My Lords, the Medicines and Medical Devices Bill is crucial to the development of a modern, safe, medical regulation regime. Its focus is the development of important innovations that will improve and save lives for the next generation, and the protection of patients in an area which has, historically, been slow to move and which, in a few months, passes from European to domestic legal oversight. When we look at our plans for the health of the nation, having the agility to revise our key regulatory regimes is not a “nice to have”; it is absolutely essential to protect the lives of patients and empower the innovations that will extend their length and quality.
I begin with safety. The first and most critical consideration of any Bill on medicines and medical devices must be the safety of patients. We also consider the safety of providers, the environment and, in Part 2 of the Bill, animals, but the safety of patients is paramount. We have all reflected on the detailed and thorough report of my noble friend Lady Cumberlege. I have listened to the testimony of some of the patients and families who have campaigned on patient safety, and shared, in a small way, their pain and suffering. They brought to life how critical this Bill is. We owe them a huge debt of thanks, as we would not be here today without their determination.
There is no disagreement among us on the importance of the safety of patients. The Bill puts safety at the heart of regulatory decision-making, facilitating the sharing of information to support public health concerns and creating mechanisms to track the use of medical devices or medicines against a patient record. The thoughtful, thorough, modern use of data is how we know that something is going wrong and how to put it right. That is the view of the Government, which my noble friend Lady Cumberlege and her team brought vividly to life in the Bill’s passage in another place. That is why I am delighted with Clause 16, introduced as an amendment, which ensures that data provisions in the Bill are central to its effectiveness. By introducing a medical devices information system—or database—we have radically improved that effectiveness.
We once faced a situation where patients could not be traced, and a conversation could not be had between a patient and their clinician because we did not know which specific device had been implanted into a person or by whom. When I found this out, I was dumbstruck. This must not happen in the future. The Bill will support the tracking and tracing of medical devices and will enable a future system of clinical registries, such as the National Joint Registry, to ensure that UK patients are better supported.
When there is a problem, it is important not only that we know that something has happened, but that we take forceful action. Part 3 of the Bill therefore sets out a consolidated suite of powers available to the regulator, including the ability to step in and recall a device if the manufacturer fails to do so where necessary. Chapter 4 of Part 3 of the Bill clarifies the powers of disclosure around devices, allowing the Secretary of State to warn members of the public about safety concerns. We must ensure that avoidable harm is avoided by acting expeditiously to protect patients. Let me be clear: the regulator can and does work in close partnership with industry to deliver on behalf of patients, but it has, and will continue to have, teeth when industry fails to protect patients.
My Lords, I thank the Minister and declare my interests as a member of the GMC board and as president of GS1, the barcoding organisation responsible for the Scan4Safety programme. The Bill is of great importance for patient safety, but also for the health of the life sciences sector, yet it is striking for its brevity and, as the Minister acknowledged, for the extensive powers given to Ministers without the exceptional justification required for the skeleton approach taken. The Minister said he was listening, but he will know that both the Delegated Powers Committee and the Constitution Committee were highly critical, and I believe there is a strong argument for the Bill’s powers in relation to medicine and medical devices regulation to be subject to sunset clauses.
Leaving the EU’s regulatory regime brings significant risks that companies will choose somewhere other than the UK to trial and launch medicines. At the moment we are nowhere near knowing whether our new regulatory system is to be aligned with the rest of Europe—the policy statement published yesterday by MHRA on devices and clinical trials regulation from 1 January 2021 is silent on this. I have to say to the Minister that I am not impressed that his department thinks it is acceptable for such a publication to be produced hours before our Second Reading debate. There is certainly no room for complacency. The European Medicines Agency covers 25% of global pharmaceutical sales; the UK on its own makes up just 3%. The odds are that companies will want to submit applications for new drugs to the EMA before the MHRA, meaning that the UK will lose its advantage and UK patients will risk getting slower access to the latest medicines.
As Sarepta pointed out to me, for many companies the attractiveness referred to in the Bill equates to speed of decision-making at every stage. That means being able to approve clinical trials faster than in the EU, maintaining swift decision-making on medicines approvals and getting approved medicines to patients faster. Yet the Minister will know that the NHS record in uptake of new medicines is very poor indeed, and I would like to hear from him what is going to be done to improve access for NHS patients to these new medicines.
