Medicines and Medical Devices Bill

Baroness Cumberlege Excerpts

Committee stage & Committee: 7th sitting (Hansard) & Committee: 7th sitting (Hansard): House of Lords
Thursday 19th November 2020 Grand Committee

Moved by

[Baroness Cumberlege]

121: After Clause 38, insert the following new Clause—
“Independent medicines and medical devices safety review: task force for implementation
(1) Within three months of this Act being passed, the Secretary of State must appoint an independent task force.(2) The task force must—(a) have an independent Chair;(b) be accountable to an oversight governance board; and(c) include representatives of the Independent Medicines and Medical Devices Safety Review, published on 8 July 2020.(3) The task force’s functions are—(a) to deliver a timeline for the implementation in full of the recommendations of the Review in subsection (2)(c); and(b) to implement the recommendations of the Review in subsection (2)(c).(4) Once the task force has fulfilled the functions in subsection (3), it will cease to exist.”Member’s explanatory statement
This new clause would establish the task force whose role it would be to implement recommendations set out in the report of the Independent Medicines and Medical Devices Safety Review.

[Baroness Cumberlege (Con) [V]]

My Lords, as noble Lords are well aware, First Do No Harm, the report of my review, was published in July of this year. Our ninth and final recommendation was that the Government should set up a task force to implement the other recommendations and the many actions for improvement contained in the report. That task force has not been set up, and the Government remain silent on whether they will agree to do so and, indeed, on the report as a whole.

This proposed new clause would require the Secretary of State to set up a task force within three months of the Bill becoming law. I would much rather not find myself tabling it; I would much rather the Government saw the urgency and had already set up the task force, because it is designed to help the department and the wider healthcare system to do the thinking, to make sure we get the details right and to set out a pathway and a timeline for implementing the report’s recommendations.

I believe it must be a collaborative venture; it should involve not just the department and its arm’s-length buddies but also patients. It would be a missed opportunity were it not to include the representatives of my review, because we have the knowledge and the expertise, acquired over two and a half years of work. To inspire confidence among people who have suffered, it needs to be independently chaired and overseen by a government board.

We feel that the task force is the right way to approach the job of implementing the review’s recommendations. My noble friend the Minister may well tell us that the Bill is not the right place for this measure—that is as may be—in which case, if he were able to reassure me that the task force would be set up separately by the Government, as we envisage in this proposed new clause, and on a similar or shorter timescale, I would be more than satisfied.

These matters are pressing. Our recommendations need to be implemented if we are to help people who have suffered so much already, many of them for decades. We must try to prevent further avoidable harm to more patients and families in the future. The task force is the key to making this happen, and those of us who have run organisations know that they need some discipline and something like a task force—a body that will ensure that the task set out is actually implemented and that it happens. I beg to move this amendment, and I look forward to the Minister’s reply.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, it is a great pleasure to follow the noble Baroness, Lady Cumberlege, and to support what she is saying. At the heart of her argument is the concern that, although the Minister said earlier in Grand Committee that the Government are weighing it up with all “seriousness and intent”, the Government are not going to run with the core of the noble Baroness’s recommendations. Because the Government have been so reluctant—very unusually—to respond immediately to the thrust of her report, there remains a lot of uncertainty about how far the Government are prepared to implement it.

Of course, the opportunity given to us with the medicines Bill enables us really to press the Government to be more detailed about what they are going to do. On Tuesday, we had a very good debate on the recommendation for the appointment of a patient safety commissioner. The Minister made a very extensive response, which essentially set out the measures that the Government are taking to embed patient safety throughout the NHS. I shall just mention a few: promoting a positive learning culture at the heart of the NHS; taking steps to help staff to speak up when things go wrong; establishing the Healthcare Safety Investigation Branch to examine the more serious patient safety incidents and promote system-wide learning; appointing medical examiners to provide much-needed support to bereaved families and improve patient safety; introducing a duty of candour, so that hospitals tell patients if their safety has been compromised, and apologise; and commissioning the NHS national director of patient safety, Dr Aidan Fowler, to publish a strategy, which, of course, has been done.

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[The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)]

I do not believe that anyone wishes to come in after the Minister, so I call the noble Baroness, Lady Cumberlege.

[Baroness Cumberlege (Con) [V]]

I thank all those noble Lords who have spoken in this debate. I am extremely grateful to them. I have listened to what the Minister had to say, and I do not deny that meetings are taking place—I understand that they are—but I have no idea what is coming out of those meetings. But we will come to that in a minute.

