[co-author: Hannah Kerr-Peterson]
Following the recent agreement to delay Brexit until 31 January 2020, the UK Department of Health and Social Care ("DHSC") has written to suppliers of UK medicines and medical devices to confirm the continued contingency planning arrangements for a "no deal" Brexit.
A "no deal" Brexit is still possible if the withdrawal agreement, which sets out the terms on which the UK would leave the EU, is not approved by the UK Parliament and European Parliament by the end of January 2020 and no further extension is agreed.
The DHSC letter confirms that the plans put in place ahead of the 31 October deadline continue to apply. The key elements of those arrangements are as follows:
- Trader readiness: Companies are advised to continue preparing for new customs and border arrangements. The DHSC has set up a dedicated trader readiness Support Unit for suppliers of medical products.
- Building buffer stocks: The DHSC is encouraging companies to "make every effort to retain the level of stockpiles they had in place in advance of 31 October".
- Procuring extra warehouse stock for stockpiled medicines: The DHSC will continue to provide warehousing capacity (including ambient, refrigerated and controlled drug storage) for use at market rates.
- Securing freight capacity: The UK Government's reasonable worst case scenario estimated that the flow of HGVs thought the French ports could be reduced by between 40-60%. The Department of Transport has put in place a four year freight procurement framework under which all companies moving priority products (including human medicines and medical devices) can request capacity if/when needed. Companies are encouraged to register for this service if they have not done so already.
- Clarifying or changing regulatory requirements: The UK Parliament has passed legislation that would amend or clarify certain regulatory requirements relating to medicinal products, medical devices and clinical trials in the event that the UK leaves the EU without a deal.
- Strengthening the processes and resources used to deal with shortages: The DHSC has put in place legislation to enable the Secretary of State for Health to issue serious shortage protocols under which community pharmacies would be able to prescribe a specified alternative medicine, or quantity, without seeking the prescriber's prior approval.
The arrangements above are intended to support the continued supply of medicines and medical devices in the event of a "no deal" Brexit. If instead the UK leaves the EU with the withdrawal agreement agreed, there would be a transitional period during which the current regulatory and customs procedures would continue in place and the contingency measures above would not be needed.
[View source.]
