New Clause 52 - Plan for implementing recommendations of the Independent Medicines and Medical Devices review

Health and Care Bill – in a Public Bill Committee at 3:15 pm on 28th October 2021.

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“The Secretary of State must, within six months, publish a report containing a plan for the implementation in full of the recommendations of the Independent Medicines and Medical Devices review that have hitherto not been implemented.” —

This new clause would require the implementation of any remaining recommendations from the IMMDS report.

Brought up, and read the First time.

Photo of Alex Norris Alex Norris Shadow Minister (Health and Social Care)

I beg to move, That the clause be read a Second time.

In February 2018, the noble Baroness Cumberlege was asked to carry out the independent medicines and medical devices review into the experiences of people—generally women—who had been treated with Primodos, sodium valproate or pelvic mesh implants. In very many cases, they had to battle for decades to be heard. They were gaslit, belittled and ignored at every turn. Some of the ways in which they were treated were just astonishing, and so upsetting. However, through that report they got their deliverance. They were vindicated: what they said had happened to them had happened to them—even though they had not been believed—and it should not have done. Acknowledging the pain that had been caused to these families was a big start in helping them come to terms with what they had experienced.

The excellent review team set out nine ways in which things would be made better, or at least a little bit easier, for those people now, and to try to prevent future incidents. Those nine recommendations should have been accepted in full. Instead, we have seen from the Government a pattern of accepting things that I suspect they were already keen to do, but otherwise taking the families for a long walk when it comes to the harder and more significant things that the Government clearly do not want to do. In aggregate, it has become a refusal to do right by these families, and that is a really poor decision.

This new clause seeks to attend to that by saying that within six months, the Secretary of State must publish a report containing a plan for the implementation of the recommendations in full. Of the nine, only four are being implemented in full and, frankly, that is not good enough. I am pleased that there has been an apology, and the families were too. I was also pleased to see legislation for a patient safety commissioner. We were lucky that the Medicines and Medical Devices Act 2021 was in front of us at that time, because it gave us a moment to introduce that and a devices database, which the hon. Member for Central Ayrshire and I pursued during proceedings on that Bill. Those things have a bit further to go, but they were significant, as were the promises of cultural reforms at the Medicines and Healthcare products Regulatory Agency. We will wait to see meaningful change there. With the remaining five recommendations, there has been a mixture of in-principle acceptance, partial acceptance and, in some cases, outright denial. I do not think that is good enough, and the new clause seeks to change that.

These are the bits that we are still missing. Recommendation 3 calls for:

“A new independent Redress Agency for those harmed by medicines and medical devices”.

The Government responded that they did not accept that. The problem is that families are therefore left to rely on conventional civil and legal routes. Those are expensive and long, and who do the families sit against in the courtroom? Very big companies with very big legal teams, so there is a significant imbalance. The whole point is that, as recommendation 3 goes on to state:

“The Redress Agency will administer decisions using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals.”

That would have been really significant, but we do not have that. Instead, families are left stuck in the court system for as long as they can stick at it.

Recommendation 4 states:

“Separate schemes should be set up for each intervention—HPTs, valproate and pelvic mesh—to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim.”

Again, the Government do not accept that. These families meet exceptionally challenging needs day after day. Some have lost their house; some have had failed relationships; and all struggle with mental health, or certainly distress, as a result of what has happened, and we are not doing enough to help them. This should have been done, if not on day one, at the very first possible moment for support, rather than us expecting them to fall back on the conventional system, as they did. What have they gained by their vindication?

Recommendation 5 states:

“Networks of specialist centres should be set up to provide comprehensive treatment, care and advice for those affected by implanted mesh; and separately for those adversely affected by medications taken during pregnancy.”

The Government accept that only in part; it is particularly with regard to valproate that those affected will not get those centres. I will listen carefully to the Minister’s justification for that. I understand that valproate is different, in the sense that its use is ongoing in certain situations where that remains medically appropriate. However, the lack of specialised knowledge is a real issue. If there is not specialisation, we need a real sense that there is a universal step change in knowledge and experience in this area to give us greater comfort.

Recommendation 8 states:

“Transparency of payments made to clinicians needs to improve. The register of the General Medical Council (GMC) should be expanded to include a list of financial and non-pecuniary interests for all doctors”.

That is very basic. There were relationships between clinicians and big drug companies that were unknown to the families when certain treatments were suggested. The Government accept the recommendation in principle, but will not use the General Medical Council model, preferring to go practice by practice. That is big mistake. Our constituents can go to one easy, obvious place—our website—to find out our exact financial interests if they have concerns or just want to know them. We ought to be able to do the same, through the GMC, when it comes to doctors. Again, there is an unwillingness to move quickly enough to resolve these issues.

