National Health Service (Wales) Bill [HL]

House of Commons

Session 2005 - 06
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National Health Service (Wales) Bill [HL]

National Health Service (Wales) Bill [HL]
Part 7 — Pharmaceutical services and local pharmaceutical services
Chapter 1 — Pharmaceutical services
55

83
Regulations as to pharmaceutical services
(1)
Regulations must provide for securing that arrangements made by a Local
Health Board under section 80 will—
(a)
enable persons for whom drugs, medicines or appliances mentioned in
that section are ordered as there mentioned to receive them from
5
persons with whom such arrangements have been made, and
(b)
ensure the provision of services prescribed under subsection (3)(e) of
that section by persons with whom such arrangements have been
made.
(2)
The regulations must include provision—
10
(a)
for the preparation and publication by a Local Health Board of one or
more lists of persons, other than medical practitioners and dental
practitioners, who undertake to provide pharmaceutical services from
premises in the area of the Local Health Board,
(b)
that an application to a Local Health Board for inclusion in a
15
pharmaceutical list must be made in the prescribed manner and must
state—
(i)
the services which the applicant will undertake to provide and,
if they consist of or include the supply of appliances, which
appliances he will undertake to supply, and
20
(ii)
the premises from which he will undertake to provide those
services,
(c)
that, except in prescribed cases (which may, in particular, include
cases of applications for the provision only of services falling within
subsection (7)—
25
(i)
an application for inclusion in a pharmaceutical list by a person
not already included, and
(ii)
an application by a person already included in a pharmaceutical
list for inclusion also in respect of services or premises other
than those already listed in relation to him,
30

may be granted only if the Local Health Board is satisfied, in
accordance with the regulations, that it is necessary or expedient to
grant the application in order to secure in the neighbourhood in which
the premises are located the adequate provision by persons included in
the list of the services, or some of the services, specified in the
35
application, and
(d)
for the removal of an entry in respect of premises from a
pharmaceutical list if it has been determined in the prescribed manner
that the person to whom the entry relates—
(i)
has never provided from those premises, or
40
(ii)
has ceased to provide from them,

the services, or any of the services, which he is listed as undertaking to
provide from them.
(3)
The regulations may prescribe the extent to which the provision of LP services
(within the meaning given by paragraph 1 of Schedule 7) must be taken into
45
account in determining whether to grant an application for inclusion in a
pharmaceutical list.
(4)
The regulations may include the provision mentioned in subsection (5) for the
case where—

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Part 7 — Pharmaceutical services and local pharmaceutical services
Chapter 1 — Pharmaceutical services
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(a)
two or more applications referred to in subsection (2)(c)(i) or (ii) relate
to the same neighbourhood,
(b)
they are considered together by the Local Health Board, and
(c)
the Local Health Board would be satisfied as mentioned in subsection
(2)(c) in relation to each application taken on its own, but is not so
5
satisfied in relation to all of them taken together.
(5)
The provision mentioned in this subsection is provision for the Local Health
Board, in determining which application (or applications) to grant, to take into
account any proposals specified in the applications in relation to the sale or
supply at the premises in question, otherwise than by way of pharmaceutical
10
services or in accordance with a private prescription, of—
(a)
drugs and medicines, and
(b)
other products for, or advice in relation to, the prevention, diagnosis,
monitoring or treatment of illness or handicap, or the promotion or
protection of health.
15
(6)
The regulations may include provision—
(a)
that an application to a Local Health Board may be granted in respect
of some only of the services specified in it,
(b)
that an application to a Local Health Board relating to services of a
prescribed description may be granted only if it appears to the Local
20
Health Board that the applicant has satisfied such conditions with
regard to the provision of those services as may be prescribed,
(c)
that an application to a Local Health Board by a person who qualified
to have his name registered under the Pharmacy Act 1954 (c. 61) by
virtue of section 4A of that Act (qualification by European diploma)
25
may not be granted unless the applicant satisfies the Local Health
Board that he has the knowledge of English which, in the interest of
himself and persons making use of the services to which the application
relates, is necessary for the provision of pharmaceutical services in the
area of the Local Health Board,
30
(d)
that the inclusion of a person in a pharmaceutical list in pursuance of
such an application may be for a fixed period,
(e)
that, where the premises from which an application states that the
applicant will undertake to provide services are in an area of a
prescribed description, the applicant may not be included in the
35
pharmaceutical list unless his inclusion is approved by reference to
prescribed criteria by the Local Health Board in whose area those
premises are situated,
(f)
that that Local Health Board may give its approval subject to
conditions,
40
(g)
as to other grounds on which a Local Health Board may, or must, refuse
to grant an application (including grounds corresponding to the
conditions referred to in section 107(2), (3) or (4) as read with section
109),
(h)
as to information which must be supplied to a Local Health Board by a
45
person included, or seeking inclusion, in a pharmaceutical list (or by
arrangement with him),
(i)
for the supply to a Local Health Board by an individual—
(i)
who is included, or seeking inclusion, in a pharmaceutical list,
or
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National Health Service (Wales) Bill [HL]
Part 7 — Pharmaceutical services and local pharmaceutical services
Chapter 1 — Pharmaceutical services
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(ii)
who is a member of the body of persons controlling a body
corporate included, or seeking inclusion, in a pharmaceutical
list,

