Medicines and Medical Devices Bill

Baroness Cumberlege Excerpts

Report stage & Report: 2nd sitting (Hansard) & Report: 2nd sitting (Hansard): House of Lords
Thursday 14th January 2021 Lords Chamber

[Baroness Masham of Ilton (CB) [V]]

My Lords, I am speaking on the telephone, as something went wrong with my iPad.

I support Amendment 16, which is tackles anti-vaccination disinformation. For some years, this has created a problem. For example, there has been an epidemic of measles in many countries because many people, including the growing number of vegans, mistrust vaccines. Clear messages should go out about the benefits of vaccines and how they work. Some vaccines are very complicated and difficult to develop, but they are desperately needed for diseases such as HIV, TB and malaria.

Regarding these important coronavirus vaccines, I hope that the Government will be very careful that disinformation is not going out to the public about the Pfizer vaccine. Many health workers and elderly vulnerable people have had one dose, and the second dose should be given in three weeks’ time. People have signed up to that, as there are written instructions to do so, but the Government are trying to delay the second dose by up to three months, which is not recommended by Pfizer-BioNTech or the regulator.

There is a risk that with only one dose, people may become carriers and the virus may become resistant to the vaccine. The Doctors’ Association is not happy about the Government’s idea of a three-month delay. More careful monitoring and research is needed, but these mixed messages are extremely unhelpful. I hope that the Government will realise that people need to trust the information they receive.

[Baroness Cumberlege (Con) [V]]

My Lords, I congratulate the noble Baroness, Lady Thornton, on her comprehensive introduction, expressing the urgency of the situation, which was also stressed by the noble Baroness, Lady Masham, in another interesting contribution for which I thank her. This is a difficult and hugely important issue, and it needs serious consideration on two counts. We have to look beyond the present situation with anti-vaccine campaigners and decide very carefully what is information and how we should combat damaging information being spread. Secondly, how do we reserve the right of the individual to use social media to express their personal views?

I spent six years on the Press Council, dealing with complaints. It was taxing, but today the print media is regulated to a greater extent. Even then, accountability for what should be published and what should not lay with not only the journalist who had written the article but with the editor and, in some newspapers, the owner.

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

My Lords, I am delighted to follow my noble friend, who speaks with such great authority both as a former Secretary of State for Health and as someone who has followed the Trade Bill and the Trade (Disclosure of Information) Act so closely.

At the risk of dancing on the head of a pin, the amendments in this group are quite close, and the Minister set out every reason why we should support his Amendment 17. He said that information would be shared only in the circumstances where there is perceived to be a public need. The amendments and explanatory statement of the noble Baroness, Lady Thornton, refine that by saying that, in the context of giving effect to an international agreement or arrangement concerning the regulation of human medicines, it should be disclosed only provided that it is in the public interest to do so. A number of noble Lords have spoken with great eloquence and passion on these issues, including the noble Lords, Lord Patel, Lord Clement-Jones and Lord Freyberg, and my noble friend Lord Lansley. I have to say that I personally would draw the line at disclosing information for a commercial need as opposed to a public one.

I have a particular question about Amendment 19, which clearly states that patient information cannot be disclosed where the patient could be identified and that that information cannot be given without their consent. I remember that I was once asked to participate in a study; I signed the form and was delighted to do so, and never heard any more about it. I would just like to know how Amendment 19 would work in practice. At what point, and by whom, would the patient be contacted if that information was about to be disclosed and their consent sought?

I have reservations about this group. I remember the important debate that we had on the Trade Bill in this regard, and I am delighted to see that those issues are being considered in the context of this Bill as well. I have two concerns that I hope can be allayed. The first is that public need should not be deemed to collude with commercial need where it might not be in the interests of the patient. The second is about informed consent: how will the patient be consulted within the provisions of Amendment 19?

[Baroness Cumberlege (Con) [V]]

My Lords, this has been an interesting and well-informed debate, and I am quite reluctant to enter into it. I support government Amendment 19 and particularly Amendment 20 tabled by the noble Lord, Lord Clement-Jones. I hope I have got this right, although I am very happy to be put right if I have not. As I understand it, Amendments 19 to 25 concern consent, relating very specifically to the disclosure of information in accordance with international agreements. This is information that I think a relevant authority such as the MHRA holds in connection with human medicines.

