Unapproved cancer treatment to be equally available in Northern Ireland, regardless of Irish Sea border, says minister

In comments which raise questions about the whole point of the approvals process for medicines, the government minister told the House of Lords that there would be no difference whatsoever for patients in Northern Ireland – even where a treatment is not approved here.

Last week the News Letter reported that The Medicines and Healthcare products Regulatory Agency (MHRA) in London had extended the licence for the drug Tagrisso to be used in treating early stage lung cancer – but only in Great Britain.

The NI Protocol means that Northern Ireland remains bound by approval of the European Medicines Agency (EMA) which is expected to licence the treatment soon, but has not yet done so.

On Friday the European Commission claimed the News Letter report was “entirely incorrect”. However, it has not asked for a correction, did not contact this newspaper and when contacted by us provided no evidence which refutes our report. The MHRA said that the commission was wrong, and the protocol prevented it from approving the treatment.

Last week Stormont’s Department of Health similarly said that patients in Northern Ireland “may still be able to access” the treatment on a case by case basis – a slower and more bureaucratic route than in GB.

However, yesterday government minister Lord Bethnell told peers the treatment “is available to all patients, including in Northern Ireland, at clinical discretion, with no delays”. Tory peer Lord Moylan questioned if this involved giving Northern Ireland patients access “on an application by clinicians on an individual case basis, which is not the same ease of access which exists in the rest of the UK”.

Lord Bethnell replied that this was not the case and “they will all have the same access as in the rest of the United Kingdom, without any delay or restraint on that access”.

In response to Ulster Unionist peer Lord Rogan, the minister said there was “absolutely no delay or problem of access for this drug”. He went on to say that the treatment “will be offered to patients across the UK, including Northern Ireland, on exactly the same terms”.

On Monday Brexit minister 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 NI rather than the UK doing that”.

‘Major implications’ for NI medicines, says health minister

The protocol “has major implications for the regulation and supply of medicines and medical devices”, Health Minister Robin Swann has told MLAs.

Speaking in a Stormont debate brought by the DUP, Mr Swann referred to Tagrisso, saying that “Northern Ireland follows the conditions of the EMA licence. When a change of licence held by MHRA was approved...it applied only to Great Britain, leaving Northern Ireland subject to an EMA update, which has not yet happened”.

However, he said officials worked with the manufacturer “in order to enable Tagrisso to be available in Northern Ireland for patient use in line with the rest of the United Kingdom while allowing it to be used outside its licence” on the basis of “compassionate use and judged on a case-by-case basis”.

He said: “Tagrisso has proven to be an example of the complex issues that we currently face and the additional steps and procedures that now need to be managed when there are differences between the decisions of the MHRA and the EMA on medicine authorisation.”

The UUP minister added: “This situation is very far from ideal. New layers of complexity and bureaucracy are being created. I appeal to members to choose their words carefully, however. There are uncertainties and challenges, but every effort is being made by my department to ensure that the needs of all our patients and people in Northern Ireland are met.”

DUP MLA Jonathan Buckely, who brought the debate, said: “I welcome the fact that there has been a grace period, but the impact has been masked. When that ends, suffering will be inevitable because of the Northern Ireland protocol.”

Fellow DUP MLA Pam Cameron said: “The fact that the EU calls it a “grace period” is in itself an insult.”.

She added that “medicines and medical devices should never have been in the conversation in the first place”.

Fellow

However, Sinn Féin’s Colm Gildernew told the Assembly: “We would not be here debating this issue if the British Government did not go down a path of a hard Brexit with maximum disruption and divergence.

“The Tories, enabled by the DUP, chose this hard Brexit, and you must both own it. Innumerable opportunities were available to minimise divergence in medicines regulations, as well as in trade and many other areas.”

TUV leader Jim Allister said: “I trust that those who vote for the rigorous implementers [of the protocol] will see what rigorous implementation means. It means that they put their ideology above their constituents’ health.”]

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