Commons consideration of Lords amendments to the Medicines and Medical Devices Bill - Jan 27
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Medicines and Medical Devices Bill Madam Deputy Speaker (Dame Rosie
Winterton) I must draw the House’s attention to the fact that
financial privilege is engaged by Lords amendments 1 and 54. If any
amendment engaging financial privilege is agreed to, I will cause
the customary entry waiving Commons financial privilege to be
entered into the Journal. Before Clause 1 Establishment and core
duties etc 19:24:00 The Parliamentary Under-Secretary of State for
Health and Social Care (Jo...Request free trial
Medicines and Medical
Devices Bill
Madam Deputy Speaker (Dame Rosie Winterton) I must draw the House’s attention to the fact that financial privilege is engaged by Lords amendments 1 and 54. If any amendment engaging financial privilege is agreed to, I will cause the customary entry waiving Commons financial privilege to be entered into the Journal. Before Clause 1 Establishment and core duties etc 19:24:00 The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill) I beg to move, That this House agrees with Lords amendment 1. Madam Deputy Speaker (Dame Rosie Winterton) With this it will be convenient to discuss the following: Government motion to disagree with Lords amendment 2. Government motion to disagree with Lords amendment 3. Lords amendments 4 to 10. Lords amendment 11, and Government amendments (a) to (d) thereto. Government motion to disagree with Lords amendment 12. Government motion to disagree with Lords amendment 13. Government motion to disagree with Lords amendment 14. Lords amendments 15 to 21. Lords amendment 22, and Government amendments (a) to (c) thereto. Government motion to disagree with Lords amendment 23. Government motion to disagree with Lords amendment 24. Government motion to disagree with Lords amendment 25. Lords amendments 26 to 29. Government motion to disagree with Lords amendments 30 and 31. Lords amendment 32, and Government amendments (a) to (c) thereto. Lords amendments 33 to 39. Government motion to disagree with Lords amendment 40. Lords amendments 41 to 47. Government motion to disagree with Lords amendment 48. Government motion to disagree with Lords amendment 49. Government motion to disagree with Lords amendment 50. Government amendments (a) to (c) in lieu of Lords amendments 2, 3, 12 to 14, 23 to 25, 30, 40 and 48 to 50. Lords amendments 51 to 56. Jo Churchill I am extremely pleased to be back at the Dispatch Box to speak to this Bill. It is a changed Bill since we last looked at it but one that still has the patient at its heart. I am pleased that it comes back to us with the same spirit of consensus and collaboration that it left us with. Since we had the Bill’s Third Reading, the pandemic’s evolution and the importance of the regulation of clinical trials, the roll-out and regulatory approval of a vaccine, and the ability of healthcare professionals to get medicines into patients has bought into sharp focus precisely how essential this Bill is. The Government made a number of amendments to the Bill through the other place in response to Committees of the House, the report of the independent medicines and medical devices review, led by Baroness Cumberlege, and, importantly, as a result of genuine, cross-party discussions on how to make this Bill better. I am glad to say that the Bill still—and for those who know me, this is my passion—puts patients first: patients who will have the opportunity to trial new treatments; patients whose safety is paramount; patients who need to see quick and effective action from regulators in the event of an emergency. The Bill that left us on Report had a new change to it, anticipating Baroness Cumberlege’s report. The medical device information system, which will transform post-market surveillance of medical devices and improve the ability to track down patients and prevent harm, followed talks across this House and in the other place. I reiterate my thanks in particular to the hon. Members for Washington and Sunderland West (Mrs Hodgson) and for Central Ayrshire (Dr Whitford) for their contributions to that effort. We said on Report that we awaited the conclusions of the Cumberlege review and that we would take steps when the review was published. I can tell the House now that we have, and Lords amendment 1 establishes a Patient Safety Commissioner—a champion for patients in relation to medicines and medical devices. I pay tribute to all those who have spoken here and in the other place of the impact of harm on patients and on women—those who have not been listened to whose stories are difficult and heart-wrenching. Much was said during the Bill’s passage in the other place about the whole system change to enshrine the voice of patients at the heart of the process and our commitment to it. The Patient Safety Commissioner will act within and outside the system. They will be an advocate for patients and ensure that the patient voice is primary. The commissioner will be able to seek information, make reports without fear or favour and expect responses, and, more importantly, get change. Lords amendments 1, 41, 47, 54 and 56 together provide for both the appointment of a Patient Safety Commissioner and regulations to support this appointment. I congratulate Baroness Cumberlege