Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021

Lord Alton of Liverpool Excerpts

Tuesday 20th July 2021 Lords Chamber

This seems to me to raise two points. First, we should do everything we can to ensure the manufacture of high-quality tests in this country, rather than rely on imports from countries whose human rights record is nothing but utterly deplorable. Secondly, it must call into question the whole future of CE marking. I want to ask the Minister whether we can take the action being taken by the Government—essentially applying their own standards to these tests, because the current CE marking is not sufficient—as a precedent for the future. Does it lay the foundations for a new regime in relation to the regulation of medical devices?

[Lord Alton of Liverpool (CB)]

I thank the noble Baroness, Lady Thornton, for giving us the opportunity to have a discussion around this; I will support her amendment. I am very pleased to follow the noble Lord, Lord Hunt of Kings Heath, and to echo some of his remarks and questions.

In doing so, I return to a Question that I put during Oral Questions, in an earlier part of our proceedings today, where I specifically asked about the number of lateral flow tests that have been produced and where they have come from. My interest in this originated during a hearing of the International Relations and Defence Select Committee, when were told by a witness that he was delighted that a package had arrived at his home containing a lateral flow test and that it had originated in China. This prompted me to ask a Written Question about how many of these tests had been produced in the People’s Republic of China. The Answer I was given was staggering: we had bought not 100,000 or 1 million, but 1 billion. I also asked, in that same Question, two other things: how much this had cost British taxpayers and which companies, both British and Chinese, were involved in these deals. I did not get an answer to the second two parts of my Question, so I tabled a further Written Question, asking again. It stands on our Order Paper today as having the greatest longevity of any unanswered Written Question. It was tabled on 12 May and it was due to be answered by 26 May; it is now 20 July. It is grossly discourteous to the House for Written Questions not to be answered in this way—it would have maybe saved the Oral Question having to be asked earlier on.

At the heart of that Question is the issue of due diligence. I echo something that the noble Baroness, Lady Smith of Newnham, asked during our earlier exchanges. The duty is on the Government, not on individuals, to ascertain, as the purchaser of these lateral flow tests, what the supply chain transparency is. I should mention two things here: I am a vice-chair of the All-Party Group on Uyghurs and I have a Private Member’s Bill before your Lordships’ House on supply chain transparency. What due diligence has been done in establishing the provenance of these lateral flow tests, and why have we not had answers? Perhaps the Minister can give the answers to us now. Who are the companies that have been involved in the purchasing of these tests and what has been the cost overall?

I would also like to ask the Minister something that was put to him on 12 July by the noble Lord, Lord Rooker, in Grand Committee. It is always a pleasure to find myself on the same side of arguments as the noble Lord, Lord Rooker. When I took my seat in another place, over 40 years ago, it was the noble Lord, then as Jeff Rooker MP, who welcomed me; I am glad he has lost none of his bite.

The noble Lord asked the noble Lord, Lord Bethell— I read the Minister’s reply and he did not appear to answer him in that debate, so I simply reiterate the noble Lord’s question:

“why do we need to buy the NHS Test and Trace kits for the lateral flow test, the one being given out by local chemists, from one of the Chinese Communist Party-approved companies? How do we know they are not made with slave labour? What kickbacks go to that corrupt political party? What efforts are being made to get them made in the UK—dare I say Europe—or, indeed, Commonwealth countries? We now have the capacity to check the tests in laboratories. Why have we not done something about manufacturing capacity? Why are we reliant—we appear to be reliant—on the fix of the Chinese industrial structure, which is controlled by the Communist Party or it cannot operate?”—[Official Report, 12/7/21; col. GC 430.]

That is at the heart of this question and of the debate today. It is not a trivial issue. One billion of these tests have been purchased by the UK. Just think what the costs of that will be: if it is 50p a time, that is half a billion pounds; if £1 a time, that is £1 billion. We have a right to know.

This is a point that the noble Baroness made in her remarks earlier: there needs to be not just due diligence but transparency. As far as I am concerned, there has not been sufficient transparency. We are right to press on this, just as it was right earlier to raise the issue of Hikvision. These are cameras that have been put up in our town centres and high streets all over this country, in NHS hospitals and in schools, and they are manufactured in Xinjiang. They are the same cameras being used to monitor Uighur people, 1 million of whom are incarcerated in camps. That company has been banned in the US but not here, and I would be keen to hear from the Minister what the Government—because he will be speaking for the whole Government—are doing to enforce such a ban in the UK.

[Lord Scriven (LD)]

My Lords, we on these Benches support the principle of this SI. Of course we want to see a mandatory standard for tests. I do not think anyone who spoke in Grand Committee argued against the principle of the SI, but there are concerns about a few issues in it. The Minister replied to the issues raised in Grand Committee with soothing words rather than convincing answers, hence the noble Baroness, Lady Thornton, has tabled her amendment to the Motion today.

I want to raise a few of the issues that the Minister either ignored by not answering or used soothing words about but did not give convincing answers to. The first question is: if we are to have a mandatory standard for tests, why have we got new Clause 39A, which is an exemption from the mandatory tests and standards that can be applied at the stroke of a ministerial pen? What is the point of having a mandatory standard for safety if the Secretary of State, at the stroke of his or her pen, can decide to do away with that? In what circumstances and for what reasons would the Secretary of State wish to bring in tests that would lower the mandatory standard, and how would the public know that they were purchasing a test that did not meet the statutory standard that had been set?

I want to address the issue of openness and transparency, as raised by the noble Lord, Lord Alton, and the noble Baroness, Lady Thornton, regarding the validity of the standard of the test as well as human rights issues. Where is the research in public on the validity of the standard of the lateral flow tests, particularly the one from China brought in via Innova, the main intermediary for a Chinese company? This test, as raised in Grand Committee, was given a class I notice in America, and an FDA email says it is not effective and gives the instruction:

“Destroy the tests by placing them in the trash”.


That is the same lateral flow test bought for billions of pounds by the UK. Again, there were soothing words from the Minister in Grand Committee about this: he said that the Government were working with the FDA. That might be true but having two differing positions— the Government saying that the test is safe while the FDA says to throw it in the trash—is not working together. Could the Minister elucidate on why the British Government still feel these tests are safe when the FDA says they should be thrown in the trash? Which part of the FDA’s analysis do the Government disagree with?

