In the space of a week, what was slow progress on the Northern Ireland Protocol has turned into a dangerous stand-off.

London has synthesised its critique of the EU's approach to the Protocol: it is guilty of a rigid approach to its implementation that is blind to unionist sensitivities.

Europe’s insistence on checks and controls on food entering Northern Ireland from GB are disproportionate to the overall risk to the EU’s single market and consumer health.

Unionist alienation is unsustainable, and therefore the Protocol, as is, poses a direct threat to the North’s institutions, and to the Good Friday Agreement itself.

This is the charge sheet.

Warning about violence during the loyalist marching season is a subtler part of the message. David Frost, the UK’s Brexit minister, told the House of Commons European Scrutiny Committee on Monday: "We all know that the late spring and summer in Northern Ireland can sometimes be turbulent."

Such rhetoric is seasoning the pot that unionism is stirring.

David Frost met four members of the Loyalist Communities Council (file image)

If loyalists have complained about not being listened to they certainly have a captive audience now. Last week David Frost met four members of the Loyalist Communities Council (LCC), including those representing paramilitary groups.

According to David Campbell, one of the delegates, Lord Frost did not disagree when they told him the Protocol breached the Good Friday Agreement.

This week the LCC was listened to again by the Northern Ireland Affairs Committee, whose chairman Simon Hoare MP was left speechless when Joel Keys, a 19-year-old member of the delegation, said: "I am not sure if and when violence will be the answer. I am saying that I would not rule it off the table."

The view in Dublin is that UK rhetoric is dangerously fuelling tensions, and raising expectations that the Protocol will be ditched or radically changed. Already the new DUP leader Edwin Poots has said it is "unimplementable" and has to go.

After the Chequers meeting between Taoiseach Micheál Martin and Prime Minister Boris Johnson last week, Irish officials came away feeling that London was changing the narrative.

"Now they're using the famous unfettered access phrase as applying in both directions [from GB-NI, as well as NI-GB], which was never the case," says one official present.

"There’s also this new approach of, well, we signed up to what we signed up to, but we didn't really think anyone was going to implement it the way the EU was going to implement it."

Furthermore, Dublin fears London will insist that, even if the current technical negotiations produce flexibilities here and there, that will still not be enough, as Northern Ireland will still be treated differently from the rest of the UK.

"If that’s what they think, then we have a real problem, a bigger problem," says a senior Irish source.

It is not clear if that is what the UK thinks, but British officials have been clear that they want a major change to the Protocol, or at least how the European Commission interprets or implements it.

This gets us back to what the Protocol requires, and what scope the EU has to be as flexible as the UK wants it to be.

The UK’s own explainer on the Protocol in October 2019 states that it ensures "an open border is maintained on the island of Ireland, a key objective for all sides in this negotiation."

It adds: "Any processes normally required on goods entering the EU will be implemented at the Northern Ireland/Rest of World border [i.e. ports and airports] or on trade moving East-West between Great Britain and Northern Ireland.

"For as long as Northern Ireland participates in the customs arrangements and regulatory zone, there will therefore be processes to ensure that goods entering Northern Ireland destined for the EU pay the right duty and that all goods comply with the appropriate rules."

The UK’s complaint is the extent to which the appropriate rules must apply, especially when it comes to sanitary and phytosanitary (SPS) controls, the ones that will hit the movement of food going from GB depots to Northern Ireland supermarkets.

But there are other concerns around plants, pets, parcels and quotas on steel imports.

Technical talks on all these issues have been continuing on an almost daily basis, and they are said to be conducted in a positive spirit. However, it is in the SPS sphere that there is a real problem.

The UK wants two things, or at least if they can have one, then they can live without the other. But both are linked.

The rhetoric from David Frost and others could, of course, be a negotiating strategy. Even if it is, it could raise expectations among unionists that the UK is capable of walking away from the Protocol.

The first is that the EU should take a risk-based approach to food entering Northern Ireland.

The argument is that consignments of food going from a Sainsburys depot in GB to a Sainsburys branch in Belfast cannot be treated the same way as a consignment of food from China arriving in Rotterdam.

The EU should assess on a category-by-category basis whether or not agri-food products, containing meat, eggs or dairy, that are produced in GB and shipped to Northern Ireland, really pose a threat to the single market, either its integrity or the health of its consumers.

