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Human Tissue Bill


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

27

 

(3)   

The Authority shall establish a procedure for dealing with complaints in

relation to the carrying-out of functions by each of the Inspectorates.

General

40      

Agency arrangements and provision of services

(1)   

Arrangements may be made between the Authority and a government

5

department, a public authority or the holder of a public office (“the other

authority”) for—

(a)   

any functions of the Authority to be carried out by, or by members of

staff of, the other authority, or

(b)   

the provision by the other authority of administrative, professional or

10

technical services to the Authority.

(2)   

Arrangements under subsection (1)(a) shall not affect responsibility for the

carrying-out of the Authority’s functions.

(3)   

Subsection (1)(a) shall not apply to functions of making subordinate legislation

(within the meaning of the Interpretation Act 1978 (c. 30)).

15

41      

Annual report

(1)   

The Authority shall prepare—

(a)   

a report for the first twelve months of its existence, and

(b)   

a report for each succeeding period of twelve months.

(2)   

A report under this section shall deal with the activities of the Authority and

20

the Inspectorates in the period to which the report relates.

(3)   

The Authority shall send each report under this section—

(a)   

to the Secretary of State,

(b)   

to the National Assembly for Wales, and

(c)   

to the relevant Northern Ireland department,

25

   

as soon as practicable after the end of the period to which the report relates.

(4)   

The Secretary of State shall lay a copy of each report received by him under this

section before each House of Parliament.

(5)   

The relevant Northern Ireland department shall lay a copy of each report

received by it under this section before the Northern Ireland Assembly.

30

42      

Directions

(1)   

The Authority may give directions for any purpose for which directions may

be given under this Part.

(2)   

Any power under this Part to give directions includes power to vary or revoke

directions given in previous exercise of the power.

35

(3)   

Any power under this Part to give directions is exercisable by instrument in

writing.

(4)   

Directions under this Part to a particular person shall be given by serving

notice of the directions on the person.

 

 

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

28

 

(5)   

Directions under this Part in respect of any licence (including one which has

ceased to have effect) may be given—

(a)   

by serving notice of the directions on the person who is (or was

immediately before the cessation) the designated individual or holder

of the licence, or

5

(b)   

if it appears to the Authority that it is not practicable to give notice in

that way, by publishing the directions in such way as, in its opinion, is

likely to bring them to the attention of the persons to whom they are

applicable.

(6)   

Directions under this Part which appear to the Authority to be general

10

directions may be given by publishing them as mentioned in subsection (5)(b).

(7)   

This section does not apply to directions under Schedule 2.

43      

Duties in relation to carrying out functions

(1)   

The Authority must carry out its functions effectively, efficiently and

economically.

15

(2)   

In carrying out its functions, the Authority must, so far as relevant, have regard

to the principles of best regulatory practice (including the principles under

which regulatory activities should be transparent, accountable, proportionate,

consistent and targeted only at cases in which action is needed).

Exceptions

20

44      

Criminal justice purposes

(1)   

Subject to subsection (2), nothing in section 14(1), 16(2) or 36(1) applies to

anything done for purposes related to—

(a)   

the prevention or detection of crime, or

(b)   

the conduct of a prosecution.

25

(2)   

Subsection (1) does not except from section 14(1), 16(2) or 36(1) the carrying-

out of a post-mortem examination for purposes of functions of a coroner.

(3)   

The reference in subsection (2) to the carrying-out of a post-mortem

examination does not include the removal of relevant material from the body

of a deceased person, or from a part of the body of a deceased person, at the

30

place where the body or part is first found by a constable.

(4)   

For the purposes of subsection (1)(a), detecting crime shall be taken to

include—

(a)   

establishing by whom, for what purpose, by what means and generally

in what circumstances any crime was committed, and

35

(b)   

the apprehension of the person by whom any crime was committed;

   

and the reference in subsection (1)(a) to the detection of crime includes any

detection outside the United Kingdom of any crime or suspected crime.

(5)   

In subsection (1)(b), the reference to a prosecution includes a prosecution

brought in respect of any crime in a country or territory outside the United

40

Kingdom.

(6)   

In this section, references to crime include a reference to any conduct which—

 

 

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

29

 

(a)   

constitutes one or more criminal offences (whether under the law of a

part of the United Kingdom or of a country or territory outside the

United Kingdom),

(b)   

is, or corresponds to, any conduct which, if it all took place in any one

part of the United Kingdom, would constitute one or more criminal

5

offences, or

(c)   

constitutes one or more offences of a kind triable by court-martial

under the Army Act 1955 (3 & 4 Eliz. 2 c. 18), the Air Force Act 1955

(3 & 4 Eliz. 2 c. 19) or the Naval Discipline Act 1957 (c. 53).

