Covid-19 Update

Chris Green Excerpts

Tuesday 9th February 2021 Commons Chamber

[Matt Hancock]

No, I do not agree with the hon. Lady. I reassure every one of her constituents and all citizens across Northern Ireland that we work closely with the Government in Dublin to ensure that data is shared properly and that both Governments have an appropriate system to safeguard our borders against the challenges that we face while allowing free travel within the common travel area.

[Chris Green (Bolton West) (Con)]

I welcome my right hon. Friend’s commitment to making a contribution to the roadmap on 22 February on the understanding of the impact on mental health of children and families. Will he commit to publish that in advance, to make sure that parents know that all of their concerns are being addressed and that they have an opportunity to make a contribution to it?

[Matt Hancock]

I will look into my hon. Friend’s suggestion.

Covid-19

Chris Green Excerpts

Tuesday 12th January 2021 Commons Chamber

[Chris Green (Bolton West) (Con)]

I thank the Minister for Health for the way in which he opened the debate, with a sense of respect for people with all sorts of opinions on this matter. We ought to be able to reflect different views as part of a healthy debate. I pay tribute to my right hon. Friend the Member for North Somerset (Dr Fox), who is not here at the moment, for speaking about the importance of the use of data, and ensuring that it is not manipulated or abused.

From the very beginning the Government have had a clear plan for how we leave this awful cycle of lockdowns, and it has always been through vaccinations. That goal is now being delivered. We are at a very early stage of the process and it may be lumpy, but there is that commitment to have 13 million of the most vulnerable people in the country at least offered the vaccination by mid-February. The vast majority of those people will take up that offer. In fact, 85% of people expressed an opinion that they wish to take up the vaccination if it is offered. We can see a clear way out once those first four cohorts have the vaccination by mid-February, with two more weeks in order for the vaccination to take its full effect.

With that success, we should all expect to see a reduction or a lightening of the load in terms of the lockdown. People have carried this burden through all this time, since March last year; they need to see the light at the end of the tunnel, and the lightening of the lockdown restrictions following the success of the Government’s vaccination programme. Many of my constituents are enthusiastically looking forward to their vaccinations, especially in Horwich, where they are looking forward to the use of Bolton Wanderers’ football ground, the Macron stadium, for this purpose. Hopefully the Minister will be able to comment on whether the ground is going to be used for the inoculation programme. The Royal Bolton Hospital and Wrightington, Wigan and Leigh NHS Foundation Trust are doing an enormous amount of good work. I pay tribute to everyone working in shops, the council, hospitals or care services for the work that they are doing. But with the first goal of delivering the vaccination, we also need to see the lightening of the lockdown load.

The third goal—to get the hat trick—ought to be consideration of whether we need to renew the Coronavirus Act 2020. By renewing it, we set out for many people a fear that lockdown will be resumed in the autumn. By not renewing it, we are telling people, “You can resume your education. You can start your business again. You can feel confident of getting that health treatment,” and we get that recovery going.

[Mr Deputy Speaker (Mr Nigel Evans)]

I call Catherine West next, but Jim Shannon ought to be on standby, because we have a problem with the following speaker’s video link.

Public Health

Chris Green Excerpts

Wednesday 30th December 2020 Commons Chamber

[Chris Green (Bolton West) (Con)]

One concern that I share with the hon. Member for Birmingham, Selly Oak (Steve McCabe) is about the certainty and clarity of the tiering system and what can be seen as a slightly erratic aspect of that. I appreciate that from the Government’s perspective it is very difficult to judge the impact that tiering will have. As the spread of the virus evolves, it is difficult to have a cast-iron guaranteed view of it, so of course there will be uncertainty in this area, and I think we all appreciate that.

One area where we ought to have a bit more clarity, however—a point well made by many colleagues—is the overall impact assessments that we ought to have for the lockdown. What impact does the lockdown have on employment and business? What impact does it have on health, whether we are thinking about cancer and heart disease, or cataract surgeries and hip replacements? We must also think about the impact on education, which is particularly pertinent today, given the statement by my right hon. Friend the Secretary of State for Education.