Finally, it remains surprising that the Government have not availed themselves of recommendation 9. I will listen carefully to the Minister’s response on this point. It states:

“The Government should immediately set up a task force to implement this Review’s recommendations. Its first task should be to set out a timeline for their implementation.”

Of course there should be a taskforce, including families and the broader aspects of the state, to do that. Again, the Government say they accept the recommendation in part, but the reality is that they have no plans to establish an independent taskforce. There is a patient reference group, and we of course support its work, but it is not in control; it is not at the table. The problem is that these things were done to families; they had no agency and no say. The solutions that come out of this cannot follow that same model. Once again, families are having things done to them, rather than being worked with.

I meet representatives of these groups frequently, as I know colleagues do. I like meeting them. These are good people who have been through incredible things and have extraordinary dignity and courage, not to mention that they are brilliant campaigners. They are probably sick of seeing me, and I would rather see them in happier circumstances. When I ask them what is next, they say that they are campaigning again. They campaigned over many years to be listened to, and were proven right in the most absolute terms, but they feel they have to campaign again to get the justice that should flow from that report and from their vindication. What an extraordinary demonstration of how we have let them down. They fought for too long. It is time that we stood up for them and did right by them by implementing the recommendations in full; otherwise we fail them again. I hope to hear of significant progress from the Minister.

Photo of Philippa Whitford Philippa Whitford Shadow SNP Spokesperson (Health and Social Care), Shadow SNP Spokesperson (Europe)

I support the new clause. For a surgeon, knowing that an operation that they were trained to carry out, and performed in good faith, has caused harm is one of the worst things that can happen. I remember how I felt in the mid-1980s when we began to realise the impact of contaminated blood. It had a huge impact on how I operated. I used special diathermy techniques to avoid blood transfusion in all elective circumstances, and that is something I carried on throughout my time doing breast cancer surgery.

In this case, there may well have been doctors who were dealing with device companies and so on—that regulatory declaration is absolutely needed—but there will be a much greater number of surgeons who were using a device that was licensed and was given to them as the correct, safe device to use.

I find it shocking that although the report was commissioned by the Government, they have accepted fewer than half of its recommendations. The others directly relate to patients who have suffered harm, whether that is the women who had vaginal meshes inserted, or the mothers of children who were harmed by the use of Primodos or sodium valproate.

Sodium valproate is still an excellent anti-epileptic and will not disappear, but it is not a matter for specialist centres. It is so widely used that it is critical that within primary care and on product boxes it is made clear that women who are looking to conceive or who are of child-bearing age should not be left on Epilim; that should be discussed with them right from when they are young teenagers, so they can think about the impact later on.

The recommendations that have not been accepted are not to do with reorganising licensing, or a yellow card system; they are all recommendations that relate to women. That is really disappointing. The redress for them—the setting up of specialist centres to try to repair the damage as far as possible—is what is not being provided. The Government should look at the fact that those are the recommendations they have skirted around and not accepted. These women and the children affected have gone through enough.

Photo of Edward Argar Edward Argar Minister of State (Department of Health and Social Care)

It is quite right that we articulate once again the suffering that was the genesis of the review. The hon. Members for Nottingham North and for Central Ayrshire spoke with passion on the issue. We are talking about procedures that had a dreadful impact on individuals and their families.

The Government recognise the effect that the independent medicines and medical devices safety review, and the lived experiences behind it, has had on all the women and children impacted, and their families. That is why, on the day after the review was published, the Government issued a full and unreserved apology on behalf of the health and care sector for the time it took to listen and respond.

I am grateful to Baroness Cumberlege for all the time and effort she put into her report. As hon. Members will be aware, that sentiment was expressed at the time by the Minister responsible for responding to the report, who is now of course the Secretary of State for Digital, Culture, Media and Sport.

The Government published our response to the review on 21 July this year, after carefully considering each of the review’s nine strategic recommendations and the 50 actions for improvement in greater depth. Our response set out an ambitious programme for change that, at its core, is focused on improving patient safety.

The Government accepted the vast majority of the strategic recommendations and actions for improvement. I reassure the Committee that we are committed to making progress on all accepted recommendations at pace. That is why, in our response to the review, we committed to publishing an update on our progress in implementing the accepted recommendations 12 months after the initial response. I know that hon. and right hon. Members from across the House will rightly vigorously continue to hold the Government to account on that. I reassure them that the Government take very seriously our responsibility to implement the accepted recommendations at pace.

Many of the recommendations will introduce large-scale changes to patient safety, and we have a duty to get their implementation right. I hope it will encourage hon. Members to hear that the Government have already made strong progress on implementing many of the accepted recommendations of the review. I will turn to those in more detail, because I think it is important that we update the Committee and the House.

