Medical Implants (EU and UK)

Andrew Miller Excerpts

Wednesday 6th March 2013 Commons Chamber

[Andrew Miller (Ellesmere Port and Neston) (Lab)]

It is a pleasure to speak to the Select Committee’s report today. I start by paying tribute to my fellow members of the Select Committee on Science and Technology who work extremely hard on very technical matters such as this one. I particularly want to pass on our thanks to staff of the House, such as Committee Clerks and specialists, who have done such a wonderful job supporting the Committee in this Parliament.

I would like to focus on the health issues considered in our report on the regulation of medical implants in the EU and UK, which was published in October last year. It was prompted partly by the scandal over PIP breast implants and the less publicised but equally concerning problem with metal-on-metal hip implants. In addition, the European Commission has drafted proposals to revise the medical devices directive, and we hope not just to influence but to assist the Government in developing a strong negotiating position on that directive.

Under the directive, a medical device is used in health care for diagnosing, preventing, monitoring or treating illness or disability. The definition does not include medicines, which have their own regulatory structure. Nevertheless, medical device regulations cover a wide range of products, from pacemakers to spectacles. Devices are classified according to the risk that they pose to patients. A device such as a stethoscope or a dental filling is a class I or a class II, while medical implants are always class IIb or class III. The classification determines how much assessment is required.

Medical implants must be verified by a notified body before they can be placed on the market. Notified bodies are overseen by a competent authority in each member state. I use the word “competent” loosely, because there are some questions about that. In the United Kingdom, the competent authority is the Medicines and Healthcare products Regulatory Agency, which oversees six notified bodies. They are private organisations which assess high-risk devices and ensure that an implant complies with the essential requirements specified by the directives—the main one, of course, being the medical devices directive.

When an implant has been given the stamp of approval, the manufacturer places the CE mark on the device, and is free to put it on the market in all European countries without further controls. I should emphasise that point, because it shows how crucial it is to get the pre-market approval process right. Once the implant has been approved by one notified body in one EU country, it can go on the market anywhere in the EU. Manufacturers can approach a notified body in any member state to get approval; what is more, if a manufacturer has previously approached a regulator who has said “That device is not up to scratch”, and then approaches another and gets approval, the first part of the information is, ridiculously, regarded as commercial in confidence. That must clearly be changed.

There are more than 70 such notified bodies in Europe. I am pleased to say that the Committee heard no evidence criticising those in the United Kingdom, but we did hear concern expressed about the possibility that those in other countries might not apply the same high standards. Such differences are open to exploitation, as a manufacturer can choose to approach a notified body that is more likely to provide approval, a practice that is sometimes described as forum shopping. There is a real lack of transparency, and we simply do not know how widespread the problem is.

A useful insight was provided on 24 October last year by The Daily Telegraph and the British Medical Journal. Notified bodies were approached to approve a metal-on-metal hip implant that was known to be faulty. Shockingly, bodies in Slovakia and the Czech Republic were prepared to approve it. Many Members will remember the names of the authors of the article in The Daily Telegraph, because they have previously been involved in stings affecting Members of Parliament, but on this occasion they did an extraordinarily important job. I have gone on record as giving credit to those journalists for uncovering what I think was a trail of deception. I hope that, in his negotiating stance, the Minister will ensure that we have a mechanism that avoids that kind of risk in the future, and I intend shortly to illustrate to him a way in which procurement can be developed to avoid it.

I am pleased that the Commission has recognised the need to improve the scrutiny of notified bodies. For example, it has been proposed that manufacturers should be unable to apply to more than one notified body at a time. Our report made a number of recommendations about notified bodies, chiefly calling for a record of all approaches by manufacturers and supporting the Commission’s proposals to use teams of experts from member states to oversee the designation of notified bodies.

These notified bodies also audit manufacturers, and that includes an assessment of their facilities. In the PIP implants story, it was the inspection of the manufacturer’s facility that led to the discovery that an unapproved implant filler was being used. Although the PIP scandal was a case of deliberate fraud, not of the failure of the regulatory system, it demonstrated the importance of inspections and audits. We were therefore supportive of the Commission’s proposals to enforce unannounced audits of manufacturers and we further recommended that audits should take place at least annually.

Another key flaw in the current system is the overuse of equivalence data in approving implants. We now come to the key difference between medicines and medical devices. Every new human medicine has to go through rigorous clinical trials to test for efficacy and safety, but medical devices do not. The clinical data that the manufacturer must provide can come from clinical investigations of that particular device or from equivalence data, which are clinical data on another device that is similar. That may sound reasonable, and in most cases it probably is reasonable, but the problem is that even a small change to the design or material of a device can radically change how it behaves in the body. Also, if we keep approving devices on the basis of equivalence but with a small change each time, we will end up approving devices that are very different from those originally envisaged.

