Human Tissue Bill

House of Commons

Session 2003 - 04
Internet Publications
Other Bills before Parliament

Human Tissue Bill

Human Tissue Bill
Schedule 3 — Licences for the purposes of section 13
42

Public records
22
In Schedule 1 to the Public Records Act 1958 (c. 51) (definition of public
records), in Part 2 of the Table at the end of paragraph 3 the following entry
is inserted at the appropriate place—

“Human Tissue Authority.”
5
Investigation by Parliamentary Commissioner
23
In Schedule 2 to the Parliamentary Commissioner Act 1967 (c. 13)
(departments and authorities subject to investigation), the following entry is
inserted at the appropriate place—

“Human Tissue Authority.”
10
House of Commons Disqualification
24
In Part 2 of Schedule 1 to the House of Commons Disqualification Act 1975
(c. 24) (bodies of which all members are disqualified), the following entry is
inserted at the appropriate place—

“The Human Tissue Authority.”
15
Northern Ireland Assembly Disqualification
25
In Part 2 of Schedule 1 to the Northern Ireland Assembly Disqualification
Act 1975 (c. 25) (bodies of which all members are disqualified), the following
entry is inserted at the appropriate place—

“The Human Tissue Authority.”
20
Freedom of information
26
In Part 6 of Schedule 1 to the Freedom of Information Act 2000 (c. 36) (public
authorities), the following entry is inserted at the appropriate place—

“The Human Tissue Authority.”
Schedule 3
25
Section 13

Licences for the purposes of section 13
Power to grant licence
1
The Authority may on application grant a licence for the purposes of section
13.
Characteristics of licence
30
2     (1)
A licence shall not authorise the carrying-on of more than one activity to
which section 13 applies.
      (2)
A licence shall—

Human Tissue Bill
Schedule 3 — Licences for the purposes of section 13
43

(a)
specify the premises where the licensed activity is authorised to be
carried on, and
(b)
designate an individual as the person under whose supervision the
licensed activity is authorised to be carried on.
      (3)
A licence shall not authorise the licensed activity to be carried on—
5
(a)
on premises at different places, or
(b)
under the supervision of more than one individual.
      (4)
It shall be a condition of a licence—
(a)
that the licensed activity shall be carried on only on the premises
specified in the licence;
10
(b)
that the licensed activity shall be carried on only under the
supervision of the individual designated in the licence as the person
under whose supervision it is authorised to be carried on;
(c)
that such information about such matters relating to the carrying-on
of the licensed activity as may be specified in directions shall be
15
recorded in such form as may be so specified;
(d)
that any record made for the purposes of the condition in paragraph
(c) shall be kept until the end of such period as may be specified in
directions;
(e)
that there shall be provided to such person and at such intervals as
20
may be specified in directions—
(i)
such copies of, or extracts from, any record to which the
condition in paragraph (d) relates, and
(ii)
such other information,

as may be so specified;
25
(f)
that there shall be paid to the Authority at such times as may be specified in
directions sums of such amount as may be so specified in respect of its costs
in connection with superintending compliance with the terms of licences.
      (5)
Directions for the purposes of sub-paragraph (4) may be given in relation to
licences generally, licences of a particular description or a particular licence.
30
3     (1)
This paragraph applies to a licence authorising the storage of anatomical
specimens.
      (2)
It shall be a condition of a licence to which this paragraph applies that
storage at the premises specified in the licence of the body of a deceased
person for use for the purpose of anatomical examination shall not begin
35
before that body’s storage there for use for that purpose has been authorised
in writing by—
(a)
the designated individual, or
(b)
an individual who has the Authority’s permission to give such
authorisation (see paragraph 12).
40
      (3)
It shall be a condition of a licence to which this paragraph applies that any
anatomical specimen which is stored at the premises specified in the licence
shall be released from storage at the premises only into the possession of a
person who is authorised in writing by the designated individual to have the
specimen in his possession.
45
      (4)
It shall be a condition of a licence to which this paragraph applies that the
designated individual shall give authority for the purposes of the condition
in sub-paragraph (3) only if he is satisfied—