The key issue for me is the one that the noble Baroness, Lady Thornton, has already raised: this is not linked into the total public health system to deal with the virus. The key issue is not the standard of the tests themselves but that it should be linked into test and trace. To say that we are going to have a high standard without linking it into the test and trace system is like saying you want the best electric car in order to be environmentally friendly, buying it and then, once you get it home, realising that the nearest charging point is 100 miles away. This is not fit for purpose. To be so, tests must be integral and integrated into the test, trace and isolate part of the public health response to coronavirus.

I ask the Minister, as I and others did in Grand Committee: if someone carries out a private test, how does that link into test and trace? There is no mandation anywhere in UK law to say that a private test, once proved positive, has to be fed into the test and trace system. All the evidence suggests that the way to deal with the virus most effectively is to break the chains of transmission within 48 hours. If tracing is not told that you have tested positive, there is no way to have an effective public health response. So, even if you have the best standard of tests, with no tracing or isolation the chain of transmission will continue.

When I and others asked in Grand Committee, the Minister said that this is also a significant public health policy change. I am not aware of any infectious disease anywhere in the UK or in the world where a market approach to the testing of infectious diseases has become the bog-standard approach, but that seems to have been the Government’s policy after September.

The Minister mentioned Germany in Grand Committee, saying that that country had moved to a specifically private-led testing system. There are two differences in the German system. First, it is controlled by state subsidies; to do it, the companies get a state subsidy, which has now been reduced significantly so the level of private testing is levelling off. Secondly, and most importantly, there is a mandatory requirement in German law to report positive cases from those positive tests to the national Covid test and trace system in Germany.

This statutory instrument, while well intentioned, is riddled with weaknesses. It is not linked to the test and trace system and will not help keep the country safe. It will not have the desired effect, and we will end up with a system that basically has a good standard of tests but then does not do the next, vital part, which is to trace people and then support them in isolating.

That is why we on these Benches will support the amendment to the Motion tabled by the noble Baroness, Lady Thornton—unless the Minister can come up with convincing answers this time, not just soothing words.

Organ Tourism and Cadavers on Display Bill [HL]

Lord Alton of Liverpool Excerpts

2nd reading
Friday 16th July 2021 Lords Chamber

[Lord Alton of Liverpool (CB) [V]]

My Lords, I declare my role as vice-chair of the all-party parliamentary groups on Uighurs and Hong Kong and as a patron of the Coalition for Genocide Response. The noble Lord, Lord Hunt of Kings Heath, has fearlessly shone a light on a practice that, even for the Chinese Communist Party, which is responsible for the deaths of tens of millions of its own people, plumbs new depths of depravity. His admirable Bill deserves our wholehearted support, and I fully endorse and agree with all the preceding speeches in the debate today.

The China Tribunal said that it was

“certain—unanimously, and sure beyond reasonable doubt—that in China forced organ harvesting from prisoners of conscience has been practised for a substantial period of time involving a very substantial number of victims.”

Dr Enver Tohti, a Uighur doctor, described to me how he had been required to remove organs and ordered to

“cut deep and work fast”

on a victim who was still alive. The theft of organs has been described as an almost perfect crime, because no one survives.

However, the crime does not end there: there is a further twist to this infamy. Anonymous, plastinated corpses taken from Chinese prisons have been paraded in a carnival of horrors at money-making exhibitions—a final sneering insult to these victims. In 2018, after one such exhibition, I wrote to the Times, along with Professor Jo Martin, President of the Royal College of Pathologists, and 55 others, saying:

“We believe that the legislation requires reform”.


The Bill of the noble Lord, Lord Hunt, now seeks to do precisely that, and he is to be commended warmly for bringing it before your Lordships’ House.

However, we should go further still. The plastinated cadavers indicate that many are young people. The Minister should establish whether it is possible to extract DNA from these corpses to discover something of their origins and ethnic identity. The law did not require the coroner to determine how the corpses exhibited in Birmingham had died. It should.

What of the World Health Organization? Will the Minister tell us why the Government resisted my freedom of information request to publish their correspondence with the WHO on organ harvesting? They should press it hard to lead an international campaign for legislation like this to be enacted elsewhere, combating and ending these criminal practices.

On 22 July it will be 22 years since the start of the persecution of Falun Gong. Jiang Zemin established the 610 Office to eradicate—his word—Falun Gong, practised at the time by 70 million Chinese people. In undercover phone calls recorded during investigations, Chinese doctors said that Jiang Zemin gave direct instructions to harvest organs from Falun Gong. Last week, the Chinese Communist Party said that it wanted Falun Gong outlawed in Hong Kong.

The Bill of the noble Lord, Lord Hunt, would demonstrate to the persecuted and cruelly treated—to the 1 million incarcerated Uighurs, Tibetan Buddhists, imprisoned Christians, lawyers, journalists and political dissidents, who are subjected to abductions, disappearances, torture, ethnic cleansing, execution and, as the House of Commons determined in April, genocide in Xinjiang—that we have not forgotten them and will not be intimidated or silenced into submission. The Bill deserves a Second Reading and has my full support.

Covid-19: Wuhan Institute of Virology

Lord Alton of Liverpool Excerpts

Wednesday 30th June 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, I attended the presentation by Sir Patrick Vallance at the G7 health track in Oxford in June, which was received extremely well, both by Health Ministers from the G7 countries and by the chief executives of the major pharmaceutical companies that are partners in that work. We are using our chairmanship to nudge it along, and it will cover both the pharmaceutical and the demographic elements of pandemic response. This is an example of where Britain is showing leadership in the world to carve out a clear idea of how we can respond to pandemics better in the future.

[Lord Alton of Liverpool (CB)]

My Lords, I return to the point made by the noble Viscount earlier. Who in the British Government is in direct touch with the US National Institutes of Health, and especially Professor Jesse Bloom, about the deletion of genomic sequences, which he said had no plausible scientific rationale? If it is proven that the virus came from the Wuhan laboratory and that that fact has been concealed by the Chinese Communist Party, does the Minister agree that Magnitsky-style sanctions against individual officials would be the beginnings of an appropriate response by our Government?

