My Lords, on behalf of my noble friend Lady Thornton, I am moving Amendment 119 on the important issue of regulatory divergence with Northern Ireland and reporting to Parliament. I am grateful for the support of the noble Baroness, Lady Ritchie, who raised this key issue at Second Reading, as did the noble Lord, Lord Patel, whose Amendment 120 is grouped with this amendment. I look forward to their contributions and to those of other noble Lords.
Amendment 119 would add a new clause to the Bill on the interpretation of Part 3, “Medical Devices”. It would require the Government to work with the appropriate authority in Northern Ireland to
“minimise the potential for and mitigate against regulatory divergence in relation to human medicines, veterinary medicines and medical devices.”
Where an area of divergence is identified, the Secretary of State would be required to lay a report before Parliament on the impact it will have and the steps being taken to mitigate it.
Human and veterinary medicines are transferred matters in Northern Ireland. For this reason, Clauses 1 and 8 lay out in black and white the possibility of regulatory divergence, as they give separate powers to Northern Ireland departments to make regulations relating to Northern Ireland. However, despite this being in the Bill, the rest of the legislation as drafted is completely silent on the implications this may have, or on any mechanism for dealing with them. This means Northern Ireland could end up passing different legislation.
As well as those powers in the Bill, there is the wider context of the Northern Ireland protocol, under which Northern Ireland will continue to apply certain European Union standards that will no longer automatically be part of the law governing Great Britain. For example, in the Government’s own guidance on regulating medical devices from 1 January 2021, it is stated that, unlike in Great Britain, the EU medical device regulations and the EU in vitro diagnostic medical device regulations will apply in Northern Ireland from May 2021 and May 2022 respectively.
The risks of divergence have been raised by Members in both Houses, including the risk that what may on the face of it seem to be only minor or technical differences could create a butterfly effect, leading to much larger legal and operational problems. The Bill
does not itself create divergence and nor for that matter does the Northern Ireland protocol, but both permit it or create a situation in which it may arise. It is therefore vital that the implications of this are part of discussions on the Bill.
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On the issue of reporting to Parliament, Amendment 120, in the name of the noble Lord, Lord Patel, which we support, calls for an
“annual report to Parliament on potential areas of regulatory divergence between Northern Ireland and the rest of the United Kingdom in matters covered by this Act.”
Can the Minister tell the Committee what preparatory work is being done, specifically in response to this Bill, to minimise and mitigate against any adverse consequences of possible divergence between Great Britain and Northern Ireland in the medium and longer term? What structures will be put in place to address this issue? Who will have responsibility for identifying possible areas of divergence? How will Parliament be kept informed?
There is deep concern about this issue and what happens if Northern Ireland and Great Britain end up with increasingly different legislation covering medicines and medical devices. I look forward to the debate and the Minister’s response.