Human Tissue Bill

House of Commons

Session 2003 - 04
Internet Publications
Other Bills before Parliament

Human Tissue Bill

Human Tissue Bill
Part 1 — Removal, storage and use of human organs and other tissue for scheduled purposes
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Existing holdings
(1)
In its application to the following activities, section 1(1) shall have effect with
the omission of the words “if done with appropriate consent”—
(a)
the storage of an existing holding for use for a purpose specified in
Schedule 1, other than anatomical examination;
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(b)
the use of an existing holding for a purpose so specified, other than
anatomical examination.
(2)
Section 5(1) shall have effect as if the activities mentioned in subsection (1)
were not activities to which section 1(1) applies.
(3)
In this section, “existing holding” means—
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(a)
the body of a deceased person, or
(b)
relevant material which has come from a human body,
held, immediately before the day on which section 1(1) comes into force, for
use for a purpose specified in Schedule 1, other than anatomical examination.
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Existing anatomical specimens
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(1)
This section applies where a person dies during the three years immediately
preceding the coming into force of section 1.
(2)
Subsection (3) applies where—
(a)
before section 1 comes into force, authority is given under section 4(2)
or (3) of the Anatomy Act 1984 (c. 14) for the person’s body to be used
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for anatomical examination, and
(b)
section 1 comes into force before anatomical examination of the
person’s body is concluded.
(3)
During so much of the relevant period as falls after section 1 comes into force,
that authority shall be treated for the purposes of section 1 as appropriate
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consent in relation to—
(a)
the storage of the person’s body, or separated parts of his body, for use
for the purpose of anatomical examination, and
(b)
the use of his body, or separated parts of his body, for that purpose.
(4)
Subsection (5) applies where—
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(a)
before section 1 comes into force, authority is given under section 6(2)
or (3) of the Anatomy Act 1984 for possession of parts (or any specified
parts) of the person’s body to be held after anatomical examination of
his body is concluded, and
(b)
anatomical examination of the person’s body is concluded—
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(i)
after section 1 comes into force, but
(ii)
before the end of the period of three years beginning with the
date of the person’s death.
(5)
With effect from the conclusion of the anatomical examination of the person’s
body, that authority shall be treated for the purposes of section 1 as
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appropriate consent in relation to—
(a)
the storage for use for a qualifying purpose of a part of the person’s
body which—
(i)
is a part to which that authority relates, and
(ii)
is such that the person cannot be recognised simply by
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examination of the part, and

Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
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(b)
the use for a qualifying purpose of such a part of the person’s body.
(6)
Where for the purposes of section 1 there would not be appropriate consent in
relation to an activity but for authority given under the Anatomy Act 1984
(c. 14) being treated for those purposes as appropriate consent in relation to the
activity, section 1(1) to (3) do not authorise the doing of the activity otherwise
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than in accordance with that authority.
(7)
In subsection (3), “the relevant period”, in relation to a person, means
whichever is the shorter of—
(a)
the period of three years beginning with the date of the person’s death,
and
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(b)
the period beginning with that date and ending when anatomical
examination of the person’s body is concluded.
(8)
In subsection (5), “qualifying purpose” means a purpose specified in
paragraph 3 or 7 of Schedule 1.
(9)
The Secretary of State may by order amend subsection (8).
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Coroners
(1)
Nothing in this Part applies to anything done for purposes of functions of a
coroner or under the authority of a coroner.
(2)
Where a person knows, or has reason to believe, that—
(a)
the body of a deceased person, or
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(b)
relevant material which has come from the body of a deceased person,

is, or may be, required for purposes of functions of a coroner, he shall not act
on authority under section 1 in relation to the body, or material, except with the
consent of the coroner.
Part 2
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Regulation of activities involving human tissue
The Human Tissue Authority
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The 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”).
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(2)
Schedule 2 (which makes further provision about the Authority) has effect.
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Remit
(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;
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(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;

Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
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(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—
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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;
(f)
the disposal of the body of a deceased person which has been—
(i)
imported for use,
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(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
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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
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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.
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(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.
(3)
An activity is excluded from the remit of the Authority if it is done for purposes
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of a qualifying museum.
(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.
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General functions
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
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(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—
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(i)
requirements imposed by or under Part 1 or this Part, and