My Lords, Brexit poses many threats to the economy and well-being of UK citizens. Perhaps the greatest is the threat to our life sciences and pharmaceutical industries which, based on our scientific resources in universities and companies that have easy access to international talent and resources, have been truly world-leading. The impact of moving away from the existing collaborative approach between the UK and the EU will be substantial. The European market accounts for 25% of all world sales of medicines and has timely access to new medicines and devices. The UK, in comparison, accounts for only 3% of the total world market. It is against that backdrop that we have to consider this legislation, which is intended to mitigate threats to our industry.
We all agree that we need legislation, but not this thoroughly unsatisfactory Bill. It is a Bill that should not be accepted unless it is thoroughly revised, for three main reasons. The first is that alluded to by the Minister: it is built on the flawed assumption that the Secretary of State or an “appropriate authority” must take equal account of the safety of human medicines and medical devices, the availability of human medicines and medical devices, and the “attractiveness” of the relevant part of the UK as a place in which to conduct clinical trials, supply human medicines or develop medical devices.
The last two considerations depend on the paramountcy of the first. If we do not accept that in legislation, none of the rest will apply; we will simply be signalling to the world a willingness to move away from international standards. One of the most interesting and detailed points made in the briefings that we were given came from the Association of the British Pharmaceutical Industry, which pointed out that it wanted to encourage the UK to apply for full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and the International Organization for Standardization. They are global organisations that produce harmonised regulatory guidance across nations. It was pointed out that previously the UK had represented the EU at meetings of those bodies and contributed to committees and regulatory thinking. Since 1 February 2020, we have had no direct recognised status as either a member or an observer. If we are willing to move away so swiftly from the international standard-setting bodies, we cannot do so on the basis of this unsatisfactory legislation.
My time limit curtails me from commenting on the Minister’s or other speeches, so I shall get on.
I know that the Government feel that this is a simple Bill that is needed to implement EU laws in UK legislation in relation to medicines and medical devices, but the implications of it go far beyond that. The Cumberlege report has added the need to strengthen the Bill in relation to patient safety.
In Part 1, the Government set out their ambition to have a world-class regulatory authority for medicines and medical devices that puts patient safety at the forefront and promotes innovation by making the UK “attractive” to investors. I cannot complain about that.
The Government have stated their ambition to make the UK a science superpower in which life sciences and the development of new medicines will play a crucial part. This Bill offers the Government an opportunity to say how they plan to do this but fails to do so. As the Science and Technology Committee report on life sciences indicated, the UK leads in life sciences research, but it is not very successful at taking research to innovation and commercialisation. The stated aim in the Bill to make the UK attractive is presumably to address this deficit, but it gives no definition of “attractiveness”, although the Minister referred to it in his speech. I hope that he will clarify it in more detail in Committee and even define “attractiveness”.
The Bill falls short of identifying how it will achieve its objectives, except that the Secretary of State will take wide powers to do it. Let me highlight the areas of my concern which I wish to explore in Committee. The Bill gives broad delegated powers to the Secretary of State to amend or supplement regulations. As the Delegated Powers Committee and the Constitution Committee—already referred to several times—recognise, some delegated powers may be necessary, but the Bill grants powers far wider.
My Lords, I welcome the Bill. As my noble friend rightly said in a very positive opening speech, it is not only a necessary Bill but one which presents us with opportunities. I hope that, during the passage of the Bill, we will look to realise those opportunities, and I want to refer to one or two.
My noble friend talked about the Delegated Powers Committee’s remarks, which made the very compelling point that, in reproducing the regulation-making powers, we are moving from the power to make regulations to meet EU legal requirements to the ability of Ministers to set down their own legal requirements; these are very different things. What we need to do in the latter case is not to move from where we are now, as my noble friend might have suggested, to something that sets out in primary legislation the detail of these regulations—nobody is intending that—but to something that moves us from a skeleton Bill to a framework Bill. What is the difference? The difference, in my mind, is a very straightforward one. The framework Bill is purposive. It sets out why regulations are being made and gives an ability to look at the primary legislation and ask, “Do these secondary instruments fulfil the purposes of the primary legislation?” During the passage of the Bill, we must look very carefully to meet that test.
