Human Tissue Bill

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Human Tissue Bill

Human Tissue Bill
Part 1 — Removal, storage and use of human organs and other tissue for scheduled purposes
6

5
Prohibition of activities without consent etc.
(1)
A person commits an offence if, without appropriate consent, he does an
activity to which subsection (1), (2) or (3) of section 1 applies, unless he
reasonably believes—
(a)
that he does the activity with appropriate consent, or
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(b)
that what he does is not an activity to which the subsection applies.
(2)
A person commits an offence if—
(a)
he falsely represents to a person whom he knows or believes is going
to, or may, do an activity to which subsection (1), (2) or (3) of section 1
applies—
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(i)
that there is appropriate consent to the doing of the activity, or
(ii)
that the activity is not one to which the subsection applies, and
(b)
he knows that the representation is false or does not believe it to be true.
(3)
Subject to subsection (4), a person commits an offence if, when he does an
activity to which section 1(2) applies, neither of the following has been signed
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in relation to the cause of death of the person concerned—
(a)
a certificate under section 22(1) of the Births and Deaths Registration
Act 1953 (c. 20), and
(b)
a certificate under Article 25(2) of the Births and Deaths Registration
(Northern Ireland) Order 1976 (S.I. 1976/1041 (N.I. 14)).
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(4)
Subsection (3) does not apply—
(a)
where the person reasonably believes—
(i)
that a certificate under either of those provisions has been
signed in relation to the cause of death of the person concerned,
or
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(ii)
that what he does is not an activity to which section 1(2) applies,
or
(b)
where the person comes into lawful possession of the body
immediately after death and stores it prior to its removal to a place
where anatomical examination is to take place.
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(5)
Subject to subsection (6), a person commits an offence if, when he does an
activity to which section 1(3) applies, the death of the person concerned has not
been registered under either of the following provisions—
(a)
section 15 of the Births and Deaths Registration Act 1953, and
(b)
Article 21 of the Births and Deaths Registration (Northern Ireland)
35
Order 1976 (S.I. 1976/1041 (N.I. 14)).
(6)
Subsection (5) does not apply where the person reasonably believes—
(a)
that the death of the person concerned has been registered under either
of those provisions, or
(b)
that what he does is not an activity to which section 1(3) applies.
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(7)
A person guilty of an offence under this section 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
(iii)
to both;
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(b)
on conviction on indictment—
(i)
to imprisonment for a term not exceeding 3 years, or

Human Tissue Bill
Part 1 — Removal, storage and use of human organs and other tissue for scheduled purposes
7

(ii)
to a fine, or
(iii)
to both.
(8)
In this section, “appropriate consent” has the same meaning as in section 1.
6
Activities involving material from adults who lack capacity to consent
Where—
5
(a)
an activity of a kind mentioned in section 1(1)(d) or (f) involves material
from the body of a person who—
(i)
is an adult, and
(ii)
lacks capacity to consent to the activity, and
(b)
neither a decision of his to consent to the activity, nor a decision of his
10
not to consent to it, is in force,
there shall for the purposes of this Part be deemed to be consent of his to the
activity if it is done in circumstances of a kind specified by regulations made
by Secretary of State.
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Powers of court to dispense with need for consent
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(1)
If the High Court is satisfied—
(a)
that relevant material has come from the body of a living person,
(b)
that it is not reasonably possible to trace the person from whose body
the material has come (“the donor”),
(c)
that it is desirable in the interests of another person (including a future
20
person) that the material be used for the purpose of obtaining scientific
or medical information about the donor, and
(d)
that there is no reason to believe—
(i)
that the donor has died,
(ii)
that a decision of the donor to refuse to consent to the use of the
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material for that purpose is in force, or
(iii)
that the donor lacks capacity to consent to the use of the
material for that purpose,
it may order that subsection (2) apply to the material for the benefit of the other
person.
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(2)
Where material is the subject of an order under subsection (1), there shall for
the purposes of this Part be deemed to be consent of the donor to the use of the
material for the purpose of obtaining scientific or medical information about
him which may be relevant to the person for whose benefit the order is made.
(3)
The Secretary of State may by regulations enable the High Court, in such
35
circumstances as the regulations may provide, to make an order deeming there
for the purposes of this Part to be appropriate consent to an activity consisting
of—
(a)
the storage of the body of a deceased person for use for the purpose of
research in connection with disorders, or the functioning, of the human
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body,
(b)
the use of the body of a deceased person for that purpose,
(c)
the removal from the body of a deceased person, for use for that
purpose, of any relevant material of which the body consists or which
it contains,
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Human Tissue Bill
Part 1 — Removal, storage and use of human organs and other tissue for scheduled purposes
8