We ought to know more clearly about those issues, because we have the experience of the impact on people’s health and education, if they are excluded from education or they do not get their healthcare. We ought to have a greater sense of that, and the Government should have the ability to share that data so that we are better informed when we come to a vote. I also appreciate that when we are looking at tier 4—it was a little bit of a surprise, but not a complete surprise, when it was announced at the beginning of Christmas—we can see why the Government would feel that it had to come in, because of this mutant strain, or variation on a theme, of severe acute respiratory syndrome coronavirus 2.

We appreciate why tier 4 came in, but it was very disappointing, as someone who represents Bolton and can see the impact of having slightly harsher conditions than much of the rest of the country, to see the south-east of England being plunged into tier 4. It was disappointing today to see Bolton as well as Wigan borough—I represent both boroughs—being put into tier 4. It is disappointing that there has not been the opportunity to have a vote on that today, but there may be an opportunity for a vote on what has already been implemented and imposed this year. It would therefore be useful if we could vote in advance and have that data and information so that we can make an informed decision when we vote and get a sense of the impact. Yes, the data on the spread of the virus will not be perfect, but we should be better informed about the impact of the lockdown on our society.

How tiering is imposed is also concerning. For example, Wigan and Bolton boroughs—I represent both—have a lower transmission rate than all the boroughs in the Liverpool city region, yet Liverpool city region is in tier 3 while my constituents are in tier 4. Earlier in the pandemic, the Secretary of State for Health was very clear that individual areas—this is represented now by Slough, I think—can be taken out of a wider lockdown, such as that imposed on Greater Manchester. We would appreciate being withdrawn from tier 4 and perhaps going to tier 3 or lower as soon as possible.

My hon. Friend the Minister for Care might not have the information to hand, but I would like her to look into that and report back, perhaps working with colleagues in the Department for Education, as soon as possible. We know that there will be far more testing in tier 4. We know that the Government’s plan is to have far more testing in schools, and we know that with each positive test, a class or perhaps even a year will be sent home. That has a major impact on children’s education. For months children were excluded from schools and, in the term we have just had, many will have been excluded not once or twice but three times. That means for six weeks. We know that this is set to get worse in the coming year, because there will be far more testing and therefore far more positive tests, which will mean the exclusion of those children. Can we at least have an assessment of the impact of this tier 4 lockdown on those children?

Covid-19

Chris Green Excerpts

Thursday 22nd October 2020 Commons Chamber

[Chris Green (Bolton West) (Con)]

The Government and the whole of British society have made an amazing response to covid and to the challenge that we have faced. We knew very little about it at the beginning, but we have evolved and adapted with time. Society now is so different—who would have believed at the beginning that we would be in this position now, sanitising our hands every time we went into a shop, wearing masks and socially distancing?

We know far more today than we did then, and we understand the impact and cost of covid, but we are also in an increasingly good position to understand the cost of the lockdown. We hear figures about millions of cancer screening appointments and tens of millions of GP appointments not being taken up, and we understand far better that in the weeks, months and years ahead there will be a huge cost from the lockdown, but the details have not been adequately explained to the British people as a whole or to right hon. and hon. Members of Parliament. We heard moments ago about colleagues asking questions—quite reasonable, quite straightforward questions—and getting a six-word answer.

I have written to the Secretary of State to raise concerns about Bolton, which has been in a particularly difficult position with a rather severe lockdown. Constituents tell me about the impact on their mental health, their physical health and their ability to get treatment—it has a cost. I wrote to the Secretary of State on 29 September to raise concerns that in Bolton borough 20,000 fewer people than last year have had a referral from a GP to hospital. Serious treatments have not been taken up as a result. This is serious—it is life and death—for my constituents, and I think it is replicated around the country.

I have yet to receive a response to my letter, but I do have an answer to my written question about what action has been taken in relation to the 20,000 fewer referrals from GPs to hospitals this year than last. The answer that came back was:

“No specific assessment has been made.”

