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NI Protocol preventing approval of life-saving cancer treatment


The Tagrisso treatment for early stage cancer is not approved in NI. (PA)

The Tagrisso treatment for early stage cancer is not approved in NI. (PA)

The Tagrisso treatment for early stage cancer is not approved in NI. (PA)

A new cancer treatment for patients in Great Britain has not been approved for Northern Ireland because of the Irish Sea border.

The News Letter reports that clearance for the treatment was given a week ago but the government did not spell out that this would not extend to Northern Ireland.

Prior to Brexit, The Medicines and Healthcare products Regulatory Agency (MHRA) in London approved medical drugs for the whole UK.

However, the Northern Ireland Protocol means that Northern Ireland is now bound by the decisions of the European Medicines Agency (EMA), while the rest of the UK can make its own decisions.

The protocol is part of the Brexit Withdrawal Agreement that has created a trade border down the Irish Sea by keeping Northern Ireland in the EU single market for goods, and as a result it means EU customs rules are enforced at its ports.

Issues around the Northern Ireland Protocol are due to be discussed during a meeting between Prime Minister Boris Johnson and Taoiseach Micheal Martin later today.

In January the UK announced that it was joining other countries – including the US and Singapore – in ‘Project Orbis’, a fast-track approval process for promising new cancer treatments.

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Last Friday the MHRA announced that the first UK approval under that scheme had been given, with clearance for the drug Osimertinib – marketed under the name Tagrisso, a post-surgery treatment for lung cancer, to be used in early stage lung cancer treatment.

The MHRA said that the extended licence for the use of the AstraZeneca medicine “offers a novel treatment option for these patients, after their cancer has been surgically removed, in an area of significant unmet need”.

Health Secretary Matt Hancock said last week: “It is absolutely vital that NHS patients have access to the most promising, cutting-edge treatments as quickly as possible.

“Leaving the EU presented us with the opportunity to join Project Orbis – an international collaboration with the top regulators around the world - to speed up the time it takes to get these new medicines to patients.”

However, Mr Hancock made no mention of Northern Ireland being left out of what he said was “absolutely vital” for the rest of the UK.

When asked about the issue, the MHRA confirmed that “any extension to the licence of Osimertinib (Tagrisso) in Northern Ireland must be authorised via the EMA’s centralised procedure which would automatically have effect in NI”.

It said that the drug “is available for all NI patients who will benefit from this treatment at the oncologist’s discretion while authorisation by the EMA is finalised”.

Stormont’s Department of Health told the newspaper that “patients in NI may still be able to access Tagrisso for this additional indication following a discussion with their clinician, in line with extant processes for access to new medicines.”

But TUV leader Jim Allister said this was “a practical demonstration that in reality, the protocol is bad for your health”.

“Cancer can pick any of us, whatever you background,” he told BBC’s The Nolan Show.

“To think that courtesy of the protocol patients in Northern Ireland who need this post-operative drug are going to be a in a disadvantaged position compared with like patients in the rest of the UK is truly appalling.”

“This is putting the protocol above the lives of citizens and how could that ever be right?” he added.

UUP health spokesperson Alan Chambers said: “Headlines around the future availability of medicines and medical equipment due to the NI Protocol will of course be extremely worrying. The Department of Health under the leadership of Robin Swann is working to find solutions and ensure that speculation does not become a reality.

“The European Union must acknowledge the damage that was caused to the confidence of suppliers by triggering Article 16 over vaccine supplies. There is a big onus on them to rebuild confidence and be active players in ensuring solutions are found.

Margaret Carr, Cancer Research UK’s public affairs manager in Northern Ireland, said many cancer patients here will find it hard to understand why they have to wait longer for life-saving treatments which are available elsewhere in the UK.

She added: “We must ensure that every effort is made for promising new cancer drugs to receive regulatory approval quickly, so that people living with cancer here can get the best possible treatments which will help them to spend more time with their loved ones.”

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