Regulation 2 Amendment of the Human Tissue Act 2004

Section 32 of the Human Tissue Act 2004^f1 (prohibition of commercial dealings in human material for transplantation) is amended as follows.

In subsection (3A)—

After subsection (3A) insert—

“(3B)

Article 12 of Directive 2004/23/EC^f2 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^f3 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”.”.