Medicines and Medical Devices Bill

3rd reading & 3rd reading (Hansard) & 3rd reading (Hansard): House of Lords
Thursday 21st January 2021 Lords Chamber

Third Reading

13:31

Relevant documents: 19th and 33rd Reports from the Delegated Powers Committee, 10th Report from the Constitution Committee

Clause 17: Power to make regulations about medical devices

Amendment 1

Moved by

[Lord Sharkey]

1: Clause 17, page 12, line 4, leave out from “subject” to end of line 8 and insert “to the super-affirmative procedure set out in section 51”
Member’s explanatory statement
This amendment is to correct the drafting.

[Lord Sharkey (LD) [V]]

My Lords, Amendments 1 to 8, in my name and that of my noble friend Lady Jolly, are to correct drafting. None of them, individually or collectively, alters the meaning or substance of the parts of the Bill that they would amend. I beg to move Amendment 1.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)]

The noble Lord, Lord Sharkey, made his points cogently on Report. We do not intend to oppose the amendments on the Marshalled List, as they are technical tidying amendments, consequential on those in the name of the noble Lord, Lord Sharkey, that were passed on Report.

[Lord Sharkey (LD) [V]]

I am very grateful to the Minister.

Amendment 1 agreed.

Clause 21: Information systems

Amendment 2

Moved by

[Lord Sharkey]

2: Clause 21, page 14, line 21, leave out from “subject” to end of line 25 and insert “to the super-affirmative procedure set out in section 51”
Member’s explanatory statement
This amendment is to correct the drafting.

Amendment 2 agreed.

Clause 52: Super-affirmative procedure: Northern Ireland

Amendments 3 to 8

Moved by

[Lord Sharkey]

3: Clause 52, page 34, line 32, leave out “section 11(1), section 17(1) and section 21(1)” and insert “and section 11(1)”
Member’s explanatory statement
This amendment is to correct the drafting.

4: Clause 52, page 34, line 36, leave out “order” and insert “regulations”
Member’s explanatory statement
This amendment is to correct the drafting.

5: Clause 52, page 34, line 43, leave out “ an order” and insert “regulations”
Member’s explanatory statement
This amendment is to correct the drafting.

6: Clause 52, page 35, line 5, leave out “order in its initial form, or a revised draft order” and insert “regulations in their original form, or revised draft regulations”
Member’s explanatory statement
This amendment is to correct the drafting.

7: Clause 52, page 35, line 8, leave out “order”
Member’s explanatory statement
This amendment is to correct the drafting.

8: Clause 52, page 35, line 10, leave out “order”
Member’s explanatory statement
This amendment is to correct the drafting.

Amendments 3 to 8 agreed.

13:33

Motion

Moved by

[Lord Bethell]

That the Bill do now pass.

[Lord Bethell (Con)]

My Lords, the Bill before us is quite different from the one we started with, but it is no doubt much better. That is entirely because of the huge value of your Lordships’ challenge and scrutiny. We have held over 50 meetings and considered 249 amendments, and the result is a tribute to the care and patience of noble Lords, for which I give profound thanks. It is also, if I may say so, a tribute to the workings of the hybrid House, which have kept legislation moving under difficult circumstances.

We would not have reached this position without the thoughtful, collaborative and constructive input of noble Lords, to whom, I pay tribute—in particular, to the noble Baronesses, Lady Thornton and Lady Wheeler, on the Opposition Front Bench, together with the noble Lord, Lord Hunt, and the noble Baronesses, Lady Jolly and Lady Walmsley, and the noble Lord, Lord Sharkey, on the Liberal Democrat Benches. I also thank, from the Cross Benches, the noble Lords, Lord Patel and Lord Alton, and the noble Baroness, Lady Finlay. They have all brought their immense experience and wisdom to our debates, to improve this legislation. And when it comes to wisdom and experience, I must also pay tribute to those from these Benches, especially my noble friend Lord Lansley, my predecessor, my noble friend Lord O’Shaughnessy, and my noble and learned friend Lord Mackay of Clashfern, who have all been of enormous help in enabling us to arrive at a consensus across the House. My noble friend Lord Howe has been a generous mentor, and my noble friend Lady Penn is a superlative Whip, both shepherding the process charmingly, discreetly and effectively.

I thank most emphatically my noble friend Lady Cumberlege. She has spoken of the importance of compassion, of the voices she has listened to, and of the paramount importance of patient safety. I have heard her, and I support her endeavour. She has the support of the House in her efforts, and we have collectively made significant progress towards her admirable goal.

I also thank officials on the Bill team, particularly Alice Clouter, and those in my private office, particularly Tilly McEwan. They have all worked tirelessly and expertly. I cannot give thanks to all the other champions in the House who have made influential interventions, but I am definitely very grateful to them.