[Lord Bethell (Con)]

My Lords, specific official engagement with the investigation is done through PHE, and we have a PHE official sitting on the investigation. That is the right way of conducting a scientific dialogue. The DHSC and FCDO also have extremely active interests in this. As for the tone in which the noble Lord talked about how we should approach this challenge, I say that we have to work in partnership with other countries. There is no way in which we can demonise one country or another in this matter. Partnership is the only way ahead. What we can, I hope, bring to the party is a sense of urgency and a sense of focus.

Medicines and Medical Devices Bill

Lord Alton of Liverpool Excerpts

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, it is a great pleasure to follow the noble Baroness, Lady Sheehan, and to join the noble Lords, Lord Alton of Liverpool and Lord Crisp, in backing her important amendment. The introduction the noble Baroness provided was powerful and comprehensive, so I will not speak at length. I endorse the two asks she put to the Minister; it is important that we hear very clear, direct answers to them.

As the noble Baroness powerfully put it, there is a contest between public need and private profit, and we know that the reality of how our current system works is that private profit comes first. That means that human rights and public health trail behind. We know that so much of our healthcare system has been dragged in the direction of the disastrous US model, the most extreme example on the planet of a private, profit-driven healthcare system that has disastrous outcomes for massive costs. We also know that there are healthcare systems around the world that spend even less than we do but have a very fair and reasonable distribution of resources and money.

We often talk about these issues in moral terms; we must make sure that everyone has these medicines, and I endorse that moral approach, but in the context of the Covid-19 pandemic, nationally and globally, we must come back to the phrase, “No one is safe until everyone is safe.” It is in everyone’s interest that everybody in the UK and around the world has access to the best possible medicines and medical devices and that the research effort and all that wonderful power of human ingenuity are put into the best possible causes and results for public health, for the good of us all.

[Lord Alton of Liverpool (CB) [V]]

My Lords, I spoke at some length on this issue in Committee and am delighted that the noble Baroness, Lady Sheehan, has given us the opportunity to explore it again. She has done so with her usual thoroughness and thought. I am also pleased to follow the noble Baroness, Lady Bennett, who spoke so well. The noble Lord, Lord Bethell, has exchanged letters, as the noble Baroness, Lady Sheehan, referred to; that has been extremely helpful, as she intimated, and I think will avoid the need for a Division, but it is right we explore this issue thoroughly.

I will not repeat all the detailed arguments made in Committee, but, in headline terms, Amendment 10 is being considered in the context of exclusive intellectual property rights which can in some circumstances create monopolies, leading to high prices and supply issues for medicines and medical devices. We are seeing those issues come to the fore in the Covid-19 response.

In an Oral Question that I asked on the Floor of your Lordships’ House on 30 November to the Trade Minister, the noble Lord, Lord Grimstone, I argued that in the context of hundreds of millions of Covid vaccines being held in the United Kingdom and the significant sums of public money invested in developing new drugs and treatments, notwithstanding the need to generate funds to enable future research and development, when companies such as Gilead repurpose drugs such as remdesivir and charge $2,340 for a Covid treatment that Liverpool University estimates can be done for $9, the Government should invoke their powers in such circumstances to use Crown licences to prevent patent monopolies impeding access to medicine, to ensure equitable access, prevent exploitative profiteering and recognise that affordable drugs and their fair distribution are a public good that this country should be at the forefront in providing.

--- Later in debate ---

[Lord Ribeiro (Con) [V]]

My Lords, like the noble Lords who have spoken before me, I thank the Minister and the Government for accepting our amendment. I believe it sends a powerful message, not only to China but to other countries such as Pakistan and India, to which I referred in my speech of 28 October in Committee. In discussion with the Foreign Office, through the noble Lord, Lord Ahmad, we were reassured that the diplomatic strategy would be to continue lobbying as many countries as possible on the issue of human rights and the immoral practice of forced organ harvesting. With the noble Baroness, Lady Finlay, we undertook to raise awareness with the British Medical Association and the surgical royal colleges.

It is worth noting the World Health Organization’s Guiding Principles on Human Cell, Tissue and Organ Transplantation. Any programme such as the kidney pairing exchange, which makes it possible to utilise kidneys that are biologically incompatible between patients and their genetically or emotionally related donors, must follow and respect the WHO’s Guiding Principles of practice, particularly principles 3 and 5, which are worth quoting.

Principle 3 says:

“Live donations are acceptable when the donor’s informed and voluntary consent is obtained, when professional care of donors is ensured and follow-up is well organized, and when selection criteria for donors are scrupulously applied and monitored. Live donors should be informed of the probable risks, benefits and consequences of donation in a complete and understandable fashion; they should be legally competent and capable of weighing the information; and they should be acting willingly, free of any undue influence or coercion.”


Principle 5 states:

“Cells, tissues and organs should only be donated freely, without any monetary payment or other reward of monetary value. Purchasing, or offering to purchase, cells, tissues or organs for transplantation, or their sale by living persons or by the next of kin for deceased persons, should be banned.”


In 2017, the World Health Assembly supported a concept of financial neutrality to protect vulnerable people from being exploited. That is the essence of what this amendment achieves, and I am grateful to the Government and to the noble Lord, Lord Bethell, and the noble Baroness, Lady Penn, for endorsing it. I hope that they will maintain their pressure on the WHO to end these practices.

[Lord Alton of Liverpool (CB) [V]]

My Lords, I start, as others have done, by thanking the noble Baroness, Lady Penn, and the noble Lord, Lord Bethell, for the way in which they have engaged with noble Lords such as the noble Lord, Lord Hunt, who has put so much work into this—along with the noble Baronesses, Lady Finlay and Lady Northover, and the noble Lord, Lord Ribeiro—in trying to draw our attention to the enormity of the depredations that have occurred in China through forced organ harvesting. It is very productive that, this evening, the Government have been able to come forward with an amendment that has been agreed with the sponsors of the Committee amendment, having listened to the argument. I am especially grateful, as others have been, to the noble Baroness, Lady Penn, for the way in which she has engaged.

