(This note is not part of the Regulations)
These Regulations are made under the Human Tissue Act 2004 (c.30) (“the 2004 Act”). Section 3 of the 2004 Act makes provision for the interpretation of “appropriate consent”. This term is used in section 1 in relation to an activity involving the body, or material from the body, of a person who is an adult or has died an adult.
Section 3(6) provides that, in relation to certain activities done in England, in certain circumstances, appropriate consent means deemed consent. Certain of those activities involve the removal, storage or use, for the purpose of transplantation, of “permitted material”. Section 3(9) defines “permitted material” as “relevant material” (as defined by section 53 of the 2004 Act) other than relevant material of a type specified in regulations. These Regulations specify types of relevant material that will not be “permitted material”.
Regulation 2(2) specifies the whole or any part of certain relevant material, for example the arm, brain and face.
Regulation 2(3) provides that the types of relevant material listed in that paragraph, which are component parts of relevant material specified in regulation 2(2)(a) to (p), are not specified when detached from the latter.
Regulation 2(4) provides that the whole or part of the trachea, which is listed in paragraph (2), is not specified if it is connected to a lung.
Regulation 2(5) specifies certain types of cells as relevant material, for example limbal stem cells, in so far as all or part of the cells is for use for the purpose of transplantation in the form of an advanced therapy medicinal product. Regulation 2(6) provides that in regulation 2(5), “advanced therapy medicinal product” has the same meaning as it does in the Human Medicines Regulations 2012 (S.I. 2012/1916).
A full impact assessment has not been produced for this instrument as no impact on the private or voluntary sectors is foreseen.