Medicines and Medical Devices Bill

Lord Ribeiro Excerpts

2nd reading & 2nd reading (Hansard) & 2nd reading (Hansard): House of Lords
Wednesday 2nd September 2020 Lords Chamber

[Lord Ribeiro (Con) [V]]

My Lords, I will focus my contribution on the safety of medical devices, post-marketing surveillance and organ donation. The noble Baroness, Lady Cumberlege, did us all a service with her review, highlighting the trauma and damage suffered by women who have had implantable devices, such as surgical mesh, inserted in the pelvis to treat urinary incontinence.

This Bill could become an important vehicle for implementing the Cumberlege review. It recommends that, in the event of an issue with a device, the Medicines and Healthcare products Regulatory Agency—the MHRA—must have the power to remove a device from the register. This can occur only if all devices, not just some, are included. The report, in recommendation 7, calls for a central patient-identifiable database for all implantable medical devices.

Post-marketing surveillance often relies on professional organisations such as the royal colleges and the specialist associations to undertake outcome studies to assess complications after surgery. The Royal College of Surgeons believes that provisions included in Clauses 13 and 16 should be strengthened to ensure expert oversight of medical devices registers. The National Joint Registry is an excellent example of a long-established registry overseen by a steering committee of experts. Recommendation 7 is key, stating that the database can be

“linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient reported outcomes measures.”

The poly implant prosthesis, or PIP, breast implant is another example of a product that causes harm and misery to many women. The utilisation of systems for tracking devices, such as the Scan4Safety programme, which involves patients wearing barcoded wristbands that can be scanned and tracked against patients’ records, is to be recommended. Although new Clause 16 is welcome, we need to be clear whether the intention is to mandate the tracking of all medical devices or just a select few.

The Healthcare Safety Investigation Branch, or HSIB, has published several reports on safety problems arising from the design, usability, regulation, procurement and marketing of medical devices. For example, it has carried out an investigation into flaws in the design and usage of smart infusion pumps and several investigations into problems with poorly designed devices and equipment which might be manageable by those familiar with them but become a problem when used by those such as staff redeployed in the Covid crisis. The HSIB can highlight these issues but needs legislation to be able to enforce the withdrawal of defective equipment.

Finally, on organ donation—we have heard much of this from the noble Lord, Lord Hunt, the noble Baroness, Lady Northover, and others—in a study published in BMJ Open, ethical issues were raised over the estimated 85,477 organ transplants in China. Ninety-nine per cent of the 445 studies failed to report whether the organ donors had given consent to transplantation. The paper concluded:

“The transplant community has failed to implement ethical standards banning publication of research using material from executed prisoners. As a result, a large body of unethical published research … exists, raising questions of complicity to the extent that the transplant community uses and benefits from the results of this research.”


The noble Lords, Lord Alton and Lord Hunt, and the noble Baroness, Lady Finlay, will be bringing forward an amendment on this issue which I plan to support.

Medicines and Medical Devices Bill

Lord Ribeiro Excerpts

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

[Baroness Jolly (LD) [V]]

My Lords, the amendment in the name of the noble Lord, Lord Hunt, and signed by my noble friend Lady Northover, allows the Secretary of State to make regulations about human tissue. I repeat the noble Lord’s explanation of the amendment:

“This amendment adds the origin and treatment of human tissue, including organs, to the list of matters about which regulations may be made by the appropriate authority, in the context that informed, valid, uncoerced and demonstrably documented consent may not have been given for the harvesting of such human tissue and organs.”


I find it hard to imagine when any state has power over its citizens that few other states share. I find it even harder to imagine how desperate and selfish people must be to buy these organs, knowing that their donors’ lives will certainly be blighted, or even lost, to feed such a market, which is the dark side of consumerism.

