Human Tissue Authority

The regulator for human tissue and organs

EU exit guidance

The Department of Health and Social Care has published guidance for industry and organisations involved in health and care about plans for a no-deal Brexit.

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.

Operational Preparedness

The Government’s 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 European Economic Area (EEA) 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

By now, you should have conducted risk assessments on your supply chain of reagents and consumables relating to the handling of tissues and cells. 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.

You should refer to our guidance on the use of alternative reagents and materials for the processing of tissues and cells in the event of supply disruption resulting from the UK exiting the EU. If you have identified any potential risks, please contact us at enquiries@hta.gov.uk.

NHS establishments should escalate any supply issues in line with established internal reporting mechanisms.

You can also refer to the Government Technical Notice on CE marking.

Import and export of tissues and cells

If the UK leaves the EU without a deal, it will become a third country for the purposes of the EU Tissues and Cells Directive and the EU Organ Donation Directives. The UK will also consider EU Member States to be third countries.

This will mean that tissues and cells from EU Member States would need to be covered by the appropriate HTA import licence. If you already have an import licence, you can apply to vary this to include individual EU Member States and EEA states . If you do not have an import licence, you will need to apply for a new import licence.

A requirement of import licences is that establishments have written agreements in place with suppliers in the third country, as set out in Directions 002/2018.

Additionally, if you send tissues and cells to any EU Member States or EEA States you will require an export licence that covers this activity.

You can find information about the licence application and variation process on our website.

In the event of a no-deal Brexit, there would be a six-month transitional period to allow establishments time to comply with any new UK requirements that result from the UK becoming a third country. This means that you will have six months from exit day to put in place any additional licensing requirements.

If you wish to begin to prepare your application, please refer to the information on our website about applying for and varying a licence and contact us to discuss your application.

Statutory instruments

Two statutory instruments were laid in November 2018 to ensure a functioning statutory book in the event of a no-deal Brexit:

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 retain the existing quality and safety standards and provide legal and regulatory certainty on exit day in the event of no deal. 

 

Description: 
Guidance for HTA establishments in the event of a 'no deal' scenario
Last updated on: 17 Sep 2019