proper development of policy, focusing on AI for public values; and the development of standards.

There are others, of course, working in a similar field. I am delighted to see present a fellow member of the APPG on data analytics, the hon. Member for North East Derbyshire (Lee Rowley). A few months ago he and my hon. Friend the Member for Bristol North West (Darren Jones) led a very good inquiry and produced, with a similarly illustrious panel of experts, an excellent report entitled “Trust, Transparency and Technology”. It is amazing how many people are working in this field at the moment. Part of that report—I suspect the hon. Gentleman will refer to it when he speaks—was focused on healthcare. He did the work, so I do not want to steal his thunder, but I will pick out a particular couple of things.

We drew on a 2018 survey by the Open Data Institute, whose statistics reflected those cited by the hon. Member for Crawley. Some 64% of consumers trusted the NHS and healthcare organisations with their personal data, which is more than the 57% who trusted their family and friends. Consumers also trusted the NHS more than they trusted their bank, the figure for which was also 57%; local government, for which it was 41%; and online retailers, for which it was 22%. I do not think they asked about the level of trust in politics; that is probably not recorded. Nearly half of respondents—47% of them—were prepared to share medical data about themselves. I have seen different figures, and I would also reflect on the fact that 53% were not prepared to share data. However, those people were prepared to share their data provided that it helped develop new medicines and treatments. In terms of the trade-offs for data sharing, they were most keen to participate when it was for medical research.

As we know in politics, however, trust is hard won and easily lost, and we have to be careful. A few months ago, I was asked to write a foreword to a report by the think-tank Polygeia, entitled “Technology in Healthcare: Advancing AI in the NHS”. The report is consistent with other work in this field and comes to broadly similar conclusions to those we have already heard. There is also a sense that NHS staff need to be closely involved in these developments, to ensure that they are not just kept informed but given a sense of understanding and confidence about how this can work. The black box algorithm to which the hon. Member for Crawley referred is still a little baffling and scary to a lot of people. If we are going to make this work, it is crucial that we consult, educate and take people with us. We must rely on the advice of medical and healthcare professionals, who are best placed to understand the concerns of both their patients and their colleagues.

We are constantly seeing new developments in the news. One of the joys of modern life is that when we go on holiday, we still watch our iPad. This summer I noticed the debate about DeepMind and its new ability to predict acute kidney failure; it wins an extra 48 hours by looking at huge volumes of data and doing the number crunching. That is bound to be a good thing but, typically, there were people who questioned the methodology and who raised concerns about unforeseen consequences. I also think there are some unforeseen consequences to these kinds of changes, and I will touch on one or two.

So far, I have been profoundly non-partisan and non-political, but I have to say that the new Secretary of State for Health and Social Care did rather wade in early on with his support for Babylon Health and GP at Hand. Those kinds of technologies provide tremendous opportunities but, as the hon. Member for Crawley said, such developments can be disruptive to the organisation of the national health service. There has been disruption to funding flows, particularly across London, and I hope the Minister will be able to reassure us about that. Simon Stevens made a commitment, but these changes are happening quickly and one of the things that we know about the NHS is that it is quite a tanker to turn around. Quick, unintended consequences are not always benign ones for the people on the receiving end.

The wider point, of course, is that some of us are worried that the NHS, which is free at the point of use, is being undermined by the creeping in of a potentially competitive system. That can be resolved in some ways: we can change the administrative structures, for example, and sort out the financial flows. My bigger fear relates to confidentiality and what is happening with patient data. It is frequently argued that the data will be anonymised, and this is where we get into the realm of the techies. Plenty of people have explained to me that it is possible to reverse that anonymisation process, because as clever as these machines are in terms of machine learning, they are also pretty clever at doing the reverse. I am now pretty much persuaded that there is no such thing as anonymity. We must face the fact that there are consequences to these tremendous gains, and think through how we should deal with some of them.

