PARLIAMENTARY DEBATE
Medicines and Medical Devices Bill - 2 March 2020 (Commons/Commons Chamber)

I beg to move, That the Bill be now read a Second time.

While the world grapples with the challenge of coronavirus, it is vital that we do not lose sight of the important long-term reforms that we must make. Medicines and medical devices are evolving faster than ever. Not long ago, we could only record an ECG with hospital-grade equipment; now we can do it at home with a cheap device linked to our phone. Already, artificial intelligence is being used to discover new drug compounds. Now that we have left the European Union, we need a regulatory system that is nimble enough to keep up with those developments while maintaining and enhancing patient safety. That is what this Bill will achieve.

The aims of the Bill are fourfold. First, it gives us the means to depart from EU rules and regulations in future, moving at a faster pace, if that is what we choose to do as an independent, self-governing nation. Secondly, it ensures that we can easily amend regulation through secondary legislation without having to bring a new Bill before the House every time we need to revise the rules. That means our system of regulation will be flexible and responsive, quick to adapt to innovation and quick to respond when a safety issue emerges. Thirdly, the Bill will strengthen patient safety by strengthening the Medicines and Healthcare Products Regulatory Agency, our world-class medicines and medical devices regulator. That includes giving it powers that were not available under the EU, including over registration of devices and disclosure. Fourthly, the Bill will ensure that we strike the right balance between capturing the benefits of innovation without compromising patient safety.

All those objectives of the Bill require a level of investment to bring about the innovations that we seek. The Prime Minister made a commitment of £200 million in September. How much private sector money does the Secretary of State expect that to leverage? What is our ambition?

We do not have a figure for medicines and medical devices specifically. As a nation, we have a goal that we should reach 2.4% of GDP spent on research. We are increasing the medical research budget; for instance, we are doubling the budget for research into dementia. As my right hon. Friend rightly points out, the public budget for research is only one part of it. There is huge private sector and charitable sector investment —for instance, from the Wellcome Trust. The Bill will allow research money—whether it comes from the public sector, private sector or third sector—to go further and get medicines and medical devices to NHS patients faster, as well as supporting our life sciences sector.

I recognise the Secretary of State’s support for innovative medical technology. I am interested in the registers to which he referred, covered in section 13 of the Bill, and in particular the need to ensure that we get the maximum benefit without their being too onerous. Will he give an assurance that there will be some kind of consolidation where there are multiple registers in the same field and that we will only collect information that is specific to the subject stated for the registers?

It is almost as though the hon. Gentleman has read my speech. That is the broad intent of that part of the Bill. I will come to it in more detail in a moment, and I am glad about the constructive tone that has been adopted across the House when discussing the Bill.

As I said, the fourth purpose of the Bill is to get innovation while not compromising patient safety—indeed, I would argue that we will enhance patient safety by being able to use modern techniques. It will do that by requiring the Secretary of State to have regard to the safety of medicines and medical devices; to the availability of medicines and devices, because sometimes getting availability as fast as possible is crucial for both innovation and patient safety; and to the attractiveness of the UK as a place to conduct clinical trials and bring medicines and medical devices to market. I will come on to clinical trials in more detail.

Let me turn to the main parts of the Bill. The first part, covering clauses 1 to 7, gives us the ability to update the law relating to human medicines—for example, to reflect changes in manufacturing methods or new types of product. We need that ability because coming down the track are cutting-edge personalised medicines that a hospital might literally have to assemble at the patient’s bedside. Those include gene therapies, medical gases and 3D-printed tablets—bespoke treatments so tailored to the individual that they will only be produced once, with a shelf life that might be measured in minutes. It is just not appropriate to regulate those kinds of treatment in the same way as a mass-produced factory drug, with mandatory batch numbers and packaging information. The Bill gives us the flexibility to respond to those developments. It also allows us to make changes to the regulation of clinical trials, ensuring that we are a globally attractive market to test new drugs and treatments.

But the Bill is not just about the latest science and innovation. It also means that we can update the rules on things such as labelling requirements—for instance, whether the leaflet in a pill packet should have a digital equivalent; rules on how online pharmacies ensure that medicines reach their intended customer; and rules on how the medicine brokerage market works.

We have said that we want to do more to boost the role of our brilliant community pharmacists, and the Bill helps us to do exactly that. It will allow us to remove the barriers to hub-and-spoke dispensing once EU rules no longer apply. Large companies such as Boots already do that, but the law as it stands prevents small, independent pharmacies from joining this kind of arrangement if the hub is not part of the same retail business as the spokes. That is an unnecessary barrier for smaller businesses in the pharmacy sector, and the Bill means that we can remove those barriers.

It also allows us to continue to add to the range of healthcare professionals who can prescribe medicines, which will relieve pressure on the frontline NHS, and it gives us the ability to make rapid changes to regulations to ensure the availability of and access to medicines in an emergency; I am sure we can all understand right now why that is important. Nothing in the Bill changes all the regulations immediately. Instead, it is about getting ahead of the game and giving us the power to make these changes as and when we need to, suitably scrutinised by Parliament.

The next part of the Bill concerns veterinary medicines. It broadly replicates the first part, giving us the ability to amend or supplement the Veterinary Medicines Regulations 2013. Changes could include, for instance, how veterinary medicines are supplied and the information that must be supplied with them. It sets out that, in making new regulations, we have an obligation to consider the safety of the medicines in relation to animals, humans and the environment. These are important matters, not least for me as the Newmarket MP. The Bill will ensure that we have a veterinary medicine system that is fit for purpose.

The third part of the Bill deals with the medical devices regulatory framework, covering everything from MRI scanners to embolisation coils and pacemakers to prophylactics. Like the first part, it allows us to fast-track a new diagnostic test in response to an emerging disease.

Is this not an example of how, having left the EU, we can now move at a much faster pace on a lot of regulatory things that are really important to our constituents?

Yes, that is right. This Bill empowers us to be able to move faster. Essentially, it empowers the UK to build a life sciences regulatory framework that is the best in the world—of course, working with EU partners, but also with partners from right around the world—and all with the intention of getting the most innovative products, as quickly as possible and as cost-effectively as possible, into the NHS. That is the goal of the entire Bill. It is a benefit of Brexit, but it is also worth doing in its own right.

The measures to strengthen innovation with respect to diagnostic tests again strengthen patient safety, because they strengthen the role of the Medicines and Healthcare Products Regulatory Agency. This includes, for instance, allowing us to legislate to create a comprehensive statutory register of medical devices in the UK. Such a register could be held by the MHRA, and we would make it compulsory to register a device along with information such as who manufactures and supplies it. This would mean that the MHRA could conduct post-market surveillance of devices in the UK, making it easier to trigger device recalls where a safety concern arises.

Indeed, we will enhance patient safety by giving the MHRA a new power to disclose to members of the public any safety concerns about a device. This was not possible while we were part of the EU. Previously, if an NHS trust raised a concern about a device and asked if similar reports had been received elsewhere, too often the MHRA was restricted in sharing that information; nor could it always routinely share information with the Care Quality Commission or other NHS national bodies. This Bill gives us the ability to share vital information about reporting patterns with the NHS family, and where necessary with the public, with enforcement powers that will be proportionate, transparent and suitably safeguarded.

I do not recognise the Secretary of State’s description that it was not possible to inform NHS bodies of concerns about machinery or devices. In my 33 years on the frontline, we received daily information about anything that was considered a danger or a failing, so I do not recognise that.

In some cases it was possible to share that information but not in all cases, and it will be possible now. I have no doubt that the hon. Member, like others on the frontline, will have received some information, but the MHRA is currently limited in the information that it can share with other NHS bodies. We are removing the limits on that information sharing, which of course needs to be done appropriately, but should not be set in primary legislation.

Our goal is this: we want the UK to be the best place in the world to design and trial the latest medical innovations. This Bill gives us the powers we need to make that happen. It will mean that the NHS has access to the most cutting-edge medicines and medical devices, with enhanced patient safety; it will help our life sciences seize the enormous opportunities of the 2020s, supported by a world-leading regulator; and it will help us pave our way as a self-governing independent nation. I commend the Bill to the House.