Human tissue and organs can currently be imported into the UK from countries such as China without traceability, documentation or consent, and there is widespread concern that forced organ harvesting is taking place. It is appalling that Falun Gong Christians are targeted as donors, although I hate to use the word “donor”, which suggests that the organ is freely and willingly given, whereas the evidence to the contrary is total. This amendment would urge the Government to introduce legislation to ensure that the UK is not complicit in this. I support my noble friend Lady Northover, the noble Lord, Lord Hunt of Kings Heath, the noble Baroness, Lady Finlay of Llandaff, and the noble Lord, Lord Ribeiro, who put his name to the amendment. If the Government do not support this amendment, will the Minister confirm that she will be prepared to look at bringing forward, on Report, a government amendment to stop this abhorrent practice?

[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 Ribeiro Excerpts

Committee stage & Committee: 5th sitting (Hansard) & Committee: 5th sitting (Hansard): House of Lords
Wednesday 11th November 2020 Grand Committee

[Baroness Finlay of Llandaff (CB) [V]]

My Lords, I will speak to Amendments 86, 88 and 102, standing in my name, and in support of Amendment 103 in the name of the noble Baroness, Lady Cumberlege.

My purpose in this group is to underscore the critical importance of unique device identifiers in maintaining patient safety. Fundamentally, I ask your Lordships to reflect on the systems we have in this country more broadly, say in retail, for product recall where a safety issue arises. Let us say that a tumble dryer is found to be a fire risk, or a washing machine is liable to flood people’s homes: it is dealt with by a media campaign urging people who have the product, with the relevant model number and bought at the relevant time, to contact their retailer and the manufacturer directly. We may examine, as the Fire Safety Bill presently before the House illustrates, whether this system is adequate for domestic electrical products, but that is for another day.

This afternoon, I hope that we can agree that devices left inside human beings and used in their medical treatment should be subject to a more rigorous and effective product recall system than tumble dryers. Tracking is absolutely essential in order to ensure that, if a product is discovered to be faulty or to have adverse effects of some kind, others who have had that device used in their treatment can be contacted and, if necessary, examined.

What is more, we already have the technology in place to make this a reality. In July this year, Scan4Safety published an evaluation of six pilot sites where a system of scanning and tracking was used. At these Scan4Safety sites, all patients have a unique GS1 barcode on their wristband, which is scanned before a procedure. The system also involves scanning all equipment used for the procedure, including implantable medical devices, and the location in which the procedure takes place. At some trusts, staff have barcodes on their badges that they can scan prior to a procedure. The result is full visibility of what has been done to which patient, when and where. To quote the noble Lord, Lord Prior, who as chair of NHS England wrote a foreword to the report, this system means:

“The time taken to recall products falls to hours from days or weeks, clinical time is freed up—significant as the NHS continues to face workforce challenges—and effective stock management becomes straightforward.”


The system is good both for patient safety—providing complete traceability, speed and accurate recall, alongside reductions in drug errors and those terrible “never events”—and for cost and efficacy. It leads to cost-effective product ordering, more efficient staff with better staff well-being, the creation of accurate patient-level costings, and reductions in unwarranted variation. Across the six trusts, the pilot produced £5 million in recurrent savings and £9 million in non-recurrent ones. Perhaps more importantly, the system is said to have released 140,000 hours of clinical time back to patient care.

The purpose of my amendments is to adduce from the Minister—who I hope will be willing to help—an absolute commitment that the Government see rolling out Scan4Safety as the future of medical device use in this country, and that we will not have devices put inside people without a clear record, including of which surgeon put in the device, when, where and so on. We will come back in the group starting with Amendment 87 and Amendment 95 to talk about registries that track outcomes. They are an absolutely essential part of this picture. However, the bare minimum for registries to function is to have a full and accurate database of what devices have been used in procedures, and on which patients.

Amendment 86 addresses this issue directly by stipulating that the provision about unique device identifiers—barcodes—must be included in regulations on medical devices made under Clause 12 of the Bill and should be part of the thinking when it comes to packaging and labelling. Amendment 102 seeks to strengthen the later Clause 16 by making the regulations about unique device identifiers mandatory.