The noble Lord, Lord Hunt, is quite right that actually implementing policy is the most critical thing and is extremely difficult. The Paterson report was a very interesting report on things that had gone terribly wrong with an individual surgeon who acted inappropriately, and, as I said when we debated the patient safety commissioner amendment on Tuesday, I understand that the Paterson report’s recommendations echo what our report said. What has happened to the Paterson recommendations? I do not believe that anything has happened. If things have happened, I would like to know what they are. I can show shelf upon shelf of wonderful reports that have been drawn together by people who have put their heart and soul into them, but, actually, nothing has happened. I am not going to let that happen with my report—I really am not—because there are too many people who have been so badly hurt and who deserve redress, which we will come on to in the next amendment. The noble Lord, Lord Hunt, is right that there is a missing piece in the jigsaw—the most important piece—because safety has to be a system.

--- Later in debate ---

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, this is a probing amendment. Although I am a member of the GMC board, I make it clear that I am not speaking on behalf of the GMC.

It is very difficult to move on to the nitty-gritty of a redress agency after the hugely eloquent and moving speech made just now by the noble Baroness, Lady Cumberlege. The Minister said in his response to the noble Baroness that this is not the Bill to respond to the report. What I say to him is that this is the only Bill in town. Medicines and medical devices are at the core of patient safety. He promised that the Minister responsible for patient safety would make a Statement on the report in December. My assumption is that that will be made after the Bill has passed through the House of Lords, and therein lies the problem: we will not be told the Government’s response before we come to the critical Report stage. We just have to work on the assumption that, as the noble Baroness, Lady Cumberlege, said, the Government are not going to embrace her core recommendations. We will therefore have to take action on Report on that basis. I do not see what other course of action the House of Lords can take, unless the Government are prepared to bring forward their Statement so that we can see it before we reach Report.

I have just one other point. I listened to the Minister, and he has been very helpful in setting out some of the initiatives that the Government are taking. However, as with the patient safety strategy—we have been here before—the department seems to have collected all the examples of good practice it can find, bunged them into a report and called it a strategy. That is the problem, because it ain’t a strategy. It does not address the fundamental crunch that the NHS has been run far too hot and is unsafe. When you really tackle that, you have to tackle the issues of resources, work force and targets. That is a huge challenge to the Government, which is why they are so reluctant to go down that course.

What does that have to do with the redress agency? I will try to come to that in a moment. However, I want to ask the Minister whether he can say anything about this recommendation. The noble Baroness, Lady Cumberlege, argued powerfully for a redress agency to be set up on an avoidable-harm basis that looks to systematic failings, rather than blaming individuals, encourages reporting and should provide faster resolution for claimants. She argues that it should be a consensual process rather than a judicial one. Redress would be offered, not awarded, and proceedings under the scheme would be voluntary. She also said that the redress agency would have an important role to play in harm prevention as claims for adverse events would be centralised, enabling data to be provided that would help regulators detect signals earlier.

This is not the first time that a redress scheme has been proposed. Indeed, 17 years ago, an NHS redress scheme was unveiled by the then Chief Medical Officer, Sir Liam Donaldson. It included no-fault compensation for babies born with severe brain damage, and payments of up to £30,000 without litigation for patients whose treatment went wrong. Under the scheme, parents would get a managed medical care package for their child, monthly payments for other care of up to £100,000 a year, lump sums for home adaptations and equipment of up to £50,000, and compensation for pain and suffering capped at £50,000. The other arm of the redress scheme, for smaller negligence claims, would have provided a package including an explanation and apology, remedial treatment, rehabilitation and care where needed and financial compensation up to £30,000 where authorised. Legislation followed in 2006, but 14 years later it has, as I understand it, yet to be implemented. The aim of the Act was to provide a genuine alternative to litigation, but it has languished on the statute book. I would be grateful if the Minister would tell me whether that is it and whether the Government do not think it the appropriate way forward.

I also ask the Minister to say something about the increase in negligence costs to the NHS. The latest annual report from NHS Resolution shows that the total cost of payments made in respect of clinical negligence in 2019-20 was £2.32 billion. Of that figure, a substantial amount was paid in legal costs: nearly £500 million to claimant legal costs and £143 million for NHS legal costs. We know that it often takes years for cases to be resolved.