I want to make three quick points. First, I think we are already among the best places in the world for medicines innovation. We may be 3% of the pharmaceuticals market but we are 10% of medicines innovation. I want to continue that. One thing the industry has told us, including me, over past years is that it wants to see our NHS take up new medicines and make them available to patients—a point that my noble friend reiterated. There is a commitment in our manifesto that says:
“We will extend the successful Cancer Drugs Fund into an Innovative Medicines Fund”.
I think the time has come for that and I hope that the Bill will make provision for that to happen.
My Lords, I declare my interests as set out in the register, in particular as an adviser to Intuitive Surgical, to Healthy.io and, until the end of August, to the Department of Health and Social Care.
I congratulate my noble friend on bringing this Bill to the House; I know how hard he has worked to do that. For those of us concerned to make sure that British patients get access to the best drugs and devices—and, frankly, after the past six months, who is not concerned with that?—this is the most important piece of legislation we have in front of us.
My belief is that the Bill gives the UK the chance to create the most rigorous, innovative and safety-conscious regulatory scheme in the world. While there are many downsides to leaving our current system in the EU, as noble Lords have pointed out, there are many benefits, too. Just look at the way that the US FDA has embraced digital and algorithmic therapeutics, while the EMA has lagged behind. To make the most of these new freedoms, we need a regulatory system that can evolve in response to new discoveries and advances in medicine.
Considerable concern has already been expressed in the House today, and no doubt will continue to be throughout the afternoon, about the use of delegated powers in the Bill to provide this kind of flexibility. Having been in my noble friend’s shoes, and having been not so gently admonished by the DPRRC in the past, I can only say that this is not a hill that I wish to die on again. But it seems to me that we are exchanging one system of delegated powers for another, with the added benefit that the authority that will be using these powers has the virtue of being elected by the people it seeks to regulate. At the very least, this is surely an improvement on the status quo ante.
There are two substantive issues that I would particularly like to focus on, already raised by my noble friend: innovation and patient safety. On innovation, we currently benefit from being in one of the top two markets in the world for medicines and devices, and our regulator is rightfully regarded as one of the best in the world. As other noble Lords have said, leaving the European system could bring challenges when it comes to patients accessing innovative therapies, but these can be more than mitigated by a new joined-up approach to research, regulation and uptake. This would require the creation of a world-beating, digitally powered clinical trials infrastructure to test ground-breaking medicines and devices; a rapid but rigorous regulatory process for the most promising technologies; as my noble friend Lord Lansley has pointed out, the creation of an innovative medicines fund to bring those to market; and harnessing the collective might of the NHS to adopt and scale those therapies.
My Lords, my noble friend Lord Hunt of Kings Heath mentioned the China Tribunal’s final report and its conclusions about forced organ harvesting in China. Despite the overwhelming evidence, China denies the claims, relying on the fact that the WHO cleared it of wrongdoing.
In June this year, I reminded the Minister the noble Lord, Lord Ahmad, that 12 months earlier he had shared my concern that the evidence on which the WHO had cleared China was based on self-assessment by the Chinese authorities. At that time, I asked about the Government’s response to the China Tribunal and what the result had been of representations to the WHO and the Chinese authorities. The Minister replied that the Government’s position remained that the practice of systematic state-sponsored organ harvesting would constitute a serious violation of human rights. He assured this House that the UK regularly raised these concerns with China. He also confirmed that the UK had consulted the WHO, which had restated its view that China’s system was ethical. The WHO does not have an independent expert compliance assessment mechanism; it merely has a reporting requirement. So why has the UK not argued for change within the WHO? We should all, including the UK, be ensuring that there is independent verification.