Human Tissue Bill
Schedule 3 — Licences for the purposes of section 13
44

(a)
that the person to whom authority is given is a suitable person to
have the specimen in his possession, and
(b)
that that person intends to use the specimen only for the purpose of
education, training or research.
      (5)
It shall be a condition of a licence to which this paragraph applies that any
5
authority given for the purposes of the condition in sub-paragraph (3) shall
specify—
(a)
the person to whom the authority is given,
(b)
the specimen to which the authority relates,
(c)
the purpose for which the specimen may be used, and
10
(d)
the duration of the authority.
      (6)
It shall be a condition of a licence to which this paragraph applies that the
designated individual shall give such notice of any authorisation for the
purposes of the condition in sub-paragraph (3) as may be specified in
directions.
15
      (7)
It shall be a condition of a licence to which this paragraph applies that such
information about authorisations for the purposes of the condition in sub-
paragraph (3) as may be specified in directions shall be recorded in such
form as may be so specified.
4     (1)
This paragraph applies to a licence authorising the activity mentioned in
20
section 13(2)(e).
      (2)
It shall be a condition of a licence to which this paragraph applies that any
former anatomical specimen which is stored at the premises specified in the
licence shall be released from storage at the premises only into the
possession of a person who is authorised in writing by the designated
25
individual to have the specimen in his possession.
      (3)
The condition in sub-paragraph (2) does not apply to the release from
storage of a specimen for the purpose of its decent disposal.
      (4)
It shall be a condition of a licence to which this paragraph applies that the
designated individual shall give authority for the purposes of the condition
30
in sub-paragraph (2) only if he is satisfied—
(a)
that the person to whom authority is given is a suitable person to
have the specimen in his possession, and
(b)
that that person intends to use the specimen only for the purpose of
education, training or research.
35
      (5)
It shall be a condition of a licence to which this paragraph applies that any
authority given for the purposes of the condition in sub-paragraph (2) shall
specify—
(a)
the person to whom the authority is given,
(b)
the specimen to which the authority relates,
40
(c)
the purpose for which the specimen may be used, and
(d)
the duration of the authority.
      (6)
It shall be a condition of a licence to which this paragraph applies that the
designated individual shall give such notice of any authorisation for the
purposes of the condition in sub-paragraph (2) as may be specified in
45
directions.
      (7)
It shall be a condition of a licence to which this paragraph applies that such
information about authorisations for the purposes of the condition in sub-

Human Tissue Bill
Schedule 3 — Licences for the purposes of section 13
45

paragraph (2) as may be specified in directions shall be recorded in such
form as may be so specified.
Power to impose conditions
5
The Authority may grant a licence subject to such further conditions as it
thinks fit.
5
Pre-conditions to grant of licence
6     (1)
The Authority may not grant a licence in pursuance of an application unless
the following requirements are met.
      (2)
The proposed designated individual must—
(a)
be the applicant for the licence, or
10
(b)
consent to the application for the licence.
      (3)
The Authority must be satisfied that the proposed designated individual—
(a)
is a suitable person to supervise the activity to be authorised by the
licence, and
(b)
will perform the duty under section 15.
15
      (4)
Where the applicant for the licence is not the proposed designated
individual, the Authority must be satisfied that the applicant is a suitable
person to be the holder of the licence.
      (5)
The Authority must be satisfied that the premises in respect of which the
licence is to be granted are suitable for the activity to be authorised by the
20
licence.
      (6)
A copy of the conditions to be imposed by the licence must have been shown
to, and acknowledged in writing by—
(a)
the applicant for the licence, and
(b)
where different, the proposed designated individual.
25
      (7)
In this paragraph, references to the proposed designated individual are to
the individual whom the application proposes the licence designate as the
person under whose supervision the activity to be authorised by the licence
is to be carried on.
Power to revoke licence
30
7     (1)
The Authority may revoke a licence on application by—
(a)
the holder of the licence, or
(b)
the designated individual.
      (2)
The Authority may revoke a licence otherwise than on an application under
sub-paragraph (1) if—
35
(a)
it is satisfied that any information given for the purposes of the
application for the licence was in any material respect false or
misleading,
(b)
it is satisfied that the designated individual has failed to discharge,
or is unable because of incapacity to discharge, the duty under
40
section 15,
(c)
it ceases to be satisfied that the premises specified in the licence are
suitable for the licensed activity,

Human Tissue Bill
Schedule 3 — Licences for the purposes of section 13
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(d)
it ceases to be satisfied that the person to whom the licence is granted
is a suitable person to be the holder of the licence,
(e)
it ceases to be satisfied that the designated individual is a suitable
person to supervise the licensed activity,
(f)
the designated individual dies, or
5
(g)
it is satisfied that there has been any other material change of
circumstances since the licence was granted.
Power to vary licence
8     (1)
The Authority may on application by the holder of a licence vary the licence
so as to substitute another individual for the designated individual if—
10
(a)
the application is made with the consent of the other individual, and
(b)
the authority is satisfied that the other individual is a suitable person
to supervise the licensed activity.
      (2)
The Authority may vary a licence on application by—
(a)
the holder of the licence, or
15
(b)
the designated individual.
      (3)
The Authority may vary a licence without an application under sub-
paragraph (2) if it has power to revoke the licence under paragraph 7(2).
      (4)
The powers under sub-paragraphs (2) and (3) do not extend to making the
kind of variation mentioned in sub-paragraph (1).
20
      (5)
The Authority may vary a licence without an application under sub-
paragraph (2) by—
(a)
removing or varying a condition of the licence, or
(b)
adding a condition to the licence.
      (6)
The powers conferred by this paragraph do not extend to the conditions
25
required by paragraphs 2(4), 3 and 4.
Power to suspend licence
9     (1)
Where the Authority—
(a)
has reasonable grounds to suspect that there are grounds for
revoking a licence, and
30
(b)
is of the opinion that the licence should immediately be suspended,

it may by notice suspend the licence for such period not exceeding three
months as may be specified in the notice.
      (2)
The Authority may continue suspension under sub-paragraph (1) by giving
a further notice under that sub-paragraph.
35
      (3)
Notice under sub-paragraph (1) shall be given to the designated individual
or, where the designated individual has died or appears to the Authority to
be unable because of incapacity to discharge the duty under section 15—
(a)
to the holder of the licence, or
(b)
to some other person to whom the licence applies.
40
      (4)
Subject to sub-paragraph (5), a licence shall be of no effect while a notice
under sub-paragraph (1) is in force.
      (5)
An application may be made under paragraph 7(1) or 8(1) or (2)
notwithstanding the fact that a notice under sub-paragraph (1) is in force.