I will come back in a few moments, if I may, to two other issues that I have raised with her but which are not included in this amendment. They concern consent and the equipment that could be used in the extraction, freezing and harvesting of organs in China, and the question of whether, if British companies were involved in the production of such equipment, there is anything that we could do to forestall that.

On consent, the noble Baroness, Lady Northover, mentioned that, thanks to the noble Baroness, Lady Penn, we have now seen the reports of the Human Tissue Authority of 2018 following its visit to the National Exhibition Centre in Birmingham to examine the plastinated bodies that had been taken there. These were corpses that had been put on public display—what the noble Lord, Lord Hunt, referred to as part of a sort of travelling circus. A second exhibition was held later in the year.

It was extraordinarily naïve—at best—that no more probing was done into the origins of those bodies or how consent could possibly have been given from unknown, anonymised sources. Of course, it leaves the question hanging in the air of whether these were people who had been executed—they probably had been. Sadly, we know that that is the fate of many people, whether they are Falun Gong practitioners or people from different denominational minorities or faith communities, including the Uighurs. We have heard much already this evening, as well as in the Statement from the Foreign Secretary, Dominic Raab, in the House of Commons this afternoon, about the plight of 1 million people who have been incarcerated because they will not conform to the diktats of the Chinese Communist Party.

It is extraordinary that such things can happen in the 21st century, but they are happening. That is why we have to be vigilant and do what we can to prevent the exploitation of people who are caught up in these circumstances. I think particularly this evening of a young woman called Zhang Zhan, who was arrested as a citizen journalist. She is a lawyer by background and had gone to Wuhan to investigate the origins of the coronavirus. She has been languishing in a jail ever since, for some of the time on hunger strike. We know that many dissidents—people who have spoken out against the regime—including lawyers, have been arrested, and some have disappeared, never to be seen again.

Therefore, it is crucial that we discover the origins of the bodies that are used in these sorts of exhibitions and displays, which I personally believe should be prohibited in their entirety. The idea that they can be paraded for macabre purposes should fill people with a sense of disgust. The anonymity of the cadavers should have made the Human Tissue Authority see that this was an issue that it should not just have turned a blind eye to. It is not good enough simply to say that we have a strong regulatory authority. We do: we have strong regulations, many of which came out following the scandal at Alder Hey in Liverpool. However, since then, we have failed to plug the loophole that I and others identified in 2018. We used that phrase—a loophole—in a letter to the Times, but it also appeared in an article in the Lancet. There was a loophole that needed to be filled when it came to organs and tissues from outside the United Kingdom.

The amendment goes some way to addressing that but I think that there also needs to be further regulation on the issue of consent. I also feel—and I would like to press the Minister on this—that we must do more about the export of equipment from the United Kingdom that could be used in forced organ harvesting. Maybe this could be done through export licence control. I noticed in the Statement to the House of Commons this afternoon and in the letter that has been circulated to Peers this evening by the right honourable Dominic Raab, the Foreign Secretary, that he talks about there being a review of export controls as they apply to the situation in Xinjiang. He says that these measures are among the most stringent being implemented globally to help ensure that supply chains are free from forced labour.

That is welcome, but how ironic it would be if, in stopping coming into this country things that have been manufactured by slave labour in Xinjiang, we permitted the export of things to Xinjiang and elsewhere in China that were being used in the extraction, freezing and transportation of body parts in order to enable China to promote one of the biggest organ industries in the world. The noble Baroness, Lady Finlay, was right to say that we also need to do far more about the phenomenon of people travelling to other parts of the world to take organs from others. That kind of organ tourism is something that the British Government need to do more about.

That is all that I want to say. I look forward to hearing the reply from the noble Baroness, Lady Penn.

Personal Protective Equipment: Procurement

Lord Alton of Liverpool Excerpts

Thursday 19th November 2020 Lords Chamber

[Lord Bethell (Con)]

I entirely agree with my noble friend. Such lists will be published. Eighty-nine per cent of the contract award notices have already been published under the Official Journal of the EU; I would be glad to send my noble friend a link.

[Lord Alton of Liverpool (CB) [V]]

My Lords, in a Written Answer, the Minister confirmed to me that the NHS warehouse for PPE at Daventry has masks made by Medwell Medical Products. It is estimated that a quarter of the workers at its Chinese factory are Uighurs in a facility 3,444 kilometres from Xinjiang, so it is implausible that they went there voluntarily. In his Answer, why did the Minister not name the intermediary company involved? Will he now say whether it was Meheco or another state-owned company, what the value of the deal was, whether our embassy was involved, whether the UK made the deal before or after July—when Medwell was named in reports—and what steps he is taking to ensure that the United Kingdom is not complicit in using Uighur slave labour to produce PPE for the NHS and profits for the Chinese Communist Party?

[Lord Bethell (Con)]

My Lords, I acknowledge the extremely good work that the noble Lord does on this issue. Of course, no one wants to see Uighur slave labour used to produce PPE for the NHS. On his specific questions, I do not have the details to hand, but I am happy to revisit the Written Answer that I gave him to see whether I can provide any further details.

Covid-19: Transparency and Accuracy of Statistics

Lord Alton of Liverpool Excerpts

Monday 9th November 2020 Lords Chamber

[Lord Bethell (Con)]

The noble Viscount and I have corresponded on this matter. I do not accept that they suggested that the number of admissions was on the way down. Undoubtedly, the rate of increase has decelerated, but a lengthening doubling time is not the same as a halving time. The doubling time for hospital admissions was eight days at the start of September, 14 at the start of October and 20 days at the end of October. That is a slowing down of the increase, but it is not the same as a decrease.

[Lord Alton of Liverpool (CB) [V]]

My Lords, can the Minister tell us what analysis the Government have made of the root cause and relationship to lockdowns of some 20,000 excess deaths unrelated to Covid-19 during the first wave of the pandemic, including suicide, bacterial sepsis, cardiovascular disease, cancer and other conditions? Should the Government not be publishing regular analyses of the overall harm and not just contested projections of 4,000 deaths each day or the other figures that the noble Lord, Lord Lilley, and the noble Viscount, Lord Ridley, have just mentioned?