As I listened to the noble Lord, Lord Freyberg, he raised a question in my mind about devices. We know that pharmaceuticals are much more closely regulated than devices have been, so can the Minister tell us a bit more about instances where there is a comparable agreement, and perhaps an amendment, for medical devices? I want to know whether they are on all fours with pharmaceuticals. I suspect not. Having listened to the noble Lord, Lord Freyberg, I think that there is more to hear on this.

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

My Lords, I want to come back to the debate on clinical negligence and the recommendation made by the noble Baroness, Lady Cumberlege, in her report for a redress agency. I declare my interest as a member of the GMC board.

We have reached a very serious position, with an exponential rise in clinical negligence costs. Twenty years ago, contingent liability was £3.9 billion; it is now £83 billion. Even allowing for inflation, I hardly think that we have become 20 times more negligent over that period. Indeed, the Minister, Nadine Dorries, told the House of Commons in a Written Answer last November:

“The continued rises in clinical negligence costs are eating into resources available for front-line care”.


It is not delivering for patients and their families, either. There are huge delays in getting cases settled and huge lawyers’ fees, in a quite remarkable situation where the NHS ends up paying damages in 80% of litigated clinical negligence claims. There is something wrong in the way we deal with these cases.

There have been endless reviews over the past 20 years, but precious little has happened. Seventeen years ago, an NHS redress scheme was unveiled by the then Chief Medical Officer, Sir Liam Donaldson. Legislation followed in 2006 but, 14 years later, it has yet to be implemented—and I doubt it ever will be. Since then, there has been much debate about the sustainability of Section 2(4) of the 1948 Law Reform (Personal Injuries) Act, which essentially promotes increased costs because it provides that

“there shall be disregarded, in determining the reasonableness of any expenses, the possibility of avoiding those expenses or part of them by taking advantage of facilities available under”

the NHS. In other words, the NHS tends to pay twice.

In 2017, the department and the Ministry of Justice commissioned the independent Civil Justice Council to draw up a new claims handling process for clinical negligence claims of up to £25,000, together with proposals for fixed recoverable costs for these cases. The report was published, with recommendations, in October 2019. Since then, there has been silence.

In that context, the noble Baroness, Lady Cumberlege, argued in her report First Do No Harm for a redress agency to be set up on an avoidable harm basis, which looks to systematic failings rather than blaming individuals. This, she thought, would encourage reporting and provide faster resolution for claimants. She argued that this

“would provide a standing structure to administer decisions using a non-adversarial process. This model is simple for patients to access as there is one point of contact. This structure enables flexibility to adapt and respond to situations as they arise.”

The proposed scheme of the noble Baroness, Lady Cumberlege, is well intentioned and has popular appeal. I recognise that details need to be spelled out in relation to eligibility, qualifying criteria or conditions of entitlement for her proposed redress scheme. Of course, causality is at the heart of any consideration of patient safety remedy. Causation is at the heart of tort. The Vaccine Damage Payments Act 1979 is limited to persons disabled as a result of vaccination. Even the NHS Redress Act 2006, to which have just referred, is concerned with arrangements for redress in relation to liability in tort. The noble Baroness’s approach is of course quite different from that.

The noble Baroness the Minister in Committee was not enthusiastic. In the past 48 hours we have heard the Government’s response that they have,

“no current plans to establish a redress agency”,

as set out in the recommendations of the noble Baroness, Lady Cumberlege. The reply went on to say:

“The government and industry have previously established redress schemes without the need for an additional agency.”


Well, that is a rather disappointing dismissal and misses the point, because the noble Baroness was essentially calling for a wholesale reform of the current clinical negligence system. I urge the Minister to reconsider this matter.

Can we really go on with the exponential rise in costs to the NHS—a system in which it loses 80% of cases that reach the courts, and where huge delays take place in patients getting access to an outcome? The system is completely bust. We need a new one and I hope that the Minister will, with his colleagues, consider what action needs to be taken to improve the current situation. I beg to move.

[Baroness Cumberlege (Con) [V]]

My Lords, I warmly thank the noble Lord, Lord Hunt. His determination is awe-inspiring. I am so pleased that he has not left this issue mouldering on the Committee Floor but has picked it up again.

I understand what the noble Lord said about the Government not being enthusiastic. However, I have known other issues on which the Government have been less than enthusiastic. It is the way in which we put forward persuasive arguments—although setting up this agency will take a lot of work, with a lot of detail to be considered. However, other schemes have been successful. I think about the one in my area—thalidomide. That trust is still running and getting redress for people who need it. So I strongly support the amendment of the noble Lord, Lord Hunt.

