1: Before Clause 1, insert the following new Clause—
“PART A1THE COMMISSIONER FOR PATIENT SAFETYEstablishment and core duties etc
(1) The Secretary of State must appoint a Commissioner for Patient Safety (referred to in this Part as “the Commissioner”) to exercise the functions set out in this Part in relation to England.(2) The Commissioner’s core duties are to—(a) promote the safety of patients with regard to the use of medicines and medical devices, and(b) promote the importance of the views of patients and other members of the public in relation to the safety of medicines and medical devices.(3) The Commissioner is not to be regarded as the servant or agent of the Crown or as enjoying any status, immunity or privilege of the Crown.(4) Schedule (Further provision about the Commissioner for Patient Safety) makes further provision about the Commissioner.”Member’s explanatory statement
This amendment inserts a new Clause which provides for the creation and core duties of a Commissioner for Patient Safety in relation to medicines and medical devices in England. The new Clause and the Schedule which it introduces would form a new Part, to appear before Part 1.
My Lords, patient safety is very much at the heart of the Bill, and while we have an enormous amount to get through this afternoon, I beg the Chamber’s forbearance if I talk in some detail about this extremely important amendment. Patient safety is the golden thread that runs through this entire Bill. Safety has been our guiding force in amendments that have made it to the Bill, from the changes to decision-making on regulatory change and the new safety lock amendment—which we will debate later—to the enforcement powers for medical devices to make clearer what the MHRA can do to take action, through to the medical devices information system.
The Government have heard the calls, including the strong cross-party support, to establish an independent patient safety commissioner for the health service in England. Of course, this was the centrepiece recommendation of the Independent Medicines and Medical Devices Safety Review helmed by my noble friend Lady Cumberlege, to whom I pay profound tribute for her tireless championing on behalf of patients. I am delighted that Amendment 1 in my name—with which it is convenient to debate Amendments 54, 65, 70 to 72, 74, 86, 87, 91, 95 and 97—delivered upon that recommendation. These amendments provide for an independent advocate to champion the safety of patients. The patient safety commissioner will promote their interests and those of other members of the public in relation to the safety of medicines and medical devices.
We acknowledge that the patient’s voice can advance safe care and system improvements but that it needs to be strengthened, as explained in my noble friend’s review published six months ago. Listening to patients is central to preventing the kinds of issues which that review brought so clearly into focus. If we do not strive to listen to patients, their families and to staff, we limit our ability to learn from mistakes, be innovative and continually improve. I pay testament to the extensive listening and the passionate advocating by my noble friend, her supporters and all patient groups.
My Lords, I thank the Minister for his huge support throughout this whole process—all the times we have had to meet and I have met with his officials. I also thank him for the way in which he has so comprehensively introduced his amendment today. To be honest—“O ye of little faith!”—there were times when I thought the patient safety commissioner would not see the light of day. However, I underestimated my noble friend and thank him for agreeing to the concept and for bringing it to fruition with his officials.
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I am very much aware of the long hours and prodigious amount of work that has gone into this amendment. I and many others are truly grateful, not least of course to my fellow parliamentarians, who have been stalwart in their support, but perhaps more importantly to all the patients and their families, who have endured the most appalling experiences over very many decades, and who have fought hard to see this day dawn.
In the report of my review, I and my small team recognised that we did not need another regulator. Many of those parts of the NHS and the healthcare system have regulators, but we did not want another regulator—we have those in plenty. We wanted something —or rather someone—new, who would be pivotal to improving patients’ safety and to prevent avoidable harm in the future. My noble friend really understands that. We need a listener, an advocate and a person of standing, who would call the healthcare system to account when needed.
In my letter to the Secretary of State, I said that the new patient safety commissioner would be the golden thread that would tie our disjointed healthcare system together for the benefit of those who matter most—the patients. I know, having listened to the Minister on many occasions and this morning, that he fully understands that. I am therefore delighted and grateful, and I thank the Government for having listened and agreed with me and my team. This new clause and the new schedule are so wonderful to see. I cannot thank my noble friend enough for his personal commitment to making this all happen. As I have said, I know a whole team has worked very hard alongside him, including other Ministers and of course his officials. I thank all of them from the bottom of my heart.
