Legal background
20 The 2004 Act, amongst other things, makes provision with respect to activities involving human tissue. Section 1(1) of the 2004 Act (authorisation of activities for scheduled purposes) sets out that certain activities are lawful if done with appropriate consent. Those activities include:
● storing the body of a person who has died for use for certain purposes specified in Schedule 1 to the 2004 Act (including transplantation – paragraph 7 of Schedule 1);
● the use of the body of a person who has died for such a purpose;
● the removal of "relevant material"from the body of a person who has died for such a purpose;
● the storage of relevant material that has come from a human body for such a purpose; and
● the use of relevant material that has come from a human body for such a purpose.
21 "Relevant material" is defined in section 53 of the 2004 Act. It is any material that consists of, or includes, human cells other than gametes, embryos outside the human body, and hair and nail from the body of a living person. Section 54(7) clarifies that material created outside the human body is not relevant material for the purposes of the 2004 Act.
22 Accordingly, under the 2004 Act it is lawful to remove, store and use organs and human tissue from a deceased person for the purposes of transplantation provided that appropriate consent is obtained. Section 2 of the 2004 Act sets out the meaning of appropriate consent for the purposes of section 1 in respect of children (a person under 18 (section 54(1)). The Bill will not make any amendment to this provision and the existing rules on when appropriate consent is given in respect of a child will continue to apply.
23 The meaning of "appropriate consent" for the purposes of section 1 in respect of an adult is set out in section 3 of the 2004 Act ("appropriate consent": adults). The Bill does propose amendments to this section. Further information on the operation of those amendments is set out in the commentary on Clause 1 of the Bill in these Explanatory Notes. Under the 2004 Act as it currently stands, if the adult made no decision before death to either expressly give or refuse consent, a person that they nominated in accordance with section 4 of the 2004 Act may give or refuse consent. Failing that, someone in a "qualifying relationship" (as listed in section 54(9) and dealt with further at section 27(4)) may give consent. Failing that, there is no consent.