In our review, we tried to achieve a very simple and accessible structure for patients through the proposed redress agency. In an update on our recommendations, the Minister in the House of Commons, Nadine Dorries, said that the Department of Health and Social Care had delivered ex-gratia payments with individual schemes without the need for a redress agency. Indeed it has.

There are four or five schemes for infected blood alone, with eligibility based on whether the patient was a haemophiliac with HIV; a haemophiliac with hepatitis C; a non-haemophiliac with HIV; or a non-haemophiliac with hepatitis C. These different schemes addressed what type of payment should be awarded according to the patient’s need. What we—I am talking about my team and I—were advocating is a single point of contact for avoidably harmed patients. We felt very strongly that they had suffered enough without the necessity of finding out how to access the schemes that are relevant to them. The noble Lord, Lord Hunt, has said that something is wrong. He is right: it is wrong. This is not the way to help people who have been seriously harmed.

The problem is that, without a redress agency, each ex gratia scheme starts from scratch, which we felt was grossly inefficient. We need a standing administrative structure, funded by contributions from manufacturers and the state—both have a responsibility. At the moment, litigation is the only route, as the noble Lord, Lord Hunt, has said, for injured people to get serious compensation. We know that the process is very damaging to people. They do not like going to court, they do not like having to put forward all the information that is absolutely necessary—and sometimes not so necessary—and they do not like the fact that it is an adversarial system. We felt that the redress agency could remove the need for adversarial litigation that focuses on blaming individual doctors and nurses. The agency would be non-adversarial and would look at the systems failings that led to avoidable harm. This would help develop an open culture in healthcare and facilitate learning—we are not good at that. We know that the same mistakes happen over and again, and we felt that this was another tool to ensure that there would be much less of that.

Gathering information in one place—the agency—would make it so much easier to learn from the data that is collected and would strengthen the ability of the healthcare system to learn from the mistakes made. We have only to look at the cost of litigation of some £83 billion a year—I was very interested in what the noble Lord, Lord Hunt, said. We know that, often, the majority of those costs go to the law firms, not the individuals who have suffered so grievously. We felt that it would be much better if those huge sums of money, which are much needed by the NHS, should be used with a redress agency, which would have other advantages, as I have just outlined. A stand-alone agency, with a single entry point, would be a much better and more cost-effective way to award redress to those who suffer such avoidable harm—and many of them suffer for decades.

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

My Lords, it is again my great pleasure to follow the noble Baroness, Lady Cumberlege, and the noble Lord, Lord Hunt of Kings Heath. I am pleased to attach my name to Amendment 67 in the name of the noble Lord.

I do not think the noble Baroness, Lady Cumberlege, will mind if I explain why I am coming in on Amendments 67 and 68 in particular. It is because I was in a meeting and asked her what her next priority would be after the broad achievement of the patient safety commissioner. She said that the redress agency was in her mind as the next priority, which is why I have chosen to make it a priority in this Bill, in which I have become considerably more involved than I was originally expecting.

Like the noble Lord, Lord Hunt, did, I have to describe the Government’s response to the noble Baroness’s review as very disappointing. Simply very curtly saying:

“The Government and industry have previously established redress schemes without the need for an additional agency”


really does not engage with the arguments put by the noble Baroness in her report or reflect the strong support seen in the British Medical Journal editorial on 20 August, which expressed growing support for the entire review but particularly for the idea of a redress agency.

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Moved by

[Baroness Cumberlege]

68: After Clause 40, insert the following new Clause—
“Redress schemes
The Secretary of State must, by the end of the period of three months beginning with the day on which this Act is passed, bring proposals before Parliament to establish redress schemes for those avoidably harmed by—(a) hormone pregnancy tests,(b) sodium valproate, and(c) pelvic mesh.” Member’s explanatory statement
This new Clause would require the Secretary of State to create redress schemes for those who have already suffered avoidable harm related to the medicines and medical devices specified in the new Clause, and would thus implement one of the recommendations made in the report of the Independent Medicines and Medical Devices Safety Review.

[Baroness Cumberlege (Con) [V]]

My Lords, it is interesting that these two amendments reflect each other, but I wanted them to be separate. The debate that we have had on the agency has been really interesting.

The noble Lord, Lord Hunt, has just talked about a further review of the whole system, which probably needs doing, but I am dealing all the time—through emails, letters and phone calls—with people who are suffering now. Rather than wait for a really good scheme, which I hope a redress agency would be, I feel that we should be compassionate and really understand how people are suffering today. They will suffer tomorrow. They have suffered for decades. It is time that they had some redress to help them in the very difficult and complicated lives that they lead, with huge suffering. It is not just the individual: it is the family and it is the children, especially with sodium valproate. One must think of the home. It is therefore important for society that we as a Government understand and are happy to supply some redress now.

