Licensing of Medical Devices

Petition - the Future of Maintained Nursery Schools – in the House of Commons at 7:14 pm on 12th February 2019.

Alert me about debates like this

Motion made, and Question proposed, That this House do now adjourn.—(Mr Goodwill.)

Photo of Owen Smith Owen Smith Labour, Pontypridd 7:20 pm, 12th February 2019

I rise to talk this evening about medical devices and the way in which they are licensed and regulated. They are a very important and growing part of medicine, and they can save and transform lives—indeed they have done for millions of patients over many generations. However, when faulty or poorly designed or poorly looked into and proven, they have also damaged, and indeed ended, the lives of many thousands of patients around the world. My principal point is that the regulatory system for medical devices in our country, and across Europe and arguably the wider world, is simply not fit for purpose and must be properly reformed.

The term “medical devices” is rather vague. It refers to everything from bandages to syringes through to heart pacemakers and artificial joints, and I want to be clear that what I am talking about is the more complex end of the spectrum: the more high-risk, class III as they are called, implantable devices.

Photo of Mark Tami Mark Tami Opposition Pairing Whip (Commons)

I want to put on record my thanks for all the work my hon. Friend has done on mesh. Does he agree that we must be careful that what might appear to be a relatively cheap quick fix can turn out to be a massive problem for a lot of patients?

Photo of Owen Smith Owen Smith Labour, Pontypridd

I thank my hon. Friend for his thanks, and I will talk about mesh shortly as it is illustrative of the wider problem.

The problem is best summed up not in my words but those of the Royal College of Surgeons, which said at the tail end of last year, in response to a big journalistic investigation, that we need to see in our country urgent and drastic regulatory reform and in particular that we need to start with the creation of a compulsory register for all new devices and implants that go into patients in the UK. Will the Minister commit to that?

Let me give a couple of examples of what I am talking about. Last year alone in the UK surgeons operated on patients for 80,000 knee joints, 60,000 hip replacements, 50,000 pacemakers and 7,000 usages of surgical vaginal mesh, down from its height in 2008 when there were 14,000 instances of surgical vaginal mesh inserted into women. Let me pause for a moment to talk about that example of vaginal mesh and why its use has declined so precipitously. The answer lies in what I am talking about—in the development and marketing, and the fact that, as with so many of these devices, their true safety and efficacy is only revealed in the real world once they have been implanted into patients, and sometimes after many years. Many of the variants of vaginal mesh, like most of the other devices now on the market, are developed without any real clinical trials, and certainly without the randomised controlled clinical trials we are familiar with in respect of medicines; that is an extraordinary fact. We understand why that is the case, but there are other ways in which the device manufacturers could ensure their devices were safer and definitely not going to harm patients.

Photo of Paul Masterton Paul Masterton Conservative, East Renfrewshire

I pay tribute to the hon. Gentleman for the work he does as chair of the all-party group on surgical mesh implants. He will be aware that when the Medicines and Healthcare products Regulatory Agency appeared before the Public Petitions Committee in the Scottish Parliament it admitted that its verification process for use of mesh implants amounted effectively to a two-week desktop exercise carried out by three people at a cost of £20,000. Does he agree that that example fundamentally shows that the way the MHRA is reviewing these devices is not fit for purpose, is completely inadequate and, as we know from the work of the APPG, puts patients, and in the case of mesh implants lots of women across the UK, at risk?

Photo of Owen Smith Owen Smith Labour, Pontypridd

The hon. Gentleman, who has also done excellent work on mesh as co-chair of the group, is completely right.

Our regulatory system for these devices, including mesh, is more akin to the system that applies to toasters or plugs, and the way in which they get kitemarks, than to the way in which medicines are approved. It is so problematic that, last year, the journalist I was talking about applied to get a kitemark—known as a CE mark—for surgical mesh. However, the item in question was a bag that had previously been used to keep oranges in, but they still succeeded in getting a CE mark for it. It obviously was not put into a woman, but real mesh has been and is being put into thousands of women all over the world, including those suffering from organ prolapse and stress urinary incontinence. The real impact of the mesh has been revealed in the chronic pain, disability and even death suffered by many women as a result of the mesh warping, breaking, morphing, changing its constitution and cutting into organs inside the body. This was revealed only after years of sales.