This does not necessarily matter. I remember years ago when, under the previous Labour Government, Alistair Darling unfortunately had to come to Parliament and explain that his Department had lost millions of people’s data. That week, everyone thought the world was going to come to an end, but it did not. An awful lot of data is out there already, which is not great because we do not know who knows what about us. That is not necessarily a disaster, but if data is being used for the wrong purposes, it could be very difficult. This is my key point, I suppose: I am afraid that the evidence from the big tech companies, as we see almost daily, is that they have been doing things with our data that we did not know about. That is a problem that we previously experienced with the Care.data failure in the NHS, which damaged public trust. It is absolutely essential that we do better in future if we are going to keep the public on board.

The report from the APPG on data analytics states:

“Key lessons from this failure are around data security and consent, and reinforce the need for proper public engagement in the development of data collection programmes, and gaining the right level of consent, if such consent is not subsequently to be withdrawn with major clinical and value for money implications. In the case of DeepMind, Dame Fiona Caldicott, the National Data Guardian at the Department of Health, concluded that she ‘did not believe that when the patient data was shared with Google DeepMind, implied consent for direct care was an appropriate legal basis’.”

There is a significant number of concerns and the issues are profound and difficult. We have a whole range of structures in place to try to deal with some of them, and I have huge respect for the Information Commissioner’s Office. The Information Commissioner frequently tells those of us who ask that that office does have the appropriate resources. Given the scale and difficulty of the task, I must say that I find that hard to believe, because it is a very big task indeed. The hon. Member for Crawley mentioned the Centre for Data Ethics and Innovation, which is at an early stage. Frankly, it, too, will struggle to find the resources to meet the scale of the task.

I sat on the Bill Committee for the Data Protection Act 2018, which introduced the general data protection regulations. Some parts could have been strengthened. I tabled amendments that would have tightened up the assurance that research institutions must process healthcare data ethically for patient gain, but sadly, the Government chose not to adopt them. I hope that they might look at the issue again. A feature of the lengthy discussions in Committee, particularly in the Opposition’s observations, was that although the legislation is worthy, it felt like it was for the previous period, rather than the future, given the pace of change that we are likely to encounter. We were not convinced that it would keep up.

We need a much more radical set of safeguards. To stray slightly into the technical areas, when my local paper asked what my summer reading was going to be, it was surprised to hear that it was Shoshana Zuboff’s magnum opus, “The Age of Surveillance Capitalism”. It is a thought-provoking work and astonishing in the way she untangles the range of uses to which our data is being put every time we pick up our smartphone—or, in some cases, when we do not even turn it on. Many people are surprised to find that, far from being a phone, it is a tracking device. As she says, the question is not just who knows about us, but who decides what data is used, and who decides who decides what that data is used for. She talks about a shadow text, effectively; there is the data that we put on there and then there are all the connections that are made.

Staggeringly, huge amounts of information are being held about all of us that we do not have any access to—that we do not know about. At the moment, those companies consider that it belongs to them. We have to change that, because I think if it is about us, it belongs to us. That is a huge challenge, because if it were to happen, it would fundamentally challenge the business model of those hugely fabulously wealthy tech giants, which are hardly likely to give it up easily. The only way to tackle it, however, is through Governments and regulation. I hate to mention the issue of the hour, but that is one reason, of course, why those companies dislike the European Union—because we need large organisations to counter the giant power that we face.

We have a fantastic opportunity, particularly with our national health service, which, as is often observed, has access to huge amounts of data that no other health system in the world has. In this country, we have the fantastic raw material and a fantastic data science industry. We have the expertise and the knowledge. We also, just about, have the good will of our citizens. We have a great opportunity, but we will need much tougher regulatory frameworks to unlock that potential in the right way. I fear that, so far, compared with what we have to do, we have merely been tinkering.