I will briefly address Amendment 103 on patient consent. The noble Baroness, Lady Cumberlege, and I are broadly aligned on this. Her report recognises the GDPR issues around recording data on patients and storing it in a database. She distinguishes between database, the subject of this group, and the registry, which is more complex and useful, and which we will discuss in a later group. There is an issue as to whether the database we are discussing here is subject to the same level of patient consent as a registry. In a registry, patient outcome data will be recorded, in addition to the simple fact of a device having been used. I will be interested to hear the Minister’s position on that, and I strongly support the idea in Amendment 103 that any distinction should be set out clearly in the regulations under this Bill.

For my own part, I would hope that the consent process and shared decision-making that are used between surgeons, radiologists and so on and their patients in deciding to go ahead with a procedure, could be used both to set out a routine action to make an entry in a database and to participate in more complex registries. We will examine the purpose of registries more thoroughly in subsequent groups. For this group, I hope that the Minister will respond by confirming a shared belief in Scan4Safety and set out a timetable for an equivalent scheme to be rolled out across the NHS. It is an approach which has the strong support of the Royal College of Surgeons and whose broad use around the country is long overdue.

I hope that the Minister will also ensure full consultation with the devolved Administrations to ensure that a system of coding is compatible with all systems across the UK. I beg to move.

[Lord Ribeiro (Con) [V]]

My Lords, it is a pleasure to follow the noble Baroness, Lady Finlay, who made a powerful case for knowing what happens to medical devices once they have been inserted. This was at the very centre of the Cumberlege review and to which I am sure my noble friend will draw our attention again, as well as to the key findings in this respect. Amendment 86 draws attention to the need for unique device identification information to be added to all packaging of medical devices, while Amendment 88 deals with the tracking of devices once inserted, as Clause 13(1)(h)(ii) requires information relating to the use of medical devices in individual procedures to be tracked and entered in a register or within hospital episode statistics data.

In my speech at Second Reading, I referred to Scan4Safety, which the noble Baroness, Lady Finlay, has just noted. In 2016, the Department for Health and Social Care awarded a total of £12 million to six hospital trusts in England for Scan4Safety demonstrator sites to investigate how the consistent use of point-of-care barcode scanning might improve efficiency and safety within the NHS. The noble Baroness also outlined the benefits of the GS1 barcodes. The result of the GS1 is a comprehensive, real-time view of stock, including that which is about to expire, as well as a complete audit trail. An audit trail is key to identifying problems with devices when they occur and to keep track of them in the future, as it may be many years before complications occur. Total hip replacements are one example. I have two of them, so I have a vested interest in knowing about the long-term future of those prostheses.

In June 2020, Scan4Safety published a report entitled A Scan of the Benefits. It gave two examples that are worthy of note and of repeating. In the North Tees and Hartlepool NHS Foundation Trust hospital orthopaedic department, barcodes helped to ensure that the correct patient is listed for the correct operation on the correct side. All items and implants are scanned before use. If the incorrect prosthesis is selected, for example a right knee implant for a patient who is supposed to be having an operation on the left knee, the barcode scanner buzzes and flashes, immediately notifying the potential error. At Leeds Teaching Hospitals NHS Trust, following the introduction of Scan4Safety, the average time taken to recall a product has fallen from 8.33 days to less than 35 minutes. The organisation reported £84,411-worth of staff efficiency savings on recall between January 2016 to December 2017 alone.

In Clause 16 on information systems, while I welcome the provisions, surely they are worthy of being strengthened by not using “may” so often. We need to move away from “may”, and its implied “perhaps”, to “must” and the implication that it will actually happen.

I shall end by restating my comments at Second Reading. The Government must undertake to mandate the tracking of all medical devices that are used in the UK, rather than a select few. I hope that these amendments will provide a means to do so. The Cumberlege review rightly recommended that a central patient identifiable database should be created, collecting key details of the implantation of all devices at the time of the operation. In the light of this, we strongly urge the Government to apply the powers provided for in Clause 16 as well and as widely as possible.

