The Organ and Tissue Donation (Deemed Consent) Bill (the Bill) was passed by the Northern Ireland Assembly in February 2022. The legislation is due to come into effect in Northern Ireland in Spring 2023. It will amend the interpretation of ‘appropriate consent’ as set out in the Human Tissue Act 2004 for Northern Ireland (NI) and introduce an ‘opt-out’ system for deceased organ and tissue donation.
All establishments licensed to carry out activities under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 must submit data relating to the activities undertaken and the tissue types worked with between 1 January and 31 December on an annual basis.
Submission of the data is a condition of your HTA licence.
Earlier this year the Minister for Innovation laid out a challenge to health regulators, the Professional Standards Authority, NICE and NHSX during an unprecedented roundtable. If the post-Brexit ambition, as outlined in the government’s Life Sciences Vision, is to provide a world-class regulatory environment that benefits patients and the public while also promoting jobs, growth, and investment, how do we collectively
The HTA was asked to provide information on the Serious Adverse Events and Reactions in the organ donation and transplantation sector.
The HTA was asked to provide information on the decision making around the NHS Organ Donation system
This position statement is intended to notify transplant units, donors and recipients of the HTA’s current position.
If a donor requests, in advance, to re-direct their organ to a secondary recipient; the HTA would need to be satisfied that there is no duress, coercion and reward involved in the re-direction. For example, a father donating to his child at the same time that his wife also requires a transplant. In the unlikely event that the organ cannot be transplanted into the child, he may wish for the organ to go to his wife instead.