I cannot hide my excitement about the future. While the Bill process is near its conclusion, we are at the end of the beginning of an exciting new regulatory system—a system that protects patients and enables innovation. It is with that vision of the future, as well as my gratitude to all, that I beg to move.

[Baroness Thornton (Lab) [V]]

My Lords, at this stage of the Bill, we take a few moments to congratulate ourselves and thank those who have made it possible to get this far. First, I thank my own Bill team, who have worked so hard, particularly Rhian Copple in the Lords Opposition office, and my noble friends Lady Wheeler and Lord Hunt—and, indeed, my noble friend Lady Andrews and others, who popped up here and there to support us.

We should all congratulate ourselves because, despite the conditions in which we have worked this autumn and winter, we have managed to build effective communications which have made it possible to make considerable progress in improving the Bill in many ways, as the Minister said. I think we can say that we did our job, as the revising Chamber.

The fact that we ended up with only three Divisions on Report is a testimony to way in which the Minister, the noble Lord, Lord Bethell, his Whip, the noble Baroness, Lady Penn, and his adviser, the noble Earl, Lord Howe, and the very hard-working Bill team led by Alice Clouter, handled the Bill. They listened, they discussed, they considered and they revised, which is really all that one can ask. This is the Minister’s first Bill, and I congratulate him on leading his team and handling what is always a baptism of fire for any Minister.

I am delighted to agree with the Minister and say that we are sending back a very different, and much improved, Bill. We have managed to address many of the big-ticket items, ranging from data sharing to human tissue, and, ultimately, patient safety. I thank participants across the House. Like the Minister, I mention in particular the noble Lord, Lord Patel, the noble Baroness, Lady Jolly, the noble Lords, Lord Freyberg and Lord Clement-Jones, and the noble Baroness, Lady Cumberlege. I also thank everybody else who has taken part in the many discussions and given us the benefit of their wisdom, particularly the noble Lords, Lord Lansley and Lord O’Shaughnessy.

First Do No Harm paved the way for the creation of an independent patient safety commissioner, and I think that changed the way in which the Bill was handled, because it is now, as it should be, a patient safety Bill. For that, I really wish to congratulate the noble Baroness, Lady Cumberlege.

Finally, I want to thank the organisations who have given us their support and expertise, which is particularly important for those of us in opposition. I am very grateful to the DPRR and Constitution Committees for their insightful scrutiny, which sometimes is painful for the Government but is almost always helpful to us; the Lords Library; and, for us, the University of Birmingham, the British Dietetic Association, Advanced Accelerator Applications, the Association of British HealthTech Industries, Cancer Research UK and, in particular, the BMA. I am very grateful for the expert briefs that they have given us.

Stakeholder engagement will remain key for many years to come, for while the Bill will soon pass—as the Minister said—the task of creating a post-Brexit medicines and medical devices regulatory regime is far from finished. I look forward to working with stakeholders and the Minister to make sure that we move forward in the best possible fashion. We have given ourselves a good start.

[Baroness Jolly (LD) [V]]

My Lords, Bills come and go. This Bill started its life as one to tidy up regulatory issues to do with the new post-EU world. In 10 years’ time, the Medicines and Medical Devices Bill is one I may not list as one of the most important I have worked on; I hope that the forthcoming mental health Bill will fit that spot. If remembered at all, it will be for the introduction of a commissioner for patient safety, born out of the First Do No Harm report by the noble Baroness, Lady Cumberlege.

There will need to be changes in the House of Commons to make the Bill really fit for purpose. The Minister has indicated the Government’s intention to lay amendments, and I am grateful to him for involving Peers in that process. When does he anticipate Second Reading in the Commons?

As the Minister and the noble Baroness, Lady Thornton, said, many people make a Bill, and they do not all sit in the Chamber. In particular, I thank both the Minister and the noble Baroness, Lady Penn, for giving us time to talk to the Bill team and allow them to explain new government amendments. Of course, I should not forget the noble Baroness, Lady Thornton, and her team; the noble Lord, Lord Patel; my noble friend Lord Sharkey; staff in opposition offices; and others who certainly made the Bill better, turning it into a workable piece of primary legislation.

[Baroness Cumberlege (Con) [V]]

My Lords, I could not let this opportunity pass without expressing my gratitude to all those who have played such a vital part in drafting, scrutinising and improving this important Bill. I know that it will now return to the other place. I wish it a fair wind and hope that we will soon see it enacted.

