Policy background Section 1: "Appropriate consent" to adult transplantation activities: England
This provision amends the 2004 Act to set out when deemed consent amounts to appropriate consent for transplantation purposes. The policy background to this provision is to amend the law regarding when consent is considered to have been given to better reflect the views of 80% of the population that support organ donation in principle by shifting the default position in relation to consent away from an option to opt-in to an option to opt-out. There are, of course, people who actively made a decision before they died as to whether they do or do not consent to organ donation, or who opted to appoint someone to make that decision on their behalf. In these cases, as in the case of children and living donors, there is no change to the rules. The provision also provides for cases where certain people close to the deceased believe that they would not have consented to being an organ donor, and allows for the presumption of consent to be overturned.
	The Act contains a power to exclude novel transplants from deemed consent. This is to ensure that the new system of consent is in line with the common understanding of organ and tissue donation. The list of novel transplants will be detailed in regulations made by the Secretary of State following consultation. The regulations will be laid under an affirmative procedure (see section 2(5) and (6)).
	Finally, there are exceptions to ensure that certain vulnerable groups and those who have not been ordinarily resident in England for 12 months are excluded from the opt-out consent system. This applies in respect of people who lacked capacity to understand deemed consent for a significant period before their death, and to visitors and short-term residents in England.