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Human Tissue Bill

Human Tissue Bill
Schedule 4 — Inspectorates: Boards
53

9
The Authority may remove a person from office as chairman or other
appointed member of the board of the Inspectorate if it is satisfied that the
person—
(a)
has been absent from meetings of the board for six consecutive
months, or longer, without the permission of the board, or
5
(b)
is unable or unfit to carry out his functions as chairman or other
appointed member.
Remuneration and pensions of appointed members
10    (1)
The Authority may pay to the chairman or any of the other appointed
members of the board of the Inspectorate such remuneration as it may
10
determine.
      (2)
The Authority may pay, or make provision for paying to or in respect of, the
chairman or any of the other appointed members of the board of the
Inspectorate such pensions, allowances, fees, expenses or gratuities as it may
determine.
15
      (3)
The Authority may make a payment of such amount as it thinks fit to a
person who ceases to hold office as chairman or other appointed member of
the board of the Inspectorate otherwise than on the expiry of his term of
office if it appears to the Authority that there are special circumstances
which make it right for him to receive compensation.
20
Delegation
11
The board of the Inspectorate may delegate any of their functions (to such
extent as they may determine)—
(a)
to any member of the board, or
(b)
to any member of the staff of the Authority who is assigned to assist
25
the board of the Inspectorate.
Proceedings
12
The board of the Inspectorate may regulate their own procedure (including
quorum).
13
The validity of any proceedings of the board of the Inspectorate shall not be
30
affected by—
(a)
any vacancy in—
(i)
the office of chairman, or
(ii)
the post of chief executive officer,
(b)
any defect in a person’s appointment as chairman or other member,
35
or
(c)
the composition for the time being of the membership of the board.
Staff, accommodation etc.
14
The Authority shall provide the board of the Inspectorate with such staff,
accommodation and other resources as the Authority thinks fit for the
40
purpose of enabling the board to carry out their functions.

Human Tissue Bill
Schedule 5 — Section 50: Supplementary
Part 1 — Qualifying consent
54

Schedule 5
Section 50

Section 50: Supplementary
Part 1
Qualifying consent
Introductory
5
1
This Part of this Schedule makes provision for the interpretation of
“qualifying consent” in section 50(1)(a)(i).
Qualifying consent
2     (1)
In relation to analysis of DNA manufactured by the body of a person who is
alive, “qualifying consent” means his consent, except where sub-paragraph
10
(2) applies.
      (2)
Where—
(a)
the person is a child,
(b)
neither a decision of his to consent, nor a decision of his not to
consent, is in force, and
15
(c)
either he is not competent to deal with the issue of consent or, though
he is competent to deal with that issue, he fails to do so,

“qualifying consent” means the consent of a person who has parental
responsibility for him.
      (3)
In relation to analysis of DNA manufactured by the body of a person who
20
has died an adult, “qualifying consent” means—
(a)
if a decision of his to consent, or a decision of his not to consent, was
in force immediately before he died, his consent;
(b)
if paragraph (a) does not apply, the consent of a person who stood in
a qualifying relationship to him immediately before he died.
25
      (4)
In relation to analysis of DNA manufactured by the body of a person who
has died a child, “qualifying consent” means—
(a)
if a decision of his to consent, or a decision of his not to consent, was
in force immediately before he died, his consent;
(b)
if paragraph (a) does not apply—
30
(i)
the consent of a person who had parental responsibility for
him immediately before he died, or
(ii)
where no person had parental responsibility for him
immediately before he died, the consent of a person who
stood in a qualifying relationship to him at that time.
35
Application to Scotland
3     (1)
In its application to Scotland, paragraph 2 has effect with the following
amendments.
      (2)
In sub-paragraphs (2) and (4)(b)(i) and (ii), for “parental responsibility for”
there is substituted “parental responsibilities in relation to”.
40
      (3)
At the end there is inserted—
“(5)
In this paragraph—

Human Tissue Bill
Schedule 5 — Section 50: Supplementary
Part 2 — Use for an excepted purpose
55


“adult” means a person who has attained the age of 16 years;

“child” means a person who has not attained the age of 16
years;