[Lord Bethell (Con)]

The noble Lord makes a very good point. We do publish data on excess deaths, which is available on the PHE website, but he is entirely right: we are deeply concerned not just about the Covid deaths but the impact of Covid on others who may be seeking to access the healthcare system. That is why we made the very hard and tough decision to lock down before the NHS was put under too much pressure, and it is why we have made the commitment to keep the NHS open during this lockdown in order to manage down that excess deaths figure to which he refers.

Blood Safety and Quality (Amendment) (EU Exit) Regulations 2020

Lord Alton of Liverpool Excerpts

Monday 2nd November 2020 Grand Committee

[Lord Alton of Liverpool (CB)]

My Lords, in thanking the Minister for introducing these statutory instruments, I am conscious of two things. First, they are procedurally necessary because of the decision to leave the European Union, but inter alia, honour a commitment not to use such transitional arrangements to dilute our commitment to uphold the highest possible standards in relation to the use of organs, tissues, blood and cells. I think that the Government have honoured that commitment. Secondly, I am conscious that it is only a few days since we had a full-blown debate on an amendment to the Medicines and Medical Devices Bill, which is currently in Committee, relating to human organs. The noble Lord, Lord Hunt of Kings Heath, referred to this earlier. Like him, I would like further clarity on the one notable change in the regulations—also touched on by the noble Lord, Lord Lansley, a moment ago. It relates to Northern Ireland, where European Union law will continue to apply while not doing so in the rest of the United Kingdom.

The opportunity for confusion and inconsistency is therefore written into the very DNA of the statutory instruments. It reminds us of what is one of the most troubling and unresolved aspects of the withdrawal agreement. I would be interested to know who within the Northern Ireland Executive has been the point man or woman in discussing the implications of the SI; who has been consulted within the Northern Ireland Assembly and what response has been received; and whether these arrangements have been signed off by the Commission in Brussels and the relevant health authorities in Dublin.

When he comes to reply, I would also be grateful to the Minister if he would return to the questions that I put to him last week concerning the trade and exhibition of body parts. Given that the Human Tissue Act does not require traceability, how is that to be resolved in the context of these statutory instruments or in the legislation being taken through the House? Will that principle now be treated differently in Northern Ireland and Great Britain?

Yesterday I sent the Minister an 87-page report, with 270 footnotes, The Economics of Organ Harvesting in China, published by the Institute to Research the Crimes of Communism. It describes forced organ harvesting as

“one of the most inhumane crimes in the entire history of humanity”.

In harrowing detail, it describes what it calls “the business offer” and details an international spider’s web of companies—including some from the United Kingdom—which have aided and abetted what it describes as primitive barbaric practices. I am grateful to the Minister, whom I had a chance to speak to just before we came into this Committee, for already having had a glance at the report. I hope that he will commit to looking at the report further and say how he intends to take forward an investigation into the companies referred to in it. Will he agree to refer it to the World Health Organization for its consideration?

In that context, and further to the remarks of the noble Lord, Lord Hunt of Kings Heath, I might add that only today the information rights unit at the Foreign, Commonwealth & Development Office has written to me in response to the freedom of information request to which I referred during our debate last week, asking for the correspondence between it and the WHO to be made public. In its response, the unit says:

“Some of the information has been withheld using section 27(1)(b) on International Relations. Section 27 is a qualified exemption and is subject to a public interest test. The application of section 27(1)(b) requires us to consider the public interest test arguments in favour of releasing and withholding information.”


The letter also says:

“The disclosure of information could potentially damage the bilateral relationship between the UK and the World Health Organization. This would reduce the UK Government’s ability to protect and promote UK interests through its relations with the WHO, which would not be in the public interest.”


I would obviously contest that strongly, not least because of the vast amounts of public money that pour from the United Kingdom into the WHO. This sits very uncomfortably with our belief in transparency and open government. Elsewhere, the letter says:

“The disclosure of information detailing our relationship with China could potentially damage the bilateral relationship between the UK and China.”


Why should information pertaining to the forced harvesting of organs and their use in organ tourism be damaging to our relations with China?

Let me conclude. I would be grateful if the Minister could say how in further legislation, whether brought through SIs or within the current Bill, we can demonstrate our determination to stamp out organ tourism that relies on the killing of non-consenting victims, and which then trades in their remains in ways which the United Kingdom should demonstrate to the rest of the world that it will not tolerate.

Medicines and Medical Devices Bill

Lord Alton of Liverpool Excerpts

Committee stage & Committee: 3rd sitting (Hansard) & Committee: 3rd sitting (Hansard): House of Lords
Wednesday 28th October 2020 Grand Committee

[The Deputy Chairman of Committees (Baroness Henig) (Lab)]

I have received a request to speak after the Minister from the noble Lord, Lord Alton.

[Lord Alton of Liverpool (CB)]

My Lords, I thank the noble Lord, Lord Bethell, for the response he has given to the debate, but I have two questions I want to put to him. Like the noble Lord, Lord Stunell, and others, I accept that pharmaceutical companies will always want to and are entitled to reclaim research and development costs. On Monday, I referred to the phenomenal difference in the cost of remdesivir when purchased in the US at over $2,000 for a five-day treatment and Liverpool University’s estimate of $9 as the basic production cost. I asked how much public money went into developing that drug. If the Minister is unable to answer that question today, I would really appreciate it if he could undertake to write to us to let us know how much public money went into the development of that drug.

My second question is about Crown use licences, a question posed to the Minister by the noble Lord, Lord Sharkey. Are the Government considering using the Crown use licence, should the circumstances require that? It was used in the 1960s, and more recently the use of it was threatened in the case of an innovative new treatment for cystic fibrosis. The Government used the power, and that had the desired effect of bringing down the cost of that drug. Are the Government giving serious consideration to how they will use Crown use licences, should that become necessary?

[Lord Bethell (Con)]

I thank the noble Lord, Lord Alton, for his questions. On remdesivir, I will be glad to find out whether any UK funds were used in its development and will write to him. I will also be glad to write to him about Crown use licences.

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[Lord Ribeiro (Con) [V]]

My Lords, I was delighted to add my name to the amendment, so ably introduced by the noble Lord, Lord Hunt, and the noble Baroness, Lady Finlay. The Human Tissue Authority code of practice refers to the EU tissues and cells directive, which requires importers of donated material to have a

“detailed description of the criteria used for donor identification and evaluation, information provided to the donor or donor family, how consent is obtained … and whether the donation was voluntary and unpaid or not.”


