The UK and EU have now got to a position to ensure there is a continued supply of medicines from Great Britain to Northern Ireland, says Paul Gershlick…

The Northern Ireland Protocol and its barriers have caused major supply problems from Great Britain to Northern Ireland where the latter was at increasing risk of not having vital goods such as essential medicines, in turn affecting supply of hundreds of different lines of medicine to patients in the area.

 
The solution
The European Commission and the UK government provided constructive statements on the status of the NI Protocol negotiations on 17 December 2021, although there were notable differences between the two.

The Commission emphasised protecting the integrity of the Single Market, whilst looking to help trade between GB and NI. The UK's statement was geared towards protecting every aspect of the Good Friday Agreement; maintaining the essential state functions and territorial integrity of the UK; respecting NI's fundamental place in the UK, its internal market and customs territory; avoiding a hard border on the island of Ireland in addition to protecting the EU's Single Market.

Although there was no formal agreement reached yet with talks continuing this year, their position provided reassurance on medicine supplies which were welcomed. That said, the UK will aim to confirm agreement to the Commission's latest document on medicines to ensure it echoed the recent talks.

Although the UK's preferred solution is still the removal of medicines from the NI Protocol entirely, they have agreed to constructively work with the EU's proposed solution to modify the EU's rules on medicines. Whilst we await new arrangements, the existing position will continue in order to manage expectations of people in NI and their medicines supplies.
 
The new solution will mean…

• Regulatory importation requirements will be removed for all medicines moving between GB and NI.
• An extension to the existing derogation on all medicines for three years under the Falsified Medicines Directive requirements.
• For generic medicines, NI suppliers can choose to license either through the EU’s or UK's processes.
• For new medicines, NI suppliers will be able to use a new bridging mechanism so their product is licensed for the whole of the UK, if the MHRA licences a product before the EMA.
• For EU licence applications for NI, suppliers will be able to use regulatory functions such as a marketing authorisation or Qualified Person based in GB.

 
Next steps
Since the Brexit vote in 2016, NI was the biggest issue to sort. The NI Protocol was designed to provide a solution, but it became clear that something more pragmatic was needed to best serve the needs of NI people including for patients to receive medicines.

In September 2021, VWV held a webinar entitled: Northern Ireland Protocol Latest: supply, pharmacy and patient challenges - what are the DHSC's plans? It was attended by over 120 people across the pharma supply chain, in association with EMIG, the Ethical Medicines Industry Group, and Sigma Pharmaceuticals.   

Leading speakers from the National Pharmacy Association, DHSC, Pharmalex and Healthcare Distribution Alliance discussed the real issues facing the pharma supply chain, but with an optimistic outlook for UK-EU agreement on medicines. Pragmatism does seem to have triumphed for medicine supplies. The 'i's need to be dotted and the 't's crossed, but this development just before Christmas is being welcomed by the pharma industry, distributors, pharmacies and most importantly patients.
 

Paul Gershlick is a partner and heads the pharmaceuticals and life sciences team at VWV. He can be contacted on 07795 570072 and at pgershlick@vwv.co.uk