45      

Religious relics

10

(1)   

This section applies—

(a)   

to the use of—

(i)   

the body of a deceased person, or

(ii)   

relevant material which has come from a human body,

   

for the purpose of public display at a place of public religious worship

15

or at a place associated with such a place, and

(b)   

to the storage of—

(i)   

the body of a deceased person, or

(ii)   

relevant material which has come from a human body,

   

for use for the purpose mentioned in paragraph (a).

20

(2)   

An activity to which this section applies is excluded from sections 14(1), 16(2)

and 36(1) if there is a connection between—

(a)   

the body or material to which the activity relates, and

(b)   

the religious worship which takes place at the place of public religious

worship concerned.

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(3)   

For the purposes of this section, a place is associated with a place of public

religious worship if it is used for purposes associated with the religious

worship which takes place there.

Supplementary

46      

Interpretation of Part 2

30

(1)   

In this Part—

   

“anatomical specimen” means—

(a)   

the body of a deceased person to be used for the purpose of

anatomical examination, or

(b)   

the body of a deceased person in the course of being used for the

35

purpose of anatomical examination (including separated parts

of such a body);

   

“appeals committee” has the meaning given by section 20(2);

   

“designated individual”, in relation to a licence, means the individual

designated in the licence as the person under whose supervision the

40

licensed activity is authorised to be carried on;

   

“export” means export from England, Wales or Northern Ireland to a

place outside England, Wales and Northern Ireland;

   

“import” means import into England, Wales or Northern Ireland from a

place outside England, Wales and Northern Ireland;

45

 

 

Human Tissue Bill
Part 3 — Miscellaneous and general

30

 

   

“the Inspectorates” means the Inspectorate of Anatomy and Pathology

and the Inspectorate of Organ and Tissue for Human Use;

   

“scheduled purpose” means a purpose specified in Schedule 1.

(2)   

In this Part, references to the carrying-out of an anatomical examination are to

the carrying-out of a macroscopic examination by dissection for anatomical

5

purposes of the body of a deceased person, and, where parts of the body of a

deceased person are separated in the course of such an examination, include

the carrying-out of a macroscopic examination by dissection of the parts for

those purposes.

(3)   

In this Part, references to a person to whom a licence applies are to a person to

10

whom the authority conferred by the licence extends (as provided by section

17).

Part 3

Miscellaneous and general

Miscellaneous

15

47      

Power of Human Tissue Authority to assist other public authorities

(1)   

The Authority may if it thinks it appropriate to do so provide assistance to any

other public authority in the United Kingdom for the purpose of the exercise

by that authority of its functions.

(2)   

Assistance provided by the Authority under this section may be provided on

20

such terms, including terms as to payment, as it thinks fit.

48      

Preservation for transplantation

(1)   

Where part of a body lying in a hospital, nursing home or other institution is

or may be suitable for use for transplantation, it shall be lawful for the person

having the control and management of the institution—

25

(a)   

to take steps for the purpose of preserving the part for use for

transplantation, and

(b)   

to retain the body for that purpose.

(2)   

Authority under subsection (1)(a) shall only extend—

(a)   

to the taking of the minimum steps necessary for the purpose

30

mentioned in that provision, and

(b)   

to the use of the least invasive procedure.

(3)   

Authority under subsection (1) ceases to apply once it has been established that

consent making removal of the part for transplantation lawful has not been,

and will not be, given.

35

(4)   

Authority under subsection (1) shall extend to any person authorised to act

under the authority by—

(a)   

the person on whom the authority is conferred by that subsection, or

(b)   

a person authorised under this subsection to act under the authority.

(5)   

An activity done with authority under subsection (1) shall be treated—

40

 

 

Human Tissue Bill
Part 3 — Miscellaneous and general

31

 

(a)   

for the purposes of Part 1, as not being an activity to which section 1(1)

applies;

(b)   

for the purposes of Part 2, as not being an activity to which section 16

applies.

(6)   

In this section, “body” means the body of a deceased person.

5

49      

Surplus tissue

(1)   

It shall be lawful for material to which subsection (2) or (3) applies to be dealt

with as waste.

(2)   

This subsection applies to any material which consists of or includes human

cells and which has come from a person’s body in the course of his—

10

(a)   

receiving medical treatment,

(b)   

undergoing diagnostic testing, or

(c)   

participating in research.

(3)   

This subsection applies to any relevant material which—

(a)   

has come from a human body, and

15

(b)   

ceases to be used, or stored for use, for a purpose specified in Schedule

1.

(4)   

This section shall not be read as making unlawful anything which is lawful

apart from this section.

50      

Non-consensual analysis of DNA

20

(1)   

A person commits an offence if—

(a)   

he has any bodily material intending—

(i)   

that any human DNA in the material be analysed without

qualifying consent, and

(ii)   

that the results of the analysis be used otherwise than for an

25

excepted purpose,

(b)   

the material is not of a kind excepted under subsection (2), and

(c)   

he does not reasonably believe the material to be of a kind so excepted.

