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.
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.
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
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.
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.
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
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.
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.
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.
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.
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 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 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.
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.”
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.
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.
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.
My Lords, I declare an interest as vice-chair of the All-Party Parliamentary Group on Hormone Pregnancy Tests. I want to raise two issues: Primodos, which is part of the investigation conducted by the noble Baroness, Lady Cumberlege; and the violation of human rights in the trading and misuse of organs and human tissue, referred to earlier by the noble Lords, Lord Hunt of Kings Heath and Lord Collins, and the noble Baroness, Lady Northover.
The Minister knows how much I admire the noble Baroness, Lady Cumberlege, but I reiterate my whole hearted support for her report and recommendations, and I place again on record my admiration for the sensitive way in which she collected evidence, dealt with the many people who were affected by these scandals and brought forward these admirable recommendations. Parliament must now ensure that the report does not gather dust. The Royal College of Surgeons rightly draws attention to the review’s recommendation of a patient safety commissioner, as referred to earlier, and I look forward to hearing from the Minister what we are going to do about that.
It is over 10 years since I first questioned Ministers about Primodos after a man called Karl Murphy came to my university office and showed me the disabilities with which he has had to live all his life. Following the recent Sky TV documentary, he emailed me last week saying:
“the lies and deceit I have seen regarding this drug is an utter disgrace … I really do hope that the Government and Bayer have some respect and understanding of what these families are going through.”
The redoubtable Marie Lyon has refused over all these years to let this scandal be swept under the carpet, and I am glad that the Minister heard from her first-hand only yesterday. She made a telling point to me that in appointing Stephen Lightfoot, an ex-director of Bayer, as the new chair of the MHRA, they have clearly learned absolutely nothing about conflicts of interest and public perception and confidence. In the light of such appointments and reports of five scientists walking out of a task force for back pain after finding out that a briefing paper was funded by the drug company Grünenthal, perhaps the Minister will say what the Government will be doing to police conflicts of interest and the suppression or manipulation of data.
If Primodos teaches us anything, it is the importance of the independent assessment and scrutiny of all clinical trials. But, like others, I would like to see the Bill tackle the misuse of human tissue and organs. In the letter sent yesterday by the Minister, he says the
“government takes these allegations seriously and we continue to monitor all available evidence”,
but monitoring is simply not enough.
Two years ago, in August 2018, along with Professor Jo Martin, the president of the Royal College of Pathologists, I wrote to the Times after the NEC in Birmingham hosted the exhibition referred to by the noble Lord, Lord Collins. It was called “Real Bodies” and from the company Imagine Exhibitions. The exhibition consisted of human corpses and body parts. It advertised those exhibits as
“real human specimens that have been respectfully preserved”.
They were categorised as “unclaimed bodies”, with no relatives to identify them. As we heard, in advance of the American equivalent of that exhibition it was stated in a disclaimer —after a settlement with the New York State Attorney-General—that these human remains could be those of persons who were incarcerated in Chinese prisons. Imagine Exhibitions admitted that there was no documentation to prove the identities of the cadavers, yet they were permitted to enter the UK to be put on public display for commercial gain. Human tissue from abroad has no consent or traceability requirements to enter the UK, nor do we prohibit commercial gain. However, we should do and this Bill gives us the opportunity to do it.
My Lords, I stand before you as a person who was shaken by the experience of personally listening to over 700 women and their families, who have been damaged by the healthcare system. Their testimonies actually haunt me. Their bravery impels me to right their wrongs.
In our report, First Do No Harm, we examined and researched two medications. First, Primodos, already very well explained by the noble Lord, Lord Alton, was a hormone pregnancy test taken between the 1950s and 1970s and associated with terrible damage to some newborn babies. Those newborn babies now need care and support as adults while their surviving mothers, now elderly, have lived a life wracked by guilt. Secondly, there is sodium valproate, an effective medication to control epilepsy. When taken in pregnancy, there is a 50% chance of a severely damaged child being born. Even today, that medication is still being given to women who are unaware of the consequences. Then there is pelvic mesh: a plastic net which can migrate, disintegrate and wrap itself around vital organs, severing some and causing appalling suffering and pain.
The root cause was the failure of the healthcare system as a whole, and by some in the medical profession who ignored the concerns of women and their families. These women knew what was wrong but they were dismissed. They were told it was all in their heads—just a woman’s problem, not to be taken seriously. This made me furious. As Sir Cyril Chantler, the review’s vice-chairman, reminded us, for whom is the healthcare system run? We pay for it; it is ours. It is run for us, the people and patients. Your Lordships all know, as I do, that when we are ill or in pain most doctors will listen. But if they sense that a mistake has been made, they clam up, become defensive and act irrationally.
Now for the good news. The report has raised a clarion call for action and I thank all parliamentarians who have been so supportive—particularly your Lordships, but you are not alone. There are the 15 patient groups, 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 British Society of Urogynaecology—all with their medical membership—along with the BMJ, in its stunning editorial last week. All these and so many more want to see our recommendations implemented and we can start right now, with the safety Bill.
I intend to put down an amendment to appoint a patient safety commissioner—a voice for, and listener to, patients. If a product raises concern, that commissioner must say “Stop—this is a worry. We need to investigate and research to ensure safety”. It is better to have a few false alarms than the tragedies we have witnessed, which have cost lives, caused suffering and family break-ups, and damaged children. These are personal costs beyond price, with millions of pounds to be paid from the public purse.
We parliamentarians are establishing a parliamentary group called “First Do No Harm”. Its purpose is to ensure that all our recommendations are implemented. The only cloud on the horizon is the Department of Health and Social Care, which simply does not get it. Asking everyone, as it does now, to work together better in the future simply will not work, any more than it has in the past. We need someone and something new: a patient safety commissioner. Yesterday, we heard that the First Minister of Scotland, Nicola Sturgeon, has announced that Scotland is to have a patient safety commissioner on our lines. But in England, rumours are absolutely rife of a ritual burial and answers to the PQs are evasive. I say to my noble friend the Minister: this is his opportunity to give an assurance that this report will be implemented with a taskforce and timetable, as set out in our Recommendation 9. Please can the families who have been hit so tragically hard have that assurance?
My Lords, it is a privilege to follow the noble Baroness and to pledge our support—I feel sure of that in this House—for what she is trying to achieve, in the light of what she has achieved so far. We all look forward to what the Minister will say in response to her plea.
This is a Bill that we can and should welcome, in many respects. For example, I share many of the ambitions mentioned by the noble Lord, Lord O’Shaughnessy, when he spoke. It sets out a necessary regulatory framework; my concern is that it comes with unnecessary risks as well. It spans the range of human and veterinary medicine. It includes clinical trials and the ability to prescribe. It addresses some of the abuses raised by the noble Baroness in her report, and it raises fundamental questions about capacity and professional standards. That means it is important, not least for the reasons which the noble Baroness has just explained in her example, that the balance between powers and accountability—between patient safety and risk—is got absolutely right. We will obviously probe this in detail as the Bill goes through the House.
I have two concerns. One is how patient safety can be protected within the context of creating an attractive environment, whatever that means. The other is the speed, direction and potential impact of the cumulative divergence from the stability and standards of inherited EU law. The Bill is designed to achieve just that and to accelerate it. Our task in this House is how to anticipate impacts and correct for perverse consequences. That is why I feel that the better purposes of the Bill are undermined by the fact that it is a skeleton Bill. We are not surprised, of course; this is what we have come to expect. Skeleton Bills have become not the exceptional position, as urged by the Constitution Committee, but the default position of this Government, who are so committed to accelerating deregulation and for whom, frankly, Brexit provides the obvious opportunity.
The first 15 clauses of the Bill consist entirely of powers to make provisions by regulations about human and veterinary medicine and medical devices. I hope that the House will challenge in particular the provocative powers of delegation in Clauses 1, 8 and 12, not least given the chaotic conditions that we seem to be approaching with no deal at the end of this year. However, it is the fundamental disregard for Parliament which explains the exasperation expressed by the Constitution Committee and the DPRRC in its report on the Bill, the latter in particular towards the flimsy and, frankly, disingenuous justifications that were offered for the use of powers.
Noble Lords will also find if they read the whole report that there is more than a disregard for the job of Parliament. In some cases, the suggestion is that the new powers offer the same restraints as the existing ones. They do not. This is why the Bill presents such a risk. The anticipated divergence is away from a stable regulatory framework into an unknown environment in ways that cannot be tested in this House because the design, as well as the delivery, is in secondary legislation. The Bill is divergence by delegation.
“the means to depart from EU rules and regulations in future, moving at a faster pace … it ensures that we can easily amend regulation through secondary legislation without having to bring a new Bill”.—[
The DPRRC has replied that the Secretary of State has taken upon himself
“very wide powers to almost completely re-write the existing regulatory regimes for human and veterinary medicines and medical devices.”
In the strongest language that I can remember, it describes the powers taken to allow regulations for making the disapplication of legislation subject to conditions set out in a protocol—whatever that might mean—as
“yet another example of ‘camouflaging legislation’.”
This is Parliament; this is our job: to expose legislation, not camouflage it. Will the Minister assure us that he will listen and respond positively to the call for restraints and the removal of those powers in the Bill that have been so insufficiently explained by the Government so far? He will save himself a lot of grief if he does.
My Lords, I very much agree with the noble Baroness, Lady Andrews. The Bill covers a multitude of issues, but apart from giving massive powers to Ministers it provides very little detail. It is an empty bucket. Henry VIII would have been proud of it.
Like others, I have read the Delegated Powers Committee’s report on the Bill. I have rarely read a report from this respected committee that is so trenchant in its criticism of a Bill and of the government memorandum, which failed miserably to justify those elements that the DPRRC finds to be “inappropriate”. The powers given to Ministers are not just for transferring EU regulations into UK law; they are extensive—almost unfettered—powers to amend, extend or disapply regulations, breaking many of which would be a criminal offence carrying a two-year prison sentence.
Many of these regulations would be laid by the negative procedure, with the excuse that they might be urgent. Even those that carry the affirmative procedure do not allow Parliament to scrutinise them or amend them in the same way as we would if they were done by primary legislation. Ministers claim that there is no alternative other than putting all the detail of all the regulatory changes into primary legislation. This is nonsense and the Government know it.
I have to agree that it is not always possible or even desirable to use primary legislation for technical changes, but there is no detail at all in the Bill about what changes the Government intend about human and veterinary medicine and very little about medical devices regulations. The Government even plan to disapply some regulations simply by introducing a protocol, thereby completely bypassing any parliamentary scrutiny at all. It is rightly described by the DPRRC as “camouflaging legislation”. Its overall conclusion is that the Bill transfers powers from the European Union directly to Ministers, completely bypassing Parliament.
If this is what the Government mean by taking back control, it is exactly what remainers feared when the EU referendum was put to the people. Control is going to Ministers, not Parliament. In a parliamentary democracy, that is unacceptable. Under the Bill, Ministers could completely rewrite the regulatory frameworks for medicines and medical devices, so it is not surprising that noble Lords have received so many very concerned briefings from the field.
Having in mind the fact that patient safety must be at the heart of the legislation, what constraints do we find on Ministers in the Bill? In making regulations, Ministers must have in mind three issues: patient safety; the availability of medicines and medical devices; and the attractiveness of the UK for clinical trials and the supply of medicines and medical devices. I was surprised when I first read the Bill to find the word “attractiveness”. I have never seen it in a health Bill before—a trade Bill, yes, but not a health Bill. My primary question to the Minister is: is this a hierarchy of issues and is patient safety paramount? I would not want rigorous regulation of the safety of medicines to be subservient in any way to the ability to attract producers or researchers to come to the UK to take advantage of a more lenient regulatory regime.
Frankly, if the Government want to attract people here to do research and clinical trials, I can think of no better way than to remain as closely aligned as possible to the EMA and set up the safest, fairest, most rigorous and transparent regulatory regime in the world. This Bill does not do that. I ask for detail, transparency, appropriate parliamentary oversight and the whole package of recommendations from the report by the noble Baroness, Lady Cumberlege.
My Lords, I declare an interest as co-chair of the All-Party Group on Speech and Language Difficulties.
The Minister responded to our letter on
All requests by professional organisations for the grant of prescribing rights will need to be subject to intense consultation before they are granted and any resulting recommendations subject to parliamentary scrutiny, as the Delegated Powers Committee points out. Will the Minister say whether that is HMG’s intention and to which professions they plan to give prescribing rights?
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.”
My Lords, I, like most other noble Lords, have been inundated with briefings from a range of interested parties. Of course, everyone sees the Bill as important and absolutely essential as we leave the EU, but there is a widespread fear that, as it stands, it leaves far too many uncertainties.
The main issue at stake is that the Bill has too little detail and leaves too many actions to the regulations that the Secretary of State may or may not wish to put in place at some unspecified date. It gives the impression that the Bill has been written in haste. The fact that the Explanatory Notes are longer than the Bill speaks volumes. Here are a few of the areas where we should seek greater clarity in the Bill and not in some uncertain future secondary legislation.
The first is the clinical trials directive. It is absolutely essential that we get this, or the successor to the EU regulations, right when those regulations are no longer available to us. Heaven knows we in the UK spent enough time trying to get the directive fit for purpose. I remember spending much frustrating time in Brussels arguing the case for the workable scheme that eventually emerged, and now it seems that we will have to start again with a UK version. The research community and the pharmaceutical industry are deeply concerned that, in undertaking the clinical trials essential both for patient safety and for the timely availability of new drugs, we do not place new barriers in their way.
Can the Minister reassure us that, whatever regulations we put in place, we can interrogate them and that they are entirely compatible with the EU schemes so that we can avoid all that time-wasting frustration of submitting applications to more than one body? There is a fear that anyone conducting trials in Europe will have to employ expensive lawyers in Brussels to sort out the problems. Can he also ensure that the MHRA is given a clear remit for what is likely to be its enhanced role and that it is given the resources necessary to take on the extra work?
While I am on about clinical trials, it is clear that for many rare diseases there are just too few cases in the UK alone and that trials of new treatments have to be done with the much larger populations available across Europe. We can do this now, but can the Minister tell us whether and how it will be possible to do so in the future? For the very many rare diseases—there is a large number of them—will we be able to continue trials across Europe without all sorts of hurdles getting in the way, and will we get the full alignment so essential if we are to encourage industry investment and if our patients are to receive new treatments as rapidly as those in the rest of the world? There are opportunities to sort out some of the issues surrounding data protection and confidentiality in relation to clinical trials.
Then there is the whole question of the safety of medical devices, on which we have the important and very impressive report of the noble Baroness, Lady Cumberlege. How could anyone listening to her impassioned speech today resist her pleas? Her recommendations are clear and necessary. Will the Government take them up? Will they ensure that Britain remains at the forefront in developing safe and effective devices by making all new devices before and after development registrable and trackable so that all outcomes can be monitored? Does the Minister agree that the appointment of a patient safety commissioner, as the noble Baroness, Lady Cumberlege, proposes, would be a very positive move? Patients certainly need some sort of shepherd to take them through the myriad regulatory bodies. They, and we, need that.
