National Health Service Bill [HL]

House of Commons

Session 2005 - 06
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National Health Service Bill [HL]

National Health Service Bill [HL]
Part 13 — Miscellaneous
163

261
Powers relating to voluntary schemes
(1)
The powers under this section may be exercised where there is in existence a
scheme (referred to in this section and sections 262 and 263 as a “voluntary
scheme”) made by the Secretary of State and the industry body for the purpose
of—
5
(a)
limiting the prices which may be charged by any manufacturer or
supplier to whom the scheme relates for the supply of any health
service medicines, or
(b)
limiting the profits which may accrue to any manufacturer or supplier
to whom the scheme relates in connection with the manufacture or
10
supply of any health service medicines.
(2)
For the purposes of this section and sections 262 and 263, a voluntary scheme
must be treated as applying to a manufacturer or supplier to whom it relates
if—
(a)
he has consented to the scheme being so treated (and has not
15
withdrawn that consent), and
(b)
no notice is in force in his case under subsection (4).
(3)
For the purposes of this section a voluntary scheme has effect, in relation to a
manufacturer or supplier to whom it applies, with any additions or
modifications made by him and the Secretary of State.
20
(4)
If any acts or omissions of any manufacturer or supplier to whom a voluntary
scheme applies (a “scheme member”) have shown that, in the scheme
member’s case, the scheme is ineffective for either of the purposes mentioned
in subsection (1), the Secretary of State may by a written notice given to the
scheme member determine that the scheme does not apply to him.
25
(5)
A notice under subsection (4) must give the Secretary of State’s reasons for
giving the notice, and the Secretary of State may not give a notice under that
subsection until he has given the scheme member an opportunity to make
representations about the acts or omissions in question.
(6)
Consent under subsection (2)(a) must be given, or withdrawn, in the manner
30
required by the Secretary of State.
(7)
The Secretary of State may after consultation with the industry body require
any manufacturer or supplier to whom a voluntary scheme applies to—
(a)
record and keep any information, and
(b)
provide any information to the Secretary of State,
35

which the Secretary of State may require for the purpose of enabling the
scheme to operate or facilitating its operation or for the purpose of giving full
effect to any provision made under subsection (8).
(8)
The Secretary of State may—
(a)
prohibit any manufacturer or supplier to whom a voluntary scheme
40
applies from increasing any price charged by him for the supply of any
health service medicine covered by the scheme without the approval of
the Secretary of State, and
(b)
provide for any amount representing any increase in contravention of
that prohibition in the sums charged by that person for that medicine,
45
so far as the increase is attributable to supplies to the health service, to
be paid to the Secretary of State within a specified period.

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262
Power to control prices
(1)
The Secretary of State may, after consultation with the industry body—
(a)
limit any price which may be charged by any manufacturer or supplier
for the supply of any health service medicine, and
(b)
provide for any amount representing sums charged by that person for
5
that medicine in excess of the limit to be paid to the Secretary of State
within a specified period.
(2)
The powers conferred by this section are not exercisable at any time in relation
to a manufacturer or supplier to whom at that time a voluntary scheme applies.
263
Statutory schemes
10
(1)
The Secretary of State may, after consultation with the industry body, make a
scheme (referred to in this section and section 264 as a statutory scheme) for the
purpose of—
(a)
limiting the prices which may be charged by any manufacturer or
supplier for the supply of any health service medicines, or
15
(b)
limiting the profits which may accrue to any manufacturer or supplier
in connection with the manufacture or supply of any health service
medicines.
(2)
A statutory scheme may, in particular, make any provision mentioned in
subsections (3) to (6).
20
(3)
The scheme may require any manufacturer or supplier to whom it applies to—
(a)
record and keep information, and
(b)
provide information to the Secretary of State.
(4)
The scheme may provide for any amount representing sums charged by any
manufacturer or supplier to whom the scheme applies, in excess of the limits
25
determined under the scheme, for health service medicines covered by the
scheme to be paid by that person to the Secretary of State within a specified
period.
(5)
The scheme may provide for any amount representing the profits, in excess of
the limits determined under the scheme, accruing to any manufacturer or
30
supplier to whom the scheme applies in connection with the manufacture or
supply of health service medicines covered by the scheme to be paid by that
person to the Secretary of State within a specified period.
(6)
The scheme may—
(a)
prohibit any manufacturer or supplier to whom the scheme applies
35
from increasing, without the approval of the Secretary of State, any
price charged by him for the supply of any health service medicine
covered by the scheme, and
(b)
provide for any amount representing any increase in contravention of
that prohibition in the sums charged by that person for that medicine,
40
so far as the increase is attributable to supplies to the health service, to
be paid to the Secretary of State within a specified period.
(7)
A statutory scheme may not apply to a manufacturer or supplier to whom a
voluntary scheme applies.

