Medical Devices (Northern Ireland Protocol) Regulations 2021

Baroness Brinton Excerpts

Monday 12th July 2021 Grand Committee

[Baroness Brinton (LD) [V]]

My Lords, I thank the Minister for a non-urgent statutory instrument that was tabled on 16 June and is being debated at an appropriate time, after MPs and Peers have had the opportunity to look at it in detail. I am sure I am not alone in looking forward to more of these in future. I also thank him for his helpful explanation at the start of this debate.

These regulations set out the mechanism to adjust legislation to ensure that the use of medical devices complies with both the EU’s and Great Britain’s regulations. As the noble Lord, Lord McColl, said, most people in Northern Ireland are likely to need to use one of these devices during their lives, so it is important that we get it right. He also referred to the problems with certain devices covered in the Cumberlege review. Can I further refine his question to the Minister? Which Minister will be responsible for the delivery of the Cumberlege review in Northern Ireland? Will it be the Minister in Stormont or the Minister in Westminster?

Even though it has been made necessary by the Northern Ireland protocol, this SI appears to have been come to sensibly, solving the problem without the noble Lord, Lord Frost, or the Prime Minister immediately blaming the EU. That has to be encouraging because an enormous amount of detail has to be sorted out. The noble Lords, Lord Empey and Lord Dodds, and the noble Baronesses, Lady Hoey and Lady Ritchie, set out their frustrations with these regulations as an inevitable necessity resulting from the Northern Ireland protocol. From these Benches—over the past three years, at least—we have warned about the problems of what became the Northern Ireland protocol and the position that it would leave Northern Ireland in, which we deplore. However, given that this Government pushed through the Northern Ireland protocol with the withdrawal Act, we believe that the issues with the implementation of the protocol will be solved only by the EU and the UK working together to find a solution.

It appears that this SI might be one of the first to take that route. This is at least better than the noble Lord, Lord Frost, and the Secretary of State for Northern Ireland, Brandon Lewis, going to the Irish press just after 21 June to accuse the EU of adopting a theological approach to the protocol that is frozen in time, only a few days after the European Commission had announced its proposals for, among other things, medicines entering NI to be exceptionally regulated by the UK. That is a step forward, despite the concerns raised by the Northern Ireland Peers.

This SI lays the pathway for current legislation to be amended, including the creation of a criminal offence. Can the Minister say what scrutiny there will be by Parliament of this specific offence nearer the time? The Explanatory Memorandum makes it plain that this is not

“to address a deficiency in retained EU law”

but because of the withdrawal Act, as has been mentioned. It is good to have that confirmed, although some detail is about the UK elements of its parallel regulation. We are just going to have to become used to this, but I have some questions about the fees for applications and inspections.

Paragraph 12.4 of the Explanatory Memorandum says that “fees for services” will be

“kept on par with those charged in Great Britain, despite there being additional resource requirements to carry out the work under the EU MDR. The fees … will therefore be below the cost recovery level.”

Which Government will bear the cost of that extra work if it cannot be recovered from the manufacturers? Will it be the UK Government or the Northern Ireland Assembly? I hope the answer is the UK Government because the Northern Ireland Assembly should not have its budget penalised because of the Prime Minister’s decision to support the Northern Ireland protocol. In Regulation 12(1)(a) of the SI, in relation to “Prior authorisation of clinical investigations by the Secretary of State”, will the Secretary of State have these powers elsewhere in the UK or does this relate only to Northern Ireland?