Medical Implants (EU and UK)

Stephen Mosley 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.

[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.

--- Later in debate ---

[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.