of a criminal conviction certificate under section 112 of the Police Act
1997 (c. 50), a criminal record certificate under section 113 of that Act or
5
an enhanced criminal record certificate under section 115 of that Act,
(j)
for grounds on which a Local Health Board may defer a decision
whether or not to grant an application,
(k)
for the disclosure by a Local Health Board, to prescribed persons or
persons of prescribed descriptions, of information of a prescribed
10
description about applicants for inclusion in a pharmaceutical list, and
refusals by the Local Health Board to grant such applications,
(l)
as to criteria to be applied in making decisions under the regulations
(other than decisions required by virtue of paragraph (e)),
(m)
as to the making of declarations about—
15
(i)
financial interests,
(ii)
gifts above a prescribed value, and
(iii)
other benefits received.
(7)
A service falls within this subsection if the means of providing it is such that
the person receiving it does so otherwise than at the premises from which it is
20
provided.
(8)
The regulations may, in respect of services falling within subsection (7),
include provision—
(a)
requiring persons to be approved for the purposes of providing such
services, or
25
(b)
requiring the Local Health Board to make the grant of an application
subject to prescribed conditions.
(9)
The approval mentioned in subsection (8)(a) is approval by the Welsh
Ministers or such other person as may be specified in the regulations, in
accordance with criteria to be specified in or determined under the regulations
30
(whether by the Welsh Ministers or by another person so specified).
(10)
Before making regulations by virtue of subsection (6)(m), the Welsh Ministers
must consult such organisations as they consider appropriate appearing to
them to represent persons providing pharmaceutical services.
(11)
In this Act a “pharmaceutical list” means a list published in accordance with
35
regulations made under subsection (2)(a).
84
Regulations under section 83: appeals, etc
(1)
Regulations under section 83 must include provision conferring on such
persons as may be prescribed rights of appeal from decisions made by virtue
of that section.
40
(2)
If regulations made by virtue of section 83(6)(g) provide that a Local Health
Board may refuse to grant an application, they must also provide for an appeal
(by way of redetermination) to the FHSAA against the decision of the Local
Health Board.
(3)
Regulations under section 83 must be so framed as to preclude—
45
(a)
a person included in a pharmaceutical list, and

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Part 7 — Pharmaceutical services and local pharmaceutical services
Chapter 1 — Pharmaceutical services
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(b)
an employee of such a person,