There are huge opportunities. I have raised a range of issues that go beyond the immediate ones. I hope that Parliament will find an opportunity to have those discussions in the period ahead. If I were asked whether we are in a position to meet the challenge, I would say, “Not yet.” I do not think it is impossible, but it will be difficult, so it is vital to start the discussion. I thank the hon. Member for Crawley for giving us the opportunity to do that today.

Oral Answers to Questions

Daniel Zeichner Excerpts

Tuesday 23rd July 2019 Commons Chamber

[Matt Hancock]

The assurance I can give is that, ahead of 29 March, we put in place the measures that are necessary to ensure that the hon. Gentleman’s constituent and others get the medicines they need, and we have taken forward those proposals and that work ahead of an exit from the European Union on 31 October.

[Daniel Zeichner (Cambridge) (Lab)]

The Secretary of State will be aware of the expert evidence, including from the BioIndustry Association, warning that, although we may be able to stockpile the bog-standard drugs, it will be very difficult to do so for specialist treatments. What guarantees can he give that we will have access to those specialist medicines?

[Matt Hancock]

Ahead of 29 March, we managed to put in place a full programme to ensure access to drugs. Of course, the approach is not just about ensuring stockpiles—there are adequate stockpiles for so many medicines all the time—but is about ensuring the flow of materials and finished drugs across the channel via ferries and, where necessary, aircraft.

Living with Dementia

Daniel Zeichner Excerpts

Tuesday 25th June 2019 Westminster Hall

[Daniel Zeichner (Cambridge) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Paisley. I thank the Backbench Business Committee for granting this debate. It is an honour to follow my hon. Friend the Member for Oldham East and Saddleworth (Debbie Abrahams), who so expertly laid out the issues. I will say a little bit about social care and then move on to research.

Some 1,179 people live with dementia in Cambridge—around 1% of the constituency population—meaning that thousands of my constituents care for or know a close friend or relative with dementia. My hon. Friend touched on some of the social care issues. It seems hard to deny that we have a crisis in social care. In March 2017, the Government said they would publish a Green Paper on ensuring that the system will be sustainable in the long term. However, two years on, and after many delays, Ministers have still not given a date for when it will be published.

I understand that 400,000 fewer older people receive publicly funded care than in 2010. With local authority budgets cut by 49.1% since 2010, including £7 billion lost from adult social care, and a further £1.3 billion to be cut in 2019-20, it is hard not to conclude that the situation for many of those living with dementia, and for their families, has been made much harsher and more difficult.

Alzheimer’s Research UK has campaigned for more money to be invested into research, so that with new treatments we can really change the lives of those who have dementia. As we all know, research has revolutionised the ways we treat, cure and prevent diseases such as cancer. There is no reason why that cannot be the same for brain diseases such as dementia. New treatments would also ease pressure on our healthcare and social care services, improving lives and saving public service resources. Public donations have allowed Alzheimer’s Research UK to invest £100 million over the last 20 years to drive forward its research, but that funding alone does not allow it to further explore emerging fields.

However, when we do invest in dementia research, look at what we can achieve. Alzheimer’s Research UK’s Drug Discovery Institute in Cambridge couples the deep disease knowledge and biology expertise of the academic community with high-quality, innovative drug discovery technologies. More than 100,000 combined hours have been committed to drug discovery by 30 new staff. The institute is currently investigating 10 new potential drug targets in its own work or through collaborations, has generated 12 new internal collaborations at the University of Cambridge and has attracted nine new partners from both the private and the academic sectors.

In addition to the institute, the Cambridge Network Centre, launched 20 years ago, has grown to include 2,200 dementia researchers across the UK. It has helped researchers to buy cutting-edge technology to carry out their research, supported grant applications and fellowship applications and enabled PhD students to buy equipment such as virtual reality technology to further their research. I suspect I am not the only one to have seen the virtual reality dementia simulation and met Helen Davies when Alzheimer’s Research UK was in Parliament. I—like others, I suspect—found it extremely interesting and slightly surreal, but also very impressive at explaining the effects of the disease.

