Human Tissue Bill

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Human Tissue Bill

Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
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(a)
adding to the activities to which this section applies,
(b)
removing an activity from the activities to which this section applies, or
(c)
altering the description of an activity to which this section applies.
(6)
Schedule 3 (which makes provision about licences for the purposes of this
section) has effect.
5
(7)
In subsection (2)—
(a)
references to storage do not include storage which is incidental to
transportation, and
(b)
“relevant material”, in relation to use for the scheduled purpose of
transplantation, does not include blood or anything derived from
10
blood.
17
Persons to whom licence applies
The authority conferred by a licence extends to—
(a)
the designated individual,
(b)
any person who is designated as a person to whom the licence applies
15
by a notice given to the Authority by the designated individual, and
(c)
any person acting under the direction of—
(i)
the designated individual, or
(ii)
a person designated as mentioned in paragraph (b).
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Duty of the designated individual
20
It shall be the duty of the individual designated in a licence as the person under
whose supervision the licensed activity is authorised to be carried on to
secure—
(a)
that the other persons to whom the licence applies are suitable persons
to participate in the carrying-on of the licensed activity,
25
(b)
that suitable practices are used in the course of carrying on that activity,
and
(c)
that the conditions of the licence are complied with.
19
Right to reconsideration of licensing decisions
(1)
If an application for the grant, revocation or variation of a licence is refused, the
30
applicant may require the Authority to reconsider the decision.
(2)
If a licence is—
(a)
revoked under paragraph 7(2) of Schedule 3, or
(b)
varied under paragraph 8(3) or (5) of that Schedule,

the holder of the licence, or the designated individual, may require the
35
Authority to reconsider the decision.
(3)
If an application for the grant, or revocation, of permission for the purposes of
an authorisation condition is refused, the applicant may require the Authority
to reconsider the decision.
(4)
If permission for the purposes of an authorisation condition is revoked under
40
paragraph 12(4)(b) of Schedule 3, any of—
(a)
the individual concerned,

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(b)
the holder of the licence, and
(c)
the designated individual,

may require the Authority to reconsider the decision.
(5)
The right under subsection (1) or (2) is exercisable by giving the Authority
notice of exercise of the right before the end of the period of 28 days beginning
5
with the day on which notice of the decision concerned was given under
paragraph 11 of Schedule 3.
(6)
The right under subsection (3) or (4) is exercisable by giving the Authority
notice of exercise of the right before the end of the period of 28 days beginning
with the day on which notice of the decision concerned was given under
10
paragraph 12 of Schedule 3.
(7)
Subsections (1) to (4) do not apply to a decision on reconsideration.
(8)
In this section, “authorisation condition” means a condition of a licence
where—
(a)
the licence is one to which paragraph 3 of Schedule 3 applies, and
15
(b)
the condition is the one required in the licence by sub-paragraph (2) of
that paragraph.
20
Appeals committees
(1)
The Authority shall maintain one or more committees to carry out its functions
in pursuance of notices under section 19.
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(2)
A committee under subsection (1) is referred to in this Part as an appeals
committee.
(3)
An appeals committee shall consist of not less than five members of the
Authority.
(4)
The quorum for an appeals committee shall be three.
25
21
Procedure on reconsideration
(1)
Reconsideration shall be by way of fresh decision.
(2)
On reconsideration—
(a)
the person by whom reconsideration is required (“the appellant”) shall
be entitled to require that he or his representative be given an
30
opportunity to appear before and be heard by the appeals committee
dealing with the matter,
(b)
at any meeting at which such an opportunity is given, the person who
made the decision which is the subject of reconsideration shall be
entitled to appear and be heard in person or by a representative, and
35
(c)
the appeals committee dealing with the matter shall consider any
written representations received from the appellant or the person who
made the decision which is the subject of reconsideration.
(3)
The appeals committee by which a decision is reconsidered in pursuance of a
notice under section 19 shall give the appellant notice of its decision.
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(4)
If on reconsideration an appeals committee upholds the previous decision, the
notice under subsection (3) shall include a statement of the reasons for the
appeals committee’s decision.

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(5)
The Authority may by regulations make such other provision about procedure
in relation to reconsideration as it thinks fit.
(6)
Where reconsideration of a decision—
(a)
is required under section 19(2) or (4) by only one of two persons by
whom it could have been required, or
5
(b)
is required under section 19(4) by only one or two of three persons by
whom it could have been required,

it shall be treated for the purposes of this section as required by both or (as the
case may be) all of them.
(7)
In this section, “reconsideration” means reconsideration in pursuance of a
10
notice under section 19.
22
Appeal on point of law
A person aggrieved by a decision on reconsideration in pursuance of a notice
under section 19 may appeal to the High Court on a point of law.
23
Conduct of licensed activities
15
(1)
Directions may impose requirements in relation to the conduct of the activity
which a licence authorises to be carried on.
(2)
Directions under subsection (1) may be given in relation to licences generally,
licences of a particular description or a particular licence.
(3)
A person shall comply with a requirement imposed by directions under
20
subsection (1) if it is applicable to him.
24
Changes of licence circumstance
(1)
Directions may make provision for the purpose of dealing with a situation
arising in consequence of—
(a)
the variation of a licence, or
25
(b)
a licence ceasing to have effect.
(2)
Directions under subsection (1)(a) may impose requirements—
(a)
on the holder of the licence;
(b)
on a person who is the designated individual immediately before, or
immediately after, the variation;
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(c)
on any other person, if he consents.
(3)
Directions under subsection (1)(b) may impose requirements—
(a)
on the person who is the holder of the licence immediately before the
licence ceases to have effect;
(b)
on the person who is the designated individual at that time;
35
(c)
on any other person, if he consents.
(4)
Directions under subsection (1) may, in particular, require anything kept, or
information held, in pursuance of the licence to be transferred in accordance
with the directions.
(5)
Where a licence has ceased to have effect by reason of the death or dissolution
40
of its holder, anything subsequently done by a person before directions are

