Medicines and Medical Devices Safety Review

Baroness McIntosh of Pickering Excerpts

Thursday 22nd February 2018 Lords Chamber

[Baroness McIntosh of Pickering (Con)]

My Lords, I welcome the review that my noble friend has announced—I can think of no better person than my noble friend Lady Cumberlege to do it. One of the concerns of those who are campaigning and have received what they consider to be very inferior treatment is that when the mesh was originally introduced it was done, they think, without proper research, it was inserted with inadequate training, and inadequate warnings were given of the potential risks. Will my noble friend assure us that if an alternative is sought, that will not be the case but that it will be subject to rigorous testing, that there will be rigorous training of the medical professionals and that the risks will be explained to the patient?

They have also raised concerns about potential trade under any future trade agreement with the United States, where I understand a lot of the mesh comes from. They are concerned that we will not just waive any suspect mesh through but will ensure our own rigorous testing so that it meets the highest requirements of the UK.

[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.