Medicines and Medical Devices Bill

Jim Shannon 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

[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.

[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.

--- Later in debate ---

[Jim Shannon]

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.

[Ms Rimmer]

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.