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given under subsection (1) shall, if the licence would have been authority for
doing it, be treated as authorised by a licence.
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Breach of licence requirement
(1)
A person who contravenes section 16(1) commits an offence, unless he
reasonably believes—
5
(a)
that what he does is not an activity to which section 16 applies, or
(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
10
(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
15
(iii)
to both.
Codes of practice
26
Preparation of codes
(1)
The Authority may prepare and issue codes of practice for the purpose of—
(a)
giving practical guidance to persons carrying on activities within its
20
remit, and
(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 carrying-out of anatomical examinations;
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(b)
the storage of anatomical specimens;
(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;
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(f)
the making of post-mortem examinations;
(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;
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(h)
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;
(i)
the storage for use for a scheduled purpose, and the use for such a
purpose, of—
(i)
the body of a deceased person, or
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(ii)
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 9;
(k)
the import, and the export, of—

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(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—
(i)
has been removed from a human body for use for a scheduled
5
purpose, or
(ii)
has come from a human body and is an existing holding for the
purposes of section 9.
(3)
In dealing under subsection (1) with the matters mentioned in subsection (2)(h)
and (i), the Authority shall, in particular, deal with consent.
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(4)
The Authority shall—
(a)
keep any code of practice under this section under review, and
(b)
prepare a revised code of practice when appropriate.
(5)
Before preparing a code of practice under this section, the Authority shall—
(a)
consult such persons as it considers appropriate,
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(b)
if the code of practice relates to Wales, consult the National Assembly
for Wales, and
(c)
if the code of practice relates to Northern Ireland, consult the relevant
Northern Ireland department.
(6)
The Authority shall publish a code of practice issued under this section in such
20
way as, in its opinion, is likely to bring it to the attention of those interested.
(7)
A code of practice issued under this section shall come into effect on such day
as may be appointed by directions.
(8)
Codes of practice under this section may make different provision in relation
to England, Wales and Northern Ireland respectively.
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27
Provision with respect to consent
(1)
The duty under section 26(3) shall have effect, in particular, to require the
Authority to lay down the standards expected in relation to the obtaining of
consent where consent falls by virtue of section 2(7)(b)(ii) or 3(6)(c) to be
obtained from a person in a qualifying relationship.
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(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).
(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.
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(4)
The qualifying relationships for the purpose of sections 2(7)(b)(ii) and 3(6)(c)
should be ranked in the following order—
(a)
spouse or partner;
(b)
parent or child;
(c)
brother or sister;
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(d)
grandparent or grandchild;
(e)
child of a person falling within paragraph (c);
(f)
stepfather or stepmother;
(g)
half-brother or half-sister;

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(h)
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
concerned is accorded the highest ranking in accordance with subsections (4)
5
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.
(8)
In applying the principles set out above, a person’s relationship shall be left out
10
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
(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
15
available if consent in relation to the activity is to be acted on.
(9)
The Secretary of State may by order amend subsection (4).
28
Effect of codes
(1)
A failure on the part of any person to observe any provision of a code of
practice under section 26 shall not of itself render the person liable to any
20
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
under section 26, 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.
25
29
Approval of codes
(1)
The Authority may not issue a code of practice under section 26 that deals with
a matter mentioned in any of paragraphs (a) to (c) and (e) to (j) of subsection (2)
of that section unless—
(a)
a draft of it has been sent to and approved by the Secretary of State and
30
laid by him before both Houses of Parliament, and
(b)
the 40-day period has elapsed without either House resolving not to
approve the draft.
(2)
Before approving a draft code of practice sent to him under subsection (1), the
Secretary of State shall—
35
(a)
if the code relates to Wales, consult the National Assembly for Wales,
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
40
subsection (1)—
(a)
if the code relates to Wales, he shall send a copy of it to the National
Assembly for Wales, and

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(b)
if the code relates to Northern Ireland, he shall send a copy of it to the
relevant Northern Ireland department.
(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
5
Ireland Assembly any document which it receives under subsection (3)(b).
(6)
In subsection (1)(b), “40-day period”, in relation to the draft of a code of
practice, means—
(a)
if the draft is laid before one House on a day later than the day on which
it is laid before the other House, the period of 40 days beginning with
10
the later of the two days, and
(b)
in any other case, the period of 40 days beginning with the day on
which the draft is laid before each House,

no account being taken of any period during which Parliament is dissolved or
prorogued or during which both Houses are adjourned for more than 4 days.
15
Anatomy
30
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
(b)
the specimen is not on premises in respect of which an anatomy licence
20
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
(b)
the person—
25
(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.
(3)
Subsection (1) does not apply where—
30
(a)
the specimen is the body of a deceased person which is to be used for
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
35
respect of which an anatomy licence is in force.
(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
40
or research.
(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—