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.

Medicines and Medical Devices Bill

Jim Shannon Excerpts

Report stage & 3rd reading & 3rd reading: House of Commons & Report stage: House of Commons
Tuesday 23rd June 2020 Commons Chamber

[Ms Marie Rimmer (St Helens South and Whiston) (Lab)]

I thank the Minister for providing us with sight of her letter to the Minister for Asia. As she committed herself to doing in Committee, she communicated it to all Committee members. I sincerely thank her for that.

Amendment 19 would empower the appropriate authority to make provisions for the process of developing or manufacturing medicines in relation to the origin and treatment of human organs. This is necessary because of the actions by the Chinese Government in Beijing. The China tribunal, headed up by Sir Geoffrey Nice QC, launched the first independent legal analysis of all evidence relating to organ harvesting in China and found beyond reasonable doubt that forcible organ harvesting was taking place. China was invited to provide evidence to this tribunal but failed to do so.

Further, a study by the medical journal BMJ Open has raised ethical issues on over 400 Chinese medical studies, and there is clear evidence that China is abusing the human rights, including the right to life, of Uyghurs, practitioners of Falun Gong, conscientious objectors and political prisoners. There is no reason to believe that China is not also experimenting on such prisoners without consent and then harvesting organs to examine the results of such experiments, and we must protect the UK health system from being morally compromised by this.

The Minister stated in Committee that my amendment was not required as regulations are already in place under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and the Human Tissue Act 2004. There are codes of practice in respect of the 2007 regulations, but section 1(4) of the 2004 Act explains that subsection (1) does not apply for a body to which subsections (5) or (6) apply:

“Subsections (1) to (3) do not apply to an activity of a kind mentioned there if it is done in relation to…a body to which subsection (5) applies”—

which includes a human body that has been imported—

“or…relevant material to which subsection (6) applies”,

and that applies to “relevant material” if has been imported. “Relevant material” means material consisting of human cells, so imported human tissue does not require appropriate consent.

The importing of human body tissue for medical research does not require any consent or traceability—it is only advised, not required—meaning that human tissue from countries like China can legally be imported to the UK for the purpose of medical research without traceability, documentation or consent. Imported human body tissue for use in medicines requires traceability from donor to recipient. Although technically consent documentation does not legally require consent, in reality it would be difficult to demonstrate donor selection requirements without it.

Without my amendment, we have no assurance that harvested organs cannot find their way into our national health service. Although the legislation and regulations provide guidance, it is just that: guidance. Why should we not want to make it clear that harvested organs will not find their way into this country? International checks on the system are failing, with the World Health Organisation’s assessment of the Chinese organ transplant system actually being one of self-assessment, as stated by the WHO to the Foreign and Commonwealth Office. Thus, the regime breaking the ethical standards is also assessing whether it meets them.

The British Medical Association has called on the Government

“to reconsider its position on this issue in light of the findings of the Tribunal”.

My amendment would empower the Government to do just that and close the hole in the existing legislation. It aims not to shut down the trade in medicines between the United Kingdom and China, but to ensure that it is ethical. It would not force the Government to implement the regulations now; it would merely empower them and the relevant authorities to take the steps necessary to regulate on this issue, when and if they are prepared to do so.

I do not intend to push my amendment to a Division today, although frankly, I should not have to: the moral and practical case is as clear as day, and the Government should accept it. It seems that they will not do so at this stage, but they should when the Bill is debated in the other place. I want to make it abundantly clear that I will not let this matter lie. A growing group of cross-party parliamentarians, both here and in the other place, are determined to stop this from happening. We now need the Government to do their bit. I will leave it there.

[Jim Shannon (Strangford) (DUP)]

It is a pleasure to be able to speak on this issue. The Minister knows how pleased I am to see her in her position. I have always followed her progress, and she has done very well. I am pleased to note how capably she responds to the issues that are raised in the debate. What a pleasure it is, too, to see the shadow Minister, the hon. Member for Nottingham North (Alex Norris), in his place.

--- Later in debate ---

[Tim Farron (Westmorland and Lonsdale) (LD)]

Jim, you could have carried on a bit longer, couldn’t you? It is an honour to follow the hon. Member for Strangford (Jim Shannon).

When it comes to the regulation of the introduction of new, innovative medicines, treatments and technologies, I am bound to say that cancer will be at the forefront of many of our minds. It is an area that deeply concerns every single one of us, and it could be severely impacted if we do not get the negotiations right. The NHS long-term plan, which is full of very good and wise things, recognised the significant problem that we have in the United Kingdom with our cancer survival rates. Our survival rates, and it has been the case under many Governments of different colours, are among the worst in Europe. We have the second lowest survival rate for lung cancers and below average survival rates for nine of the 10 major cancers. The terrifying statistic for us personally is that one in every two of us is likely to get cancer at some point in our lives. That means we will, all of us, almost certainly be touched by cancer in some way in our families at some point during our lives, if we have not been already.