We do not intend to divide the House on the Bill this evening. We understand the need for the Bill because its purpose is for the UK Government to take the powers they need as a result of Brexit. In that respect, we broadly support the principles of the Bill, and we offer to work constructively with the Government on strengthening and improving aspects of it. I have a couple of remarks to make that are related to this, but not to the exact contents of the Bill.

May I start by saying that we all know, not least because of the coronavirus outbreak, that disease knows no borders and defeating disease cannot be done in isolation? International co-operation and research and development are vital and must be accelerated, not hindered. Will the Secretary of State—or indeed the Under-Secretary of State for Health and Social Care, the hon. Member for Bury St Edmunds (Jo Churchill), in her winding-up speech—explain or comment on the press reports today suggesting that the UK is not seeking to participate in the EU pandemic preparedness measures, which may obviously help in relation to coronavirus and other future outbreaks?

I am of course talking about the early warning and response system. It was suggested in The Daily Telegraph today that No. 10 had overruled the Secretary of State. Since then, a former Minister, Baroness Blackwood, has told Sky News:

“My advice while I was in there was that I thought it was absolutely appropriate that we should stay engaged with that system… I think this is something that the EU would want to maintain and we as Britain should seek to maintain.”

I agree with her. I believe it would be foolhardy to pull out of something like this at the best of times, but to do so at the time of an outbreak such as this is surely putting narrow dogma before the public health of the country. I would be grateful if the Minister responded on that.

Secondly, we also learned at the weekend that the UK will not participate in the unified patent court, which will make developing medicines here in the UK more expensive, not cheaper and easier, and it may make doing clinical trials here less attractive. The Government have done lots of briefing on this Bill, but over the weekend they slipped it out while briefing trade magazines that the UK will not be seeking involvement in the unitary patent system. Again, that is disappointing, and I would welcome some remarks from the Minister on that front when she sums up.

However, this Bill is important, and we do not want to see anything that undermines what has been built up over many years in the United Kingdom. We do have much to be proud of in the field of medical innovation. We have a long history of taking a leading role in scientific advance and novel trial design. Indeed, the recent deal to give NHS patients early access to a new cholesterol treatment demonstrates that the UK is already a world-leading destination in which to develop cutting-edge treatments. We want to build on that, not undermine it.

Members across the House will be aware that our pharmaceutical industry is the single largest private sector investor in UK R&D and provides many jobs across the country for many of our constituents. We should be proud of that sector and of the contribution that life sciences make in providing access to the most cutting-edge treatments. We should be proud that they are vital to economic growth, enhance UK productivity and ensure prosperity for the future.

Yet while the opportunities before us to develop medicines and medical devices are transformative—both saving lives and radically improving the quality of life for those with the most debilitating of conditions—we also know that things can go wrong. There must never be any compromise on patient safety. Patients put their trust in practitioners, literally trusting them with their lives, and they rightly expect medicine and medical devices to be safe, yet too often in recent years the system has failed patients.

For many years, long before I acquired the health brief in my party, I worked closely with a constituent, Emma Friedmann, who has campaigned for justice for women whose children were impacted by sodium valproate. Members from across this House have spoken with passion and eloquence on behalf of women affected by Primodos. Equally, we have heard heartbreaking stories in this House about the surgical mesh scandal. My hon. Friend the Member for Washington and Sunderland West (Mrs Hodgson), the shadow Minister, has been one of the leading campaigners on this issue, along with colleagues across the House. We eagerly anticipate the Cumberlege independent medicines and medical devices review, but there have been other scandals too—breast implants, hip replacements—that are not necessarily covered. We would welcome an update from the Minister about that review and some remarks on whether the Government expect to implement its findings.

My point is that a robust regulatory framework for medical devices to protect patients and users is paramount. We will be testing this Bill to ensure that it provides the safety standards that our constituents deserve, while at the same time ensuring it is forward looking enough to be the correct framework to capture the fast pace of innovation in this field, which the Secretary of State mentioned. However, I believe that the existing regulatory framework has become complex and, arguably, unwieldy.

The House will be aware that much of the regulatory landscape derives from EU directives that have been implemented in domestic legislation. At the end of the transition period, these frameworks will be preserved as retained EU law, but as I understand the Bill, the Secretary of State is proposing to take delegated powers to allow these existing regulatory frameworks to be updated without the need for primary legislation. The Bill requires the Secretary of State, as he said, to have regard to the safety and availability of medicines and medical devices, as well as to the attractiveness of the relevant part of the UK with respect to the life sciences sector. We argue that that attractiveness clause could benefit from some definition, and it would allay concerns if the Government accepted an amendment in Committee to indicate that the Secretary of State, or some other appropriate authority, would always prioritise safety.

The overall effect of the provisions is to confer on the Secretary of State an extensive range of delegated powers to make regulations that span the manufacture of medicines, marketing and supply, falsified medicines, clinical trials, fees, information and offences, and emergencies. That extensive range of powers risks inadequate scrutiny of what will become major policy decisions, and in Committee Labour will press Ministers to support time-limiting those delegated powers.

I am sure that this debate will continue in Committee, but for clarity, those delegated powers existed under the European Communities Act 1972. The Bill proposes to replace existing delegated powers from the 1972 Act with new powers to make such regulations under the new Act. This is not a new set of delegated powers; it replaces one set with another—indeed, the Bill replaces those powers with clearer safeguards on those matters to which the Secretary of State must have regard.

That is a welcome clarification, but I am sure the Secretary of State will agree that it is important that decisions made in this field are properly scrutinised through the usual procedures. We are keen to ensure that by tabling an appropriate amendment in Committee.

We are leaving the EU, but Labour Members consider it essential that we stay closely aligned with it on medicine regulation. With that in mind, the Government should clarify their attitude to new EU regulations such as the in vitro diagnostic medical devices regulation, which is due to be implemented in 2022. As I understand it, that regulation will not automatically apply to the UK. Is it the Government’s intention to align with it? The EU tissue and cells directive is being reviewed. Do the Government intend us to align with it? To ensure that the UK remains a world leader in scientific research and discovery, it is vital that we align with guidelines on clinical trials. Otherwise, patients could miss out on participating in trials and the UK could find it harder to access funding.

Effective joint working with our European partners has been vital for the NHS over recent years on everything from infectious disease control to the licensing, sale and regulation of medicines. Patients in the UK can access EU-wide trials for new treatments and the UK has the highest number of phase 1 clinical trials across the EU, as well as the highest number of trials for rare and childhood diseases. It is vital for improving health outcomes in the UK and EU that the UK continues to access those networks. Otherwise, we run the high risk of patients with rare diseases being adversely impacted.

The Bill contains provisions to extend the range of professions that can prescribe medicines, thereby allowing additional health care practitioners such as paramedics and midwives to be given restricted prescribing rights. We welcome those provisions and, assuming that their competencies have been assessed in the same way as those of other prescribers and that equal safeguards are in place, we support that sensible and timely reform. Will there also be plans for a consultation on the future prescribing rights of physician associates and surgical care practitioners?

I will not say too much about part 2 of the Bill, other than to confirm that any measures that help in the battle against anti-microbial resistance have Labour’s support. Part 3 is about medical devices. I have already commented on the use of delegated powers, and as I said at the outset, patient safety must be the priority and we will look to strengthen regulation in that area. Unlike medicines and drugs, many surgical innovations can be introduced without clinical trial data or centrally held evidence. That is a clear risk to patient safety, and it undermines public confidence. Manufacturers are often in charge of testing their own products after faults have developed and they can shop around for approval to market their products without declaring any refusals.

Two years ago, freedom of information requests to the Medicines and Healthcare Products Regulatory Agency revealed 62,000 adverse incident reports that were linked to medical devices between 2015 and 2018, and more than 1,000 had resulted in death. Most devices are cleared through a pathway that allows new products to inherit the approval status of “substantially equivalent” products already on the market. In some cases, after lengthy chains of equivalence-based approvals, the new devices scarcely resemble the original version. Indeed, a study in The BMJ in 2017 found that the family tree of 61 surgical mesh products related to two original devices that were approved in 1985 and 1996. Unless we fix that and put patient safety at the heart of the regulatory framework, patients will suffer and lack confidence.

