Two statutory instruments for organs, tissues and cells were approved on 7 February 2019 as part of preparations for 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 EU Exit (Amendment) Regulations 2019
The two statutory instruments will be needed if the UK leaves the EU on 29 March 2019 without a deal. Depending on the outcome of the negotiations, they can be revoked or amended as required.
Leaving the EU without a deal would result in the failure of the existing domestic legislation to work as intended. The changes made by these statutory instruments ensure that the requirements in relation to quality and safety of organs, tissues and cells (including reproductive cells) will remain broadly the same once the UK leaves the EU.
They also make necessary changes to reflect that the UK and EU countries will consider each other as third countries if there is no deal. This means that licensed establishments will need to make administrative changes, as detailed above, to continue to import organs, tissues and cells from EU countries.
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. The UK will also consider EU Member States to be third countries.
Tissues and cells from EU Member States will need to be covered by an appropriate HTA import licence. This may require establishments to apply for new import licences, or to amend existing licences, to include these products.
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.
UK establishments that send tissues and cells to any EU Member states will require an export licence that covers this activity.
The 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.
If you require a licence to import or export from/to EU Member States, you will need to have this in place. You can find information and application form to apply for a licence here.
Disruptions to Supply Chains
Establishments are advised to conduct risk assessments on their supply chains of reagents and consumables relating to their handling of tissues and cells.
If you have identified potential causes of disruption, please do let us know and refer to our guidance below. NHS establishments should escalate any supply issues in line with established reporting mechanisms.
Please 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 here.
You may also want to refer to the Government Technical Notice on CE marking here.