While £269 million is invested in cancer research, only £83.1 million is invested in dementia research—just 0.3% of its total cost to society. Alzheimer’s Research UK is calling for the Government to increase that to just 1% of its total cost, which would unlock the resources needed to really cement the UK as the world leader in dementia research and to make real breakthroughs. I very much hope that the Minister will commit to discussing that with her colleagues in the Department for Business, Energy and Industrial Strategy and the Treasury—even possibly one or two Conservative party leadership candidates, for whom money suddenly seems to be no object—to ensure that we make the progress that we all need.

Oral Answers to Questions

Daniel Zeichner Excerpts

Tuesday 18th June 2019 Commons Chamber

[Stephen Hammond]

The hon. Gentleman is right—immigration has benefited the national health service. This Minister, this Secretary of State and this ministerial team celebrate the fact that global immigration has benefited the NHS. From 2021, the new system will allow people with skills to come to the UK from anywhere in the world. It will remove the cap on skilled migrants, abolish the requirement to undertake the resident labour market test, and should improve the timeliness of being able to apply for a visa.

[Daniel Zeichner (Cambridge) (Lab)]

11. What recent comparative assessment he has made of the adequacy of NHS funding in Cambridgeshire and local population growth.

[The Minister for Health (Stephen Hammond)]

NHS England is responsible for the allocation of resources to clinical commissioning groups. Funding is distributed on the basis of a weighted capitation formula informed by the Advisory Committee on Resource Allocation. Population estimates are provided by the Office for National Statistics. This year, as the hon. Gentleman will know from a debate that we had last week, ACRA recommended and NHS England accepted a wide-ranging set of changes to that formula. Those changes are likely to benefit his constituency.

[Daniel Zeichner]

We had a discussion last week, but the Minister was unable to answer my question so I will try again. Is Cambridgeshire’s clinical commissioning group correct that it will have less money to spend on providing health services next year than it does this year?

[Stephen Hammond]

As I pointed out to the hon. Gentleman last week, we recognise that historically, Cambridgeshire and Peterborough CCG has received less funding per person than neighbouring CCGs, but as I also pointed out to him, the CCG has received an absolute increase of 5.7% in 2019-20, bringing the funding up to £1.1 billion. We had a disagreement about the figures, because I could not agree the figures that he provided. As he knows, I have promised to write to him when I have been able to resolve his figures.

Cambridgeshire and Peterborough CCG: Funding Pressures

Daniel Zeichner Excerpts

Tuesday 11th June 2019 Westminster Hall

[Daniel Zeichner (Cambridge) (Lab)]

The hon. Lady is making a very important speech. I would like to underline that final fact. It feels very much like the situation with our schools, where the Government tell us that we have more money, but teachers and headteachers tell us that we do not. I would like to underline her crucial point: we have less money to fund health services in 2019-20 than in 2018-19. I hope the Minister will be able to explain why.

[Heidi Allen]

The hon. Gentleman, who is my neighbour, is absolutely right. Everyone knows that Cambridge and the surrounding region are growing, yet somehow we are expected to manage on less and less money every year.

Let us bring some colour and real life to the situation. The provision of in vitro fertilisation, of any number of cycles, is totally under question. Hearing aids for those with moderate hearing loss, and community diagnostics, such as ultrasound services, might go, as might vasectomies. The CCG has to reduce its spend on services outside of hospitals by £33 million this year. That means, speaking plainly, significant cuts to community care—everything we are trying to do to stop people from being admitted into hospital, which we know is the most expensive form of care. Every single one of our major out-of-hospital care services is under review.