There are many other concerns with the Bill where matters are skimmed over and left to be dealt with by regulations that bypass parliamentary scrutiny. I hope that the Minister will tell us when he expects those regulations to be available and that he will help us to fill in those huge gaps.
My Lords, as we have heard loud and clear today, this Bill is fraught with many critical flaws that the Government must address. However, I will focus on the concerns that have been expressed by pharmacists about the wording of Clause 3, relating to the development of a successor UK system to prevent the supply of falsified medicines, which is symptomatic of the Government’s high-handed approach.
The clause refers to
“the use, retention and disclosure, for any purpose to do with human medicines” of information collected by such a system, which considerably broadens the original data-collection provisions of the Falsified Medicines Directive. Yet the Explanatory Notes make no mention of this legislative creep and, indeed, the Health Minister, Jo Churchill, said in Committee in the Commons:
“The Bill, in the main, does not deliver any immediate change to the regulation of medicines and medical devices.”—[Official Report, Commons, 8/6/20; col. 7.]
In this context, data is sensitive, commercial currency. All parts of the medicines supply chain need access to broad patterns of medicines usage but, in the current scheme, access to pack information, which could highlight purchasing decisions and margins being made, is restricted to details such as the name, batch, expiry, serial number and active/inactive status, with some exceptions for investigating incidents and the national competent authority, MHRA, used for various purposes.
Because of the issue of the commercial sensitivity of data, Article 54a, regarding the protection of personal information or information of a commercially confidential nature generated by the use of the safety features, was inserted into the preamble of the Falsified Medicines Directive and the principle of “whoever generates the data owns the data” was enshrined in Article 38 of the associated delegated regulation of 2016, which followed the Falsified Medicines Directive.
The Department of Health and Social Care already has access to a very wide range of data on medicines sales and use in the UK under the Health Services Products (Provision and Disclosure of Information) Regulations. Ministers can request more detailed information if required. Given both this access and the known sensitivities around falsified medicines data, it is unclear why the department wants to extend the purposes for which data is collected under a future UK system and why this has not been discussed with stakeholders in the existing Falsified Medicines Directive scheme. Pharmacists have concerns not just that the department might accidentally release commercially sensitive data but that it might use such data to gain an unfair advantage, given its monopoly position as the main purchaser of medicines in the UK.
Of course, the details of a new scheme will need to be set out in regulation, but the regulation-making powers under Clause 1 are, as the Delegated Powers and Regulatory Reform Committee pointed out in very clear terms in its damning report—which many noble Lords have referred to—considerable, and they provide no guarantee at all that the use of falsified medicine data will follow the previously agreed pattern.
It is clearly important to ensure that primary legislation provides the necessary protection. I hope the Minister, on mature consideration, will agree to ensure that the Bill is amended to enshrine a duty of full consultation and agreement in the Bill over this data use as we go forward.
My Lords, I will raise two issues, the first being organ harvesting. I propose to support the amendment of the noble Lord, Lord Hunt of Kings Heath, and the noble Baroness, Lady Finlay of Llandaff. Like other noble Lords, I am very concerned by the activities in China. There are other countries where organs, particularly kidneys, are also sold, and we should not be allowing them to be used in this country.
Secondly, I support the constitutional concerns of the Delegated Powers and Regulatory Reform Committee, especially with regard to the proposed use of negative rather than affirmative procedures. I am also very concerned about the creating and adjusting of criminal offences by regulation and I would strongly support sunset clauses.
My Lords, many noble Lords, including the noble Baronesses, Lady Andrews and Lady Walmsley, have made reference to the extremely strong—you might almost say scathing—report of the Delegated Powers and Regulatory Reform Committee. It is worth going back to its conclusions, in which it states that Ministers are
“given very wide powers to almost completely rewrite the existing regulatory regimes for human and veterinary medicines and medical devices”.
This Bill sees the Government seize control, rejecting the oversight and scrutiny of the elected Members in the other place and the technical experts here. In the best Trumpian style, it declares that the rules will be whatever they want them to be. Forget checks and balances, forget consultation and careful consideration; let Ministers rip. Indeed, that is what the Minister suggested he wanted in his opening remarks, focusing on speed of action, which would happen with scant parliamentary scrutiny. What he is suggesting is something new and radical.
Yet, as the Delegated Powers and Regulatory Reform Committee points out, the Government claim elsewhere that this is like-for-like replacement of existing powers. The Government cannot have this both ways: it is either new and radical or just more of the same. However, the Minister is clearly right: this is new and radical, because what exists now is
“a mechanism for transposing into UK law EU rules on medicines and medical devices ... The new powers are subject to no such constraint”.
The answer here is not to concentrate power in the hands of the Government. The current system is clearly not good enough, but the answer is not to take away controls and oversight but rather to strengthen them through democracy, openness, a focus on the patient experience and independent expertise. As the Cumberlege report suggests, a commissioner for patient safety is crucial, and I am pleased to offer the Green group’s support for the noble Baroness’s proposed amendment, which she just outlined. We need a more democratic, listening approach, as the noble Baroness, Lady Cumberlege, demonstrated so effectively, not a centralised, unchecked one, in which few have input.
Let us consider what the UK regulation might look like if the Bill goes through. We will have a Minister who will be bombarded by well-funded industry lobbyists on what the new rules should look like. A pharmaceutical company or a device manufacturer has not taken the Hippocratic oath. Their job—their legal obligation, in fact—is to maximise profits, and their profits are very large. As the former editor of the New England Journal of Medicine suggested, an appropriate metaphor for the pharmaceutical industry is an 800-pound gorilla. “What does that do?” he asked rhetorically. Whatever it likes. Your Lordships’ House might like to contemplate the image of Matt Hancock up against that gorilla.
We have already seen drug companies flexing their muscle in the notable case of Selexipag—also known as Uptravi—using a patient representative group as cover for a massive lobbying effort. We know that pharmaceutical companies are lining up for a post-Brexit bonanza, increasing the price that the NHS pays for drugs. As the noble Lord, Lord Alton of Liverpool, made clear in his excellent speech, there is a huge problem in our system with conflict of interest, which is only likely to grow.
I am most often talking about the disastrous model of US healthcare in the context of the rush to privatise our NHS, but a significant contributor to its disastrous and highly expensive outcomes is the political power of the pharmaceutical companies. This Bill is not “take back control”. This is “abandon control” and, when you are talking about medicines and medical devices from the industry that gave us thalidomide, the US opioid epidemic, Primodos and pelvic mesh, that is a frightening development.
My Lords, I too extend my congratulations to the Minister on introducing the Bill. I suspect it will be a somewhat different Bill by the time we have finished with it.
This exposes the whole nonsense of “taking back control”. We are 3% of the world drugs market; the European Medicines Agency is 25%. The way for us to gain control is to work with our colleagues in large organisations where we can have considerable impact, not to start setting up our own organisations. The impact of moving away from the European Medicines Agency is going to be a considerable extension of a centralised process of regulation and it is also going to add to the unaccountable powers of Ministers, because the EMA does have a certain amount of accountability attached to it, which I do not think will happen. Indeed, it will not be the Ministers who will be making these decisions; it will be civil servants some way down the pecking order—and many of them will in the end have to take account of what the medicines agency has to say.
One danger we face is what the British Medical Association has called the butterfly effect: we have a slight derogation from a slight position of an EMA rule, then it multiplies, because one leads to another and then to another. You have to ask yourself whether this divergence can be kept under constant evaluation, because it needs to be. I put it to the Minister—he may not like it—that in the end we are going to have to negotiate a formal agreement for continued participation in EMA assessments, because we need a common assessment. We face otherwise the danger of delay—that manufacturers will say, “Let’s be logical: 22% of the market is in Europe, 3% is in Britain, so let’s get the European agreement first, because that’s where things are based.”
As a side-effect, we will then need an agreement with Euratom for isotopes, which has not yet been mentioned but is crucial to the health service, and that will have to be a separate agreement. We will also need to maintain access to EU funding programmes; we need these joint programmes to develop to do the best job for the citizens of this country—and, of course, we need alignment with the clinical trials regulations. We cannot have a different clinical trial regulation in Britain from what is in practice in the rest of Europe. We need all those things, and we need a professional structure in Britain for advising the Minister and drawing on the advice available.
I support the idea of a commissioner for patient safety. I hope that the Minister will go away and work out how it is to be done before he gets defeated on the Floor of the House. I also believe that the proposal on the harvesting of organs will not get through this House, and there will be an amendment on that. I say to the Minister: please do your homework and bring us something that we can agree with. Otherwise, the Government are going to get defeated.
My Lords, I shall raise just one issue—that of prescribing rights, already highlighted by the noble Lord, Lord Ramsbotham. Clause 2(1)(n) deals with amendments made to provisions that govern who can supply or prescribe human medicines. As the Minister, Jo Churchill, recognised in Committee in the other place on
The Minister informed the Committee that the Government had published an illustrative SI, showing how the provision could be made to permit dental hygienists to supply and administer certain medical products in the course of their professional duties. That is important, because the Government could use the opportunity presented in this Bill to extend supplementary prescribing rights training for occupational therapists and extend independent prescribing rights training to other allied health professionals, including dieticians, orthoptists, diagnostic radiographers and speech and language therapists. As the noble Lord, Lord Ramsbotham, has made clear, this could help to deliver better support and more timely care for patients; reduce pressure on other health professionals; increase system efficiency; and maximise the ability to respond to the Covid-19 pandemic now and in the predicted post-pandemic surge on services. The extension would also build on the groundwork already undertaken by NHS England’s scoping exercise over the last few years on extending prescribing rights. However, having had full consultation with professional bodies, any SIs laid must be subject to affirmative resolution in this House—and, of course, such SIs must be underpinned by efficient, robust and coherent regulation.
I support the views of the allied health professionals that there could be considerable benefits to extending these prescribing rights, including better support and more timely care for the patients they work with, enabling them to have more equitable access to treatment and reduced pressure on other stretched professionals, especially GPs. As an example of those benefits, I highlight the work of speech and language therapists. Without independent prescribing rights, speech and language therapists have to hand over a prescription to a different prescriber, such as the GP. If the prescriber is on another site, that can sometimes result in considerable delays. In addition, for those patients with eating and drinking difficulties, the current situation could increase the risk to their safety, including adverse effects such as aspirational pneumonia or reflux, with the possible increased likelihood of hospital admissions.
As noble Lords will be aware, speech and language therapists provide life-changing treatment, supporting care for children and adults who may have difficulties with communication or with eating, drinking and swallowing. They are also involved in key clinical and health pathways, including cancer, particularly head and neck cancers, learning disabilities, brain injuries, stroke and progressive neurological conditions such as dementia. Expending prescribing rights to them and allied health professionals could enable safer and more efficient patient care, and I hope that the Minister will confirm that he will support this issue as this legislation progresses though this House.
A lady local to me wrote to me about the excellent Cumberlege report. She said: “Mesh has ruined my life. I have lost my colon, appendix, cervix, uterus and parts of my vagina to mesh. I have been violated with at least two unconsented mesh procedures in my rectum and bladder—the scans don’t lie—and if I want removal, I may lose those parts of me as well. I have lost my sex life, my continence and my well-being. I have lost four jobs and I will shortly be losing my home since I cannot work.”
I shall call this lady Jane, which is my middle name, but it could be any woman in this Chamber or this country. Indeed, the online support group for women victims of mesh alone has over 8,000 members. Jane, like many others, has been brushed off, patronised and accused of imagining symptoms or being hysterical, while the perpetrators closed ranks, covered up their mistakes and made her suffer.
Vaginal mesh implants have caused women extreme pain, “like having razor blades inside them.” The noble Baroness, Lady Cumberlege, found in her report inadequately tested and poorly regulated meshes to be the cause of so much pain and misery. But the treatment of women over mesh, and the two drugs in her report, seem symptomatic of a culture of exasperation, impatience and disbelief on the part of many medical professionals when women tell them what they are going through. Barbara Ellen of the Guardian speculates about what would happen if the boot were on the other foot, and men had penis implants that felt like slashing razors. Would they be written off as “hysterics” and “whingers”?
Although I normally steer well clear of all matters medical, I cannot allow this Bill to pass without doing my utmost to ensure that women such as Jane, and all the Janes to come, will be properly protected from the inadequate testing of products, the failure to react and recognise when things are going wrong, and the cover-ups of life-ruining mistakes which have gone on without being called to account.
I am entirely in accord with the recommendations of the noble Baroness’s report and those of the Royal College of Surgeons. What we need in this Bill is proper traceability for all medical devices; a redress agency and revision of the MHRA; registries to monitor patient outcomes and spot early on if things are going wrong; and the setting up of a patient safety commissioner. Above all, we need to recognise the importance of giving primary regard to the safety of medicines and medical devices. This medical misogyny has to end.
My Lords, I would like to thank the noble Baroness, Lady Cumberlege, for her excellent work on the report that she has presented to the House. I would like to support her recommendations, and most particularly her recommendation for a patient safety commissioner.
This is an important Bill, and there is an opportunity presented by it to improve the regulation of human organ harvesting across the world. Organ transplantation is one field of medicine that offers great hope to the recipient. Organs are taken from deceased donors in particular circumstances and for years living donations have been possible. A person can donate a kidney, part of a liver and so on, and live perfectly well afterwards. I have seen it. It can make the difference between life and death. It is a rapidly growing field of medicine in which demand exceeds supply.
Here in the UK, we have stringent regulation of the process of organ donation to ensure that those who donate are protected and that donation is only allowed from those who are fit and are willing to donate without any payment but to help someone else. That is how it should be and at its best this is a wonderful development. Similarly, organ transplantation after death can, in the right circumstances, bring untold blessing to those who receive an organ.
However, the very fact that demand for organs for transplant exceeds supply means that there is a market in organ harvesting, both from the living and the dead. For decades, people have been forced through poverty to sell their own organs. This is unethical and wrong. There should be no support for such practices, and we must ensure control over any contribution made by British companies that enable such activity.
We know, too, that there is transplant tourism, where people travel to countries where they may be able to get a transplant, in some cases with few questions asked about where the organ donated to be transplanted came from. We know, too, that organs can be shipped and transplanted into recipients across the world without proper procedures. There continues to be a major problem in the lack of global control over organ harvesting. There has been a reference to the work of the China Tribunal and to reports of a state-run programme of forced organ harvesting in China, the organised butchery of living people to sell body parts, which the China Tribunal compared to the
“worst atrocities committed in conflicts of the 20th century.”
We know that Uighurs, Falun Gong practitioners and others are being killed and subjected to forced organ harvesting.