Recommendation 2 called for the appointment of a patient safety commissioner. I am pleased to say that, through the Medicines and Medical Devices Act 2021, we have legislated for the establishment of that commissioner. A consultation on the proposed legislative details of the appointment and operation closed in August 2021. The responses from this consultation will feed into the drafting of the detailed regulations on the appointment and operation of the commissioner. A campaign to fill the position is due to be launched later this year. It will be in line with the public appointments process, and we expect to appoint the Commissioner in the first half of 2022.

Recommendation 5 called for the establishment of specialist centres for those adversely affected by implanted mesh. Rapid progress has been made, and as of April 2021 there were eight specialist centres in operation across England to provide comprehensive treatment, care and advice for women affected by implanted mesh. Good progress is being made towards the establishment of a regional service with a south-west provider to ensure patients across the country can access these vital services.

Recommendation 6 highlighted the need for the Medicines and Healthcare products Regulatory Agency to undergo substantial revision, particularly in relation to adverse event reporting, medical device regulation and patient engagement. The MHRA has initiated a substantial programme of work to improve how it listens and responds to patients and the public, to develop a more responsive system for reporting adverse incidents, and to strengthen the evidence to support timely and robust decisions that better protect patient safety.

Recommendation 7 called for the establishment of a central patient-identifiable database that would collect details of the implantation of all devices at the time of the operation. The Government welcomed this recommendation and have legislated for a patient-identifiable database in the Medicines and Medical Devices Act 2021, which creates a power for the Secretary of State to regulate for the establishment of a UK-wide medical device information system, known as MDIS. As required by the 2021 Act, the Government are planning to hold a public consultation on the MDIS regulations, and aim to lay the regulations before Parliament in due course; that will be subject to availability of parliamentary time and the agreement of the usual channels.

The first part of recommendation 8 highlighted the need for greater transparency on payments made to clinicians. The recommendation called for a register of doctors’ interests, including financial, non-pecuniary and clinical interests, and recognised and accredited specialisms, to be held by the General Medical Council. Our response goes further than the review’s recommendation by ensuring that this regulatory requirement applies to all registered healthcare professionals, not just doctors. The Government believe that publications of interests should be held by healthcare providers at the local level, not the General Medical Council. The shadow Minister has set out eloquently, as always, why he does not agree with that. While we do not agree, I respect his integrity. He knows his mind and has studied these issues very carefully, particularly through his work on this report. Our view is that our approach is more appropriate because patients know where healthcare professionals work and are more likely to seek information from the organisation that provides their treatment and care.

Over the coming year, as we approach that update, we will continue to work with professional regulators, NHS England, NHS Improvement and independent providers to monitor implementation.

The latter part of recommendation 8 calls for mandatory reporting for the pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians. We agree with the need for greater transparency. As in the case of doctors’ interests, it is important that information be published and easily accessible for patients. We are therefore exploring options to expand and reinforce current industry schemes, including making reporting mandatory through legislation.

I appreciate that the objective of the amendment is to hold the Government to account for implementation of their response. The Government have already committed to publishing an update on implementation; we intend to do that by summer 2022. I believe that significant progress on the recommendations has been made, but I am conscious that the shadow Minister, with his depth of knowledge in this area, may wish to press further in the coming months. I suspect that he will rightly continue to hold the Government to account.

Photo of Alex Norris Alex Norris Shadow Minister (Health and Social Care) 3:30 pm, 28th October 2021

I am grateful for colleagues’ contributions. The comments of the hon. Member for Central Ayrshire presaged what the Minister said: yes, the Government have been able to do the more strategic aspects of this, but they have done half a job. The half they left out relates to people who have fought for so long just to get a little support, and recognition that they have been badly wronged in a way that significantly changed their life. They really do not ask for much—just a bit of support. It is not a nebulous or open-ended ask; it is just for what was in the report, and that does not seem too much to me.

The Government have been in defensive mode for a long period on this issue, but I desperately hope that they do not think they have done the job, because they really have not. I also hope that they do not think these women will go away, because they absolutely will not, and a lot of right hon. and hon. Members in this place want to help them and give them a platform from which their voices will be heard. A good way to act would have been through the new clause. With that in mind, I intend to press it to a Division.

Question put, That the clause be read a Second time.

Division number 44 Health and Care Bill — New Clause 52 - Plan for implementing recommendations of the Independent Medicines and Medical Devices review

Aye: 6 MPs

No: 7 MPs

Ayes: A-Z by last name

Nos: A-Z by last name

The Committee divided: Ayes 6, Noes 7.

Question accordingly negatived.