The Government’s amendments reflect crucial elements set out in our report: for example, the need for the patient safety commissioner to be independent. I hear what the Minister has said today, but we still need some reassurance on that. The patient safety commissioner cannot work or be effective if he or she is not independent. We are also very pleased that the patient safety principles underpin the commissioner’s work—that has been set out very clearly today and on other occasions—and of course, always, that patients will be closely involved in all that work. There is also an obligation on the system to respond to and co-operate with the commissioner. That is absolutely critical and is now in statute, and I thank those who enabled that to happen.
Having met so many people who have suffered avoidable harm and listened to their concerns, I know that the creation of a patient safety commissioner will mean a huge amount to them. One thing we heard so often from many them was the phrase, “Please don’t let this happen to anyone else”, a selfless plea that we should act to stop harm happening to other people in the future. Today, we are doing that. The patient safety commissioner him or herself will do just that, and I hope that will at least bring some peace of mind to those who are suffering now.
As my noble friend is aware, I have three points on which I would welcome some further reassurance. First, the importance of the role dictates that we must act as swiftly as possible to establish this role and this person in their job. The Government must of course have a credible selection process. I understand and welcome that; however, I know that my noble friend appreciates the urgency and there will be considerable pressure from patient groups and parliamentarians if we do not act at speed. This is not the time to dally. We must not risk losing the trust placed in us to get this person in post, up and running.
It is unclear to me whether the appointment of the patient safety commissioner will be independent of, and separate from, the much broader and lengthier public consultation and making of regulations. These regulations may determine some of the commissioner’s terms of office and how that person should operate. In my view, it is imperative that the two are kept separate—not least because this will facilitate the early appointment of the commissioner, who can then properly influence and shape those regulations. There is a precedent for this with the appointment of the designate domestic abuse commissioner. I see no reason for delay and would welcome my noble friend’s assurance that this appointment will be made with express urgency. I am sure the Minister will agree that we want a high-speed train, not a rumbling steam engine.
My second point concerns the definition of “relevant persons”. As I understand it, “relevant persons” will include healthcare providers in England and bodies exercising public functions relating to medicines and medical devices, but I am concerned that that does not go far enough. Other public bodies may have relevant information that could and should usefully inform the commissioner’s signal detection activities—opportunities to look wider than the norm and to scan the horizon. I include in this group, for example, the coroners’ courts, where cause of death may be found to be attributable to a medicine or medical device. I should be grateful if my noble friend could clarify whether the phrase “relevant persons” may include any public body that has information relevant to the duties of the patient safety commissioner.
I am also concerned about information of relevance to the commissioner that is held by manufacturers of medicines and medical devices. I know from my review that not all information from clinical trials, in particular, is published and shared with regulators. I should be grateful if my noble friend could reassure me that manufacturers will be required to share information and co-operate with the commissioner. Does he agree that it would be appropriate to place a duty to co-operate with the commissioner on manufacturers as a condition of selling to the UK market?
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Patient safety is a system-wide concern. It cannot be tackled by a single individual but needs to be rooted in all the branches of our health system. Good progress has been made: for example, we are improving system-wide learning through measures such as the Healthcare Safety Investigation Branch and the implementation of the 2019 NHS Patient Safety Strategy with our National Director of Patient Safety, Dr Aidan Fowler, in charge. That strategy has been listening to patients.
Staff are also encouraged and protected to speak up if they have concerns about anything they believe is harming the services their organisations deliver or commission. They are supported by the NHS People Plan, which envisages a health service that is compassionate and inclusive, not hierarchical, and where staff are listened to. The Government’s emphasis on patient safety will also be reinforced by the establishment of a new patient safety programme board. The board will take an overview—with pace and rigour—of measures and actions across the health system to improve patient safety.
The Government fully support sharpening our focus on the safety of NHS-funded services to patients and the public. We accept that the patient safety system needs to get better at identifying issues and listening to patients’ experiences of avoidable harm. Better co-ordination across and between regulators and other oversight bodies is also needed.
A patient safety commissioner will help us to champion the views of people who have been harmed by treatments provided by the health service. He or she would reinforce a culture of humility, openness and learning. The role is essentially about prioritising the insights of patients as a vital source of learning.
The Government’s amendment puts this new part of the Bill first. Amendment 1 provides for the appointment by the Secretary of State of a patient safety commissioner who is an independent statutory officeholder funded by the Department of Health and Social Care. It sets out the commissioner’s core duties, which are to promote both the safety of patients and the importance of ensuring that they are heard.
