keep The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2020
The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2020 is a Brexit-related statutory instrument that amends the 2019 Amendment Regulations. It makes technical modifications to split the UK's regulatory framework into Great Britain and Northern Ireland regimes following EU exit, including: substituting 'import from third countries' for 'import into the United Kingdom'; designating separate competent authority treatment for Northern Ireland; modifying references to EU Directives to freeze GB law at April 2015 levels while NI remains aligned to EU requirements; and making numerous other technical amendments to licensing, import/export definitions, traceability requirements, and inspection provisions to reflect the post-Brexit constitutional settlement.
This regulation performs essential technical fixes required by Brexit. While it maintains regulatory complexity by distinguishing Northern Ireland (EU-aligned) from Great Britain, deleting it would create immediate regulatory gaps in the framework governing human tissue and cell applications. The underlying purpose—ensuring quality and safety in human tissue applications—serves legitimate public health interests, and the amendment structure, while complex, represents the minimum necessary adjustment to maintain functional regulation post-Brexit. The alternative of deletion would leave the regulatory framework incoherent and unenforceable, harming both public health and commercial activity in this sector.