UK legislation requires prior consent and traceability for human tissue for medical research and use in medicines when sourced from the UK, but if human tissue has been imported then the consent requirements do not apply. We have seen exhibitions in New York and Birmingham, in 2008 and 2018 respectively, both of which used plastinated bodies from Dalian Hoffen Bio-Technique in Dalian in China. They were classified as unclaimed bodies with no relatives to identify them. In 2008, the New York state attorney-general required a disclaimer that included the words that the organisers
“cannot independently verify that the human remains you are viewing are not those of persons who were incarcerated in Chinese prisons.”
My Lords, I want to address two areas. The first is the future of life sciences research and the pharmaceutical industry and the other, as mentioned by the noble Lords, Lord Collins and Lord Hunt, is the use of human tissue.
As we have seen so clearly during the pandemic, life sciences in our universities, working closely with the pharmaceutical industry—for example, the Jenner Institute with AstraZeneca—have been a key UK strength. However, our life sciences are already threatened by the Government’s decision to leave the single market and end the free movement of people, as well as by their losing access to EU funding. The pharmaceutical industry is affected by our pulling out of EU regulation, damaging its ability to access that market. Our standards must therefore be at least as high as those in the EU, and I ask for the Minister’s reassurance on that.
As my noble friend Lady Barker noted, the ABPI cogently argues that the UK should apply for full membership of the ICH and the ISO. Previously, as she said, the UK represented the EU at meetings, but since Brexit the EU has had no status here at all. We must urgently rectify that. We were global leaders because of the NHS and our history in the development of clinical trials and comprehensive data registries, such as that which demonstrated the link between smoking and cancer. As the noble Lord, Lord Patel, has flagged, we are risking that. We must not damage our life sciences sector further.
Consistent with the need to maintain standards, I come to my second area, where I fully endorse what the noble Lords, Lord Hunt and Lord Collins, have said about imported human tissue and biological medicines. We simply cannot allow human tissue from victims of forced organ harvesting to enter the UK. We have become more aware in recent times of the treatment in China of the Falun Gong and the Uighurs. The China Tribunal, chaired by Sir Geoffrey Nice, released its full report in March. Has the Minister read the report? Forwarding the letter from the WHO to the noble Lord, Lord Hunt, when he must know the current constraints on the WHO, is, frankly, astonishing. If the Minister has read the report, he will know the tribunal concludes that crimes against humanity have been committed against these groups beyond reasonable doubt.
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We live in a world where big data, artificial intelligence and genetics have become enormously powerful engines of innovation, and where engineering and computer science have combined with medicine to create an unexpected synthesis. These drivers of development are generating exciting new medical innovations that are aiding patients who were previously beyond help, bringing down the costs of treatment and driving growth in Britain’s thriving life sciences industry. I have seen the power of innovation at first hand in the last few months, during the Covid-19 crisis. Our National Health Service is the first around the world to have determined the importance of an effective therapeutic drug, dexamethasone, through the recovery clinical trials programme. Our medical manufacturing industry worked closely with the regulator to move swiftly and safely and put 14,000 ventilators into the health system. In the area of diagnostics—my specialist subject—innovation is driving the accuracy, cost, speed and scale of devices beyond our initial hopes.
We need this pace of innovation in day-to-day, back-to-business delivery too. That is why we are investing in the partnership between the NHS, with its unique pool of patients, and the life sciences sector, which can make treatments happen. I pay tribute to the noble Lord, Lord Darzi, who is chair of the excellent Accelerated Access Collaborative, which gets the best new treatments and technologies into the hands of patients and clinicians faster than ever before. We face a new horizon of tailored treatments and diagnostics that we never could have envisaged five or even three years ago: biotechnology, artificial intelligence, robotics. We are at an inflection point where innovation can make a huge difference. I am pleased and proud to be a Minister championing the role of innovation in the healthcare system at this incredible time. Supporting innovation through this Bill ensures that UK patients benefit from the thriving life sciences sector by bringing investment, jobs and prioritisation to Britain’s medical needs, balanced by the need to manage risk.
Availability and attractiveness are the twin pillars of the Government’s strategy on medicines and medical devices, and the key themes of this Bill. Availability means the reliability of medicines and medical devices and their availability to UK patients. Attractiveness means doing everything reasonable to be the first place where new treatments are rolled out and adopted, where investment in life science takes place and where the enrolment of patients in clinical trials is supported.