The Minister will be familiar with a CCG’s “distance from target”, which is how far away a CCG is from what the NHS would consider the fair funding position to be. I can tell him that that will deteriorate yet further to 3.71% by 2019-20 from an already unacceptable gap of 3.5% in 2018-19. That position is simply unsustainable. The goalposts are being moved further and further away. In monetary terms, it means that we are underfunded by £43 million this year. If nothing changes, over the next five years we will be underfunded by £200 million. Our CCG has just agreed the 2019-20 financial plan with NHS England. That agreed plan will show a deficit of £192 million. That just cannot continue. I cannot believe for one minute that the Minister would be content with such a depleted health service.

What are the Minister’s views on what he can do specifically to correct the flawed growth forecasting? How will he address our significantly lower funding per capita? Will he tell me why the problems have not been addressed in the five-year funding allocation? I would appreciate a commitment to an early review of the funding allocation and extra intermediate emergency funding. At this rate, we are going to be cutting just about everything. If that funding is not available, I sincerely ask the Minister to explain exactly how my CCG and its providers are expected to close that deficit gap. Without cutting more health services for my constituents in South Cambridgeshire and for people across the whole Cambridgeshire and Peterborough area, I do not see how the CCG can make ends meet.

--- Later in debate ---

[Stephen Hammond]

I will say two things to the hon. Lady. First, the reflection of the formula and the increase in the money is coming through this year and next year. We have spoken about the additional per capita funding that is coming through.

[Daniel Zeichner]

There is a complicated set of issues surrounding national health service funding, but the CCG is telling us that it will have less money to spend in 2019-20 than in 2018-19. I really just want confirmation from the Minister that that is his understanding too.

[Stephen Hammond]

All I have are the percentage increases in additional per capita funding for 2018-19 and 2019-20. I will seek inspiration to confirm the absolute totals, and if that inspiration reaches me while I am still on my feet, obviously I will relay it to the hon. Gentleman. If not, I am happy to confirm that I will write to him.

My point is that the NHS England allocation is based on the ACRA assessment and on the change in the funding formula. The hon. Member for South Cambridgeshire and the hon. Member for Cambridge rightly point out that, historically, the funding of their CCG has not been equivalent to that of local areas. That historical funding disparity is being improved, and is moving back towards the target of funding for CCGs over the next two or three years. I pointed out that last year there was a funding increase of 2.7%, and there will be one of more than 5% this year.

--- Later in debate ---

[Daniel Zeichner]

We could probably swap numbers for the remaining 11 minutes of the debate, but I am told that the CCG has additional nationally mandated commitments that exceed the extra money that it is getting, which is the nub of the problem. The overall problem, however, is that the Prime Minister has been going around telling people that a huge amount of money is coming into the national health service, but locally it appears that we have less. That is obviously difficult for local people to understand.

[Stephen Hammond]

The Prime Minister has rightly been telling people that there is a huge commitment to put more money into the NHS. Throughout the debate, I have recognised that the moneys that the CCG historically received were below the target for CCGs. I have stated that more money is now coming into the CCG and that NHS England is committed to moving all CCGs to target. Although he may say that is a historical issue, I hope he would also recognise the fact that the Government are putting more money into the national health service and that that money is coming to his area.

That brings me to the point I wanted to make about wider funding. The Government are making a commitment and backing the NHS with an extra £20 billion a year by 2023, which will be reflected in the resources available to CCGs.

[Daniel Zeichner]

I note, however, that my reading of what is happening to the CCG is that it has already spent a lot of the money that is coming through, so it will mean not more money, but dealing with past debt. Again, could the Minister confirm that that is in fact the case?

Oral Answers to Questions

Daniel Zeichner Excerpts

Tuesday 7th May 2019 Commons Chamber

[Stephen Hammond]

The hon. Lady raises a very important matter. The Government recognise the concerns that have been expressed by NHS doctors, and my right hon. Friend the Secretary of State is engaging in numerous conversations with the Chancellor. I am reluctant to give a running commentary on the nature of those internal discussions, but I can say that we hope to resolve the matter soon.

