Human Tissue Bill

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Human Tissue Bill

Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
20

(a)
that what he has possession of is not an anatomical specimen,
(b)
that the specimen is on premises in respect of which an anatomy licence
is in force, or
(c)
that any of subsections (2) to (5) applies.
(7)
A person guilty of an offence under subsection (1) shall be liable—
5
(a)
on summary conviction—
(i)
to imprisonment for a term not exceeding 12 months, or
(ii)
to a fine not exceeding the statutory maximum, or
(iii)
to both;
(b)
on conviction on indictment—
10
(i)
to imprisonment for a term not exceeding 3 years, or
(ii)
to a fine, or
(iii)
to both.
(8)
In this section—

“anatomy licence” means a licence authorising—
15
(a)
the carrying-out of an anatomical examination, or
(b)
the storage of anatomical specimens;

“storage licence” means a licence authorising the storage of anatomical
specimens.
31
Possession of former anatomical specimens away from licensed premises
20
(1)
Subject to subsections (2) to (5), a person commits an offence if—
(a)
he has possession of a former anatomical specimen, and
(b)
the specimen is not on premises in respect of which a storage licence is
in force.
(2)
Subsection (1) does not apply where—
25
(a)
the specimen has come from premises in respect of which a storage
licence is in force, and
(b)
the person—
(i)
is authorised in writing by the designated individual to have
possession of the specimen, and
30
(ii)
has possession of the specimen only for a purpose for which he
is so authorised to have possession of it.
(3)
Subsection (1) does not apply where the person has possession of the specimen
only for the purpose of transporting it to premises—
(a)
in respect of which a storage licence is in force, or
35
(b)
where the specimen is to be used for the purpose of education, training
or research.
(4)
Subsection (1) does not apply where the person has possession of the
specimen—
(a)
only for the purpose of its decent disposal, or
40
(b)
for purposes of functions of, or under the authority of, a coroner.
(5)
Subsection (1) does not apply where the person reasonably believes—
(a)
that what he has possession of is not a former anatomical specimen,
(b)
that the specimen is on premises in respect of which a storage licence is
in force, or
45

Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
21

(c)
that any of subsections (2) to (4) applies.
(6)
A person guilty of an offence under subsection (1) shall be liable—
(a)
on summary conviction—
(i)
to imprisonment for a term not exceeding 12 months, or
(ii)
to a fine not exceeding the statutory maximum, or
5
(iii)
to both;
(b)
on conviction on indictment—
(i)
to imprisonment for a term not exceeding 3 years, or
(ii)
to a fine, or
(iii)
to both.
10
(7)
In this section, “storage licence” means a licence authorising the storage, for use
for a scheduled purpose, of relevant material which has come from a human
body.
Trafficking
32
Prohibition of commercial dealings in human material for transplantation
15
(1)
A person commits an offence if he—
(a)
gives or receives a reward for the supply of, or for an offer to supply,
any controlled material;
(b)
seeks to find a person willing to supply any controlled material for
reward;
20
(c)
offers to supply any controlled material for reward;
(d)
initiates or negotiates any arrangement involving the giving of a
reward for the supply of, or for an offer to supply, any controlled
material;
(e)
takes part in the management or control of a body of persons corporate
25
or unincorporate whose activities consist of or include the initiation or
negotiation of such arrangements.
(2)
Without prejudice to subsection (1)(b) and (c), a person commits an offence if
he causes to be published or distributed, or knowingly publishes or distributes,
an advertisement—
30
(a)
inviting persons to supply, or offering to supply, any controlled
material for reward, or
(b)
indicating that the advertiser is willing to initiate or negotiate any such
arrangement as is mentioned in subsection (1)(d).
(3)
A person who engages in an activity to which subsection (1) or (2) applies does
35
not commit an offence under that subsection if he is designated by the
Authority as a person who may lawfully engage in the activity.
(4)
A person guilty of an offence under subsection (1) shall be liable—
(a)
on summary conviction—
(i)
to imprisonment for a term not exceeding 12 months, or
40
(ii)
to a fine not exceeding the statutory maximum, or
(iii)
to both;
(b)
on conviction on indictment—
(i)
to imprisonment for a term not exceeding 3 years, or

Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
22

(ii)
to a fine, or
(iii)
to both.
(5)
A person guilty of an offence under subsection (2) shall be liable on summary
conviction—
(a)
to imprisonment for a term not exceeding 51 weeks, or
5
(b)
to a fine not exceeding level 5 on the standard scale, or
(c)
to both.
(6)
For the purposes of subsections (1) and (2), payment in money or money’s
worth to the holder of a licence shall be treated as not being a reward where—
(a)
it is in consideration for transporting, removing, preparing, preserving
10
or storing controlled material, and
(b)
its receipt by the holder of the licence is not expressly prohibited by the
terms of the licence.
(7)
References in subsections (1) and (2) to reward, in relation to the supply of any
controlled material, do not include payment in money or money’s worth for
15
defraying or reimbursing—
(a)
any expenses incurred in, or in connection with, transporting,
removing, preparing, preserving or storing the material,
(b)
any liability incurred in respect of—
(i)
expenses incurred by a third party in, or in connection with, any
20
of the activities mentioned in paragraph (a), or
(ii)
a payment in relation to which subsection (6) has effect, or
(c)
any expenses or loss of earnings incurred by the person from whose
body the material comes so far as reasonably and directly attributable
to his supplying the material from his body.
25
(8)
For the purposes of this section, controlled material is any material which—
(a)
consists of or includes human cells,
(b)
is, or is intended to be removed, from a human body,
(c)
is intended to be used for the purpose of transplantation, and
(d)
is not of a kind excepted under subsection (9).
30
(9)
The following kinds of material are excepted—
(a)
gametes,
(b)
embryos, and
(c)
material which is the subject of property because of an application of
human skill.
35
(10)
Where the body of a deceased person is intended to be used to provide material
which—
(a)
consists of or includes human cells, and
(b)
is not of a kind excepted under subsection (9),

for use for the purpose of transplantation, the body shall be treated as
40
controlled material for the purposes of this section.
(11)
In this section—

“advertisement” includes any form of advertising whether to the public
generally, to any section of the public or individually to selected
persons;
45

“reward” means any description of financial or other material advantage.

Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
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Transplants
33
Restriction on transplants involving a live donor
(1)
Subject to subsections (3) and (5), a person commits an offence if—
(a)
he removes any transplantable material from the body of a living
person intending that the material be used for the purpose of
5
transplantation, and
(b)
when he removes the material, he knows, or might reasonably be
expected to know, that the person from whose body he removes the
material is alive.
(2)
Subject to subsections (3) and (5), a person commits an offence if—
10
(a)
he uses for the purpose of transplantation any transplantable material
which has come from the body of a living person, and
(b)
when he does so, he knows, or might reasonably be expected to know,
that the transplantable material has come from the body of a living
person.
15
(3)
The Secretary of State may by regulations provide that subsection (1) or (2)
shall not apply in a case where—
(a)
the Authority is satisfied—
(i)
that no reward has been or is to be given in contravention of
section 32, and
20
(ii)
that such other conditions as are specified in the regulations are
satisfied, and
(b)
such other requirements as are specified in the regulations are
complied with.
(4)
Regulations under subsection (3) shall include provision for decisions of the
25
Authority in relation to matters which fall to be decided by it under the
regulations to be subject, in such circumstances as the regulations may
provide, to reconsideration in accordance with such procedure as the
regulations may provide.
(5)
Where under subsection (3) an exception from subsection (1) or (2) is in force,
30
a person does not commit an offence under that subsection if he reasonably
believes that the exception applies.
(6)
A person guilty of an offence under this section is liable on summary
conviction—
(a)
to imprisonment for a term not exceeding 51 weeks, or
35
(b)
to a fine not exceeding level 5 on the standard scale, or
(c)
to both.
(7)
In this section—

“reward” has the same meaning as in section 32;

“transplantable material” means material of a description specified by
40
order made by the Authority.
34
Information about transplant operations
(1)
The Secretary of State may make regulations requiring such persons as may be
specified in the regulations to supply to such authority as may be so specified
such information as may be so specified with respect to transplants that have
45

Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
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been or are proposed to be carried out using transplantable material removed
from a human body.
(2)
Any such authority shall keep a record of information supplied to it in
pursuance of regulations under this section.
(3)
A person commits an offence if—
5
(a)
he fails without reasonable excuse to comply with regulations under
this section, or
(b)
in purported compliance with such regulations, he knowingly or
recklessly supplies information which is false or misleading in a
material respect.
10
(4)
A person guilty of an offence under subsection (3)(a) is liable on summary
conviction to a fine not exceeding level 3 on the standard scale.
(5)
A person guilty of an offence under subsection (3)(b) is liable on summary
conviction to a fine not exceeding level 5 on the standard scale.
(6)
In this section, “transplantable material” has the same meaning as in section 33.
15
Inspectorates
35
Inspectorate of Anatomy and Pathology
(1)
There shall be an Inspectorate of Anatomy and Pathology consisting of—
(a)
a board,
(b)
a chief executive officer appointed by the Authority, and
20
(c)
such other staff of the Authority as may be assigned by the Authority
to assist the board.
(2)
The chief executive officer and the other staff assigned to assist the board of the
Inspectorate of Anatomy and Pathology shall be under the direction of the
board.
25
(3)
The board of the Inspectorate of Anatomy and Pathology shall carry out on
behalf of the Authority such of the Authority’s functions in relation to activities
within the remit of the Inspectorate as the Secretary of State may by order
provide.
(4)
The Authority may delegate to the board of the Inspectorate of Anatomy and
30
Pathology (to such extent as it may determine) any function in relation to an
activity within the remit of the Inspectorate.
(5)
Schedule 4 has effect in relation to the board of the Inspectorate of Anatomy
and Pathology.
36
Remit of Inspectorate of Anatomy and Pathology
35
(1)
The following are the activities within the remit of the Inspectorate of Anatomy
and Pathology—
(a)
the removal from a human body, for use for a scheduled purpose other
than transplantation, of relevant material of which the body consists or
which it contains;
40
(b)
the use of—
(i)
the body of a deceased person, or

Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
25

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

for a scheduled purpose other than transplantation;
(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
5
(ii)
relevant material which has come from a human body,

for use for a scheduled purpose other than transplantation;
(e)
the import or export of—
(i)
the body of a deceased person, or
(ii)
relevant material which has come from a human body,
10

for use for a scheduled purpose other than transplantation;
(f)
the disposal of the body of a deceased person which has been—
(i)
imported for use,
(ii)
stored for use, or
(iii)
used,
15

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
20
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 other than transplantation,
(iv)
has come from a human body and been imported for use for a
25
scheduled purpose other than transplantation, or
(v)
has come from the body of a deceased person which has been
imported for use for a scheduled purpose.
(2)
Without prejudice to the generality of subsection (1)(a) and (b), the activities
within the remit of the Inspectorate of Anatomy and Pathology include, in
30
particular—
(a)
the carrying-out of an anatomical examination, and
(b)
the making of a post-mortem examination.
(3)
An activity is excluded from the remit of the Inspectorate of Anatomy and
Pathology if—
35
(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.
40
(4)
The Secretary of State may by order amend this section for the purpose of
adding to the activities within the remit of the Inspectorate of Anatomy and
Pathology an activity within the remit of the Authority.
37
Inspectorate of Organ and Tissue for Human Use
(1)
There shall be an Inspectorate of Organ and Tissue for Human Use consisting
45
of—
(a)
a board,

Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
26

(b)
a chief executive officer appointed by the Authority, and
(c)
such other staff of the Authority as may be assigned by the Authority
to assist the board.
(2)
The chief executive officer and the other staff assigned to assist the board of the
Inspectorate of Organ and Tissue for Human Use shall be under the direction
5
of the board.
(3)
The board of the Inspectorate of Organ and Tissue for Human Use shall carry
out on behalf of the Authority such of the Authority’s functions in relation to
activities within the remit of the Inspectorate as the Secretary of State may by
order provide.
10
(4)
The Authority may delegate to the board of the Inspectorate of Organ and
Tissue for Human Use (to such extent as it may determine) any function in
relation to an activity within the remit of the Inspectorate.
(5)
Schedule 4 has effect in relation to the board of the Inspectorate of Organ and
Tissue for Human Use.
15
38
Remit of Inspectorate of Organ and Tissue for Human Use
(1)
The following are the activities within the remit of the Inspectorate of Organ
and Tissue for Human Use—
(a)
the removal from a human body, for use for the purpose of
transplantation, of relevant material of which the body consists or
20
which it contains;
(b)
the use, for the purpose of transplantation, of relevant material which
has come from a human body;
(c)
the storage, for use for the purpose of transplantation, of relevant
material which has come from a human body;
25
(d)
the import or export, for use for the purpose of transplantation, of
relevant material which has come from a human body;
(e)
the disposal of relevant material which—
(i)
has been removed from a human body for use for the purpose
of transplantation, or
30
(ii)
has come from a human body and been imported for use for the
purpose of transplantation.
(2)
The Secretary of State may by order amend this section for the purpose of
adding to the activities within the remit of the Inspectorate of Organ and Tissue
for Human Use an activity within the remit of the Authority.
35
(3)
In this section, “relevant material” does not include blood or anything derived
from blood.
39
Duties in relation to discharge of functions by Inspectorates
(1)
In carrying out functions of the Authority, each of the Inspectorates shall have
regard to the general principles which the Authority has for the time being
40
stated for the purposes of section 15(a)(ii).
(2)
The Authority shall monitor the carrying-out of functions by each of the
Inspectorates.