Recent months have proved how the availability of medicine relies on fast, accurate, responsive regulation. It is the work of the regulator, hand in hand with the industry, that has ensured that therapeutics, including those used in intensive care, have been in safe supply and that devices, including the important vaccines, get into the right hands to bring this crisis to an end. Clauses 2, 6, 8, 12 and 15 all deal with how we ensure the essential and safe flow of medicines and medical devices. Clauses 2, 8 and 12 allow for regulations to be made that could, for example, affect how medicines or devices are distributed. Clauses 6 and 15 allow us to make pre-emptive regulations to reflect the realities of an emergency, such as a pandemic, and to prepare early.
It is right that we do more to get regulated medicines into patients’ hands and do not keep people waiting long for innovative treatments. I pay tribute to a number of noble Lords who I know tirelessly make the case for certain therapeutics or treatments to be accelerated through the health system. The attractiveness of the UK is fundamental to getting new breakthroughs to patients here quickly.
Let me say a word about regulating for the future, and the work of the Delegated Powers and Regulatory Reform Committee and the Constitution Committee. I pay tribute to learned colleagues on these committees: I know they approach their work diligently and seriously, with significant legal expertise, and I anticipate discussion of their conclusions. I know a number of noble and noble and learned Lords will wish to speak to those reports today, and I will pay serious attention to the points raised.
This is, as it must be, a framework Bill. I recognise that concerns have been expressed about the breadth of the powers and a number of suggestions have been made as to how the Bill might be improved. I am listening, but it is important to note the challenges of taking a different approach to that outlined here.
These delegated powers are necessarily broad, given the hundreds of pages of the Human Medicines Regulations alone. These regulations can span many different matters and it is vital that the ability to make a change for the benefit of patients, where even a really minor point can be important, is not lost. We live in a world where it was only 12 years ago that the iPhone was released, yet today we are trying to figure out how to regulate an AI-supported cancer-screening gadget from KardiaMobile that plugs in to your smartphone and delivers a medical-quality ECG in about 30 seconds. We live in a world where 3D bionic arms, such as the Hero Arm from Open Bionics, have multigrip functionality, and where the national lung matrix trial at the University of Birmingham is exploring how patients with non-small cell cancers respond to tailored treatments.
Primary legislation cannot be relied on to be passed quickly when there are matters of concern for the safety of medicines and medical devices. For example, when concerns were raised across the EU about the scrutiny of notified bodies, and safety concerns arose from certain implants, it took years to update legislation. My noble friend Lady Cumberlege has made clear what happens when change is slow: it has an impact on patients. I know this from another area and I will give an example. When the Communications Act 2003 was passed, the internet was hardly mentioned. Some will say we could not have predicted the immense role that video sharing and social media platforms would now play in our lives, but I remember at the time that legislators were urged to take internet innovations seriously and put in place frameworks to anticipate technical change. Now we have widespread fake news, cyberbullying, the intimidation of public figures and a pornography boom, but without the legislative powers that perhaps we would like to stop or regulate them, because there was no framework to make new regulations to cover these innovations. I am here to listen, so I would like to listen to the advice of the Chamber on how to handle this complex challenge.
In conclusion, I remind noble Lords that because of its importance for patients, we need to get the Bill done and to secure the ability to protect patients quickly if the need arises. We need powers to deliver and to trace and track medical devices as soon as possible. I know it is important that we discuss these issues properly, but the Bill is not just exciting, ambitious and direction-setting; it is essential that it makes it to the statute book by the end of the year. I look forward to listening to the contributions ahead; we are receptive to how we might make the Bill better, as we did in the other place. My door is open, and in that spirit of co-operation and consensus building, I beg to move.
On patient safety, Ministers are silent on whether they will accept many of the recommendations of the Cumberlege review. In particular, will the Minister support the appointment of a commissioner for patient safety, which the noble Baroness, Lady Cumberlege, argued for very persuasively in her report?