I thank my noble friend Lord O’Shaughnessy, the noble Lord, Lord Hunt, and the noble Baroness, Lady Bennett, who have put their names to this amendment. I look forward very much to hearing what they have to say.

In the two and a half years that we spent travelling the country, listening to tragic stories from women and their families, there was absolutely no doubt in our minds that avoidable harm had been inflicted on those who openly, honestly and with great dignity told us their life stories. I have frequently mentioned what they and their families have told us, but I will spare your Lordships on this occasion because I do not need to reiterate it. Your Lordships know what we found. It is all in our report, First Do No Harm, if you want to dig a bit deeper. Hormone pregnancy tests, sodium valproate and surgical mesh are three interventions that have caused avoidable psychological harm in some patients. It is also clear that surgical mesh has caused significant physical harm and that sodium valproate has caused physical and neurodevelopmental harm.

Having listened to these ruined lives, we believe that the state and manufacturers have an ethical responsibility to provide discretionary payments to those who have experienced avoidable damage in these three interventions. Each of them should have its own scheme and tailored eligibility criteria. When we have, as I hope we will, a redress agency, these schemes can be subsumed into the agency.

I make it clear that these payments are not intended to cover the costs of services that are already available free of charge. I am thinking of healthcare and social security payments, and in some cases education for children. This is rather for other needs, which could include things such as travel to medical appointments—we have heard a lot about the costs of that—respite breaks or emergency payments, when a parent has had to stop working to cover the care needed for that child or members of the family.

Patients have waited far too long for redress, some for decades, and any scheme must be set up promptly, as soon as possible. However, it should be structured so that it can be incorporated into the redress agency in future. Individuals who obtain compensation through litigation or out-of-court settlements—and we have heard of some, particularly from Johnson & Johnson and the Scottish pelvic mesh settlement—will not need recourse to these schemes. It is over and above what is already supplied by the state or is totally inadequate. So we are not setting a precedent: ex gratia payments have made by the Government to those suffering from infected blood, for example, as I mentioned in the last debate, as well as variant CJD and other areas, where treatments have caused avoidable damage.

In responding to the report’s recommendations, the Patient Safety Minister, Nadine Dorries, said that our recommendation that these schemes should be established is still under consideration. I am very heartened by her words, which give me—and, much more importantly, those who are suffering—cause for hope that the Government will do the right thing.

I ask my compassionate and noble friend the Minister if he could give us more information on this. If it has not been ruled out of court, can he tell us what plans are made to ensure that these schemes become a reality, and very soon, because they are much needed? I beg to move.

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

My Lords, I shall be brief, since I am following the powerful case put by the noble Baroness, Lady Cumberlege, for Amendment 68, to which I am pleased to attach my name, along with the noble Lords, Lord O’Shaughnessy and Lord Hunt. This is not a lesser amendment than Amendment 67 but a more limited one. As the noble Baroness said, agreeing Amendment 68 would not stop Amendment 67 from happening in future. The scheme for each individual could be rolled into a broader redress agency. I join her in welcoming the initial response to her report from the Government, which says that proposals such as that in Amendment 68 remain under consideration.

The case has been made—and I am not sure that I am allowed to do this post Brexit, but I note that in France the Government already pay into a fund for valproate damage. There are other cases around the world which reflect what already happens in other instances of medical disasters that have been acknowledged.

I commend the amendment to your Lordships’ House. I do not think that we will be pressing it to a vote tonight, but I hope that the consideration that the Government continue to give will turn into action very soon.

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[Lord Bethell (Con)]

My Lords, what a moving and heartrending set of speeches on a very important amendment, which I take extremely seriously. It raises the issue of establishing a specific redress scheme for those medicines and medical devices considered by the review: sodium valproate, the use of pelvic mesh and hormone pregnancy tests. The stories in the review, which have been told here this afternoon, are extremely moving on every single level. I cannot but pay testimony to those who have conducted the campaign and given evidence about their own personal suffering—and who, quite reasonably, look for some form of redress.