We know the Secretary of State is a great champion of and has promoted many health-based apps. We need a robust and sophisticated mechanism to evaluate app-based healthcare for use in the NHS, and in Committee we will look to strengthen the regulation of that. We welcome what appear to be plans for a devices register, and I took note of what the Secretary of State said in his interaction with my hon. Friend the Member for Birmingham, Selly Oak (Steve McCabe). We believe, however, that such a register must provide comprehensive data on who, where, how and why devices were implanted, and by whom, so that any recall could be quickly enacted.

To achieve that, we encourage Ministers to strengthen the Bill by reflecting provisions in existing EU regulation and to ensure there are unique device identifiers, such as serial numbers on medical devices that are labelled with tracking information, as well as the power to track the use of those devices, so that the NHS can find and notify affected patients if and when problems arise. By the same token, the Government must reassure us that with such a register it is practically possible to cover all devices, including everything from implants to bone screws, software, apps, mesh, medical cannulas, pacemakers and so on. That is an extensive list of different devices, and I would be keen to hear how such a register could be implemented practically.

The hon. Gentleman’s point about “why?” is important. As a doctor, I know that things move on, and when someone leaves medical school 50% of what they have learned is out of date. With devices that are likely to exist for 10, 20, 30 or 40 years, looking back it can be difficult to work out exactly why something was implanted. I would like the Bill to request an explanation from the clinician at the time to say what the thinking was. In the future, that would inform people who needed to deal with someone who had something implanted in their heart 20 years ago, for example, by which time the history might be exactly that—history.

It has taken me some time, but let me welcome the hon. Gentleman to his place, particularly as a fellow Leicestershire MP. His contribution is well made, and I look forward to working constructively with him on health matters, as well as on various Leicestershire matters. I hope the Minister will reflect on his contribution and answer it when responding to the debate.

The Opposition will not seek to divide the House. We want the Bill to proceed to Committee, and we will work constructively with the Government to improve and strengthen it. It is up to Ministers to allay concerns about patient safety and about the UK’s ability to develop medicines rapidly for NHS patients in the future, and we look forward to a constructive debate on the Bill.

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.

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?

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.

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 the 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.

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.

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.

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.

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.

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?

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.

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.

I thank my hon. Friend for answering the extremely important points that have been raised. Does she agree that it is also extremely important that those with rare diseases still have access to the clinical trials that can perhaps only take place in the EU, because they need to have so many participants? The UK on its own might struggle to have those clinical trials for rare diseases.

That is an excellent point, which I will come on to shortly, and I absolutely agree with my hon. Friend.

The Bill puts attractiveness as a place to do trials and supply medicines almost on a par with safety and drug availability. What exactly does that mean? The shadow Health Secretary was right to seek a definition of that phrase. Is it about cutting red tape? If so, I would point out that one man’s red tape is another man’s life and limb. The Association of the British Pharmaceutical Industry says that the industry does not want divergence or lower standards, or standards that change all the time. Alignment with the EMA and the FDA in America keeps costs down, reduces delays and keeps bureaucracy down. The industry here will have to match EU standards for the bulk of its production and will not be keen on doing small-batch production for the UK only if that has a totally different set of standards.

It is important that the new measures on falsified and counterfeit medicines be taken. The unique identifier number, including barcode scanning, is important, as are tamper-proof containers. There is a whole market out there in counterfeit drugs and it endangers patient safety, which is vital in all of this. As part of that, we will have to negotiate data sharing with the EU and the EMA to enable pharmacovigilance on a bigger scale and make it possible to recognise much earlier patterns of side effects and complications.

How will the Government provide the extra funding and support to the MHRA, which is to take on an extensive area of extra work? How will it combine that with delivering quicker assessments and licensing so as to encourage companies to launch their devices or other drugs in the UK? As has been referred to, there is a need to replace the clinical trials directive, which in the original version was indeed very bureaucratic. As a clinical trialist within breast cancer, I found it to be often quite off-putting. The new clinical trials regulations create an EU-wide portal—a single point of digital registration of trials and collaboration on design, recruitment, data, entry and analysis. Unfortunately, UK-only regulations will not replace that when it finally goes live in 2022.

International collaboration is critical to research, and the European research network is the biggest in the world—bigger than China and bigger than the US. As mentioned by my hon. Friend the Member for East Kilbride, Strathaven and Lesmahagow (Dr Cameron) and the hon. Member for Bolton West, that collaboration is vital for rare diseases, where the number of patients in any one country is low. That is why we have made so much progress in rare diseases, childhood diseases and childhood cancers in the past decade or so—because of funding from the EMA and collaboration on an extensive Europe-wide basis. As regards cancer, my own specialty, half of all UK cancer trials are international, and 28% of Cancer Research UK trials involve at least one other EU state. The BEACON trial for recurrent neuroblastoma involves 10 countries. It was designed in the UK, but the principal investigator is in Spain. Some of the original funding came from the UK, but the drug comes from Switzerland. Ten countries are contributing to trying to find hope for children and families suffering from this horrible disease, for which we are struggling to find a cure. There were 4,800 UK-EU trials between 2014 and 2016. How will the Government maintain that sort of collaboration and involvement?

Part 3 of the Bill relates to medical devices, and I totally agree it is not before time. The EU has also moved to bring in regulations regarding medical devices. It is important to apply similar rules to devices as are applied to drugs. Until now, it has been far too lax. As was mentioned, manufacturers pay for assessments, and I would suggest the same apply to digital health apps. At the moment, the companies that design them assess them themselves. We need instead a neutral and independent system of ensuring that they are safe. Just because something is AI or digital does not mean it will give patients good advice.

Registered clinical trials of devices should report all findings. It is far too common, where there are negative findings or findings of no advantage, that they are not published and that therefore in essence the information is hidden. As we have heard, there should be no tabletop licensing of devices whereby a device is simply migrated from one form to another without being retrialled. This was exactly the problem with vaginal mesh, where in essence the end operation, compared to the original operation in the trials, was unrecognisable. The Cumberlege review should give us food for thought and help us focus on safety and not market expediency. It is also important that there is a system to report complications to the MHRA, like the yellow card system with drugs, so that problems are spotted sooner. Again, across a bigger population that is likely to be quicker.

Implants should also have a unique identifier number that can be scanned as a barcode to the patient’s electronic records, to the hospital episode system and to any registers. A register will be data that is just sitting there and which can be interrogated if someone needs to recall patients with certain implants because of a problem. Following the scandal around PIP implants, which did not have medical grade silicon in them, I remember having to wade through the case sheets of patients who had had breast reconstruction. It was not an implant we had ever used in our hospital, but we had to be 100% certain that no patient treated in the plastics unit in Glasgow had had the implants either. It is critical that we avoid such chaos in the future, and if a register has an expert steering committee, it can become a registry, a dynamic beast that can monitor practice and bring knowledge back to medical practitioners, researchers and so on. One of the earliest and biggest examples is the national joint registry.

The Bill includes provisions to extend low-risk drug prescribing to other healthcare professionals. We all recognise the changes in the workforce that have already happened and which are coming in the future. There are processes for assessing competency and certifying that someone—an advanced nurse practitioner, for example—can prescribe in their own right. The Royal College of Surgeons and the Royal College of Physicians have raised the issue of physician associates and surgical care practitioners. They feel that if prescription powers are to be given to such individuals it is critical that they are registered and regulated, but while these new professions are developing they are not registered or regulated. If this is the future of the NHS workforce across the UK, it has to be dealt with—they need to be registered practitioners.

The hon. Member refers to physicians and others and to the shortage of doctors, but is there not also a role for pharmacies to play in diagnosing people early on? Is that not something that should be done as well?

In Scotland, we have had the community pharmacy system since 2005, which includes that, and the range of protocols for a pharmacist to prescribe against has been increased, but I agree it has further potential. One advantage is that pharmacies are usually open all day Saturday and often have longer hours. For people who are working who have a relatively minor condition, being able to get both advice and treatment from a pharmacist makes a big difference.

I forgot to mention that I also believe pharmacies could play a role in diagnosing sight loss, glaucoma and other things—small things that can be done in pharmacy. Is that something else that could be addressed?