British officials insist there is no evidence that such products have turned up in the Irish Republic or Latvia or France.

The EU’s response is that it has its own body of law on food safety and animal health. It is already risk-based, and the preference is for zero-risk.

"The [UK’s] risk-based idea won’t work because the risk today will not be the risk tomorrow, as soon as we say the rules don't apply," says one source. "As long as the UK refuses to apply our rules we have no guarantee how that's going to be in the future."

There are over 100 pieces of EU food safety and animal health legislation, covering abattoirs, storage, residues, additives, ingredients, animal feed, transportation, GMOs and so on.

These are, indeed, onerous rules, and all those legislative acts are contained in an annexe to the Protocol.

However, once you sign up to these rules you are part of the EU’s SPS zone, and can trade food with virtually zero checks and controls across 27 member states, as well as Switzerland, Norway, Lichenstein, Iceland, Andorra and San Marino.

The EU’s approach is also underpinned by the precautionary principle.

The legislation which set up the European Food Safety Authority in 2002 states that "the precautionary principle has been invoked to ensure health protection in the Community, thereby giving rise to barriers to the free movement of food or feed.

"Therefore it is necessary to adopt a uniform basis throughout the Community for the use of this principle."

In other words, if there are uniform rules across the EU and EEA, then there are no barriers to the free movement of food and animal feed.


Brexit Republic Podcast - Equivalence vs Alignment


This approach was confirmed by the European Court of Justice in the Fidanato case in September 2017, which dealt with GMOs in animal feed.

It’s understood the European Commission did explore the UK’s "risk" proposal in depth.

In the end it was concluded that London was asking the EU to overturn, or at least compromise on, a substantial body of law and jurisprudence, which 27 sovereign governments - including the UK when it was a member - negotiated, approved and currently apply, in order to reassure a public still spooked by food scandals.

Europe instead suggests that if the UK wants a sweeping solution to the food issue, one that would take care of up to 90% of Irish Sea checks and controls, then it should align with EU food safety rules.

There is, as yet, no formal proposal, but sources have suggested that because the UK is largely currently aligned, and because the grace periods agreed to in December required the UK to remain aligned for the duration of those grace periods, then a joint SPS agreement would be doable.

"The agreement could be incredibly short," says an EU diplomat, familiar with the negotiations. "It wouldn’t be 500 pages long, and it could be done quite quickly, because they are aligned at the moment.

"It’s not something that's regarded as a major technical exercise. You would have to factor in some language around the fact of the UK being a sovereign nation and that it could rescind the agreement with a period of notice if they felt they needed to."

That would be in the event of a UK-US trade deal, so in the Commission’s view any such alignment could be temporary.

However, the UK has flatly ruled it out, in public and in private.

David Frost told the House of Lords European Affairs Committee on Tuesday: "It’s been a fundamental issue of principle that we don’t dynamically align with EU rules in this or other areas."

This, he said, was not for ideological reasons but because if the UK was going to conclude free trade deals with other countries, for example Australia, it had to be in charge of its own rules.

Instead (and this is the second thing the UK has asked for), Frost referred to an "equivalence" agreement.

He said: "What we would like to see is an equivalence arrangement which reflects the fact that we both operate the high food standards which are, in most areas, extremely similar and which should enable reductions in paperwork and checks."

Frost said the EU had agreed equivalence arrangements with New Zealand and Canada, as well as with "half a dozen" other countries, but "unfortunately not with us."

He told the Committee: "[The EU] didn’t want to do an equivalence mechanism with us last year, but if they’d like to, we’d be happy to pick it up again."

Why is the EU opposed to an equivalence arrangement?

One reason EU member states excluded equivalence from Michel Barnier’s negotiating mandate in the free trade negotiations was that the UK had made it clear ahead of, and during, the negotiations was that it intended to diverge from EU SPS standards.

The view in Brussels is that if the UK plans to diverge, with no clarity as to when and by how much, then equivalence will not work.

Also, while alignment with the EU’s food safety rulebook permits participants to trade freely in every category, equivalence is patchy.

Separate arrangements for meat and milk, for example, are said to require detailed analyses and take years of negotiation, with separate legal frameworks for public health, animal health and labelling, and not covering other aspects contained in the EU’s rulebook such as residues and additives.

