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
43

      (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 (3) shall
specify—
(a)
the person to whom the authority is given,
(b)
the specimen to which the authority relates,
5
(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 (3) as may be specified in
10
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-
paragraph (3) as may be specified in directions shall be recorded in such
form as may be so specified.
15
4     (1)
This paragraph applies to a licence authorising the activity mentioned in
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
20
possession of a person who is authorised in writing by the designated
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
25
designated individual shall give authority for the purposes of the condition
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
30
education, training or research.
      (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,
35
(b)
the specimen to which the authority relates,
(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
40
purposes of the condition in sub-paragraph (2) as may be specified in
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-
paragraph (2) as may be specified in directions shall be recorded in such
45
form as may be so specified.

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

Power to impose conditions
5
The Authority may grant a licence subject to such further conditions as it
thinks fit.
Pre-conditions to grant of licence
6     (1)
The Authority may not grant a licence in pursuance of an application unless
5
the following requirements are met.
      (2)
The proposed designated individual must—
(a)
be the applicant for the licence, or
(b)
consent to the application for the licence.
      (3)
The Authority must be satisfied that the proposed designated individual—
10
(a)
is a suitable person to supervise the activity to be authorised by the
licence, and
(b)
will perform the duty under section 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
15
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
licence.
      (6)
A copy of the conditions to be imposed by the licence must have been shown
20
to, and acknowledged in writing by—
(a)
the applicant for the licence, and
(b)
where different, the proposed designated individual.
      (7)
In this paragraph, references to the proposed designated individual are to
the individual whom the application proposes the licence designate as the
25
person under whose supervision the activity to be authorised by the licence
is to be carried on.
Power to revoke licence
7     (1)
The Authority may revoke a licence on application by—
(a)
the holder of the licence, or
30
(b)
the designated individual.
      (2)
The Authority may revoke a licence otherwise than on an application under
sub-paragraph (1) if—
(a)
it is satisfied that any information given for the purposes of the
application for the licence was in any material respect false or
35
misleading,
(b)
it is satisfied that the designated individual has failed to discharge,
or is unable because of incapacity to discharge, the duty under
section 15,
(c)
it ceases to be satisfied that the premises specified in the licence are
40
suitable for the licensed activity,
(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,
45

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

(f)
the designated individual dies, or
(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
5
so as to substitute another individual for the designated individual if—
(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—
10
(a)
the holder of the licence, or
(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
15
kind of variation mentioned in sub-paragraph (1).
      (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.
20
      (6)
The powers conferred by this paragraph do not extend to the conditions
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
25
revoking a licence, and
(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
30
a further notice under that sub-paragraph.
      (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
35
(b)
to some other person to whom the licence applies.
      (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.
40
Procedure in relation to licensing decisions
10    (1)
Before making a decision—

Human Tissue Bill
Schedule 3 — Licences for the purposes of section 13
46

(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
paragraph 5,

the Authority shall give the applicant notice of the proposed decision and of
5
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—
(a)
the holder of the licence, and
(b)
where different, the designated individual.
10
      (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,
namely—
(a)
oral representations by him, or a person acting on his behalf;
15
(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
beginning with the day on which the notice under sub-paragraph (1) or (2)
was given.
20
      (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.
Notification of licensing decisions
11    (1)
In the case of a decision to grant a licence, the Authority shall give notice of
25
the decision to—
(a)
the applicant, and
(b)
the person who is to be the designated individual.
      (2)
In the case of a decision to revoke a licence, the Authority shall give notice
of the decision to—
30
(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
8(1), the Authority shall give notice of the decision to—
(a)
the holder of the licence, and
35
(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—
(a)
the holder of the licence, and
(b)
the designated individual.
40
      (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.
      (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.
45

Human Tissue Bill
Schedule 3 — Licences for the purposes of section 13
47

      (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).
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
5
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—
(a)
permission granted by the Authority on an application made, in
conjunction with the application for the licence, by—
10
(i)
the applicant for the licence, or
(ii)
the person who, within the meaning of paragraph 6, is the
proposed designated individual, or
(b)
permission granted by the Authority on application by—
(i)
the holder of the licence, or
15
(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
person to give authorisation under that condition.
      (4)
The Authority may revoke permission granted to an individual for the
20
purposes of the authorisation condition—
(a)
on application by the individual, the designated individual or the
holder of the licence, or
(b)
if it ceases to be satisfied that the individual is a suitable person to
give authorisation under that condition.
25
      (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.
      (6)
Before revoking permission under sub-paragraph (4)(b), the Authority shall
give notice of the proposed revocation and of the reasons for it—
30
(a)
to the individual concerned, and
(b)
to the designated individual and, where different, the holder of the
licence.
      (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).
35
      (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
give notice of the decision—
(a)
to the individual concerned, and
40
(b)
to the designated individual and, where different, the holder of the
licence.
     (10)
Notice under sub-paragraph (8), and notice under sub-paragraph (9) of
revocation under sub-paragraph (4)(b), shall include a statement of the
reasons for the refusal or revocation.
45
     (11)
Where the Authority—