When an organ is taken, whether from a living or a dead body, it needs to be preserved and transported to its destination. Just as we now require that imported products, whether they be clothes or anything else, should be manufactured in ethical conditions, we need to ask ourselves whether British manufacturers are selling to China the devices, medicines and technology which will enable China to sell organs which have been harvested from people in China’s detention camps or otherwise wrongly obtained. There could be many spin-offs from such activity, including the use of such organs—that can be imported here without any evidence of consent or traceability—for medical research, a market in immunosuppressant drugs for the recipient, and a market in harvested organs which might even be imported and used here in the absence of full regulation.
China is not self-sufficient; it is highly reliant on the West for the equipment and medicines which it needs to help its organ transplant and harvesting industry. The extent of British engagement is not immediately accessible in the context of the Chinese organ transplantation process. The report The Economics of Organ Harvesting in China indicates that there are British companies with interests in this area—in research and in producing and selling organ-preservation solutions to China.
It is right to support and develop ethical, regulated organ transplantation. It is profoundly important that this Bill provides for proper regulation. We can provide regulation to prevent companies being empowered and enriched by the mass crimes that may be facilitated elsewhere. This will show the People’s Republic of China and the Chinese Communist Party that the balance between human rights and commerce will change.
We need to think very carefully about how this Bill will proceed, so that it does that which it seeks to do and protects the health and safety of those who may be forced organ donors.
My Lords, this Bill, the scope of your Lordships’ debate and the report from the noble Baroness, Lady Cumberlege, emphasise the importance of government supervision of the supply, distribution and safety of medicines and medical devices.
The noble Baroness’s report is entitled a “Safety Review”. In the Commons debates, the junior Minister for the Government, Jo Churchill, described patient safety as paramount. The conduct of the affected families, described in the report, is exemplary: the way they try to cope with their suffering; their attempts to change things, to be listened to and to make reasoned submissions; and they deserve the assistance of this House and the Government.
The report refers to three conditions arising from two drug-related circumstances and one involving a medical device. The report identifies six other separate conditions that have not been investigated. History reveals to us thalidomide, the haemophiliacs given infected plasma that caused them to have AIDS, CJD or mad-cow disease, and one or two more. There has been over a dozen major, medical events affecting the safety of our people over two generations. This is a problem that is always to be dealt with—preferably before the problem happens.
The noble Baroness’s report therefore recommends that the Government should act. First, it should create a redress agency. Doctors and staff are taught “First, do no harm”. The necessary consequence of that is, if harm is done then there should be a remedy for it. That can best be done through a no-fault fairly based redress agency, which does not take away social care, special educational provision or additional provision but gives help in addition. Some of these children will never be able to manage their own affairs.
Who should pay for it? It should include manufacturers of drugs and medical devices. The industry’s capitalised market value in this country is several hundred billion pounds. The French company Sanofi, which makes sodium valproate, have a capitalised value of over €100 billion. Such companies can afford to contribute to the downside that comes from their place in the market.
Secondly, a patient safety commissioner should be created. Legislation has three principal tests: purpose, structure and effectiveness. Let us not become hypnotised by structure. What is the purpose? How can we make it effective and safe? Those questions guide us to the structure. He or she could co-operate with the MHRA and any other relevant authorities.
Lastly, as to what is to be done, the Government should set up a task force now that is government-based, with independents involved, to find out how, at what time, in what manner and at what cost this report’s recommendations can be implemented. Let us not be told that it is too complicated. Within days of becoming Prime Minister, after years of litigation in which I was involved on behalf of the haemophiliac AIDS victims, John Major’s Government publicly accepted all the terms. I thank noble Lords for their patience.
My Lords, this potentially useful Bill raises many questions. I declare my interests as patron of the British Stammering Association—I am a stammerer myself—and vice-chair of the All-Party Group on Speech and Language Difficulties. In particular, it will be important to use the Bill to establish the post of patient safety commissioner, which was so powerfully advocated by the noble Baroness, Lady Cumberlege, and supported by many speakers today.
Like the noble Lord, Lord Ramsbotham, I echo the concerns of the Royal College of Speech and Language Therapists, which wants to work with the commissioner to safeguard people with communication needs, especially those with additional health inequalities, to ensure that their needs are identified and tackled, and their voices heard. There is a deficit here.
In addition, I add my voice to the call to extend powers to undertake supplementary training and to prescribe to occupational therapists, radiographers, dietitians and members of the British and Irish Orthoptic Society. This would greatly improve the efficacy of these services while reducing pressure on other professionals. I look forward to the Minister’s answer.
My Lords, I declare my interests as chair of the Association of Medical Research Charities, whose members contributed £1.9 billion to medical research last year, and of the Specialised Healthcare Alliance, which campaigns for those with rare conditions and those needing specialised care.
I will make three broad points. The first is to do with the Bill’s structure. I welcome the Bill, in that it could create opportunities for improved regulatory regimes. We cannot, however, tell whether it will. It is a skeleton Bill with a whole array of delegated powers and no detail of how the powers will actually be used. This makes effective, proper scrutiny very difficult, if not entirely impossible. The DPRRC report is especially damning on this point, as many noble Lords have noted. It is worth quoting its conclusion:
“We are deeply concerned not only by the Government’s failure to provide sufficient justification for the adoption of a ‘skeleton bill’ approach—which would give Ministers sweeping powers to almost completely re-write the existing regulatory regimes for medicines and medical devices—but also by their failure to acknowledge the breadth of the powers that the Bill would confer.”
The Minister wrote to me on
“You expressed some concern that this way of regulating the sector meant that Parliament would not be able to scrutinise the powers in the Bill if we did not provide further clarity about the policy changes we intended to make through the delegated powers. I have asked my officials to think further about the extent to which we can provide Parliament greater information to aid its scrutiny.”
That was a month ago. Can the Minister say what progress has been made in his thinking and whether we will see the fruits of it before Committee? For our part, in Committee we will want to explore means to improve scrutiny mechanisms, including the use of the made affirmative procedure mentioned by the DPRRC, and the use of a sunset provision, as discussed in the Commons.
My second point is to do with clinical trials, which are an absolutely critical part of UK life sciences and of what makes the UK a global leader in medical research. Anything that reduces the number of clinical trials will weaken that leadership and could delay access to new drugs and treatments. The Government understand this, which is why I was surprised by the weakness of their approach. The Bill simply requires the Minister, in making regulation, to “have regard to” the attractiveness of the UK as a place to carry out these trials or to supply human medicines. “Attractiveness” is not defined, and in any case this is a very weak and perhaps meaningless obligation that also entirely omits to mention manufacturing. We will want to return to all that in Committee.
We will also want to ask again which aspects of the CTR the Government believe to be in the best interests of UK patients, industry and non-commercial researchers, and which they will regulate for. We will also ask how the Government will assess these best interests and what they may be.
My final point is about consultation. We welcome the commitment to consultation and to a possible early start for it. Such consultation is necessary, but is not, as the DPRRC points out, a substitute for parliamentary scrutiny. The Bill and the Explanatory Memorandum contain no detail about the form of consultation, who is to be consulted and when, or when the consultation results will be available to Parliament. Will the Minister provide answers to these questions ahead of Committee, and could he confirm that patient groups, medical research charities and academic researchers will be among the consultees?
My Lords, I begin by referring to the entries in the register regarding my legal career.
When I first read the Bill, I appreciated immediately that its powers of delegation to legislate by regulation were extraordinarily broad. I do not think anyone has disputed that. The Government have done no more than say how its breadth will assist them. They have not yet dealt with the concerns that are naturally being expressed by committees of this House, and by others, about the lack of anything more than a skeletal framework for the Bill.
In that connection, I noted with interest that the noble Lord, Lord Lansley, made the point that what was needed was to make the Bill a framework Bill, which it currently is not. If his plea were accepted by Ministers, as I believe it should be, there would be a power to make sure that the regulatory power, though undesirable—especially on criminal matters—is at least capable of being controlled. What the Government actually then do in exercising the delegated powers can be tested against the framework—indeed, it can be tested by the courts. This would enable the proper disciplining of any misuse of the regulatory powers provided by the delegated legislation.
If the Minister is in listening mode, as he said, I ask him to bear the wise remarks of the noble Lord, Lord Lansley, very much in mind. It may be thought that giving powers like this is harmless. It is not. We do not know who will exercise the powers, why, and with what result, because that cannot be supervised in the way that a Bill could be. However, at least it helps.
I suggest that another thing that would help would be a sensible sunset clause. It has been suggested that the difficulty with a sunset clause is the timespan that would inevitably be involved before it would come into operation. I suggest that that matters not. The advantage of a sunset clause in this case is that those who are exercising the delegated powers will know that what they have done will come under scrutiny again within a set limit. It would be really helpful to the effectiveness of the Bill if a sunset clause of that sort were there.
Having said that, there are many things that have been said in the course of the debate today that I agree with. The first, of course, is what the noble Baroness, Lady Cumberlege, had to say in her report. I strongly endorse the support that she has already received. There are particular difficulties with harvesting paths, referred to by my noble and learned friend Lady Butler-Sloss and others. Again, I exercise my support. We must make this Bill better than it is now.
My Lords, I support this Bill as it will enable us to put together and implement the various regulations governing human medicines, veterinary medicines and medical devices. We live in a world that is changing and the medical and veterinary sciences are constantly evolving. The Bill will enable us to innovate and ensure that all medicines and medical devices will be safe to be used by the public when needed. The Bill will enable us to amend the regulations periodically and we will be able to act and react swiftly through secondary legislation and be a world leader in the pharmaceutical industry.
In formulating the regulations, we must ensure complete patient safety. In the regulations, we need to ensure that all the important issues are full covered. I note that Parts 1, 2 and 3 of the Bill stipulate that the appropriate authorities must have regard to the safety, availability and conducting of clinical trials of medicines and medical devices. I fully agree with and support Part 4 of the Bill, as it states that the regulations under Parts 1, 2 and 3 will be subject to the draft affirmative process. The proposed legislation would be required to be fully scrutinised and approved by both Houses.
Furthermore, I note that under Clause 41, the relevant authority would be asked to approach such persons as the authority considered appropriate. This consultation will be essential. I note that under Chapter 3, the enforcement authority will issue notices in respect of compliance, suspension, safety and information. The right to issue these notices will be essential to consolidate the enforcement regime.
I noted the remedies under Clause 24, which include criminal convictions. Will the Minister say whether it is in order to do so under this Act? I welcome the proposals in Clause 27 and Schedule 1 to apply civil sanctions rather than impose criminal proceedings in relation to offences connected with medical devices.
I will talk briefly about Clause 5, which refers to fees, offences and powers of inspection. Under Clause 5(1)(b), it is stated that the regulations may create a criminal offence
“for failure to comply with a provision made in the regulations”,
which may be punishable by a prison sentence of no more than two years. Will the Minister tell us whether the creation of the criminal offence is in order under the regulations?
I will now discuss the provisions of Clause 35, which relates to the disclosure and sharing of information. My slight concern is the protection of data, particularly relating to the patient. We must ensure that there is complete protection in regard to this. Will the Minister comment on the issue of protection? Will the recommendations in the Cumberlege report be fully implemented, including the appointment of a patient safety commissioner?
Finally, I have three more questions for my noble friend to address. First, under Part 1 of the Bill, will there be provisions to regulate alternative medicines, as some of these can cause serious problems? Secondly, what measures are being taken to prevent the importation of medicines from countries where human organs have been removed for medical testing? Falun Gong and Muslim Uighurs are subjected to these horrible practices in China. I am also concerned about tackling antimicrobial resistance. Can the Minister assure us that this issue will be looked into as a matter of priority?
My Lords, I came in earlier today to listen to the Minister respond to the Question asked by my noble friend Lord Dubs on child obesity. I was pleased with what the Government announced in July—I thought it was a step forward—but then I was disappointed when I heard that Public Health England was to be dismembered. I had hoped that when the Minister responded earlier today he would have given a more positive response than he did. I was disappointed to hear that he was simply going out on consultation again to see what would follow and who would supervise the implementation of the policy. It is this kind of change of direction when we are making progress that disturbs people. That is why there have been so many criticisms made of what is happening in this area.
The Bill is needed; we are out of Europe, we need regulation and we are dealing with a technological, fast-changing world. The Minister, in presenting his case, talked about the difficulties we face in handling AI and with biotechnology, how we stay abreast of it and keep pace with it. He went on to give the example of mobile phones: how life has changed so dramatically in such a short space of time and how we have also run into difficulties. He spoke of how, having run into difficulties, the Government have learned that we need to have proper regulation of what is happening with online matters, particularly those relating to children and harm. They are now moving on that, but it has taken some years to get to that point. The Minister said that he was in a listening mood and asked how we should deal with these complex changes. Well, we try to learn from history. The history there is that we should have had a regulator in place earlier. We would then have avoided many of the problems that we currently have.
The noble Baroness, Lady Cumberlege, has come up with a range of recommendations in her warmly welcomed report that are so deserved by people who have suffered as a consequence of medical devices and treatment in the past in a way that they should never have suffered. So I suggest to the Minister that he answer the question himself. We need confidence in dealing with this; I am not going to deal with the technicalities relating to the report, particularly the regulatory report that many others here are well able to dissect and determine what is needed in terms of the law. In general political terms, the Government need to add something that will give people confidence in this piece of legislation. If the Minister is in a listening mood, he will have heard from almost every speaker that the Cumberlege report must be addressed. I ask him to answer one simple question, as there is a limit to the number of recommendations that the Government would be prepared to embrace. Is he prepared to think again about the possibility of having a patient safety commissioner to go along with this piece of legislation? If he were willing to take that step, it would be a big move in the direction that so many people in this Chamber want.
My Lords, the Bill is necessitated by Brexit but, as many noble Lords have said, it does not provide the detail required to address the concerns about protecting patient safety, promoting innovation and helping British businesses at such a difficult time.
Soon after the Brexit vote, I attended a meeting convened by the MHRA involving many of the trade associations representing businesses in the healthcare sector. There was a strong feeling that the best way of addressing some of these issues would be for transitional arrangements to continue for quite some time, if not indefinitely. This case has been strengthened by the Covid crisis.
The UK has been a powerful player within the licensing framework for European medicines and medical devices for many years. The crucial role played by our scientists has been greatly appreciated across the EU and has benefited everyone, so the principle of dividing scientific expertise into two camps, one covering the UK and one covering 27 EU member states, is not a good one.
The case for the UK becoming an independent regulator of medicines and medical devices has never really been made convincingly and we have yet to see any real evidence that the risks and difficulties are likely to be outweighed by any benefits. Patients in the UK may find themselves accessing the latest innovations significantly later than patients in the EU. Businesses are told that they may benefit from different licensing arrangements in future, but if they are different, approval may well still be needed for export to the EU or to other countries which have learned to rely on EU standards. Likewise, patients who might benefit from new products licensed by the EU may not be able to get them until the UK has also approved them.