Human Tissue Bill
Schedule 3 — Licences for the purposes of section 13
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Procedure in relation to licensing decisions
10    (1)
Before making a decision—
(a)
to refuse an application for the grant, revocation or variation of a
licence, or
(b)
to grant an application for a licence subject to a condition under
5
paragraph 5,

the Authority shall give the applicant notice of the proposed decision and of
the reasons for it.
      (2)
Before making a decision under paragraph 7(2) or 8(3) or (5), the Authority
shall give notice of the proposed decision and of the reasons for it to—
10
(a)
the holder of the licence, and
(b)
where different, the designated individual.
      (3)
A person to whom notice under sub-paragraph (1) or (2) is given has the
right to require the Authority to give him an opportunity to make
representations of one of the following kinds about the proposed decision,
15
namely—
(a)
oral representations by him, or a person acting on his behalf;
(b)
written representations by him.
      (4)
The right under sub-paragraph (3) is exercisable by giving the Authority
notice of exercise of the right before the end of the period of 28 days
20
beginning with the day on which the notice under sub-paragraph (1) or (2)
was given.
      (5)
The Authority may by regulations make such additional provision about
procedure in relation to the carrying-out of functions under this Schedule as
it thinks fit.
25
Notification of licensing decisions
11    (1)
In the case of a decision to grant a licence, the Authority shall give notice of
the decision to—
(a)
the applicant, and
(b)
the person who is to be the designated individual.
30
      (2)
In the case of a decision to revoke a licence, the Authority shall give notice
of the decision to—
(a)
the holder of the licence, and
(b)
the designated individual.
      (3)
In the case of a decision to vary a licence on an application under paragraph
35
8(1), the Authority shall give notice of the decision to—
(a)
the holder of the licence, and
(b)
the person who is to be the designated individual.
      (4)
In the case of any other decision to vary a licence, the Authority shall give
notice of the decision to—
40
(a)
the holder of the licence, and
(b)
the designated individual.
      (5)
In the case of a decision to refuse an application for the grant, revocation or
variation of a licence, the Authority shall give notice of the decision to the
applicant.
45

Human Tissue Bill
Schedule 3 — Licences for the purposes of section 13
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      (6)
Subject to sub-paragraph (7), a notice under sub-paragraph (2), (4) or (5)
shall include a statement of the reasons for the decision.
      (7)
In the case of a notice under sub-paragraph (2) or (4), the notice is not
required to include a statement of the reasons for the decision if the decision
is made on an application under paragraph 7(1) or 8(2).
5
Permission for the purposes of the licence condition required by paragraph 3(2)
12    (1)
This paragraph applies to a licence authorising the storage of anatomical
specimens.
      (2)
The reference to the Authority’s permission in the condition of the licence
required by paragraph 3(2) (“the authorisation condition”) is to—
10
(a)
permission granted by the Authority on an application made, in
conjunction with the application for the licence, by—
(i)
the applicant for the licence, or
(ii)
the person who, within the meaning of paragraph 6, is the
proposed designated individual, or
15
(b)
permission granted by the Authority on application by—
(i)
the holder of the licence, or
(ii)
the designated individual.
      (3)
The Authority may grant permission to an individual for the purposes of the
authorisation condition only if it is satisfied that the individual is a suitable
20
person to give authorisation under that condition.
      (4)
The Authority may revoke permission granted to an individual for the
purposes of the authorisation condition—
(a)
on application by the individual, the designated individual or the
holder of the licence, or
25
(b)
if it ceases to be satisfied that the individual is a suitable person to
give authorisation under that condition.
      (5)
Before refusing an application for the grant or revocation of permission, the
Authority shall give the applicant notice of the proposed refusal and of the
reasons for it.
30
      (6)
Before revoking permission under sub-paragraph (4)(b), the Authority shall
give notice of the proposed revocation and of the reasons for it—
(a)
to the individual concerned, and
(b)
to the designated individual and, where different, the holder of the
licence.
35
      (7)
Paragraph 10(3) and (4) shall apply in relation to notice under sub-
paragraph (5) or (6) as to notice under paragraph 10(1).
      (8)
In the case of a decision to refuse an application for the grant or revocation
of permission, the Authority shall give notice of the decision to the applicant.
      (9)
In the case of a decision to grant or revoke permission, the Authority shall
40
give notice of the decision—
(a)
to the individual concerned, and
(b)
to the designated individual and, where different, the holder of the
licence.