Finally, I turn to the abhorrent practice of forced organ harvesting taking place in China today, and to the importance of ensuring that the UK is not in any way complicit in these crimes. In a letter to me last night, the Minister referred to the World Health Organization’s view that China is implementing an ethical voluntary organ transplant system. That is simply not credible, and in fact it is based on a self-assessment by China itself. A much more objective assessment comes from the China Tribunal, which concluded:
“Forced organ harvesting has been committed for years throughout China on a significant scale.”
At the moment, human tissue and organs can be imported into the UK from countries such as China without traceability, documentation or consent. Marie Rimmer MP tabled an amendment in the Commons to deal with this. A similar amendment will be tabled here and I very much hope that the Government will agree to it.
The second reason for rejecting this Bill is that it is a Toom Tabard Bill, as we would say in Scotland; it is an empty cloak. The Minister put the best gloss possible on the reports from the Delegated Powers Committee and the Constitution Committee, whose comments were detailed, comprehensive and scathing—I have rarely seen reports of that nature.
On the delegated powers, Clauses 1, 8 and 12 allow Ministers by regulations to amend or supplement the whole regulatory regime for human medicines and clinical trials under important legislation such as the Human Medicines Regulations 2012. Those regulations alone contain 350 criminal offences which a Secretary of State could unilaterally or without any scrutiny change completely. It is something when the Constitution Committee says, as it has done:
“The delegated powers to create and adjust criminal offences in this Bill are constitutionally unacceptable.”
That is a very powerful reason.
Both the Delegated Powers Committee and the Constitution Committee were deeply critical of the way in which the Government have used this legislation, coming as it does at the time of the current pandemic, to confer emergency powers on Ministers to disapply existing health medicines regulations. They point out that there are no formal requirements to set out the form, publication or dissemination of protocols; Ministers can do that simply by publishing a document on a website. That is not taking back control; it is taking the mickey. It is time for us as a Parliament to stand up and say that this is not an acceptable way forward.
The third reason for rejecting this Bill is its potential to do harm. Many professionals in the pharmaceutical and medical devices industries have expressed the fear that by slightly and incrementally moving away from existing regulation from the EU we could very quickly put ourselves into sudden isolation. We should be fearful of that, not just because it could harm our ability to market into the European Union but because many other countries—African countries, for example— use EU approval as a short-cut mechanism for approving medicines which they do not have the capacity to trial themselves.
The report of the noble Baroness, Lady Cumberlege, is sobering. If we were to take just one thing from it, it would be the need for us to set up as soon as possible and as a matter of urgency not just databases but registries of medical devices. Those of your Lordships who have read the report will understand the difference that makes to traceability.
The Government are in trouble with the timescale that they have set for Brexit. This Bill demands detailed and lengthy scrutiny. For the health not just of our fellow citizens but of future generations, some forensic surgery needs to be done on it. It should not pass without receiving detailed attention from your Lordships’ House.
Furthermore, the Bill adds to the complex regulatory regime rather than simplifies it. Clarification is needed as to how it intends to prioritise patient safety, even when there might be conflicting interests, such as “attractiveness” for investors. The findings of the Cumberlege review, that patients’ concerns were ignored, need to be addressed in the Bill. While the creation of a registry of devices is welcome, their safety and efficacy need to be addressed. I hope that my noble friend Lord Kakkar takes up this cause. If he does, I shall certainly support him.
Why will the MHRA be the regulator that licenses devices and maintains the register, but any new information systems are to be held by NHS Digital, referred to in the Bill as the information centre? What pre-market processing will there be for devices prior to approval for usage?
Clarification is needed from the Minister on the powers that the Secretary of State will have in emergency situations and on the removal of the duty of confidentiality and privacy afforded to patients. I want to explore how the Government plan to make the United Kingdom a prime destination to conduct clinical trials, an area of considerable concern for a wide sector of pharma. The Minister may well remember the debate at the time of the withdrawal Bill on clinical trials and making the UK a prime destination to conduct trials. The key point in being able to do this was the ability for the MHRA to have a close relationship with the EMA. What discussions are going on currently to enable this to happen? Regulations for medicines is a devolved issue for Northern Ireland, a potential area of divergence in the future from the rest of the UK. The implications of this need to be clarified in the Bill.