That is 20,000 people in Bolton as a whole whom GPs think should have a hospital appointment of one form or another. I do not know how many of that 20,000 would be in the category of life or death, but I suspect a very significant number. I suspect that this would be replicated right across the country. To get a six word answer —“No specific assessment has been made”—to cover that 20,000 is disappointing to say the least. It is also covering a health time bomb that will explode. That is already happening at the moment. Far more needs to be done so. Will my hon. Friend commit to delivering a covid lockdown health impact assessment for every constituency around the country?

Covid-19 Update

Chris Green Excerpts

Thursday 17th September 2020 Commons Chamber

[Matt Hancock]

We need to do both. I would just ask the hon. Lady to look at the work the SNP Scottish Government are doing. They are themselves employing and deploying some of the new technologies.

[Chris Green (Bolton West) (Con)]

In Bolton, the national lockdown has been followed by the local lockdown and economic lockdown. Positive covid cases are rocketing up, and that is having a devastating impact on people’s physical and mental health, as well as people’s livelihoods and businesses. Many people are heading out of the borough to get beauty treatments, and to go to pubs and restaurants. At the same time, the testing system is failing to deliver, so people are increasingly going to accident and emergency departments in Bolton and Wigan in the hope of getting a covid test. What actions is my right hon. Friend taking to deal with that?

Independent Medicines and Medical Devices Safety Review

Chris Green Excerpts

Thursday 9th July 2020 Commons Chamber

[Ms Dorries]

Every recommendation in the report is a priority and everything will be given equal consideration. I hope that either I or the Secretary of State will be able to come back to the House as soon as possible after the report has been evaluated in full and make our own recommendations at that time.

[Chris Green (Bolton West) (Con)]

I thank my hon. Friend for her statement. Will she confirm that the Medicines and Medical Devices Bill incorporates steps to establish a database of medical devices, including information about device safety, which is a key part of the Cumberlege review? I wish to pay tribute to the many campaigners for their tireless work and, in particular, to my neighbour the hon. Member for Bolton South East (Yasmin Qureshi) for her work on Primodos.

[Ms Dorries]

I thank my hon. Friend for that. The Bill makes it clear that patient safety is paramount in any regulatory change on medicines and medical devices in the future. The Bill will allow us to implement a framework to continue to update and amend the Medical Devices Regulations 2002 and the Human Medicines Regulations 2012 to respond to patient safety concerns. It already explicitly set out provision of the medical device registers and information gateway, which will allow the Secretary of State or the Medicines and Healthcare products Regulatory Agency to disclose information about medical devices to the NHS family.

Innovation in the NHS

Chris Green Excerpts

Tuesday 3rd March 2020 Westminster Hall

[Chris Green (Bolton West) (Con)]

I beg to move,

That this House has considered innovation in the NHS.

It is a delight and a pleasure to have secured this important debate. We are going through an incredible time, with advances in technology across so many different fields, and there is a big question about how the national health service can adopt this important technology that makes such a difference to people’s lives. There is so much potential in the healthtech sector that has led to a transformation in patient outcomes, and that capacity must be expanded within the national health service. Some good work has already taken place to deliver innovation within the NHS, through the structures and approaches established by NHS Digital, Health Data Research UK and NHSX, which is creating the right framework to deliver innovation. However, if the true potential of the NHS is to be harnessed and if innovation is to feed through to trusts right across the country, there needs to be a dramatic acceleration of health technology.

Despite the presence of innovation accelerators such as HS. and bodies such as the Accelerated Access Collaborative, designed to find ways to help innovation products reach patients more quickly, there remain barriers that restrict the ability of healthtech businesses to scale effectively and get their products to market. The first challenge is the speed of the pathway to adoption. NHS Improvement estimates that it takes an average of 17 years for a new product or device to go from successful clinical trial to mainstream adoption, a figure that was highlighted by the Secretary of State earlier this year. Considering the rapid pace of technological change, that is a very concerning statistic for the healthtech business.