The need to step up our efforts to fight this horrific disease is amplified by the current context. We have seen a 60% drop in cancer referrals and a 20% fall in the numbers of those starting treatment during the covid crisis—for obvious reasons, and some of them justifiable reasons. Clearly, there are people who are at risk of their immunity being suppressed during the virus or who could gain the infection via surgery during the pandemic, so we understand why clinicians make such decisions.

[Jim Shannon]

The week past was Men’s Health Week, and I know the hon. Gentleman is of the same opinion as me about the importance of highlighting prostate cancer. Bowel cancer is another example. Those are two of the cancers that take people out of this world very quickly. I know the Minister will respond very positively, but is it his understanding that those are two of the cancers that, critically, we need to address early on?

[Tim Farron]

The hon. Gentleman makes a very good point. The two statistics I rattled out—and not for the first time, even today—are the 60% drop in referrals and 20% drop in treatments beginning. The referrals one is broadly down to people not coming forward because they do not want to trouble the NHS. It is massively important to amplify what I know Ministers and clinicians are saying around the country, which is that if people are even the remotest bit concerned, they must come forward and seek advice, because the NHS undoubtedly is open. Some of the cancellations of treatment have been for other reasons, such as not having had full access to kit and, in the early days, NICE advising against it taking place when perhaps it could have done. However, I am pleased that the Government have managed to make significant progress in recent weeks.

The statistics on the reduction of people coming forward for treatment and for referral, and on the reduction in treatments beginning, are, of course, all true, yet the numbers of people with cancer at this point is the same as it would be in any other year, give or take. That tells us that we are in danger of seeing a serious peak in late diagnoses, and, therefore, sadly, in people tragically not living as long as they would have done otherwise.

In the context of the Bill, removal from the European Medicines Agency would do our people harm. Choosing to go from being part of an organisation that represents 25% of medicine sales on the planet to one making up only 3% will inevitably see us fall down the list for those applying for new drugs and treatments. In that case, the wisest course of action would be to negotiate associate membership of the European Medicines Agency. We must be at the cutting edge of cancer treatment, yet we will hobble ourselves if we reduce access to new treatment and scale back research and development.

Of course, Britain’s membership of the EMA is no guarantee of progress. I am thinking particularly of radiotherapy technology. NHS England has just agreed to roll out the commissioning of stereotactic ablative radiotherapy—SABR technology—and to bring it forward by a year. This comes after an arduous 10-year battle for this precise and powerful treatment to be rolled out to every cancer centre in the country. To be clear, 100% of radiotherapy centres are equipped to give this treatment, but only half of them are currently commissioned to do so. I am very grateful to Ministers and in particular to the one in her place, who intervened to ensure that all centres will now be commissioned. We are very grateful.

The reason given time and again by NHS England for wasting this resource was that it did not have enough data. This is relevant, because this was a treatment being used effectively across Europe with significantly improved outcomes. If this is the case when the data is there, I dread to think what the impact will be of having reduced access to data on medicines and medical devices when we are outside the EMA.

If effective and co-ordinated implementation does not follow regulation, regulation becomes utterly meaningless. Many colleagues have rightly raised concerns about maintaining access to the best possible treatment for those in the UK, but we also need to recognise that countless people are not able to access the treatment that they need and that has been approved even now. The idea that this could be further curtailed and cost further lives is deeply troubling. Indeed, it would be an outrageous injustice. The process between the approval of a medicine or medical device and its use to treat illness and save lives is hugely important, as the experience of the development of radiotherapy in this country proves.

Medicines and Medical Devices Bill

Jim Shannon Excerpts

Consideration of Lords amendments & Ping Pong & Ping Pong: House of Commons
Wednesday 27th January 2021 Commons Chamber

[Ms Marie Rimmer (St Helens South and Whiston) (Lab) [V]]

In 2018, the imported bodies of political prisoners and human rights abuse victims in China were on display in Birmingham. It was supposed to be a Real Bodies exhibition, to inform the public about biology, yet in reality it was a barbaric travelling circus. The British public unknowingly paid £15 each to view the remains of these poor souls.

Since I learned of that horrific display, I have become determined to work on behalf of these human rights abuse victims to end forced tissue and organ harvesting. Our nation and the people who live here must not be complicit in the brutal acts of the Chinese communist regime. The first step is to put a stop to the importing of tissue and organs of human rights abuse victims. Currently, neither the human tissue regulations nor the Human Tissue Act 2004 requires appropriate consent for imported human tissues to be used in medicines. After several attempts to bring forward an amendment to achieve this, both here and in the other place, the Government have finally included a negotiated amendment in this Bill, which I welcome.

That amendment provides the opportunity to prevent complicity in this crime within the UK medicine industry, and gives Ministers the powers to do the right thing. It is important to stress that the amendment has not dealt with the issue of organ transplant tourism, or the issue of plastinated unclaimed bodies being imported and commercially displayed, as we saw in Birmingham. The amendment is a welcome start, but it is only the beginning; there is much more to do.

