Medicines and Medical Devices Bill

Luke Evans 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

[Jonathan Ashworth]

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.

[Dr Luke Evans (Bosworth) (Con)]

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.

[Jonathan Ashworth]

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.

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[Chris Green]

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

[Dr Luke Evans]

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

[Chris Green]

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

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

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[Dr Luke Evans (Bosworth) (Con)]

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 that 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 vigorous 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.

[Jim Shannon]

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.

[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.

[Ben Everitt]

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.

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[Dr Evans]

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.