Patient engagement will be integral to the role of the commissioner. Proposed new Schedule A1 outlines the ways in which the commissioner must inform, consult and involve patients. This will ensure that patients’ concerns are being heard and that the work of the commissioner has focus and relevance for the people he or she is being set up to serve.
We have reflected carefully on the patient safety commissioner model set out by my noble friend’s comprehensive report. We agree on the importance of the commissioner’s role; it is a critical new part of the map of patient safety. But there are other areas of significant importance to the Government. The commissioner is one part of the whole system—the fundamental change that it required to tackle unsafe care and empower patients. A step change is required in how the health service transforms itself in a joined-up way to put patient safety at its core. Significantly, the introduction of the commissioner should not create overlap or confusion within that health service architecture, thereby reducing the potential to deliver patient safety improvements for patients. Indeed, my noble friend’s report rightly made it clear that the duplication of the roles of other regulatory bodies should be avoided.
In view of this, the patient safety commissioner will not act as an ombudsman. He or she will not carry out functions in pursuit of specific cases. But they can consider individual cases in their role as an overarching advocate for all patients and of making thematic and systemic recommendations. These areas are where we believe the commissioner can have greatest impact.
We have also given the patient safety commissioner deliberately intrusive powers, as called for by my noble friend Lady Cumberlege. He or she will be empowered to request and share information from relevant public authorities or a “relevant person”, meaning anyone providing health care, in relation to medicines and medical devices in England. The commissioner’s ambit will cover both the public and the independent sector.
Where my noble friend and I differ is on the process of the appointment and sponsorship of the commissioner. The patient safety commissioner will be appointed by the Secretary of State for Health and Social Care and funded by the Department of Health and Social Care. It is absolutely right that this should be the case. For example, the Secretary of State is able to initiate action on reports and understands, and has strategic oversight of, the system the commissioner is looking at.
Some noble Lords have expressed concerns about how such a commissioner might maintain their independence, but I believe that such concerns are unfounded. I am encouraged by the precedent of the Office of the Children’s Commissioner, which drew praise from several noble Lords in Grand Committee for its independence. As noble Lords know, the Children’s Commissioner is sponsored by the Department for Education and guards its independence very well. The Victims’ Commissioner does exactly the same and is sponsored by the Ministry of Justice.
It is critical—that is agreed—that the patient safety commissioner is able to speak out without fear or favour. He or she must have the powers and functions to act independently to maximise their impact and confidence. That is absolutely the case here. It is also critical that the right calibre individual with a strong voice for patients is appointed to the role. I do not think any such person would accept such a role if they felt they would in any way be constrained in that role. Nor do I think they would remain silent. Furthermore, we would expect the Secretary of State to work with the commissioner to establish how they will safe- guard and secure the commissioner’s independence. Independence is not static but an active objective, which we would expect the patient safety commissioner to be prepared to approach continuously.
The commissioner will have the power to make reports to both the public sector and independent sector, and to the Department of Health and Social Care if they so wish. Those reports are entirely independent. There is no intention—and indeed no restriction—that would allow for the Secretary of State to edit those reports. As an independent public appointee, the commissioner will also be subject to the scrutiny of Parliament, including through the Health and Social Care Select Committee.
The powers in the Bill are accompanied by a regulation-making power about the terms of office of the patient safety commissioner, the appointment of staff, and other operational matters. But while this power is exercised by the Secretary of State, we are not proposing that the Secretary of State would have any power over the commissioner regarding the fulfilment of his or her functions. However, it is right that the detail is left to regulations so that we can publicly consult on this, as we are obliged to do so under Clause 45. It is important that we get the details right. That is also why the regulations will be subject to the draft affirmative procedure.
Other amendments make minor changes to ensure that the patient safety commissioner clauses work well with the rest of the Bill.
From the First Do No Harm report by my noble friend Lady Cumberlege, to earlier, well-known inquiries and investigations, we have heard numerous harrowing stories with terrible examples of how patients have been let down badly by our most loved institutions. As noble Lords have said, now is the time to act. The Government have listened to the impassioned and compelling arguments from all sides, and I thank my esteemed colleagues for their help in shaping this amendment.
We have no doubt that restoring patient trust will be at the heart of the patient safety commissioner’s role and that he or she will advance patient safety. Our commitment to amplifying and acting on the voices of patients in our health service is paramount. To that end, I beg to move.