Throughout, noble Lords from all sides of the House have, quite rightly, focused on using the Bill to strengthen patient safety. Safety is now threaded throughout the Bill. I do so welcome that; it is something that the noble Baronesses, Lady Thornton and Lady Jolly, have both just mentioned. We have enshrined a very important safety recommendation in the Bill: we will now have a proper database to record the medical devices that are used and on which we and patients will be able to track their outcomes and detect safety more quickly. I cannot overstate just how important that is. Without this data, the healthcare system has been flying blind.

I have been very touched by the kind and thoughtful expressions of support from so many noble Lords in general debates and, in particular, for my amendments, which were triggered by the recommendations in First Do No Harm. The report enshrined in me that, at every opportunity, we must be reminded that the NHS is run for the people and is paid for by the people. Right now, the NHS is demonstrating a total commitment to saving lives and defeating this deadly virus—a virus that, as it sweeps around the world, devastates lives, livelihoods, education, personal budgets and a national aspiration for a better world.

In the dark days of the Second World War, Beveridge was preparing for a better Britain. In these dark days, there is a need to make plans—not just to return to what was there before but to look forward to something better. I believe that the patient safety commissioner will provide something better and will improve patient safety and healthcare as a whole. I was thrilled that so many of your Lordships lent me their support in calling for this; I know that their voices made all the difference. I thank the Minister and the noble Baronesses, Lady Thornton and Lady Jolly, for their generous remarks today.

13:45

The new commissioner will certainly have a challenging task. We continue to get a flow of calls, letters and emails recounting lives devastated by hormone pregnancy tests, the risks of sodium valproate taken by pregnant women and the insertion of surgical mesh. Only this week, a woman wrote to me saying: “I was left devastated that I was never given the truth by my consultant. I have suffered incredible, irreparable harm since 2010 and have lost my loving intimacy with my husband. I suffer constant pain and am unable to walk too far. I am not able to enjoy the interaction with nine grand- children and, most of all, I do not feel like a female at all”. The patient safety commissioner will have to respond to these sorts of concerns rapidly—more rapidly than we found during our review. In doing so, the commissioner will prevent avoidable harm and, I am sure, save lives.

In my last amendment, concerning redress for patients unavoidably harmed, I was heartened by the Minister’s response. The Minster told us:

“We are moved by the stories; I am totally and utterly sympathetic to the situation that the patients affected by these conditions find themselves in on a day-to-day basis. They are still living through it today. I would like to regard myself as a compassionate person”.

We recognise that. He went on to say that

“it is not appropriate to make policy on this kind of matter through primary legislation”;—[Official Report, 14/1/21; col. 963.]

perhaps he is right on that. He also went on to tell us that work is under way. I just ask: what work? When will it be delivered? These injured women and their families need answers. They deserve justice and some redress—and, what is more, they need it now.

Although my amendment was not carried, my noble friend knows that I am not one to give up easily. Indeed, we have established a powerful all-party parliamentary group. Its purpose is to see the remaining recommendations in my report implemented. On Tuesday, the First Do No Harm APPG will meet to hear the Minister for Safety, Nadine Dorries, address the group. Of course, everybody is welcome to join.

In summing up, I reserve special thanks for my noble friends the Minister, Lady Penn and Lord Howe. They have been a formidable trio, guiding the Bill through and designing and tabling a lot of government amendments. I know that steering through important legislation and improving it with a pandemic raging all around has been a most demanding task. The Minister has risen to that challenge. He has chosen and shown endless patience with me personally; he has listened; and, above all, he has acted. I also know that he has been truly moved by the suffering he has heard about, as he said today, and that this has motivated him to act. I thank him very much.

I also thank the officials who, behind the scenes, have worked so very hard on the Bill, with endless meetings, conversations and negotiations—not least in bringing forward a whole range of government amendments. They are warned: no doubt we shall meet again for the raft of statutory instruments that will be before the House. But, actually, I look forward to that.

I consider this Bill a reforming Bill—perhaps a small step, not a great stride, but we must look on the bright side. I congratulate all noble Lords who put forward the other important amendments on medicines and medical devices that have been accepted by the Government, as we have just witnessed. With an independent patient safety commissioner, who will listen, especially to the patient groups and campaigners, put all patients first and fight for their causes, a significant change may arise. Out of Covid darkness, with the astonishing example set by NHS staff, I believe a better system will emerge.

In a time of war, Beveridge realised the aspirations of people had changed. In the time of Covid, they are changing now, and we have to acknowledge that patients and the public voice must be heard. If private enterprise can bring forward a vaccine in under a year, Ministers, parliamentarians, the department and the healthcare system should rise to the challenge of reform towards a totally patient-oriented service. That is what I believe is essential for the future of our country and our future health and well-being.