Historically, a good deal of that time was taken up by National Institute for Health and Care Excellence appraisals. In 2012, statistics released about the timelines for appraisals showed that the average time for multi-technology appraisals was 5.5 years, and about 2.5 years for single-technology appraisals. The Minister might be interested to know that I will host an event in a couple of weeks, in conjunction with AbbVie, to launch a report entitled “Bridging the Gap between Clinical Trials and Real-World Practice”. That research found that breakthrough medicines that might address high unmet medical needs and have been earmarked for fast-track approval are approved on average one month later than non-prioritised medicines, meaning that patients have slower access to those medicines.

Overall, that report found that approval processes take significantly more time in England than in other European countries, including Germany and France. It also found that NICE is more likely to place restrictions on new medicines than are other countries. On a more positive note, although NICE takes longer to assess medicines, it has one of the highest approval rates among health technology assessment bodies, meaning that a greater number of medicines are available. Although there have been significant positive improvements to the process since 2012, which have greatly accelerated it—for example, the medical technologies guidance, as well as the digital health technologies pilot scheme within that guidance—a lot more needs to be done so that those benefits can reach across the entire health sector.

A bigger concern is the funding opportunities available to healthtech businesses when they have an appraisal. Funding is obviously one of the most important building blocks for growth, but even if a healthtech business has had a NICE appraisal, there is no guarantee that its product will be adopted within the national health service. The medtech funding mandate and schemes such as the AI innovation award within the AAC are welcomed, but there should be greater emphasis on ensuring that centres are allocated the required funding from the NHS, so that they can pay for the devices and services and utilise them to improve patient outcomes.

Furthermore, the current criteria for the inclusion of new medical devices are based on how savings are generated within one year, which can be challenging given the higher up-front costs. For example, complicated surgical implants can be expensive, but can save money for the system through reduced spending on drugs and social care. There are also incoming regulatory barriers that will harm the healthtech sector’s ability to sell its products and the UK’s ability to be a competitive market for innovation. At present, medical devices are operating within the three-year transition period that ends in May 2020, after which devices on the market must fully comply with the medical devices regulation. There is a concern that the lack of notified bodies designated under the MDR may prevent the industry from getting life-changing products to market.

Currently, at a time when the industry will be rushing to ensure its devices are compliant with new regulations, only six notified bodies across the EU are authorised to accept work related to the forthcoming MDR. It is of concern that there is only one notified body in the UK, the Medicines and Healthcare Products Regulatory Agency. There are growing concerns across the industry that a bottleneck will emerge, potentially causing innovative and cost-effective technologies to be taken off the market as they wait to be certified again under the MDR. In a recent Med-Tech Innovation survey, only 4.8% of businesses said they were sufficiently prepared for the new MDR, despite 55% of businesses having begun preparations for those changes over 12 months ago. That shows the extent to which the lack of notified bodies is affecting the sector.

The UK’s departure from the EU presents an opportunity for the UK to establish itself as an international hub for certifications. Furthermore, with both the NHS long-term plan and the Government’s prevention Green Paper highlighting the importance of technologies in easing pressures on health services, it is vital to ensure that new regulation does not instead stifle innovation or discourage global medical device manufacturers from entering the UK market. I am also pleased by the Government’s ambitious strategy to maintain the UK as a global leader in the life sciences, reflected in the life sciences sector deal and their commitment to spend 2.4% of GDP on research and development by 2027. We must make sure that the medical devices sector and the life sciences sector more broadly get their fair share of that investment in R&D.

There are therefore positives that we can point to, but there are still challenges that are holding back innovation. Although the work of the academic health science networks in spreading and driving innovation across the regions of England is welcome, large variations remain, especially in individual centres’ attitudes towards health technology. AHSNs continue to play an important role in spreading best practice and therefore reducing variation across regions; however, the challenges facing healthtech companies in this area should not be underestimated. One challenge faced by technologies as they attempt to become adopted across the NHS relates to the differing nature and characteristics of individual centres. Due to the differing priorities and attitudes of centres across the country, medical device companies must employ different approaches as they roll out across the country. That inevitably delays the adoption of new technologies across the NHS, since individual companies must develop complicated strategies for each local business case. Some areas have more streamlined processes for adopting innovation, but it is by no means uniform, and will further the inequalities in healthcare between different regions. If a more joined-up approach towards innovation adoption were implemented across the NHS, medical technologies could be rolled out more quickly so that centres with the most need could access them.

