Part 2 E+W+N.I.Regulation of activities involving human tissue

The Human Tissue Authority E+W+N.I.

13 The Human Tissue Authority E+W+N.I.

(1) There shall be a body corporate to be known as the Human Tissue Authority (referred to in this Act as “the Authority”).

(2) Schedule 2 (which makes further provision about the Authority) has effect.

Commencement Information

I1 S. 13 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)

14 Remit E+W+N.I.

(1) The following are the activities within the remit of the Authority—

(a) the removal from a human body, for use for a scheduled purpose, of any relevant material of which the body consists or which it contains;

(b) the use, for a scheduled purpose, of—

(i) the body of a deceased person, or

(ii) relevant material which has come from a human body;

(c) the storage of an anatomical specimen or former anatomical specimen;

(d) the storage (in any case not falling within paragraph (c)) of—

(i) the body of a deceased person, or

(ii) relevant material which has come from a human body,

for use for a scheduled purpose;

(e) the import or export of—

(i) the body of a deceased person, or

(ii) relevant material which has come from a human body,

for use for a scheduled purpose;

(f) the disposal of the body of a deceased person which has been—

(i) imported for use,

(ii) stored for use, or

(iii) used,

for a scheduled purpose;

(g) the disposal of relevant material which—

(i) has been removed from a person’s body for the purposes of his medical treatment,

(ii) has been removed from the body of a deceased person for the purposes of an anatomical, or post-mortem, examination,

(iii) has been removed from a human body (otherwise than as mentioned in sub-paragraph (ii)) for use for a scheduled purpose,

(iv) has come from a human body and been imported for use for a scheduled purpose, or

(v) has come from the body of a deceased person which has been imported for use for a scheduled purpose.

[F1 (h) the procurement, processing, F2 ... testing, storage, distribution, import or export of tissue or cells, in so far as those activities are activities to which regulation 7(1) [F3 , (1A)] or (2) of the 2007 Regulations applies and are not within the remit of the Authority by virtue of paragraphs (a) to (g).]

[F4 (i) the donation, testing, characterisation, procurement, preservation, transport, transplantation and disposal of human organs, in so far as those activities are activities to which regulation 5(1) of the 2012 Regulations applies and are not within the remit of the Authority by virtue of paragraphs (a) to (h).]

(2) Without prejudice to the generality of subsection (1)(a) and (b), the activities within the remit of the Authority include, in particular—

(a) the carrying-out of an anatomical examination, and

(b) the making of a post-mortem examination.

[F5 (2ZA) The activities within the remit of the Authority do not include the use, for a scheduled purpose, of relevant material where the use of the material requires consent under paragraph 6(1) or 12(1) of Schedule 3 to the Human Fertilisation and Embryology Act 1990 (use of human cells to create an embryo or a human admixed embryo) or would require such consent but for paragraphs 16 and 20 of that Schedule.]

[F6 (2A) Expressions used in paragraph (h) of subsection (1) and in the 2007 Regulations have the same meaning in that paragraph as in those Regulations; and the reference to activities to which regulation 7(1) [F7 , (1A)] or (2) of those Regulations applies is to be read subject to regulation 2(3) of those Regulations.]

[F8 (2B) Expressions used in paragraph (i) of subsection (1) and in the 2012 Regulations have the same meaning in that paragraph as in those Regulations.]

(3) An activity is excluded from the remit of the Authority if—

(a) it relates to the body of a person who died before the day on which this section comes into force or to material which has come from the body of such a person, and

(b) at least one hundred years have elapsed since the date of the person’s death.

(4) The Secretary of State may by order amend this section for the purpose of adding to the activities within the remit of the Authority.

(5) In this section, “relevant material”, in relation to use for the scheduled purpose of transplantation, does not include blood or anything derived from blood.

Textual Amendments

F1 S. 14(1)(h) inserted (25.5.2007 for specified purposes, 5.7.2007 in so far as not already in force) by Human Tissue (Quality and Safety for Human Application) Regulations 2007 (S.I. 2007/1523), reg. 1(2)(3)30(2)

F2 Word in s. 14(1)(h) omitted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), reg. 1(2)(3), 9(2)(a)(i)

F3 Word in s. 14(1)(h) inserted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), reg. 1(2)(3), 9(2)(a)(ii)

F4 S. 14(1)(i) inserted (12.7.2012 for specified purposes, otherwise 27.8.2012) by The Quality and Safety of Organs Intended for Transplantation Regulations 2012 (S.I. 2012/1501), reg. 1(2)(3)25(2)(a)

