The Department of Health and Social Care has published guidance on EU Exit Operational Readiness on actions the health and care system in England should take to prepare for a ‘no deal scenario’. The Government also recommends that private sector businesses are similarly prepared, enacting their own ‘no-deal’ plans as they judge necessary.
We would like to draw your attention to some key information that all establishments in the Human Application and Organ Donation and Transplantation sector should consider.
The Guidance includes advice on the supply of medicines, vaccines, medical devices and clinical consumables; the supply of blood and other products of human origin including tissues, cells and organs; the supply of non-clinical consumables, goods and services; workforce; and research and clinical trials.
You should consider this guidance in both the context of the transport of tissues and cells to and from the EU and your requirements for, and the supply of, consumables and reagents required to carry out your work.
If you are a licensed establishment within the NHS, you should ensure that your supply needs have been considered through the ongoing preparedness planning.
If you work outside of the NHS, you will also need to be working with your partners and suppliers to ensure as little disruption as possible to your supply chain.
It is important that you maintain the integrity of your supply chain through agreements with your suppliers and have contingency measures in place in case of any issues.
Business continuity planning
As part of business continuity planning, you should assess the risks to the supply of all materials essential to assuring the quality and safety of cells, tissue and organs.
You should ensure that you have considered what steps you would take in the event that any tissues, cells or reagents go outside of validated parameters during transit, or in the event that you are unable to access a critical reagent or material.
As part of the HTA’s planning, we will be issuing guidance on making variations to preparation processes.
Two statutory instruments were laid in November 2018 in case of a “no deal” EU exit:
- The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019
- The Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019
These Regulations have been prepared as part of wider contingency planning for a ‘no deal’ scenario and could be revoked or amended as required.
Import and Export of Tissues and Cells
In event of a ‘no deal’, the UK will become a third country for the purposes of the EU Tissues and Cells Directive and the EU Organ Donation Directive.
UK establishments responsible for the import of tissues and cells from EU Member states will require an import licence that covers this activity as the UK be become a “third country” on exiting the EU.
A requirement of import licences is that establishments have written agreements in place with third country suppliers, as set out in Directions 002/2018.
UK establishments that send tissues and cells to any EU Member states will require an export licence that covers this activity.
The draft Regulations provide for a six-month transitional period.
This will allow establishments time to comply with any requirements that result from the UK becoming a third country.
Further guidance on timelines for applying for, or varying, a licence will be issued in due course.