It is not practical to demand a clinical investigation of each and every device, as there are hundreds of thousands of devices in the EU, and doing so would not necessarily pick up the problems of wear and tear that happen over a long period of time or take account of how patients interact with their implants, but we were unimpressed by the extent to which reliance on equivalence data appeared to be acceptable for high-risk devices such as implants. We concluded that revisions of the directive should draw a clear distinction between where equivalence data are and are not acceptable.

Before moving to the second half of the regulatory system, which is the post-market surveillance, I want to make a point about the transparency of clinical data. Very little information about a device is public. Clinical data are generally not published, which makes clinical decision-making and informing patients difficult. I think we would all agree that patients have a right to know what is being put inside them and the associated risks. The Commission proposed to make manufacturers of high-risk devices publish summaries of safety and performance with key pieces of clinical data. We did not think that went far enough and called for all clinical data to be made available for both new implants and those already on the market. Similar transparency issues are being explored in our current inquiry on clinical trials, which starts very soon.

I said I would offer the Minister a practical solution to address the challenges of what is a very complex regulatory structure. We need to ensure that both doctors and patients have the fullest possible information about any product that is being used and inserted in a person as a medical device. It seems to me that the answer lies very much with the Minister. I had this discussion when some of his support team came to see me recently with Sir Bruce Keogh, who is doing the work on some of the medical implant devices, particularly those relating to cosmetic use. It strikes me that there is an obvious way forward, and it is a way in which other countries operate European procurement rules. Whoever sets out the procurement process—in whichever trust or at whichever level in the NHS—should simply make a requirement that anyone bidding for the contract must provide the fullest and most transparent data about the trials that have been conducted, the design of the product and the regulatory processes it has gone through, including the ones where there has been a failure. That is a perfectly reasonable regulatory requirement for the Minister to impose on anyone seeking to sell products that are to be used in the NHS.

[Stephen Mosley (City of Chester) (Con)]

It is worth saying that the Committee also saw the importance of ensuring that negative data are released and made available. We often find that similar products are available and if something is failing in one product, there will often be a similar problem in another product. If we do not produce those negative data to show where problems are with some products, we may miss problems with other medical implants.

[Andrew Miller]

The hon. Gentleman, who works hard on the Select Committee, is absolutely right in what he says. I stress to the Minister that not only was this report unanimously endorsed by the Committee members, but we were angry at the lack of available information. That was no fault of the Minister or his predecessors; it resulted from a system that had grown, as the use of implants had grown, into a mechanism that was not fit for purpose. The Minister is rightly participating in the process of revising the directive, but some urgent requirements mean that he has to take a proactive approach and encourage—indeed, instruct, if he has that power—procurement offices of the NHS to set a new standard. They should simply require anyone tendering for a product in this category to provide, as part of the tendering process, totally transparent information about the process and the regulatory regime it has gone through.

[Sarah Newton (Truro and Falmouth) (Con)]

Perhaps the hon. Gentleman will elaborate on some of the positive examples that the Committee found, which included the groups of orthopaedic surgeons who voluntarily shared information on different hip replacement devices and could contextualise the outcomes. The implant itself is not always responsible for the outcome—that could result from other factors to do with the medical condition of the patient or all sorts of other circumstances—but these people were able to contextualise that information in large enough sample sizes to help other surgeons to come to the right decisions about the right implants for their patients.

[Andrew Miller]

The hon. Lady, another hard-working member of the Committee, is absolutely right and that could take us on to a much more complex debate about how we move from where we are in today’s medicine to future developments in stratified medicine and so on. The way in which our medical profession works in such a strong collegiate manner helps to maintain standards at the highest level. Lessons can be learned in that regard that underline the importance of the NHS as the lead body in this area.

Post-market surveillance is a crucial element of the regulatory system and is technically the responsibility of the manufacturers. However, the notified bodies also have some oversight through auditing. The Medicines and Healthcare products Regulatory Agency investigates adverse incidents once they have been reported. Again, we called for greater transparency by recommending that manufacturers publish the results of post-market surveillance studies. We proposed that a system such as the MHRA’s black triangle system, which flags up new medicines approved on limited clinical data, should be adopted for devices approved on equivalence alone. We found some evidence that clinicians under-report adverse incidents, so we wanted the Government to consider making reporting mandatory.

