Medicines and Medical Devices Safety Review — House of Lords, 2018-02-22
Topic: Health
James O’Shaughnessy (Conservative, Centre-right): I thank both noble Lords for their extensive, well-informed and probing questions; I will try to deal with all of them. I want first to take the opportunity to pay tribute to those involved in each of the three campaigns. They are almost exclusively women. A factor that needs consideration is not only that users of healthcare services are disproportionately women but that women seem to be disproportionately on the end of things when things go wrong—that issue needs investigating in itself. I have had the chance to meet not only the mesh campaigners but campaigners on sodium valproate and Primodos. They have gone to extraordinary lengths to raise these issues; they are remarkable women On the position relating to mesh, I have asked the MHRA and NICE as the two regulatory bodies to get in touch with their counterparts in Australia and New Zealand. There is some quite long, technical advice which I will not attempt to repeat, except to say that perhaps the simplified public view of what has happened in each of those countries is not entirely accurate. I shall certainly write to all noble Lords taking part in this debate and place a copy of that evidence in the Library. It is quite important. It is detailed, but it is well worth looking at I emphasise that collaboration is going on not only internationally but within the four corners of the United Kingdom. The CMOs of those four countries have met. I am meeting the Scottish Cabinet Secretary for Health—I think, next week—to talk about this specific issue and other things as well, so we are cognizant of the need for a joined-up UK approach On the scope of the review, it is very open. In the noble Baroness, Lady Cumberlege, we have an ideal chair: someone who has campaigned on safety issues, who is deeply knowledgeable, well respected and fiercely independent—as we know. She has the opportunity to look not just at issues around marketing, as the noble Lord, Lord Hunt, mentioned, but around the private sector. She will be able to look, too, at whether there should be public inquiries or other types of inquiry and to make recommendations. She will be able to look at pharma companies and gather evidence from wherever it is required. I want to emphasise that the review is very broad in scope. As the noble Baroness, Lady Brinton, said, we are trying to mark a break from the past. We know that we have not dealt with these things well. We are beginning to address that in the clinical and medical space in terms of medical practice; we now need to move on to medicines and devices, which is what we hope to do with this process On issues around the mesh, the audit and the registry, the audit is obviously retrospective. It will not be a perfect exercise, because the data is not always perfectly gathered, but it will be quite extensive in scope. It will be able to pick up not just complications associated by women, or indeed men, with having mesh but whether they have turned up in pain at another setting. We are confident that it will paint a much broader picture than we have had. The intention is to publish that in the spring. Obviously, if any interim reports relating to it come out, they will be shared with the noble Baroness, Lady Cumberlege, but clearly there needs to be robustness to them On the registry, this is an important moment. We have found the money to do this; it will be funded for the set-up and then for the first three years, which is the normal way in which registries are done. I do not yet have a timeline for how it will be delivered, but clearly we want to get it up and running as quickly as possible. It needs to be commissioned, but it is in everyone’s interest to do that Primodos presents a challenging issue, because it is not available on the market and has not been for 40 years, so it is not possible to carry out studies on what is happening to women now. However, new evidence has come to light which will also need to be considered and which was not available for the expert working group. Again, my noble friend Lady Cumberlege will be able to consider that as she looks at what needs to happen in each of those three cases One thing that we have to do—this moves on to the expert working group’s recommendations from the Primodos review, which is obviously very germane for women taking sodium valproate—is make sure that there is proper training for health professionals, not just in the yellow card scheme but for obstetricians in terms of their pharmacological advice and expertise. Indeed, that is one of the recommendations I will be taking forward, as was set out in the Statement. The valproate issue is very difficult, because it is an extremely effective anti-epilepsy drug but it can have very bad consequences for pregnant women and their children. I have met one of the campaigners; four or five of her children are affected and it is having a devastating impact on her life. We need to get to a position where no women of childbearing potential are using it. That needs to be done in the context of recognising that it does work for epilepsy Finally, I absolutely agree with the noble Lord, Lord Hunt, about meeting the groups to define the terms of reference. Again, we have learned from past experience that that has not always been done well and it is best done independently of government, with that degree of objectivity. I think that that is what this review will bring. As I say, the overall hope is that not only do we deal with the issues under each of these three headings, historical and current, but that we put in place a system that means that patients do not have to go through this tortuous process to get their concerns heard in future.