To give assurances in the context of this amendment, the Royal College of Surgeons believes that the Government should publish their intended regulations under Clause 16 in draft before Report, as they have for the various regulations on medicines. Early sight of the regulations would establish whether the Government intend to apply the powers covered by Clause 16 widely enough to satisfy the recommendations of the Royal College of Surgeons and those of the Cumberlege review.

In closing, perhaps the Minister would update us on the future of the medical devices information system and its application to the private sector.

[Baroness Cumberlege (Con) [V]]

My Lords, I very much appreciate the support that I have already received today from the noble Baroness, Lady Finlay, and my noble friend Lord Ribeiro. I am going to go into a bit of detail on what we found during the review, but I want to say to both noble Lords that I strongly support their views on Scan4Safety. Indeed, I spent a day in Derby going through the whole process with the clinicians, support staff and policymakers, and it was very impressive.

The noble Baroness, Lady Finlay, is absolutely right to say that we should look at more than just one example. Her research, which she has told us all about today, took on the six different areas, which is excellent. However, I agree with her that we should think seriously about introducing this system across the country.

Medicines and Medical Devices Bill

Lord Ribeiro Excerpts

Committee stage & Committee: 6th sitting (Hansard) & Committee: 6th sitting (Hansard): House of Lords
Tuesday 17th November 2020 Grand Committee

[Baroness Finlay of Llandaff (CB) [V]]

My Lords, this is a large group of amendments relating to expert registries. I have Amendments 95, 99, 100 and 101 and support the others in this group.

First, I welcome Clause 16, which the Government added during the Bill’s passage in the other place. The clause is a clear step in the right direction. Amendment 95, like Amendment 96, would build on this to ensure efficacy by tracking the use, and the outcomes from the use, of all medical devices rather than just a select few. We must not forget the conclusions of the Cumberlege review that registries are too

“few and far between and all too often prompted by catastrophe”. 

The Bill provides a prime opportunity to move away from that position. Without tracking all devices, we will allow another scandal, involving an as-yet-unknown device, to emerge undetected until many have been affected. A proper warning system is essential.

Amendment 99 seeks to make the list of objectives for regulations listed under Clause 16(2) mandatory rather than permissive. These should be minimum standards against which to hold any regulations the Government publish, not just aspirations.

Amendments 100 and 101 then seek to add to that list of standards. In doing this in Grand Committee, I would welcome some commitments from the Minister, setting out where the Government share the objectives in those amendments. In essence, the difference between the Government’s approach and mine is that the Government foresee a future in which some medical devices continue not to be tracked, hoping that their outcomes will be audited. I strongly believe that this is a mistake. 

Registries, which track patient outcomes through proper monitoring and audit, are an essential component of post-market surveillance and a prerequisite for patient safety. They should be the rule, not the exception. This is a principle that the Royal College of Surgeons of England strongly supports too. Indeed, its former president, Professor Derek Alderson, made this clear in his evidence to the review of the noble Baroness, Lady Cumberlege. As he put it

“a registry of its own right does not create patient safety; it’s just a list. The registry must contain information that can be audited”.

Essentially, as the Cumberlege review acknowledges, a registry is a registry only if it contains patient outcomes, which are then subject to expert oversight. To that end, Amendment 100, which is at the core of this group of amendments, sets out the following principles.

First, the use of all implantable devices should be recorded in a registry. That goes to the heart of the issues explored by the Cumberlege review and is surely the central lesson that must be learned from the unnecessary—and unnecessarily long—suffering of thousands of women whose experiences with mesh were horrific.

