The UK Government Department of Health and Social Care has published advice that existing quality and safety standards for work with human organs, tissues and cells will be retained, when the UK leaves the EU. Arrangements also cover the possibility of the UK leaving the EU without a deal. This means that facilities working with these materials can continue to follow existing quality and safety procedures.
However, after UK leaves the EU, it will no longer be party to the Single European Code or the EU Coding Platform, so UK establishments will not be included or required to use them. Any UK facility working with tissues or cells which are moved in or out of the EU will require approval of import/export licences from the UK Human Tissue Authority. For movement of reproductive cells, authorisation will be needed from the UK Human Fertilisation and Embryology Authority. There will be a 6-month grace period for users to comply with the new requirements.
The UK government has drafted three statutory instruments, covering Human Tissue, Organs for Transplantation and Human Fertilisation and Embryology, to ensure that these arrangements remain codified in UK law after departure from the EU. These may need to be amended or revoked, depending on the final outcome of negotiations between the UK and the EU.
NOTE: Arrangements for the UK departure from the EU are subject to change. This summary is not binding. Please use the embedded links the official UK websites for the most current and definitive information.
This summary has been prepared by Queen’s House Consulting, which provides consultancy services to the pharmaceutical and healthcare industry. Please contact Queen’s House Consulting to discuss your particular needs.
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