Photo of Paul Sweeney Paul Sweeney Shadow Minister (Scotland)

My hon. Friend is making a powerful speech about the devastating impact that mesh has had on women. I discovered the real impact of it when a constituent came to visit me on Friday. Wendy talked about the impact that it had had on her life. She said that she had been concerned about the mesh and had discussed it with her surgeon, who had insisted that it was not mesh but tape. She was therefore misled by a medical professional. Does my hon. Friend agree that that is another worrying aspect of how these medical devices are being marketed and communicated to patients?

Photo of Owen Smith Owen Smith Labour, Pontypridd

Yes, I absolutely agree. There are many instances of similar mis-selling of these products to women. We need to examine the relationship between the doctors who are selling or marketing these products to their patients and the companies that develop them. Some have an interest in those companies, and others are getting a money benefit through doing this in the private sector. All these things desperately need to be looked at.

The terrible truth is that the surgical mesh scandal that is unfolding is just one of the scandals relating to medical devices. We had the metal-on-metal hip joint scandal, with metallosis poisoning people’s bodies. We had the scandal of textured PIP breast implants poisoning women’s bodies. Those implants are now connected with increased incidences of cancer. We had spine-straightening devices for children that were only ever tested on corpses. We had pacemakers such as the Nanostim, which was designed to sit inside the heart and work for up to 19 years. It has now been removed from the market because the batteries started to break down and cease to work and, worse, it was giving people electric shocks. The devices are now being cut out of people. Between 2015 and 2018, UK regulators alone received reports of 64,000 adverse events involving medical devices. A third of those incidents resulted in serious medical repercussions for patients, and 1,004 resulted in death.

Photo of Ann Clwyd Ann Clwyd Labour, Cynon Valley

I would like to pay tribute to the tremendous work that my hon. Friend has done on mesh. Quite a number of people in my constituency have suffered as a result of the use of mesh, and they are extremely grateful for the work that he has been doing. About 20 years ago, we had the scandal of silicone implants, and someone in my constituency had a double mastectomy because the silicone had leaked inside her body. These problems are still happening. We set up a register, but suddenly the register disappeared. I am glad that my hon. Friend has made a point about the register and asked for the Minister’s commitment on this.

Photo of Owen Smith Owen Smith Labour, Pontypridd

I am grateful to my right hon. Friend for her kind words. She is completely right to say that there are devices on the market here and across the world that are still causing grave medical problems for patients. The question we have to ask is: how did these things get on to the market in the first place? How have we got so many of these devices that are causing such significant problems? The common problem that unites mesh with all the other device scandals in our country and across the globe is the weakness of the regulatory system in the UK, in the EU and, to a lesser extent, in America, where the pathway for testing approval, marketing and surveillance of such devices just is not good enough.

How does the system work? It will shock people to hear that we do not have a central body that is responsible for checking out, authorising and licensing devices in the same way as for medicines. If a company in the UK wants to create a new prosthetic hip joint, it does so and then it shops around among a group of what are called notified bodies. These are effectively commercial organisations that are in turn licensed by the MHRA to be a body that checks safety and efficacy through the clinical data provided by the companies and then gives them their conformité Européenne—their EU kitemark. Once a company has received that mark, the device can be sold all across the EU.

Companies do not need clinical trial data in order to substantiate their claims that devices are efficacious and safe. Quite often—this is true of a remarkable proportion of the devices on the market—they do not even have to undertake first-hand clinical evaluations themselves and can rely on being follow-on products that go through a regulatory pathway that is termed as being “substantially equivalent” to the products that have gone before. For instance, there are examples of mesh on the market now that are the 61st iteration of an original licensed mesh that is no longer on the market because it was proven to be dangerous. There is no real mandatory post-marketing surveillance of these devices.

Given that the difficulty of randomised control trials versus placebo for a device—someone cannot put a wooden heart into one patient and a pacemaker into another in order to see which one works—means that there will be a degree of risk in testing such things in the real world, one would think that we would have a system that would test how devices are doing in the real world and get companies or the Government to monitor them, but we do not, which is in stark contrast to the regime for medicines. Changes are coming into effect, however. A new medical devices regulation was launched across the EU in 2017 and will come into effect in May 2020. It was introduced with the acknowledgement of many of the problems that I have highlighted.

Photo of Jim Shannon Jim Shannon Shadow DUP Spokesperson (Human Rights), Shadow DUP Spokesperson (Health)

I congratulate the hon. Gentleman on securing this debate on an issue that is important to many of us. With the EU’s new medical device rules coming into place in May 2020, as he says, does he agree that the number of available notified bodies is already diminishing? The Government must be aware of that and must work to find a way to secure acceptance of UK notified bodies as part of any arrangement, allowing for the smooth transition of notified bodies and product certification.

