Licensing of Medical Devices — House of Commons, 2019-02-12
Topic: Mixed Topics
Owen Smith (Labour, Centre-left): 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.