In Scotland, we put a lot of effort into sweating the assets, if you like, within the community, so optometrists can carry out that job. They no longer refer through a GP. If they diagnose cataracts, for example, they refer directly, and they provide a lot of out-of-hours care for people with acute eye problems, foreign body inflammation, infection and so on, to the point that very few patients now go to A&E with an acute eye problem. We have all sorts of expertise in our communities, and we should use it, so I agree with the hon. Gentleman.

I welcome the Bill’s reference to internet pharmacy provision, but I think that there should be a step up—a whole step change—in the form of stronger action to control internet pharmacy providers, especially in the context of what are described as prescription-only medicines. The son of a constituent who came to see me was able to obtain large quantities of dihydrocodeine, a fairly addictive painkiller, over the internet simply by filling in an online form, having not seen a GP and without producing a prescription. I asked the constituent to find out what the website was so that I could report the organisation, but the website had gone. That is the problem with the internet: it is ephemeral. Unfortunately, that young man has now become addicted to dihydrocodeine, and is trying to be weaned off it. As in the case of other versions of online harm, we need to deal with people who are hiding in the internet: we cannot allow the supply of counterfeit or addictive medicines to patients without any form of control.

I have some concerns about the Bill. For instance, I agree with the hon. Member for Leicester South (Jonathan Ashworth) about the extensive delegated powers. The Secretary of State said that the same powers had been in place when the United Kingdom was in the European Union, but their purpose in the past was to enact EU directives which had been debated and consulted on in the European Council and the European Parliament. They had been worked out before agreement was reached, and were therefore purely about enacting something that had been hammered out and agreed within Europe. That is not the case here. Almost every clause in the Bill simply hands over a delegated power, but I think some of the major changes that are being introduced in the Bill are significant and should be in primary legislation. Of course regulations will flow from that and will be covered by delegated powers, but for radical changes to be made purely in relation to such powers represents a missed opportunity, and they should be limited.

Part 3 provides for the maximum sentences for offences against the Bill to be set at six months. In Scotland, the maximum sentence in a summary case is 12 months. Removing that sentencing power in Scotland with no consultation does not seem right, and a presumption against sentences below 12 months there would make custodial sentences less likely. What kind of prevention and what kind of warning will there be if it is clear to people that imprisonment is never going to happen? The civil penalties presided over by the Secretary of State prevent criminal prosecution if either the maximum or a lower sum is paid in advance. That fetters the operation of the Scottish criminal justice system, because those involved in it would lose the right to prosecute if they felt that the issue was serious enough. The Lord Advocate in Scotland should have been consulted on both issues, and I suggest that that should be corrected as the Bill proceeds.

Part 4 does indeed call for consultation prior to any new regulations, but there is no formal mention of Ministers in the devolved Governments, despite their responsibility for healthcare. In other Bills with which I have been involved, it has been normal for the Ministers of the devolved nations to be listed specifically. When legislation is to impinge on such a major devolved competency, it is important for them to take part in discussions. I also think it important to have a structure enabling medical bodies, experts and industry to contribute to the consultations, to ensure that all aspects have been considered.

There is no choice but for the Bill to go ahead because of the legislative gap that will result from our leaving Europe and the European Medicines Agency, particularly at the end of the transition period. We will therefore not force a vote, although I hope that we will be able to strengthen some aspects in Committee. Having to leave the EMA is just one example of what we are losing because of Brexit. Far from cutting red tape, Brexit will increase bureaucracy and costs for the pharmaceutical industry, the NHS and patients—and that is even before the possible impact of a United States trade deal on drug costs.

I am concerned by the threat to walk away from negotiations in June and move towards a no-deal outcome yet again. That would increase the risk to patients. Simply calling it an Australian deal does not cut it, because the Australians do not have a trade deal with the EU. I should like to know whether the Prime Minister or the Secretary of State has somehow solved the problem of supplies of insulin and medical radioisotopes, not just for a couple of months around the transition point but in the long term. The UK does not produce insulin or medical radioisotopes, and any friction at the border—which at present looks inevitable—will increase costs and delay access.

I also find it concerning that despite covid-19, which initiated a Cobra meeting this morning, the UK apparently does not even want to remain in the PANDA—Protocol for the Assessment of Nonviolent Direct Action—early warning and response system of the EU post transition. Such isolationist policies are dangerous for everyone: for our constituents, and for our patients. We cannot get away from it: Brexit is a loss to healthcare and research, and the Bill cannot stop that. The principle of collaboration is central to the EMA, the European research network and, indeed, the EU itself, and it will be hard to replace that if we are throwing up barriers.

I congratulate the hon. Member for Central Ayrshire (Dr Whitford), who has made me feel rather nostalgic. Listening to her speech gave me a flashback to when I used to go to Grand Ronde and hear someone speak so eminently plausibly in many a debate of which I had very little understanding.

Let me make this declaration now: I am a simple GP. When I entered the House, I always said that I would speak about the coalface and what really affected me at that point, and that is why I felt that I needed to speak about the Bill today. I welcome it because I approve of the emphasis on the creation of a world-leading research-driven, standards-based clinical care framework that can drive the UK forward, but two aspects have struck me in particular. The first is prescribing, and the second is trials and tests.

Members on both sides of the House have broadly welcomed the provision for new prescribers, and the flexibility for that within the framework. As the workforce and the demand grow and as the roles change, that new prescription will be necessary. I agree about the importance of ensuring that those prescribers have the necessary due diligence, training and registration, which, after all, will provide the safeguards and the accountability that are needed when it comes to writing a prescription. However, I think that the Bill has missed the issue of prescription waste, or waste medication. On numerous home visits doctors see piles of unused medication, and that does not apply only to their patients: there is a crossover in hospitals and, of course, in care homes. Some of it is purely coincidental as people are taken into hospital or from hospital into a care home, but there is a huge amount of it, and, anecdotally, doctors see it all the time. I have seen patients hand in up to 100 boxes of, say, warfarin, and that cannot be right.

When I consulted the House of Commons Library, it came up with a figure of £300 million a year in losses from 2011 on the basis of only one study. That suggests to me that, over a decade, it is hard to find sufficient information. Last week I spoke in the debate on the Environment Bill, one of whose first principles is that any other legislation should consider environmental impacts. I think that this Bill would do well to take account of prescription waste, which it could do in a couple of ways.

Pharmacies and, indeed, any dispensers could be asked to legally collect the statistics on returns. That would allow us to see how big the problem actually is, and allow us to create solutions. It might sound strange for someone who has worked in the workforce and had lots of paperwork to be suggesting more paperwork, but at least if we open up the statistics, I am confident that my medical colleagues would look at them and see a way to resolve this.

I would also argue that we should review the charitable donation of medications. I freely admit that there are issues over their storage and over how to check the safety of this practice. However, the problem is not insurmountable if the medications are returned in their original state. If the Government do not address the matter in this Bill, I suggest that they might want to consider it going forward. We could, however, consider a more severe statutory obligation on pharmacies, care homes and dispensers to be far more rigorous in the way in which they dispense their medications and follow up, particularly for repeat prescriptions. Things such as emollients, moisturisers and day-to-day painkillers often pile up and end up on repeat prescriptions, and it is quite hard to monitor them. As someone who has written hundreds of prescriptions in a day, I know that it is very easy to sign them off rather than check them, and if there is no obligation for me to check whether the patient actually needs the medication, who does that responsibility fall to? It is arguably the patient, but if that is not happening, and if there is as much waste as we think there is, I suggest that the Government might want to consider that issue.

I recognise the fact that the hon. Gentleman is a GP. I declare an interest, in that I am a type 2 diabetic. At my surgery, my doctors and those who are in charge check my prescription every time to make sure that I am not over-ordering or getting more than I should be getting. Some GPs are doing that already and thereby controlling what medications people get.

Absolutely, and I agree with the hon. Gentleman that that is exactly what a GP should be doing. However, when a GP is dealing with hundreds of requests for repeat prescriptions, it is unlikely that they will have time to phone every single one of those patients to say, “Is this what you need? Have you already got it?” That has been the role of clinical pharmacists, particularly in relation to people who have multiple prescriptions for four, five or six medications, at the time of their medication review, which I entirely agree with. A GP will indeed look at a medication review, but when someone asks for a repeat prescription, they usually do it either electronically or by making a simple mark or cross on a piece of paper that they take to the GP surgery. It is unlikely, if the prescription has already been set for six or 12 months, that there would be a review of the prescription each month. That is the whole idea of having an annual review. In the old days, people could be on medications for months, if not years, without ever being checked. The reason for doing that was convenience. If a patient had to come in to see their GP every month to justify why they wanted their medication when their condition, say diabetes, was stable, that system would not be sustainable, given the current pressures on the NHS.

