Medicines and Medical Devices Bill

Baroness Cumberlege Excerpts

Committee stage & Committee: 3rd sitting (Hansard) & Committee: 3rd sitting (Hansard): House of Lords
Wednesday 28th October 2020 Grand Committee

Taking these amendments together, we seek to make the UK an innovative and safe marketplace for trialling and developing medicines and medical devices. I believe these objectives are entirely consistent with those of the Government as described by the Minister. I hope that the Government will look very carefully at these amendments, which have been drafted with the support of the esteemed medical Royal Colleges that I have mentioned. I beg to move.

[Baroness Cumberlege (Con) [V]]

My Lords, I will speak briefly in support of Amendment 84 in the name of the noble Baroness, Lady Finlay. I also wish to raise a question on Amendment 97 in the names of noble Lords, Lord Kakkar and Lord Patel, and to ask the Minister a question on equivalence, of which I have given him notice.

During my review, we heard much that greatly concerned us about the way that medical devices reach the market. Our focus was on pelvic mesh, but similar concerns apply to devices more generally. When mesh for stress incontinence and pelvic organ prolapse first came into use, the safety data available was woefully inadequate. It relied on very short-term studies, often funded by manufacturers with vested interests, with limited follow-up. Mesh is a product that is designed to remain inside the body, which presents a problem, because it is designed not to be removed. Removal can be done, on rare occasions, but it is very difficult and dangerous. Implanting a device such as this into so many patients with such a lack of safety data is, as we said in our report, foolhardy.

I recognise that some risks of new treatment options may become apparent only when they have been in use for some time. I agree with the noble Lord, Lord Hunt, that surgeons need to be able to offer new, innovative treatments. That is how medicine has made such tremendous progress in our lifetimes. We must not stifle innovation, but we must do all we can to improve patient safety and to prevent avoidable harm. We had a full discussion of this on our previous day in Committee.

In clinical trials of medicines all adverse events are reported, whatever their cause, and that is good. In the case of mesh, if selected cohorts of patients had undergone enhanced reporting, it is most likely that the adverse impacts we heard about would have been detected sooner. Thousands of ruined lives, in this country alone, could have been avoided.

In the field of medical devices, better, more thorough trials with long-term follow-up are vital, but they are not the whole answer. We also need transparency. It is one thing for trials to be conducted, but quite another to ensure that the findings they produce, and the concerns they may give rise to, are made available to the public and to potential patients. Patients have the right to know about trial outcomes and safety concerns that arise in trials. They have the right to know who is conducting the trial and who is funding it. Without that knowledge, there cannot be an informed decision about an individual’s treatment options.

Many common themes arose during our review, but one that is particularly powerful, and relevant to today’s discussions, is the phrase that so many women with terrible mesh complications used. They said to us: “If only I had known”. If only they had known the risks, perhaps they would never have had the procedure and their lives—and those of their families—would not have been ruined.

This amendment would ensure that medical device trials are entered on a publicly available database and would bring devices into line with medicines. This is much needed, which is why I support the amendment.

I turn to Amendment 97, proposed by the noble Lords, Lord Kakkar and Lord Patel. One of the issues that we encountered during our review was that the full safety implications of an implantable medical device may become obvious only once the device is inserted. Some women told us that they sensed immediately that something had gone wrong; for others it was not until years later. Trials need to be sufficiently long term to detect safety concerns some years after the device is implanted.

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[The Deputy Chairman of Committees (Baroness Fookes) (Con)]

I have received a request to speak after the Minister. I call the noble Baroness, Lady Cumberlege.

[Baroness Cumberlege (Con) [V]]

My Lords, it has been a really interesting debate. One of the things that I have found so wonderful in this House is all the professors. I did not go to university and, when I listen to the professors and the way they care for their students—and in this case I am something of a student—I really value it. I thank the noble Lord, Lord Patel, for pointing out the dilemmas that we face. They are very difficult. I am sure that the Minister also feels that: it is how you balance what we are trying to achieve as a successful United Kingdom in innovation, marketing and all the rest of it, and the dilemma of safety as well.

I thank the noble Lord, Lord Kakkar, very much. I need to read very carefully in Hansard what he said and then come to some conclusions. I am not sure that we have quite cracked it, but I believe we are working towards it. The noble Lord, Lord O’Shaughnessy, had some really interesting ideas about how we can take this forward, and we need more work to be done on it.

I want to say one thing. In the review, we were so horrified by the stories that we heard that we said we had to do something to prevent further surgeries taking place in women who were suffering so deeply. We called it the pause; we went to NHS England and the department and very quickly they agreed to our pause, with six safety conditions that had to be introduced if it was to be lifted—and, of course, they still have not been introduced. That was in July 2018.

The interesting thing about the pause is that, because surgeons were prevented from using what they would see as the normal solutions to stress urinary incontinence, with pelvic mesh, they started to think of different ways in which to do things and help women, ensuring that the discomfort that they had through these conditions was ameliorated. We are getting innovation in a very interesting way. I am convinced that such innovation would not have taken place if we had not introduced the pause. But it should not have been us, the review team, who introduced it. It should have been the healthcare system, which had put forward some measures and thoughts about it years before, but nothing happened. Of course, that was one of the burdens that I carried throughout the review—that promises were made and nothing happened. We called the healthcare system glacial; it just did not move. There are some hugely bright people in this country and throughout the healthcare system and beyond, in universities and everything else. Surely, if we could only utilise the wonderful brains that we have in this country, we could do much better.

I thank my noble friend for the very full summing-up today. The categories of risk relevant to devices have been so badly used in the past in terms of how pressure has been put on to change the risk when people knew that harm was being committed. We have a meeting with the MHRA, and I am sure that a lot of these issues will be discussed.

I thank the noble Lord, Lord Hunt, for introducing the amendment. It is very difficult to pick up somebody else’s work, but he did it with his usual tremendous skill.

[Lord Bethell (Con)]

I completely endorse the words of the noble Baroness, Lady Cumberlege, about the failings around some of the medical device regulatory regimes, which failed to pick up many of the problems with mesh. I am grateful for the interventions from the review team on that matter.

I remind noble Lords that the Bill seeks not to lay down the policy on what precise regime will suit the future of medical device regulation but to set up the framework in which those regulations are put together. The Bill meets the need on that matter. I cannot urge enough how important it is that we get the Bill on the statute book as soon as possible.