Organ Donation (Deemed Consent) Bill

Explanatory Notes

Commentary on provisions of Bill

Clause 1: "Appropriate consent" to adult transplantation activities: England

25 Under section 1(1) of the 2004 Act, the removal, storage and use of organs and tissue from a deceased person is lawful if there is appropriate consent. Clause 1 sets out amendments to section 3 of the 2004 Act ("appropriate consent": adults), which defines "appropriate consent" in respect of adults for the purposes of section 1.

26 Clause 1 inserts a new paragraph (ba) into section 3(6) of the 2004 Act. This new provision introduces deemed consent, in the absence of express consent. The amendments to section 3 of the 2004 Act in Clause 1 set out that with respect to specific listed transplantation activities carried out in England, in the absence of an express decision on consent either by the person before their death or by a person appointed to make that decision for them, deemed consent will apply unless-

a person in a qualifying relationship to the deceased (as listed in section 54(9)) provides information that would lead a reasonable person to conclude that the deceased would not have consented (new subsection (6B) under subsection (4));

the deceased person had not been ordinarily resident in England for a period of at least 12 months immediately before they died (an "excepted" person under subsection (5)); or

the deceased person had, for a significant period before their death, lacked capacity to understand that deemed consent would apply (an "excepted" person under subsection (5)).

27 This clause also introduces a new term to the 2004 Act, "permitted material". The Bill proposes that deemed consent will only apply in respect of "permitted material". The Bill defines "permitted material" as relevant material other than relevant material of a type specified in regulations made by the Secretary of State. Relevant material that is to be excluded from deemed consent will be specified in regulations made by the Secretary of State. These regulations will be subject to an affirmative resolution procedure that applies to statutory instruments (as set out in Clause 2(5) and (6)).

Clause 2: Consequential amendments

28 Clause 2 makes further amendments to the 2004 Act as a consequence of the amendments made by clause 1 to section 3 of the 2004 Act. Clause 2 inserts in the 2004 Act a new subsection into section 1 after subsection (9B), and amends subsection (10)(c) to allow for the storage and use in Northern Ireland of relevant material removed from a human body in England for transplantation purposes.

29 This clause also inserts two new subsections in section 27 of the 2004 Act (provision with respect to consent). These new provisions place a duty on the Human Tissues Authority (HTA) to give practical guidance on how deemed consent will work in practice, including guidance about the provision of information by a family member or friend of the deceased to override the presumption of consent.

30 This clause amends section 52 of the 2004 Act to set out that the delegated power in Clause 1 for the Secretary of State to make regulations to specify relevant material to which deemed consent will not apply, is subject to the affirmative resolution procedure. It also sets out with whom the Secretary of State shall consult with on such regulations (subsections (5) to (7)).

Clause 3: Extent, commencement and short title

31 Clause 3 provides that the Bill extends to England, Wales and Northern Ireland, although Clause 1, the deemed consent provisions, only apply in respect of activities carried out in England. It also sets out that apart from Clause 3 which comes into force on the day that the Bill is passed, the rest of the provisions, Clauses 1 and 2 will come into force on a date, or dates, appointed in a statutory instrument by the Secretary of State. The clause also sets out the short title for the Bill on receiving Royal Assent as the Organ Donation (Deemed Consent) Act 2018.


Prepared 29th October 2018