My second point relates to trials and tests. For me, another element that is missing from the Bill is a duty of care. I would like to give an example of a patient who came to see me who had had her genome sequenced. She came in with a report, and she said, “Dr Evans, I have been told I have a 50% chance of having cardiovascular issues and an 80% chance of having Parkinson’s disease. Please can you help me out?” That was very difficult to deal with. First, there is as yet very little we can do to influence Parkinson’s. Secondly, at that point I had had no training on counselling someone who had had genomic testing. The cardiovascular side was easier: we know some remits, and we can make a difference with cholesterol, exercise and lifestyle advice. But this is just the tip of the iceberg, and as the tests become more advanced and more people have them, I would like to see emphasis being put on ensuring that those doing the tests have a duty of care to ensure that there is follow-up and comeback for the person who has the test.

Does the hon. Gentleman therefore agree that it was completely wrong last year when the NHS in England tried to offer genomic testing for £500 or £600, provided that people were willing to allow the data from their genomic testing to be used in research, without any thought of the outcome that that would generate for general practices right across the country?

The hon. Lady makes a good point. I have no problem with that, provided that those doing the tests are also doing the follow-up and ensuring that the patient who has had the test has had counselling before, during and after it.

If the hon. Gentleman thinks that genomic testing for completely asymptomatic people without any family history is a benefit, does he then support the idea that it would only be the better-off people who could afford £500 or £600 who would have the test? Would that not widen health inequalities, which we will be debating on Wednesday?

I am grateful for the hon. Lady’s point, but I would simply say that the NHS is going that way and will be providing those tests. My simple point is that whoever goes through such a test must have counselling afterwards to tell them what to do with the information. We could put that in law. It does not matter if the testing is done by the NHS or by a private testing facility. If an individual makes the choice to have the test, it must be incumbent on the person doing the test to inform them completely and counsel them throughout the test and of course afterwards when they are given the result. That duty should fall on the NHS, if the NHS has done the test, and on the private provider if the private provider has done it.

This is a brave new world for medical science and for the NHS, and we should not let ideology get in the way of getting the data that we need or of trialling things and accepting good ideas when they come our way, while of course taking on board what my hon. Friend is saying about getting it right at the GP end and ensuring that we look after the people who are involved in this pioneering work.

Absolutely, and I am grateful to my hon. Friend for pointing that out. As I said at the start of my speech, this is about creating a framework that can be built on, and that framework should have standards and safety, but I would argue that a third strand that is needed is communication. That is the angle that is missing at this point.

That leads me on to my final point. When it comes to some medical devices, I use the term “device” in a slightly quizzical manner. For example, is lip filler a medical device? I would argue that it is probably not, but in the context of this Bill it might well fall into that category, and it probably should. Many people have cosmetic surgery. They have lip fillers, and all too often, I as a GP have had to pick up the pieces when something has gone wrong. My hon. Friend the Member for Sevenoaks (Laura Trott) is not here today, but she is bringing forward a private Member’s Bill to try to address some of these issues. This illustrates the point that now is the time to enshrine in legislation a duty of care to talk to people and to inform them, categorically, before, during and after any test or medical intervention. After all, that is the duty of a good health professional.

I support the Bill. I believe that it is about responsible research, medical provision and future-proofing medicines and medical devices, and I hope that in considering my points on prescribing, tests and trials, the Government will provide a framework that helps to strengthen our world-leading position on health.

It is a pleasure and a privilege to follow the hon. Members for Central Ayrshire (Dr Whitford) and for Bosworth (Dr Evans). I agree with everything they said.

I welcome this Bill and the steps that will be taken to improve patient safety and the availability of medicines and medical devices. I will keep my comments short today, as I hope to be further involved in the Bill’s later stages. There are some key points to make on Second Reading, however, as the Bill has the potential to affect so many people’s lives, both domestically and abroad.

As we all know, patient safety is vital and should not be compromised. Sadly, we have seen patient safety standards disregarded in the cases of valproate, Primodos and surgical mesh, which shows a clear need for the legislation in this area to be tightened. The experience of those patients shows the life-changing effect that medicines and medical devices can have on people if they are not thoroughly tested—a medical intervention designed to drastically improve a patient’s quality of life can, instead, leave them in a more dire situation.

We not only need to be aware of, and have concern for, patients in our own nation when we look at the medicines entering our national health service; we must also ensure that due care is given to the patients involved in the development of those medicines. We cannot sacrifice the health, rights and dignity of other human beings just to gain medicines for people in our country.

When we look to China, for example, we see that the evidence supplied by the independent China tribunal, which was released in full yesterday, overwhelmingly shows that organs have been harvested from unwilling political prisoners and prisoners of conscience such as members of Falun Gong and the Uyghur Muslims.

It is important that is put on the record. There was a question in the other place today on this very issue of organ harvesting. The hon. Lady and I, like others in this House, recognise that commercial organ harvesting is happening in China. Is it not important for our Government, and for all responsible Ministers, to contact the Chinese authorities directly to ensure that organ harvesting does not take place? It is not just the Uyghur Muslims but Christians and those of other ethnic minorities, too. They are all being discriminated against for being alive.

The China tribunal report was issued yesterday, and it clearly states that organ harvesting is being done in a commercial, business-like manner. It is absolutely horrendous. People are being taken into prison for nothing, and their DNA is taken. A doctor who now drives an Uber taxi in London was forced to remove the liver and kidneys of a Uyghur Muslim while he was still living, which is horrendous. I and a number of others intend to get this resolved. We must ensure that medicines entering the United Kingdom have not been tested on or developed using those organs or any other human rights abuses, and I am sure the Government are aligned with me on this issue.

If appointed to the Public Bill Committee, I hope to move an amendment on this issue, on which there is cross-party support in both Houses. In the light of this week’s stories in The Guardian and The Daily Telegraph about major companies profiting from Uyghur slave labour, it seems there is no indignity, no suffering, that those poor people are not forced to endure. The trade in their organs must surely be one of the most wicked crimes against humanity of the 21st century. This Bill will provide the House with one small opportunity to strike a blow on their behalf.

Domestically, we must ensure that regulators are properly equipped with the resources and financial support to take on the new responsibilities outlined in this Bill so that we do not place more stress on an already overstretched NHS system. We must also better understand how the Government intend to monitor the effectiveness of those regulations and regulatory bodies, as well as the nature of their role in doing so.

The NHS is one of our nation’s greatest achievements, and any attempt to make it stronger is always to be welcomed. We must make sure that the United Kingdom’s health industry and the NHS help to make the lives of our citizens and those abroad safer, healthier and more dignified.

I welcome this Bill. It is crucial that we have an effective regulatory system in this country, so we should enable the Government to amend existing regulations post Brexit. We could be a little more ambitious, however. Government time is precious, and I doubt we will have many occasions to discuss medicines and medical devices, which I suspect is why many of my colleagues have raised things that are not covered in the current legislation.

In a world in which medicines and medical devices are changing fast, the Government need to take greater powers to meet those changes and take advantage of them post Brexit. They need to be able not just to amend but to create regulations. My real concern is that the parameters of these new powers are drafted in such a way that they give power to the Government only to amend existing regulations—four sets of them. The Bill does not give the Government the power to do more, which is a missed opportunity.

Although I am conscious of the need to consider this at a European level, medicines and medical devices are, for most of us, a global issue. This Bill should not just be about ensuring we can cope after leaving Europe; it should be about the opportunity that can be created in the new global world we are entering.

A lot has been said, and rightly so, about the challenge of medical devices, which is a fast-growing area in which Britain is a leader, but it involves a huge variety of small and medium-sized enterprises, and innovation within devices is happening at a faster rate than within medicines. That is what we need to address, and I do not feel we achieve it with this Bill.