Photo of Owen Smith Owen Smith Labour, Pontypridd

I agree in part with the hon. Gentleman. One thing that I did not say earlier is that there are 50 notified bodies across the EU, so if a company goes with its new artificial hip to one body and says, “Will you approve this for my CE mark, because I would like to sell it in the EU?” and the body says no, because it does not think the data is good enough, all the company has to do is go to the next notified body, and if it says no, the company can go to the one after that, and if the third body says no, the company can go to the fourth one. Neither any of the notified bodies nor the manufacturer are under any obligation to disclose that the device had been turned down earlier. I agree that fewer notified bodies would be a good thing, but there are big questions for us in the UK because we will have no notified bodies once we have left the EU.

There are other problems with the new directive, which is a strengthening of the regulations, but it is not strong enough. For example, it now says that companies should summarise their clinical trials data, that they should take clinical data that is, if possible, sourced from clinical investigations carried out under the responsibility of a sponsor—meaning something more akin to randomised control clinical trials—and that they should ordinarily have a quality management system and a post-market surveillance system that should be proportionate to the risk class of the device in question. However, the point is that none of those things is mandatory.

There is no mandatory requirement to conduct proper trials or to max out the tests that are done. There is no mandatory requirement to publish data. There is no mandatory requirement to publish all data, including negative data. There is nothing to stop the companies continuing to conceal data, or shopping around between different notified bodies, and there is nothing to stop the companies doing the bare minimum on surveying how their product is doing in the marketplace. The directive is a strengthening but, unfortunately, it is not the strengthening we need.

If we leave the EU, the directive will not necessarily apply in all regards in the UK. The Government have tried to respond to the concern voiced by others before me by saying that they will effectively apply the regulation in future, but that would bring difficulties in and of itself. As I said, we would effectively be accepting products that are kitemarked and approved elsewhere in Europe, and not by our own notified bodies, because we will not be part of that system any longer. I assume we will be using the European database on medical devices, which is designed to work right across Europe, but we will not be part of the expert panels that reflect on the findings reviewed through that database.

Crucially, I assume that the MHRA will be filling some of those gaps. It will already have an almighty job on its hands in trying to fill the gap on medicines once we are outwith the purview of the European Medicines Agency. I fear that devices will once again be the Cinderella of the medical game. We did not have regulations for devices at all before 1990, and we may find that we are playing catch up with the European Union in future.

Whichever way Brexit turns out, and in reflecting on the flaws in the regulatory system I have highlighted, I ask the Minister, first, to try to get the MHRA, or whatever replaces our current regulatory pathway, to go back to the first principles of protecting patient safety at all times. There is too much talk in Europe of maintaining our advantage over other markets as an early adopter of innovation. Well, early adoption can go wrong if the innovation has not been adequately tested, and mesh is a great example.

Secondly, will the Minister do what the Royal College of Surgeons has asked her and the Government to do and set up a national registry of all “first implanted into a man or woman” devices—the innovations—so that we can track what happens with those devices, as we should have been able to do with mesh? Thirdly, will the Minister make sure that whatever system we have imposes much more stringent obligations on companies to undertake the most rigorous tests in respect of such medicines? In any new system, we should rule out anything like the substantial equivalence model that has been deployed in Europe for so long. It seems crackers to have a system that is basically a paper-based exercise without any real-world tests.

Lastly, I would like our Government to follow the example of the Australian Government, where the Minister’s counterpart, Greg Hunt, issued a national apology to the many women whose lives have been ruined by the debilitating effect of pelvic mesh implants:

“On behalf of the Australian government I say sorry to all of those women with the historic agony and pain that has come from mesh implantation, which have led to horrific outcomes”.

Our Government should similarly apologise to women damaged by surgical mesh. Irrespective of how Brexit turns out, they should pledge to radically reform the regulatory pathway for this class of medicines in order to make sure that no patients, men or women, suffer, as patients have in the past, as a result of medical devices.

Photo of Jackie Doyle-Price Jackie Doyle-Price The Parliamentary Under-Secretary for Health and Social Care 7:39 pm, 12th February 2019

I congratulate Owen Smith on securing this debate and again challenging me on the regulation of medical devices. Obviously, we have discussed issues relating to mesh before, but this evening he has given a comprehensive critique of the weaknesses in the regulation of medical devices. We have to be very conscious that, unlike drugs, once a medical device is implanted, it stays there for good; the body does not process it and it does not leave the body. We can, therefore, imagine that clinical evidence and trial evidence will take many years to build up. Our perspective, from the point of view of trying to guarantee patient safety, needs to consider that in any future method of regulation.