Two sets of licensing processes will mean two sets of applications, two sets of costs and two potential sets of delays, with the consequence that businesses may be less inclined to invest in innovation than they are under present arrangements. In future, we really need closer alignment in regulation between the UK, the EU and other international standards bodies.
The government case is that the UK will now be able to give more of a lead and to deal with approval processes more expeditiously, but the Bill lacks any detail showing how this could be the case. We might hope that in future greater emphasis will be placed on regulating areas of emerging and cutting-edge science where the UK has significant expertise, such as cell and gene therapies. We may aim for the UK to be seen more widely as a destination for the regulation and trialling of innovative and advanced medicines.
We should want the UK to be an attractive place for companies to undertake research and launch new products and therapies, but we have no real evidence yet that the UK will be able to achieve any of these things alone, and everything appears to be left to government Ministers to decide how things will be done at a time when confidence in some Ministers is very low. Greater detail and greater provision for parliamentary scrutiny may provide greater hope of progress on some of the worthy aspirations that have been outlined.
My Lords, I thank the Minister for introducing this Bill. In so doing, I remind noble Lords of my registered interests, particularly as professor of surgery at University College London and chairman of UCLPartners.
The Bill is important, as has been emphasised on so many occasions during this debate, because at its heart its purpose is to secure patient safety. Beyond that, it has the objective of ensuring a regulatory environment in which our life sciences industry can thrive. That is important because, beyond financial services, the life sciences are the second-largest contributor to our economy. However, patient safety comes first.
A number of issues in the Bill should have enjoyed detailed debate at Second Reading, but the way we are forced to conduct Second Readings at this time and the limited time we have to explore these issues make that impossible. However, I will identify and bring to your Lordships’ attention two specific issues that will need to be explored in Committee.
The first is the question of clinical trials. Twice in your Lordships’ House, Her Majesty’s Government have given very clear assurances that the clinical trials regulation that will at some point be adopted and implemented in the European Union would have its provisions reflected in UK legislation. It is regrettable that the new clinical trials regulation will not be in place by the time we leave the European Union and therefore not automatically become part of EU retained law.
The important issue here is that the trials regulation replaces the current clinical trials directive, which is defective. It seems unfortunate and unacceptable that, having lobbied so strongly in Europe to replace the current directive with the new regulation, our country, our patients and our researchers will be left with the defective current directive on the statute book. Why do Her Majesty’s Government not wish to use the current opportunity of this Bill to undertake implementation of the key improving provisions of the clinical trials regulation so that our research community and patients can benefit from an enhanced and much more effective clinical trials regulatory environment as we move forward?
The second issue is regulation of medical devices. We have heard much discussion about this problem during this debate. It is quite right that Clause 16 of the amended Bill, having completed its passage in the other place, provides for the opportunity to create registries to look at marketed device products to ensure that they can be traced and patients identified, but it does not deal with the important question of what level of evidence for the safety and efficacy of a device should be necessary before marketing authorisation is provided in the United Kingdom. This is vital.
There are trial methodologies beyond clinical, randomised trials which could be instituted that provide the opportunity for limited authorisation of new devices with patients included in prospective registries with very careful follow-up. The comparison of data from those patients with broader patients with similar diseases and conditions would allow for a proper safety evaluation of newly marketed devices and, ultimately, broader marketing once those initial data were made available. That would be the appropriate approach to patient safety. I hope Her Majesty’s Government will consider using the Bill to provide that kind of certainty.
I congratulate the Minister on introducing this important Bill and the review team, led by my noble friend Lady Cumberlege, on its commitment to patient safety.
This Bill delivers an extensive programme for the regulation of medicines, veterinary medicines and medical devices in the UK, and provides for a high standard of safety. To capture the fast pace of innovation in these areas within a regulatory legal framework, it is important to share vital information and be responsive and flexible, while being less complex and unwieldy, with data central to effectiveness. Can the Minister say how the duty to consult on regulations about human medicines will be carried out and which stakeholders will be involved?
I am pleased to see the Bill upholding and enhancing of the attractiveness of UK life sciences, as mentioned by previous noble Lords, while not hindering its ability to continue to provide for these important innovations for patients. It demonstrates a wish to make clear the importance of commitment to the life sciences sector, which is worth over £75 billion to our economy. We all know and acknowledge that enhancing continued collaboration of technical and scientific expertise is of significant importance to the UK going forward, but it should not be put before patient and user safety.
There is also a government commitment to a world- leading regulatory system, enhancing us as an attractive destination for clinical trials; to allowing strong collaboration, not just across the EU but maintaining alignment with global standards on the different routes to accessing innovation; to supporting patients’ access to innovation, creating more opportunities as we leave the EU; to maintaining and strengthening our position as a global player in the world of R&D; to allowing the removal of barriers to hub and spoke dispensing, giving smaller community pharmacies the same opportunities as large pharmacies; and to extending low-risk drug prescribing to other healthcare professionals.
An area of concern in the dispensing of medicines is oversupply, particularly in repeat prescriptions. Unused medicines have an environmental impact, so I would like to know how that can be responded to. How, too, can regulations be made to provide for a database of information on medical devices, to be established and managed by the Health and Social Care Information Centre?
As with human medicines regulations, the framework in the Veterinary Medicines Regulations 2013 upholds the safety of veterinary medicines by having a robust system for their availability, development and supply. Changes making prescribing professionals for veterinary medicines as accessible as possible, without compromising animal safety and while ensuring that the person administering the medicine is protected, are to be welcomed.
The Bill is an important piece of legislation for the regulatory system for medicines and medical devices, and for enabling new developments, but it must always display safety front and centre. The Government have stipulated that they do not intend to make any bold policy changes without full consultation, and that is to be welcomed.
My Lords, I will raise an issue that was not raised in the other place; I cannot hope to do it justice in four minutes. However, it is topical and urgent and, as confirmed by the Public Bill Office, within scope.
A safe and effective vaccine for Covid-19 is critical if we are to return to life as we knew it just a few short months ago. One does not yet exist. There are promising candidates out there, but we know from our experience in setting up an efficient testing regime that it is not easy to get from concept to delivery, however much of a world-beater a candidate may be. Bearing that in mind, thought and planning are necessary to help us beat this disease. Moreover—this point lies at the crux of my contribution today—we must act in unison with all countries of the world to ensure equitable access for all to any successful vaccines and treatments, because until everyone is safe, no one is safe.
Our experience here also shows that a small number of local cases can very soon become an outbreak and stringent restrictions have to be reimposed, Glasgow being the most recent example. It does not need a great leap of imagination to extrapolate this to the global stage. We really do all have to work together and co-ordinate action. Pharmaceutical companies have to play their part too.
Let us suppose that a safe and effective vaccine is found. The volumes of production required to inoculate the entire global population will be staggering and vastly outstrip the manufacturing capacity of individual companies. Holding exclusive licences over Covid-19 health technologies will not only affect pricing and hinder further research but prevent countries producing the volumes needed. Given that the UK, US, Japan and the EU countries have already secured over 1.8 billion of CEPI’s estimated 2 billion to 4 billion dose volume available until the end of 2021, the sharing of IP and know-how will be key to scaling up manufacturing capacity to meet global demand, in particular to ensure that low and middle-income countries can access a Covid-19 vaccine. To control the spread of Covid-19, it is crucial for all countries to be able to vaccinate the minimum 20% of their population necessary to protect key workers and vital health systems that, once lost, will take much time and money to reinstate.
Together with partners such as Gavi and CEPI, the WHO has been working to co-ordinate global action, resulting in myriad acronyms—the ACT accelerator, the AMC COVAX facility and CTAP, among many others. It is good that the Government have supported these initiatives, but—this is the huge part—they lack safeguards to ensure that vaccines and treatments, often resulting from huge investment from public purses, will be made available for all at a fair price.
I will give just a couple of examples of why these safeguards are so necessary. Gilead’s Remdesivir has been proven to reduce the need for mechanical ventilation for Covid-19 patients in hospital. However, with monopoly protection, Gilead was able to charge the US $2,340 per five-day treatment course of the drug, despite the substantial amount of public funding to develop the drug and researchers at the University of Liverpool calculating that the drug can be made for $9 at a reasonable profit. AstraZeneca has said it will supply the vaccine at cost to the UK Government during the pandemic phase, but what price will the NHS have to pay post pandemic? What happens to the money paid in advance if the vaccine is not approved? The contract between the UK Government and AstraZeneca has still not been published.
The Bill represents a timely opportunity to ensure that intellectual property rights support public health imperatives, as per the 2001 Doha declaration on trade-related aspects of intellectual property rights, TRIPS. The Government also have another tool in the issuance of Crown-use licences, similar to steps taken by countries such as Australia, Canada and Germany. In conclusion, will the Government take up the International Trade Select Committee’s recommendation to evaluate the case for measures to allow compulsory licensing, so that Covid-19 technologies are available as quickly, cheaply and widely as possible?
My Lords, I congratulate my noble friend Lady Cumberlege and her committee on producing such a thorough and important report.
I draw attention to a practice that many of us clinicians used for years. It detected clinical problems in treatment, equipment and management early on. We had weekly meetings for an hour or so to discuss any complications that had occurred in the previous week. It was attended by consultants, junior staff, medical students, nurses and a manager or two. It was always an interesting and very instructive meeting, and it brought problems to light early on. People were very honest about their mistakes; it became rather like the general confession. Of course, it was essential to have as a chairman of these meetings somebody who was friendly and encouraged people to adopt the attitude of “There but for the grace of God go I”. It was a very inexpensive and successful kind of quality assurance.
I have a few questions to put to the Minister. First, do the Government plan to mandate the tracking of all medical devices used in the UK and not just those selected at random? Secondly, will the use of medical device registries be extended to patient outcomes? Thirdly, will the Government go ahead and establish the post of a patient safety commissioner, as strongly recommended by my noble friend Lady Cumberlege and many of your Lordships? Some years ago, I used to carry out transplant operations and became very familiar with the problems involved.
I emphasise that in Committee I shall fully support the amendments in the names of the noble Lord, Lord Hunt of Kings Heath, and the noble Baroness, Lady Finlay of Llandaff, dealing with forced organ harvesting. As mentioned before, Sir Geoffrey Nice QC stated in his report that forced organ harvesting has been committed for years throughout China. [Inaudible.]
Perhaps those who spend so much time attacking the Government about this and that might like to turn their attacks on the Chinese Government, whose morally corrupt behaviour demonstrates to the world what is going on in China.
Finally, I again congratulate my noble friend on her outstanding report.
My Lords, I express at the outset my gratitude to many organisations, including the BHF, PSA, Birmingham University and of course our own House of Lords Library for their insightful briefings. The Bill seeks to keep high standards and safeguard patient safety as paramount considerations and to propel the UK as a standard bearer of new innovations. Like other noble Lords, I am uncomfortable about the extensive range of delegated powers afforded to the Government over medicines and medical devices and I would have liked, given time, to have elaborated further on the implications of Clauses 2, 4, 15 and 16 on the regulatory requirements during public health emergencies. I can only hope and pray that the other place and this House will ensure continuous scrutiny, with an agreed timeframe for a review of this legislation.
While I appreciate the legislative context of the Bill and the need for it, I wish to make some general points and do so as a grass-roots advocate who has campaigned for more than four decades for accountability and equity within healthcare and social services. I spent years working in this field and recall supporting many women who had experienced untold misery as result of medical intervention; I therefore welcome the sensitive way in which the Minister in the other place, Nadine Dorries, acknowledged that women’s voices and informed choices continue to be discarded and not believed, as has gone on for decades. This recognition is critical, as the noble Baroness, Lady Cumberlege, so powerfully and lovingly spoke of: women cried out for help to alleviate the massive damage caused to them by the medicines and medical devices deemed safe for years by health institutions and professionals. Women have endured countless years of unnecessary pain and injury, leaving many with insurmountable psychological, physical and financial scars. Even the most outspoken champions for their needs found it difficult to be heard, while women awaited justice.
The report from the noble Baroness, Lady Cumberlege, First Do No Harm, must be at the forefront of the Government’s mind as we look to safeguard and embed patient safety with this Bill. We have an opportunity to ensure that this legislative framework is watertight against any such injustice and costly negligence occurring again.
I support the creation of patient safety commissioners to improve patient safety and represent patient interests. In this Bill, glaring fragmentation remains; no clear pathways are indicated in the regulatory system to where patient safety is located. The Paterson inquiry referred to these anomalies as a “jigsaw of organisations” to keep patients safe without sufficient clarity. In this context, I would have wished for clarity on further safeguarding of informed consent.
Can the Minister say how the Government intend to complete this obligation for consultation with patients and the wider healthcare sector, as called for in the most recent proposals, including the Cumberlege Report, in order to rebuild trust and confidence that another set of disasters is not in the making as we proceed rapidly to create a new vaccine in the face of this horrendous pandemic?
Of equal significance, but which appears to be absent, is reference to safeguarding informed consent. I therefore welcome the Minister’s willingness to listen. Would the Minister consider that the proposed commissioner be supported by a diverse group of experts to ensure that women, as well as minority groups, have full confidence that their voices and needs are not overridden by the Government’s rush for central decision-making? Prioritising patient safety must not be compromised. The noble Baroness, Lady Cumberlege, has reminded us of the thin wedge where the medical profession and women patients, in particular, interact. There is urgent need for a robust regulatory framework for medicine and medical devices with the principal aims of serving and protecting patients and users of our service.
My Lords, I have a personal interest in this most important Bill, as medicines have saved my life on several occasions, and I use several medical devices. But most important to me is the safety of our country in this difficult time of coronavirus and leaving the EU.
The Secretary of State has an immense responsibility in providing safe functions relating to medicines for humans and animals and to medical devices. Leaving the EU means that we will not have the advantage of voting at the European Medicines Agency, where we were among the leaders, and it puts extra stresses and strains on our MHRA. The MHRA works so well with the European Medicines Agency, which has now moved from London to Amsterdam. I ask the Minister: will the MHRA be given more support and funds to carry out its extra and vital work? What will happen with clinical trials in the UK, which are based on the EU clinical trials directive and operate through the MHRA? It is not expected to apply in the EU until after the end of the transition period. This means it will not be part of the EU law, so what will the UK do about this important matter? My noble friend Lord Kakkar also stressed this.
Thousands of clinical trials seeking new treatments for diseases, including cancer, heart disease and many rare conditions, have been suspended or abandoned in the wake of the Covid-19 pandemic. Charities that raise money to provide funds have lost millions of pounds in revenue that would go a long way to helping to research new medicines and therapies that are desperately needed. Coronavirus has cast a shadow across the world. We should work together to fight this disease. But the emphasis on the attractiveness of the UK to conduct clinical trials or develop medical devices must not be put before patient and user safety.