In health and other sectors, it is always important and necessary to have leadership. I often hear about different trusts and centres that have strong leadership and that can, therefore, drive change. Other centres without such strong leadership are holding themselves back. I will discuss the chief innovation officer position later.

The UK’s great potential for data research is well known. The UK has some excellent datasets, globally leading data scientists and the ambition to make the UK the home of data-driven life sciences research and innovation. In terms of data collection, however, the national health service does not behave as a single organisation. The potential of health data cannot be fully realised until structures and processes enable the interoperability and straightforward accessibility of datasets across the country.

Moreover, health data is globally competitive, with significant investment being made in improving the health data environment in other countries, including the USA, Germany, Israel, France and China. It is not an exact science, but NHS England estimates suggest that harnessing data and delivering on digital plans for the NHS could unlock productivity benefits of about £10 billion a year, allowing for greater investment in other priority areas.

An example of the industry working closely with health service bodies to tackle those challenges is the academic health science networks’ production of an atrial fibrillation toolkit that concisely outlines the relevant data for innovators working to prevent AF-related strokes. The toolkit provides innovators with data on the proportion of patients in a local area diagnosed with AF who have not been anticoagulated and encourages innovators to gather local knowledge on waiting times, pathways and referral criteria.

Unlocking the potential of patient data is key to driving forward research and innovation. The NHS is a rich and unique source of patient data, but public trust and confidence in the use of data is vital. The public need to feel that they can trust and have confidence in the health and social care system to share their information with care and confidence. People want to share their data, but they want to be confident that when their data is being shared, it will be used in the right way by the right organisations.

People are not necessarily hugely concerned by the private sector having access to their data, but they need more reassurance and more confidence in the anonymity that is provided in the data and in the control of the extent to which the data is given to companies, so they cannot just pass it on to other organisations. If the public do not trust the system, they will be unwilling to share their data for research. Ultimately, everyone is a loser from that—charities, the NHS and patients; there will be significant disadvantages across the sector in the UK.

It is essential that we continue to enhance the UK clinical research environment to ensure that global companies look to the NHS first when setting up trials for breakthrough therapies. An essential element for attracting R&D investment into the UK and reaching the Government’s target of 2.4% of GDP is to enhance the UK’s commercial clinical research offer.

Despite the significant size and growth of the global market for clinical research, the UK’s share of clinical trial applications and patient recruits has fallen since 2016, with the UK falling behind the USA, Canada, Germany and Spain for commercial clinical trials. We must build on our strong scientific base and on existing NHS infrastructure and expertise to grow the UK’s share of the global market and improve its commercial clinical trials offer.

The industry already supports the Government’s commitments to clinical research in the life sciences industrial strategy, sector deals and the NHS long-term plan. To be at the forefront of clinical research, however, there needs to be a simplification of the processes for setting up and running clinical trials, harnessing the UK’s data infrastructure for medicines and R&D, embedding patient involvement in clinical research and ensuring continuing high standards for transparency.

In my view, the challenges of adopting innovation in the NHS result, to some extent, from a lack of leadership in the NHS. The Secretary of State leads the way on getting health technology into the system. We need that culture to be better established in the national health service. No one within NHS trusts is specifically addressing the issue as part of their job. If more people were appointed to the chief innovation officer position in NHS trusts, the adoption of innovation might be accelerated. At the moment, about 20 chief innovation officers are in place. More such appointments would do two things: first, accelerate the adoption of innovation in the national health service and secondly, drive innovation and improvement to challenge and bring up to date legacy systems in the NHS.

