Medicines and Medical Devices Safety Review

Countess of Mar Excerpts

Thursday 22nd February 2018 Lords Chamber

[Lord O’Shaughnessy]

I thank my noble friend for those points; she highlights some very important issues. Medical devices are regulated differently from medicines: they have to go through a safety procedure and they are not licensed in the same way as medicines are. They come onto the market, they are used and safety assessments are made as time goes on. We are now in the position with mesh that we will have a registry, so that every time it is used we will know what the consequences are. That will also give us a comparator, as will the audit, for effectiveness against alternative procedures. As I have said, there is still a view in the medical and regulatory communities that, when used according to guidelines in the appropriate way, it can be transformative for women. However, it can also be the wrong thing and NICE has been very clear that in some cases, in some surgeries, the risks outweigh the benefits, in which case it should not be used. It is important that there is absolute conformity with those guidelines and that is part of what the registry will ensure.

On the issue of trade, under no circumstances will our trade relationships with any country in the future dilute the regulatory rigour that we apply and have always applied in this country. We have a very well regarded regulatory system in this country but we also know that we can do better and it is absolutely our intention to continue to strengthen it.

[The Countess of Mar (CB)]

My Lords, I am very grateful to the Minister for repeating the Statement but I put on the record my severe reservations about the safety of HPV vaccines. The noble Lord knows of my concern. I have had meetings with the MHRA but it seems to think that mañana is quite rapid enough to be dealing with it. The situation he described for those patients dealt with in the Statement is exactly the same as that of young girls and their families who have suffered bad reactions to HPV vaccines. Will the Minister ensure that the MHRA deals with some rapidity on this matter, as at the beginning of the Statement?

[Lord O'Shaughnessy]

I thank the noble Countess for raising that point. We have met to discuss this issue and she has been a great campaigner on medicine safety issues. That dialogue is going on. As she knows, that view concerning the safety is not currently shared by the regulators. But I want to stress that the work that my noble friend Lady Cumberlege will be leading will try to set up a process which deals equitably, objectively and compassionately with these concerns when they arise. One of the problems in the past has been, frankly, that we have not dealt with these things in the same way. It is dependent on the strength of the lobby group, the type and strength of the Government and what is on their agenda at any one time. That is not good enough. We need a consistent and compassionate approach to listening to concerns, scrutinising them properly and dealing with the consequences, which may entail no further action or could be anything up to a full public inquiry. That is what my noble friend will be dealing with and that will be a huge step forward. It will be precisely that kind of process to which any concerns about HPV or anything else should be directed.