The Bill covers so many aspects of safety. I have been involved with the disaster of sodium valproate, the drug given to pregnant women with epilepsy; their children were born with autism. I hope that the recommendations of the Cumberlege report will be accepted, especially the creation of the post of patient commissioner. I am pleased that the Bill addresses the dangers of falsified medicines. However, the Company Chemists’ Association would like to avoid the unintended consequences of data being used for purposes other than to ensure that medicines are safe. It is asking for “any purpose” to be amended to “in agreed framework”.
Everyone to whom I have spoken agrees that we should maintain the highest possible standards of patient and animal safety. I hope that we can work globally and not become isolated.
My Lords, I suspect that much of my contribution will echo that of other noble Lords as this vital piece of legislation makes its way through our House. I say “vital” not simply because the overall market in pharma-medical devices and medical products is worth some £74 billion a year, but because without this legislation the chaos that derived from a no-deal Brexit would be catastrophic for patients and their families.
Let us be clear: this Bill is short on detail and accountability and places far too much power in the hands of the Secretary of State. The one overriding consequence is to deliver a system of regulation that is inferior to and more expensive than the one that currently exists. That is quite a triumph.
That said, there are elements of the Bill I welcome, particularly the registry of medical devices, and the greater enforcement powers over rogue operators, which are so clearly needed, following the excellent report by the noble Baroness, Lady Cumberlege—a report, incidentally, whose recommendations are embarrassingly absent from the Bill.
I welcome a more realistic approach to prescribing and extending the ability to prescribe to more healthcare professionals. What is not clear is how this is to be achieved. Will the Human Medicines Regulations 2012 be amended by a new clause in the Bill? Will a common framework for competency, based on the Royal Pharmaceutical Society’s competency framework, be included as a requirement for any new professional prescribing group? If not, where will its standards come from? Do the Government intend to address the issue of competency for those who do not prescribe but who administer drugs to patients? A safe administering practice is crucial, particularly in community settings, where often prescribing colleagues are in short supply.
Like many Peers, I am deeply concerned about aligning future regulatory systems. I welcome assurances given by Ministers, but we have to anticipate a situation where divergence of regulation may lead to the non-compliance of either our products or those of the EU and the US, our two major suppliers. Currently, the UK is a key player in the global regulation of medicines. Despite having only 3% of the global market, compared to the rest of Europe with 25%, we are able, through the MHRA, to punch well above our weight, as the noble Baroness, Lady Masham, so clearly stated. Three years ago, the UK was a rapporteur, assistant rapporteur or scientific advice co-ordinator for one in five EMA regulatory decisions—decisions that were accepted across the globe. The UK is a global player because of our excellent science but also because it has access, through the EMA, to the EU. Should we not retain the closest possible alignment with the EU, when the regulatory cost and impact burden might see huge problems for the UK medicines industry, with a rapid decline of market authorisations?
Finally, given the surge in personalised medicine which will drive so many novel treatments, I hope that the Bill can be amended to make it a requirement that, should a health professional offer a patient treatment using a fast-track drug, therapy or device with which they have had or will have a pecuniary interest, it must be declared. That is not the case today and it certainly should be. The report by the noble Baroness, Lady Cumberlege, looked particularly at areas such as fertilisation treatment, where there are some very important differences to be made. I look forward to further examination of the Bill in Committee but regret the fact that we have to have this at all.
My Lords, the purpose of the Bill before us today is set out very clearly in the Long Title and few could disagree with the Government’s objectives. Indeed, the Bill had a relatively untroubled passage through the other place. However, I am slightly confused. At least part of the motivation for improving the law and regulation in this area was the subject of the review of the safety of medicines and medical devices by my noble friend Lady Cumberlege—a first-class if somewhat harrowing report. I am therefore unclear how the Government can be entirely confident that the Bill achieves what it purports to, as it was drafted before my noble friend’s report was published.
I would like to take this opportunity to make a few comments about my noble friend’s review, because I became concerned and, frankly, pretty horrified by its findings, particularly in relation to the use and misuse of surgical mesh. We have become accustomed over the last few months to applauding outside our homes the sterling work of front-line NHS staff during the pandemic at a time when large numbers of people became very ill and required significant interventions and care in a particularly challenging environment. We were right as a nation to acknowledge the work that they selflessly undertook on our behalf.
However, my noble friend’s review sets out a description of another side of our National Health Service that we need to be equally willing to acknowledge, although it is less palatable and some people may not be willing to admit it. Everybody makes mistakes, and large, nationally delivered services are no exception. So it is important to keep things in perspective, which is not easy when we are talking about the lives of people we know, or our loved ones.
One thing that sticks out to me in the review is the extraordinary lack of data, which has been mentioned before in this debate. I can tell your Lordships that 336,000 people have been infected with coronavirus in the UK this year and that 41,000 have died—precise and tragic statistics. But I cannot tell your Lordships how many women have had their lives ruined by the insertion of medical mesh, because the National Health Service does not have those figures. It does not know how many people had those operations or how many have suffered adverse effects, although the number is probably in the tens of thousands, and certainly more than those who have died of Covid.
Doesn’t know, or doesn’t care? It is very hard to tell from the review or from talking to those who have suffered. But the language of the review bears repeating and should go on the record. I am obviously not going to quote all 267 harrowing pages, but perhaps I can take a few quotes from page 4, which cites
“lack of awareness of who to complain to and how … the struggle to be heard … not being believed … dismissive and unhelpful attitudes on the part of some clinicians … a sense of abandonment … life-changing consequences … breakdown of family life … loss of jobs … loss of identity and self-worth”.
Lastly, “inaccurate or altered patient records” is a particularly shocking remark to me. I will not go on, noble Lords have heard enough. This is not a service that we should be applauding on our doorsteps. This is a service that in this area should be hanging its head in shame.
I have two questions for my noble friend. Can he assure the House that the Bill will go a long way—a very long way—to ensuring that something like this can never happen again? Can he explain exactly how the Bill will contribute to that, because it is far from clear to me from his remarks on opening this debate. It is far from clear to me because, as many noble Lords have pointed out, it is only a skeleton Bill or a framework Bill—I am not sure what the difference between the two is.
Secondly, can he explain what steps the Government are taking now, today, to make redress to those women who have been harmed and how exactly they are doing that? I have read what my noble friend’s review recommends but have not yet heard the Government’s response, and this Bill does not cover that most important point.
Lastly, if my noble friend Lady Cumberlege moves an amendment to set up a patient safety commissioner, I shall be delighted to support her in the Lobbies.
My Lords, this Bill is being debated against the background of the UK exiting the EU by the end of this year and the Covid-19 pandemic, which has paralysed this country and virtually the whole world. It covers a multitude of subjects, from medical devices and medicines, to research and consultation with the medical community and the general public. I will comment on Part 1, entitled “Human Medicines.”
This vast Bill ultimately will affect every citizen in this country. Many of us have illnesses and depend on our NHS. Our GPs are our first contact; they assess our health conditions and decide on the next step of treatment. The enormous responsibility that GPs carry is truly awesome. Their work decides our fate, whether medication is needed and whether to send us to a consultant or to an NHS hospital. Few of us realise that our GP practices have budgetary problems.
Next in line are the pharmacists, who deliver the medications prescribed by GPs. In the lockdown era, they must deliver those medications to our homes. We are rightly recognising and applauding the work of our NHS hospitals, doctors, surgeons, nurses and other staff, but few of us recognise the work of the pharmacies. They work long hours. In most cities and towns a pharmacy is open 24 hours a day. They too have budgetary problems. Before the pandemic they could run profitably, since customers collected their medications and, while doing so, could buy other, non-medical items, ranging from toothbrushes to perfumes and soaps. Because of the lockdown, that extra trade has disappeared and none of us realises that pharmacies may now be running at a loss. Supermarkets have their own pharmacies and competing products. There should be better recognition of the work of pharmacies and some level of subsidy provided following the lockdown.
My Lords, I declare my registered medical and university interests, and that my son is developing cardiac medical devices.
The Bill could either cripple UK medical devices development or enable the UK to become a major player in advancing new devices and medicines for the world market. There must be safety—the report First Do No Harm is aptly titled. Its recommendations must be fast tracked. I will address the proposed information centre, the need for a provisional licensing system for medical devices development, and our duty to uphold international standards.
The information centre that will be formed to collect data on medical devices must establish a level playing field, as a four-nation institution, with representatives from each nation on the board to ensure governance oversight and strategic direction, equal access to data analysis and data sharing, and reporting to all four Health Ministers. The model exists in the joint biosecurity centre, yet the lop-sided power base currently proposed will bleed the devolved Administrations of funds and information. Parity of funding and powers is essential. Clause 41 needs strengthening to require consultation with UK devolved Governments and health bodies impacted by the medical device information system.
Others have stated how EU-UK clinical trials for medicine must continue, with regulation that is compatible worldwide and rapid reciprocity in licensing. The UK must be attractive to medicine and device development by ensuring efficient streamlined systems that provide economic benefit to international investors.
We must catalyse medical device development pathways in the UK, as happened in Galway in Ireland. The UK—a small part of the world market—must grasp the opportunity to become a medical devices development and production hub by being worldwide-compatible and attractive to start-ups. Currently start-ups have the initial brilliant idea and do the safety studies required by the MHRA, but often cannot fund the utility studies in the second phase of licensing. The start-up is then bought out by overseas manufacturers, which market the device back to the NHS at great profit. A provisional MHRA licence would allow the start-up to sell to the NHS when safety studies have been completed as the utility data is gathered. A provisional licence would allow marketing to the NHS with post-marketing surveillance. I think that that reflects the proposals made by my noble friend Lord Kakkar. Patients would benefit more rapidly, with high monitoring standards in place, and it would stimulate the manufacturing infrastructure if the second stage of development happened in the UK.
Regarding China’s organ harvesting and experimentation on detained citizens, the Minister wrote to me last night, citing the WHO’s view as reassuring. It is not, as many noble Lords have already pointed out. Consent documentation for tissues from outside the UK is required only on an advisory basis. It must be statutory. There are now reports of Covid vaccine experiments in China being carried out on prisoners without consent. The UK cannot ignore increasing evidence of abuses, so I will co-sign an amendment to close the glaring gap. The Government can then prove that they really take this extremely seriously.
My Lords, I wholeheartedly agree with the noble Baroness, Lady Finlay of Llandaff, that Britain can and must become a world leader in medical innovation. I strongly supported the Saatchi Bill on medical innovation. I am currently trying out a couple of MS drugs and will volunteer for everything. Personally, I am not too worried about safety, but that is a unique viewpoint.
I begin by paying a warm tribute to my noble friend the Minister. He is one of the finest Ministers I have encountered in this House: intelligent, knowledgeable, on top of his brief, courteous and very hard-working. I am delighted that he is going to listen to the criticisms on delegated powers today. Thus it grieves me to say that the structure of the Bill is absolutely atrocious and an affront to parliamentary democracy. Of course, it is not unique; it is just one more Bill stuffed full of Henry VIII clauses but devoid of substantive content. It is the barest skeleton, all to be filled in with negative secondary legislation.
I am speaking in my capacity as chair of the Delegated Powers Committee. We considered the key clauses—Clauses 1, 8 and 12—and concluded that they contain inappropriate delegations of power. We say that
“the Government have failed to provide sufficient justification for … the Bill adopting a ‘skeleton bill’ approach, with Ministers given very wide powers to almost completely re-write the existing regulatory regimes”.
But of even greater concern are the powers in these clauses allowing Ministers to create completely new criminal offences by statutory instrument: see paragraphs 29, 30 and 31 of our report.
Then we come to the negative/affirmative procedure ploy. We say:
“We are wholly dissatisfied by departments repeatedly arguing for powers … to be subject to the negative procedure where there is a need to act quickly, and seeking to justify this without acknowledging the existence of the made affirmative procedure. Departments are very well aware of that procedure and we can only conclude that their failure to mention it is a device to try to minimise Parliamentary scrutiny. In future … we will expect them to explain why the made affirmative procedure should not apply.”
That is pretty hard-hitting, and I am sorry that my noble friend the Minister is bearing the brunt of this criticism when it applies equally to dozens of Bills across all government departments. It is simply that my committee is fed up with Bill after Bill drafted with the negative procedure, on the excuse that the only alternative is the affirmative procedure. This is simply not true. The Office of the Parliamentary Counsel and the Cabinet Office are perpetuating a falsehood in their official guidance on drafting legislation, which completely, and I say deliberately, ignores the “made affirmative” procedure.
Then we come to the wonderful new term “protocols”, another ploy invented by draftsmen to avoid parliamentary scrutiny. We say:
“Allowing regulations to make … legislation subject to conditions set out in a ‘protocol’ is yet another example of ‘camouflaging legislation’ … those powers … should be set out in the regulations themselves and not in a ‘protocol’ which is not subject to Parliamentary scrutiny”.
The memorandum states on Clause 2 that the negative regulations will be made
“following extensive consideration and scrutiny by the relevant professional bodies”.
Jolly good for them—everyone is to be consulted except this Parliament.
Finally, we say in our conclusion:
“We are deeply concerned not only by the Government’s failure to provide sufficient justification for the adoption of a ‘skeleton bill’ approach—which would give Ministers sweeping powers to almost completely re-write the existing regulatory regimes … but also by their failure to acknowledge the breadth of the powers that the Bill would confer. In future, we will expect a more transparent approach in which a department acknowledges the breadth of the powers and seeks to fully justify it.”
Of course, Ministers must take responsibility for their legislation, but the root cause of this abuse of Parliament can be found in the Cabinet Office guidelines to departments on preparing legislation. The Office of the Parliamentary Counsel boasts on its website:
“We are committed to promoting good law—law that is: necessary, clear, coherent, effective, accessible.”
If the lawyers drafting our laws think this Bill is good law, God help us. Do they think good law includes skeleton bills, Henry VIII clauses, negative procedure everywhere, regulations masquerading as guidance and protocols, and criminal offences created with no parliamentary scrutiny at all? Parliament is effectively bypassed; that is a sick joke of good law.
I will return to this theme at a later date. I apologise again to my noble friend the Minister that he is on the receiving end of criticism that applies across the board.
My Lords, I feel that I have drawn the short straw, speaking at this point.
Like other noble Lords, I broadly welcome and support this relatively short, important and necessary Bill. To promote patient safety, the meaning of
“the attractiveness of the … United Kingdom” environment for medical research in future, particularly in relation to clinical trials, requires clarification. We see the global race to produce safe vaccines for Covid-19 that must, despite their urgency to protect populations, be tested for safety as well as efficacy. The UK currently adheres to the EU protocols that apply to ensure the safety of such products before licences are given for mass use. Can the Minister explain if there are any plans to relax our adherence to current EU legislation on clinical trials?