(2)   

Bodily material is excepted if —

(a)   

it is material which has come from the body of a person who died

30

before the day on which this section comes into force and at least one

hundred years have elapsed since the date of the person’s death,

(b)   

it is an existing holding and the person who has it is not in possession,

and not likely to come into possession, of information from which the

individual from whose body the material has come can be identified, or

35

(c)   

it is an embryo outside the human body.

(3)   

A person guilty of an offence under this section—

(a)   

is liable on summary conviction—

(i)   

to imprisonment for a term not exceeding 12 months, or

(ii)   

to a fine not exceeding the statutory maximum, or

40

(iii)   

to both;

(b)   

is liable on conviction on indictment—

(i)   

to imprisonment for a term not exceeding 3 years, or

 

 

Human Tissue Bill
Part 3 — Miscellaneous and general

32

 

(ii)   

to a fine, or

(iii)   

to both.

(4)   

Schedule 5 (which makes provision for the interpretation of “qualifying

consent” and “use for an excepted purpose” in subsection (1)(a)) has effect.

(5)   

In this section (and Schedule 5)—

5

   

“bodily material” means material which—

(a)   

has come from a human body, and

(b)   

consists of or includes human cells;

   

“existing holding” means bodily material held immediately before the

day on which this section comes into force.

10

51      

Power to give effect to Community obligations

(1)   

The Secretary of State may by regulations amend this Act—

(a)   

for the purpose of implementing a relevant obligation or enabling a

relevant obligation to be implemented, or

(b)   

for the purpose of dealing with matters arising out of or related to a

15

relevant obligation.

(2)   

The power under subsection (1)—

(a)   

includes (in particular) power to add or omit provisions, and

(b)   

includes power consequentially to amend or repeal any other

enactment and any instrument made under an enactment.

20

(3)   

In this section, “relevant obligation” means a Community obligation of the

United Kingdom relating to material which consists of, includes or is derived

from human cells.

52      

Power to de-accession human remains

(1)   

This section applies to the following bodies—

25

   

The Board of Trustees of the Armouries

   

The Trustees of the British Museum

   

The Trustees of the Imperial War Museum

   

The Board of Governors of the Museum of London

   

The Trustees of the National Maritime Museum

30

   

The Board of Trustees of the National Museums and Galleries on

Merseyside

   

The Trustees of the Natural History Museum

   

The Board of Trustees of the Science Museum

   

The Board of Trustees of the Victoria and Albert Museum.

35

(2)   

Any body to which this section applies may transfer from their collection any

human remains if it appears to them to be appropriate to do so for any reason,

whether or not relating to their other functions.

(3)   

If, in relation to any human remains in their collection, it appears to a body to

which this section applies—

40

(a)   

that the human remains are mixed or bound up with something other

than human remains, and

(b)   

that it is undesirable, or impracticable, to separate them,

 

 

Human Tissue Bill
Part 3 — Miscellaneous and general

33

 

   

the power conferred by subsection (2) includes power to transfer the thing with

which the human remains are mixed or bound up.

(4)   

The power conferred by subsection (2) does not affect any trust or condition

subject to which a body to which this section applies holds anything in relation

to which the power is exercisable.

5

(5)   

The power conferred by subsection (2) is an additional power.

General

53      

Powers of inspection, entry, search and seizure

Schedule 6 (which makes provision about powers of inspection, entry, search

and seizure for the purposes of this Act) has effect.

10

54      

Offences by bodies corporate

(1)   

Where an offence under this Act is committed by a body corporate and is

proved to have been committed with the consent or connivance of or to be

attributable to any neglect on the part of—

(a)   

any director, manager, secretary or other similar officer of the body

15

corporate, or

(b)   

any person who was purporting to act in any such capacity,

   

he (as well as the body corporate) commits the offence and shall be liable to be

proceeded against and punished accordingly.

(2)   

Where the affairs of a body corporate are managed by its members, subsection

20

(1) applies in relation to the acts and defaults of a member in connection with

his functions of management as if he were a director of the body corporate.

(3)   

Where an offence under this Act is committed by a Scottish partnership and is

proved to have been committed with the consent or connivance of a partner, or

to be attributable to any neglect on the part of a partner, he (as well as the

25

partnership) commits the offence and shall be liable to be proceeded against

and punished accordingly.

(4)   

In subsection (3), “partner” includes a person purporting to act as a partner.

55      

Prosecutions

No proceedings for an offence under section 5, 32 or 33 shall be instituted—

30

(a)   

in England and Wales, except by or with the consent of the Director of

Public Prosecutions;

(b)   

in Northern Ireland, except by or with the consent of the Director of

Public Prosecutions for Northern Ireland.

56      

Offences: Northern Ireland and Scotland

35

(1)   

This Act has effect in relation to Northern Ireland with the modifications

specified in subsections (2) and (3).

(2)   

In sections 32(5)(a) and 33(6)(a), for “51 weeks” there is substituted “6 months”.

 

 

 
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