The hon. Gentleman has highlighted some of the weaknesses. It is fair to say that perhaps in the past regulation has focused excessively on what is in the commercial interests of businesses to maintain competition, rather than having patient safety at its heart; I think that, when it comes to medical regulation, it should have that at its heart. Naturally, he referred to mesh, which he and I have discussed many times before. There is no doubt that mesh has transformed the lives of some women when they were living with the debilitating consequences of stress incontinence, but it is becoming clear that mesh was deployed far too insensibly—far too many women were given this treatment, often at comparatively young ages, given that this was going to stay in their body for a long time.

I do not want to pre-empt what will come out of the Cumberlege review, but I have discussed some of the findings with Baroness Cumberlege. On the whole issue of how our medical establishment have dealt with this, the conversations that have taken place with women who were having this treatment were utterly inadequate and we will learn many lessons. I say to those women who have suffered badly at the hands of mesh treatment that there are clear medical criteria relating to that product and, if they have any complaint about the treatment they have received, they should be pursuing claims for clinical negligence against their practitioners. We look forward to the conclusions of Baroness Cumberlege’s review.

The hon. Gentleman and Ann Clwyd mentioned the issue of the national devices registry. I will say, up front, that I can assure them that this matter is already under consideration by the Department and it is linked to our wider digitisation agenda for the NHS. We have the technology and we should use it, in the interests of patient safety. We will be implementing that under new EU regulations to trace medical devices through unique device identifiers. I would be more than happy to meet him at a later date as we progress these proposals. As we depart from the European Union, we have an opportunity to alter our regulatory system. I am not sure that all my Conservative colleagues, in pushing Brexit, see it as an opportunity to tighten regulation, but that opportunity remains, so I look forward to that dialogue.

We clearly need to improve the existing system of regulation. As the hon. Gentleman mentioned, the EU directive currently under consideration will deliver that improvement, and we fully intend to take that forward. As he has described, medical devices are regulated in an entirely different way from medicines, and we need to make sure that regulation remains fit for purpose and that it responds to technological innovation. We also need to make sure that we have sufficient pre-market assessment, so that in assessing their efficacy we can really give evidence of how these devices are used by patients. That is why manufacturers, notified bodies and the MHRA conduct ongoing post-market surveillance. We will all wish to be made more confident that that is fleet of foot where it identifies any potential weakness. The more data we can collect, the more we can make those judgments earlier. The emergence of a better registry will enable us to do exactly that. I acknowledge wholeheartedly that there is scope for improvement and that systems and processes need to be constantly tested against the ultimate purpose—that guiding star, the principle of patient safety. No patient who presents themselves to any area of the national health service should expect anything other than the best possible care. They should be able to trust that we have in place a regulatory regime that will protect them. I am personally committed to that review and challenge.

As I mentioned, we will implement the regulatory improvements currently being taken through the EU, even though we are now leaving the EU institutions. We are confident that the regulation will drive system-wide improvement, including to the levels of clinical data mandated before products can be placed on the market. That will establish a strong and improved baseline for any system we implement after our departure from the EU. These changes to our system will place more stringent requirements on those manufacturing and supplying medical devices and will enhance the MHRA’s market surveillance responsibilities, resulting in clearer obligations to conduct inspections and the ongoing safety monitoring of devices.

In advance of those new regulations, the Government have taken a number of actions to ensure that existing legislation is operating as effectively as possible. That includes a programme of joint assessments of notified bodies, including inspections by multiple competent authorities to ensure that notified bodies’ assessments of new products and robust implementation of new standards for the clinical data are required for the new high-risk devices coming to the market.

It is true, I have to confess, that there has been a historic lack of transparency in the current system. It has not always been easy for patients to investigate and find more data about the things being put in their bodies. That is why the Government have prioritised the issue in negotiations on the new EU legislation. When those changes are implemented, there will, as the hon. Gentleman said, be an EU database that will contain details of all devices on the UK market, including where safety issues are identified. We are committed to ensuring that that will happen as part of our planning for a no-deal exit from the European Union.

Before I run out of time, I again want to mention the Cumberlege review, which will report later this year. It will give us many lessons about just how our medical device regulation has been less than optimal in the past. We will of course commit ourselves to any changes to respond to that review. I thank the hon. Gentleman for securing this debate and I look forward to further debate with him on these issues.

Question put and agreed to.

House adjourned.