Medicines and Medical Devices Bill

Philippa Whitford Excerpts

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

[Matt Hancock]

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.

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

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.

[Matt Hancock]

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.

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[Chris Green (Bolton West) (Con)]

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

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

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

[Dr Whitford]

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

[Chris Green]

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

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

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[Chris Green]

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

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

[Dr Whitford]

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

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

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

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

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

[Chris Green]

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

[Dr Whitford]

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

[Dr Lisa Cameron (East Kilbride, Strathaven and Lesmahagow) (SNP)]

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.

[Dr Whitford]

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.

[Jim Shannon (Strangford) (DUP)]

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?

[Dr Whitford]

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.

[Jim Shannon]

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?

[Dr Whitford]

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 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 Government, 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.

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[Dr Evans]

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.

[Dr Whitford]

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?

[Dr Evans]

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.

[Dr Whitford]

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?

[Dr Evans]

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.

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[Liz Twist (Blaydon) (Lab)]

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.

[Dr Whitford]

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.

[Liz Twist]

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?