In conclusion, I reiterate that there are many positives and much good practice to draw on, and there is no lack of ambition to place the NHS at the forefront of innovation. I look forward to the Minister’s remarks.

Medicines and Medical Devices Bill

Chris Green Excerpts

2nd reading & 2nd reading: House of Commons & Money resolution & Money resolution: House of Commons & Programme motion & Programme motion: House of Commons & Ways and Means resolution & Ways and Means resolution: House of Commons
Monday 2nd March 2020 Commons Chamber

[Chris Green (Bolton West) (Con)]

It is a pleasure to follow the hon. Member for Leicester South (Jonathan Ashworth) and to speak in this important debate. This is an immensely important subject of great national interest. In the context of leaving the European Union, the Bill will allow existing European Union regulations on medicines and medical devices to be transposed into UK law. The Bill is closely linked to the timings of the transition period as we leave the EU—and perhaps to any extension, which we hope to avoid.

I welcome the Bill’s principal thrust, which is to remove unnecessary bureaucracy for the lowest risk clinical trials, to encourage the rapid introduction of new medicines, to ensure patient safety by combating counterfeit medicines, and to extend the UK’s global lead in personalised medicines and artificial intelligence in health. Ultimately, all those concerns link up to what ought to be our principal focus in this debate: better patient outcomes and creating a healthier society.

Many people would be surprised to hear just what a contribution the life sciences sector makes to the UK economy. It encompasses pharmaceuticals, medical devices and medical technology, and it is worth over £74 billion per annum. The sector also employs close to 250,000 people in the UK. Many of those jobs are often secure, and are highly skilled and highly qualified. We will shortly introduce an immigration Bill. It is right that we focus on the skills and the contribution people can make to the UK. Bringing more people to the UK with PhDs and STEM—science, technology, engineering and maths—qualifications ought to complement and enhance the support of our life sciences sector. The more we hear about technicians, engineers and scientists who want to come to the UK, the more it will be a really positive thing not only for the sector but for immigration to the UK as a whole, and how people perceive it.

[Dr Whitford]

Does the hon. Gentleman recognise that young graduates with a degree or a PhD, technologists and researchers often do not earn more than the threshold the Government have set for a visa?

[Chris Green]

That is a significant concern. The Government have reduced the starting point in the immigration Bill from £30,000 to about £25,000 and I believe the points-based system will have the flexibility we require, but those areas should be judged and reviewed as time goes on. Certainly in these sectors we want highly qualified, highly skilled and highly experienced people to come to the UK.

One big concern in medicine is data. A lot of what we do in medicine falls into the category of big data: the acquisition, transmission, storage and application of that data. This is a really interesting time for technology. The devices themselves are able to generate good quality data. As has been highlighted, it is now so much easier for personal devices to be worn not just for a few hours or a couple of days, but for a long period of time. People are now able to go about their daily lives in a normal way, whether they are exercising or doing something as basic as having a shower. Some devices could not previously cope with people taking exercise or having a shower, but increasingly, devices are able to cope. They can amass a vast amount of data. It is pretty much impossible for a clinician or a GP to judge such a huge wealth of data, so we are increasingly looking at how GPs and hospital consultants can use artificial intelligence and other methods to give them a helping hand in carrying out the assessments. They might end up with tens of thousands of pages of data and a consultant just will not have time to consider it all. Using artificial intelligence could help them to do the assessments and come to conclusions.

[Munira Wilson (Twickenham) (LD)]

Does the hon. Gentleman agree that all Members, on both sides of the House, still have a big job of work to do with the public to inspire confidence in how their data is used in an appropriate and anonymised way? What he is saying is really important. Data saves lives and can improve outcomes, but there is, understandably given previous experiences, a great deal of suspicion among the public about how their medical data might be used.

