Draft Medical Devices (Northern Ireland Protocol) Regulations 2021

Alex Norris Excerpts

Thursday 15th July 2021 General Committees

[Alex Norris (Nottingham North) (Lab/Co-op)]

It is a pleasure to serve under your chairship, Dr Huq.

The Minister and I have had a touring show in Committee, implementing various parts of the Northern Ireland protocol, and this instrument is very much in the same vein. However, unlike the Minister himself, the Northern Ireland protocol is not ageing well. [Laughter.]

Lord Frost said last week that it is wrong to view the Northern Ireland protocol as a “definitive” text. I would say that when we consider instruments of this nature—I have done an awful lot of them now—the things that we are doing feel rather “definitive”, and it is an extraordinary failure of statecraft to characterise an agreement that the UK entered into willingly in this fashion. I recommend that hon. Members read the transcript of the consideration of this instrument in the other place. It is quite something to read the level of criticism of the status of Northern Ireland now with regard to instruments such as this one, with much of it coming from some of those who were the most enthusiastic about our embarking on this course in the first place.

So why are we here today? As the explanatory memorandum says, it is not to implement the EU medical devices regulation, which came into effect from 26 May; Northern Ireland has taken those rules in a way that the Government said it would not have to. Within that regulation, there is latitude for individual countries to diverge from the MDR where national law differs and in the areas that the Minister talked about: on single-use devices and custom-made devices, we differ. This instrument is therefore necessary to ensure that we can do that across the whole of the United Kingdom. Of course, we support that idea, so I will not seek to divide the Committee today. However, I will briefly pick up a few points with the Minister regarding alignment, enforcement, and the conformité Européenne or CE mark more broadly.

First, the instrument addresses the fact that, although the EU MDR is fully applied, our MHRA remains the regulator. Therefore, we need to give it—again, this is why we support the SI in front of us—provisions for enforcement of fees and so forth where national divergences exist, so that we can have alignment. However, I wonder what this will mean in practice for the people of Northern Ireland. What impact will there be if the European Medicines Agency and the MHRA depart markedly from each other’s regulatory regimes, and what would that mean for businesses and their products? What conversations has the Minister had with colleagues in the Northern Ireland Executive?

While the Northern Ireland protocol is in effect, and very definitively so, a CE mark is required to go to market. That is potentially advantageous for patients in Northern Ireland versus those in Great Britain, as the vast majority of products—for example, 600,000 medical devices—that have been approved in the EU are already CE-marked across the whole of the UK. That would continue to be the case under the protocol, but the situation could change in Great Britain after 2023. Indeed, I believe that the plan is to introduce the new UK(NI) mark. At the moment, we have access to 600,000 devices with the CE mark, but we do not know what the plan will mean in years to come.

Will the Minister give some detail about parliamentary opportunities to scrutinise and improve plans for the relationship between the CE mark and the UK(NI) mark? That will become a fundamental question of patient safety across the UK in years to come, and we really ought to have a very strong plan for it, all lightness aside, even if there are elements of the Northern Ireland protocol that the Government think will be dropped at some point. This element definitely will not be, because it is a core part of our medical devices regime going forward. We would benefit from having more opportunity to discuss that point.

On enforcement, the SI will give the MHRA powers to serve notices for breaches of the EU MDR, so manufacturers will need to take a number of steps to ensure that their goods can still be sold after the deadline, as noble lords mentioned in great detail when they considered the SI. What discussion and consultation have the Government had with the sector? I agree wholly with the judgment that the SI does not pass the threshold for an impact assessment, but ongoing consequences may do so in the future, so I am keen to know what sorts of questions the Government have received.

My final point is on an issue that I raise every time we have a matter relating to the MHRA, but I am never quite sure that we get a strong answer. There was a similar issue in Committee yesterday. What enforcement capacity does the MHRA really have for the range of duties that it has acquired through our exit from the European Union, through the Medicines and Medical Devices Act 2021, through the SI on coronavirus tests that we discussed yesterday, and through the responsibilities picked up in the SI we are debating? Are there more people doing enforcement than there were three years ago, when none of those responsibilities existed? Is the funding for that on a sustainable footing? Is it something that can be built around? Can people be trained and developed and become real experts on this issue? We will need that to have a secure regime, because we will lose all our protections from working in a flock with our colleagues on the continent. The Minister mentioned that the SI does not apply to in vitro devices and that we still rely on the 2002 regulations. Are there plans to update that in due course?

This is the tip of a bit of a whopper of a mess. Approving the SI is the right thing to do today to ensure that, to the best of our ability, Northern Ireland can be part of our medical devices regime. In the conversations that we are having outside this place on issues relating to this matter, the central question should always be patient safety, but the central question is now about borders and bureaucracy, which is what we were told it would not be about. I hope the Minister can address my questions.