and her team, and thank her and others who contributed to getting this into the Bill so quickly after her report. Lords amendment 31 provides for a small but important change that was also recommended in that review: a power to put the devices expert advisory committee on to a legislative footing. I am very conscious of the passion and commitment shown by the hon. Member for St Helens South and Whiston (Ms Rimmer) when we were last discussing the Bill. She has shown admirable determination. I am pleased to draw her attention to Lords amendment 8, which the Government were happy to support in the other place. That important amendment provides for provisions about the origin and treatment to be made in relation to the regulation of human medicines. We have had two reports, one from the Delegated Powers and Regulatory Reform Committee and one from the House of Lords Constitution Committee. 19:30:00 When we last stood opposite each other, the hon. Member for Nottingham North (Alex Norris) challenged me on how to make it clear that patient safety was the absolute priority. I thank him and his team, and those who work in the other place, for their constructive dialogue on these issues. We all want to see patients receiving effective, safe medicines and medical devices, and we all want to ensure that the UK remains at the forefront of pharmaceutical innovation. Amendments 4, 5, 6, 7, 15, 16, 17, 18, 19, 26, 27, 28 and 29 all change the nature of the regulatory powers in clauses 1, 8 and 12. They introduce an objective to safeguard public health, putting it at the heart of regulations. They remove the word “attractiveness” from the Bill and set out what I hope is as agreeable here as it was in the other place—a list of the types of activity we would hope the UK would be a favourable place to conduct. Importantly, they apply a safety lock. Regulations that affect the safety of a medicine or a medical device can be made only if the benefits outweigh the risks. Hon. Members here were very clear that we should go further to demonstrate that patient safety was absolutely paramount. These changes do that, but they also assist in turning a Bill that was called a skeleton Bill into a true framework Bill that makes it clear how delegated powers will be used and how, in making regulatory changes, safeguarding public health remains key. These changes better reflect the discussions in this House and the other place, and answer the criticisms of the DPRR and the Constitution Committee. We have also made changes to criminal offences—another area of earlier concern. Amendments 9, 10, 20, 21 and 55 clarify the maximum penalty that may be created by regulations. Both the DPRR and the Constitution Committee recommended increased parliamentary scrutiny, and the shadow Minister’s colleagues also pressed for public involvement. Amendments 44, 45 and 46 all provide for Parliament to have multiple opportunities to inform, and be informed by, the Government’s plans for regulatory changes. First, consultations have become public consultations under clause 44. Secondly, the appropriate authority is obliged to produce an assessment of how the regulatory proposal meets the overarching framework considerations at the time of going out for consultation. As Members are aware, the Government prepare a response to the consultation, and how the consultation responses are considered will be made public in that way. The amendments introduce a reporting requirement that means a separate report back to Parliament every two years summarising how regulations made under clauses 1, 8, 12 and 18 have been operating during that time. It must include any concerns raised, what has been done as a consequence, and any plans for further changes to regulations. This gives the flexibility for Parliament to be interested in—and if individual Members or Committees wish it, to submit responses to—any individual consultation, without requiring it to. Last time we discussed this Bill, the hon. Member for Nottingham North asked whether we could accept a sunset clause as a way of settling his colleagues’ concerns as to how we might use the powers contained in the Bill. I hope that he can agree that how these powers can be used has materially changed as a result of the Bill’s going through the other place. Another option that was put forward in the other place, as well as a sunset clause, was a requirement to bring forward and publish draft legislation. Unfortunately, we cannot accept these changes. Three years is simply not long enough to have a fully settled regime in a steady state to make reassessment practical, and amendments 2, 12, 13, 23, 24 and 40 would definitely introduce a cliff edge for new legislation. That is not the best way to go about legislation in general, but in this Bill, where essential changes could be needed to protect patients, there are better and more effective alternatives. Lords amendments 3, 14, 25, 30 and 48 to 50 also introduce the use of the super-affirmative procedure for regulatory changes that introduce significant new policy or changes to policy. Quite aside from how difficult it would be to assess what “significant” means, it is very much using a sledgehammer to crack a nut—as we are often guilty of doing in this place. In both cases, I have heard the arguments for these amendments. People are concerned about the lack