[Chris Green]

That is an incredibly important point. We need confidence that when data is taken, it is secure, protected and anonymised in the appropriate way, and that only the right organisations have access to it. I believe that data is a key area for the NHS and what it ought to be able to deliver. The NHS should be a huge repository of data, and universities, charities and businesses, with the appropriate controls, ought to be able to use it. As we move on—perhaps a particular aspect relates to rare conditions—the size of population needed in order to gather and analyse that data will increase. I hope my hon. Friend Minister will take note of this point and perhaps elaborate on it at the end of the debate. We need to ensure that our relationship with the EU will enable us to continue to collaborate on clinical trials and that data transmission across the European Union, and across Europe more widely, is efficient and effective.

[Dr Luke Evans]

My hon. Friend talks wisely about big data. Big data can be used to empower patients as individuals. Providing them with more data to understand and interpret, if it is provided in the right way, can empower them to make better choices. After all, the biggest under-utilised resource we have in healthcare is our patients. Healthcare is very doctor-heavy and nurse-heavy. Empowering patients helps them to make better choices. For example, patients with diabetes can monitor their own blood sugar. That has revolutionised the way in which people care for themselves. I would like my hon. Friend’s thoughts on whether he thinks we should explore this area further.

[Chris Green]

That is a vital and well-made point. Data can empower the individual. They can have more detailed access to their own records and their own data. The data generated by someone wearing a device day in, day out, week in, week out can be transmitted to a consultant, who can call a patient more promptly if there is anything a little worrying. If there is a heart murmur or someone feels a bit dizzy, the person can register that concern at that moment. That is useful information for the clinician, who will be able to recognise when someone’s lifestyle has aggravated a condition. There are many ways that the data can be used. I think we are in relatively early days. I am not sure I would include Fitbits and that kind of technology—there is far more interesting and advanced technology—but it is important that people are increasingly engaged.

There is a concern about the embrace of technology, devices and data, and the streamlining of processes in hospitals. The contribution of individuals, GPs and consultants provides an opportunity to consider a more engaged approach to hospital and GP services in a way that could reduce the number of appointments that are necessary. Some hospital trusts have a chief innovation officer on their board. I think there are about 20 across the country, which is a relatively small proportion. It may be worth considering what the Minister can do to promote that. Ideally, we need the early adoption of approved medicines in the system. This is where the register ought to help. If we can have people in hospital trusts leading and championing the adoption of new technologies, providing information and insight, perhaps we can give more confidence to chairmen and boards as a whole. We could then have more trusts adopting technologies. We could therefore support the industry and patients, and get them the medical treatment they need earlier.

[Dr Whitford]

That might well be the case with gadgets, devices or new digital apps, but with new drugs, it is usually the clinicians who are desperate to get their hands on them. Most new drugs, particularly for challenging conditions such as cancer, are expensive and it will be several years before they are passed by NICE in England or the Scottish Medicine Consortium. The delay is not the clinicians not wanting access; it is the cost of introducing them.

--- Later in debate ---

[Chris Green]

I agree—the hon. Lady makes a good point. What I was saying relates more to devices than drugs. Devices and drugs each have their own challenges and we will hopefully make some progress in resolving those concerns.

One of the concerns about the current system relates to the legal framework, which has been criticised for being complex and lacking in consistency and transparency, and it is somewhat difficult for it to respond quickly to problems, especially when patient safety is at risk. The Bill provides us with the perfect opportunity to streamline our approach to giving access to new and innovative treatments to patients, particularly those with rare diseases and conditions, while ensuring that we are fully committed to a system of regulation for medicines and medical devices that can respond to changes in technology and patient safety concerns as soon as possible. This is more relevant now than ever, given the dramatic expansion of digital health and artificial intelligence, and other rapid advances.

