Solution Found for Northern Ireland Medicines Supply Issues
A major issue facing the pharma supply chain across the UK in 2021 has been the impact of the Northern Ireland (NI) Protocol and what this means for the ability to supply medicines to patients in NI.
Most medicines in NI come from Great Britain (GB), but suppliers have been withdrawing their supply. The UK and EU have now got to a position to enable supply of medicines from GB to NI to continue.
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 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 GB 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 so that a detailed solution for NI could be worked through.
However, as 31 December 2021 was approaching, NI was at increasing risk of not having vital goods including essential medicines. Many suppliers had said it was simply not worth their supplying to NI. This affected supply of hundreds of different lines of medicine to patients in the territory.
What’s the Solution?
On 17 December, the European Commission and UK Government provided two different statements on the status of negotiations over the NI Protocol. The Commission's focus was on protecting the integrity of the Single Market, whilst looking to help trade between GB and NI. The UK's statement was focused on protecting the Good Friday Agreement in all its dimensions; respecting NI's integral place in the UK, its internal market and customs territory; upholding the essential state functions and territorial integrity of the UK; avoiding a hard border on the island of Ireland; as well as helping protect the EU’s Single Market. There were also notable differences in tone between the two statements.
However, what was clear was that the talks had been constructive, and although there was no agreement reached yet on how to deal with issues in many areas with talks continuing into the New Year, the position gave the reassurance that was needed on medicines. That said, the UK said it was going to have to confirm agreement to the Commission's latest document on medicines to ensure it reflected the recent talks.
The UK's preferred solution would still be to remove medicines from the NI Protocol, but has agreed to constructively work with the EU's proposed solution to change the EU's rules on medicines. Until the new arrangements are in place, the existing position will continue so that people in NI can have the predictability and legal certainty they need.
In practice, what the proposed new position will mean is as follows:
- Regulatory importation requirements will be removed for all medicines moving between GB and NI.
- With Falsified Medicines Directive requirements, there will be an extension to the existing derogation on all medicines for three years.
- For generic medicines, suppliers in NI can choose to license either through the EU’s or UK's processes.
- For new medicines, suppliers in NI will be able to use a new bridging mechanism to ensure their product is licensed for the whole of the UK if the MHRA licences a product before the EMA.
- Suppliers will be able to use regulatory functions such as a marketing authorisation or Qualified Person based in GB for EU licence applications for NI.
Looking Ahead
The biggest crunch point since the Brexit vote in 2016 was the situation in NI. The NI Protocol was designed to try to provide a solution, but its application to pharma has caused real concern to all sides that patients in NI would not get medicines. A pragmatic solution was needed.
VWV held a webinar in September that was attended by over 120 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?. Speakers from the DHSC, National Pharmacy Association, Healthcare Distribution Alliance and Pharmalex discussed the real problems facing the pharma supply chain, but with a positive outlook for agreement between the EU and UK on medicines.
Despite issues for many other products, pragmatism does seem to have prevailed for medicine supplies. The 'I's need to be dotted and the 't's crossed, but this is a great Christmas present for the pharma industry, distributors, pharmacies and most importantly patients.