This legislation will not help with the challenges of breast implants, vaginal mesh and spinal implants that crumble, because the registry that is to be created is within the constraints and confines of existing registries that, by and large, collect information about devices. They do not collect information about the journey of those devices through the patient experience, from implant through to removal and replacement, including where the device may be defective. That information, properly recorded, would enable us not only to recall devices that we knew were faulty, but to go to patients in whom we knew a device had been implanted to expedite dealing with a medical emergency.

More importantly, medicine is about innovation and creativity. Unless we have a mechanism to evaluate the progress of medical devices implanted in individuals, how can we know which ones work and which ones do not? If a patient does not re-present, and if there is nothing added to the record, we will never know. Such a registry is mission critical.

The Government should be brave and consider a new clause to create such a registry, and they need to consider how we can consolidate the existing registries. There are many national, European and international registries for particular disease areas, and a lot of thought has been given to what best practice and the ideal registry look like. The International Medical Device Regulators Forum set out in 2016 exactly what it thought that should look like, and it seems to me that the Government would be well advised to consider that. It suggests collecting information not just about the device but about the journey through and in the patient. It seems to me that only through a change to the Bill will we achieve what we want to achieve.

Things probably go beyond that. Indeed, some of my hon. Friends have explained the complexity of understanding what a “device” is—does it include lip fillers, artificial intelligence and so on? The list of new innovations grows and will, to be honest, grow beyond current human imagination and we need a regulatory system that enables us to take advantage of that and regulate appropriately and quickly. We therefore need the capacity to change the definition of a device, and right now we do not have that because we are effectively adopting the definitions in the rules we adopted from Europe. We are giving ourselves the ability to fiddle, but not to change them fundamentally, and that is actually quite important.

We need to create an international search database so that we can deliver on some of the challenges of urgent harm, which we can prevent and deal with once a defective device is identified, and so that we can create something that gives us the opportunity to be world leaders in not only medical devices but medicines. It seems to me that that is the opportunity. Why do we constrain ourselves to being a follower? Why do we always talk about keeping up with Europe? Why not be the leaders? The National Institute for Health and Care Excellence was always set out as the global standard that everybody looked to—as absolutely what we wanted in every country. Why not have exactly the right system, whatever the NICE or the Medicines and Healthcare Products Regulatory Agency of the future looks like? Why not set the standard that others then follow?

In the earlier part of the Bill, where it covers the regulation of medicine as opposed to medical devices, there are some changes that look to the future—that is certainly the case for the changes regarding medical trials. However, it seems to me that that is a missed opportunity not only to consider the sort of regulatory system we might want in the future, but—even though we have NICE, the MHRA and notified bodies for the lower levels of medical devices, which provide CE marks— to look at this all over again. As has been said, some things that seem to be harmless and very simple, and seem simply to merit a CE mark, can become very dangerous in how they are ultimately used by a practitioner. We might need to look at all this again, but the power to do that simply is not in the Bill.

There is also nothing in the medicines section, as far as I can see, about increasing the speed of access to new developments and new medicines. That has always been a mantra of this Government, but I cannot see any provision for it. If we had control to look at the MHRA and NICE, we could do that, but as the Minister well knows the reality is that she has no power. The power to deal with the regulatory system and the regulations set by the MHRA and NICE is in the gift of NHS England. Following the Lansley reforms, that power is not now in the gift of the Government and it seems to me that the Government, who have this proactive agenda, should be taking the initiative so that they can be more direct in ensuring that we have the regulatory system we need. At the moment, all we have is the ability to limit the money that is available.

For example, the Government have talked about an innovative medicines fund, but I see nothing in the Bill to provide for that. I understand that the idea is that it can be just an extension of the cancer drugs fund, but, I ask the Minister, is that actually right? There should be different criteria—there will be different tests and different needs. Simply extending the cancer drugs fund will muddy the water and not deliver what we are really looking for, which is something that looks specifically at innovative medicines, which need clearly defining and properly clarifying. If we are to cover both groups, we need to increase the pot, but there is no suggestion of doing so.

There is a lot still to be done. Earlier, one of my colleagues made the good point that if we are to be a global leader rather than just a follower, we ought perhaps to look at how our marketing authorisations could be adopted and accepted in other countries, effectively saving costs and getting medicines to market faster. The UK would therefore be seen as the place to come for one’s marketing authorisation, rather than Europe, despite the size differential, because we would be the market leader in the mechanism to develop that.

For me, the Government have made a good start, but there is much to do. I look forward very much to the Minister’s closing remarks and, more importantly, to her confirmation that the Government have an ambitious vision and will be working hard during the following stages of the Bill’s consideration, of which I would very much like to be part, to consider changes that will deliver opportunities that the as drafted Bill does not offer. That said, it is a good start and something we can build on.

The Bill is, of course, necessary to ensure that, in the absence of the European regulations under which we operate until the end of the implementation period, there are effective ways to regulate medicines and medical devices. Even under the current regulatory arrangements we have seen some patients face real difficulties, so it is vital that we get this right, as others have said.

The Minister will be aware that I and many hon. Members across the House have been working with the National Society for Phenylketonuria, or PKU, through the all-party group, to ensure that people with PKU have access to Kuvan, a drug widely available in many other countries. It feels like that has been a pretty hard slog at times, and we have not got there yet. I pay tribute to the NSPKU and, in particular, to Kate Learoyd and Caroline Graham, who have done such a lot of work to get the all-party group established and keep it very lively.

How much more difficult must it be for those people living with PKU—children and adults—to know that there is a drug that would help many of them, but to find that it is not available, than it is for us to see that situation for our constituents? In introducing the debate, the Secretary of State made a great deal of our new powers to act under these arrangements, and I hope very much that that means that Kuvan will become available very quickly. More broadly, I ask the Minister what this Bill will mean for patients with PKU who are hoping to have that drug made available, and how it will affect new therapies and drugs that are in development to treat PKU. How will they be licensed and made available?

Many rare diseases require a large pool of patients to have effective clinical trials of new treatments, and again I ask the Minister if she can say how she will ensure that UK patients can take part in those trials and benefit from innovative treatments. This will be important to the community of patients with rare diseases, not only those with PKU, and I know that there will be great anxiety about the issue of translating EU regulation into UK law and making sure that issues of access, safety and clinical trials are fully covered and regulated. UK patients with rare diseases must not be disadvantaged by separate licensing and trial arrangements, and I ask the Minister to comment on that.

Secondly, this legislation clearly impacts on the role of the MHRA. At this point, I want to mention the great work of Emma Murphy and Janet Williams, who have worked so hard on the issue of fetal valproate spectrum disorder, to which my hon. Friend the Member for Leicester South (Jonathan Ashworth) referred. They have found that, despite the devastating impact arising from women with epilepsy being prescribed the drug valproate during pregnancy and despite these problems being known about among the medical profession for many years, that drug is still being prescribed, sometimes in unmarked boxes, and is still causing damage to babies whose mothers have taken the drug. I hope that this new system will ensure that the regulations are strengthened to ensure that that cannot happen in any case in the future—the will is there to do it. This is happening even after advice to doctors and pharmacists had already been given as a result of the fetal valproate syndrome campaign, so we need action to resolve that straightaway.

I totally agree with the hon. Lady about the concerns and, we hope, the opportunity to ensure that any pack of sodium valproate that is dispensed carries the information. Does she share my concerns at the talk of having digital information, as many people are digitally excluded? Having actively to seek information about a drug is perhaps an additional barrier. We should be making this easier, simplifying the leaflets that are in with drugs, perhaps by having more infographics, to allow people with poor English or limited understanding to recognise what they should be doing around their medication.

I thank the hon. Lady for her intervention, and I agree that there is a concern about that. All forms of communication are great, and digital, as an extra, is good, but it must not exclude people who do not have access to computers or the internet. It certainly must not replace those paper warnings on boxes of tablets—we need to strengthen that bit as well.

I would like to see a strengthening of this legislation to make sure that what I have described could never happen again. I would also like to see effective data sharing, so that issues such as this were identified and acted upon quickly. Data sharing with the EU will continue to be important, so I ask the Minister, how will such data be shared with EU countries to ensure that we share those experiences and warnings?

