Medicines and Medical Devices Safety Review

Jonathan Ashworth Excerpts

Wednesday 21st February 2018 Commons Chamber

[Jonathan Ashworth (Leicester South) (Lab/Co-op)]

I thank the Secretary of State for the advance copy of his statement. I welcome the tone of his remarks and generally welcome his commitment to a review of medical device safety, although I note that the 2017 Labour manifesto called for an inquiry into medical devices and product licensing and regulation. Today’s announcement is an acknowledgement that there are major problems, going back decades, to do with safety and lack of proper scrutiny and research.

In debate and Committee, Members in all parts of the House have offered moving testimonies about the devastating impact of mesh, Primodos and sodium valproate on the lives of thousands of women and children in our constituencies. I wish to put on the record my thanks and tribute to all the campaigners and the MPs from across the House, but especially those who have worked so hard with the all-party groups, including my hon. Friends the Members for Pontypridd (Owen Smith) and for Bolton South East (Yasmin Qureshi), and the right hon. Member for North Norfolk (Norman Lamb), who have all spent many years campaigning for justice on these issues.

We have heard how mesh implants have left women in permanent pain, unable to walk, unable to work. This is an ongoing public health scandal, and we hope the Government will do much more to support those who are affected. Mesh has been suspended in Scotland and banned in other countries around the world. I understand that mesh has been paused for use in cases of prolapse. Will the Secretary of State consider fully suspending mesh use while the review is carried out?

On Primodos, the Secretary of State indicated that the Department will drive forward and “accelerate” the recommendations of the expert working group, but does he accept that that report was met with concern on both sides of the House? Indeed, campaigners branded it a whitewash.

I am grateful to the Secretary of State for including sodium valproate. My constituent, Emma Friedmann, took sodium valproate during and after her pregnancy, leaving her son, Andrew, with severe autism along with hearing and sight problems. Andrew, who is now 18, needs round-the-clock, full-time care. Emma, like thousands of others affected, was never fully informed of the risks of taking sodium valproate during pregnancy. Last year, a charity survey found that almost one fifth of women who are taking the drug still do not know the risks that the medicine can pose during pregnancy. I welcome the Government’s efforts to raise awareness of the dangers of sodium valproate, but will the Secretary of State tell us whether the review will look at the guidelines for clinicians who prescribe it to women of childbearing age?

We offer the review our support, but note that it falls short of the calls for a full public inquiry, which campaigners have been demanding. Will the Secretary of State give the House an absolute reassurance that the review will gain access to medicine regulation files held in the National Archives, access to any valuable evidence cited in unsuccessful legal actions and access to documents and information held by pharmaceutical companies and that all such material will be made public?

Does the Secretary of State agree that those affected must have trust and confidence in the review? Who will the noble baroness report to, and who will provide the secretariat to the review? I say this with no discourtesy to the Department or the Medicines and Healthcare Products Regulatory Agency, but does he agree that the review must be independent to avoid any sense of conflict of interest that has hampered previous inquiries? I understand the steer that he has given to the noble baroness on setting the terms of reference, but I press him to ensure that victims agree with the terms of reference to maintain trust and confidence in the review.

Is the Secretary of State now ruling out a full public inquiry, or is he saying to victims that they should wait for the review’s outcome? When can we expect it to report back to the House? More broadly, can he reassure us that the inquiry will have three separate strands that will look in depth at each issue to ensure that nothing gets watered down and lost?

In the broader context of Brexit, when profound uncertainty remains about medical and device regulation as we leave the European Medicines Agency, does the Secretary of State agree that the review must inform future regulatory mechanisms and take into account how we best co-operate with other national and international regulators post Brexit? What assurances can he offer the House that the medicines and devices that women use today—especially pregnant women—will not become the tragic and desperate scandals of the future?

On the treatment of the victims involved, the Secretary of State will know that many women have been denied access to legal aid to pursue compensation claims. Does he agree that women and children deserve full compensation and support? Is that not the Government’s responsibility? Will they establish a compensation fund, and what consideration has he given to compelling the pharmaceutical industry to support a compensation fund for those affected?

Finally, mesh, sodium valproate and Primodos have devastated the lives of hundreds of thousands of women and children. Is it not time that they were given a full apology? Surely, that is the very least they deserve.

[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.