I completely understand why my noble friend Lady Cumberlege has raised this issue and why she and other noble Lords have asked for progress on her review. I also completely understand the importance that she and her team attach to this recommendation. They rightly spent considerable time drawing on a wide range of complex evidence before reaching their recommendations. The Government feel it is only right that we also give that incredibly helpful report our full consideration before responding to its recommendations. I remind noble Lords about the timeline for a response to these kinds of reviews, which we have gone over before. I think we are well within the normal response time for such reviews, Covid notwithstanding.

In order to determine whether redress schemes should be established, the Government have a duty to ensure that the final decision is fair for patients and for citizens more generally—not just the patients and citizens affected by the three treatments that my noble friend Lady Cumberlege alluded to, but all citizens and patients; you cannot favour someone over another. This requires extremely careful consideration of any proposed scheme but also the precedent that any decision sets for future policy-making. We spoke in the previous debate about the £83 billion problem. That kind of financial impact has a profound bearing on this kind of discussion.

My noble friend Lady Cumberlege asked when the Government will respond to her review. The Written Ministerial Statement of 11 January sets out the Government’s interim response. I emphasise to anyone who may be confused that it is just an interim response to the report of the IMMDS review. We currently plan to respond to the report later this year; that is a commitment made by my honourable friend Nadine Dorries, the Minister in the other place. The report took over two years to compile and we therefore consider it absolutely vital for the sake of patients, especially those who have suffered greatly, to give this recommendation the full consideration it deserves.

The noble Baroness, Lady Bennett, asked why the Government have established redress schemes in the past but are unwilling to commit to the schemes proposed in this amendment. I think that one is too early to call. It is right and proper for the Government to carefully consider proposals for redress schemes on their own merits to ensure a fair outcome for patients, and citizens more generally.

The noble Lord, Lord Hunt, asked why it is taking so long to consider the recommendations. The report took over two years to compile, so we need to consider it very carefully. I do not want to use the Covid pandemic as a catch-all excuse, but the reality is that our hospitals are overwhelmed; the Department of Health has doubled in size in the last six months and even with that it is overworked and overstretched. The resources and capacity to respond to this kind of report are, I am afraid, distracted on other matters of national health crisis. However, I reassure the noble Baroness, Lady Cumberlege, and other noble Lords who have spoken that work is under way and we will set out the Government’s response to this report later this year.

I could not help but be enormously moved by the testimony of the noble Lord, Lord O’Shaughnessy. In essence, he asked why the Government do not recognise that the patients highlighted in the report of the medicines and medical devices review suffered unavoidable harm, particularly those who took hormone pregnancy tests. The Government absolutely do regard their suffering most seriously indeed and are considering the contents of the report. I am restricted in what I can see regarding hormone pregnancy tests in particular, given the live litigation, but I want to make clear the Government’s position regarding a causal association between HPTs and adverse outcomes in pregnancy. The scientific evidence has been reviewed on a number of occasions, most notably by the Commission on Human Medicines expert working group on HPTs, which, as noble Lords will know, reporting its findings in November 2017. The EWG concluded that the scientific evidence did not support a causal association and that remains the Government’s position.

Just as Covid-19 impacted the publication of the report, it has also had an impact on the timing of our response. I know, and recognise, that that is enormously frustrating. The Government are committed to responding and I assure the noble Baroness, Lady Cumberlege, that work is under way. Our upcoming full response will address recommendation number four. 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, but it is not appropriate to make policy on this kind of matter through primary legislation. For that reason, I ask my noble friend to withdraw her amendment and await the Government’s full response to her report.

[Baroness Cumberlege (Con) [V]]

My Lords, I am so grateful to noble Lords who have taken part in this debate. It has been quite short, but it is very important. As the noble Baroness, Lady Bennett, said in the previous debate on the agency, she has been involved with this Bill in a way that she did not anticipate. She has been such a stalwart, coming to my rescue on occasions, and supporting so much of what has been in the Bill from other sources. I thank her for all of that. The noble Lord, Lord O’Shaughnessy, made a powerful speech about the individuals he has met. We know Susan Morgan well; we have worked with Janet and Emma and many others who have led their own organisations. We think of patient groups as being a few people who got together—when we did not have lockdown—to have coffee and just discuss life generally. That is not the case.

One of the groups I know has 8,500 members—from all over the world, in fact. Other groups have an equal number of members, or numbers of that order. So these are important organisations. They know what it is to have real research. They come up with not just experiences; they beaver away at all our institutions, they look at what they are producing and they challenge. They are so valuable. In the way they work, when they are people who are in considerable pain—very often, they have complicated and difficult lives, having to deal with constant pain—they are thinking of others all the time. That really is so uplifting.