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Part 2 — Regulation of activities involving human tissue
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(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
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advising the Secretary of State, the National Assembly for Wales and
the relevant Northern Ireland department on issues relating to such
developments;
(f)
advising the Secretary of State, the National Assembly for Wales or the
relevant Northern Ireland department on such other issues relating to
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activities within its remit as he, the Assembly or the department may
require.
Licensing
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Licence requirement
(1)
No person shall do an activity to which this section applies otherwise than
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under the authority of a licence granted for the purposes of this section.
(2)
This section applies to the following activities—
(a)
the carrying-out of an anatomical examination;
(b)
the making of a post-mortem examination;
(c)
the removal from the body of a deceased person (otherwise than for the
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purposes of an anatomical, or post-mortem, examination) of relevant
material of which the body consists or which it contains, for use for a
scheduled purpose other than transplantation;
(d)
the storage of an anatomical specimen;
(e)
the storage (in any case not falling within paragraph (d)) 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;
(f)
the use, for the purpose of public display, of—
(i)
the body of a deceased person, or
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(ii)
relevant material which has come from the body of a deceased
person.
(3)
The Secretary of State may by regulations specify circumstances in which
storage of relevant material by a person who intends to use it for a scheduled
purpose is excepted from subsection (2)(e)(ii).
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(4)
An activity is excluded from subsection (2) if it is done for purposes of a
qualifying museum.
(5)
The Secretary of State may by regulations amend this section for the purpose
of—
(a)
adding to the activities to which this section applies,
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(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.
(7)
In subsection (2)—
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Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
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(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
blood.
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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
by a notice given to the Authority by the designated individual, and
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(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
It shall be the duty of the individual designated in a licence as the person under
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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,
(b)
that suitable practices are used in the course of carrying on that activity,
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and
(c)
that the conditions of the licence are complied with.
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Right to reconsideration of licensing decisions
(1)
If an application for the grant, revocation or variation of a licence is refused, the
applicant may require the Authority to reconsider the decision.
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(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
Authority to reconsider the decision.
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(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
paragraph 12(4)(b) of Schedule 3, any of—
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(a)
the individual concerned,
(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
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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
paragraph 11 of Schedule 3.

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Part 2 — Regulation of activities involving human tissue
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(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
paragraph 12 of Schedule 3.
(7)
Subsections (1) to (4) do not apply to a decision on reconsideration.
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(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
(b)
the condition is the one required in the licence by sub-paragraph (2) of
that paragraph.
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Appeals committees
(1)
The Authority shall maintain one or more committees to carry out its functions
in pursuance of notices under section 16.
(2)
A committee under subsection (1) is referred to in this Part as an appeals
committee.
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(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.
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Procedure on reconsideration
(1)
Reconsideration shall be by way of fresh decision.
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(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
opportunity to appear before and be heard by the appeals committee
dealing with the matter,
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(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
(c)
the appeals committee dealing with the matter shall consider any
written representations received from the appellant or the person who
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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 16 shall give the appellant notice of its decision.
(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
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appeals committee’s decision.
(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 16(2) or (4) by only one of two persons by
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whom it could have been required, or
(b)
is required under section 16(4) by only one or two of three persons by
whom it could have been required,

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Part 2 — Regulation of activities involving human tissue
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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
notice under section 16.
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Appeal on point of law
5
A person aggrieved by a decision on reconsideration in pursuance of a notice
under section 16 may appeal to the High Court on a point of law.
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Conduct of licensed activities
(1)
Directions may impose requirements in relation to the conduct of the activity
which a licence authorises to be carried on.
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(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
subsection (1) if it is applicable to him.
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Changes of licence circumstance
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(1)
Directions may make provision for the purpose of dealing with a situation
arising in consequence of—
(a)
the variation of a licence, or
(b)
a licence ceasing to have effect.
(2)
Directions under subsection (1)(a) may impose requirements—
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(a)
on the holder of the licence;
(b)
on a person who is the designated individual immediately before, or
immediately after, the variation;
(c)
on any other person, if he consents.
(3)
Directions under subsection (1)(b) may impose requirements—
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(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;
(c)
on any other person, if he consents.
(4)
Directions under subsection (1) may, in particular, require anything kept, or
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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
of its holder, anything subsequently done by a person before directions are
given under subsection (1) shall, if the licence would have been authority for
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doing it, be treated as authorised by a licence.
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Breach of licence requirement
(1)
A person who contravenes section 13(1) commits an offence, unless he
reasonably believes—
(a)
that what he does is not an activity to which section 13 applies, or
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