Quality and safety of human organs, tissues and cells if the UK leaves the EU without a deal
What you need to do to ensure continued use of human organs, tissues and cells (including reproductive cells) if the UK leaves the EU on 29 March 2019 (may also apply to new exit date on 31 December 2020) without a deal.
If the UK leaves the EU without a deal on 29 March, the UK will be a third country operating outside of EU rules and you must prepare your organisation for the new situation.
Quality and Safety
The UK will retain the existing quality and safety standards. This means that if you are a UK establishment in this area, such as a hospital, stem cell laboratory, tissue bank or fertility clinic you will continue to work to the same quality and safety standards as you do now and will not need to change your current practice.
Single European Code and EU Coding Platform
After the UK leaves the EU, the UK will be considered a third country under the EU directives and therefore you will not need to use the Single European Code (SEC), unless you wish to do so.
However, you must still ensure the traceability of tissues and cells (including reproductive cells). You will be able to use the traceability systems that were in place before the introduction of the SEC.
The EU Coding Platform provides a list of all licensed establishments across the EU but UK establishments will no longer need to be added to the platform.
Organs for transplantation
Transplant centres do not need to take any further action. NHS Blood and Transplant (NHSBT) is working with UK regulator the Human Tissue Authority (HTA), to ensure that agreements are in place with EU organisations.
Tissues and cells for human use (non-reproductive cells)
If you import or export tissues or cells from/to the EU for human use you will need an import or export licence. If you already have one, you will not need to apply for a new one, but you will need to have the appropriate approval from HTA.
You will have 6 months to comply with the requirements to import tissues and cells from the EU and European Economic Area (EEA) states. You should ask HTA for detailed guidance on import and export arrangements.
If you import or export reproductive cells from/to the EU you will need to have appropriate authorisation from the Human Fertilisation and Embryology Authority (HFEA). You will have 6 months to comply with the requirements to import reproductive cells from EU and EEA states. You should ask HFEA for detailed guidance.
Government contingency plans
The government has helped prepare by creating the following statutory instruments:
- 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 Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019
The 3 statutory instruments will be needed if the UK leaves the EU on 29 March 2019 (may also apply to new exit date on 31 December 2020) 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 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.