Citation, commencement and extent

1. —(1) These Regulations may be cited as the Quality and Safety of Organs Intended for Transplantation (Amendment) Regulations 2014 and come into force on 14th July 2014.

(2) Subject to paragraph (3), these Regulations extend to England and Wales, Northern Ireland and Scotland.

(3) Regulation 12 extends to England and Wales and Northern Ireland only.

Amendment of the Quality and Safety of Organs Intended for Transplantation Regulations 2012

2.The Quality and Safety of Organs Intended for Transplantation Regulations 2012( 3 ) are amended in accordance with regulations 3 to 10.

Amendment of regulation 3

3. In regulation 3 (interpretation), after the definition of “donor characterisation” insert—

“ “the Implementing Directive” means Commission Implementing Directive 2012/25/ EU laying down information procedures for the exchange, between Member States, of human organs intended for transplantation ( 4 ) ; ” .

Amendment of regulation 6

4. In regulation 6 (application of the 2004 Act in relation to licences under Schedule 1)—

(a) in paragraph (1), for “paragraphs (4) to (7)” substitute “paragraphs (4) and (5)”;

(b) in paragraph (4)(a), omit “and section 19(4) shall apply as if sub-paragraph (c) were omitted”; and

(c) in paragraphs (4)(b), (4)(c) and (4)(e), after “the Directive” insert “and the Implementing Directive”.

Amendment of regulation 12

5. In regulation 12 (guidance), in paragraph (1), after “the Directive” insert “and the Implementing Directive”.

Amendment of regulation 13

6. In regulation 13 (framework and compliance with licensing conditions and directions), in paragraph (1), after “the Directive” insert “and the Implementing Directive”.

Amendment of regulation 16

7. In regulation 16 (serious adverse events and serious adverse reactions), in paragraph (1)(a), for “such” substitute “the”.

Amendment of regulation 18

8. In regulation 18 (organs sent to another country)—

(a) in the title, after “sent to” insert “or received from”;

(b) in paragraph (1), for “any procedures established by the Commission under article 29 of the Directive” substitute “the requirements of Articles 4, 5 and 6(1) of the Implementing Directive”;

(c) after paragraph (1), insert—

“ (1A) Where an organ is received from another country in the European Union, the Authority shall ensure that—

(a) the requirements of Article 4 of the Implementing Directive in relation to information transmitted to the Authority in accordance with that Directive in respect of the organ have been complied with; and

(b) information to ensure the traceability of the organ is transmitted in accordance with Article 6(2) of that Directive. ” ; and

(d) in paragraph (2)—

(i) for “a country” substitute “another country”; and

(ii) for “any procedures established by the Commission under article 29 of the Directive” substitute “the requirements of Articles 4 and 7 of the Implementing Directive”.

Amendment of regulation 27

9. In regulation 27 (amendment of the Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2004)—

(a) in the title, for “2004” substitute “2006”; and

(b) omit sub-paragraph (a).

Amendment of Schedule 2

10. In Schedule 2 (directions of the Authority), after paragraph (2), insert—

“ 3. For the purpose of ensuring compliance with the requirements of Articles 4(1), 4(2), 4(3), 5(2) and 5(3) of the Implementing Directive, the Authority shall specify in directions given under section 23(1) of the 2004 Act the requirements relating to the transmission of information that apply to a licence holder when an organ is sent to, or received from, another country in the European Union. ” .

Amendment of the Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006

11. In regulation 3 of the Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006( 5 ) (exceptions from licensing requirement), in paragraph (5)(a), after “level of autonomy” insert—

“ , and a part of an organ is also considered to be an organ if its function is to be used for the same purpose as the entire organ in the human body, maintaining the requirements of structure and vascularisation ” .

Amendment of the Human Tissue Act 2004

12. In section 32 of the Human Tissue Act 2004( 6 ) (prohibition of commercial dealings in human material for transplantation), for subsection (3A) substitute—

“ (3A) The Authority may not designate a person under subsection (3) if doing so could result in the United Kingdom being in breach of—

(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 ( 7 ) , 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 ( 8 ) . ” .