During my career as a surgeon and a urologist, I supported transplant teams to harvest organs from patients who had requested that their organs be used in the event of their death. In every case, informed consent was obtained, and relatives were in agreement and consented to the procedure. One cannot be confident that such arrangements pertain in relation to donor parts used in transplantation in China and elsewhere, particularly where the donors are likely to be prisoners.

Advice that I have received from the Royal College of Surgeons notes that, sadly, the issue of UK patients travelling overseas for transplant surgery is not confined to China and is known to occur also in Pakistan and India. A considerable number of UK patients have undergone kidney transplantation from living donors in this way. For the report mentioned by the noble Baroness, Lady Finlay, Sir Geoffrey Nice met with the Royal College of Surgeons to discuss the allegations relating to China. It found the allegations alarming and the evidence concerning. We know that, in China, patients can receive organs within a matter of weeks. Heart transplant surgery can be bought in advance and, according to data collected by the China Liver Transplant Registry, the percentage of emergency, compared to non-emergency, liver transplants is far higher than one would expect. During his investigation, the BBC journalist Matthew Hill was offered a liver for $100,000 by a Chinese hospital, at very short notice. Patients in the UK would struggle to achieve this with a waiting time of several months.

According to experts, an estimated 60,000 to 90,000 organ transplants are happening in China each year, yet China’s voluntary donation system was only established in 2013. Quite recent data, from June 2020, shows that 2,127,955 people have registered as organ donors in China. That is a significant increase on the figure in 2014, which was 22,660. Is it a coincidence that the UK signed the Council of Europe Convention against Trafficking in Human Organs in 2015 and that, in the same year, the Chinese Government introduced legislation that rendered illegal the use of executed prisoners as organ donors? Contacts in the transplant society in the UK believe that this legislation was introduced in good faith and that any such practices that continue are illegal and without official sanction. I hope that that is the case, but the perception is that these practices have not ceased completely. It is the view of some UK transplant surgeons who have visited China, as I have, for transplant-related meetings, that large, prestigious hospitals practise within the law. However, illegal practices do occur and we should use this amendment to send a clear message to the Chinese Government that they must make greater efforts to stamp out the illegal practices that tarnish the reputation of their country.

We have a moral and ethical obligation to investigate UK patients who receive transplants in China, as identified by the noble Baroness, Lady Finlay, and to clearly identify the source of the transplant organs. That is doubly important because, if complications occur, it will be the NHS that has to pick up the pieces.

Finally, it would appear that, although the UK has signed the Council of Europe convention on organ trafficking, we have yet to ratify it. Will my noble friend undertake to explain why this has not been done?

[Lord Alton of Liverpool (CB)]

My Lords, it is a great pleasure to be able to follow the noble Lord, Lord Ribeiro, and to support the noble Lord, Lord Hunt of Kings Heath, my noble friend Lady Finlay and other noble Lords who have spoken to the amendment. In doing so, I return to an issue that I raised at Second Reading and declare my interests as set out in the register.

On 2 August 2018, the Times published a letter signed by me, Professor Jo Martin, President of the Royal College of Pathologists, and 55 others, including Dr Adnan Sharif, a consultant nephrologist in Birmingham, who is the secretary of Doctors Against Forced Organ Harvesting. We began the letter by recalling the Liverpool Alder Hey Children’s Hospital scandal, which had involved the retention of human organs and tissue, without consent, and which led to the Human Tissue Act 2004.

With my antecedents as a Liverpool Member of Parliament and a one-time grateful parent, deeply appreciative of the skills of Alder Hey doctors, I was appalled that such an ill-judged breach of ethics had inflicted such damage on a wonderful hospital. Fourteen years later, and notwithstanding that scandal and that important Act of Parliament in 2004, I was incredulous that in 2018 an exhibition, entitled “Real Bodies”, of Chinese corpses and body parts preserved with silicon in a process called plastination, was being staged for commercial gain at the National Exhibition Centre in Birmingham—denigrating ethics, science, and human rights, and far worse than even the scandal of Alder Hey.

Medicines and Medical Devices Bill

Lord Alton of Liverpool Excerpts

Committee stage & Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords
Monday 26th October 2020 Grand Committee

[Lord Lansley (Con)]

My Lords, I am glad to have the opportunity to contribute to this important debate, to which I have very much appreciated listening. I want to talk about Amendments 10, 12, 74 and 75, in the name of my noble friend Lady Cumberlege, on which I think I very much follow and share the views of the noble Lord, Lord Kakkar.

We are all agreed about what we are trying to achieve at this stage; the issue is how we go about putting it into effect in this Bill. My first point is on patient safety. In the excellent report of my noble friend Lady Cumberlege and her colleagues, what I read is the imperative to minimise harm and to stop avoidable harm. It is clear in the report that stopping avoidable harm is what is being sought and I am assuming that that is what is meant by the proposition that we must make patient safety a prime consideration. In my view, we are all agreed that patient safety is a consideration above those of availability of medicines and the attractiveness of the United Kingdom as a place for life sciences. I do not object to that; I think that that must be true. Indeed, as a number of noble Lords have said, the achievement of a regulatory regime that properly prioritises the safety of patients is absolutely right.

However, when we think about how we translate that into law, we have to look at all the considerations for a medicines regulator. Let me take two angles on that. First, what do my noble friend Lady Cumberlege and her colleagues expect the MHRA to do? In their report, they say that they expect the MHRA to engage with patients and understand better patient-reported outcomes and patient-reported experiences in order better to be able to assess the benefits and risks of the medicines that it regulates—I emphasise “benefits and risks”, not just risks. In that sense, I want the legislation to tell the MHRA that that is indeed what it should be doing.

Secondly, we start with the medicines regulations that we have from the European Union. To some extent, as noble Lords will have gathered from my incorporation of the phrase “safeguard public health” into Amendment 5, which we debated last week, I think that that proposition enables that consideration by the regulator to be incorporated into its operations. It should be there. Otherwise, how can safeguarding public health be demonstrated if one is not properly assessing both the benefits and risks of new medicines?