Finally, I am concerned at the use of Henry VIII powers to create pharmacy hubs. There is already a concern that some community pharmacies face challenges from prescription-by-post services, at the same time as we are encouraging people to seek advice from their local pharmacist first. It is really important that local pharmacies are not pushed out of communities as a result of these measures, because they are really valued by the people who use them. Will the Minister tell me how she will ensure that that does not happen as a result of the powers to create pharmacy hubs?

This has been an excellent debate—and we seem to have plenty of time left for winding up. I thank all Members from all parties who have taken part, and particularly my hon. Friends for their excellent speeches: my hon. Friend the Member for Blaydon (Liz Twist) made the case for Kuvan for sufferers of PKU, which I shall mention again in a moment, and my hon. Friend the Member for St Helens South and Whiston (Ms Rimmer) made a powerful speech about organ harvesting that I am sure we will discuss in more detail in Committee.

The hon. Member for Bosworth (Dr Evans) raised an issue that is not currently on the face of the Bill but perhaps should be. It is something that I have discussed with Health Secretaries for well over a decade now—probably around 12 years—starting with the then Member for Kingston upon Hull West and Hessle when Labour was in government, and I raised it with the Minister only last week. The issue is the waste of prescription medication. The hon. Gentleman mentioned a possible figure of £300 million a year from the House of Commons Library, and that did not surprise me. I can well believe that that could be the figure and agree that there has to be a way to reduce that waste. As the hon. Gentleman said, we should start by measuring it, and perhaps consider the active, safe charitable donation of such medicines, because £300 million-worth of perfectly good medicines being put into an incinerator every year cannot be the best outcome. There has to be a better way. I am grateful to the hon. Gentleman for raising that issue, which the Minister will remember we discussed just last week.

I thank the Minister and her officials, who have taken the time last week and since to brief me and my team on the Bill. As my hon. Friend the Member for Leicester South (Jonathan Ashworth) said in his opening remarks, the Opposition support the principle of the Bill, but we have some concerns that I shall briefly outline and to which I hope the Minister will respond, if not now then perhaps at a later stage in the Bill’s progress through the House. The Bill deals with both human and animal health, and I shall start with human health.

Patient safety is of the utmost importance and I recognise that with the Bill the Government are taking steps to improve both patient safety and the availability of medicines and medical devices to patients in the UK after the transition period is over on 31 December this year. However, as the Minister knows, in the cases of valproate, Primodos and surgical mesh, which we have heard about already in the debate, patient safety and patients’ experiences in the past—sometimes even now, in respect of mesh—have sometimes been disregarded when they have reported issues to their GP. The independent medicines and medical devices safety review has been looking into that, and I very much look forward to seeing Baroness Cumberlege’s recommendations later this month.

I should also mention that there are questions of patient safety in respect of other devices, such as breast implants and metal-on-metal hip implants. There are a host of examples of patient safety having been compromised. We must ensure that that does not happen again.

Medical devices are not subject to the same strict regulations as medicines. Faulty washing machines are treated with far more caution than a medical device that goes wrong. A case in point is that we will all have been written to recently by Whirlpool. Regulations must be tightened for both medicines and medical devices. I am sure that the Government will consider seriously the forthcoming recommendations from Baroness Cumberlege in the review.

One mechanism in the Bill to increase patient safety is the provision to establish a database for medical devices and provide the Secretary of State with new powers to share information about medical devices in limited circumstances. However, there are approximately 80,000 different medical devices on the UK market. Will every device be entered into the database? What steps have been taken to establish such a database? Will the Minister please provide some more information about the point at which the Secretary of State will be mandated to share the information held on a medical device with the public? I wholeheartedly agree that there should be a database of this nature, but it must be fit for purpose and healthcare professionals must be able to access an updated database to make sure that they can provide the best treatment and care for their patients that is safe. I hope that the database would go further and become a register or even a registry, as the hon. Member for Central Ayrshire (Dr Whitford) suggested. A barcode could be included on each device that is scanned into a patient’s records so that a register or registry is created.

As I have mentioned, the Bill makes provisions for access to medicines and medical devices after 31 December. However, it is causing concern for some patients who are currently participating in EU-wide clinical trials and for patients who fear that they may miss out on future trials. Can the Minister provide any assurances today about access to EU-wide clinical trials, especially for those patients who are already on them? Access to such clinical trials would especially benefit patients with rare diseases, who have a small patient group here in the UK. Will the Minister please set out what provisions will be made for patients with rare diseases who could benefit from participating in a clinical trial?

As this Bill comes into force on 1 January 2021, will the Minister reassure the House that the supply of medicines and medical devices will be maintained in the run-up to the end of the transition period? This Bill could enhance access to medicines, but what does that mean for patients with rare diseases? For example, as we heard from my hon. Friend the Member for Blaydon, who spoke so passionately about PKU, patients have been waiting for more than 10 years for the drug Kuvan to be made available on the NHS. We know that Kuvan works for patients with PKU, because some have raised funds for it and been paying for it privately. Although it is expensive, the cost is not outwith the reach of some patients, but patients in the UK should not have to go without effective drugs. I am sure that we have all had constituents who have brought these cases to us. I therefore hope that provisions will be made to improve access to medicines, particularly for those people with rare diseases.

I welcome the Government’s announcement today about faster access to cannabis-based medicines, and I would be very grateful if the Minister could please expand on that announcement and how that relates to this Bill in particular. I also welcome the provisions in the Bill that allow for prescription powers to be granted to some bodies within the healthcare system—for example, to physiotherapists. Will the Minister set out what she envisages this system will look like, who will be able to prescribe, and what they will be able to prescribe and under what circumstances? Will these new prescribers be trained sufficiently to fulfil this role? Where will they get their information from about medicines and medical devices that they are prescribing, especially if there are new warnings on them, as we have seen, for instance, with valproate.

The Bill also allows for pharmacy hubs to be established under a Henry VIII power, so will the Minister give the House a timescale for this power to be used? I would also be grateful if she outlined how these pharmacy hubs will work in practice, as I am concerned that this could open up an Amazon-style prescription service.

Let me move on to animal health and veterinary medicine. Although this subject is more likely to come under a DEFRA brief, I know that there is a link between human health and animal health, not least when it comes to antimicrobial resistance. Keeping our animals fit and healthy and ensuring that vets have the medicines that they need to provide treatment and care for animals is, of course, crucially important to many of us. Will the Minister please assure the House that the supply of veterinary medicines in the UK will be maintained in the run-up to the end of the transition period and that standards for veterinary medicines will be upheld to ensure that animals are given the best possible treatment after the transition period.

The Bill gives powers to relevant bodies to amend regulations as necessary, so will the Minister assure the House that the regulators are equipped with the right finance and resources to take on these new responsibilities? I am pleased that, in non-urgent cases, there will be consultations held before any regulations are changed, but can the Minister outline how long these consultations will run for and how soon after the consultation closes the new regulation will be implemented? What formal processes will be put in place to ensure that industry is involved in these consultations and, finally, how will the Government monitor the effectiveness of the regulations? What bodies will be able to scrutinise the performance and delivery of the regulators?

As I mentioned at the beginning of my speech, we do not want to find ourselves in several years’ time with news that a medical device or medicine is causing serious harm to patients—more than we have already, given what Baroness Cumberlege is looking into. Regulators must be held to account on this as much as the manufacturing industry and healthcare system.

In closing, human and animal safety is of the utmost importance, which is why we on the Labour Benches welcome this Bill, but I would be grateful if the Minister could answer these questions. If that is not possible in the time available tonight, especially given the rate at which I have put these questions to her, then perhaps in writing or indeed, during the passage of the Bill in Committee.

First, let me thank all hon. Members for their support in discussing this enabling legislation. It is a pleasure to close this debate on the Medicines and Medical Devices Bill. The Bill is both a piece of legislation to future-proof our regulatory regime going forward and an opportunity to clarify and improve the one that we have now.

I am gratified that hon. Members have approached this debate with thoughtful consideration. Obviously, there is a lot more to discuss in Committee, because several themes came up during the course of this afternoon’s debate on which I can only touch now. I will take up the request of the hon. Member for Washington and Sunderland West (Mrs Hodgson) and write to her. I have not had the chance thus far to have a specific briefing with the hon. Member for Central Ayrshire (Dr Whitford), so perhaps we could do so to enable us all to understand our direction of travel.

