Licensing of Medical Devices

Jim Shannon Excerpts

Tuesday 12th February 2019 Commons Chamber

[Owen Smith]

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.

[Jim Shannon (Strangford) (DUP)]

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.

[Owen Smith]

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.