“parental responsibilities” has the meaning given by section
1(3) of the Children (Scotland) Act 1995 (c. 36).”
5
Part 2
Use for an excepted purpose
Introductory
4
This Part of this Schedule makes provision for the interpretation of “use for
an excepted purpose” in section 50(1)(a)(ii).
10
Purposes of general application
5     (1)
Use of the results of an analysis of DNA for any of the following purposes is
use for an excepted purpose—
(a)
the medical diagnosis or treatment of the person whose body
manufactured the DNA;
15
(b)
purposes of functions of a coroner;
(c)
purposes of functions of a procurator fiscal in connection with the
investigation of deaths;
(d)
the prevention or detection of crime;
(e)
the conduct of a prosecution;
20
(f)
purposes of national security;
(g)
implementing an order or direction of a court or tribunal, including
one outside the United Kingdom.
      (2)
For the purposes of sub-paragraph (1)(d), detecting crime shall be taken to
include—
25
(a)
establishing by whom, for what purpose, by what means and
generally in what circumstances any crime was committed, and
(b)
the apprehension of the person by whom any crime was committed;

and the reference in sub-paragraph (1)(d) to the detection of crime includes
any detection outside the United Kingdom of any crime or suspected crime.
30
      (3)
In sub-paragraph (1)(e), the reference to a prosecution includes a
prosecution brought in respect of a crime in a country or territory outside the
United Kingdom.
      (4)
In this paragraph, a reference to a crime includes a reference to any conduct
which—
35
(a)
constitutes one or more criminal offences (whether under the law of
a part of the United Kingdom or a country or territory outside the
United Kingdom),
(b)
is, or corresponds to, conduct which, if it all took place in any one
part of the United Kingdom, would constitute one or more criminal
40
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).

Human Tissue Bill
Schedule 5 — Section 50: Supplementary
Part 2 — Use for an excepted purpose
56

      (5)
Sub-paragraph (1)(g) shall not be taken to confer any power to make orders
or give directions.
Purpose of research in connection with disorders, or functioning, of the human body
6     (1)
Use of the results of an analysis of DNA for the purpose of research in
connection with disorders, or the functioning, of the human body is use for
5
an excepted purpose if the bodily material concerned is the subject of an
order under sub-paragraph (2).
      (2)
The Secretary of State may by regulations specify circumstances in which the
High Court or the Court of Session may order that this paragraph apply to
bodily material.
10
Purposes relating to existing holdings
7
Use of the results of an analysis of DNA for any of the following purposes is
use for an excepted purpose if the bodily material concerned is an existing
holding—
(a)
clinical audit;
15
(b)
determining the cause of death;
(c)
education or training relating to—
(i)
human health, or
(ii)
research in connection with disorders, or the functioning, of
the human body;
20
(d)
establishing after a person’s death the efficacy of any drug or other
treatment administered to him;
(e)
obtaining scientific or medical information about a living or
deceased person which may be relevant to any other person
(including a future person);
25
(f)
performance assessment;
(g)
public health monitoring;
(h)
quality assurance;
(i)
research in connection with disorders, or the functioning, of the
human body;
30
(j)
transplantation.
Purposes relating to material from body of a living person
8
Use of the results of an analysis of DNA for any of the following purposes is
use for an excepted purpose if the bodily material concerned is from the
body of a living person—
35
(a)
clinical audit;
(b)
education or training relating to human health, other than education
or training of the kind mentioned in paragraph 7(c)(ii);
(c)
performance assessment;
(d)
public health monitoring;
40
(e)
quality assurance.
9     (1)
Use of the results of an analysis of DNA for the purpose of obtaining
scientific or medical information about the person whose body
manufactured the DNA is use for an excepted purpose if—

Human Tissue Bill
Schedule 5 — Section 50: Supplementary
Part 2 — Use for an excepted purpose
57

(a)
the bodily material concerned is the subject of an order under sub-
paragraph (2) or (3), and
(b)
the information may be relevant to the person for whose benefit the
order is made.
      (2)
If the High Court is satisfied—
5
(a)
that bodily 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 person) that DNA in the material be analysed for the purpose
10
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 consent to the use of the
material for that purpose is in force, or
15
(iii)
that the donor lacks capacity to consent to the use of the
material for that purpose,

it may order that this paragraph apply to the material for the benefit of the
other person.
      (3)
If the Court of Session is satisfied—
20
(a)
that bodily 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 person) that DNA in the material be analysed for the purpose
25
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 consent to the use of the
material for that purpose is in force, or
30
(iii)
that the donor is an incapable adult within the meaning of the
Adults with Incapacity (Scotland) Act 2000 (asp 4),

it may order that this paragraph apply to the material for the benefit of the
other person.
10
Use of the results of an analysis of DNA for the purpose of research in
35
connection with disorders, or the functioning, of the human body is use for
an excepted purpose if—
(a)
the bodily material concerned is from the body of a living person,
(b)
the research is ethically approved in accordance with regulations
made by the Secretary of State, and
40
(c)
the analysis is to be carried out in circumstances such that the person
carrying it out 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.
Purpose authorised under section 1
45
11
Use of the results of an analysis of DNA for a purpose specified in paragraph
7 is use for an excepted purpose if the use in England and Wales, or Northern

