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.
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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 people of Northern Ireland must have the same access to the full range of medicines as anyone else in the rest of the UK. Solutions to such challenges need to be found urgently. We have been calling on the EU to show the flexibility and pragmatism required to reach permanent solutions,” another added.
Margaret Carr, Cancer Research UK’s public affairs manager in Northern Ireland, warned: “The divergence of regulations between GB and NI will potentially have implications for approvals of some new cancer drugs in the future.”
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.
Jim Allister, leader of the Traditional Unionist Voice party, said the wrangle proved the Northern Ireland protocol was “literally bad for your health”.
He added: “When a life-giving cancer drug is prohibited in Northern Ireland, because we have been left under the control of the EU Medicines Agency and denied what our fellow UK citizens can avail of, then, the iniquity of the protocol is plain for all to see. Not only has our equal citizenship been trashed but the health of our cancer patients is jeopardised.”
Referring to the start of today’s Judicial Review in Belfast, he added: “It is because of punitive outcomes like this that today we take our fight against the protocol to the High Court.”
Tagrisso is made by AstraZeneca, the drugs company which is already the subject of EU legal action over its alleged failure to supply the agreed number of doses of its coronavirus vaccine to the bloc.
Earlier this month, the MHRA licensed the drug in accordance with Project Orbis, an innovative programme coordinated by the US Food and Drug Administration (FDA), with Canada, Australia, Switzerland, Singapore, Brazil and the UK as other participants.
Health Secretary Matt Hancock said: “It is absolutely vital that NHS patients have access to the most promising, cutting-edge treatments at 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.
“I am delighted that today we are able to see the first results of our involvement in this partnership, with a groundbreaking drug for lung cancer which will soon benefit hundreds of patients, and I look forward to seeing what further innovations it will bring to the table.”
Tom Keith-Roach, President, AstraZeneca UK, added, “Project Orbis is a powerful example of how collaboration between regulatory authorities around the world can accelerate the approval of life-changing treatments and we’re delighted that osimertinib is the first medicine to undergo this innovative review process with the MHRA.
“It’s fantastic news that NHS patients in England with this specific type of early-stage lung cancer will have early access to this medicine, which could significantly improve their chance of disease-free survival. We will continue our work to secure access for patients in the devolved nations at the earliest possible opportunity.”
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MHRA chief executive Dr June Raine CBE, said Project Orbis offered an opportunity to ensure patients received earlier access to promising, life-saving cancer treatments.
She explained: “We know that the earlier we can treat patients, the better their outcomes. Through international cooperation, innovation in regulation, and working with others across the whole health system, the MHRA is cementing the UK’s global position at the centre of life sciences and healthcare access.”