One place to keep post-market data is a registry. The National Joint Registry for England and Wales—meaning joints in the body, not joint between England and Wales—is a success story. It collects data on all joint replacements in the NHS and the private sector and is the biggest such register in the world. The NJR provided data on the DePuy metal-on-metal hip implant, which was then recalled worldwide in 2010.

Registries do not always succeed. Between 1996 and 2003, we had the national breast implant registry, but that failed, partly because of the unwillingness of patients to give follow-up information. Nevertheless, our colleagues on the Health Committee called for Sir Bruce Keogh to pursue the creation of a register of breast implants in his review of PIP implants. I hope that the Government will put in place measures to ensure that any new registry learns lessons from the NJR’s successes.

I recently went through a minor medical procedure and was asked to provide data as part of a broader clinical dataset and to allow them to be used. The form started off by saying how to opt out of providing that data, rather than explaining to me as the patient why it was beneficial for those data to be collected. When such registers are produced, I hope that the Minister will agree that the starting point should be that the authorisation form should not start with the negative procedure of how to opt out but start with positive information about why such data are beneficial to the individual and to society more broadly.

[Stephen Mosley]

The NJR is a fantastic resource that is very well used, but it might be worth while pointing out that problems with metal hips were first detected in Australia in 2007 because there is a registry there that allowed them to be noticed. The metal hips were withdrawn in Australia in 2009, but it took until 2010 for the problems to be noticed by the British registry and they were withdrawn in the UK. Although it can be a good system, it is not perfect and it needs people to monitor it and ensure that any problems are picked up.

[Andrew Miller]

You will be pleased to know, Mr Deputy Speaker, that the hon. Gentleman has just taken the next paragraph out of my speech. He is absolutely right, but the interesting point is that the Government told us that the Australian regulator did not communicate its data to the MHRA or other international regulators and the MHRA first learned of safety concerns in April 2010. Although it is not necessarily the MHRA’s job to keep an eye on adverse incidents worldwide, we must remember that over those two or three years many risky implants were put into patients, with some devastating consequences. The hon. Gentleman’s observation is spot on.

The European Commission and the UK Government must seek to improve the speed of reaction to incidents such as the two adverse ones that were picked up outside the EU and I will be interested to hear the Minister’s suggestions about how that can be achieved. I believe there is general agreement between the Committee and the Government on the broad principles of the system and what needs to be changed. I hope hon. Members will agree that our inquiry shed some light on important issues affecting UK patient safety.

In conclusion, I will sum up our inquiry on the regulation of medical implants in the EU and the UK as a call for two things: better use of evidence in implant approvals and more transparency throughout the system. I hope we can find a way forward.

[Stephen Mosley]

The hon. Gentleman has gone through almost the entire checklist of points that I wanted to make. However, one aspect that he has not covered yet is self-reporting by patients. We heard examples in Committee and we suggested that it would be good practice if patients self-reported, which might allow problems to be picked up earlier than they are through the formal channels. Does the hon. Gentleman have any comments on self-reporting?

[Andrew Miller]

I have some ideas about how that can be developed. That angle, although not central to the inquiry, is important for the development of a registry. I gave an example of people being invited to opt out of a registry before anything else is put to them. What needs to be explained to them are the health benefits of working in a more collegiate way and sharing data, and they should be encouraged both for their personal health and for broader societal benefit to self-report. That is a hugely important area that we need to develop through better engagement between clinician and patient at the point when the procedure is about to start.

This is a complex subject and I do not envy the Minister his task in negotiating on it. Unfortunately, some regulators have demonstrably not maintained the standards that occur in most of the 27 countries, but in the interests of patient safety and the advancement of medical science it is vital that we work together and solve the problems that the report has highlighted.

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[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.

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[The Minister of State, Department of Health (Norman Lamb)]

I thank the hon. Member for Ellesmere Port and Neston (Andrew Miller) for the clarity with which he presented the Committee’s findings, and I thank the Committee for its valuable work.

The shadow Minister, the hon. Member for Copeland (Mr Reed), made some interesting points about the challenge of diabetes. I note his diagnosis of type 1 diabetes and the impact it has had, particularly in the run-up to the general election. It beggars belief that he had to cope with that in the middle of a campaign. He made a point about the potential power of science and devices to make a difference to patients’ lives and to save the system money—a double win that we are all after.

Before I go on to talk about points raised in the Committee’s report, let me deal with the specific point about Northern Ireland, which was raised by the hon. Member for Strangford (Jim Shannon). Most issues relating to the regulation of medical devices are UK-wide, and the MHRA operates across the UK. Some issues are devolved if they relate to the operation of the health service, and officials at the MHRA work closely with their counterparts in all the devolved Administrations. I hope that reassures the hon. Gentleman.

