Overview of the Act
- The Human Tissue Act 2004 ("the 2004 Act"), among other things, makes provision with respect to activities involving human tissue, such as organ transplantation, and authorises the removal, storage and use of organs and tissues for the purpose of transplantation if there is "appropriate consent". The meaning of appropriate consent differs depending on whether the relevant material is obtained from an adult or child, but, under the 2004 Act the overarching principle was that consent must be given expressly and cannot be deemed to have been given in the absence of an objection.
- The Act amends the 2004 Act to introduce provisions that would allow for consent to organ and tissue donation in England to be deemed to have been given by a potential adult organ donor before their death unless they had expressly stated that they did not wish to be a donor or an exception applies. This is often referred to as an "opt-out" system of consent as people may "opt-out" of becoming an organ donor if they do not consent. The Act does not change rules on consent to organ donation in respect of children under 18 or people who have expressly made a decision on consent before their death (either by recording their decision to give or refuse consent or appointing someone to make that decision on their behalf). This Act also does not change consent concerning living donations. Further, the Act sets out that deemed consent will not apply where a person in a qualifying relationship to the deceased (partners, certain family members or a friend of long standing) provides information that would lead a reasonable person to conclude that the deceased potential organ donor would not have consented to be a donor. The Act also provides exceptions applicable to the following groups of adults, in respect of whom the deemed consent provisions will not apply:
- people who are short-term visitors or temporarily resident in England for less than 12 months immediately before dying. Examples include overseas workers, students, overseas Armed Forces personnel; and
- people who lack the capacity to fully understand the consequences of deemed consent for a significant period before dying.
- Deemed consent will not apply to all organs and tissues. Organs and tissues that are to be excluded from deemed consent will be set out in regulations made by the Secretary of State. These will cover transplants that are currently rare or novel and many may not regard as normal to donate.
