EU Exit and Medicines Shortages

EU Exit

The UK has left the EU and the transition period is set to come to an end on 31 December 2020.  Government continues to consider what the final EU Exit arrangements might be.

DHSC has written to suppliers of medicines (4 August 2020 and 14 August 2020) setting out the Government’s preparations alongside its expectations of the industry in the run up to 31st December 2020. The letters mention the Reasonable Worst Case Scenario (RWCS) that Government is using. This includes a risk of significant disruption across the short straits for 6 months following the end of the transition period, with a particular risk during the first 3 months.

To combat this, suppliers are encouraged to review their own logistics arrangements and consider the appropriateness of using existing supply chain routes during this period. From the Government side, a 4-year procurement framework for freight capacity for ‘Category 1’ goods, which includes all health supplies, was initiated in 2019 and remains in place. DHSC has also retained its express freight service arrangements to support the urgent movement of medicines and medical products if other measures experience difficulties  Full text is available below.

The fourth meeting of the Ireland/Northern Ireland Specialised Committee was held on 5 Nov 2020 via video conference and co-chaired by officials from the UK Government and the European Commission.

The UK and the EU exchanged updates on the implementation of the Protocol. The Committee noted that an agreed approach had been reached on a phased process for implementing medicines regulation in Northern Ireland up to 31 December 2021, providing the additional time needed for businesses to prepare in relation to batch testing, importation and Falsified Medicines Directive requirements. Full press is available below.

Correspondence and Links

Medicines Shortages

Medicine shortages is a continuing issue with an increasing number of products being awarded a concessionary price. We appreciate the lengths contractors take to try to maintain medicine supply to patients but inevitably we know there are instances when not all medicines prescribed can be supplied at once.

CPNI has produced a standard patient leaflet to help contractors explain to patients the ongoing matter of medicine shortages.

Furthermore, CPNI has developed a Medicines Shortage Reporter to help contractors report problems experienced in obtaining medicines. This includes generic items and branded medicines.