[Daniel Zeichner (Cambridge) (Lab)]

4. What discussions he has had with the Secretary of State for Education on the provision of NHS mental health services for university and college students.

[The Parliamentary Under-Secretary of State for Health and Social Care (Jackie Doyle-Price)]

The Secretary of State for Health and Social Care met the Secretary of State for Education in February to discuss concerns about mental health and the prevalence of self-harm among young people. “The NHS Long Term Plan” states that we will

“extend current service models to create a comprehensive offer for 0-25 year olds”,

and I expect to have regular dialogue with our counterparts in the Department for Education to make that a reality.

[Daniel Zeichner (Cambridge) (Lab)]

The all-party parliamentary university group has heard consistent evidence about the rising number of students presenting with mental health problems. We have been told that it has increased sixfold in the last 10 years, from 9,675 to 57,000. That poses huge challenges to what used to be counselling services but are now becoming a mainstream part of health provision, funded by universities. What are the Government going to do about it?

[Jackie Doyle-Price]

Young people often fall out of care when they leave their home addresses to go to university. To deal with that transition, we extended the service to nought to 25-year-olds through the forward plan rather than cutting it off at adulthood. That will ensure that we can do more to achieve continuity of care.

I pay tribute to the efforts that universities have made. They have seized on the challenge posed by the increasing prevalence of mental health problems, and I will continue my dialogue with them.

Human Medicines (Amendment) Regulations

Daniel Zeichner Excerpts

Monday 18th March 2019 Commons Chamber

[Jonathan Ashworth]

I thank the right hon. Gentleman. He is quite right to raise those concerns about patients with epilepsy, which I will touch on in the course of my remarks, echoing the point that he made with great eloquence.

These changes represent an extraordinary power grab. Ministers should have brought them to the House for proper scrutiny, and then, of course, they should have gone out for proper consultation with patients, patient groups and health stakeholder. That is why the Academy of Medical Royal Colleges stated that it is

“inexplicable and unacceptable that an issue of this importance is not the subject of wide consultation and that medical royal colleges as doctors’ professional bodies were not specifically engaged in the process.”

The British Medical Association said that it

“should have far more time to adequately consider the Government’s proposals for change.”

That is why we have brought this prayer motion and why I am pleased that we have the opportunity to debate these proposals today.

It is worth saying a word about the context in which we debate these proposals. Notwithstanding the confusion on the Government Benches about when we actually do exit the European Union—the Under-Secretary of State for Exiting the European Union, the hon. Member for Spelthorne (Kwasi Kwarteng) has given us no greater guidance today in his remarks at the Dispatch Box—it is worth recalling that, as The Lancet said only last month, Brexit, especially a no-deal Brexit, will affect the healthcare workforce, NHS financing, the availability of medicines and vaccines, the sharing of information and medical research.

Our effective joint working with our European partners has been vital for the NHS over recent years, in everything from infectious disease control to the licensing, sale and regulation of medicines. Developing new medicines depends on the international co-operation that is fundamental to accessing clinical trials. Patients in the UK are currently able to access EU-wide trials for new treatments, and the UK has the highest number of phase 1 clinical trials across the EU.

Thanks to the strength of our pharmaceutical base, every month, 45 million packs of medicine move from the UK to the EU, with 37 million packs going from the EU to the UK. We know that 99% of the insulin used in the United Kingdom is not manufactured in the UK. Current EU legislation allows for the legitimate trading of medicines quickly and swiftly cross-border, but the cost of no deal could see pharmaceutical products subject to 44 separate checks and controls at the borders, hugely delaying access to medicines.

[Daniel Zeichner (Cambridge) (Lab)]

My hon. Friend is making some very important points. I wonder whether he has seen the advice from the UK BioIndustry Association, which knows what is going in the life sciences sector and says:

“Despite the expertise and efforts of the MHRA…with 12 days …until Brexit, being prepared for a ‘no deal’ is an impossible task”.