Indeed, one of the early paragraphs of EU directive 2001/83/EC on medicines for human use says:

“The concepts of harmfulness and therapeutic efficacy can only be examined in relation to each other”.


The end of the paragraph says that applications for marketing authorisation for a medicinal product must

“demonstrate that potential risks are outweighed by the therapeutic efficacy of the product.”

For this reason I wanted to incorporate safety and therapeutic efficacy in an early draft of my Amendment 5, since both are essential. It is correct to prioritise safety over availability, attractiveness or other considerations, but to attach to patient safety the proposition that it is an overriding consideration seems wrong. It is not an overriding consideration; it is an essential one, alongside the therapeutic efficacy of the current or new intervention being examined, whether a device or medicine.

That is not reflected in the amendment’s language at this stage, entirely due to where we are in Committee: we should understand that and decide how to capture that thought. It might be that we have done it already by capturing the proposition of safeguarding public health—in my view we have. However, we should make safety not an overriding consideration but a primary consideration for the medicines regulator. That is a difference. Perhaps my noble friend Lady Cumberlege and the Minister might like to think hard about how we might reflect that.

Finally, I think Hippocrates would agree. “Do no harm” is of course not in the Hippocratic oath, but it derives from Of the Epidemics, in which he wrote,

“have two special objects in view with regard to disease, namely, to do good or to do no harm.”

The two must be together. The medicines regulatory system must ensure that we can do good through better outcomes for our medicines and devices, but also do no harm.

[Lord Alton of Liverpool (CB)]

My Lords, I support Amendment 12 and the other amendments in the name of the noble Baroness, Lady Cumberlege. In doing so, I also express my support for the amendments in the name of the noble Baroness, Lady Thornton.

At Second Reading I referred to the Primodos scandal. I remind the Committee of my interest as vice-chair of the All-Party Group on Hormone Pregnancy Tests. I know that the Committee will join me in wishing Yasmin Qureshi, Member of Parliament for Bolton South East, the chair of that group, a full and speedy recovery to good health following her discharge from hospital last week, having contracted Covid-19. Ms Qureshi and I have been working with Marie Lyon and the campaign group seeking justice for Primodos victims since 2011.

I am not surprised that the redoubtable and admirable noble Baroness, Lady Cumberlege, has chosen to make, in the words of Amendment 10,

“the safety of human medicines as the overriding consideration”

the standard or battle flag to raise through these amendments. The paramountcy of patient safety is a battle flag to which anyone who has read her compelling report will flock. I concur with the remarks of my noble friends Lord Kakkar, Lady Masham and Lady Watkins of Tavistock on putting the centrality of patient safety at the heart of the Bill, but I also listened carefully to what the noble Lord, Lord Lansley, just said about the use of the word “overriding” and the need to balance conflicting needs. I do not think that there needs to be any conflict between the United Kingdom being a place that upholds patient safety as an overriding concern and a leader in life sciences. However, it might be that the words need to be considered further between now and Report.

Too often after a public outcry over something such as surgical mesh or Primodos, Governments say that they will set up a committee to carry out a review and then everything will be all right. The committee goes away, evidence is gathered and hearings take place. By the time it reports, public indignation and media interest have often moved on to some other injustice. Recommendations are politely acknowledged, those who compiled the report are dutifully thanked and, after promises are made to consider appropriate action, the report is found covered in dust on a basement shelf in a padlocked room in the department, preferably marked “Confidential”, with a get-out clause to tell anyone who inquires, “We can’t say anything because there are legal proceedings pending, but don’t worry, everything will be all right.”

The noble Baroness, Lady Cumberlege, told us at Second Reading that she had learned that attempts were being made to bury her report and to rely on the passage of time, the constant shuffle of ministerial chairs, the comings and goings of elected representatives and the shifting sands of changing priorities to assist in that task. But the people making those attempts made three serious miscalculations. The first is the noble Baroness, Lady Cumberlege. They are significantly underestimating the noble Baroness—a former Minister in the Department of Health and a highly experienced and effective parliamentarian—if they believe that they can bury her report; she will bury them first. Secondly, they have the misfortune of a Bill before Parliament—this one. It provides a legislative vehicle to give effect to some of her central recommendations. Across both Houses, in all parties and none, she has allies who will not be easily bought off. Thirdly, the House knows that it has a duty to act in response. We have heard so many accounts. I listened again to the moving testimony of the noble Baroness, Lady Burt, about victims of mesh. We have an overriding responsibility to act because of the abject failure to protect the public. As legislators we have an overriding duty to ensure that the law protects the public. Manifestly, the law has failed to do that and the amendments seek to put that right.

As we just heard from the noble Lord, Lord Lansley, and from the noble Baroness, Lady Cumberlege, herself, the noble Baroness’s report takes inspiration for its title from the Hippocratic oath: First Do No Harm. I say in parenthesis that the Hippocratic oath should be restored to a central place in the training and teaching of doctors and all those involved in the medical profession. Having systematically and sensitively investigated, winning plaudits from all those with whom she dealt, she found that “avoidable harm” had been caused to women by the drug Primodos—an oral hormone pregnancy test—but also by the epilepsy drug sodium valproate, and by vaginal mesh.

I first raised Primodos a decade ago, in the House in Questions and in letters to the noble Earl, Lord Howe, who we heard from at the beginning of our proceedings, after a Primodos victim, a man called Karl Murphy, had been to see me at my university office in Liverpool. On Primodos, the report laid bare widespread and systemic failings, repeatedly ignored, again and again, for decades. The review rightly concluded that the system was

“disjointed, siloed, unresponsive, and defensive.”

Despite repeated requests—I have written to the noble Lord, Lord Bethell, and tabled Parliamentary Questions —I regret that the Government have so far declined to say how and what redress will be provided. They have also failed to set out clear guidance on how those who have suffered should receive better care and support and, most notably, have failed to set out a timeline.

The Minister could put that right and tell us that there will be no ritual burial of the report. He could tell say why, as the noble Baroness reminded us, we are lagging behind the Scottish Government, who have already started to implement some of the report’s recommendations, notably the crucial appointment of a patient safety commissioner. Perhaps he could also tell us whether the Government will assist the German Government, who have finally set up a similar review after years of refusing to engage with parliamentarians or with Primodos victims in Germany.

