Medical Implants (EU and UK)

John Pugh Excerpts

Wednesday 6th March 2013 Commons Chamber

[John Pugh (Southport) (LD)]

With your indulgence, Mr Deputy Speaker, I should like to break some new ground in this debate on estimates day by talking just a little bit about the estimates. We have quite a lot to agree to. I do not know whether hon. Members have studied the papers for the day. We are agreeing to an extra £1.2 billion of expenditure in the revenue account and a reduction in the consolidated fund draw-down of £472 million. In previous debates we have debated similar figures for the Department for Work and Pensions, the Ministry of Justice, the Department for Communities and Local Government and so on. At the end of the day we will vote through £213 billion of Government expenditure and probably talk about none of it at all.

There is a reason for my raising the issue at this point. There is an odd gap between what we are notionally doing and what we are actually doing. A few months ago we had another estimates day when we voted through similar huge amounts but talked about Turkey. The nation’s finances were relatively undiscussed. It is odd procedure that the one thing we do not talk about on estimates day is numbers or estimates, but does it matter? It does in a funny sort of way, because Parliament is supposed to scrutinise the nation’s accounts and it clearly does not do so. I think the Government are aware of it. The hon. Member for Gainsborough (Mr Leigh) and I were tasked by the Chancellor of the Exchequer and the Chief Secretary to the Treasury with looking at how we scrutinise the nation’s accounts on occasions like this. It was announced at the Dispatch Box—

[Mr Deputy Speaker (Mr Nigel Evans)]

Order. I am giving the hon. Gentleman a little leeway but the matter under discussion is as on the Order Paper, so I would like reference to be made to that, rather than a general debate.

[John Pugh]

I am coming to that, Mr Deputy Speaker. In a way, that illustrates my point, because what we are actually debating is the supplementary estimate. My hon. Friend the Member for Gainsborough and I were tasked with looking at how the House debates supplementary estimates, and the answer we came to was this: not very well. Our report, a copy of which is in the Library for hon. Members to consult, testifies to that finding, and we produced adequate evidence for it, because the report was co-ordinated to some extent by the Treasury, which keeps a close eye on these things. I am suggesting that the work of examining the nation’s finances is boring, dull and, at times, anorakish, but it certainly needs to be done, and it probably should be done by Parliament, and on occasions like this.

[Mr Jamie Reed (Copeland) (Lab)]

On that point, which the hon. Gentleman is making very well, can he recall when the House last divided on an estimates debate?

[John Pugh]

I certainly cannot. There are occasions when we talk about general topics, but I think that I am right in saying that the reasons we have estimates days is so that Parliament, as well as the Treasury, can scrutinise the nation’s accounts. I regard that as highly desirable in this age of austerity, when we need to count every penny and record the overspend, underspend, virement and so on.

I will now turn to the subject that appears to be the subject of this debate but is not actually on the Order Paper: medical devices and implants. I would like to make a few observations on what the hon. Member for Ellesmere Port and Neston (Andrew Miller) calls post-market surveillance, which we agree needs to be improved. That is obviously wholly desirable because it will eliminate problems, improve patient security and so on. I would not disagree with a single word voiced by him or his Committee. I agree that there should be more transparency and more feedback from patients and clinicians so that devices are safe and do exactly what they are supposed to do. However, we can improve regulatory vigilance. The MHRA has done a good job so far, but it obviously could do better. There is clearly a role for increased manufacturer responsibility. That is all very important.

The simple point I want to make about implants—I am not allowed to talk about the huge sums of money we are voting through—is that detecting failings is quite a complex matter. It is not as simple as it was with the breast implants, which was a case of the wrong substance being provided, which is fraud. I will illustrate my point with a real-life example. I am familiar with a case in Nottingham involving a number of unfortunate episodes that followed heart surgery in which a particular type and brand of stent was used. A number of people were called back for second operations because the stents leaked. I believe that there were a number of deaths and some litigation. Initially it was thought that the device was at fault, because it looked as though the people who had the device experienced certain problems and complications, and there had been other problems with it elsewhere. It was subject to a court case and prolonged investigation. Ultimately, the blame was attributed—this bears out the point made by my hon. Friend the Member for Truro and Falmouth (Sarah Newton)—to the surgical procedure, rather than to the device itself.

Therefore, there is a particular problem when it comes to post-market surveillance. Is it the equipment or how it is used that is responsible, because the equipment is only as good as its user? That is a particular issue in surgery, because surgeons up and down the land are very particular about what bits of kit they use and what type of equipment they work with.

[Andrew Miller]

The hon. Gentleman is making a perfect case for a proper registry. If a proper registry were maintained, one would be able to see whether the patterns of failure related to a location, which would mean it was a surgical failure, or a particular type or brand of product. He is underlining one of the Committee’s key recommendations.

