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

Noble Lords will note that the original regulations were developed through close consultation and co-operation with stakeholders, and that the department has published an impact assessment. After a period of informal consultation in August last year, the MHRA published an initial proposal for the UK’s medicines regulation framework and followed this up through a four-week public consultation in October. The feedback from that consultation—which received about 170 responses—led to revised proposals, which were published in January, and informed the development of the system that will come into place in the event of no deal. Noble Lords will have seen the published impact assessment, which was developed by experts at the MHRA and influenced by responses to the consultation. Noble Lords will want to be reassured that none of the proposed amendments change this impact assessment.

I will now give some specific detail of the arrangements set out in this SI. The majority of the changes being made are technical in nature and have arisen as we have reviewed the legislation and identified areas requiring changes to the legal text to ensure that it gives effect to the published policy. There are no new policy changes introduced in this SI.

This SI makes the following amendments for medicines specifically. First, it makes clear the requirements for a responsible person for import and RPI and for a wholesaler’s licence to hospitals importing human medicines directly from a country on an approved list for their own use. Secondly, it clarifies that UK generic applications can rely on data supplied in relation to medicinal products whose EU marketing authorisations were cancelled pre-exit on grounds other than safety, quality and efficacy. Thirdly, it gives additional detail in relation to the process by which companies may make representations to the Commission on Human Medicines about decisions on rare disease medicines and paediatric matters. Fourthly, it provides for a temporary exemption, subject to a specified condition, from the obligation to maintain a UK pharmacovigilance system master file for companies whose UK authorisations are included in an EU file. This also includes the condition that information required by the licensing authority be provided by the marketing authorisation holders on request. Fifthly, it clarifies that the temporary exemption as to the geographical location of an appropriately qualified person for pharmacovigilance applies to all marketing authorisations and herbal registrations that a company holds, whether granted before or after exit day. This is provided that they are covered by a single pharmacovigilance system in respect of which there is the same qualified person. Lastly, it adds the Republic of Korea to the approved list of countries with equivalent regulatory standards for the manufacturing of active substances on exit day. This is to reflect the updates to the EU list since the no deal SI was made.

For medical devices, there are some changes resulting from amendments made by the EU to the underlying medical devices regulations since the no-deal SI was made via the recently published corrigendum. The changes range from grammatical and reference corrections to a change concerning what is included in the transitional arrangements. Two further changes are inserted to ensure that products mainly used for cosmetic purposes are required to comply with common specifications and to require the information registered with the MHRA about medical devices to be updated by the manufacturer.

In conclusion, in the event of no deal these regulations will put in place technical changes that will ensure that the UK’s medicines regulations legislation continues to function effectively after exit day. These provisions will minimise any impact on patients and businesses and will ensure the timely availability of safe, effective medicines in the UK market.

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?

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.