Sam McBride: A curious episode shows that the NI protocol is now too confusing for even the EU to understand

Almost 2,500 years ago, the Greek tragedian Sophocles observed that “no one loves the messenger who brings bad news”.

By Sam McBride
Saturday, 22nd May 2021, 7:01 am
Both the EU and the UK seem to have been bamboozled by the complexity of the protocol they negotiated. Photo: Ben Pruchnie/Getty
Both the EU and the UK seem to have been bamboozled by the complexity of the protocol they negotiated. Photo: Ben Pruchnie/Getty

That truth remains unchanged. Just over a week ago, the News Letter reported that a new cancer treatment has been approved for patients in Great Britain but has not been approved for Northern Ireland because of the Irish Sea border.

The story caused significant concern because the drug involved was essentially a test case for medicines in the post-Brexit era.

Within hours, European Commission spokesman Daniel Ferrie tweeted the strongest possible denunciation short of announcing a libel action. Linking to our report, he said that “this is entirely incorrect” and linked to a 3,600-word commission notice setting out the implications of the ‘grace period’ whereby the medicines border in the Irish Sea will largely be delayed until the end of this year.

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However, that night the UK medicines regulator – The Medicines and Healthcare products Regulatory Agency (MHRA) – said that Mr Ferrie was wrong and that the lengthy notice which he cited was irrelevant to the issue at hand, dealing instead with other aspects of the elaborate regulation of medicines.

Some bureaucrats love complexity because it can obscure awkward realities. Of course, some areas of government are unavoidably complicated but in these areas there is a particular need for scrutiny.

Some within the EU saw the report about approval for a life-saving drug as a disreputable attempt by Boris Johnson’s government to brief an emotive story designed to undermine the protocol. Seeing it as a low blow, they responded robustly.

In fact, the EU’s reaction was founded on a false premise. The story began two weeks ago yesterday when I got a call from Oliver Wright, The Times’ Policy Editor.

It was Wright who in September 2019 reported that the DUP had agreed to drop its objection to regulatory checks in the Irish Sea.

Arlene Foster denounced that report with the nonsensical retort that “anonymous sources lead to nonsense stories”, despite the fact that every party – including the DUP – briefs stories anonymously every week. Wright’s story was accurate, as was apparent within three weeks.

He rang two weeks ago because a health industry source – not anyone in government – had spotted an unusual decision by the MHRA.

The regulator had extended the licence for the drug Tagrisso to be used in treating early stage lung cancer. However, two parts of it were odd: the decision only covered Great Britain, but the government press release did not make clear that Northern Ireland had been excluded.

After a week of attempting to get answers in Belfast while Wright tried to get answers in London, The Times and the News Letter both reported on the issue last Friday.

This newspaper’s front page said that “a new cancer treatment has been approved for patients in Great Britain – but has not been approved for Northern Ireland because of the Irish Sea border”.

We did not report that the drug itself was unapproved – Tagrisso has been approved by the EMA for later stage lung cancer, but not for this new use. Nor did we claim that it is banned even for the new use in Northern Ireland – the report made clear that there are other routes by which unapproved drugs can be prescribed, but they are more complicated and time consuming.

It is the first time in my career where a claim that an important story is fundamentally flawed did not involve a request for a correction, clarification, or retraction.

Indeed, the EU did not at any point attempt to contact the News Letter to dispute any part of the report or to have it changed. It remains unamended on our website.

Rather, I contacted the commission to seek clarification on what it said was inaccurate. Mr Ferrie responded: “I’d like to apologise...if I was out of line with my tweet”, suggesting he was rowing back.

However, rather than setting out inaccuracies in the report, he showed that he had misread the article. The commission spokesman included his full briefing note circulated to other journalists last Friday which began:

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

Yet, the News Letter never said the treatment was “prevented”, but that approval for the treatment was prevented.

When it was pointed out that he was misrepresenting what this newspaper reported, Mr Ferrie stood over what he had said – even quoting back the accurate words of the report, seemingly not realising the difference between regulatory approval and other routes by which a medicine can be prescribed.

The real significance of this situation stretches beyond the patients in Northern Ireland whose lives could be saved by Tagrisso; the far wider truth is that every time a new drug or treatment is approved in London it will not automatically mean that it is approved in Northern Ireland.

Attempting to get Mr Ferrie to clarify this point, I asked him if the UK can approve this use of Tagrisso – or any other drug or treatment outside of a health crisis such as a pandemic for Northern Ireland if the EU has not done so.

Mr Ferrie’s answer began with the word “yes”, appearing to show that the protocol wasn’t an issue here after all, and therefore our report was wrong. However, the heavily spun answer did not mean that at all.

He said: “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.”

The answer cleverly gave the impression that the protocol did not stop a medicine circulating in Northern Ireland – but the reference to “compassionate grounds” gives away that it is an unapproved medicine.

“Compassionate grounds” only need to be used as an emergency route because the protocol means that London cannot approve the medicine for Northern Ireland.

In the House of Lords on Tuesday, government minister Lord Bethnell confused things further by claiming that the unapproved treatment would be available in Northern Ireland in exactly the same way as in Great Britain, as if it was approved.

He said that patients here “will all have the same access as in the rest of the United Kingdom, without any delay or restraint”.

When asked if it stood over those comments, Whitehall’s Department of Health did not do so. Instead, it passed the question to the MHRA which did not repeat the minister’s pledge.

Health Minister Robin Swann has said that the treatment will be available on “compassionate grounds” – an ad hoc process which involves a doctor contacting the manufacturer, AstraZeneca, directly.

Crucially, when asked if doctors faced a greater legal risk in these circumstances, the department admitted that “the responsibility that falls on healthcare professionals when prescribing an unlicensed medicine or a medicine off-label may be greater”.

Mr Ferrie’s tweet was the equivalent of Donald Trump’s cries of “fake news” – and was every bit as inaccurate. And yet, the response to Mr Ferrie’s words shows why even some of those who probably loathe Mr Trump’s politics borrow his methods.

Irish Foreign Minister Simon Coveney retweeted it uncritically, former EU Ambassador to the US David O’Sullivan said it showed my “fake news” had been debunked, Manufacturing NI said it uncovered “a lack of appreciation, understanding or indeed what the protocol is”, and Freight NI’s Seamus Leheny retweeted it approvingly with the message: “Like medicines, some people really need to start reading the small print”.

In fact, 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.