Medicines and Medical Devices Bill

Baroness McIntosh of Pickering Excerpts

Committee stage & Committee: 7th sitting (Hansard) & Committee: 7th sitting (Hansard): House of Lords
Thursday 19th November 2020 Grand Committee

[Baroness Ritchie of Downpatrick (Non-Afl) [V]]

My Lords, I am delighted to follow the noble Lord, Lord Hunt of Kings Heath, and support the noble Baroness, Lady Cumberlege, in her amendment, to which I have added my name.

The report that the Government commissioned and appointed the noble Baroness, Lady Cumberlege, to do on these issues of medicines and medical devices made nine very clear recommendations in July. One central recommendation in that report, First Do No Harm, was the need for a task force to oversee the implementation of the recommendations from the report —hence this amendment today.

If the Government, the Minister and his colleagues, are serious about the recommendations and recognise that there is an issue and a problem in relation to certain medicines and medical devices, they should see fit to implement all nine recommendations. I think back to when I was doing some research on this. An eminent QC, Lauren Sutherland, said that the Government should not ignore these recommendations—they should implement them.

I made the request, along with many other noble Lords, for the implementation of the task force during Second Reading in early September. I said that it should be set up without delay to oversee progress, and I believe that, if the Government are to take this report seriously and ensure that such failures do not happen again, that needs to happen. What better way to have an implementation group than by the task force that is already in existence, because it was independent of government, has worked on these issues for two years and is fully acquainted with all the matters, problems and challenges met by many people, who have suffered indignity and immeasurable pain as a result of the imprecision in relation to medical devices? To ensure proper implementation and oversight of the recommendations, a task force is a necessary prerequisite and needs to be placed in the Bill. The first remit or task of such a task force should be to set a timeline for its work and delivery of the review’s recommendations. The only way for that to work is if the implementation task force is put in the Bill.

As the report states, the task force should be made up of representatives of the various arms of the healthcare system that have a recognisable role to play in delivering patient safety—in other words, people acquainted with the issues and who have knowledge and expertise. Those responsible for implementation need to know that their work and progress will be monitored and they will be accountable. Supporting the implementation process should be a reference group made up of a range of patient interests going far wider than the groups the report members dealt with. Yet again, such a reference group would consist of people with direct experience, and ongoing daily experience, of the impact of such medicines that have been specified, as well as other types of medicines, where there have been side effects, and the medical devices that have caused so many problems to so many women and men.

We need a system and task force that listens, hears and acts with speed, compassion and with proportionality to prevent further avoidable harm—hence my support for the amendment in the name of the noble Baroness, Lady Cumberlege, to establish such an implementation task force without delay in the Bill.

[Baroness McIntosh of Pickering (Con) [V]]

My Lords, I congratulate my noble friend Lady Cumberlege on the work that she and her able team have done on the report, First Do No Harm. I entirely support the amendment, and I am delighted to follow in this the noble Baroness, Lady Ritchie, who has pointed out that by definition it will have only a limited life. Its main work will be to ensure that the functions of the report and all the recommendations are followed through. However, I take this opportunity to ask both Ministers if they are minded to support this. Possibly, when my noble friend comes to respond, we might hear what the nature might be of the budget allocated to the task force, as well as to whom, if at all, the oversight governance board in subsection (2)(b) of the proposed new clause might report, and whether it is intended that Parliament might have an overview of the work of the task force.

In establishing the task force, it is absolutely vital that there is a body that has the role, as is intended in this amendment, of implementing the recommendations set out in the report of the Independent Medicines and Medical Devices Safety Review. I would personally favour the mechanism in this amendment that a task force should be set up for this purpose, limited in time with a specific view. I would be interested to know what budget might be allocated, and from which budget this would come, and also if there was a mechanism to keep Parliament informed of the work of the task force for its limited life.

[Lord O’Shaughnessy (Con)]

My Lords, when I was preparing for today’s debate and I saw where I was in the speaking list, I anticipated that there would not be much left to say by the time we got to me. I was wondering what I might be able to add to support my noble friend Lady Cumberlege in the very powerful argument she made about the need to set up the task force in recommendation 9 from her review.

I went to look at the latest data on the use of valproate in girls and women in the UK, and I declare my interest as a vice-chair of the APPG that looks at these issues. The MHRA publishes a regular report and its version 4, which tracks the data from 2010 to 2019, was published earlier this year. From that I draw two lessons that are very germane to this debate. The first—which the noble Lord, Lord Hunt, alluded to—is that there is this fear of independence, but there is also something else that perhaps goes on, which is almost a sense of helplessness: well, harm is going to happen in practice, there are things you can do, but it is something we are always going to have to accept. The positive message that comes from the work of the noble Baroness, Lady Cumberlege, and her review, is that we can make a difference. If you look at the prescribing of valproate in pregnancy, you see that it fell by 78% from 2010 to 2019 on the back of concerted action from many people—clinicians, officials, Ministers, patients of course, patient campaigning groups particularly, and many others. It halved, year on year, from 2018 to 2019. So we can make a difference through concerted action.

The other data point I take out of it is that even now there are still 200 babies exposed each year to valproate and, as we know, half of them will experience physical or mental harm. That is 100 babies whose lives, and whose families’ lives, are going to be irreparably changed because of that exposure, when everybody accepts that exposure to valproate in pregnancy should be zero, or as close to that as humanly possible.

It is the point about urgency that I want to get across to my noble friend the Minister. I do believe that he is deeply sympathetic to the findings of the review and the need to move forward, but we cannot wait any longer, because these harms are going on. They are going on every day and we can do something about them—and the recommendations in my noble friend’s review are precisely the way we can do something about them. As my noble friend Lady Cumberlege said in her opening remarks, this is not the kind of thing on which you really want an amendment. It is not the kind of thing that should require legislation, but the reason there is such support for it is the sense that nothing is happening when there are harms going on that could be prevented if we took the concerted action that is necessary. That is why I am speaking in support of the amendment today.