[Baroness McIntosh of Pickering (Con) [V]]

My Lords, I am delighted to follow my noble friend Lady Cumberlege; I pay fulsome tribute to her and the team that, through her leadership, produced the report, First Do No Harm, from which we see this Bill. I would like to join her and others in paying tribute to my noble friends Lord Bethell, Lady Penn and Lord Howe, who I had the honour to work with, as a humble bag carrier, in the other place.

In recalling my interest with the Dispensing Doctors’ Association, I would like to make one plea to the Minister as this Bill proceeds to the other place. For clinical trials and patient safety, which is the focus of the Bill, which I wholeheartedly support, we need to rely on patients making their data available and giving consent for it to be used for clinical purposes. During the passage of the Bill, I raised what has now been seen in Denmark—a huge reaction against patient data having been abused and used for commercial purposes against the wishes, and without the consent, of patients. Were that to happen here, it would detract from the fundamental good of this Bill and the wider public benefit to the NHS and future patients of sharing the clinical data that permeates this Bill. I urge the Minister, therefore, to look seriously at the practical question that remains of how patient consent will be obtained and confidentiality respected, particularly in meeting the requirements of clinical need. But I am delighted to have played even a small part in the passage of this Bill, and we look forward to its passage through the other place.

[Lord Patel (CB) [V]]

My Lords, I am delighted to have this opportunity to express my thanks to the Minister—the noble Lord, Lord Bethell—the noble Baroness, Lady Penn, and all the other noble Lords who have been taking part in this legislation, in particular those who spoke to and supported my amendments from all sides of the House.

Much has already been said about what we have achieved. I know that time is running short, so I will try and be brief. Of course I congratulate, first and foremost, the noble Baroness, Lady Cumberlege, for achieving what I had tried before—getting patient safety on statute. I did not have her tenacity or clout. So, many congratulations to her and, I believe, the commissioner for patient safety, who will make patient safety stronger in the whole of the health service.

I am very grateful to the Minister, the noble Lord, Lord Bethell, to the noble Baroness, Lady Penn, and to the noble Earl, Lord Howe, for the many meetings they arranged with us to hear our concerns and find solutions. I know it is a privilege for me to speak in person, but I hope all my colleagues on the Cross Benches—more than 12 of them—who took part in the Bill will feel I can speak on their behalf to thank Ministers and all other noble Lords.

I am also grateful to members of the Bill team, who were very helpful at the many meetings that the Minister arranged. And I am grateful to outsiders, in particular the University of Birmingham faculty of law, which worked very hard to produce the details of the legislation. Thank you all.

[Lord O’Shaughnessy (Con) [V]]

My Lords, there is not much more to say that has not already been said by other noble Lords. I just wanted to use this opportunity to thank and pay tribute to particular groups. The Bill team and private office, which have worked so hard to produce this legislation, are amazing in what they do and often unsung. It is important we recognise them.

Secondly, I thank those patients and patient groups who have provided so much moving information and testimony that has informed our work. After all, we serve them, and I hope and believe that we have served them through improving this Bill in this House in the way we have.

Thirdly, I pay particular tribute to my noble friend Lady Cumberlege. When I was in government and we commissioned her report, I could not have dreamed that she would have done such a thorough job and carried it with her customary tenacity, to the point where we have, on statute, the commitment to a patient safety commissioner. It is such an important step forward and it will make a massive difference to the lives of hundreds of thousands of people in this country. For that, we should all be proud of this step—and she in particular should be.

Finally, I thank the Minister—my noble friend Lord Bethell—the noble Baroness, Lady Penn, and the noble Earl, Lord Howe, but particularly the Minister; he has performed with absolute aplomb in the difficult 10 months since he became a Minister. He has so much on his plate, yet throughout this process he has listened, engaged and acted in a way that does him enormous credit, and I really want to pay tribute to him for everything he has done.

I share the Minister’s optimism that, having produced this Bill, we can produce a regulatory system for the UK outside Europe that is the envy of the world, that makes sure that every company, every charity and every researcher who wants to bring a transformative therapy into a health system will come to us because of what we are able to do and how we are able to bring them through into mainstream treatment, just as we are doing with vaccines and have done with the recovery trial. That is the template, and I look forward to working with my noble friends and other noble Lords to make that happen in the months to come.

[Lord Bethell (Con)]

My Lords, I am extremely touched by the kind words of noble Lords and pay tribute once again to the hard work of all those concerned. I look forward to the future—to, as my noble friend Lord O’Shaughnessy said, the opportunity for patient safety and innovation to be enhanced by this Bill. In that spirit, I beg to move.

Bill passed and returned to the Commons with amendments.

13:58

Sitting suspended.