[Jonathan Ashworth]

I thank my hon. Friend. As the Member of Parliament for Cambridge, he works very closely with the life sciences and pharmaceuticals industries and is a great champion for them. He is quite right to raise those concerns—although it is not clear if we are leaving in 12 days because, as I said, the Minister at the Dispatch Box earlier was pretty hopeless in giving the House any clarity on that matter. I suppose we will have to wait for further statements from the Government tomorrow, unless the Health Minister wants to clarify matters for us in a moment.

One of the issues that the organisation my hon. Friend mentioned is concerned about is the parallel trade in medicines, where pharmaceutical exporters seeking to profit from currency fluctuations could see medicines intended to meet UK patient requirements being quickly distributed out to the EU because of the advantage that a fall in sterling, perhaps, could accrue to them in those circumstances. This is why we have seen widespread concerns about medicine shortages in the event of no deal.

Exiting the European Union (Medicines)

Daniel Zeichner Excerpts

Tuesday 19th February 2019 Commons Chamber

[The Parliamentary Under-Secretary of State for Health and Social Care (Jackie Doyle-Price)]

I beg to move,

That the draft Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019, which were laid before this House on 23 January, be approved.

Before I discuss the regulations, it is important to reiterate that we wish to retain the closest possible working partnership with the EU to ensure that those engaged in clinical trials can continue to develop innovative and cost-effective treatments and that patients recruited in trials can continue to have timely access to medicines. However, we are bringing forward this legislation to continue preparations for no deal, in case we need to be prepared for that eventuality.

In developing this amending legislation, my Department’s priorities have been to minimise any disruption to ongoing trials and to make sure that the UK regulator can still protect public health and, importantly, that the UK’s biomedical, health and life sciences research sectors can continue to be world-leading. With that in mind, the Medicines and Healthcare Products Regulatory Authority has sought to take a pragmatic and proportionate approach in establishing the new regulatory requirements. Importantly, that has been done through continued close co-operation with stakeholders. After a period of informal consultation in August, the MHRA published an initial proposal, and it followed that up with further consultation. The feedback from that consultation, which received over 170 responses, led to the statutory instrument before us.

Let me bring a few details to the attention of the House. First, wherever possible, we have sought to maintain existing arrangements. Given that the system for clinical trials is currently based on national-level decision making in the EU and globally, we have not had to make any substantial change in some key areas. In particular, on the ability of the UK to participate in multinational trials in the EU or in the rest of the world, there will be no change. Also, the data gained from trials in the UK can still be deposited in international repositories and be accessed by others. I think the House will agree that that reflects our approach, which is to continue multinational co-operation on clinical trials.

In other areas, we have faced a choice regarding the UK’s regulatory requirements. In those instances, we have sought to maintain current arrangements, provided that the regulator still has sufficient ability to protect public health. For example, we will continue to recognise existing approvals, so there will be no need to reapply for both regulatory and ethics approvals. We will have the same information requirements as the EU for any new applications for multi-state trials in the UK. There is also a requirement that a clinical trial sponsor or legal representative for clinical trials in the EU should be based in the EU. That will ensure continuity of the existing clinical trials landscape and maintain the UK as an attractive, open environment in which to conduct clinical trials.

[Daniel Zeichner (Cambridge) (Lab)]

The Minister is making an important speech. Does she recognise industry concerns about the introduction of an extra level of regulation through the proposals for a qualified person requirement? There is a worry that it will make our country a less attractive place to conduct clinical trials, which are, of course, extremely important to my part of the world.

[Jackie Doyle-Price]

I appreciate the hon. Gentleman’s point. Perhaps I can reassure him by emphasising that the UK is committed to establishing a far-reaching science and innovation pact with the EU to facilitate the exchange of research and ideas, so we continue to maintain the competitiveness to which he refers.

In bringing forward these proposals, we have been determined to establish our pattern of regulation from outside the EU if need be, but as much as possible we wish to continue with business as usual. We will continue to engage with the sector to maintain competitiveness, because we fully appreciate the value of the life sciences sector to our economy.

