Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 — House of Lords, 2019-09-30
Topic: Health
Andrew Lansley (Conservative, Centre-right): Perhaps I may add a few words on the subject of medical devices. I apologise that I was not able to be here to talk about these regulations earlier in the year, but I would like to say something about the regulation of medical devices now. The world has slightly moved on and, from my own point of view, that is rather helpful. I want to focus on medical devices in particular I remember the 2017 European regulations, to which the noble Baroness, Lady Thornton, referred and which will come into effect next year for medical devices and in 2022 for in vitro diagnostics. The ones on medical devices stemmed from the breast implant activity from way back when I was Secretary of State. I remember a conversation with my then French counterpart, Xavier Bertrand—now, I think, in charge of the Nord-Pas-de-Calais region. In response to that activity, his contention was that we had to change EU regulation so that all medical devices went through exactly the same authorisation process as all medicines. That would have been a complete disaster for the industry. Happily, that did not happen, but these regulations represent a considerable tightening of the risk classification processes under the EU regulations I think that the answer to the question from the noble Baroness, Lady Thornton, is that the intention—I think it is already in our regulations in preparation for a no-deal exit, if necessary—is to continue to recognise EU regulations for medical devices and in vitro diagnostics, and to recognise them in the future. Clearly, we would do that under a transitional process with the withdrawal agreement and I think our intention is to do so in any case. That means that, if we leave and are treated as a third country, we will recognise a CE marking from the European Union but it will not recognise an authorisation made in the United Kingdom. It will not be a mutual recognition process, which ideally is what we are aiming for and which a transition process under the withdrawal agreement would have enabled us to negotiate for a future relationship. That is much to be wished for This is not a small deal. In the European Union context, something like 40% of the highest-risk medical devices in Europe have in the past been authorised by the UK’s Medicines and Healthcare products Regulatory Agency. Approaching 50% of bodies requiring a certificate of conformity have gone to UK notified bodies, so the UK notified bodies are in an extremely strong position and, as a necessity of our leaving the European Union, to some extent they will lose that position. For example, the British Standards Institution will be a notified body in the United Kingdom, but it is also a notified body in the EU by virtue of being based in Amsterdam—as indeed the European Medicines Agency has gone to Amsterdam. There is a transition process which, unfortunately, is not the one under the withdrawal agreement but one away from the United Kingdom, which is to be regretted The point I particularly want to make today—and all of this will be well known to the Minister and the department, and I am not asking him to comment on all of it—is about the combination of changes all occurring at one time. We may leave the European Union at the end of October or at the beginning of next year. In either case, it is very close to the point at which the medical device regulation comes into force in May 2020. The European Union is not ready. In a report published by KPMG a couple of weeks ago, only 27% of the 200 manufacturers of medical devices sampled said they were ready for the changes in the regulations next May. They may be ready by May, but they have had quite a lot of notice and are finding the new requirements very difficult The European Commission has recognised this and given a grace period for a number of products to enable the introduction of the new requirements to be pushed off to 2024. Frankly, at this stage it would be in our interests to encourage the European Commission to extend that grace period for all products through to 2024. New products coming in would be required to be certified in line with the new regulation, but all existing products would be grandfathered through and given until 2024 to go through the process. At the moment, there are only five notified bodies in the whole of the European Union, and that is not enough. If we leave at the end of next month without a deal, UK medical device manufacturers will have to go to notified bodies in the European Union to secure authorisation for their products within the EU—they cannot place them on the market by virtue of a United Kingdom authorisation. There are a range of coincident changes, and the more we can do at the moment to try to encourage the European Commission to push all existing products off from the requirements of this new regulation into 2024, the better it will be. I hope our Government, even if they seem to have taken the rather perverse decision not to engage with the European Commission while we are planning to leave, should engage with the European Commission and ask for this to happen Perhaps the European Commission might even embrace the thought that they were not ready, because the new Commission President, Commissioner Ursula von der Leyen, has decided to shift the responsibility for medicines and medical devices from DG Grow to DG Santé. Perhaps DG Santé, recognising that it has this new responsibility in the midst of all this transition—yes, even more—can say that the starting point is to put in place an extended grace period for all manufacturers, given the lack of capacity in the EU notified bodies system in the short run I do not expect my noble friend to reply on that, but I hope he will at least say that he will encourage the department to see whether it and the MHRA might engage their counterparts in the European regulatory system with that view in mind.