The Bill refers to regulations relating to medical devices and the fact that Ministers will be given delegated powers in relation to their approval. Do the Government intend to adopt the EU regulation on medical devices 2017/745, which is not due to come into force until after the end of the transition period? Will the Government ensure that, as well as approving new devices in future, any maintenance of devices necessary to keep them safe in operating terms will also be included in the provision of granting such licences? We know that patients have occasionally been put at risk due to inadequate and/or irregular maintenance of devices—for example, with smart infusion pumps used to deliver medication. What onus will the Government put on purchasers of approved devices not only for safe maintenance but for adequate training for people to use the new devices to protect patients? This does not seem to be mentioned at all in the legislation as drafted.
I too fully support the excellent report and recommendations produced by the noble Baroness, Lady Cumberlege, and the way it uses plain English to describe the horror that some patients and their families have suffered. I am reminded of trying to find out, when I was training as a nurse, what “iatrogenic complications” meant. I think it is stark that the noble Baroness uses modern language that we can all understand. That is so important.
Will the Bill be used to incorporate some of the principles of the Health Service Safety Investigations Bill, which reached a Second Reading in this House, or is it the intention that that Bill will not be timetabled for completion and therefore the medical devices Bill will need to take up many of those issues at the same time?
Without doubt, I fully support the concept of a patient safety commissioner being appointed.
My Lords, like many noble Lords who have spoken today, I agree that the provision of high-quality healthcare in which its citizens can all have confidence defines any nation. That is why this Bill, with all its warts, is so important.
We must always ensure that our ethical practices are of the highest standard. Any medical product available in the UK, or indeed anywhere, must be rigorously tested, safe and effective. That is also particularly true of any future vaccine for Covid-19.
However, I want to focus today on one aspect of this Bill, that relating to medical devices. I have long campaigned on the issue of winning justice for pelvic mesh sufferers, who have been left with internal damage and intense, chronic pain. They were failed by an appalling culture of mismanagement, ignorance and apathy within the health system. These victims deserve justice, and we must ensure that this sort of systemic failure never happens again.
The recent report by the noble Baroness, Lady Cumberlege, entitled First Do No Harm, on surgical mesh and other medical interventions was scathing in its assessment of the failures of a disjointed and defensive health system to listen to and address patient concerns. Much of the suffering, it concluded, was entirely avoidable. As someone who met victims of this appalling mismanagement when I was a Member in the other place and learned at first hand of the pain they had been forced to endure and its effect on their quality of life, I am pleased that this review was commissioned and am happy to support the noble Baroness in her proposals. I am pleased, too, that it was able to be so honest in its findings.
I am further pleased that the Minister, the noble Lord, Lord Bethell, provided an apology in your Lordships’ House on the
In relation to Northern Ireland, there is also the issue of potential regulatory divergence. As medicines are a devolved power but medical devices are not, the Bill in its current form raises the possibility of future regulatory divergence between Northern Ireland and the rest of the UK. That matter requires clarification in relation to the report of the noble Baroness, Lady Cumberlege, and this Bill. Can the Minister provide that? There is no doubt that such assurances are very necessary, but they should not and will not close the door on the past.
My Lords, I refer to my interests in the register and congratulate the noble Baroness, Lady Cumberlege, on her review, which, as we have heard, was asked to look at three interventions in particular detail: hormone pregnancy tests, the use of sodium valproate in pregnancy, and pelvic mesh implants. The connection between these was not lost on the review, which noted that each of them are
“taken or used by women and, in the cases of valproate and hormone pregnancy tests, usage is during pregnancy.”
The review found a litany of failures in the system to monitor harmful effects and heard about: patients not being provided enough information to make informed choices; a lack of awareness as to how to raise complaints; struggles to be heard; not being believed; dismissive attitudes by clinicians; and life-changing consequences due to the harms that ensued.
For women, there seemed to be a confounding factor, which the report described as
“the widespread and wholly unacceptable labelling of so many symptoms as ‘normal’ and attributable to ‘women’s problems’.”
In my field, we call this diagnostic overshadowing. The review described the stories of adversity and harm it heard as being “harrowing”. This is what happens when a group is not believed and when systematic prejudices diminishes a speaker’s credibility. This stark example of epistemic injustice should serve as a reminder to all of us of the harms of ignoring the voices of the disfranchised. Of course, there are many groups whose voices are not heard and have, for too long, proved to be too easy to ignore. These include, for example, the voices of some patients detained under mental health legislation.
As we have heard, the Bill we are debating today grants wide-ranging powers to the Government—and, indeed, the Minister—in relation to medicines and medical devices, with a large number of putative regulations subject only to the negative procedure. Will Her Majesty’s Government commit to using this timely opportunity to implement the recommendations of the noble Baroness, Lady Cumberlege, in the framework of the present Bill?
There were nine recommendations, which included appointing a “patient safety commissioner” and the formation of an independent “redress agency”. Another was, quite simply, for the Government to apologise to all the women who have suffered lasting harm. I hope the Minister will inform the House of Her Majesty’s Government’s specific intentions with respect to patient safety.
The report suggests that the MHRA’s yellow card safety-monitoring scheme is poorly sensitive to adverse treatment outcomes and that the MHRA needs “substantial revision”. Will the Government commit, in this Bill, to a far greater emphasis on post-market surveillance of medicines and medical devices? In Clause 1(2), the Bill places market considerations on an equal footing with patient safety and distributive justice—namely, the availability of human medicines.
While the economic implications of the pharmaceutical and medical devices market are, of course, important, there is no implicit or explicit hierarchy in the current drafting of the Bill that would enable defence of the appropriate authority’s decision-making being based primarily on safety, or safety and availability. Will Her Majesty’s Government amend the Bill to ensure that the hierarchy of these principles is recognised in statute? I am considering such an amendment myself.
The Bill gives the Government power to extend prescribing responsibilities to new professional groups where it is safe and appropriate to do so. Can Her Majesty’s Government comment as to which professional groups they propose to extend prescribing responsibilities to and, if they do not intend to do so at the present time, when they would consider addressing this issue? What safeguards would they consider to be necessary?
My Lords, I refer to my interests as declared in the register.
I pay tribute to all those who have worked tirelessly to deliver lightning-fast and globally important Covid trials, including RECOVERY, REACT and the Genomics England genomic host sequencing study. These have been a clear demonstration of the strength of the MHRA and UK life sciences. However, surely none of us can read my noble friend Lady Cumberlege’s heartrending report or watch the race to a Covid vaccine without knowing that we have more to do. Therefore, although this Bill has been triggered by Brexit, it is in fact timely regardless of Brexit.
A great deal has been said regarding the delegated powers—I note my noble friend Lord Lansley’s comment regarding framework Bills—and we will have time in Committee to cover all this, but I add that while current frameworks governing MMD will be retained, the loss of the ECA Section 2(2) power causes specific challenges for operating a safe and responsive regulatory regime. By its nature, MMD regulation requires frequent, prompt updating. The Human Medicines Regulations 2012 have been updated 11 times using Section 2(2). Over and above this, as has been mentioned, we have significant decisions to come on MDR, CTR, in vitro diagnostics and much that is as yet unknown.
Passing this Bill will mean that we will be able to shape our MMD regulatory environment in a far more tailored way. We may well choose to mirror upcoming EU regulations. The MHRA has been clear that we want a seamless process for multisite clinical trials not just across Europe but globally. However, there are other areas, such as genomics and cell and gene therapies, where innovative regulation may be highly desirable for novel trial design or surrogate end points, for example.
From Genomics England to Wellcome Sanger and Biobank, we have a unique concentration of institutions, skills and industry that puts us at the forefront of this field. This is a position that we must maintain. Furthermore, genomics drives two of our most highly skilled and high-growth sectors: life sciences and data science. These are critical to our economic recovery. However, primarily, these technologies should be assured and accelerated due to their promise for patients: more accurate diagnostics, personalised medicines, and screening tools that may even help prevent certain diseases altogether. The value of knowing that you carry a faulty BRCA1 gene and therefore have an increased risk of ovarian or breast cancer is well known. However, combining this genotyping with emerging tech such as polygenic risk scoring can sharpen that risk profile and prevent inappropriate interventions. The same is true of familial hypercholesterolaemia, promising to improve care of the highest-risk CVD patients.
We know that gene editing tools are producing entirely new casts of medicine, including cell and gene therapies such as the blood cancer drug Kymriah. It was the UK that struck the first full-access deal in Europe for this breakthrough CAR-T therapy, and there is promise of much more, with 12% of global ATMP trials happening here. The benefit of cell and gene therapies is patient-specific treatment with curative potential. The challenges include cost, complex manufacturing and short shelf lives. This Bill would help, enabling approved therapies to be processed at the bedside, and much more.
Genomics and other such tech generate vast swathes of data, and none of us needs to be reminded of the challenge and urgency of regulating the intersection of novel medicines, medical devices and health data. This Bill would help us develop a future-proof health data regulatory framework that could unlock the potential of ML in healthcare while maintaining the highest ethical and data standards. But align or innovate, it will be our decision. Clause 41 makes it clear that these decisions will be fully consulted on and largely subject to the affirmative procedure, but it would be helpful for the Minister to clarify the points raised by the noble Lord, Lord Sharkey.
The balance to be struck is articulated in all three sections, which call for Ministers to consider safety, access and attractiveness of UK life sciences. Of course, patient safety is paramount, but a sick patient is not safe if they cannot access the treatment they need, and they will not be able to do that if the UK becomes an unattractive environment to trial and launch the best treatments. This requires rigour and prompt intervention to ensure the highest standards of patient safety, yes, and I fully support the patient safety commissioner and an effective devices register, but it also requires addressing barriers to access and uptake and creating certainty and right-touch regulation that limits bureaucracy and takes a proportional approach to fostering innovation in life sciences. That way, not only will UK patients get the best and safest care but we will ensure our life sciences sector remains one of the most productive in the country and one of the most innovative in the world.
I would like to start by congratulating the noble Baroness, Lady Cumberlege, and her colleagues on her committee, for her report and her compelling contribution today; it was incredibly moving. I, too, will be supporting steps to see this Bill serve as a vehicle for the implementation of her recommendations, most notably, as so many Peers have commented today, the establishment of a patient safety commissioner.
This Bill covers two areas of particular concern to cancer patients that I wish to emphasise today, which others have touched on, too. These are access to clinical trials and speed of access to newly licensed medicines. For the estimated 35,000 women living with incurable secondary breast cancer in the UK, clinical trials can provide early access to potential new treatments which might extend the time before their disease progresses, which might extend their lives and which can improve quality of life. These women often have few treatment options available to them, and clinical trials really do offer people with incurable secondary breast cancer and other cancers hope for the future. I do not want us to underestimate the value of that in these debates.
Research is, as we have heard, underpinned by pan-European and international collaboration. As an example, over 4,800 EU clinical trials involved the UK between 2004 and 2016. That is a significant number of important trials. The new EU clinical trials regulation, which we have already heard about today, will improve patient safety and streamline the process for setting up new trials, and this is vital. The Government made an extremely welcome commitment in 2018 to align as closely as possible with the new regulation, and it is essential that this commitment is restated and honoured. Today is an opportunity for that. However, without access to the infrastructure that clinical trials require, such as the portal and the database to support the regulation system, it will become much more difficult to run clinical trials across borders; that has already been talked about today.
Where trials show that medicines are safe and effective, it is vital that they are licensed and made available to patients as quickly as possible. We have heard today that the EMEA area represents 25% of global pharmaceutical sales and the UK just 3%. These are important numbers to bear in mind. If the pharmaceutical companies have to make a separate application to the MHRA, and incur additional costs, to license their medicines, delays are likely in those medicines becoming available in the UK. This is a threat to timely access for patients to new medicines, and its importance should not be underestimated.
We are also particularly concerned about access to medicines developed by small pharmaceutical companies. Can the Minister give some reassurance to patients with secondary breast cancer and other incurable cancers that access to clinical trials and newly licensed medicines will not be adversely impacted by the effects of this Bill? I look forward to hearing from the Minister.
My Lords, I have spoken at length about the value of harnessing healthcare data in the UK, and the Bill reads across to that topic. The Bill is needed to regulate medicines and the estimated 500,000 medical devices licensed for manufacture world- wide as we transition from membership of the European Union. However, it is heavily reliant on definitions set out in the Medical Devices Regulations 2002, and the use of technology has advanced significantly since then.
Simply stated, the Bill would benefit from up-to-date definitions of medical devices, or what are commonly referred to as decision support tools, that more readily reflect recently developed and near-future technologies. Many are deployed by professionals in clinical settings, while others are designed for use by members of the public. The Bill should guarantee patient safety and the efficacy of tools, including, for example, algorithm-based smartphone apps that help people assess the extent to which they may be at risk of skin cancer. A recent study found that the regulatory process for awarding the CE kitemarking to algorithm-based apps does not currently provide the public with adequate protection.
The onus is currently on the professional or individual to make appropriate use of such devices, rather than on the developers and regulators to take clearly defined steps to guarantee patient safety. Ideally, the Bill should offer at least the same level of protection afforded to patients in the EU and the US, where legal provisions make use of contemporary definitions associated with data-driven devices.
Medical devices are being developed in novel ways, and the regulation of software that makes use of algorithms to process vast quantities of data raises different issues to the regulation of software that has traditionally controlled, for example, pacemakers. These newer products are also developed, realised and updated in a very different way. By their very nature, many change, or learn over time, as they are informed by, or amass, new data. Without the means to monitor such updates, it is impossible to assess how many patients might be adversely affected by them at any point in time.
The Government have made plain their ambition to invest in science and innovation while boosting digital trade post Brexit, and the Bill is in part designed with that in mind. However, Ministers must negotiate new trade agreements with countries that subscribe to an increasingly protectionist approach to intellectual property. I am concerned that the effect of some provisions in agreements could be to reduce access to and understanding of the algorithms which underpin data-driven medical devices, in particular where developed countries seek restrictions on forced disclosure of digital technology, treating source code and algorithms as trade secrets.
I will therefore ask the Minister three questions about the Bill. First, do the Government intend to make provision for decision-support tools and the use of algorithms in medical devices now or in the future, and, if so, when? Secondly, does the Minister perceive merit in building on pertinent provisions introduced to safeguard systems of the European Union or under development in the US, and, if not, why? Finally, if there is an opportunity to learn from other countries, can the Minister highlight which nations the UK is looking towards and outline what he thinks he can usefully learn from them?
My Lords, first, I thank the Minister for the excellent way in which he introduced this Bill. Secondly, I want to say a word or two about the distinction made by the noble Lord, Lord Lansley, and the noble and learned Lord, Lord Woolf, between a skeleton Bill and a framework Bill. I understand that a framework Bill would be one in which the powers given under the Bill would have to be used for purposes specified in the Bill. Accordingly, if we are to make this a framework Bill, we will have to produce realistic purposes for which the powers must be used.