I will set out briefly what is currently being done to improve the regulatory system for medical devices. In October 2012, the Government began negotiations with other EU member states to revise the regulatory framework for medical devices, including implants. That will mean completely overhauling the regulatory system that has been in place for more than 20 years. The changes will take effect in 2017 at the earliest. In the interim, member states and the Commission are tightening up the most critical aspects of the current legislation. On top of the legislative changes, member states are implementing a voluntary programme of action that takes on board the lessons learned from the PIP scandal, which was mentioned earlier. However, we are not merely relying on the EU. The UK is taking its own action, including putting in place the recommendations of Earl Howe’s report, which was published in May last year. In addition, Sir Bruce Keogh’s review of the regulation of cosmetic interventions is due to report later this month.

Let me now turn to the issues raised in the Committee’s report. First, I would like to talk about the requirements on clinical data for medical devices. There are legitimate concerns about the quality of manufacturers’ clinical evidence, as well as about how rigorously notified bodies then evaluate the evidence they are presented with. The Government’s response highlights how the Commission’s proposal will address those concerns. In particular, we consider that the requirement on notified bodies to have in-house clinical expertise will be a big and important step forward that will ensure that notified bodies really scrutinise and challenge manufacturers on the quality of their clinical evidence.

I am pleased that the draft legislation requires manufacturers to comply with clear rules on clinical evaluation. It is also much clearer on when manufacturers can use clinical data from an equivalent device when conducting their own investigation—one of the issues discussed during this debate. None the less, by the end of the negotiations, we should have legislation that goes even further to ensure that notified bodies have access to high-quality clinical expertise. We do not have any detailed proposals, at this stage, but one idea is to establish an approved list of clinical experts that notified bodies must consult when assessing clinical evidence.

In addition, clinical data must be transparent, so that the procurement of devices is based on solid evidence. The hon. Member for Ellesmere Port and Neston raised concerns about this point. Current practice in the NHS means that clinicians take into account several factors before using a device, including the clinical evidence provided and the track record of the manufacturer. In the light of issues identified with some brands of metal-on-metal hips, the chief medical officer and the NHS medical director wrote to all NHS trusts in England last March asking them to ensure that there was sound clinical governance of procurement decisions about joint implants—this is the important point I want to make in response to what he said. I would expect these principles for the procurement process to apply to all medical devices used in the NHS.

It is worth highlighting how the UK is taking action, over and above the requirements of EU legislation, to support the safe introduction of new hip and knee implants into the market. Manufacturers, including Johnson & Johnson, Stryker and Biomet, have applied to participate in a pilot scheme that will give surgeons earlier and more accurate data on how well new hip and knee implants performed. This project involves close co-operation with clinicians, the NHS and the UK’s national joint registry. The MHRA is currently considering how this pilot could add value to other categories of device.

[Andrew Miller]

Will the Minister confirm that it would be perfectly reasonable, as part of the regulatory process a device must go through, for a procurement officer to ask to be notified of any failed applications to other countries?

[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.

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[Andrew Miller]

With the leave of the House, I thank the Minister for his response and thank the Members who have contributed to this short but important debate, which has underlined the value of our Select Committee structure. We have produced a report that has genuinely informed the House and that has, I hope, helped progress some difficult areas of negotiation being undertaken by the Government.

The hon. Member for Strangford (Jim Shannon) made an important point about small businesses. Next Wednesday, he will be interested to read the Science and Technology Committee’s next report on bridging the “valley of death”, which is such a complex issue for many of our high-tech businesses. The same can be said about any of the businesses described by the hon. Gentleman, which find it so difficult to grow organically in a complex business environment.

I thank my hon. Friend the Member for Copeland (Mr Reed) for his kind comments and for adopting the same spirit as we did in trying to deal with the issue in a collegiate way. Although UK plc is sometimes renowned for being the awkward squad with regard to matters European, this is an issue on which we are in a very strong position, and many of our European partners—I use that word deliberately—recognise the value of what we have done to maintain standards. We have worries with regard to only a minority of European countries.

My only concern with the Minister’s response was in respect of the black triangle issue, but perhaps we can deal with that offline at a more convenient time. I thank him and other Members who have contributed to the debate, and once again thank my Committee and its staff for their contribution to this important discussion.

Question deferred (Standing Order No.54).

[Thomas Docherty (Dunfermline and West Fife) (Lab)]

On a point of order, Mr Speaker. You, of course, are the guardian of good debate. You will have heard the comments of the hon. Member for Southport (John Pugh) about not being clear about what is and what is not in order to discuss on estimates day. Do you have any advice for Members on how we can stay in order when discussing estimates?