Medicines and Medical Devices Safety Review

Sarah Wollaston Excerpts

Wednesday 21st February 2018 Commons Chamber

[Mr Hunt]

I thank the hon. Gentleman for his considered response and for its tone. Like him, I thank all the all-party groups who have worked incredibly hard to raise this incredibly difficult issue. Let me go through the points that he raised; he asked detailed questions, which I want to give a proper answer to.

When it comes to mesh, no EU country has banned its use. In my understanding, Australia and New Zealand have not introduced a full ban. We have taken very clear advice. We obviously have a responsibility to all patients, and the medical advice from the chief medical officer is clear that some women benefit from mesh, if it is appropriately used, so we are following that advice. However, the review will look at all the processes around mesh. We will publish NICE guidelines on persistent pain and ventral meshes—it is also important to say that meshes are used in men as well as women—and we absolutely have to get this right.

I fully accept the point that the hon. Gentleman made on the concerns of many patients and families about the findings of the expert working group. He will know that this is a very difficult, hotly contested area. We are not proposing to revisit the science, but we are giving Baroness Cumberlege full freedom to look at what the expert working group did and to come to her own views. We are not excluding her from looking at what happened, even though we think that it is important to accept throughout that we have to follow the science at every stage to get this absolutely right. We will be going forward with some important recommendations of the expert working group regardless, such as the yellow-card system.

One thing that is clear is that when people, whether clinicians or patients, have an immediate concern about a medicine, there is no easy way to raise that quickly. If women are raising these concerns all over the country, we need to find that out very quickly at the centre, so that we can take action more quickly than happened in this case. We will also be offering genetic testing to families who have suffered, or who think that they have suffered, as a result of Primodos.

On valproate, we will issue guidelines to clinicians. We also want to make sure that there is greater awareness among patients. We are changing the NICE guidelines and the labelling. When it comes to valproate, we want to push for this to be a contra-indication for women of childbearing age who are not taking effective contraception, because it is so important to get this right.

The hon. Gentleman made very important points about the public inquiry. We are asking Baroness Cumberlege to give us her considered view on the appropriate way forward in this case, and that, of course, has implications for the issue of compensation. What I would say is that we have a problem in our system, in that there is no proper process for deciding what next steps are appropriate. Is it an investigation by the Department of Health and Social Care and NHS England, or do we need a full statutory public inquiry? We particularly want her to look at whether we should have an independent process to evaluate what happened. In my time, and in the hon. Gentleman’s time, we have been approached by a lot of people who want public inquiries, but it should not simply be about the strength of lobbying. There needs to be a process, because there may be people who do not have a loud voice, who are equally worthy of a public inquiry, but who do not get considered in our system at that moment. That would not be right.

Baroness Cumberlege will report to Ministers, not to the MHRA, and there will be full consultation with the families affected by the three issues over the terms of reference. That is absolutely the right thing to do.

The hon. Gentleman made a final very important point about how we regain the trust of families deeply scarred by these issues. We can do it in two ways: first, by being open and transparent in everything we do in this process so that they can see we want to get to the bottom of it as much as they do; and secondly by recognising the fundamental issue that in the past when we have assessed these clinical medical safety issues the voice of patients has not been as strong as it should have been. We have to put that right, and I know that everyone in the NHS, as in the House, is committed to doing so.

[Dr Sarah Wollaston (Totnes) (Con)]

I welcome the Secretary of State’s statement and his ongoing focus on patient safety, which has added so much to the patient experience. I also welcome the fact that he is clearly representing the voice of patients when learning lessons. Many of those who, courageously, have come forward, including many of my own constituents, have been harmed in the private sector. Will he confirm that all patients, wherever they were treated, will be included within the review and that there will be a focus on clinical governance, not only in the NHS but in the private sector?