My second point is in relation to tissue. I strongly support all that has been said about that already.
My third point is that I am very concerned about the question of trials. It is very important that clinical trials are ready to be used over quite a large area of population, particularly, as has been mentioned, in specialist diseases.
My last point is about my noble friend Lady Cumberlege’s report. I fully support it in every aspect. I worked with my noble friend Lady Cumberlege long ago and I know how valuable her work is. The thing that worries me somewhat is how long this might take to implement. There is certainly the possibility of a task force, which was recommended in the report and mentioned today by the noble Lord, Lord Brennan. That strikes me as a signal that nothing much will happen for some time. I regard the present situation with regard to the people mentioned who have suffered so greatly as a very pressing situation, to be dealt with immediately. I would like this to be stopped as soon as possible.
The Bill requires Royal Assent by the end of the year and therefore there is a limited amount of time available. I suggest that a possible way to deal with this would be to set up a patient safety commissioner whose job is to hear from the public and treat that information as important and give it to the people who are responsible for the authorisation and use of various medicines and devices.
I think it would be possible to frame very quickly an amendment that could be used now to set up such a commissioner, with the responsibility to hear from the public and then bring the information that he gets from the public appropriately before the authorities responsible for carrying out the safety assessments in authorisation and use. That could be done now; then a task force would be able to look with slightly more leisure at what else could be added. That could be a Bill separate from, but associated with, what I am proposing.
My Lords, I am not a medicines or medical devices expert, but I have enjoyed this debate and have benefited hugely from the breadth and depth of your Lordships’ expertise. I am an IP litigator qualified in the UK and the US and I have experience of representing pharma and medical device companies in both jurisdictions.
Many thanks to the Minister for his hard work on this Bill and throughout the current pandemic response. Never in our lifetime have our medical expertise and ability to foster cross-border innovation research and reliable clinical trials been more important. This is why the Government’s approach to this issue is such a disappointment. During the four years before I joined your Lordships’ House, I worked in the London office of a large US law firm, advising companies on the management of IP portfolios in Europe. Of particular interest to US pharma and medical devices companies was the unitary patent and the Unified Patent Court. As currently stated on the GOV.UK website, the UPC would give such companies,
“the choice of protecting your invention in up to 25 EU countries with a single unitary patent. This will streamline the system … You will be able to challenge and defend unitary patents in a single court action through the Unified Patent Court.”
The ability to use the UK’s academic and research expertise as a stepping stone for EU-wide IP protection was key to international investment in the industry and the professional services that support it in this country. In recognition of the UK’s pre-eminence in the field of medicines and medical devices, the UK was able to secure London as the seat of the UPC’s specialist central division to hear appellate cases relating to chemistry, including pharmaceuticals and the life sciences. In other words, London was to be Europe’s specialist centre for pharma and life-science intellectual property development and litigation.
Post Brexit, the previous Conservative Government agreed to proceed with ratification of the UPC, showing that it would be possible to leave Europe but retain the UK’s leadership in this field. But the current Government abandoned that sensible middle ground; in February, they withdrew our ratification of the UPC without consultation or debate. With that simple decision, London lost the UPC central division and the UK lost the opportunity to be at the forefront of the development of medicines and medical devices for a generation.
I raised this important issue with the Minister before the Summer Recess, noting how withdrawal from the UPC was simply not consistent with the Government’s aim, as stated by Matt Hancock, that they wanted the UK to be
“the best place in the world to design and trial the latest medical innovations.”—[
Lord Bethell responded to me by saying that the Government did not believe that withdrawal from the UPC would make the development of medical devices, medicines and clinical trials harder and more expensive. However, in support, the Minister cited only the fact that this Bill provides for a consideration of the attractiveness of the UK as a place to develop medicines as part of the process of making regulations. This is Alice in Wonderland stuff. The Government cannot in February choose to withdraw the UK from the UPC and terminate its leadership position, and then hope to replace that leadership position with some warm words in a framework Bill. That is simply not enough.
The UK is currently negotiating free-trade agreements with Europe, the US and a host of other countries. Will the Minister enlighten us as to what the Government’s goals are in those negotiations with respect to intellectual property? How will the Government use those opportunities to make the UK once more
“the best place in the world to design and trial the latest medical innovations”?
My Lords, I am sorry that my noble friend Lady Brinton is unwell and not able to lead today. I hope that she is better and back in her place soon.
The Bill creates extensive delegated powers in the fields of human medicines, veterinary medicines and medical devices—but, I note, not veterinary devices. They enable the existing regulatory frameworks in those fields to be updated following the UK’s departure from the EU. The Bill creates a delegated power to establish one or more information systems in relation to medical devices, consolidates enforcement provisions for medical devices, introduces sanctions and provides an information gateway to enable the sharing of information held by the Secretary of State about medical devices. Your Lordships’ Delegated Powers and Regulatory Reform Committee published a report on the Bill in July. I was going to have a go at the Government about how poor the Bill was, but the noble Lord, Lord Blencathra, did it so much better.
Medical devices legislation currently relates only to medical devices for the field of human healthcare. Thanks to the health and cost benefits, these devices have also found their way into veterinary medicine. Somewhat surprisingly, however, the regulation of these products is missing altogether, unlike in some other European countries. Veterinary practice makes use of all kinds of medical devices, including products designed for use on humans, regardless of their regulatory status and control. With rapid growth in the animal health monitoring field, there should be opportunities to regulate such devices with regard to their safety and efficacy. Given the complexity and potential hazards of certain veterinary devices, the current unregulated state of affairs may lead to health and safety risks, both for animals and the clinical personnel involved. Perhaps the Minister would like to comment and think again.
Claims of medical relevance of new diagnostic tools should be considered because of the potential impact on animal welfare. Although ultimate responsibility for diagnosis should always rest with vets, reliance on these devices will increase, as will the need for regulation of performance standards. Although I recognise that Part 3 of the Bill, entitled “Medical Devices”, currently relates only to medical devices for the field of human healthcare, remote animal health and welfare services and remote health monitoring is a field of rapid growth. Opportunities to regulate such devices with regard to safety and efficacy, and to set standards for production, should be considered.
I move on to people. The timing of this debate, only two months after the publication of the Cumberlege report, is opportune. Many aspects of the report have not been debated, and I am sure that other noble Lords will have areas from the report that suggest amendments to the Bill. It will give us an opportunity in Committee to debate some of the recommendations.
For as long as I have been actively involved in either health governance or policy—some 20 years—the NHS has said that it wants to put the patient at the centre; there are various ways of framing it, but that is what it has said. The recommendations in the Cumberlege report do just that, absolutely and without any equivocation. We should legislate for a patient safety commissioner, tasked with focus on the patient, and for a redress agency, based on looking at systemic failure, not individual blame; I think there has been quite a lot of agreement in the House this afternoon on that.
The MHRA needs to highlight its public protection roles and ensure that it actively engages with the patient body. This is another theme running through the Cumberlege report. There will be a searchable register of who has had an implant and when; details about its type; the clinician carrying out the procedure; and, I would hope, any financial or other interests of that clinician.
While I recognise the need for the UK to remain competitive, patient and user safety must be paramount. There is a real need for strong regulatory oversight. Recent scandals, such as those concerning DePuy metal-on-metal hips, as well as those already discussed today relating to Primodos, sodium valproate and pelvic mesh, highlight the importance of safety.
The final recommendation of the Cumberlege report is that the Government should set up a task force to implement its recommendations. Public confidence needs to be restored, and with a matter of urgency, so will the Minister tell the House when he expects the task force to start its work and how its members will be selected?
The Bill confers on the Secretary of State an extensive range of powers to make regulations pertaining to medicines, clinical trials and medical devices. This is necessary in the short term to facilitate alignment with those parts of EU law which are to be implemented post transition—notably, the EU clinical trials regulation and the medical devices and in vitro devices regulations. However, the ongoing use of delegated powers in this area should be time-limited. Will the Minister tell the House whether this was debated in the department when the Bill was being drafted and why time-limiting was rejected?
On trade, the UK has a strong industry base in both medicines and devices, but we will not be able to be self-reliant. How does the Minister expect that we will be able to trade with the rest of the world in the future? What conversations has the department had with the EU, and what strategy is in place to work with non-EU countries? Time is against us. Negotiations with the EU are ongoing but if we have to set up treaties with various countries, it will be some time before all this is pulled together.
Our pharmacies not only dispense medicines, and some devices, but act as a local high-street source of information and advice; that is welcome to those who think that they do not need a doctor but want an expert’s opinion. The Bill enables community pharmacy contractors to use innovative new systems to support dispensing and is welcomed by members of the profession.
There is much that I have not had time to outline and I suspect that we all have a long list of points that we were not able to shoehorn into our speeches, but I look forward to the detailed work in Committee. I hope that the Minister will acknowledge that this Bill is important but needs detailed examination.
My Lords, I thank the Minister for introducing the Bill, all noble Lords for their contributions and all the organisations, including the Library, that have sent us briefings. I particularly thank the Delegated Powers and Regulatory Reform Committee and the Select Committee on the Constitution for their reports, produced in a timely fashion at the beginning of the recess, thus giving us all time to digest and reflect upon the issues concerning powers contained in the Bill.
We on these Benches recognise that this is an important Bill; indeed, the issues that it addresses are vital. I will concentrate on two or three, or maybe four, issues, most of which have been mentioned in the debate.
As the noble Lord, Lord Blencathra, said in his stirring contribution earlier, it seems that most of the Brexit Bills between now and Christmas will contain the same or similar constitutional challenges, so I think that we can anticipate some serious learned and constitutional debates throughout the autumn.
I am not sure whether I want to describe the Bill as a Trojan horse—something that has a seemingly innocent and benign exterior hiding huge and serious dangers within. Perhaps it is yet another example of the Prime Minister’s cavalier disregard for both timeliness and accountability, combined with our own Health Minister’s self-confessed aptitude for hustling, or perhaps it is all those things combined. However, it is worth recalling the words of one of our most distinguished Cross-Bench colleagues, the noble Lord, Lord Wilson, during the passage of the international healthcare arrangements Bill in February and March last year. On
“My assistant secretary was asked why we needed a particular power, and he rather flippantly replied, ‘Because I thought it might be useful’. Parliamentary counsel gave him a withering look and said, ‘I am not going to draft a clause for you simply because it might be useful. You have to know what you want it for’. He did not know, and we did not get that power.”—[Official Report, 19/2/19; col. 2185.]
It feels as if it is the same with this Bill. Powers have been thrown in just in case they might be useful. The Minister called it “agility”. We agree that agility can be useful, but if it is not linked to policy and what you want to do with it, it is a power that can be abused.
Do the Government know what they want, or are they are putting these powers in simply because they might be useful later? I suggest that they do know what they want: they want the power to do exactly as they decide, whenever they decide it, without scrutiny, accountability or due consideration. For our NHS and care services the important matters are whether medicines are available and how much they cost, the future of scientific research, fake medicines, proper safeguards for medical devices and putting patients at the heart of this. They deserve our full scrutiny and the best constructed Bill possible.
As my noble friend Lord Hunt said—this risk was amply illustrated in the stark narrative of the noble Earl, Lord Devon—leaving the EU’s medicines regulatory regime poses a significant risk to the UK. The Bill is crucial for maintaining the attractiveness of the UK’s life sciences sector and ensuring that patients continue to benefit from the excellent clinical research that takes place in the UK. Therefore, it is vital that we fully understand what constitutes “attractiveness” on the global stage.
Will the Minister reflect on the rumour that leaving the EU is likely to see the UK drop down the list of markets that companies will choose to trial and launch medicines in if mitigating steps are not taken? It is crucial that this legislation carefully defines what the Government mean when they talk about the UK’s attractiveness as a place to conduct clinical trials or supply human medicines. Does “attractiveness” equate to the speed of decision-making at every stage of the medicine pathway? How will patient safety be assured? Will the Minister set out what the Government mean when they talk about attractiveness, how they will apply this to medicines access and what he is doing to ensure that patients in the UK can access new therapies on the NHS as soon as countries such as France can?
The British Medical Association asked about the potential divergence in standards and suggested that this must be kept under constant evaluation to ensure that such changes do not negatively impact the timely supply of safe medicines to UK patients, as my noble friend Lord Turnberg said. The new EU regulation on medical devices is an example of a change coming through from the EU that the UK should seek to capture in the future regulatory framework around medical devices, as facilitated by the Bill. Expected to come into force in 2021, the revised rules were drafted in the aftermath of the metal-on-metal hip and PIP implant scandals. They will introduce stricter requirements on the bodies authorising medical devices and ensure greater post-market surveillance. Will UK patients benefit from changes such as these, which were orchestrated at EU level, when we are no longer part of the EU’s processes? How will that happen?
The impact of moving away from the existing collaborative approach between the UK and the EU could be substantial. The centralised processes that we are currently part of reduce the burden on the regulatory authority in each member state, create a larger European market for the pharmaceutical industry and medical device manufacturers, and thereby facilitate timely access to new therapies and technologies to patients across the EU and EEA. As many noble Lords have said, the EMA accounts for 25% of world sales of medicines, second only to the United States. By comparison, the UK accounts for only 3%.
On medical research, negotiating a formal agreement to maintain access to EU funding programmes, ensure alignment with clinical trials regulations and secure the participation of the MHRA in clinical trials that cross the EU and the UK to maximise collaboration between researchers in both is particularly important if UK researchers are to benefit from the EU’s new clinical trials regulation, which is due to be introduced in 2022 and is expected to significantly improve the current research climate via the introduction of a single clinical trial database and a centralised clinical trial portal. I have been talking to your Lordships’ House about this portal ever since the Brexit vote. It looks like we will not be part of it. I would like the Minister’s comments on that and an explanation of the disadvantage that this will bring to UK patients.
As many noble Lords have said, the Bill presents an opportunity to address the issues raised in the excellent report First Do No Harm, launched and led by the noble Baroness, Lady Cumberlege, whose remarks were very moving indeed in addressing the terrible sufferings of women at the hands of the NHS and the regulatory regimes that failed them so comprehensively. Surely we need to take this opportunity to provide for its recommendations. As other noble Lords have said, we need to consider amendments that will fall within the scope of the Bill and cater for the nine recommendations in the report. At the heart of the Bill lies the issue of patient safety in terms of medicine and medical devices, so it must be an appropriate vehicle with which to implement the report’s recommendations. Will the Minister bring forward amendments to remedy these omissions?
It is rumoured that there are mutterings, possibly among officials, about burying the proposed patient safety commissioner. I would really appreciate it if the Minister could take this opportunity to refute such rumours and commit to working with colleagues across the House—I include these Benches—to make sure that the necessary amendments happen.