from taking part in the decision whether an application such as is mentioned
in section 83(2)(c) should be granted or an appeal against such a decision
brought by virtue of subsection (1) of this section should be allowed.
85
Power to charge
5
(1)
The Welsh Ministers may give directions to a Local Health Board requiring it
to charge a fee in cases or descriptions of case specified in the directions to
persons who make an application referred to in section 83(2)(c)(i) or (ii).
(2)
The Welsh Ministers may in the directions—
(a)
specify the fee themselves, or
10
(b)
require the Local Health Board to determine the amount of the fee in
accordance with any requirements set out in the directions.
(3)
Before determining the amount of the fee-
(a)
in a subsection (2)(a) case, the Welsh Ministers must consult such
organisations as they consider appropriate that appear to them to
15
represent persons providing pharmaceutical services and such
organisations as they consider appropriate that appear to them to
represent Local Health Boards,
(b)
in a subsection (2)(b) case, the Local Health Board must undertake any
consultation required by the directions.
20
(4)
The Welsh Ministers must publish in such manner as they consider
appropriate any directions they give under this section.
(5)
In a subsection (2)(b) case, the Local Health Board must publish in such manner
as it considers appropriate the fee which it determines.
86
Persons authorised to provide pharmaceutical services
25
(1)
Except as may be provided for by or under regulations, no arrangements may
be made by a Local Health Board with a medical practitioner or dental
practitioner under which he is required or agrees to provide pharmaceutical
services to any person to whom he is rendering primary medical services or
primary dental services.
30
(2)
Except as may be provided for by or under regulations, no arrangements for
the dispensing of medicines may be made under this Chapter with persons
other than persons who—
(a)
are registered pharmacists or persons lawfully conducting a retail
pharmacy business in accordance with section 69 of the Medicines Act
35
1968 (c. 67), and
(b)
undertake that all medicines supplied by them under the arrangements
will be dispensed either by or under the supervision of a registered
pharmacist.
(3)
Regulations must provide for the preparation and publication by each Local
40
Health Board of one or more lists of medical practitioners who undertake to
provide drugs, medicines or listed appliances (within the meaning given by
section 80) under arrangements with the Local Health Board.
(4)
The regulations may, in particular, include provision—

National Health Service (Wales) Bill [HL]
Part 7 — Pharmaceutical services and local pharmaceutical services
Chapter 1 — Pharmaceutical services
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(a)
as to grounds on which a Local Health Board may, or must, refuse to
grant an application for inclusion in a list of medical practitioners
referred to in subsection (3) (including grounds corresponding to the
conditions referred to in section 107(2), (3) or (4) as read with section
109(2)),
5
(b)
as to information which must be supplied to a Local Health Board by a
medical practitioner included, or seeking inclusion, in such a list (or by
arrangement with him),
(c)
for the supply to a Local Health Board by a medical practitioner who is
included, or seeking inclusion, in such a list of a criminal conviction
10
certificate under section 112 of the Police Act 1997 (c. 50), a criminal
record certificate under section 113 of that Act or an enhanced criminal
record certificate under section 115 of that Act,
(d)
for grounds on which a Local Health Board may defer a decision
whether or not to grant an application for inclusion in such a list,
15
(e)
for the disclosure by a Local Health Board to prescribed persons or
persons of prescribed descriptions, of information of a prescribed
description about applicants for inclusion in such a list, and refusals by
the Local Health Board to grant such applications,
(f)
as to criteria to be applied in making decisions under the regulations.
20
(5)
If regulations made by virtue of subsection (4)(a) provide that a Local Health
Board may refuse to grant an application for inclusion in such a list, they must
also provide for an appeal (by way of redetermination) to the FHSAA against
the decision of the Local Health Board.
(6)
The regulations must include provision for the removal of an entry from a list
25
in prescribed circumstances.
(7)
No arrangements for the provision of—
(a)
pharmaceutical services falling within section 80(3)(e), or
(b)
additional pharmaceutical services provided in accordance with a
direction under section 81,
30

may be made with persons other than those who are registered pharmacists or
are of a prescribed description.
(8)
Where—
(a)
arrangements for the provision of pharmaceutical services have been
made with a registered pharmacist, and
35
(b)
a suspension order or an interim suspension order is made with
respect to him,

he may not provide pharmaceutical services in person during the period of
suspension.
(9)
“Suspension order” and “interim suspension order” have the same meaning as
40
in the Pharmacy Act 1954 (c. 61).
87
Inadequate provision of pharmaceutical services
(1)
Subsection (2) applies if the Welsh Ministers are satisfied, after such inquiry as
they consider appropriate, that—
(a)
as respects the area, or part of the area, of a Local Health Board, the
45
persons whose names are included in any pharmaceutical list are not
such as to secure the adequate provision of pharmaceutical services in
that area or part, or