Secondly, other devices used in the course of operations should similarly be subject to outcomes tracking. I raise this in particular because it is not just devices left inside people that can later cause problems. We know, for example, that machines used in the heating and cooling of blood during open heart surgery can cause a Mycobacterium chimaera infection. The NHS now warns people of this risk, but it seems clear that the Bill should put in place measures to ensure that the use of particular machines is tracked, and that where infections develop later, a flag can be raised against that machine. To be clear, the machines involved do not actually make contact with the patient or their blood. The heater-cooler units contain two water tanks and tubing. One water tank uses warm water, which, through indirect thermal transfer, keeps the patient warm during the surgical procedure, often through the use of a warming blanket. The second water tank contains cold water, used, again indirectly, to cool the cardioplegic solution that slows or stops the patient’s heart to allow the surgical procedure to proceed. It is thought that where Mycobacterium chimaera develops in these machines, it can escape as aerosol—a fine spray—into the surgical area and thus cause infection from there. I raise the example simply to illustrate that medical devices are not only about what is left inside people, or even what comes into contact with people. The new provisions for information systems need to be flexible in recognising that.

The third provision of Amendment 100 is that information systems must be subject to expert oversight. That is to deal with the central point raised by the Royal College of Surgeons of England, which is that without this oversight a registry is just a list—not really a registry at all. A good example of a registry in action is the National Joint Registry, which is overseen by a steering committee of experts. The expert committee monitors outcomes achieved in joint replacement surgery, analysing procedures by brand of prosthesis, hospital and surgeon. Instances where performance falls below expected levels are highlighted to ensure appropriate investigation and follow-up. This is a standard we need to see replicated across surgical specialities and across the NHS.

Fourthly, and perhaps most critically, the amendment seeks assurances from the Minister that information systems set up under the Bill will provide a direct route for patients to report their own outcomes. Clinicians, of course, want to assume the best about the treatment they have commissioned and undertaken for a patient. It is a natural and not ignoble instinct to try to reassure a patient who presents with a problem following a procedure. There is human nature in a clinical transaction. When a problem emerges, patients are often reassured that they “need to give it more time” or “things will settle down”. Each GP may see only one or two patients who have been subject to a particular device or procedure. With follow-up appointments decreasing, these patients with problems can become invisible to secondary care. Yet the patients know that they feel worse, feel that they are not being properly listened to and speak to others in online communities, discovering a specific pattern of concerns.

The yellow-card notification scheme is greatly underused, and patients do not know how to self-report on it. For that reason, we need two ways for information to reach a registry. We hope that a majority will be tracked from patients, through clinicians. Where there are multiple instances of concerning outcomes, these should be flagged through expert monitoring, but there must be a failsafe for patients to approach the holders of the registry directly to have their outcome reported and considered in its monitoring. The fourth limb of Amendment 100 seeks to achieve this objective and Amendment 101 reflects the same principle. Together, the measures in Amendments 100 and 101 seek to implement this key conclusion of the Cumberlege review:

“A central patient-identifiable database should be created … This can then be linked to specifically created registers to research and audit the outcomes in terms of both the device safety and patient reported outcomes measures.”


That surely is the goal to which we must all aspire.

I want finally to address Amendment 104, to which I have added my name. The noble Lord, Lord Lansley, draws attention to the balances we have to get right in collecting all this data in the name of patient safety. As I said on a previous group of amendments, I hope and expect that dealing with consent to recording this data could and should be dealt with as part of shared decision-making between the clinician and the patient at the point of agreeing to a procedure. Of course, it should be open to a patient to have a procedure without the data being recorded, but they would have to be made aware of the increased risk to their own health if problems with a device used in the operation were later to arise.

I have sought to reflect this point in Amendment 100 by making clear that collecting data should be subject to patient consent. None the less, the noble Lord, Lord Lansley, offers another way to deal with the issue by putting in the Bill that regulations under Clause 16 should have regard to the Caldicott principles. I do not see how the Minister could argue with that and I hope he will be able to give a positive response.

This group of amendments is designed to assist the Government and to catalyse faster movement on their part. I understand that Ministers see tracking and auditing the outcomes from the use of all medical devices as the right direction of travel, but as yet we do not have a destination or an estimated time of arrival. We need to hear both from the Minister this afternoon. I beg to move.

