No clarity over whether EU rules could ban UK vaccines from Northern Ireland

Yesterday TUV leader Jim Allister expressed alarm at the implications of what Health Minister Robin Swann had told him in response to a written Assembly question seeking clarity on whether a UK-approved vaccine which had not been cleared by the EU authorities could be administered in Northern Ireland under the NI Protocol.

Mr Swann’s answer appeared to suggest that would not be possible, but his department failed to clarify the issue when contacted by the News Letter.

At the time of going to press, neither the government nor the European Commission had clarified the position either, although both said that they will issue statements.

Mr Allister had asked Mr Swann to set out the position for importing and approval of medicines from December 31, when one of the grace periods delaying aspects of the new border will expire.

Mr Swann responded: “Following the implementation of the Northern Ireland Protocol on 1st January 2021 Northern Ireland remains aligned with the EU acquis for medicines, whereas Great Britain does not.

“Medicines for Great Britain and Northern Ireland are now regulated under different regimes but overseen by the Medicines and Healthcare Product Regulatory Agency (MHRA), the UK’s medicine and medical product regulator.

“The UK Government and the EU Commission have agreed a 12 month period to allow industry time to prepare for the regulatory and supply chain changes that will be required to comply with the NI Protocol by 1st January 2022.”

Mr Swann highlighted that last month Michael Gove wrote to European Commission Vice President Maros Sefcovic to propose an extension the grace period for medicines until at least January 2023.

Mr Allister said the response showed that “in simple terms, Northern Ireland is only able to benefit from the UK’s successful vaccine rollout now because of a grace period. But for the grace period, we would be tied to the failed and failing EU policy on vaccination.”

Highlighting how far ahead of the EU the UK vaccination programme has been, he asked: “Do we really want to follow such a path? The success of the UK vaccination program is a telling reminder of just what the benefits of Brexit are to a liberated United Kingdom. Freedom from bureaucracy and Brussels red tape meant the UK was able to lead the world in protecting its citizens from the virus.

He said the issue showed that the problems with the sea border were “not just constitutional” and that far from the protocol representing ‘the best of both worlds’, it would be “quite literally bad for your health.”

When asked about the issue, the Department of Health said that the MHRA “can license new medicines, including vaccines, on behalf of the whole UK both now and beyond the 12 month phased in period”. However, when asked if that meant it could disregard EU rules in doing so, the department did not respond.

Medicines are referred to in some detail in Annex 2 of the Northern Ireland Protocol, which sets out the provisions of EU law which continue to apply in Northern Ireland.

However, the phrasing of the annex is highly complex, referring to multiple EU laws, some of which will fully apply and some of which will apply in modifed form

Nevertheless, the lengthy section of the protocol dealing with medicinal products does make clear that many medicines will be covered by EU law – from medicines for human and veterinary use to those for paediatric use, advanced therapy medicinal products and the conduct of clinical trials.

One of the difficulties of the lack of clarity on what the situation will be at the end of this year is that it makes it hard for medical authorities and pharmacists to plan – in what is meant to be a transition period – for the new rules.

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