The equivalence deal between the EU and New Zealand, regarded as the model by David Frost, is the most advanced of its kind, but it only covers 14 legal acts, compared to the more than 100 that come with alignment.

Furthermore, official figures show the volume of agri-food trade between New Zealand and the EU is only 10% of that between GB and Northern Ireland, and the range of products - mainly lamb and dairy subject to further processing - is small compared to GB-NI.

Despite the equivalence arrangement, the EU still bans fresh minced meat, poultry meat and minced poultry from New Zealand.

UK officials believe the New Zealand approach should still be pursued, even if it reduces some checks here and there. Critics will also argue that, since the UK was still aligned with EU standards at the start of January, then an equivalence deal should have a head start.

Frost told the House of Lords Committee: "The discussions are not over. There is still a pretty significant difference between the two conceptions that may in the end may make it difficult to reach agreement."

What it means if they don’t reach agreement is hard to say. The UK continues to hint that it will trigger Article 16 of the Protocol should the EU not agree to a substantial and rapid change in approach.

Furthermore, the UK wrote to the Commission last week warning it would not hesitate to use the concept of force majeure in how it approaches the Protocol.

The 20-page letter - London’s response to EU legal action launched in March after the UK took unilateral action on the Protocol - levelled a series of accusations at the Commission for its handling of the Protocol, its apparent disregard for the sensitivities of unionists, and indeed the propriety of taking legal action in the first place.

But it also suggested there was an "interaction" between the Covid pandemic and the "delicate political balance in Northern Ireland". What’s more, the UK should be excused for not fulfilling the obligations of the Protocol because of the pandemic.

A less charitable interpretation is that London is keeping force majeure in reserve if the negotiation process runs out of steam.

Indeed, the letter states: "...if it should be necessary to do so, the United Kingdom will rely on the principle of force majeure…"

The letter has, needless to say, gone down badly in Brussels.

"The general message was that this wasn't a legal answer to legal questions," says one diplomat. "It was a political response. There was an element of querying the Commission's entitlement to do it in the first instance. It was politically aggressive, rather than any effort to deal with the substantive issues that were raised in the original letter."

Several weeks ago officials were hopeful that the UK response to the legal action could coincide with solid strides in the technical negotiations. This suggests the Protocol discussions are now well off course.

A Joint Committee meeting, bringing together Frost and his EU counterpart Maros Sefcovic, was tentatively envisaged for the first week in June. There was talk of renewed political momentum and a joint working document mapping out a comprehensive conclusion to the Protocol problems.

While diplomats say a Joint Committee meeting is still on the cards, a breakthrough seems unlikely.

In the meantime, charges against the Protocol are coming thick and fast.

Last Friday, the Belfast Newsletter ran the headline: "Irish Sea border prevents approval in Northern Ireland of life-saving cancer treatment now allowed in Great Britain."

The paper reported that the UK medicines regulator, the MHRA, had been prevented from licensing a new cancer treatment for Northern Ireland patients because of the Protocol.

Jim Allister, leader of the TUV, told the Newsletter: "Not only has our equal citizenship been trashed but the health of our cancer patients is jeopardised."

Jim Allister said the health of cancer patients was being jeopardised

What was behind this?

Under the Protocol, Northern Ireland remains in the EU single market for goods, including medicines.

The circulation of medicines throughout 27 member states is regulated by the European Medicines Agency (EMA).

Once licensed by the EMA, medicines are subject to quality control ("batch testing") and labelling rules, and retailers distributing and selling the products must hold an authorisation to do so, so that if any problems emerge the seller can be traced.

Those "authorised holders" must be located in an EU member state.

Before Brexit, the UK distributed EMA-approved medicines to other English-speaking member states such as Ireland, Malta and Cyprus. This made commercial sense.

So long as the "authorised holder" was located in the UK, the medicines could be distributed anywhere in the EU.

Now, however, the UK is out of that system, meaning the "authorised holder" can no longer be located in the UK.

Under the Protocol, medicines circulating in Northern Ireland will have to be approved by the EMA, and the "authorised holder" will have to be located in Northern Ireland (or in any EU member state).

Becoming an "authorised holder" is expensive and is often something only large pharmacy retailers do.

Both the EU and UK identified this as a problem during negotiations last year, and in December a one year grace period was agreed. On 8 January, the EU issued a unilateral declaration confirming this on the basis that "Northern Ireland faces particular challenges in this regard".

