The Quality and Safety of Organs Intended for Transplantation (Amendment) Regulations 2014

Amendment of the Human Tissue Act 2004

12.  In section 32 of the Human Tissue Act 2004(1) (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(2), 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(3).”.

(1)

2004 c.30. Section 32(3A) was inserted by S.I 2012/1501, regulation 25(1), (3).

(2)

OJ No L 102, 07.04.2004, p48.

(3)

OJ No L 207, 06.08.2010, p14.