Encouraging Signs for Northern Ireland Medicines Supply Issue
A major issue facing the pharma supply chain across the UK this year has been the situation relating to the Northern Ireland and the impact of the Northern Ireland Protocol.
There are now encouraging noises coming from both the UK and EU sides for a resolution, although there is no firm agreement yet.
What's Been the Issue?
The NI Protocol was introduced to deal with the situation where NI would have access to the EU's Single Market and Customs Union without a hard border in the island of Ireland, but in a way which noted that NI was still a part of the UK. The reality is that the barriers have caused problems for supplies from Great Britain to NI.
In the world of medicines, following the end of the Brexit transitional period on 31 December 2020, there was a one year grace period for a detailed solution for Northern Ireland to be worked through. However, as 31 December 2021 has been approaching, it has become apparent that there was no solution yet, and instead of NI having the best of both worlds in being both within the EU's Single Market / Customs Union AND a part of the UK, they were at risk of not having vital goods including essential medicines. Many suppliers said it was simply not worthwhile supplying to NI, affecting the supply of hundreds of different product lines to patients in the territory. The problem has become more severe as we have headed towards the end of this year.
What's the Current State of Play?
The European Commission and the UK Government have both recognised that the supply chain problems for NI is a major issue and they have been negotiating hard to do something about it.
VWV held a webinar in September that was attended by over 100 people across the pharma supply chain, in association with EMIG (the Ethical Medicines Industry Group) and Sigma Pharmaceuticals Plc (one of the UK's leading wholesalers for parallel imports and generics) entitled: "Northern Ireland Protocol Latest: supply, pharmacy and patient challenges - what are the DHSC's plans?"
After major concerns expressed by the pharma supply chain and patients of the partitioning of the medicines market within the UK and the prospect of medicines not getting to patients in NI following the UK's departure from the EU, things now appear to be heading in a more positive direction. The encouraging noises were vocalised by the Department of Health and Social Care speaker, Antonia Jeans, at the September webinar, and recent statements from both sides have continued to move along those lines. However, there is still no agreement.
Maroš Šefčovič for the Commission has offered what he described as "far-reaching" proposals to solve NI protocol issues. They have involved simplifying the procedures for supplying goods coming from Great Britain that are destined for the NI market. The Commission's proposal was that pharma suppliers in Great Britain – when supplying the NI market – can keep all their regulatory functions where they are currently located, and so Great Britain can continue to act as a hub for supplying to NI, despite the UK now being a third country.
In the meantime, the UK's Lord Frost said that any solution needs to do the following:
- remove the burdens on trade within the UK whilst managing the risks to the EU’s single market
- ensure that NI can continue to be supplied from Great Britain
- remove the NI protocol from the jurisdiction of the European Court of Justice
The sticking point remains the last point.
Where Are We Now?
Brexit was never going to be totally smooth. The biggest crunch point since the vote in 2016 was the situation in NI. The NI Protocol was set up to try to provide a solution, but it is clear that its application to pharma will have a real danger of meaning that patients will not get their medicines when they need them.
After some difficult times this year, the recent developments suggest common sense, pragmatism and a desire to work together for a common solution.
It is to be hoped that the final issue can be resolved so that ultimately patients can get access to all the medicines they need.
Watch a recording of the September webinar, now.