The declaration said the EU would ensure "an undisrupted supply of medicines to Northern Ireland and other small markets historically dependent on medicines supply from or through Great Britain."

As such, medicines entering Northern Ireland could continue to undergo quality control testing in Great Britain, and the "authorised holder" could still be located in GB.

So, why then did the MHRA refuse to authorise the new cancer drug for Northern Ireland?

Indeed, when the Newsletter story broke, the European Commission issued a swift denial, saying the story that the Irish Sea border prevented a life-saving cancer drug was "entirely incorrect."

This had already become a political issue, beyond Jim Allister’s reaction in the Newsletter. It’s understood Boris Johnson alluded to the report "indirectly" during his meeting with the Taoiseach in Chequers, as evidence of the burden of the Protocol.

On Monday, David Frost brought up the cancer story again during his hearing before the European Scrutiny Committee: "Over the weekend, we saw an example of the kinds of problems that can be generated, whereby it is clear, despite a little bit of dust thrown in the eyes by the EU, that they are asserting their right to regulate cancer drugs in Northern Ireland, rather than the UK doing that."

Frost’s deputy Rebecca Ellis then suggested that, despite the one year grace period, the MHRA was still prevented from licensing the drug in Northern Ireland.

"This is a medicine that is subject to what is called the 'centralised procedure’, meaning that the MHRA cannot, even now during this year, license it in respect of Northern Ireland," she said.

The drug in question is called Osimertinib, marketed as Tagrisso. The Newsletter reported that it had been authorised by the MHRA for England, Scotland and Wales after the UK - post-Brexit - had joined a global collaboration among medicine regulators to fast-track the approval of new cancer drugs.

The EMA had yet to approve the drug, the paper reported.

However, Tagrisso was already available in Northern Ireland and had been since 2016. It has also been available throughout the European Union.

What was different now was that it was being approved for a new cohort of cancer patients, those with early onset lung cancer. It’s understood that, in Northern Ireland, they number around 10 people.

Furthermore, those patients have not been denied access to Tagrisso.

During the Committee hearing on Monday, Rebecca Ellis confirmed that, contrary to the reported concerns from Cancer Research UK that Northern Irish patients would have to "wait longer for life-saving treatments", oncologists in Northern Ireland can dispense the drug "off-label... so it can still be made available to patients in Northern Ireland".

The European Commission insists that the grace period would have applied to Tagrisso’s authorisation for Northern Ireland.

The EU has codified the grace period into law, and it was published in the Official Journal of the EU on 25 January.

The law allows for "importers placing medicinal products supplied from or through Great Britain on the market in Cyprus, Ireland, Malta or Northern Ireland or wholesale distributors placing such medicinal products on those markets...to have, in justifiable cases, certain controls carried out in Great Britain."

In other words, if the quality controls on Tagrisso were carried out in Great Britain, then there would be no reason for the product not to be prescribed in Northern Ireland.

When asked what was the chink in the Protocol grace period that prevented the UK regulator from extending the use of Tagrisso to a new cohort of patients in Northern Ireland, an MHRA source said: "Our position is that the grace period doesn't cover authorisation routes."

There is no doubt that the Protocol will bring about a new regime in Northern Ireland when it comes to the authorisation of medicines.

This is, indeed, unsettling and will anger those on the unionist side who deeply resent Northern Ireland from being treated any differently from the rest of the UK.

However, there are still intense negotiations between EU and UK officials on a long term solution, and sources say an overall agreement is possible.

It is also worth noting, as an MHRA source did, that the EMA may, in some circumstances, authorise life-saving drugs quicker than the UK, and patients in Northern Ireland would have access to them sooner than those in England, Scotland and Wales.

All that aside, the UK’s ambiguous attitude to the Protocol, and the wide gap in expectation as to how flexible the European Union can be, remain worrying features.

The rhetoric from Frost and others could, of course, be a negotiating strategy.

Even if it is, it could raise expectations among unionists that the UK is capable of walking away from the Protocol, either because the EU refuses to gamble on its body of law, or if the UK invokes force majeure, blaming the pandemic.

Or even by claiming that, as a sovereign government, the UK has a straightforward responsibility not to upset the balance of the Good Friday Agreement.

Why that sense of responsibility was nowhere to be found in the run up to the Brexit referendum in 2016 does not appear part of London’s current thinking.