Human Tissue Bill

House of Commons

Session 2003 - 04
Internet Publications
Other Bills before Parliament

Human Tissue Bill

Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
14

(b)
that he acts under the authority of a licence.
(2)
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.
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Codes of practice
23
Preparation of codes
(1)
The Authority may prepare codes of practice for the purpose of—
(a)
giving practical guidance to persons carrying on activities within its
remit, and
15
(b)
laying down the standards expected in relation to the carrying-on of
such activities.
(2)
The Authority shall deal under subsection (1) with the following matters—
(a)
the conduct of anatomical examinations;
(b)
the storage of anatomical specimens;
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(c)
the storage and disposal of former anatomical specimens;
(d)
the definition of death for the purposes of this Act;
(e)
communication with the family of the deceased in relation to the
making of a post-mortem examination;
(f)
the conduct of post-mortem examinations;
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(g)
communication with the family of the deceased in relation to the
removal from the body of the deceased, for use for a scheduled
purpose, of any relevant material of which the body consists or which
it contains;
(h)
the removal from a human body, for use for a scheduled purpose, of
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any relevant material of which the body consists or which it contains;
(i)
the storage for use for a scheduled purpose, and the use for such a
purpose, of relevant material which has come from a human body;
(j)
the storage for use for a scheduled purpose, and the use for such a
purpose, of an existing holding within the meaning of section 7;
35
(k)
the import, and the 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;
(l)
the disposal of relevant material which—
40
(i)
has been removed from a human body for use for a scheduled
purpose, or
(ii)
has come from a human body and is an existing holding for the
purposes of section 7.
(3)
The Authority shall—
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Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
15

(a)
keep any code of practice under this section under review, and
(b)
prepare a revised code of practice when appropriate.
(4)
Before preparing a code of practice under this section, the Authority shall—
(a)
consult such persons as it considers appropriate,
(b)
if the code of practice relates to Wales, consult the National Assembly
5
for Wales, and
(c)
if the code of practice relates to Northern Ireland, consult the relevant
Northern Ireland department.
(5)
The Authority shall publish a code of practice under this section in such way
as, in its opinion, is likely to bring it to the attention of those interested.
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(6)
Codes of practice under this section may make different provision in relation
to England, Wales and Northern Ireland respectively.
24
Provision with respect to consent
(1)
In dealing under section 23(1) with the matters mentioned in—
(a)
section 23(2)(e) and (g), and
15
(b)
so far as relating to the body of a deceased person, section 23(2)(h),

the Authority shall, in particular, lay down the standards expected in relation
to the obtaining of consent for the purposes of section 1.
(2)
Subject to subsection (3), the standards required to be laid down by subsection
(1) shall include provision to the effect set out in subsections (4) to (8).
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(3)
The standards required to be laid down by subsection (1) may include
provision to different effect in relation to cases which appear to the Authority
to be exceptional.
(4)
The qualifying relationships for the purpose of sections 2(6)(b)(ii) and 3(5)(c)
should be ranked in the following order—
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(a)
spouse or partner;
(b)
parent or child;
(c)
brother or sister;
(d)
child of a person falling within paragraph (c);
(e)
stepfather or stepmother;
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(f)
half-brother or half-sister;
(g)
friend of longstanding.
(5)
Relationships in the same paragraph of subsection (4) should be accorded
equal ranking.
(6)
Consent should be obtained from the person whose relationship to the person
35
concerned is accorded the highest ranking in accordance with subsections (4)
and (5).
(7)
If the relationship of each of two or more persons to the person concerned is
accorded equal highest ranking in accordance with subsections (4) and (5), it is
sufficient to obtain the consent of any of them.
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(8)
In applying the principles set out above, a person’s relationship shall be left out
of account if—
(a)
he does not wish to deal with the issue of consent,
(b)
he is not able to deal with that issue, or

Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
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(c)
having regard to the activity in relation to which consent is sought, it is
not reasonably practicable to communicate with him within the time
available if consent in relation to the activity is to be acted on.
(9)
The Secretary of State may by order amend subsection (4).
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Effect of codes
5
(1)
A failure on the part of any person to observe any provision of a code of
practice under section 23 shall not of itself render the person liable to any
proceedings.
(2)
The Authority may, in carrying out its functions with respect to licences, take
into account any relevant observance of, or failure to observe, a code of practice
10
under section 23, so far as dealing with a matter mentioned in any of
paragraphs (a) to (c) and (e) to (j) of subsection (2) of that section.
26
Approval of codes
(1)
Where a proposed code of practice under section 23 deals with a matter
mentioned in any of paragraphs (a) to (c) and (e) to (j) of subsection (2) of that
15
section, the Authority shall send a draft of the proposed code to the Secretary
of State for approval.
(2)
Before approving a draft code of practice sent to him under subsection (1), the
Secretary of State shall—
(a)
if the code relates to Wales, consult the National Assembly for Wales,
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and
(b)
if the code relates to Northern Ireland, consult the relevant Northern
Ireland department.
(3)
If the Secretary of State approves a draft code of practice sent to him under
subsection (1)—
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(a)
he shall lay a copy of it before each House of Parliament,
(b)
if the code relates to Wales, he shall send a copy of it to the National
Assembly for Wales,
(c)
if the code relates to Northern Ireland, he shall send a copy of it to the
relevant Northern Ireland department, and
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(d)
the code (in the form of the draft) shall come into effect on such day as
may be appointed by directions.
(4)
If the Secretary of State does not approve a draft sent to him under subsection
(1), he shall give reasons to the Authority.
(5)
The relevant Northern Ireland department shall lay before the Northern
35
Ireland Assembly any document which it receives under subsection (3)(c).
Anatomy
27
Possession of anatomical specimens away from licensed premises
(1)
Subject to subsections (2) to (6), a person commits an offence if—
(a)
he has possession of an anatomical specimen, and
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(b)
the specimen is not on premises in respect of which an anatomy licence
is in force.

Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
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(2)
Subsection (1) does not apply where—
(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
5
possession of the specimen, and
(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—
(a)
the specimen is the body of a deceased person which is to be used for
10
the purpose of anatomical examination,
(b)
the person who has possession of the body has come into lawful
possession of it immediately after the deceased’s death, and
(c)
he retains possession of the body prior to its removal to premises in
respect of which an anatomy licence is in force.
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(4)
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 an anatomy licence is in force, or
(b)
where the specimen is to be used for the purpose of education, training
or research.
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(5)
Subsection (1) does not apply where the person has possession of the specimen
for purposes of functions of, or under the authority of, a coroner.
(6)
Subsection (1) does not apply where the person reasonably believes—
(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
25
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—
(a)
on summary conviction—
(i)
to imprisonment for a term not exceeding 12 months, or
30
(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
(ii)
to a fine, or
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(iii)
to both.
(8)
In this section—

“anatomy licence” means a licence authorising—
(a)
the carrying-out of an anatomical examination, or
(b)
the storage of anatomical specimens;
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“storage licence” means a licence authorising the storage of anatomical
specimens.
28
Possession of former anatomical specimens away from licensed premises
(1)
Subject to subsections (2) to (5), a person commits an offence if—
(a)
he has possession of a former anatomical specimen, and
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Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
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(b)
the specimen is not on premises in respect of which a storage licence is
in force.
(2)
Subsection (1) does not apply where—
(a)
the specimen has come from premises in respect of which a storage
licence is in force, and
5
(b)
the person—
(i)
is authorised in writing by the designated individual to have
possession of the specimen, and
(ii)
has possession of the specimen only for a purpose for which he
is so authorised to have possession of it.
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(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
(b)
where the specimen is to be used for the purpose of education, training
or research.
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(4)
Subsection (1) does not apply where the person has possession of the
specimen—
(a)
only for the purpose of its decent disposal, or
(b)
for purposes of functions of, or under the authority of, a coroner.
(5)
Subsection (1) does not apply where the person reasonably believes—
20
(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
(c)
that any of subsections (2) to (4) applies.
(6)
A person guilty of an offence under subsection (1) shall be liable—
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(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—
30
(i)
to imprisonment for a term not exceeding 3 years, or
(ii)
to a fine, or
(iii)
to both.
(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
35
body.
Trafficking
29
Prohibition of commercial dealings in human material
(1)
A person commits an offence if he—
(a)
gives or receives a reward for the supply of, or for an offer to supply,
40
the body of a deceased person or any relevant bodily material;
(b)
seeks to find a person willing to supply the body of a deceased person,
or any relevant bodily material, for reward;

Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
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(c)
offers to supply the body of a deceased person, or any relevant bodily
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, the body of a
deceased person or any relevant bodily material;
5
(e)
takes part in the management or control of a body of persons corporate
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,
10
an advertisement—
(a)
inviting persons to supply, or offering to supply, for reward the body
of a deceased person or any relevant bodily material, or
(b)
indicating that the advertiser is willing to initiate or negotiate any such
arrangement as is mentioned in subsection (1)(d).
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(3)
A person who engages in an activity to which subsection (1) or (2) applies does
not commit an offence under that subsection if—
(a)
he is designated by the Authority as a person who may lawfully engage
in the activity, or
(b)
he engages in the activity for the purpose of, or in connection with,
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acquisition for purposes of a qualifying museum.
(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
(ii)
to a fine not exceeding the statutory maximum, or
25
(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.
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(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
(b)
to a fine not exceeding level 5 on the standard scale, or
(c)
to both.
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(6)
References in subsections (1) and (2) to reward, in relation to the supply of the
body of a deceased person, do not include payment in money or money’s
worth for defraying or reimbursing any expenses incurred in, or in connection
with, transporting, preserving or storing the body.
(7)
References in subsections (1) and (2) to reward, in relation to the supply of any
40
relevant bodily material, do not include payment in money or money’s worth
for defraying or reimbursing—
(a)
any expenses incurred in, or in connection with, transporting,
removing, preparing, preserving or storing the material, or
(b)
any expenses or loss of earnings incurred by the person from whose
45
body the material comes so far as reasonably and directly attributable
to his supplying the material from his body.

Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
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(8)
For the purposes of this section, “relevant bodily material” means any bodily
material which—
(a)
consists of or includes human cells, and
(b)
is not of a kind excepted under subsection (9).
(9)
The following kinds of bodily material are excepted—
5
(a)
gametes,
(b)
embryos,
(c)
hair and nail from the body of a living person, and
(d)
material which is the subject of property because of an application of
human skill.
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(10)
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;

“bodily material” means material from a human body;
15

“reward” means any description of financial or other material advantage.
Transplants
30
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
20
person intending that the material be used for the purpose of
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.
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(2)
Subject to subsections (3) and (5), a person commits an offence if—
(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
30
person.
(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
35
section 29, and
(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.
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(4)
Regulations under subsection (3) shall include provision for decisions of the
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.
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