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?
In evidence to the review, Professor Carl Heneghan repeated a question:
“Is the whole system commercially conflicted? Yes it is”,
he replied. In last week’s BMJ, Sir Cyril Chantler, vice-chairman to the review, recalled that a
“constant voice across the country was of patients telling us they felt the mesh had been commercially promoted and doctors were receiving benefits from companies prescribing it.”
Does the Minister 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?
My third point concerns the following phrase in paragraph 3(3) of the Schedule:
“A relevant person must, so far as reasonably practicable, comply with a request by the Commissioner to provide information within such period as the Commissioner may reasonably require.”
It is those five words—
“so far as reasonably practicable”—
that provide the reluctant person or organisation a get-out, not to co-operate with the commissioner. I am concerned that the words
“so far as reasonably practicable”
provide too much wriggle-room to the organisation from which the patient safety commissioner has requested information. The Freedom of Information Act requires the holder of the information to reply within 20 working days. I am not requesting anything so specific, but simply that we should not give the holder of information an opportunity to evade their responsibility when the words of the schedule require the commissioner to be reasonable in his or her request. There should be parity on that.
The commissioner must be in control. As currently drafted, it rests on the commissioner to have to challenge the relevant person’s reason for noncompliance. This could be a crucial waste of time if the information could prevent serious harm. I appreciate that the phrase exists elsewhere in legislation and its use here is not considered unusual. It is said that the commissioner should go to the lengths of naming and shaming. I do not think naming and shaming is a good solution. It is a distraction, a further waste of time and requires publicity and input from the media, which be against the commissioner’s whole raison d’être and what he or she is trying to do.
I add finally on this that those of us who were, or are employers, marvel at the fertile imagination of individuals and organisations intent on hiding some inconvenient truth, and we came across a lot of that in our review. Timely information is so important. It is crucial, because information is power, and we should not encourage a get-out in the schedule for those who still wish to hide things. It is a very small ask, but I should be grateful if my noble friend would consider omitting just those five words from the schedule prior to Third Reading.
In conclusion, it strikes me that one of the qualities of good government and good leadership, as in so many walks of life, is the willingness to listen. As we found during the review, that is not something that the healthcare system does well. When we listened to the women, they said, without fail, “Thank you for listening. You are the first people who really have listened”. This time, the Government have listened and, above all, acted. They have been inordinately patient with me and have listened to me and to my team and, more importantly, to so many people who have suffered and who want there to be a patient safety commissioner. I am truly grateful.
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