Last night, there was a fresh Brexit spat after the EU reaffirmed its resolve to continue with a solution to a heated border row that the UK had downplayed this summer.
Under the Northern Ireland Protocol, the European Commission is currently developing a plan to ensure the continued long-term supply of medicines from the United Kingdom to Northern Ireland beginning next year.
Despite the UK government’s objections, Eurocrats are working on a legislative proposal for the European Council and European Parliament to consider.
According to reports, the plan would include regulatory compliance functions, such as quality control tests for new medicines destined solely for the Northern Ireland market, which would be performed in the UK on an ongoing basis.
Then, instead of requiring that companies set up these procedures in Northern Ireland or the EU after existing grace periods expire in December 2021, this would be an alternative.
However, according to Brussels, the UK government led by Boris Johnson would have to put specific safeguards in place to ensure that those products did not cross the border into the EU’s internal market beyond Northern Ireland.
When it is time to approve goods for use in Northern Ireland, UK ministers would also be required to fully apply EU medicines legislation on quality, safety, batch testing, and release.
Last night, the Commission stated clearly that the proposed solution would be “based on a clear commitment from the UK to put in place the safeguards.” While a Brussels source said the legislative proposal will be presented to the Council and Parliament before the end of the year.
If no solution is found soon, it may warrant drug manufacturers to withdraw up to 90% of the drugs they ship to the region. Meanwhile, a Whitehall source close to the Protocol’s negotiations slammed the request to align with EU rules for medicines, calling it absurd.
They said, “The EU’s system would be a bureaucratic nightmare to run. We have already made clear to them the proposal will not work, it seems they are just pressing ahead with their own agenda.”
The UK’s tough stance on medicines comes after ministers revealed intentions to postpone border inspections on goods entering the country from Northern Ireland while crucial discussions to rework the Protocol begin.
The Protocol is a component of the Brexit divorce agreement that aims to avoid a hard border between Ireland and Northern Ireland.
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