A major issue facing the pharma supply chain in the UK coming out of Brexit has been the impact of the NI Protocol and what this means for the ability to supply medicines to patients in NI. The NI Protocol had been introduced to deal with the situation where NI would have access to the EU's Single Market without a hard border in the island of Ireland, but in a way which noted that NI was still a part of the UK. The reality has been that the barriers have caused problems for supplies from Great Britain (GB) to NI.
Following the end of the Brexit transition period on 31 December 2020, there was a grace period covering supplies of medicines to NI, which had been due to expire on 31 December 2021.
However, given confusion and concerns for what it would mean for supplies coming from GB, suppliers started to withdraw supplies to NI as they did not see that it was worth their while having different arrangements for a relatively small market. Both the UK and EU sides wanted to avoid that, as ultimately patients in NI would suffer.
After months of discussions, where the UK had been proposing to withdraw medicines from the NI Protocol altogether, in December 2021 the Commission came up with an alternative proposal to amend EU law to accommodate the NI issue.
The Commission proposal was published just before the Christmas break, so, despite an apparent solution, the detail has needed to be absorbed and worked through.
On 2 and 3 February, the MHRA ran webinars to help with the understanding of the latest position, and has promised to provide guidance to be published on its website very soon. Of particular note from the MHRA webinars:
This continues to be a very complex area and an on-going legacy from Brexit. Judging by the complexity of issues covered in the MHRA webinars and the scope of the questions, a lot of detail needs to be fully explained and understood. To that end, suppliers will look forward to the further guidance documents being published from the MHRA. The MHRA will also be providing an FAQs document in due course.