Frost renews call to exclude medicines from Northern Ireland Brexit rules

Lord Frost has renewed calls for medicines to be excluded from the Brexit trading rules in Northern Ireland amid claims that supplies could be threatened in December when regulation of pharmaceuticals in the UK further diverges from the EU.

He described the much-praised fix put in place by the EU last year to ensure the continued long term supply of medicine supplies as “Heath Robinson” and said it the issue needed further addressing.

The former Brexit minister was speaking after leading pharmaceutical figures told a House of Lords committee that supplies were “OK” following the EU change in legislation but that a change in regulations in December threatened a “cliff edge” for supplies.

The head of an organisation that represents medicines wholesalers said supplies to Northern Ireland were already made complex by Brexit, which requires NI to observe EU rules on goods.

“Distributing medicines into Northern Ireland is challenging, problematic, inefficient, and a sort of slow strangulation by a thousand cuts if you like,” said Martin Sawer, executive director of the Health Distribution Association, which supplies 90% of high street chemists and the NHS with prescription drugs twice a day.

His members “feel that the UK and the EU has done its best to interpret regulations sympathetically” but that “most” of the HDA’s concerns related to the future, he told a House of Lords committee examining the protocol.

In December, new British rules come into play which may require separate licences and separate packaging for medicines in Northern Ireland, which may deter some from continuing supplying in the region.

“The tectonic plates between GB and NI are slowly moving apart and all the regulations have been stuck on top like sticking plasters,” Sawer said. “Medicines need to be available universally to all citizens of the UK equally,” he told peers. “And we believe the divergence will make will put that under threat.”

Lord Frost said in a tweet: “We told the EU repeatedly during 2021 this would happen if they insisted on imposing their Heath Robinson solution unilaterally.

“It would have been much simpler for all to take pharma out of the protocol but the EU ruled this out a priori.”

Paul Williams, senior corporate affairs director at the medicines manufacturer Teva UK, said he had “grave concerns” about the future.

“The only issue that keeps me awake at night, and I say this not as a metaphor, but as a reality, is a thought of a patient not getting a medicine they need,” he said.

Some of the medicines that are currently covered by EU centralised procedure rules include innovative drugs treating migraine and cancer pain, he said.

He commended staff at the Department of Health and the MHRA as being “unfailingly courteous” and helpful regarding the issue but said it was not the same as talking to the decision-makers.

The committee heard that the discontinuation of at least 1,000 drugs at the end of 2021 in Northern Ireland had been averted by the EU change in legislation on medicines going into the region, but that it was only a temporary fix.

“We still don’t have that stability and certainty over the coming years. It feels like we steered away from one cliff edge but there’s still more to come,” he said in reference to the divergence of regulations between the EU and the UK in December.

The Department of Health and EU have been approached for comment.