Patient safety is not a partisan issue; it is paramount. It is what drives us to do what we do. It does not matter which side of the House we sit on, the patient is at the centre of our concern. We hope that, in going forward, we can enhance and strengthen that view and show ourselves as an exemplar to the world in the way that we conduct trials and in the way that the life science and pharmaceutical industries work. We hope to assist the whole industry in making sure that we never compromise on patient safety.

This will be the first opportunity in 40 years for the UK to make choices regarding how we regulate medicines, veterinary medicines and medical devices in the best interests of the UK now that we have left the EU. This is all part of our making sure that we transition smoothly on 1 January next year. Members from all parts of the House feel passionately about the outcome of negotiations on the future relationship. I would like to assure hon. Members that the Bill allows us, in the future, to set rules that are best for the UK, whatever the outcome of those negotiations. The Bill is important, as it makes clear the Government’s commitment to the life science sector, which is worth over £75 billion to our economy and which contributes almost 250,000 jobs to the UK. We are rightly proud of that sector, but innovations and advancement must be matched by rigorous standards to protect patients. I very much take on board the comments of the hon. Member for Twickenham (Munira Wilson), which were particularly pertinent to the experience that she brings to this House. I hope to enjoy more of that debate when we are in Committee.

The Bill sets out clear principles: ensuring patient safety; ensuring their continued access to medicines and devices; and maintaining the attractiveness of the UK as a market and a place for clinical trials. There is a delicate balance there that we must continue to strike, and the debate today demonstrates the paramount importance of all those principles. On that point, I will move on to the comments of hon. Members.

The provisions on veterinary medicines are essentially a straight lift from the human medicines part of the Bill. There is one significant difference, of course: animals that have been prescribed and administered medicines are put into the food chain. With regard to withdrawal periods, that, in turn, can have a significant impact on the access to markets of exported meats. Will the Minister consider later an amendment to clause 8(2), to provide at least some regard to the commercial position of the end meat products?

As the right hon. Gentleman knows, I am always happy to have a discussion to see whether any accommodation can be made. As far as veterinary medicines go, I should say that, unlike with human medicines, we pay attention to the environmental impact as they go through.

I should declare an interest as a veterinary surgeon. I want to bang the drum for part 2 of the Bill and the importance of the way in which it addresses veterinary medicines. The Bill will go some way towards providing assurances to the UK veterinary profession that there will be continuity in its ability to prescribe for and treat a group of patients that have not been discussed much tonight: animal patients in our country.

I am happy to give my hon. Friend the assurance that there will be that continuity. That is precisely the aim of the Bill.

The shadow Secretary of State asked me to comment on reports that he had read in the papers today about health security. The UK is open to exploring co-operation between the EU and other specific narrowly defined areas when it is in the interests of both sides—and on matters of health security, it would be foolish not to.

Several Members discussed clinical trials, with a particular eye to the rare diseases cohort, which is obviously, by its nature, small. It is only sensible to ensure that we have the ability to collaborate across Europe to determine that we have the best environment for the development of drugs. I would caution people to breathe before we go forward. We are committed to ensuring that we remain the best place for those on rare disease trials.

The Medicines and Healthcare Products Regulatory Agency has taken steps to ensure that there is absolutely no disruption to clinical trials and that they can continue seamlessly. It is important that we are tempered in tone to ensure that people’s clinical trials carry on. We want a world-leading regulatory system for clinical trials that allows us to collaborate effectively—not only across Europe, but globally. We have one of the best life sciences industries in the world, for which effective collaboration is important.

Now that we have left the European Union, it is important to make it clear that UK sponsors will still be able to run multi-state trials across the world. We want a regulatory system that maintains and enhances the attractiveness of the UK as a site for global co-operation in research.

I move on. We will extend prescribing rights to physician associates through other means. We are discussing the extension of physician associates’ rights for prescribing in the context of the increase in clinical professionals who will be working in the health service. The broader ability of the Bill to ensure prescribing rights will be carried through only in collaboration with the appropriate regulatory oversight, whether from the General Medical Council or the Health & Care Professions Council, depending on whether allied health professionals or physician associates are involved.

The hon. Member for St Helens South and Whiston (Ms Rimmer) asked whether clinical trials data would include those forced to participate. I assure her that clinical data used to support regulatory activity in the UK needs to comply with international good clinical practice standards, including ethical considerations such as the critical principle of informed consent. That means that the appalling cases to which she alluded could not be involved in clinical trials.

There are signs up in Chinese airports saying “Organ transplants this way” in English; there is a clear path through. I am not saying that it is the English who are going, but the system is international. People are going out. France is already taking steps to stop organ tourism.

I thank the hon. Member for that intervention.

Let me point out to the shadow Secretary of State that it is possible that the use of artificial intelligence—to determine what treatment to give a patient, for example—would fall within the scope of the regulation-making powers in the future. It is right that we have the tools to respond to this kind of technology in the years ahead. I was most interested by the comments of my hon. Friend the Member for Bolton West (Chris Green) about better patient outcomes. I could not agree with him more about the importance of the life sciences sector, and about using data to inform as we go forward. The MHRA will be able to conduct inspections for manufacturing, distributions, clinical trials, laboratories and pharmacovigilance, and it is important that that continues to ensure that we uphold standards.

There were numerous other comments, particularly about the medicines and medical devices lists and register. I look forward to ensuring that we have a robust debate in Committee about what is best for the patient and the clinician. My hon. Friend the Member for Bosworth (Dr Evans) made an important point about clinicians perhaps annotating patients’ notes with information about why they used a particular medicine or device.

We have spoken about medical devices perhaps being manufactured at a patient’s bedside. The shadow Minister mentioned having a barcode on each device. It would be quite hard to barcode a device when it was manufactured in order to put it on to a register. I hope that having this discussion in later stages will inform us all how best to do this.

I hope that the spirit of this debate—one in which we are all in support of a common purpose—carries through to the examination of the Bill. This legislation offers an opportunity for the UK to protect patients, support the development of an exciting and important sector, and do what is best in the UK for the UK’s interests. I commend this Bill to the House.

Question put and agreed to.

Bill accordingly read a Second time.

Medicines and Medical Devices Bill (Programme)

Motion made, and Question put forthwith (Standing Order No. 83A(7)),

That the following provisions shall apply to the Medicines and Medical Devices Bill:

Committal

(1) The Bill shall be committed to a Public Bill Committee.

Proceedings in Public Bill Committee

(2) Proceedings in the Public Bill Committee shall (so far as not previously concluded) be brought to a conclusion on Thursday 23 April 2020.

(3) The Public Bill Committee shall have leave to sit twice on the first day on which it meets.

Proceedings on Consideration and up to and including Third Reading

(4) Proceedings on Consideration and any proceedings in legislative grand committee shall (so far as not previously concluded) be brought to a conclusion one hour before the moment of interruption on the day on which proceedings on Consideration are commenced.

(5) Proceedings on Third Reading shall (so far as not previously concluded) be brought to a conclusion at the moment of interruption on that day.

(6) Standing Order No. 83B (Programming committees) shall not apply to proceedings on Consideration and up to and including Third Reading.

Other proceedings

(7) Any other proceedings on the Bill may be programmed.—(James Morris.)

Question agreed to.

Medicines and Medical Devices Bill (Money)

Queen’s recommendation signified.

Motion made, and Question put forthwith (Standing Order No. 52(1)(a)),

That, for the purposes of any Act resulting from the Medicines and Medical Devices Bill, it is expedient to authorise the payment out of money provided by Parliament of:

(1) any expenditure incurred by a Minister of the Crown, a government department, a person holding office under Her Majesty or any other public authority by virtue of the Act; and

(2) any increase attributable to the Act in the sums payable by virtue of any other Act out of money so provided.—(James Morris.)

Question agreed to.

Medicines and Medical Devices Bill (Ways and Means)

Motion made, and Question put forthwith (Standing Order No. 52(1)(a)),

That, for the purposes of any Act resulting from the Medicines and Medical Devices Bill, it is expedient to authorise the charging of fees, or other charges, arising by virtue of the Act.—(James Morris.)