of detail in the new likely changes to the existing regulatory regimes, in particular for medical devices, and therefore Parliament wants greater visibility of what happens next. We have stressed the critical importance of consultation and have made changes there, and we have provided the reporting, as I have outlined. Amendment (b) in lieu, in the name of my right hon. Friend the Secretary of State, proposes an alternative that goes further. This would require a report to be prepared within five years of Royal Assent that looked at the operation of the legislation. It would oblige the Secretary of State to take into account a report of any parliamentary Committee. That could mean, for example, a Select Committee choosing a report on the basis of a post-legislative scrutiny memorandum, and that report would need to address a series of considerations, such as whether the legislation needs restructuring or consolidating, whether certain parts of the legislation should be an Act of Parliament, and whether any of the powers in the Bill need amending or repealing. That provides the time needed to get the regulatory system into a steady state. It allows for consideration of how the system works on the ground and of all the factors that the hon. Member for Nottingham North and others have fairly raised in arguing in support of their amendments. I hope that he will support this solution. I do not intend to spend very long on Lords amendments 11, 22 and 32 to 39, not because they are not important, but because they have been arrived at with significant consensus. We introduced these important powers to allow for information to be shared with relevant persons, such as regulators and regulatory networks outside of the UK, in order to give effect to international arrangements. These amendments provide safeguards on data shared by the Medicines and Healthcare Products Regulatory Agency and the Veterinary Medicines Directorate. They define patient information. They provide a definition of relevant persons with whom information can be shared. Government amendment (a) to Lords amendment 11 would remove the reference to pharmaco-vigilance from the requirement to share information in the public interest, as, of course, pharmacovigilance is in the public interest and therefore covered. Madam Deputy Speaker, I do not intend to spend any time at all—you may be glad to hear—on Lords amendments 51 to 53, which make consequential commencement changes. To finish, the Bill has gone through with a great deal of well-informed, well-intentioned debate and changes. I am pleased that the constructive discussions that we had before it left us have continued. The other place has brought something back to us that I hope we can agree delivers for UK patients and the UK life sciences industry, which is vital and enables us to build a stand-alone regulatory system for the UK for the future and one that has patients absolutely at its heart. Alex Norris (Nottingham North) (Lab/Co-op) It is a pleasure to resume proceedings on this Bill, and we are now very close indeed to the finish line. For us and, I think, for all Members, this has always been about patient safety and about making sure that people of the United Kingdom have the best access to medicines and medical devices. The exchanges so far have been of a high quality in both content and tone. As the Minister has characterised, the Bill started as a skeleton, but it is certainly thin no more. There is much in there that will make a significant difference to our country. I have been proud to take the lead for the Opposition since the Committee stage, and I thank my predecessor in the earlier rounds, my hon. Friend the Member for Washington and Sunderland West (Mrs Hodgson), for setting the tone for us. I am also grateful to the Minister for her level of engagement and for giving us generous access to her officials and the Government in general throughout this process. The stages of the Bill through the Commons were of a high quality, and clearly considerable progress has been made in the other place, which we consider today. I welcome the Government’s concessions on the Bill, and I congratulate my colleagues in the other place, particularly Baronesses Thornton and Wheeler and Lord Hunt, on their hard work on and dedication to securing these vital amendments. That hard work will ensure that the Bill will promote patient safety and privacy, as well as proper consultation and scrutiny. I might even be mischievous enough to say that I tabled a number of these amendments in Committee, but I was unable to get them accepted at that point. I am therefore delighted to see them accepted at this stage. We will support the Lords amendments where the Government have indicated their support, and where they have tabled amendments in lieu we will accept those as a reasonable compromise. I therefore do not intend to divide the House this evening. Similarly, I do not intend to speak to all 56 amendments, but I might cover a few of the pertinent major themes. The Minister was right to say that in previous exchanges I challenged her to demonstrate that safeguarding public health and, critically, patient safety was uppermost, and that is reflected in Lords amendments 4 and 5. I knew from the outset that that was the Minister’s intention, and I think the amendments improve and make the Bill clearer, as well as future-proofing it for future Ministers and—dare I say it?