Medicines and Medical Devices Bill

Baroness Cumberlege Excerpts

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

[The Deputy Chairman of Committees (Lord Duncan of Springbank) (Con)]

I have received a single request to speak after the Minister, so I hope that we can now go to the noble Baroness, Lady Cumberlege.

[Baroness Cumberlege (Con) [V]]

No, that is a mistake. Somebody else involved with the conversation that I have been having thought that I wanted to come in on this occasion. I thought that I would give noble Lords a rest—they hear enough from me, so on this occasion I did not want to come in.

[The Deputy Chairman of Committees (Lord Duncan of Springbank) (Con)]

I thank the noble Baroness, Lady Cumberlege—that is very gracious. On that basis, we have nobody else to come in after the Minister at this point so I come directly to the noble Baroness, Lady Finlay of Llandaff.

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[Baroness Cumberlege (Con) [V]]

I put my name to Amendment 108 and, when listening again to the noble Lord, Lord Patel, and my noble and learned friend Lord Mackay of Clashfern, it was so good to hear this tremendous commitment to the safety of patients. The public must be paramount and know where there are issues, conflicts and risks. It seemed to me that if there really are concerns that a medical device, for instance, may pose a threat to safety, surely the public have a right to know?

We should have the right to make informed decisions about our healthcare, our treatment options and the medicines and medical devices available to us. Too often—we have heard this and written about it in the report, First Do No Harm—the healthcare system has shown itself to be unwilling, or even unable, to be transparent. There are too many examples of cases where people have had treatments or medical devices inserted without really being aware of the known safety concerns surrounding them. That is quite unacceptable.

My hope and expectation is that, once we have an independent patient safety commissioner—of course, we are coming on to that in the next amendment—these safety concerns will be more swiftly and thoroughly identified and communicated so that patients and the public know what is going on. I fully support the amendment. It would provide another layer of transparency and assurance, which is why I am very happy to support my noble and learned friend and the noble Lord, Lord Patel, who I consider my noble friend, on this amendment.

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Moved by

[Baroness Cumberlege]

117: After Clause 38, insert the following new Clause—
“Independent Patient Safety Commissioner
(1) An independent Patient Safety Commissioner is established.(2) The Office of Patient Safety is to be hosted and funded by the Cabinet Office.(3) The Patient Safety Commissioner must publish a business plan, reviewed annually, which sets out, in relation to the discharge of the Commissioner’s functions—(a) the Commissioner’s proposed main activities for the period covered by the plan (including the matters he or she intends to consider or investigate), and(b) the Commissioner’s proposed strategic priorities for that period.(4) The Patient Safety Commissioner must appoint an advisory board to provide the Commissioner with advice and assistance relating to the discharge of his or her functions, consisting of persons who (taken together) represent a broad range of interests which are relevant to the Patient Safety Commissioner’s functions, and must from time to time publish a report on the procedure followed and the criteria used when making appointments to the advisory board.(5) The Commissioner’s functions are to—(a) promote and improve patient safety with respect to the use of medicines and medical devices;(b) promote the views and interests of patients and other members of the public in relation to the safety of medicines and medical devices;(c) make recommendations to the Secretary of State;(d) establish and, when deemed appropriate, revise Principles of Better Patient Safety;(e) receive direct reports from patients and other members of the public, any other persons (whether natural or corporate), and the Secretary of State and, when the Commissioner deems appropriate, share those reports with relevant organisations and the Secretary of State;(f) produce and lay before Parliament for the attention of any committees of either House whose remit covers medicines and medical devices—(i) an Annual Report and Accounts, and(ii) any other reports regarding patient safety, which may include recommendations to improve patient safety with respect to the use of medicines and medical devices.(6) For the purposes of subsection (5)(d), the Principles of Better Patient Safety must—(a) describe expected patient safety outcomes relating to the safety of medicines and medical devices; and(b) be drafted in consultation with the public.(7) For the purposes of subsection (5)(f), the Commissioner may require a public body and other persons (whether natural or corporate) to provide such information as is reasonable in order to fulfil that function relating to the safety of medicines and medical devices.(8) In fulfilling his or her functions, the Commissioner may do anything which appears to be necessary or expedient for the purpose of, or in connection with, the performance of his or her functions.(9) The Commissioner has the duty to involve and inform patients and other members of the public in carrying out his or her functions.(10) The Commissioner may make recommendations to the Minister for the Cabinet Office for any additional powers which the Commissioner considers may be necessary to fulfil the duties and functions under this section.(11) The Minister for the Cabinet Office may by regulations make any other provision relating to the establishment of the Commissioner, including—(a) the appointment of a Commissioner,(b) the terms of office,(c) remuneration and financial and other assistance,(d) staff, and(e) any other matters the Minister for the Cabinet Office considers appropriate.(12) A statutory instrument containing regulations under this section may not be made unless a draft of the instrument has been laid before and approved by a resolution of each House of Parliament.”Member’s explanatory statement
This new clause would establish the Patient Safety Commissioner on a statutory basis, as recommended in the report of the Independent Medicines and Medical Devices Safety Review.

