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Session 2003 - 04
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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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7       

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)   

In this section, “existing holding” means—

(a)   

the body of a deceased person, or

(b)   

relevant material which has come from a human body,

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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.

8       

Existing anatomical specimens

(1)   

This section applies where a person dies during the three years immediately

preceding the coming into force of section 1.

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(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

for anatomical examination, and

(b)   

section 1 comes into force before anatomical examination of the

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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

consent in relation to—

(a)   

the storage of the person’s body, or separated parts of his body, for use

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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—

(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

30

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—

(i)   

after section 1 comes into force, but

(ii)   

before the end of the period of three years beginning with the

35

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

appropriate consent in relation to—

(a)   

the storage for use for a qualifying purpose of a part of the person’s

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body which—

(i)   

is a part to which that authority relates, and

(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.

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

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(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

than in accordance with that authority.

5

(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

(b)   

the period beginning with that date and ending when anatomical

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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).

9       

Coroners

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(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

(b)   

relevant material which has come from the body of a deceased person,

20

   

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

Regulation of activities involving human tissue

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The Human Tissue Authority

10      

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”).

(2)   

Schedule 2 (which makes further provision about the Authority) has effect.

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11      

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;

(b)   

the use, for a scheduled purpose, of—

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(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;

(d)   

the storage (in any case not falling within paragraph (c)) of—

(i)   

the body of a deceased person, or

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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,

5

   

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,

10

   

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

15

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 it is done for purposes

of a qualifying museum.

(4)   

The Secretary of State may by order amend this section for the purpose of

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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.

12      

General functions

The Authority shall have the following general functions—

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(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

(ii)   

in the carrying-out of its functions in relation to such activities;

(b)   

providing in relation to activities within its remit such general

40

oversight and guidance as it considers appropriate;

(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;

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

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(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

advising the Secretary of State, the National Assembly for Wales and

5

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

activities within its remit as he, the Assembly or the department may

10

require.

Licensing

13      

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.

15

(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

purposes of an anatomical, or post-mortem, examination) of relevant

20

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—

(i)   

the body of a deceased person, or

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(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

(ii)   

relevant material which has come from the body of a deceased

30

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).

(4)   

An activity is excluded from subsection (2) if it is done for purposes of a

35

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,

(b)   

removing an activity from the activities to which this section applies, or

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(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)—

 

 

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.

5

14      

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

10

(c)   

any person acting under the direction of—

(i)   

the designated individual, or

(ii)   

a person designated as mentioned in paragraph (b).

15      

Duty of the designated individual

It shall be the duty of the individual designated in a licence as the person under

15

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.

16      

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.

 

 

Human Tissue Bill
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.

5

(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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17      

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.

18      

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

30

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

35

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

40

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,

 

 

Human Tissue Bill
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.

19      

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.

20      

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.

10

(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.

21      

Changes of licence circumstance

15

(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—

25

(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

30

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.

22      

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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