Question to the Department of Health and Social Care:

To ask Her Majesty's Government what plans they have to review the policy that deemed consent should not apply to transplants used to create Advanced Therapy Medicinal Products.

Advanced Therapy Medicinal Products (ATMPs) are an exciting technology with new therapies being developed all the time. Current ATMPs use tissues and cells taken from living donors. However, it is also becoming possible to use material from deceased donors. Such ATMPs would be novel and the Government wants to ensure that under the new deemed consent arrangements for organ donation, donation of cells for ATMPs cannot happen without express consent being in place.

The list of organs, tissues and cells excluded from deemed consent are set out in the Human Tissue (Permitted Material: Exceptions) (England) Regulations 2020. Any changes to the regulations would need to balance evidence, public acceptability and clinical need. Before making any changes, the Government will be guided by recommendations from NHS Blood and Transplant’s Research and Innovation in Transplant Advisory Group with advice from the Human Tissue Authority.