I hope the House will forgive me if I place my thanks on record, as securing that amendment has been a long, drawn-out battle across both Chambers. First, I congratulate Lord Hunt of King’s Heath for persevering so tenaciously, along with his co-signatories Lady Finlay, Lady Northover and Lord Ribeiro. I also thank Lord Alton and Lord Collins for their tireless efforts on this issue. Finally, I thank my hon. Friend the Member for Nottingham North (Alex Norris) for his support and advice.

One of my predecessors as MP for my home town, St Helens, was Sir Hartley Shawcross, the chief British prosecutor at the Nuremberg trials. Just like the Nazis he prosecuted for, among many reasons, using human beings for medical experiments, I hope and pray that one day, those responsible for these despicable, heinous acts will be prosecuted for their crimes against humanity, for that is what forced organ harvesting is. Last year, the China tribunal, led by Sir Geoffrey Nice QC, a former lead prosecutor at The Hague, concluded that

“Forced organ harvesting has been committed for years throughout China on a significant scale and that Falun Gong practitioners have been one—and probably the main—source of organ supply”,

and that

“In regard to the Uyghurs the Tribunal had evidence of medical testing on a scale that could allow them, amongst other uses, to become an ‘organ bank’.”

The amendment sends a very clear message that we will not tolerate such appalling acts against humanity and that we will deliver for the people of China, not for the Communist party of China. Let the amendment truly mark the beginning of a new relationship with China—a relationship that is not naive. Today, Holocaust Memorial Day, is the day when the world says “Never again” to genocide. Let this be the start of the Government putting those words into practice.

[Jim Shannon (Strangford) (DUP) [V]]

I thank the Minister for all the work that she has done on the Bill, and I commend the hon. Member for Nottingham North (Alex Norris) for his dedication.

The Bill seeks to address the regulatory gap by introducing dedicated regulation-making powers covering the fields of human medicines, including clinical trials of human medicines, veterinary medicines and medical devices. That is clearly absolutely necessary, and the most pertinent reason is one about which I wrote to the Secretary of State for Health and Social Care just last week: the ability of my young constituent Sophia Gibson to have continued access to her medication post Brexit. Her family were informed that there would be issues sourcing the medication—medicinal cannabis—that has made such a difference to her life. Her parents began their battle, still traumatised from their last battle to source this life-saving medication, and we began to work on it. The Secretary of State and the Northern Ireland Department of Health have worked hard, and initial reports are that we will produce the medication here, in co-ordination with the lab that creates it in the Hague. That is good news, although I await confirmation. It would appear that this is just one story that is working out, but it flags the necessity of the United Kingdom of Great Britain and Northern Ireland creating and prescribing our own medications. That is why this legislation is vital.

I echo and support wholeheartedly the comments of the hon. Member for St Helens South and Whiston (Ms Rimmer) in relation to the commercial forced organ harvesting that is happening in China against Falun Gong members, Christians and Uyghur Muslims. We need to address that, and I know that the Minister and other Ministers have that responsibility. It is very worrying, and I echo the hon. Lady’s comments about that.

I know that the thousands of people who believe that their quality of life has been affected by mesh, for example, will wonder why this legislation has not been in place before. I ask for clarity that the aim of the Bill will be achieved and that it will allow for much greater scrutiny and accountability in the world of medical devices.

The Lords amendments make a few suggested additions to the Bill. There is an understanding that we must allow our medical field the ability to produce medication and medical devices, but also that it must be better regulated and offer better protection to those who rely on these devices. The Bill extends to England, Northern Ireland, Scotland and Wales. Parts 1 and 2, relating to human medicines and veterinary medicines respectively, are within the legislative competence of the Northern Ireland Assembly. A legislative consent motion has been sought for those parts, and I welcome that following close on the heels of this debate.

Our goal is not simply to pass continuity legislation post Brexit but to improve and upgrade our legislation, and that is what the Bill achieves. The Government indicated in the background briefing to the Queen’s Speech and in a press release that they intend to use these powers to support the development of medicines and medical devices in the NHS and amend prescribing power. That needs to happen, and it needs to happen now; will the Minister confirm that that is the case? The Government stated in the explanatory notes to the Bill that they intend to use these powers to keep the existing regulatory frameworks updated, while consolidating the enforcement regime for medical devices. In addition, the Bill will provide the Secretary of State with the ability to impose civil sanctions as an alternative to criminal prosecution for breaches of the medical device regime.

I have long worked with those who believe that the use of mesh in their bodies has caused substantial harm—not just females and ladies, but males. I have had a number of meetings with them about that. We are all aware that, when something is termed a medical device and not a medication, the testing is less stringent. The civil sanctions will provide the emphasis that we all want to see, to ensure that any device placed in a person’s body has been tested to a high standard before widespread use. I commend the Government, and I commend all Members for their contributions.