Stiff medicine needed to get the Protocol over the line before Christmas

The pace of Protocol negotiations is quickening.  Yesterday and earlier today The BBC nationally was giving rare prominence to this incomprehensible topic (if you’re not NI/Irish).  After today’s meeting the straws in the wind were a bit more favourable but without Lord Frost  clearly  shifting position.

Technical talks ahead of Friday’s meeting had focused on guaranteeing the supply of medicines from Great Britain to Northern Ireland.

Mr Šefčovič said there had been progress in this area, adding: “We now need to press on and get this crucial issue across the line.

“This is a real test of political goodwill.”

He said that on the issue of customs there had been “initial useful engagement at a technical level”.

Lord Frost said that with medicines, any solution needed to ensure that products were available at the same time and on the same basis across the whole of the UK.

He added that there had not been “substantive progress on the fundamental customs and SPS (agrifood) issues relating to goods moving from Great Britain to Northern Ireland”.

Yesterday the EU /Irish side was sounding more hopeful. At a, meeting of the British Irish Council   the Taoiseach Micheál Martin said the “mood music had changed”,  and urged the UK to believe that the EU’s desire for a deal was real. And he hoped that Boris Johnson would not “let the perfect be the enemy of the good”.

Without wanting to remind you of all the angst of last year’s Christmas Eve trade deal, he also pleaded with the prime minister not to run things down to Christmas.

Speaking in his role as Intergovernmental Minister at the British-Irish Council summit in Cardiff, Michael Gove  added:Lord Frost has signalled that while, of course, it’s always possible that Article 16 may require to be invoked, we’re confident that we’ll be able to make progress without it.

Meanwhile, a piece of  “best of both worlds” news from the FT.

A total of 170 jobs are to be created in Northern Ireland by one of the world’s biggest packaging companies, the latest business seeking to exploit the region’s “best of both worlds” post-Brexit trading status. Ardagh Metal Packaging on Friday announced plans to build a $200m beverage can plant near Belfast, from which drinks will be exported both to Britain and EU markets. The investment is one of the largest greenfield projects in the region since Brexit took effect and will be seen as a vote of confidence in the controversial Northern Ireland protocol.

in the negotiations,  the devil is now deep in the detail rather than on local politics, none more so at the moment than on medicines. Consider the compelling evidence in the pharma industry’s assessment of the Protocol’s impact on servicing Northern Ireland. Not exactly new but acquiring extra significance because taken up by the Lords subcommittee on the protocol headed by a former  permanent head of the Foreign Office in a letter to David Frost yesterday. To the UK government the Lords is a nest of Remoaners, none more so than anybody from the Foreign Office tradition, like its former chief, Michael Jay.  Jay ‘s predecessor David Kerr, later  as senior Commission official  drafted the famous Article 50 of the Lisbon Treaty which set the tough conditions  for withdrawing from the EU, on which Theresa May came such a cropper and created the conditions for the hard Brexit under which we all labour .

Jay’s sub- committee has accepted the industry’s analysis including the claim that NI pharmacists cannot simply switch to supply from Dublin. I would guess that the UK Government would simply defy the EU to do its worst rather than accept such restrictions on supply. Hopefully the EU will go the extra mile when the two sides meet again next week.

 Extracts from the letter to Lord Frost from Lord Jay of Ewelme, Chair of the Protocol on Ireland/Northern Ireland Sub-Committee

Michelle Riddalls (pharam industry rep) drew attention to the requirements under EU law for importing medicines into the EU. These require a medicine to be retested in a certified laboratory when it enters the EU, and for a qualified person listed on a manufacturer’s import licence to check that this has been done and re-release the product. These tests repeat processes in the country of the manufacturer, and require a valid manufacturer’s import licence. As a result of 2 Brexit, and under the terms of the Protocol (if the standstill period ends without agreement of a permanent solution), these processes would be required on movement of all medicines between Great Britain and Northern Ireland. She said that this “has basically meant that we cannot distribute to Northern Ireland in the way we used to.

