My Lords, from the outset it has been clear that there was a potential for regulatory divergence in Northern Ireland from the rest of the UK for medicines and veterinary medicines, since they are referred to separately in the Bill as reserved matters in Northern Ireland. However, it has been made clear in the last quarter of 2020 that interaction with the Northern Ireland protocol makes that divergence inevitable for medical devices as well.
Guidance published by the MHRA in October, which I referred to previously, and statutory instruments laid before Parliament in the final months of 2020, set out two different systems of market authorisation and registration, among other issues, and distinguished between the Northern Ireland and Great Britain markets for medical devices and medicines alike. The Northern Ireland protocol requires that EU regulations relating to medicines, veterinary medicines and medical devices apply to Northern Ireland, while CE marks will cease to be recognised in the Great Britain market from July 2023 unless the products in question are from manufacturers based in Northern Ireland.
There are essentially two paths for manufacturers based in Northern Ireland to bring a medical device product into the Great Britain and Northern Ireland markets. The first is to go through UK-based approved bodies for their assessment and market authorisation, which will be approved for both the Great Britain and Northern Ireland markets but will not be recognised in the EU. The second is to submit an application to approved or notified bodies in the EEA to gain a CE mark and thus access to the markets of Great Britain, Northern Ireland and the EU without further needing to apply to a UK body for approvals for the Great Britain market.
By contrast, manufacturers based in Great Britain will need approval from UK-based bodies to place their products on the market in Great Britain and Northern Ireland, but will need to undertake the separate task of setting up an EU-based responsible person and apply separately for a CE mark in the EU. It appears that the recognition of a CE mark on a medicine or device coming from Northern Ireland provides easier access for Northern Ireland-based manufacturers to both the UK and EU markets. What is not clear is the extent to which this dual system between Northern Ireland and the rest of the UK will diverge in substance.
For these reasons and many others, the Government should clarify the position. The amendment would provide greater transparency on potential regulatory divergence, with a commitment to mitigate it where possible. Of course, I will not be surprised if the Minister does not accept the amendment, and neither do I think the noble Baroness will divide the House on it, but whether we agree with it or not, I hope the Minister will agree that somebody has to have some way to recognise what this divergence will do. Who will that be? Would she agree that this will be needed in due course?
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