[Baroness Cumberlege (Con) [V]]

My Lords, this proposed new clause, which would implement one of the most important recommendations in our report, First Do No Harm, is about the independent patient safety commissioner. I am conscious that you cannot change history, but you can plan for the future; that is what we seek to do through the independent commissioner.

I thank noble Lords from all sides of the House who have put their names to this amendment, particularly the noble Baroness, Lady Jolly, and the noble Lords, Lord Hunt of Kings Heath and Lord Patel. I also thank the noble Lords who spoke in favour of the commissioner at Second Reading and have done so often since then.

Many people outside Parliament have also voiced their support. It really gladdens my heart, when we live in such troubled times, to have a rock-solid consensus. Of course, I await the response from my noble friend the Minister but I really do hope that he will choose not to stand apart but to be instrumental in improving safety and the lives of thousands of people by supporting this amendment, even if it requires a bit of redrafting.

I think that noble Lords will be grateful that I will not go through the amendment subsection by subsection, paragraph by paragraph, because that would take all night and it is all there for noble Lords to see. First, though, let me put a question. Why do we need this independent patient safety commissioner? It is quite simple: because there is no one person whose task it is to listen to the voices of patients, to stop the trends and patterns that give rise to safety concerns, and to encourage or require the healthcare system to act on those concerns when they are not being recognised and realised.

The healthcare system has failed to listen to patients’ concerns. Our review vividly and tragically illustrated that. Thousands of people have suffered. Lives have been ruined. I am absolutely convinced that, had we had a patient safety commissioner—that is, if that person had existed—much of the harm done could have been prevented.

It is not only what we found in our review that proves the need for this. Think of the recent Paterson inquiry. Its findings echoed ours, with patients voicing concern but their voices not being heard and avoidable harm going undetected. Sadly, we all know that there is a long line of similar examples; indeed, Essure, a contraceptive device that has caused many women terrible suffering, was reported on by the BBC last weekend.

We know our own bodies. We know when something is not right. We know when a treatment is causing a problem. We are the first to know, yet patient voices and experiences are all too often simply referred to as anecdotes and written off. They are not; they are serious research. We think that a patient safety commissioner would put an end to that—an end to anecdotes simply being written off.

There have been suggestions that existing organisations are already responsible for patient safety so we do not need another one. I want to tackle that fallacy head on. If it is true that organisations in the healthcare system are performing this task and doing it effectively, why has so much avoidable harm occurred?

The system simply is not working. Yes, the organisations within the healthcare system are doing their job; people are working very hard as individuals, and in the organisation, but they are disjointed and siloed, and patient safety is not their overriding purpose. They did not prevent the avoidable harm that we discovered. While some organisations have elements of safety within their remit, not one has patient safety as their total focus, and not one considers that they have the responsibility to listen, spot trends, raise concerns and get the system to act.

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[Lord Bethell (Con)]

I take the encouragement of the noble Baroness to heart. I would be very happy to think further on it. She makes a very good point: we know about the terrible incidents of the past and the very substantial responses that they had. I share with her the frustration that these problems continue to arise. For that reason, as I said, we are looking for a really thoughtful, considered response to the review overall. As I said in my earlier remarks, the case for a patient safety commissioner is one that we are looking at. I listened to absolutely everyone who has spoken in its advocacy, but we do not regard it as a silver bullet or a single point of catalysis, which I do not think the noble Baroness was alluding to. We are looking for a broad response to the review that would ultimately take on all the different points that the noble Baroness and her review team have made.

[Baroness Cumberlege (Con) [V]]

My Lords, I will come to the Minister’s summing up at the end, but I thank all noble Lords who have taken part in this debate. I have not heard anything really contrary or disturbing against a patient safety commissioner. It has been supported, and I am very grateful for that.