Martin Sawer said that application of the EU Falsified Medicines Directive, in particular, was “very costly for manufacturers but also impossible for us to administer”. He said that 80% of medicines distributed by HDA members and destined for Northern Ireland are stored in Great Britain and shipped daily based on orders for hospitals and pharmacies. He added that the cost of HMRC declarations for HDA members moving medicines to Northern Ireland had amounted to £5 million in the first half of 2021. 8. Paul Williams said that the practical impact of the Protocol if the standstill period ends without agreement would be to require manufacturers to complete separate marketing authorisations for Great Britain and Northern Ireland. A licence for a prescription medicine with three strengths, of 20, 40 and 100 milligrams, would amount to £30,000 for the first year, and anywhere between £7,500 and £27,000 for subsequent years. He gave an example of a medicine for treating depression and migraines, of which 120,000 packs were sold in Northern Ireland in 2020, with a total gross margin of £4,700: “straightaway, you can imagine that that medicine is no longer viable in Northern Ireland/

(Michael Jay asks Lord Frost..)  

What is your response to our witnesses’ description of the practical difficulties around medicine provision to Northern Ireland under the Protocol? Do you share their analysis? Were these issues anticipated either by the UK or the EU at the time the Protocol was agreed? Have each of the practical issues outlined by our witnesses been raised in the context of the current dialogue with the EU?

The scale and risk of product withdrawal 10. Michelle Riddalls said that a survey of PAGB members in February revealed that they anticipated between 75% and 98% of OTC medicine products could be discontinued at the end of the grace period. Following the announcement of the standstill period and as companies had adjusted their processes, they now estimated that 52% of products could be discontinued. Medicines for pain relief, cold and flu remedies, smoking cessation, indigestion and heartburn relief, dandruff/nits/headlice, eye care, oral care, hay fever/allergies and antiseptics were likely to be affected. The practical impact of this was that consumers may not be able to buy products to self-care and treat minor illnesses at home, but rather would visit GPs or A&E. Although entire categories of medicine would not be discontinued, and companies would seek to ensure that at least one pack size of major brands would continue to be available, choice was likely to be limited: “there may be only one pack size of that left, you may only get it in certain shops”. 11. Martin Sawer said that, before the standstill period was announced in September, there had been official notification that nearly 1,000 lines of medicines would have been discontinued from January 2022. Paul Williams said that an assessment of the viability of Teva UK’s portfolio of 610 products found that, having excluded exclusive products with little or no alternative, and those where there would be safety concerns around switching (for instance epilepsy medicine), there remained over 250 medicines where “it simply does not make economic sense to supply to Northern Ireland”. Prior to the announcement of the standstill period, he had written “probably the hardest letter I ever had to write in my 15 years in the pharmaceutical industry” to the Secretary of State for Health “telling him that these medicines could be at risk.

The scope for cross-border provision on the island of Ireland and the risk to the EU Single Market

. Our witnesses explained that the different models for medicines provision in Ireland and Northern Ireland constrained the development of cross-border supply chains on the island of Ireland. Paul Williams said that “the status quo evolved over many years, worked extraordinarily well and allowed pretty much seamless access to medicines for patients”. On the other hand, the scope for supplying products to Northern Ireland from Ireland was limited. Teva supply 600 products in Northern Ireland and 300 in Ireland, but “for licensing reasons and even reasons of habit of doctors in Ireland, the overlap of licenses between the two is less than 100”. All our witnesses agreed that, given the distinct nature of the pharmaceutical industry in Northern Ireland and Ireland, the risk of leakage to the EU Single Market was very low. Indeed, Mr Williams told us that the unique identifiers required under the Falsified Medicines Directive mean that, “if a pharmacist in Dublin tries to dispense a product with a UK marker, that Dublin pharmacist’s system should say, ‘No, this is a UK pack. You may not dispense it’.” As a result, the volume of cross-border trade “is virtually nil”.

We would be grateful for a response to this letter by 6 December 2021