EU embarrassment: Brussels confused by own Brexit laws – accidentally blocks cancer drug

Northern Ireland: Talks with EU 'unproductive' says Frost

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The Commission said it is “entirely incorrect” to blame Brussels over the issue, arguing that the Northern Ireland protocol and other arrangements in the Brexit agreement “ensure the continued availability of medicines” in Northern Ireland. Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) last week approved osimertinib (brand name Tagrisso) for patients with early-stage lung cancer, in line with a worldwide scheme aimed at fast-tracking promising medicines.

The treatment can improve survival rates by as much as 75 percent – but because it has not yet been given the green light by the European Medicines Agency (EMA) patients living in Northern Ireland are not eligible for it, as things stand.

The issue, which relates to the terms of the Northern Ireland protocol whereby the region remains bound to some EU rules and regulations, was described to the Times by one Government insider as being of “significant concern” because it has the potential to inflame already heightened tensions within the unionist community.

The EU has yet to complete its own assessment of osimertinib, meaning the drug cannot yet be prescribed within the bloc – or within Northern Ireland, under the current arrangements.

The news was originally denounced by Sam McBride on News Letter, who is now accusing the EU Commission of failing to understand its own rules.

Within hours from breaking the news, EU Commission spokesman Daniel Ferrie tweeted that the report was “entirely incorrect” claiming the issue had to do with the “grace period” whereby the medicines border in the Irish Sea will largely be delayed until the end of this year.

But the MHRA dismissed Mr Ferrie’s account and said the notice which he cited had nothing to do with the problem they faced.

After being contacted by Mr McBride for further clarification, the EU Commission spokesman said: “I’d like to apologise…if I was out of line with my tweet.”

But a full note he later gave reporters showed Mr Ferrie had completely misread the article and lacked an understanding of the difference between regulatory approval and other routes by which medicine can be prescribed.

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He wrote: “Recent reports suggesting that the protocol prevents the use of certain cancer treatment in Northern Ireland are entirely incorrect”.

The original report, which remained unchanged, claimed the approval of the use of the medicine as a cancer treatment was “prevented”, not the treatment itself.

In an attempt to make Mr Ferrie clarify this point, the News Letter reporter asked him if the UK can approve this use of Tagrisso if the EU is yet to do so.

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Mr Ferrie replied: “Yes, in the event that a particular medicine has not yet been approved by the EMA, but has been approved by the UK regulator, the UK regulator could authorise its use on the basis of… an exemption on compassionate grounds.”

“Compassionate grounds” are however only a route to be used in emergencies because the Northern Ireland protocol means that London cannot approve the medicine for Northern Ireland.

Lashing out at the bloc, Mr McBride wrote: “The EU had not been reading its own small print. This is not really about Mr Ferrie, who is ultimately just a messenger for the EU.

“What this suggests is that the EU and the UK have been bamboozled by the complexity of the protocol and are making this up as they go along.

“In an area where lives are at stake, that message is more important than the messenger.”

Speaking in the House of Lords when the news broke out, Brexit minister Lord David Frost Lord Frost told MPs that “despite a little bit of dust thrown in the eyes by the EU” it was “clear that they are asserting their right to regulate cancer drugs in Northern Ireland rather than the UK doing that”.

“That sort of thing is going to be a problem if we can’t find pragmatic ways through it that protect our UK National Health Service.”

He added: “It’s absolutely clear that the people in Northern Ireland must have access to a broad range of medicines as people do everywhere else in the UK.”

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