[Lord Ribeiro (Con) [V]]

My Lords, I thank the noble Baroness, Lady Finlay, for introducing this group. As a surgeon, I will focus on the registries and, in particular, the National Joint Registry—the NJR—and the Breast and Cosmetic Implant Registry. The noble Lord, Lord Hunt, was Parliamentary Under-Secretary of State when the NJR was introduced in 2003, with the aim to

“improve surgery through learning from best practice, and … improve the quality of care to patients.”

The NJR is the largest of its kind in the world, with data from 3 million hip, shoulder, knee, elbow and ankle replacements. In the last year before Covid-19, nearly 200,000 hip and knee replacements were recorded. By analysing this information, surgeons are supported in choosing the best artificial joints for their patients. It helps surgeons decide whether their patients need to return to hospital by flagging up problems with a particular type of implant. I was lucky enough to have bilateral metal-on-ceramic hip implants. Had I received a metal-on-metal implant, I would be concerned, as the NJR in 2010 identified higher than expected revision rates for metal-on-metal implants, with metal debris damaging patients’ soft tissue and causing pain and loss of function. Without the NJR’s comprehensive registry, hospitals would be unable to track their patients’ progress and identify problems early. Similarly, the Breast and Cosmetic Implant Registry records implants used in patients, along with the surgeon and organisation responsible for the procedure, allowing patients to be traced in the event of a safety concern or product recall.

Medicines and Medical Devices Bill

Lord Ribeiro 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 Northover (LD) [V]]

My Lords, praise will be ringing in Ministers’ ears from the first group of amendments, concerning the patient commissioner, in the name of the noble Baroness, Lady Cumberlege. There is praise again for listening on this issue.

The noble Baroness, Lady Penn, had the task, in the first instance, of rebutting the original amendment. I, for one, asked her to read the China Tribunal report to get a strong sense of the horrendous problem that was part of the context for this amendment. You could see that she was listening, and subsequent engagement has been very useful, as the noble Baroness, Lady Finlay and the noble Lord, Lord Hunt, have said. I am glad that the ministerial team has responded. It comes on the day that the Foreign Secretary has made a Statement in the Commons that focuses on human violations against the Uighurs.

I pay tribute to the noble Lord, Lord Hunt, for consistently, and with great political skill, taking forward this issue, as he has done on the scandal of the “Real Bodies” exhibitions. I also pay tribute to the others who have worked in this area, including the noble Baroness, Lady Finlay, and the noble Lords, Lord Ribeiro and Lord Alton. This is a terrible problem and one that it would be easy to turn away from, but those noble Lords simply do not do so.

We need to make further progress across this area, and I am sure this will be taken forward. Forced organ harvesting, which according to the China Tribunal has happened on a mass scale in China, is a horrific crime. Organs are removed from living victims by doctors in state-run hospitals for transplantation, inevitably killing the victim in the process.

As the noble Lord, Lord Hunt, said, the China Tribunal concluded that many victims were Falun Gong practitioners. A brutal and systematic crackdown on Falun Gong was initiated in 1999, with the Chinese leadership ordering their eradication. Many disappeared without trace, which was when China’s organ transplant trade rapidly increased. As we now recognise, in recent years there has been a similar crackdown on the ethnic-minority Uighurs. They have been put into re-education camps and have endured forced labour, brainwashing, rape and torture. The China Tribunal stated:

“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’.”


Our amendment aims to ensure that no human tissue or cells that have been sourced from victims of organ harvesting can be used in human medicines or enter the UK medical supply chain. This is the first time the United Kingdom Government will enact legislation in this area, and we must hope that it sends a strong and clear message internationally. Thus far, as the noble Lord, Lord Hunt, said, it is enabling, but the Government will know that many will be monitoring this area. We need to see those regulations in place.

I note the weakness of the HTA assessment of the “Real Bodies” exhibition, on which I am sure the noble Lord, Lord Alton, will expand, and its acceptance of what it was told, seemingly at face value. The noble Baroness, Lady Finlay, also, rightly, pointed to this. The amendment that we are agreeing today will help move things forward. I am grateful to the Government and their lawyers for working on this, although, clearly, we will all need to be vigilant and there is still much to do.

[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.