We’re not to blame for cancer treatment not being approved in NI, says EU – but regulator says that’s wrong

The EU has claimed that Stormont’s Department of Health and the UK medicines regulator are wrong in saying that a pioneering new cancer treatment has not been approved for Northern Ireland because of the NI Protocol.

Saturday, 15th May 2021, 7:53 am
The lung cancer treatment has not been approved for Northern Ireland

Yesterday the News Letter and The Times reported that the drug Osimertinib – marketed under the name Tagrisso, a post-surgery treatment for lung cancer, has been approved for use in early stage lung cancer treatment.

The EU has approved the drug for other uses, but has not yet approved that treatment.

Last week Health Secretary Matt Hancock said it was “absolutely vital” that NHS patients have access to cutting-edge treatments as quickly as possible – but failed to mention that Northern Ireland has not been treated the same as the rest of the UK.

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The EU’s European Medicines Agency has indicated that it is likely to approve the treatment, meaning that if that happens quite soon the delay for Northern Ireland may be slight.

However, the case highlights that every time a new drug is approved in London it will not automatically mean that it is approved in Northern Ireland.

Yesterday European Commission spokesman Daniel Ferrie tweeted a link to the News Letter story and said: “entirely incorrect” and that the protocol would “ensure the continued availability of medicines in NI”.

He linked to a complex EU document of almost 4,000 words entitled C/2021/450 with no further explanation as to why the treatment has not been approved for Northern Ireland.

As of last night, neither the MHRA nor Robin Swann’s Department of Health had responded to requests for comment.

However, two sources with knowledge of the issue questioned the accuracy of Mr Ferrie’s tweet.

Robin Swann’s Department of Health did not respond to the EU. However, the MHRA last night stood by its position that the protocol is the reason why the treatment has not been approved for Northern Ireland.

When Mr Ferrie’s tweet was put to the regulator, it told the News Letter: “MHRA authorisation approval was not addressed by the grace period covered in the Commission’s notice C/2021/450.

“The grace period temporarily waives a number of different regulatory requirements for NI medicines including FMD and importation issues but it does not cover authorisation routes.

“Under the Protocol, NI must follow the EMA centralised procedure for medicines authorisation. In the meantime, Tagrisso can be dispensed in NI for patient use in line with the rest of the UK at the discretion of oncologists.”

That process is much more complicated and involves delays which do not exist when a treatment is approved by the regulator.

The MHRA added that the government and the Stormont Executive “are committed to ensuring equitable access to new treatments for all UK citizens. This means that all parties will work together to support access to new drugs through innovative pathways, including Project Orbis”.

In yesterday’s News Letter report Cancer Research UK’s public affairs manager in Northern Ireland, Margaret Carr, said that “the divergence of regulations between GB and NI will potentially have implications for approvals of some new cancer drugs in the future” and that some cancer patients will find that “difficult to understand”.


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