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Part 7 — Pharmaceutical services and local pharmaceutical services
Chapter 1 — Pharmaceutical services
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(b)
for any other reason any considerable number of persons in any such
area or part are not receiving satisfactory services under the
arrangements in force under this Chapter.
(2)
Where this subsection applies, the Welsh Ministers—
(a)
may authorise the Local Health Board to make such other
5
arrangements as the Welsh Ministers may approve, or may themselves
make such other arrangements, and
(b)
may dispense with any of the requirements of regulations made under
this Chapter or Part 8 so far as appears to the Welsh Ministers necessary
to meet exceptional circumstances and enable such arrangements to be
10
made.
Remuneration
88
Remuneration for persons providing pharmaceutical services
(1)
The remuneration to be paid to persons who provide pharmaceutical services
under this Part must be determined by determining authorities.
15
(2)
Determining authorities may also determine the remuneration to be paid to
persons who provide those services in respect of the instruction of any person
in matters relating to those services.
(3)
For the purposes of this section and section 89 determining authorities are—
(a)
the Welsh Ministers, and
20
(b)
so far as authorised by the Welsh Ministers to exercise the functions of
determining authorities, any Local Health Board or other person
appointed by them in an instrument.
(4)
The instrument mentioned in subsection (3)(b) is called in this section an
“instrument of appointment”.
25
(5)
An instrument of appointment—
(a)
may contain requirements with which a determining authority
appointed by that instrument must comply in making determinations,
and
(b)
may be contained in regulations.
30
(6)
Subject to this section and section 89, regulations may make provision about
determining remuneration under this section and may in particular impose
requirements with which determining authorities must comply in making, or
in connection with, determinations (including requirements as to consultation
and publication).
35
(7)
Regulations may provide that determinations may be made by reference to any
of—
(a)
rates or conditions of remuneration of any persons or any descriptions
of persons which are fixed or determined, or will be fixed or
determined, otherwise than by way of a determination under this
40
section,
(b)
scales, indices or other data of any description specified in the
regulations.

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Part 7 — Pharmaceutical services and local pharmaceutical services
Chapter 1 — Pharmaceutical services
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(8)
Where regulations provide as mentioned in subsection (7)(b), they may
provide that any determination which falls to be made by reference to a scale,
index or other data may be made by reference to the scale, index or data—
(a)
in the form current at the time of the determination, and
(b)
in any subsequent form taking effect after that time.
5
(9)
Regulations may—
(a)
provide that determining authorities may make determinations which
have effect in relation to remuneration in respect of a period beginning
on or after a date specified in the determination, which may be the date
of the determination or an earlier or later date, but may be an earlier
10
date only if, taking the determination as a whole, it is not detrimental
to the persons to whose remuneration it relates,
(b)
provide that any determination which does not specify such a date has
effect in relation to remuneration in respect of a period beginning—
(i)
if it is required to be published, on the date of publication,
15
(ii)
if it is not so required, on the date on which it is made.
(10)
A reference in this section or section 89 to a determination is to a determination
of remuneration under this section.
89
Section 88: supplementary
(1)
Before a determination is made by the Welsh Ministers which relates to all
20
persons who provide pharmaceutical services, or a category of such services,
they—
(a)
must consult a body appearing to them to be representative of persons
to whose remuneration the determination would relate, and
(b)
may consult such other persons as they consider appropriate.
25
(2)
Determinations may make different provision for different cases, including
different provision for any particular case, class of case or area.
(3)
Determinations may be—
(a)
made in more than one stage,
(b)
made by more than one determining authority,
30
(c)
varied or revoked by subsequent determinations.
(4)
A determination may be varied—
(a)
to correct an error, or
(b)
where it appears to the determining authority that it was made in
ignorance of or under a mistake as to a relevant fact.
35
(5)
Determinations may, in particular, provide that the whole or any part of the
remuneration—
(a)
is payable only if the determining authority is satisfied as to certain
conditions, or
(b)
must be applied for certain purposes or is otherwise subject to certain
40
conditions.
(6)
Remuneration under section 88 may be determined from time to time and may
consist of payments by way of—
(a)
salary,
(b)
fees,
45