Independent Medicines and Medical Devices Safety Review
(Limited Text - Ministerial Extracts only)
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The Minister for Patient Safety, Suicide Prevention and Mental Health (Ms Nadine Dorries)
I thank the hon. Member for Kingston upon Hull West and Hessle (Emma Hardy) and my right hon. Friend the Member for Elmet and Rothwell (Alec Shelbrooke) for securing this debate on the implementation of the recommendations of the independent medicines and medical devices safety review.
Hon. Members have spoken passionately across a range of issues mentioned in the review, but before going into the detail of the recommendations I want to make a number of main points. First, the hon. Member for Bolton South East (Yasmin Qureshi) raised that issue of Primodos with huge passion again today, but I am afraid I have to rebut her criticism. I am not allowed as a member of the Government to discuss an issue that is sub judice and that is a live litigation in the courts at the moment; I am simply not allowed to do that. I have made this point a number of times and cannot make it much clearer: as a Government Minister, I am not allowed to discuss something that is in the process of live litigation.
Ms Dorries
I will not, as I am about to move on to the other matters raised. I would also say that as a Government we make our decisions on the basis of scientific recommendations, and the scientific evidence provided to us at this moment in time does not support there being a causal link between Primodos and adverse outcomes in pregnancy. I am afraid that is all I am allowed to say. So on Primodos I say to those who have raised the matter that I hear everything they say and I hear the issues, but because it is sub judice I am not allowed to comment.
Ms Dorries
I will give way, but I am afraid I will not be allowed to comment.
Yasmin Qureshi
I thank the hon. Lady for giving way. I heard both the points she made, but would the victims be compensated if the legal proceedings were withdrawn, or is this issue about the expert working group still going to be an obstacle?
Ms Dorries
I apologise, but I cannot answer the question.
Moving on, I want to address sodium valproate, in general terms now and later in more detail. I have heard the speeches today and some pertinent points were raised, and I would like to make an overall point on valproate again before going into the recommendations: valproate is a drug that saves the lives of women who can receive no other treatment for their epilepsy. Some women suffer life-threatening epileptic fits of such severity that only sodium valproate can save them; their lives would be lost if they did not take sodium valproate. Therefore it is not possible to ban the use of sodium valproate, because those women’s lives would be compromised.
A number of changes have taken place, too. A letter was sent out to women taking sodium valproate to make sure they were aware, and other measures have been put in place, which I will discuss in a moment, including ensuring that prescriptions for sodium valproate go into one box rather than being partial prescriptions, and the boxes have very clear and significant warnings on them. I could go into further detail, but the inquiry covers—
Ms Dorries
No, because the hon. Lady will be able to respond at the end of the debate and, without going into a huge amount of detail, I want to address a number of overall points that I feel can be made clear.
First, I thank Baroness Cumberlege for her report, of course. She is sitting in the Public Gallery—watching over me, as she does every day. I am delighted and not surprised that she is here, and we are all grateful to her. The report was commissioned by the then Secretary of State, my right hon. Friend the Member for South West Surrey (Jeremy Hunt), in response to public concern. It examined how the healthcare system in England responded to reports about harmful side-effects from the three specific subjects discussed today. Baroness Cumberlege was asked to chair the review. It is just not possible to do the review justice. It took two years, it was incredibly thorough, and it listened to so many voices on so many complex issues. It is not possible to do this overnight. No review undertaken by any Government on issues as serious as these has been implemented rapidly. They take a lot of discussion, time, evaluation and implementation by the NHS.
The review was published on 8 July 2020 and contains nine strategic recommendations that have wide-ranging implications for the healthcare system. That is why it is not possible to implement them rapidly. I pay tribute to the women and families who bravely shared their experiences and brought these issues to light.
Recommendation 1 was an apology. A year ago, I made that apology, and I will make it again. Having met the patient reference group members, spoken to those who have been harmed and read the report, which makes very harrowing reading, I want to make that apology again. I am desperately sorry. I have heard the stories of harm, which are harrowing. I am desperately sorry for those women who have been harmed. Of course, we all want to ensure that this ends and never happens again. The Government absolutely recognise the need for effective patient engagement to begin to rebuild trust and to ensure that we get the implementation right. That is why we established the patient reference group to work with the Department to develop this response. My officials and I have met the group regularly to gather their insights and to ensure that patient voices are heard as we progress towards a full response, which will be given in this place at the Dispatch Box before the end of this year.
Some Members said that none of the recommendations have been implemented or that we have not paid attention to them. That is simply not true. Recommendation 2 was on the establishment of a patient safety commissioner. I happen to know from discussions with Baroness Cumberlege that it was a prime concern for her that we established that role. As part of the written ministerial statement that I published in January, I announced that the Government had tabled an amendment to the Medicines and Medical Devices Bill before the Christmas recess to establish the role of an independent patient safety commissioner in line with recommendation 2. That is now in law under the Act. The commissioner will promote the safety of patients who use medicines and medical devices by ensuring that the views of the wider public about them are heard. There would be absolutely no point in having a patient safety commissioner if the role was not fully independent. That is what we are working on putting in place now. A public consultation is currently open and running until 5 August. I urge all Members who have spoken today and have constituents who have been affected to respond to that consultation to make sure that their views are known.
Recommendation 5 was on specialist centres, which are in place. There are eight specialist centres, and another will be opening in the south-west of England very shortly. Recommendation 6 was on reform of the Medicines and Healthcare products Regulatory Agency. I have announced that the MHRA has begun a substantial programme of work to improve how it involves patients in all aspects of its work to reform the system. Recommendation 7 was on establishing a medical device information system, again through the Medicines and Medical Devices Act 2021. In line with Baroness Cumberlege’s recommendation, this will mean that the NHS can track patients’ outcomes and spot issues. Work is under way to build, test and cost options on how a medical device information system could be embedded into the UK healthcare system.
Turning to the recommendations that we do not accept, I was honest when I stood here and said how desperately sorry I was and how harrowing those stories were, and I am not going to stand at this Dispatch Box and say that we are reviewing all the recommendations, which is what has happened in the past. I will be honest: we are not going to accept the redress agency in recommendation 3, or the taskforce. No Government have ever asked someone to chair or undertake a review and then asked those who conducted the review to implement the recommendations on behalf of the Government. That has never happened before. It is the responsibility of the Opposition to hold me to account and it is our responsibility as Ministers to implement the recommendations that the Government see fit to implement.
The Cumberlege report is a document that vividly shows the importance of patient safety and of listening to women. It is incredibly important that we listen to women. I am delighted that many people today have highlighted the adverse situations that many women experience, suffer and have to endure because they are women. It is absolutely right to say that many women are not listened to, and the hon. Member for Central Ayrshire (Dr Whitford) also made that point. This was the substance of the report by Baroness Cumberlege. Women are not listened to, and they have not been listened to. The women’s health strategy was not a recommendation but it was seriously influenced by Baroness Cumberlege’s review. That is why I established the women’s health strategy, and 112,000 women responded. It was not one of the recommendations, but we implemented it because women’s voices have to be heard.