[John Pugh]

I am grateful to the hon. Gentleman and pay tribute to his Committee for the work it has done. My simple point is that post-market surveillance is complex, because devices need to be judged alongside the patient experience and the clinician experience, and that gets more complex and difficult if the market for a particular device is relatively small. In the Nottingham case, the patients could not get fully informed feedback because it was neither in the manufacturer’s nor the surgeon’s interest to incriminate themselves. There was the added problem, as there is often is, that the manufacturer was in a different country from the user of the device. That is partly why products that have been found over time to be faulty in one country can still be used in another country because its regulatory body has not picked up on the problem.

This is not an easy matter, and I applaud the Committee’s efforts to get things right. I am slightly disappointed that we cannot have a wider debate on the nation’s finances. I hope that the Minister will explain what the £1.2 billion of expenditure that we are agreeing is all about, because that will be a blessing to the House.

--- Later in debate ---

[Norman Lamb]

It would be absolutely in order for a procurement officer to do that. The more searching their inquiries, the better, given the importance of what we are trying to achieve. We welcome the hon. Gentleman’s opinions on this issue and will consider how the system can be further strengthened. He makes a valuable contribution to our considerations.

The Government agree with the Committee about the need to improve the environment for clinical trials in this country, and we are doing a lot of work on that already. Things such as the life sciences strategy are making it easier for patients to get involved in research, and we have also set up the Health Research Authority, which is simplifying the approval process for ethical research.

To return to a point made by the shadow Minister, we wholeheartedly agree on the importance of transparency, which brings numerous benefits. I have always strongly believed that it empowers patients, informs and liberates health care professionals and builds trust in industry, notified bodies and public authorities. The proposed new European regulations will increase transparency, giving the public, patients and clinicians access, first, to clear information on the safety and performance of devices; secondly, registration information on devices and the companies that make, distribute and use them; and thirdly, information on the electronic traceability system for devices.

Furthermore, the outcome of peer reviews between different national authorities—reports from each member state on how they have monitored their notified bodies and statements from notified bodies on their independence and impartiality—will also be made public. The hon. Member for Ellesmere Port—I apologise for abbreviating his constituency—drew attention to concerns about the quality of different authorities across the EU, so this is an important step. The UK is already pushing for improvements in transparency in negotiations with other member states. For example, as we highlighted in our response, we would like to see clinical data from post-market surveillance published, so that the available information on the safety and performance of devices always remains up to date. We can do more as well. The Government’s public consultation on the proposed regulation closed on 21 January. It provided us with a lot of useful ideas, which we are currently considering in detail.

Let me turn to the issue of notified bodies and pre-market assessment. Strengthening the quality of notified bodies is absolutely one of the most important ways to improve the regulatory system. The Government agree with the Committee’s recommendations in this area. We are pleased that the Commission’s proposal goes a long way towards addressing the current weaknesses in the system. Competent authorities will review each other and share ideas on how to improve the way in which they monitor notified bodies. The Commission can take action in response to a member state’s concern about a particular notified body. There is significantly more detail on the criteria that notified bodies must fulfil, and teams of experts from different competent authorities will audit notified bodies every three years. The Government agree with the Committee that a new layer of European bureaucracy is not the solution to problems with notified bodies. We need to focus not on who carries out pre-market assessment, but on how it is carried out.

Regardless of all that, we cannot just sit back and wait for the revised legislation to come into place—it is some way off yet. As I outlined previously, we are acting before then to ensure that notified bodies improve as soon as possible. Interim action is being taken across Europe. It includes, first, joint audits of notified bodies on a voluntary basis. The first of these took place in the UK in January and many more are planned for 2013. Secondly, all member states are auditing the quality of their notified bodies that assess high-risk devices. Thirdly, rules on notified bodies and how they audit manufacturers, including undertaking unannounced inspections, are being put together.

While we strengthen the pre-market assessment of devices, it is equally important that adequate post-market surveillance and vigilance procedures are put in place. My hon. Friend the Member for Southport (John Pugh) entertained us and educated us on some important issues. He drew attention to the complexity of identifying the cause of a problem and whether it is the equipment or how it is used. That is not always easy, and the court action he referred to very much drew attention to the complexity of these issues. I am afraid that I am unlikely to be able to satisfy him on the £1.2 billion, but I liked the effort on his part.

[John Pugh]

I hope the Minister did not think I was being awkward in any way, but the original purpose of estimates day was clearly not to discuss medical implants. However, I have now learnt not only that we do not talk about estimates on estimates day, but that we are not allowed to talk about them.