I first thank the noble Lords, Lord Patel and Lord Hunt of Kings Heath, and the noble Baroness, Lady Jolly. I know that the noble Lord, Lord Patel, has been a champion of safety both in Scotland and in this country. I share his impatience. He considered some of the interesting reports that have been produced and we hope that they all have made a little difference—but not enough. He is so right to say that we are searching for independence, as other noble Lords have mentioned. The person who we appoint to this position is so important. We do not want a patsy or someone who is just going to do what the department and Ministers want. We want an independent voice. I thank all those who also talked about a patient safety commissioner and the Children’s Commissioner, who, as we all said, has been outstanding. I also thank the noble Lord, Lord Patel, for his revealing statistics, which were interesting.

I understand the cynicism of the noble Lord, Lord Hunt of Kings Heath, about NHS England. I say just one thing about it, but I should have declared my interest at the start of the debate because I am employed by NHS England in the context of maternity services. The chief executive took our report, Better Births, and said, “I am giving you five years to implement it”. He gave us the people, resources and everything else. We were making real progress until March. The virus has really knocked us back—we did not expect it. However, in the four years that we have completed, we have changed much of the culture within maternity services and improved the lot of many women. We have not had that response from the Government on this report. They have not said, “We will give you five years and some resources. See what you can do”. No, they have been silent. Today, the Minister told us a bit about what he has been doing. However, none of that was news to us. We know all that already.

Moving on, I refer to what the noble Lord, Lord Hunt of Kings Heath, said about the tension within boards. I chaired the Brighton health authority board when the Grand Hotel was bombed. It was a tragedy—lives were lost—but when one looked at the whole system, it worked. Why was that? It was because we had a good leader in A&E who conducted a rehearsal three weeks before the bombing. That rehearsal paid off. Preparation is extremely important. The noble Lord was of course right about the financial problems that must be weighed up within trusts.

We are so lucky to have in our House my noble and learned friend Lord Mackay of Clashfern, a previous Lord Advocate and Lord Chancellor. I remember working with him on debates about the family and all sorts of matters. If you want somebody with true wisdom, understanding and foresight, you go to him. He has done it all, knows about it and always has such integrity. I thank him very much for his support and his impatience, which I share. We know today that babies are being born deformed. One in two have a chance of having a disabled child if they are on sodium valproate, and they do not know about it. We are impatient. We do not want to see more of that. We want to see safety become a reality.

My noble friend Lord O’Shaughnessy has, of course, been a Minister in the House and he knows the tensions and difficulties. One of the things that I know about him is that he listens to patients: he takes time out to do that. He appreciates, almost more than all of us, how people have waited for decades in terrible conditions, suffering terribly. I know that he has done a lot with sodium valproate and the patient groups there, and I thank him for that. What he was telling us about Jeremy Hunt and the way that this review was first commissioned was really helpful, because Jeremy Hunt set the parameters. He was invited to take on three different areas by the Prime Minister, Theresa May. It was really her initiative first, and then Jeremy worked extremely well. I am of course delighted that he appointed me to chair the team.

I want to say a word about the noble Lord, Lord Blunkett. I am very pleased that he is taking part in this Committee; he apologised for not being at Second Reading. Whenever he comes in on a debate, we welcome him. Again, with him having been a really strong leader in his own area and then in the Commons, it is really good to have had him join us today. He talked about the Health and Safety Executive and how we have to work with it. He is of course right.

The Minister, in his summing up, asked who this patient safety commissioner is going to work with. We do not know exactly—of course not. He can read the amendment, which sets out quite a lot. He can read the report and see there what we were thinking about, but of course this needs more work. In fact, one of the members of our team said to us, “Do not lose out on the coroners’ courts; you learn a lot from them”. Her husband is a judge, so she knows a bit about it. We are saying that you have to map the whole horizon and see where things are not quite right. Why is something going wrong? That is something we ought to look at more carefully.

It is about listening to patients but, much more than that, it is about working with all the different healthcare systems. My noble friend Lord Sheikh and others talked about the NHS. We are thinking much more broadly than the NHS. We are thinking about it, of course, and we know it has done a fantastic job with the coronavirus, but we are also thinking about private providers. I was very interested that the noble Baroness, Lady Masham, brought in private providers. We need to think about other public bodies and certainly about the royal colleges, the pharmaceutical and devices industries, the manufacturers and of course the policymakers—the politicians. I appreciate that it is a broad area but that is the problem with it at the moment: it is disjointed and siloed, it is unresponsive and defensive. We need some person who is going to get into all of that and call all the organisations to account—encourage them but call them to account when things are not working right.