UK, EU agree Northern Ireland medicine stopgap post-Brexit

A trade agreement between the UK and EU may still be elusive, but the two sides have agreed a transition period that will maintain the status quo for medicines in Northern Ireland for a year.

The UK and the EU have agreed a phased process for implementing medicines regulation in Northern Ireland up to December 31, 2021, which means that the current batch testing, importation, and Falsified Medicines Directive requirements remain in place for 12 months after the end of the Brexit transition period.

Under the Northern Ireland Protocol of withdrawal agreement, the EU pharmaceutical regulatory framework will continue to apply in Northern Ireland, which means that pharmacies there will have to comply with FMD even after the end of the transition period.

Great Britain, which is the main supply route for medicines into Northern Ireland, will no longer have to comply with the FMD, which could disrupt trade in medicines across the Irish Sea.

The agreement means that for a year at least, medicines in Northern Ireland will still be governed by EU regulations, but these will be enforced by the UK Medical and Healthcare products Regulatory Agency (MHRA).

It’s a temporary solution if the ongoing trade talks between the UK and EU are abandoned without a deal, in which case the UK would trade with the EU on Word Trade Organisation (WTO) terms.

However, that should buy enough time to adapt to the new situation – whatever that may be – according to the Association of the British Pharmaceutical Industry (ABPI).

It’s estimated that around 80 per cent of medicines used in Northern Ireland are delivered daily from the UK mainland. Under the current regulations, those medicines need to be scanned and its unique identifier verified at the point of dispensing to comply with FMD safety feature provisions to protect patients from falsified, expired or recalled drugs.

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As it stands, there are a lot of unanswered questions about how the FMD safety verification system will operate, with some reports suggesting that the European Commission doesn’t want that to apply outside the bloc.

If so, the UK will have to develop its own system and in principle at least identifiers would have to be decommissioned as medicines moved from the UK to the EU and vice versa.

“We are pleased the UK Government and EU Commission have responded to the concerns raised by industry and removed the immediate threat of a cliff-edge in the way medicines are distributed to Northern Ireland from the end of this year,” said the ABPI and other trade bodies in a joint statement.

“We await the detail of how this will work in practice and there is much work to do. But this is a pragmatic step in the right direction. Both sides must now use the next 8 weeks to clarify the rules which will apply in Northern Ireland from 2022, so that companies can make full use of this extra time to prepare for the long-term.”

Both sides need to agree how the regulations will be interpreted and implemented come December 2021, and the ABPI is also calling on the UK Government and EU Commission to negotiate a mutual recognition agreement for medicines manufacturing.