Is the Minister confident that we are getting this right? Does the noble Baroness’s recommendation not deserve examination, at least? I beg to move.

[Baroness Cumberlege (Con) [V]]

My Lords, it is hard to follow the very well-researched contribution to this whole issue from the noble Lord, Lord Hunt. It was interesting to hear about Sir Liam Donaldson’s report, which got on to the statute book but was not implemented. Is that not a disgrace? It is really dreadful.

Very near to where I live is the centre for Chailey Heritage, now the Chailey Heritage Foundation, for children who suffered through their mothers having taken the drug thalidomide. I chaired its governing body for years. It is interesting that that redress system still continues; it is supported by a trust, which inherited the disaster of the medication, and it has honoured that and receives government support. So we have examples where this is working.

The redress agency that we recommend is really about the future. My amendment is about the present. We know that so many patients and their families have suffered such harm, and we need a system that is more compassionate and a much more certain route for obtaining redress to compensate them. We are talking not about compensation as such, but about redress. You have to go to the courts to achieve compensation, and it is a very miserable experience—we have heard that from patients. It also takes a very long time and, as the noble Lord, Lord Hunt, said, very often the people who benefit most are the lawyers.

We are talking about Primodos, sodium valproate and pelvic mesh—the three interventions through which people have suffered avoidable harm. The suffering they endure now is terrible. All three have caused and are causing avoidable psychological and, of course, physical and neurological harm. These families really need a little help with the conditions they are living with. Indeed, some are looking after some very disabled children. We do not believe that their needs are adequately met by the healthcare, social care or benefits systems. Some of these people are actually very elderly—the parents of the children who took Primodos. It would be a scandal if those people were to live their lives unable to access the redress they need and the outcome they deserve. After all, the harm was caused not by them, but by the state.

In the case of these three interventions, there is a moral and ethical responsibility to provide ex gratia payments in respect of the avoidable damage that occurred. That responsibility falls on the state and the manufacturers of the products in question. The schemes that would be established through this proposed new clause would provide discretionary payments, and each of the three schemes would have tailored eligibility criteria.

The payments the schemes make would not be intended to cover the cost of services that are already available free of charge, such as healthcare and social security payments. They would be for other needs—for example, the cost of travel to medical appointments. We have met and talked to many of those people, and they have said that it is a significant cost burden. The payments might be for respite breaks or emergency payments where a parent has had to stop work to cover care. These redress schemes would not be in place of litigation, nor will they be to deliver compensation. People should retain the right to take legal action if they wish to obtain compensation—of course they should; that is in our law. The schemes I am talking about should be set up in such a way that they can be incorporated into the wider redress agency that the noble Lord, Lord Hunt, spoke about, once it is established.

These people have suffered for decades. They have tried to obtain compensation through the courts. That action has failed in the case of valproate and Primodos, although I am aware that a new Primodos action is under way. I have been told by solicitors that, in fact, the report does not in any way affect that action. There have been some awards and settlements in the case of mesh, but legal action takes time, as the noble Lord, Lord Hunt, said. It creates added stress and much more personal cost can be involved.

I believe that a measure of a decent society is how well it looks after those who have suffered harm, especially when that harm was avoidable. From having met many hundreds of people who have suffered and heard from many more, I am clear that help is needed and deserved. People should not be made to wait any longer. I hope my noble friend the Minister will agree with that.

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, I shall speak to Amendments 122 and 123, to which I attached my name. The first is in the name of the noble Lord, Lord Hunt of Kings Heath, and the second in the name of the noble Baroness, Lady Cumberlege. They have both introduced these very clearly, so I will make only three points to add some extra, different perspectives.

The first point I wish to make is that there is what I can describe only as a heart-rending report in the Guardian today about Windrush compensation two years on. The headline talks about

“long waits and ‘abysmal’ payouts”.

The story mentions an agency that talks about five people waiting more than 18 months for compensation. If this—as high-profile a scandal as we can possibly imagine, which attracted far more attention than the issues covered by the report from the noble Baroness, Lady Cumberlege—is going so badly, surely we have to address this issue, which in many ways is smaller, more limited and perhaps much less complicated, to create a situation via Amendment 123 to deal with these three issues. Amendment 122 would create a situation to deal with all cases, so that we would have a system and framework that, I hope, would do better than the Home Office is doing. I hope that such an agency in the health framework would not suffer from the same hostile environment in the Home Office that the Windrush compensation scheme has to act within.