I have some questions about the Bill. Will the Minister provide clarification about the exact role that the Medicines and Healthcare Products Regulatory Agency will play in constructing and maintaining a register of devices that have been approved for industry use? Industry has generally welcomed the idea of registries and their usage, but how will registry data be used in the future? Should the Bill not consider changing the way in which NICE prioritises data? NICE currently prioritises level one data—data gained through randomised clinical trials—ahead of real-world registry data. For medical devices, it is often impossible to conduct a blind, randomised clinical trial, so this level of data is unavailable, making it more difficult to get positive NICE guidance. Can we perhaps consider placing a higher weighting on registry data in decision-making processes and use it to inform outcome measures to assess the success of treatments? Registries could support the collection of data on longer-term outcomes—perhaps five to 10 years, for example, rather than the standard 12 months. There is a very significant concern relating to the contrast between drugs and devices. A drug will perhaps be more likely to have in-year savings or result in an in-year delivery, whereas it might take two, three, four, five or even 10 years to see the improvements, delivery or financial return from a device, or medical technology that has been purchased. It is not certain that the current financial landscape lends itself to longer-term planning.

Will the Minister clarify whether the Bill will include provisions on how countries and notified bodies might be considered competent to make an assessment on behalf of the United Kingdom? This would help to avoid duplication and having to seek approval for new devices and treatments from bodies in different countries that share very similar standards.

Much of industry has expressed the need for further clarification on how closely we will remain aligned with European Union regulations after the end of the transition period. That is particularly relevant to how we conduct clinical trials, particularly for rare diseases, where there are not a significant number of patients to test new ideas on. Maintaining easy access to patients and co-operation around data sharing has been cited as a top priority, so will the Minister clarify whether she intends for us to remain closely aligned with the EU regulations where there is a mutual interest in doing so? The transition from the clinical trials directive to the clinical trials regulation is of particular interest. It has not yet been adopted across the EU and there has been a succession of delays. I understand that it should have been adopted in 2016, but it has been delayed and delayed, and there are plans for it to be adopted later this year if conditions work in its favour.

In conclusion, I welcome the Bill and the framework that it seeks to create by ensuring that the UK remains a global player in the world of R&D. The powers in the Bill provide us with the perfect opportunity to significantly build on and improve aspects of medicine development processes in the UK—notably, by speeding up the approval process. The Bill has been generally welcomed by industry, but I would be grateful if the Minister, time permitting, took note of the questions I have asked and offered as much clarification as possible.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

The Bill is necessary because of Brexit, as the UK is losing the European Medicines Agency—one of the great advantages was working together to have a single licensing system that licensed new drugs right across Europe. As the hon. Member for Bolton West (Chris Green) described, it is about working with other countries to avoid duplication and to speed up getting new drugs from the laboratory to patients who need them.

The problem is that manufacturers will have to apply separately to the UK, which means extra processes and additional costs. It is important, therefore, that whatever system is adopted is as similar to the EU as possible and does not ask for a whole different set of work-up, investigation and paperwork, or that will put manufacturers off launching their drugs in the UK. The same issues apply to veterinary medicines, hence they are in the Bill.

The simple fact is that the EU is a market of 500 million people—a quarter of the world pharmaceutical market. The UK on its own is only 3%, which is why drugs tend to be launched in the US and Europe at the same time. In all my 33 years on the frontline, I saw an acceleration of drugs getting from the bench top to the patient, because of the EU and the European Medicines Agency. This means that there are likely to be delays for patients. Canada and Australia wait another six to 12 months before drugs are launched there, so how will the Government avoid a delay in patient access, particularly for new drugs from outside the UK and for conditions such as cancer, where patients are literally waiting for the drug?

[Chris Green]

I realise that this is a distinct area, but does the hon. Lady share my concern that sometimes the EU as a whole is quite slow at reform—for example, with the clinical trials directive and the clinical trials regulation? The CTD was first devised in 2001. We are now in 2020 and we have not yet updated it. Industry and wider sectors would like the update to happen, but it is taking a very long time.

[Dr Whitford]

I thank the hon. Gentleman for that point. When we are trying to collaborate and get a group of 28 countries—indeed, 31 countries, because the European economic area is involved—to all agree to such enormous changes, with legal ramifications for their drug and device producers, and so on, it takes time, but in the end, I think it will be worth it. Of course, I would have liked it earlier. Having been involved in breast cancer trials, I know that the clinical trials directive was clunky and bureaucratic, but it is being changed.