Human Tissue Bill
Schedule 6 — Powers of inspection, entry, search and seizure
58

Ireland, for that purpose of the bodily material concerned is authorised by
section 1(1) or (10)(c).
Purposes relating to DNA of adults who lack capacity to consent
12    (1)
Use of the results of an analysis of DNA for a purpose specified under sub-
paragraph (2) is use for an excepted purpose if—
5
(a)
the DNA has been manufactured by the body of a person who—
(i)
has attained the age of 18 years and, under the law of
England and Wales or Northern Ireland, lacks capacity to
consent to analysis of the DNA, or
(ii)
under the law of Scotland, is an adult with incapacity within
10
the meaning of the Adults with Incapacity (Scotland) Act
2000 (asp 4), and
(b)
neither a decision of his to consent to analysis of the DNA for that
purpose, nor a decision of his not to consent to analysis of it for that
purpose, is in force.
15
      (2)
The Secretary of State may by regulations specify for the purposes of this
paragraph purposes for which DNA may be analysed.
Power to amend paragraphs 5, 7 and 8
13
The Secretary of State may by order amend paragraph 5, 7 or 8 for the
purpose of—
20
(a)
varying or omitting any of the purposes specified in that paragraph,
or
(b)
adding to the purposes so specified.
Schedule 6
Section 53

Powers of inspection, entry, search and seizure
25
Inspection of statutory records
1     (1)
A duly authorised person may require a person to produce for inspection
any records which he is required to keep by, or by virtue of, this Act.
      (2)
Where records which a person is so required to keep are stored in any
electronic form, the power under sub-paragraph (1) includes power to
30
require the records to be made available for inspection—
(a)
in a visible and legible form, or
(b)
in a form from which they can readily be produced in a visible and
legible form.
      (3)
A duly authorised person may inspect and take copies of any records
35
produced for inspection in pursuance of a requirement under this
paragraph.
Entry and inspection of licensed premises
2     (1)
A duly authorised person may at any reasonable time enter and inspect any
premises in respect of which a licence is in force.
40

Human Tissue Bill
Schedule 6 — Powers of inspection, entry, search and seizure
59

      (2)
The power in sub-paragraph (1) is exercisable for purposes of the
Authority’s functions in relation to licences.
Entry and search in connection with suspected offence
3     (1)
If a justice of the peace is satisfied on sworn information or, in Northern
Ireland, on a complaint on oath that there are reasonable grounds for
5
believing—
(a)
that an offence under Part 1 or 2 is being, or has been, committed on
any premises, and
(b)
that any of the conditions in sub-paragraph (2) is met in relation to
the premises,
10

he may by signed warrant authorise a duly authorised person to enter the
premises, if need be by force, and search them.
      (2)
The conditions referred to are—
(a)
that entry to the premises has been, or is likely to be, refused and
notice of the intention to apply for a warrant under this paragraph
15
has been given to the occupier;
(b)
that the premises are unoccupied;
(c)
that the occupier is temporarily absent;
(d)
that an application for admission to the premises or the giving of
notice of the intention to apply for a warrant under this paragraph
20
would defeat the object of entry.
      (3)
A warrant under this paragraph shall continue in force until the end of the
period of 31 days beginning with the day on which it is issued.
Execution of warrants
4     (1)
Entry and search under a warrant under paragraph 3 is unlawful if any of
25
sub-paragraphs (2) to (4) and (6) is not complied with.
      (2)
Entry and search shall be at a reasonable time unless the person executing
the warrant thinks that the purpose of the search may be frustrated on an
entry at a reasonable time.
      (3)
If the occupier of the premises to which the warrant relates is present when
30
the person executing the warrant seeks to enter them, the person executing
the warrant shall—
(a)
produce the warrant to the occupier, and
(b)
give him—
(i)
a copy of the warrant, and
35
(ii)
an appropriate statement.
      (4)
If the occupier of the premises to which the warrant relates is not present
when the person executing the warrant seeks to enter them, but some other
person is present who appears to the person executing the warrant to be in
charge of the premises, the person executing the warrant shall—
40
(a)
produce the warrant to that other person,
(b)
give him—
(i)
a copy of the warrant, and
(ii)
an appropriate statement, and
(c)
leave a copy of the warrant in a prominent place on the premises.
45