--- Later in debate ---

[Jackie Doyle-Price]

My objective this afternoon is to make sure we can continue with business as usual on exiting the European Union, but clearly once we have left the European Union that would be open to us. The ethos behind the regulations and the consultation we have had with the sector very much recognises that this is an international market place. We must ensure that in taking forward these requirements we remain competitive.

As I was saying, we will require the same information requirements as the EU for any new applications for multi-state trials in the UK. There is a requirement that a clinical trial sponsor should be based in the EU. There are a few areas where it has been necessary to add a new requirement, as a result of the UK no longer being part of the European regulatory framework, relating to the MHRA putting in place a new national IT system for safety reporting and submissions. In addition, investigational medicinal products, known as IMPs, imported from the European Economic Area will now require an import licence, as they would no longer be part of the single market. As the hon. Member for Central Ayrshire (Dr Whitford) said, they will be overseen by a qualified person to ensure that the products are appropriately certified. That builds on the existing import licensing system, which allows the transport of IMPs direct from the EEA to UK trial sites to continue. Recognising that this is a new system, we have provided stakeholders with a 12-month transition period from exit day before it comes into force.

While not specifically covered in this statutory instrument, I would like to reassure Members that the Government are engaging with organisations running clinical trials to ensure continuity of supply and that drugs continue to be received. The Government are undertaking a comprehensive deep dive into clinical trial supplies to gain detailed understanding of what is required, and are putting place contingency plans in case the sponsors need them. They will include access to the same prioritised shipping routes that will be available for all other medicines.

As I mentioned in response to the hon. Member for Cambridge (Daniel Zeichner), the Government are committed to ensuring that the UK remains one of the best places in the world for science and innovation. Members should note the Government’s commitment to aligning with the EU’s new clinical trials regulation as far as we can, without delay, when it does come into force, subject to the usual parliamentary approvals.

[Daniel Zeichner]

Will the Minister also comment on the concerns raised by organisations such as Cancer Research UK about future pan-European trials, for which it would appear that the sponsor or lead would have to be from within the EU rather than within the UK?

[Jackie Doyle-Price]

As I said in response to earlier questions, the Government’s approach is that this an international marketplace. We clearly want access to the best possible medicines and to ensure that we can continue to co-operate and share that information as best as possible. I fully expect the MHRA to share that information with the European regulators, as it currently does. Regardless of EU exit, the MHRA and partners across the UK healthcare ecosystem are already taking steps to improve the UK clinical trials application process to ensure that it is as seamless as it can be.

In conclusion, in the event of a no deal, these regulations will put in place a pragmatic solution that ensures that the UK’s clinical trials legislation continues to function effectively after exit day. Essentially, we want this to be business as usual following exit, and I commend this statutory instrument to the House.

Oral Answers to Questions

Daniel Zeichner Excerpts

Tuesday 15th January 2019 Commons Chamber

[Steve Brine]

Yes, I will. I spoke at the launch of Bloodwise’s excellent report at its parliamentary reception last week. I have been clear since the new ambition was announced that the 75% target applies to all cancers, and we will not achieve it unless we focus on harder-to-diagnose cancers, such as blood cancer.

[Daniel Zeichner (Cambridge) (Lab)]

Given that the number of people suffering from rare diseases in any one country is always likely to be small, and given our changing relationship with the European Medicines Agency and the European medicines market, what is the Minister doing to ensure that the future development of orphan drugs in this country is safeguarded?

[Steve Brine]

The hon. Gentleman will know that the draft withdrawal agreement hopefully sets us on a relationship with the EMA, but the UK’s strategy for rare diseases, which was published in 2013, sets out our commitment to improve the diagnosis and treatment of patients with rare diseases and to end the diagnostic odyssey that has been referred to throughout the past few years.