—future Governments. It is important that that was done, and we appreciate that. On Lords amendment 1, it is welcome that the Government have heeded the second recommendation in the Cumberlege review, and legislated for an independent Patient Safety Commissioner. We were lucky to have a review as seismic as that one, which crystallised many decades of suffering and pain for lots of people who had been crying in the darkness and ignored for a long time. That report was a cathartic moment, but it cannot remain just a report, and the fact that we had primary legislation that was the perfect vehicle for the independent Patient Safety Commissioner was a real blessing. I am pleased we were able to find a way to include that. Mark Tami (Alyn and Deeside) (Lab) Does my hon. Friend agree that many of the people he said were in the dark often felt that they were on their own, and it was only when groups were set up that they realised otherwise? Many doctors were telling them there was not a problem. Alex Norris Yes, and I met as many of those groups as I possibly could. That commonality in the story of people often being ignored and left alone, or told that they were wrong, lying or making it up, added insult to the significant injuries that they had suffered. That collective action was a big part of people getting their salvation and securing that review which then vindicated them so strongly. That is so important. The presence of the independent commissioner will ensure that patient wellbeing is prioritised and there will be a voice for those citizens. That is an essential step forward to ensure that our wonderful national health care system is responsive and hears challenging messages, even if perhaps it does not always want to. That will give people a voice, which is important. We welcome the amendments on transparency and accountability, and I pay tribute to the hon. Member for Central Ayrshire (Dr Whitford) for her leadership at other stages of the Bill. Frequent reporting will ensure that the system is monitored and accountable, which is good. With Lords amendment 31 the Bill will provide for the establishment of the independent statutory device expert advisory committee, to ensure that the regulation of devices is transparent, and that decision making is better structured and more accountable. That can only be a good thing. Making urgent regulation subject to positive affirmation, as in amendment (a) in lieu, will allow the regulatory system to respond to changing situations, while ensuring proper accountability and scrutiny. As the Minister says, amendment (b) in lieu sweeps up and replaces the Lords amendments that relate to sunset clauses and clauses on the super-affirmation procedure. It was not quite what I was after, but I think it is a pretty fair deal. It is certainly more than I thought I would get—perhaps I should not say that before the amendments have been made. As a former trade union negotiator, I always thought that going in and getting 60%, 70% or 80% for our members was a pretty good outcome, so we will certainly take that. The five-year review is a good thing as it gives the Government more time—those arguments were well made by the Minister, and on reflection I think they are right. At the root of this, the Secretary of State is acquiring significant powers, and it is right to review that as well as to have scrutiny down the line, and an opportunity for right hon. and hon. Members to determine whether the system might need consolidating or restructuring. That is vital to improve the quality of the regulatory system. I am really pleased that we got there, and with where we have arrived. I welcome the opportunity in Lords amendment 8 for the use of human tissue in medicine to be further regulated, thus preventing the NHS from being compromised by the trade in harvested organs, including those from ethnic minorities and political prisoners in authoritarian states. My hon. Friend the Member for St Helens South and Whiston (Ms Rimmer) will be pleased with that inclusion. It is her hard work that made that happen, and I commend her for it, as she battled away. She feels strongly about this, and what has come out is very positive indeed. As I say, I commend her greatly for that. 19:45:00 Briefly, I shall pick up a couple of outstanding things from the medicines and medical devices safety review, which the Minister may deal with in her response. Again, significant progress has been made in the Bill and in associated regulations to make those recommendations a reality, but there are still a number of things outstanding that are accompanied by the words “in due course”, so I would be keen to get a sense from the Minister of when that is. She will be asked about that by others, as will her colleague, the Minister for Patient Safety, Suicide Prevention and Mental Health, and many right hon and hon. Members. It is an important part of finishing the process that those recommendations are adopted. The decision has clearly been made that they were not within the scope of the Bill or that the Bill was not the best place for them. I hope that when she closes the debate the Minister will detail the Government’s plans or at least a timetable for plans to address that. Finally, the Bill—certainly the guidance relating to it—has