The Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019

The Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019

Draft Affirmative
Laid on: 19 November 2018 

These regulations are one of a package of three regulations on the safety of organs, tissues and cells, and reproductive cells (gametes and embryos) for treating patients are ‘no deal’ SIs. They have been developed as part of contingency planning and will be needed in the event that the United Kingdom (UK) leaves the European Un ion (EU) in March 2019 with no agreement in place; i.e. a ‘no deal’ scenario. The other two regulations, which related to reserved matters, are:
 

• Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019 – referred to here as the ‘HFE SI’; and
• The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019

The SIs are being made on a UK-wide basis. The Tissues and Cells and Organs SIs are being made with the agreement of each of the Devolved Administrations (DAs) and the HFE SI is reserved to Westminster. The SIs have been drafted separately as each amends different underlying legislation. The purpose of the SIs is to ensure that, in the un likely scenario that the UK leaves EU with no deal, the law in this area will still function properly and the UK regulatory framework for the safety and quality of organs and tissues and cells (including reproductive cells) is maintained.

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