(d)
the storage for use for that purpose of any relevant material which has
come from a human body, or
(e)
the use for that purpose of any relevant material which has come from
a human body.
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Restriction of activities in relation to donated material
5
(1)
Subject to subsection (2), a person commits an offence if he—
(a)
uses donated material for a purpose which is not a qualifying purpose,
or
(b)
stores donated material for use for a purpose which is not a qualifying
purpose.
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(2)
Subsection (1) does not apply where the person reasonably believes that what
he uses, or stores, is not donated material.
(3)
A person guilty of an offence under this section shall be liable—
(a)
on summary conviction—
(i)
to imprisonment for a term not exceeding 12 months, or
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(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.
(4)
In subsection (1), references to a qualifying purpose are to—
(a)
a purpose specified in Schedule 1,
(b)
the purpose of medical diagnosis or treatment,
(c)
the purpose of decent disposal, or
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(d)
a purpose specified in regulations made by the Secretary of State.
(5)
In this section, references to donated material are to—
(a)
the body of a deceased person, or
(b)
relevant material which has come from a human body,

which is, or has been, the subject of donation.
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(6)
For the purposes of subsection (5), a body, or material, is the subject of
donation if authority under section 1(1) to (3) exists in relation to it.
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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”—
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(a)
the storage of an existing holding for use for a purpose specified in
Schedule 1;
(b)
the use of an existing holding for a purpose so specified.
(2)
Subsection (1) does not apply where the existing holding is a body, or
separated part of a body, in relation to which section 10(3) or (5) has effect.
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(3)
Section 5(1) and (2) shall have effect as if the activities mentioned in subsection
(1) were not activities to which section 1(1) applies.

Human Tissue Bill
Part 1 — Removal, storage and use of human organs and other tissue for scheduled purposes
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(4)
In this section, “existing holding” means—
(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.
5
10
Existing anatomical specimens
(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)
10
or (3) of the Anatomy Act 1984 (c. 14) for the person’s body to be used
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,
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that authority shall be treated for the purposes of section 1 as appropriate
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.
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(4)
Subsection (5) applies where—
(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
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(b)
anatomical examination of the person’s body is concluded—
(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
30
body, that authority shall be treated for the purposes of section 1 as
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
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(ii)
is such that the person cannot be recognised simply by
examination of the part, and
(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
40
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
than in accordance with that authority.
(7)
In subsection (3), “the relevant period”, in relation to a person, means
whichever is the shorter of—
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Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
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(a)
the period of three years beginning with the date of the person’s death,
and
(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
5
paragraph 6 or 9 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.
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(2)
Where a person knows, or has reason to believe, that—
(a)
the body of a deceased person, or
(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
15
consent of the coroner.
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Interpretation of Part 1
In this Part, “excepted material” means material which has—
(a)
come from the body of a living person, or
(b)
come from the body of a deceased person otherwise than in the course
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of use of the body for the purpose of anatomical examination.
Part 2
Regulation of activities involving human tissue
The Human Tissue Authority
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The Human Tissue Authority
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(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.
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Remit
(1)
The following are the activities within the remit of the Authority—
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(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;
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(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

Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
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(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,
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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,
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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
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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
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scheduled purpose, 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 Authority include, in particular—
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(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—
(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
30
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.
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(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
40
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;
(b)
providing in relation to activities within its remit such general
oversight and guidance as it considers appropriate;
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Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
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(c)
superintending, in relation to activities within its remit, compliance
with—
(i)
requirements imposed by or under Part 1 or this Part, and
(ii)
codes of practice under this Act;
(d)
providing to the public, and to persons carrying on activities within its
5
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
advising the Secretary of State, the National Assembly for Wales and
the relevant Northern Ireland department on issues relating to such
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developments;
(f)
advising the Secretary of State, the National Assembly for Wales or the
relevant Northern Ireland department on such other issues relating to
activities within its remit as he, the Assembly or the department may
require.
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Licensing
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Licence requirement
(1)
No person shall do an activity to which this section applies otherwise than
under the authority of a licence granted for the purposes of this section.
(2)
This section applies to the following activities—
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(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 in the
course of an activity mentioned in paragraph (a) or (b)) of relevant
material of which the body consists or which it contains, for use for a
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scheduled purpose other than transplantation;
(d)
the storage of an anatomical specimen;
(e)
the storage (in any case not falling within paragraph (d)) of—
(i)
the body of a deceased person, or
(ii)
relevant material which has come from a human body,
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for use for a scheduled purpose;
(f)
the use, for the purpose of public display, of—
(i)
the body of a deceased person, or
(ii)
relevant material which has come from the body of a deceased
person.
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(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).
(4)
An activity is excluded from subsection (2) if—
(a)
it relates to the body of a person who died before the day on which this
40
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.
(5)
The Secretary of State may by regulations amend this section for the purpose
45
of—