At the beginning of this month the leaders of the SNP, the Liberal Democrats, the DUP, the SDLP, Plaid Cymru and the Green Party all wrote to the Prime Minister, urging him to implement the findings of the noble Baroness’s review. They make the point that many mothers who took Primodos, believing it would help their pregnancy, are “now elderly” and have

“lived a life wracked by guilt.”

Yet this was through no fault on their part. They also point out that, as the noble Baroness reminded us, even today sodium valproate is given to women, who are unaware of its potential consequences, with a 50% chance of a baby in the womb being severely damaged if the drug is taken during pregnancy. In their letter, the political leaders point out that 15 patient groups, along with the Royal College of Surgeons, the Royal College of Obstetricians and Gynaecologists, the Royal College of Physicians, the Royal College of General Practitioners and the BMA have all called for the report’s recommendations to be implemented.

--- Later in debate ---

I would like to end by saying thank you to STOPAIDS and its coalition partners for their tireless work on this issue, no doubt driven by their bitter experience during the HIV/AIDS pandemic—or global epidemic, whichever term you prefer. However you look at it, they more than most understand the urgency of putting safeguards on to the face of the only Bill we will see for some time on medicines and medical devices. No one in Britain should die needlessly while the NHS is held to ransom by unscrupulous pharmaceutical companies. I beg to move.

[Lord Alton of Liverpool (CB)]

My Lords, in her prescient, topical and important speech, the noble Baroness, Lady Sheehan, asked a number of important questions of the Minister. I look forward, as I know other Members of the Committee will, to his response later in his remarks. The noble Baroness was right to remind us of the importance of fair access to medicine and the role of pharmaceuticals. Any vaccination programme for Covid-19 should be equitable and fair. She referred in her remarks to some work done at Liverpool University, which I will return to a bit later in my remarks. In her amendment specifically, she draws our attention to the International Covenant on Economic, Social and Cultural Rights of 1966, and, as she has done in her remarks, reminds us of the public health safeguards within the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights—TRIPS.

Earlier this year, with other noble Lords who serve on the International Relations and Defence Committee, I participated in hearings which led to the publication on 10 July of our report entitled The UK and Sub-Saharan Africa: prosperity, peace and development co-operation. The inquiry was chaired by the noble Baroness, Lady Anelay of St Johns. We became acutely aware of the potentially catastrophic effect of Covid-19 on already fragile economies and societies. John Hopkins University suggests that across the continent of Africa, with its population of around 1 billion people, there have been about 37,000 deaths, compared with 230,000 in Europe. Indeed, there have been more deaths in the United Kingdom than in the whole of Africa. But we must treat the data with some caution and even scepticism. Reporting in many places is rudimentary, with Nigeria carrying out just 2.7 tests per 1,000 people, compared with 381 in the United Kingdom, so the data may have to be treated with caution.

Mercifully, the reported death rate—18,000 in South Africa, for instance—does seem to be lower than in some parts of the world, perhaps assisted by younger populations; few homes for the elderly; less common incidence of type-2 diabetes and obesity; more outdoor living and low travel; and experience of dealing with Ebola, malaria and AIDS. We should nevertheless be concerned that, as recently as last week, the World Health Organization said there had been a substantial rise in deaths and recognised that disparities in our health systems and economic power could still see an acceleration in infections and fatalities.

The smouldering pandemic in Africa has been held at bay by swift and significant lockdowns in many African countries, leading inevitably to significant loss of jobs. That cannot be sustained indefinitely. These fragile economies will see increases in destitution and chronic poverty if we are unable to ensure protection for all as and when a vaccine becomes available.

James Duddridge MP, the Africa Minister, told the inquiry that, as a consequence of Covid-19, the World Bank projected 40 million to 60 million additional individuals falling into extreme poverty, and it has been projected that the economy of sub-Saharan Africa will be between 2.1% and 5.1% smaller by the end of the year. The London School of Hygiene & Tropical Medicine told the inquiry that the region was likely to face particular contextual challenges from Covid-19, including

“economic, social and cultural inequalities, lack of personal protective equipment … and the additional health burden of communicable and non-communicable diseases”.

It cited three factors which could worsen the impact:

“overcrowding and large household sizes”,

which increases transmissibility, a

“high baseline prevalence of co-morbidities”

and

“lack of intensive care capacity”.

Health Protection (Coronavirus, Restrictions on Gatherings) (North of England) Regulations 2020

Lord Alton of Liverpool Excerpts

Friday 25th September 2020 Lords Chamber

[Lord Alton of Liverpool (CB) [V]]

My Lords, I declare an interest as I live in the north-west of England, as do members of my family, one of whom is an A&E doctor working with Covid patients.

Greater Manchester’s mayor, Andy Burnham, has described the situation in the region as “chaotic”. Across the political divide, Bolton’s MP, Chris Green, laments a breakdown in the communication of decisions. Constantly changing messaging has been buttressed by muddle and confusion. Take my unanswered Written Questions about why grandparents are prohibited from helping frontline workers with their young grandchildren, while simultaneously, several separate adults have been able to go to a public house together. Others, urged to return to the office just weeks ago, are now told not to, unless it is essential.

We must be honest with the public about risks but let them judge for themselves. The priority must be to protect the vulnerable, remembering that there were nearly 30,000 extra care home deaths between 2 March and June 12 this year, compared with the same period in 2019. A new study in the Lancet of data from Salford found that between March and May, diagnoses of serious health conditions halved, with lethal consequences.

For the general population, clearer decisions should be decided more locally, as in Germany and South Korea, where decentralisation has been effective. An over-centralised “pushmi-pullyu”, stop-start approach destroys jobs and drives up unemployment. That in turn will have catastrophic consequences across the north-west every bit as destructive of health and well-being as Covid-19. Chaos and confusion undermine confidence in government, while an emasculated Parliament gives the illusion of accountability and scrutiny. Our loss of liberty under the cover of Covid-19, and the intolerable threat to use our Armed Forces to enforce decrees and edicts touching every aspect of our lives, is simply not acceptable, and Ministers need to understand that.