The Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019

Amendment of the Human Tissue Act 2004 U.K.

2.—(1) Section 32 of the Human Tissue Act 2004 M1 (prohibition of commercial dealings in human material for transplantation) is amended as follows.

[F1 (2) For subsection (3A) substitute—

“(3A) The Authority may not designate a person under subsection (3) if doing so would be incompatible with the principles set out in—

(a) Article 12 of Directive 2004/23/EC of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, or

(b) Article 13 of Directive 2010/53/EU of the European Parliament and of the Council on standards of quality and safety of human organs intended for transplantation,

and for the purposes of this subsection as it applies in relation to Great Britain, those Articles of those Directives are to be read subject to the modifications set out in subsections (3B) and (3C).”.]

(3) After subsection (3A) insert—

“(3B) Article 12 of Directive 2004/23/EC M2 is to be read as if—

(a) in paragraph 1—

(i) for the first subparagraph there were substituted—

“Donations of tissues and cells shall be voluntary and unpaid.”;

(ii) in the second subparagraph, the second sentence were omitted;

(iii) the third subparagraph were omitted;

(b) in paragraph 2, for the first subparagraph there were substituted—

“Any promotion and publicity activities in support of the donation of human tissues and cells shall comply with any directions of the Authority or any provision of any enactment which relates to such activities.”;

(c) also in paragraph 2, in the second subparagraph—

(i) “Member States shall endeavour to ensure that” were omitted;

(ii) for “is” there were substituted “ shall be ”.

(3C) Article 13 of Directive 2010/53/EU M3 is to be read as if—

(a) in paragraph 1—

(i) “Member States shall ensure that” were omitted; and

(ii) for “are” there were substituted “ shall be ”.

(b) in paragraph 2, the second sentence were omitted;

(c) in paragraph 3—

(i) “Member States shall prohibit” were omitted; and

(ii) at the end there were inserted “shall be prohibited”;

(d) in paragraph 4—

(i) “Member States shall ensure that” were omitted; and

(ii) for “is” there were substituted “ shall be ”.”.

Textual Amendments

F1 Reg. 2(2) substituted (31.12.2020 immediately before IP completion day) by The Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1305), regs. 1, 3

Commencement Information

I1 Reg. 2 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M1 2004 c. 30. Section 32 was amended by S.I. 2012/1501 and 2014/1459.

M2 OJ No L 102, 07.04.2004, p48.

M3 OJ No L 207, 06.08.2010, p14.