F5 S. 14(2ZA) inserted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), s. 68(2), Sch. 7 para. 23; S.I. 2009/2232, art. 2(y)

F6 S. 14(2A) inserted (25.5.2007 for specified purposes, 5.7.2007 in so far as not already in force) by Human Tissue (Quality and Safety for Human Application) Regulations 2007 (S.I. 2007/1523), reg. 1(2)(3)30(3)

F7 Word in s. 14(2A) inserted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), reg. 1(2)(3), 9(2)(b)

F8 S. 14(2B) inserted (12.7.2012 for specified purposes, otherwise 27.8.2012) by The Quality and Safety of Organs Intended for Transplantation Regulations 2012 (S.I. 2012/1501), reg. 1(2)(3)25(2)(b)

Commencement Information

I2 S. 14 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)

15 General functions E+W+N.I.

The Authority shall have the following general functions—

(a) maintaining a statement of the general principles which it considers should be followed—

(i) in the carrying-on of activities within its remit, and

(ii) in the carrying-out of its functions in relation to such activities;

(b) providing in relation to activities within its remit such general oversight and guidance as it considers appropriate;

(c) superintending, in relation to activities within its remit, compliance with—

(i) requirements imposed by or under Part 1 or this Part [F9 or under the Human Transplantation (Wales) Act 2013], and

(ii) codes of practice under this Act;

(d) providing to the public, and to persons carrying on activities within its remit, such information and advice as it considers appropriate about the nature and purpose of such activities;

(e) monitoring developments relating to activities within its remit and advising the Secretary of State, the [F10 Welsh Ministers] and the relevant Northern Ireland department on issues relating to such developments;

(f) advising the Secretary of State, the [F11 Welsh Ministers] or the relevant Northern Ireland department on such other issues relating to activities within its remit as he, the [F11 Ministers] or the department may require.

Textual Amendments

F9 Words in s. 15(c)(i) inserted (E.W.) (1.12.2015) by Human Transplantation (Wales) Act 2013 (anaw 5), ss. 16(5)(a), 21(1) (with s. 14); S.I. 2015/1679, art. 3(e)

F10 Words in s. 15(e) substituted (E.W.) (1.12.2015) by Human Transplantation (Wales) Act 2013 (anaw 5), ss. 16(5)(b), 21(1) (with s. 14); S.I. 2015/1679, art. 3(e)

F11 Words in s. 15(f) substituted (E.W.) (1.12.2015) by Human Transplantation (Wales) Act 2013 (anaw 5), ss. 16(5)(c), 21(1) (with s. 14); S.I. 2015/1679, art. 3(e)

Modifications etc. (not altering text)

C1 S. 15(a) extended (Scotland) (with modifications) (12.7.2012 for specified purposes, otherwise 27.8.2012) by The Quality and Safety of Organs Intended for Transplantation Regulations 2012 (S.I. 2012/1501), regs. 1(2)(3), 7(1)(b)(2)

C2 S. 15(b) extended (Scotland) (with modifications) (12.7.2012 for specified purposes, otherwise 27.8.2012) by The Quality and Safety of Organs Intended for Transplantation Regulations 2012 (S.I. 2012/1501), regs. 1(2)(3), 7(1)(b)(2)

C3 S. 15(a)(b)(c)(ii)(d)(e)(f) extended (with modifications) (25.5.2007 for specified purposes, 5.7.2007 in so far as not already in force) by Human Tissue (Quality and Safety for Human Application) Regulations 2007 (S.I. 2007/1523), regs. 1(2)(3), 9 (with reg. 2(3))

C4 S. 15(d) extended (Scotland) (with modifications) (12.7.2012 for specified purposes, otherwise 27.8.2012) by The Quality and Safety of Organs Intended for Transplantation Regulations 2012 (S.I. 2012/1501), regs. 1(2)(3), 7(1)(b)(2)

C5 S. 15(e) extended (Scotland) (with modifications) (12.7.2012 for specified purposes, otherwise 27.8.2012) by The Quality and Safety of Organs Intended for Transplantation Regulations 2012 (S.I. 2012/1501), regs. 1(2)(3), 7(1)(b)(2)

C6 S. 15(f) extended (Scotland) (with modifications) (12.7.2012 for specified purposes, otherwise 27.8.2012) by The Quality and Safety of Organs Intended for Transplantation Regulations 2012 (S.I. 2012/1501), regs. 1(2)(3), 7(1)(b)(2)

Commencement Information

I3 S. 15 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)