In conclusion, I am able to support much of the Government’s ambitions through this Bill to make UK regulations in medicine world-leading. Having said that, I will support amendments that allow for greater scrutiny of the powers of the Secretary of State, place greater emphasis on patient safety and give a clear commitment to allow the MHRA to make strong partnerships with other regulators. I look forward to Committee.
Secondly, the MHRA is a world leader—for example, in the assessment of medical devices—but we have a problem, as the noble Lord, Lord Hunt of Kings Heath, said. We will be accepting CE markings through to 2023. I am pretty sure, unless somebody tells me otherwise, that the EU is not going to accept UK conformity assessments any time soon. So we are in an asymmetric relationship, and we have to think very hard about how we can sustain the MHRA. In the course of that, what the noble Baroness, Lady Barker, said is absolutely right: we must not be pulled between American FDA standards and EMA standards. We should be trying to move everybody to international standards, and that is something we will have to look at hard.
As we put more registries in place, I hope that they will include patient-reported outcomes: that is important. For medical devices, I hope that we will show how we are going to take them up in the NHS as well. On the consultation that ended last year on the medtech funding mandate, the time has come to do it. Ministers have not said that it will be brought into place this year or next. I think that the Bill should bring forward the medtech funding mandate, as the medicines mandate is in place. Finally, on clinical trials, the EU has not implemented its clinical trials information system and is not at present expected to do so until the end of 2021. We need to be in it. The legislation says “corresponding or similar to” but I do not know what “or similar to” means. We are either in it or not in it, and I hope we will be in it.
My noble friend the Minister pointed out that during the Covid crisis this is precisely what we have done for therapeutics, vaccines and other technologies that can help. The pandemic has shown British science and medicine at its best. Does he agree that we now need this kind of regulatory regime for all medicines and devices in the future? If so, will he tell the House when comprehensive plans for creating such a regime will be published?
Even as we go about producing the most pro-innovation regulatory regime in the world, we must never forget, as my noble friend Lady Cumberlege put it in her excellent report, that our obligation is first to do no harm. Too many people—often, it seems, women—have borne the brunt of an approach to post-licensing surveillance that, historically, has been too analogue and too unresponsive to patients’ needs. The sad consequences of this are movingly documented in my noble friend’s report. I wholeheartedly endorse her recommendations, and I am delighted that the government amendments in the other place will improve the use of data for patient safety.
But let us be clear: there is much more to do, so I ask my noble friend the Minister, when will the Government respond to the Cumberlege report’s thoughtful and sensible proposals? Does my noble friend agree that we should use the next few weeks to make progress on implementing its recommendations? Otherwise, as I am sure he is aware, he might find that the House does that work for him.
I have every confidence that my noble friend will work with noble Lords to produce a pro-innovation, safety-conscious regulatory system for the UK. He has my support for those efforts, and I am happy to welcome and support his Bill.
The UK has arguably some of the most ethical and comprehensive consent requirements for human tissue in the world, yet imported human tissue slips through the net. It has also been reported that two UK companies supply organ-preserving devices to mainland China, which could explain how they are being transported around China.
I hope the Minister will heed the words of my noble friend Lord Hunt of Kings Heath and other noble Lords and ensure that the Government have the means to ensure that the UK is no longer complicit in the harvesting of human organs from living victims.
As the noble Lord, Lord Hunt, noted:
“Forced organ harvesting has been committed for years throughout China on a significant scale and that Falun Gong practitioners have been one – and probably the main – source of organ supply.”
With regard to the Uighurs, the tribunal says it has
“evidence of medical testing on a scale that could allow them, amongst other uses, to become an ‘organ bank’.”
We now hear that they are being used for unapproved Covid vaccines.
The Human Tissue Act 2004 has strict requirements for tissue sourced within the UK, but it does not restrict imported tissue in this way. That gap must now be filled if we are to maintain that the UK has the highest standards in this area. The Minister will be hearing the signs of cross-party support, and I trust that the forthcoming amendment will be immediately accepted by the Government. That is clearly right, but it is also vital if the UK is to remain a leader in the life sciences field. There are many challenges that this field now faces.