Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Lord Lansley Excerpts

Monday 30th September 2019 Lords Chamber

[Lord Rennard (LD)]

My Lords, I begin by declaring my interests as in the register. My work with the British Healthcare Trades Association has identified concerns among the manufacturers of medical devices about what might happen with the future regulation of their products as a result of Brexit.

The regulation of medical devices and medicines is, of course, very necessary to protect patient safety, and it enables businesses to sell their products in the UK market, the much larger EU market and overseas. The evident need for the technical amendments that we are now considering suggests that the Government’s preparations to leave the EU are being made in great haste. It is also clear from them that there will be no benefit to anyone in changing the basis of the existing provisions for the regulation of medicines and medical devices.

Most countries recognise the great worth of current EU standards when they consider whether to allow products to be imported and sold to their citizens. If we leave the EU on 31 October, existing products that have been approved by the EU regime will of course continue to be approved, but surely problems will arise with new products as standards diverge in future—as inevitably they will. Will the Minister therefore say something about the potential impact of this legislation on the innovation of medicines and medical devices? British businesses will in future have to apply for licences to UK authorities if they want to sell new products here, and they will also have to seek approval from EU bodies if they wish to sell those new products in the European market and in the many other countries that already respect EU standards. This will mean two application processes, a potentially longer wait for approval and two sets of costs incurred in securing approval for new products.

Does the Minister accept that some businesses will feel inhibited in seeking approval for new products on that basis, that they might be tempted just to continue trying to sell old products that have already been approved, and that such inhibition might have a damaging impact on patient care and on the capacity of businesses to grow, especially if they seek to export new products? Will the Minister say something about how this impact on innovation might be ameliorated?

Most fundamentally, will the Minister confirm that leaving the EU on a no-deal basis will mean that we deny ourselves, and the rest of the EU, the benefits of sharing costs and expertise concerning the regulation of medicines and medical devices? Furthermore, does he accept that in the long run we need to work towards greater worldwide acceptance of standards to avoid new products requiring the approval of multiple agencies in the UK, the EU and elsewhere?

[Lord Lansley (Con)]

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.