I briefly turn to other issues. We are very supportive of extending the prescribing rights to additional healthcare professionals, as the noble Lord, Lord Ramsbotham, and my noble friend Lord Bradley outlined. It is time that this issue was resolved. We intend to support or table amendments in Committee requiring proposals and a timetable for additional prescribing rights.
We will seek clarification about Northern Ireland and regulatory divergence. We will probe the changes to the hub-and-spoke proposals. We will look closely at the work of the proposed patient safety commissioner, the medical devices register and, of course, the impacts of the Bill on animal medicine and veterinary regulation.
Although only 46 clauses, the Bill is a veritable cornucopia of medical and other proposals. We hope to work with the Minister, the Bill team and other noble Lords to improve it and make it worthy of the importance attached to it.
My Lords, what a debate. This is without doubt the House of Lords at its best, with thoughtful and powerful points covering medical regulation, legal propriety, patient safety, the European transition, animal welfare, foreign relations and much more. We have listened to powerful points made by 50 speakers. There was a great deal to take in. Our time together in Committee and on Report promises to be rich with important material. I fear I will therefore be unable to address every single point from every noble Lord who has spoken today, but I will give it my best shot.
Noble Lords addressed five broad themes in their contributions: my noble friend Lady Cumberlege’s review, improving regulation for medicines and medical devices, the Delegated Powers and Regulatory Reform Committee report, organs and tissues, and the UK’s future relations with the EU. I will take them in turn.
I am exceptionally grateful to my noble friend Lady Cumberlege for her report and her contribution today. Noble Lords have sent a clear message to the Government and the public that patient safety must be paramount in how we regulate medicines and medical devices. My noble friend is right that patients should be believed. She is also right that it is counterproductive to create an environment in which health professionals clam up or go into hiding. I note her intention to table an amendment on a patient safety commissioner and the large number of noble Lords who expressed their support.
The noble Lord, Lord Alton, gave poignant testimony from his own long-standing campaign on these important causes, including on Primodos. The noble Baroness, Lady Hollins, spoke of the epistemic injustices towards the disfranchised, and the noble Baroness, Lady Burt, spoke movingly about mesh, giving testimony of what she called “medical misogyny” that was hugely uncomfortable. There is a limit to how much I, as a man, can really understand all these cases, but as a husband and a father of two daughters I understand the claim that our healthcare system has not treated women fairly. This Government and this Minister are committed to doing what we can to address this.
I have heard the clear commitment from many Peers, including the noble Lords, Lord Brooke and Lord Patel, the noble Baronesses, Lady Ritchie, Lady Uddin and Lady Watkins, and my noble friend Lord Sheikh to see the report of my noble friend Lady Cumberlege implemented. I said that I would listen, and I have heard very clearly the support for a patient safety commissioner. The nine strategic recommendations in the review need to be considered carefully and we will respond in due course.
I reassure the noble Baroness, Lady Barker, who asked that registries of devices as well as databases should be our expressed direction of travel: we have set this out in the government guidance published alongside the amendment. I would be happy to write to set this out clearly. Many have spoken of the importance of Clause 16 and the underpinning of data. I assure Members that we are able to capture all devices where it is considered necessary to track their use. My noble friend Lord Mancroft is quite right that it is unacceptable in the 21st century, and makes no sense, that our National Health Service cannot keep track of who puts what in whom, and we are determined to change that.
The noble Baronesses, Lady Barker, Lady Walmsley and Lady Andrews, and the noble Lords, Lord Patel and Lord Brennan, raised patient safety. That must be a first consideration. I concur completely with the Minister in the other place that patient safety is paramount—under no circumstances will we seek to make changes that increase risk to patients in the UK. It is absolutely right that we ensure the delicate balance between supporting innovation and maintaining the UK’s position as an attractive place to develop new medicines and devices, but patient safety remains paramount. Innovation and patient safety are not mutually exclusive, and we want to continue to ensure that our regulatory framework facilitates the furtherance of both.
Several noble Lords mentioned the importance of consultation with patient safety groups on regulation that directly affects patients. I reassure all noble Lords that the consultation clause is worded such that where matters affect a particular group or groups, it will be entirely appropriate for them to be consulted.
I turn to the improved regulation of medicines and medical devices. The noble Lord, Lord Patel, expertly described the need to ensure the safety of medical devices. This is something I have indicated that we are wholeheartedly committed to, as indicated by the inclusion of Clause 16. The Government are determined to deliver regulatory change to the current UK system for medical devices to increase patient safety and drive pre-market scrutiny, and we will continue to assess opportunities to improve the wider regulatory system at the end of the transition period. The Bill is vital as it provides the necessary powers that will allow us to make regulatory changes in the interests of patient safety and confidence. The Government are committed to ensuring that patients continue to have rapid access to new medicines, and we have increased access through the early access to medicines scheme. We recognise the importance of innovation and clinical trials for patients and are absolutely committed to building on the UK as a centre of excellence for trials after the end of the transition period. We will ensure that no patients are disadvantaged.
I reassure my noble friend Lord Balfe that the UK already has substantial capacity and expertise to regulate and evaluate the safety of our medicines and medical devices. The Bill ensures that the legal frameworks around medical devices, human medicines, veterinary medicines and clinical trials can be updated to protect patient safety and reflect innovative practices. This is vital as negotiations on the UK’s future global relations continue, as several noble Lords alluded to.
I agree with the noble Baronesses, Lady Redfern and Lady Whitaker, and the noble Lords, Lord Ramsbotham, Lord Bhatia, Lord Willis and Lord Bradley, that it is right that patients are treated by the healthcare professional best qualified to care for them, including prescribing for them where that is safe and appropriate. However, putting individual professions on the face of primary legislation is not the right platform for any potential amendments to medicine supply or prescribing responsibilities. Over time the roles of staff within the health service will evolve and, using this proposed power, professional groups can be given new or additional powers to supply or prescribe medicine, subject to consultation, by amending human medicines regulations. NHS England and NHS Improvement are considering across all non-medical groups, influenced by learning from the Covid-19 pandemic, where there is a need to consider undertaking formal consultation on potential amendments to prescribing responsibilities for several professional groups.
The noble Lord, Lord Hunt, spoke of his frustration that the NHS is slow to adopt new technologies. He is right. Uptake of new medicines is still too slow, and we are working to address that. We recognise the importance of aligning regulatory and health technology assessment processes to ensure timely access to effective medicines.
My noble friend Lord Lansley is right that 10% of global medical innovations in the UK is good—but it is not good enough. I welcome his persuasive points on a new innovation fund and confirm that the Government have made a commitment to support innovative medicines by extending the successful Cancer Drugs Fund into an innovative medicines fund. The Cancer Drugs Fund shows the impact that this approach can have for patients, with 81 drugs treating 167 cancer indications funded by the CDF since July 2016.
I reassure the noble Baroness, Lady Bennett, that there is no contradiction between an intention to change very little in the immediate future and a commitment to evolving our domestic regime to protect patients, to meet the opportunities of technical revolution and to make Britain a destination for life sciences investment, clinical trials and better health services for patients.
My noble friend Lord O’Shaughnessy spoke wisely about the regulatory arms race, the impact of the FDA’s competitiveness and the opportunity of leaving the EMA. I welcome my noble friend Lady Blackwood’s point about the fact that the Bill is incredibly timely, irrespective of EU exit. I am proud of the energy and flexibility that the MHRA has shown during the response to Covid. I agree wholeheartedly with my noble friend Lord O’Shaughnessy that this is an opportunity that must be taken.
The noble Lord, Lord Clement-Jones, speaks knowledgeably about falsified medicines and the importance of commercial data. I reassure him that our objective is to fully consult with industry, patient groups, pharmacists and all interested parties on any regulatory changes before they are implemented.
To the noble Baroness, Lady Sheehan, I say respectfully that I reject the idea that we need to move away from the intellectual property rights regime that has provided incentives to create new inventions and accelerate the development of health technologies, such as Covid vaccines, over more than a generation.
By way of conclusion of this point, I echo my noble friend Lady Blackwood, who set out the opportunity well: there are key areas of regulation where we must choose to develop new regulatory regimes, including gene therapies, genetics, AI and big data. The Bill will help us to produce future-proof, proportionate regulations and standards in full consultation and largely with affirmative regulations that will have full parliamentary scrutiny.
On the question of parliamentary scrutiny, I turn to the DPRRC report. I reassure noble Lords that the majority of the delegated powers in the Bill are not new. They are absolutely necessary if we are to have the appropriate powers to make changes to the critical regulatory frameworks after the end of the transition period. We can currently make changes to those frameworks under Section 2(2) of the European Communities Act 1972, but that power will not be available once we have left the EU and we cannot allow those regulations to stagnate. While oversight of the delegated powers in the Bill will be different from that which currently occurs, we have taken deliberate steps to ensure that the oversight will involve greater parliamentary scrutiny and secure greater involvement by patients, industry and other experts. We will carefully consider the specific and detailed recommendations of the DPRRC as to how we might go further.
As reiterated by my noble friend Lady Blackwood, the majority of regulations are subject to the draft affirmative procedure—a high level of scrutiny that has usually been applied when we have used Section 2(2) of the European Communities Act 1972. As noble Lords know, by its nature this procedure requires parliamentary approval before those regulations may be made and come into force.
I am grateful to my noble friend Lord Blencathra for early sight of his speech, which was a model of courtesy and delicacy. I have heard his message loud and clear. I would welcome his counsel on the central challenge of how to legislate for a fast-moving industry in which there is so much opportunity and so much danger, but also so much uncertainty.
The noble Lord, Lord Hunt, and the noble and learned Lord, Lord Woolf, called for sunset clauses. Here I must express some scepticism. Sunset clauses would emasculate a Bill that is meant to give regulators the powers to be effective and to future-proof medical regulations in a fast-changing industry for many years to come. We must understand the impact on an industry that needs regulatory certainty or else, as many noble Lords have noted, will move elsewhere.
I firmly agree with my noble friend Lord O’Shaughnessy that the Bill gives us the ability to respond flexibly in future to regulate, for example to support the transformation of community pharmacy, to respond to innovations in the market and to improve standards of scrutiny of medical devices. Without the powers in the Bill to update the existing comprehensive regimes, we will be in danger of having static rules that could jeopardise patient safety. We must not allow ourselves to end up in this position.
The noble Baroness, Lady Barker, suggested that there is no scrutiny of the regulations generated under this Bill, but in fact the regulations come back to Parliament and cannot be enacted without scrutiny. I assure the noble Baronesses, Lady Andrews and Lady Walmsley, that we are certainly listening carefully. We are open to ideas for improving the Bill.
I welcome the constructive remarks by my noble friend Lord Lansley, my noble and learned friend Lord Mackay and the noble and learned Lord, Lord Woolf, on the building of a clear framework for the Bill. I have sought to outline such a framework in my remarks on patient safety, availability and attractiveness. I anticipate that these thoughts will be developed ahead of Committee and I look forward to further discussions on these points.
On China and organs, I have heard clearly the points of the noble Lords, Lord Hunt, Lord Collins, Lord Sheikh and Lord Alton, the noble and learned Baroness, Lady Butler-Sloss, the noble Baronesses, Lady O’Loan and Lady Northover, and my noble friends Lord McColl and Lord Ribeiro on imported human tissue, the suggested role of British firms in enabling this trade, the plight of the Falun Gong and the Uighurs, and potential forced organ donors. As the noble Lord, Lord Alton, put very clearly, the idea that British companies are profiting from these trades is abhorrent.
The noble Lord, Lord Collins, is right that we have one of the most ethical regimes for human tissue use in the world, and I share his concerns that we should in no way enable a horrible trade. I recognise that noble Lords are concerned about reliance on overseas reassurances, as outlined in the Human Tissue Act, and I hear these arguments clearly. I note that the noble Lord, Lord Alton, and the noble Baroness, Lady Finlay, will bring an amendment with the support of other noble Lords, including the noble Lord, Lord Balfe, and my noble friend Lord McColl. I reiterate my offer to the noble Lords, Lord Alton and Lord Hunt, and the noble Baroness, Lady Finlay: I would be happy to meet them to discuss this in further detail and will take this up with my noble friend Lord Ahmad, Minister for South Asia and the Commonwealth.
On EU exit, I am committed to ensuring that the UK has one of the best regulatory regimes that ensures patient safety and that patients benefit from innovative products. My noble friend Lord Lansley and the noble Lords, Lord Turnberg, Lord Kakkar and Lord Sharkey, raised the EU clinical trial regulations, which are currently expected to take effect during 2022. I am committed to ensuring that the UK’s regulatory framework for clinical trials is geared towards providing the best possible environment that takes into account the needs of patients, industry, non-commercial researchers and hospitals. That is why this Bill is so critical. The powers will ensure that we have the flexibility to adapt our regulatory framework and that the UK retains a thriving clinical trials environment, so that those engaged in clinical trials can continue to develop innovative and cost-effective treatments that both benefit patients and boost growth.
To the noble Baroness, Lady Morgan, I say that I am totally committed to improving the clinical trials regime. I assure the noble Baroness, Lady Masham, who touched us all with her account of the life-saving efficacy of modern medicines, that we are looking to give the MHRA the resources it needs to provide the best regulations and to give horizon-scanning intelligence and industry insight to help innovation.
The noble Lords, Lord Clement-Jones and Lord Freyberg, highlighted the importance of data. We are considering how to improve the regulation of software-driven devices, including AI and algorithms, and will consult on this. The Bill provides a power to make regulations about the use of data collected for the purpose of preventing the supply of falsified medicines.
Currently, the EU scheme information held on the system can also be used for the purpose of reimbursement, pharmacovigilance and pharmacoepidemiology. Determining the best model for the UK will be subject to consultation and parliamentary scrutiny of the proposed regulations. I will be happy to follow up with further detail in writing.
To my noble friend Lord Balfe, whose knowledge of European democratic structures is extensive, I say that we should embrace the opportunity we have now to discuss our own future and regulatory system here in this place. However, we should continue to work with our international partners.
A number of noble Lords referred to the importance of co-operation with the EU and EMA. As outlined in our approach to negotiations with the EU, we want to agree with the EU an annexe on medicinal products to facilitate trade and support high levels of patient safety.
The noble Lords, Lord Hunt and Lord Rennard, referred to the guidance published yesterday on standstill arrangements. We recognise the importance of continued access to medicine and medical devices. Therefore, to ensure continuity of supply of medicines and medical devices from
The noble Baroness, Lady Ritchie, referred to arrangements in Northern Ireland and I want to underscore that the implementation of the Northern Ireland Protocol is a top priority for the Government.
There is much more that could be said about the debate tonight. It is a testament to the interest in these issues and the importance of getting this right. I welcome the scrutiny of noble Lords in seeking to make the Bill better, as we so diligently try to do when it reaches us.
Bill read a second time and committed to a Grand Committee.
House adjourned at 7.18 pm.