Part 2Regulation of activities involving human tissue
The Human Tissue Authority
I313The Human Tissue Authority
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.
I114Remit
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.
F1h
the procurement, processing, F11... testing, storage, distribution, import or export of tissue or cells, in so far as those activities are activities to which regulation 7(1) F9, (1A) or (2) of the 2007 Regulations applies and are not within the remit of the Authority by virtue of paragraphs (a) to (g).
F4i
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.
F32ZA
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.
F22A
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) F10, (1A) or (2) of those Regulations applies is to be read subject to regulation 2(3) of those Regulations.
F52B
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.
I215General functions
The Authority shall have the following general functions—
C2a
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;
C3b
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 F8or under the Human Transplantation (Wales) Act 2013, and
C1ii
codes of practice under this Act;
C4d
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;