Human Tissue Bill
Schedule 4 — Inspectorates: Boards
48

(a)
has reasonable grounds to suspect that there are grounds for
revoking permission granted to an individual for the purposes of the
authorisation condition, and
(b)
is of the opinion that the permission should immediately be
suspended,
5

it may by notice suspend the permission for such period not exceeding three
months as may be specified in the notice.
     (12)
The Authority may continue suspension under sub-paragraph (11) by
giving a further notice under that sub-paragraph.
     (13)
Notice under sub-paragraph (11) shall be given to—
10
(a)
the individual concerned, and
(b)
the designated individual and, where different, the holder of the
licence.
Applications under this Schedule
13    (1)
The Authority may by regulations make provision about applications under
15
this Schedule and may, in particular, make provision about—
(a)
the form and content of such an application,
(b)
the information to be supplied with such an application, and
(c)
procedure in relation to the determination of such an application.
      (2)
An application under this Schedule shall be accompanied by such fee (if any)
20
as the Authority may determine.
Schedule 4
Sections 32 and 34

Inspectorates: Boards
Membership
1     (1)
The board of the Inspectorate shall consist of—
25
(a)
a chairman appointed by the Authority with the approval of the
Secretary of State,
(b)
the chief executive officer of the Inspectorate, and
(c)
such number of other members appointed by the Authority as it
thinks fit.
30
      (2)
The Authority shall exercise its power to appoint members of the board of
the Inspectorate to secure that at all times the membership of the board
includes persons who have, and persons who do not have, a professional
interest in any of the kinds of activity within the remit of the Inspectorate.
Disqualification
35
2
A person is disqualified for being appointed as chairman of the board of the
Inspectorate if he is a member of the Authority.
3     (1)
A person is disqualified for being appointed as chairman or other member
of the board of the Inspectorate if—
(a)
he is the subject of a bankruptcy restrictions order or interim order,
40

Human Tissue Bill
Schedule 4 — Inspectorates: Boards
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(b)
a bankruptcy order has been made against him by a court in
Northern Ireland, his estate has been sequestrated by a court in
Scotland or, under the law of Northern Ireland or Scotland, he has
made a composition or arrangement with, or granted a trust deed
for, his creditors, or
5
(c)
in the last five years he has been convicted in the United Kingdom,
the Channel Islands or the Isle of Man of an offence and has had a
qualifying sentence passed on him.
      (2)
Where a person is disqualified under sub-paragraph (1)(b) because a
bankruptcy order has been made against him or his estate has been
10
sequestrated, the disqualification shall cease—
(a)
on his obtaining a discharge, or
(b)
if the bankruptcy order is annulled or the sequestration of his estate
is recalled or reduced, on the date of that event.
      (3)
Where a person is disqualified under sub-paragraph (1)(b) because of his
15
having made a composition or arrangement with, or granted a trust deed
for, his creditors, the disqualification shall cease—
(a)
at the end of the period of five years beginning with the date on
which the terms of the deed of composition or arrangement or trust
deed are fulfilled, or
20
(b)
if, before then, he pays his debts in full, on the date on which the
payment is completed.
      (4)
For the purposes of sub-paragraph (1)(c), the date of conviction shall be
taken to be the ordinary date on which the period allowed for making an
appeal or application expires or, if an appeal or application is made, the date
25
on which the appeal or application is finally disposed of or abandoned or
fails by reason of its non-prosecution.
      (5)
In sub-paragraph (1)(c), the reference to a qualifying sentence is to a sentence
of imprisonment for a period of not less than three months (whether
suspended or not) without the option of a fine.
30
Tenure of office of appointed members
4
Subject to the following provisions of this Schedule, the chairman and other
appointed members of the board of the Inspectorate shall hold and vacate
office in accordance with the terms of their respective appointments.
5     (1)
The terms of appointment of the chairman and other appointed members of
35
the board of the Inspectorate shall be such as the Authority may determine,
subject to sub-paragraph (2).
      (2)
Appointment as chairman or other member of the board of the Inspectorate
shall be for a term not exceeding three years.
6
Previous service as chairman or other member of the board of the
40
Inspectorate does not affect a person’s eligibility for appointment to either
office.
7
A person holding office as chairman or other appointed member of the
board of the Inspectorate may resign that office by giving notice in writing
to the Authority.
45
8
A person holding office as chairman or other appointed member of the
board of the Inspectorate shall cease to hold that office if he ceases to be
qualified for appointment to it.