advanced the idea of making fundamental change to community pharmacy by moving towards a hub and spoke model. I will say what I said in Committee and on Report. The Government have chosen not to include that in the Bill—that is their decision—but I believe that they intend to do it, and it will be a seismic change for community pharmacy. I hope to hear from the Minister a clear commitment to something so significant that it requires wide-ranging consultation with all manner of stakeholders to make sure that we do it right. I think that that is the case, but I am keen to have on-the-record clarity. In conclusion, the Bill deals with patient safety and making sure that the British people have access to the best medicines and medical devices. We have fought hard to make it the best Bill that we can, and I am really proud and pleased with the progress that we have made. Anthony Mangnall (Totnes) (Con) It is a pleasure to follow the hon. Member for Nottingham North (Alex Norris), and to have followed the Bill from afar. It is a shining example of cross-party support, and to see it emerge from a skeleton Bill into a framework Bill is a credit to everyone who participated in Committee and in the House of Lords, and to Members across the House. It is, in short, a pleasure to be able to speak in this debate, and I support Lords amendments 1 and 54. The creation of a commissioner for patient safety has long been sought, and it will not only enhance the fact that the NHS is viewed as one of the safest healthcare systems in the world but will reinforce the view that it is an organisation that can learn from its mistakes. One such mistake is the unconsented and experimental use of TVT mesh. The intent was for the best of purposes, but in fact it caused utter devastation, both physically and emotionally, to those who suffered adverse side effects. Those effects went unreported and were misdiagnosed for a great length of time, and change was down to people such as Janet Peck and Susan Morgan—two of my constituents and victims themselves—who fought hard for action to be taken. Their determination and hard work have resulted in the excellent report by Baroness Cumberlege, which calls for the appointment of a Patient Safety Commissioner, which the Bill seeks to put in place, to ensure that scenarios such as those surrounding TVT mesh become never events. The Minister for Patient Safety, Suicide Prevention and Mental Health gave a heart-felt and meaningful apology to those who have been failed by medical treatments as outlined by the Cumberlege report last year. The new position will be welcomed by patients and practitioners alike, and I hope that the Minister responding to the debate will go further and explain the commissioner’s remit and the parameters of their work, and how recruitment will find a suitable person to report back. I welcome the fact that the Government will respond further to the independent medicines and medical devices safety review. Finally—much of what I wanted to say has already been said—I pay tribute to Susan and Janet. Their fortitude and determination have helped to shape the Cumberlege report and shape this Bill and, as we have already heard, their repeated efforts to ensure that patient safety is put first have allowed the Bill to be created in such a way that it will have a long and meaningful impact on those who seek the best service possible from the NHS. As has already been said, the cross-party support is a credit to this House. I congratulate all Members who have taken a significant step in helping to shape the Bill. Ms Marie Rimmer (St Helens South and Whiston) (Lab) [V] In 2018, the imported bodies of political prisoners and human rights abuse victims in China were on display in Birmingham. It was supposed to be a Real Bodies exhibition, to inform the public about biology, yet in reality it was a barbaric travelling circus. The British public unknowingly paid £15 each to view the remains of these poor souls. Since I learned of that horrific display, I have become determined to work on behalf of these human rights abuse victims to end forced tissue and organ harvesting. Our nation and the people who live here must not be complicit in the brutal acts of the Chinese communist regime. The first step is to put a stop to the importing of tissue and organs of human rights abuse victims. Currently, neither the human tissue regulations nor the Human Tissue Act 2004 requires appropriate consent for imported human tissues to be used in medicines. After several attempts to bring forward an amendment to achieve this, both here and in the other place, the Government have finally included a negotiated amendment in this Bill, which I welcome. That amendment provides the opportunity to prevent complicity in this crime within the UK medicine industry, and gives Ministers the powers to do the right thing. It is important to stress that the amendment has not dealt with the issue of organ transplant tourism, or the issue of plastinated unclaimed bodies being imported and commercially displayed, as we saw in Birmingham. The amendment is a welcome start, but it is only the beginning; there is much more to do. I hope the House will forgive me if I place my thanks on record, as securing that amendment has been a long, drawn-out battle across both Chambers. First, I congratulate Lord Hunt of Kingâ |