The EU is set to announce significant changes to post-Brexit regulations that will allow medicines to continue to flow between Britain and Northern Ireland.
The move signals welcome progress in difficult and complex negotiations about the implications for Northern Ireland amid the UK’s departure from the EU.
As part of Brexit, Northern Ireland remains in the EU’s Single Market for goods, including pharmaceutical regulations.
This is to avoid a hard border between UK province Northern Ireland and the Republic of Ireland, which remains part of the EU.
Some fear the re-emergence of border infrastructure between the two would see a return to the sectarian violence that blighted the region for decades.
Why are the changes necessary?
The changes signalled by Brexit were not due to take place until next month when a 12-month grace period expires.
Yet problems were foreseen, prompting Brussels to act and change the Northern Ireland Protocol.
With Northern Ireland in Britain’s medicines supply chain, there were fears that important medicines — including cancer drugs and COVID drugs — would no longer get through.
However, some pharmaceutical firms had already confirmed they would end the supply of certain medicines to Northern Ireland due to the cost of having to comply with processes arising from being part of the EU system.
But the EU is now proposing to make fundamental changes to Single Market legislation as part of a bespoke arrangement for Northern Ireland.
It will allow Northern Ireland to continue to access medicines including generic drugs from the NHS.
EU’s Brexit negotiator Maros Sefcovic announced plans last July, saying the EU was “adapting supply chains to the new situation is still particularly challenging, in particular for suppliers of generics”.
Are relations improving between Brussels and London?
After several weeks of inflexible and at times fruitless talks, the development is set to be announced on Friday.
“It’s a unilateral legislative proposal because it’s EU law but it’s based on an understanding with the UK,” said an EU source close to the talks.
Meanwhile, the UK is insisting on the removal of the European Court of Justice as part of any wider deal on the future of the protocol.
It is a red line for the EU as the ECJ is the final arbiter of EU law, including the EU’s Single Market.
Just weeks ago it was heavily anticipated in Brussels that the UK would effectively suspend indefinitely the protocol by triggering Article 16 – a dispute mechanism procedure contained within it.
The EU warned of grave consequences for doing so including major trade sanctions across all sectors of the British economy.
”It feels like they [the UK] want to calm things for now, maybe because the risk is too great for Boris Johnson, and the UK is fully aware of the repercussions if they try to suspend the protocol,” said a source.