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Detail of outcome
The government response summarises the responses to the consultation and other stakeholder engagement activities. It was prepared by the Department of Health on behalf of all 4 UK health administrations.
The consultation responses made useful suggestions on a number of operational issues, including the practical implementation of exemptions and the clarification of the type of changes that should be considered as substantial.
The implementing regulations will be laid before Parliament and, subject to parliamentary approval, we anticipate that the regulations will come into force on 1 April 2018.
The European Union (EU) has published 2 new commission directives on the coding and import of tissue and cells for human application.
We would like your views on a range of questions regarding implementation, including the estimate of the likely cost of implementing both directives for establishments licensed by the Human Tissue Authority (HTA) and Human Fertilisation and Embryology Authority (HFEA), and for the authorities themselves. We would also like your views on the associated HTA guidance.
There are 2 consultation documents and 2 sets of consultation questions:
- one for the Human Fertilisation and Embryology (Quality and Safety) Regulations 2017, about reproductive cells
- one for the Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2017 about all other types of human tissue and cells
Annexes B to D are the same for both regulations. Annexes A and F are different for the 2 sets of regulations.
The quality and safety standards for the donation, procurement, testing, processing, preservation, storage and distribution of human tissue and cells intended for human application are regulated by the HTA. In the case of reproductive cells regulation is by the HFEA.
The directives sets out the information that must be provided to and the duties placed on HTA, HFEA and the UK government.