Frost renews call to exclude medicines from Northern Ireland Brexit rules

Industry figures warn of supply ‘cliff edge’ when new regulations come into effect in December

David Frost has renewed calls for medicines to be excluded from 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 the issue needed addressing further.

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”.

The head of an organisation that represents medicines wholesalers said supplies to Northern Ireland were already made complex by Brexit, which requires Northern Ireland 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, the executive director of the Healthcare Distribution Association (HDA), 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 “most” of the HDA’s concerns related to the future, he told a 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 suppliers from continuing to deliver to 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 told peers. “Medicines need to be available universally to all citizens of the UK equally. 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, a 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 were covered by EU centralised procedure rules included innovative drugs for treating migraine and cancer pain, he said. He commended staff at the Department of Health and the Medicines and Healthcare products Regulatory Agency (MHRA) as being “unfailingly courteous” and helpful over 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,” Williams said in reference to the divergence of regulations between the EU and the UK in December.

The Department of Health said changes to UK and EU legislation havd meant that “medicine supply to Northern Ireland is stable”. However, it confirmed there were “medium- to long-term risks to supply created by the protocol”.

A government spokesperson said: “Patients in Northern Ireland have access to the medicines they need, just as those in Great Britain do, and our priority is to safeguard the continued supply of medicines to patients in Northern Ireland and help ensure equity of access for patients across the UK.”

The EU has been approached for comment.


Lisa O'Carroll Brexit correspondent

The GuardianTramp

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