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165

264
Statutory schemes: supplementary
(1)
The Secretary of State may, after consultation with the industry body, make
any provision he considers necessary or expedient for the purpose of enabling
or facilitating—
(a)
the introduction of a statutory scheme or of a limit under section 262, or
5
(b)
the determination of the provision to be made in a proposed statutory
scheme.
(2)
The provision may, in particular, require any person to whom such a scheme
or limit may apply to—
(a)
record and keep information,
10
(b)
provide information to the Secretary of State.
(3)
Where the Secretary of State is preparing to make or vary a statutory scheme,
he may make any provision he considers necessary or expedient for
transitional or transitory purposes which could be made by such a scheme.
265
Enforcement
15
(1)
Regulations may provide for a person who contravenes any provision of
regulations or directions under sections 261 to 264 to be liable to pay a penalty
to the Secretary of State.
(2)
The penalty may be—
(a)
a single penalty not exceeding £100,000, or
20
(b)
a daily penalty not exceeding £10,000 for every day on which the
contravention occurs or continues.
(3)
Regulations may provide for any amount required to be paid to the Secretary
of State by virtue of section 261(8)(b), 262(1)(b) or 263(4) or (6)(b) to be
increased by an amount not exceeding 50 per cent.
25
(4)
Regulations may provide for any amount payable to the Secretary of State by
virtue of provision made under section 261(8)(b), 262(1)(b) or 263(4), (5) or
(6)(b) (including such an amount as increased under subsection (3)) to carry
interest at a rate specified or referred to in the regulations.
(5)
Provision may be made by regulations for conferring on manufacturers and
30
suppliers a right of appeal against enforcement decisions taken in respect of
them in pursuance of sections 261 to 264 and this section.
(6)
The provision which may be made by virtue of subsection (5) includes any
provision which may be made by model provisions with respect to appeals
under section 6 of the Deregulation and Contracting Out Act 1994 (c. 40),
35
reading—
(a)
the references in subsections (4) and (5) of that section to enforcement
action as references to action taken to implement an enforcement
decision,
(b)
in subsection (5) of that section, the references to interested persons as
40
references to any persons and the reference to any decision to take
enforcement action as a reference to any enforcement decision.
(7)
In subsections (5) and (6), “enforcement decision” means a decision of the
Secretary of State or any other person to—

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(a)
require a specific manufacturer or supplier to provide information to
him,
(b)
limit, in respect of any specific manufacturer or supplier, any price or
profit,
(c)
refuse to give his approval to a price increase made by a specific
5
manufacturer or supplier,
(d)
require a specific manufacturer or supplier to pay any amount
(including an amount by way of penalty) to him,

and in this subsection “specific” means specified in the decision.
(8)
A requirement or prohibition, or a limit, under sections 261 to 264, may only be
10
enforced under this section and may not be relied on in any proceedings other
than proceedings under this section.
(9)
The Secretary of State must consult the industry body before making any
regulations under this section.
(10)
The Secretary of State may by order increase (or further increase) either of the
15
sums mentioned in subsection (2).
266
Controls: supplementary
(1)
Any power conferred on the Secretary of State by sections 261(6) to (8) and 262
to 264 may be exercised by—
(a)
making regulations, or
20
(b)
giving directions to a specific manufacturer or supplier.
(2)
Regulations under subsection (1)(a) may confer power for the Secretary of State
to give directions to a specific manufacturer or supplier; and in this subsection
“specific” means specified in the direction concerned.
(3)
The powers to refuse approval under section 261(8)(a) or 263(6)(a) or to impose
25
a limit under section 262(1)(a) or 263(1) are exercisable only with a view to
limiting by reference to the prices or profits which would be reasonable in all
the circumstances—
(a)
the prices which may be charged for, or
(b)
the profits which may accrue to any manufacturer or supplier in
30
connection with,

the manufacture or supply for the purposes of the health service of health
service medicines.
(4)
In so exercising those powers (in the case of sections 262(1)(a) and 263(1) and
(6)(a)) the Secretary of State and any other person must bear in mind, in
35
particular—
(a)
the need for medicinal products to be available for the health service on
reasonable terms, and
(b)
the costs of research and development.
(5)
The powers conferred by sections 261 to 264 do not affect any other powers of
40
the Secretary of State to control prices or profits.
(6)
In this section and sections 261 to 265—
“health service” includes the health services within the meaning of the
National Health Service (Scotland) Act 1978 (c. 29) and the Health and
Personal Social Services (Northern Ireland) Order 1972 (S.I. 1972/1265
45
(N.I.14)),

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“health service medicine” means a medicinal product used to any extent
for the purposes of the health service,
“the industry body” means any body which appears to the Secretary of
State appropriate to represent manufacturers and suppliers,
“manufacture” includes assemble and “manufacturer” means any person
5
who manufactures health service medicines,
“medicinal product” has the meaning given by section 130 of the
Medicines Act 1968 (c. 67),
“supplier” means any person who supplies health service medicines,

and contravention of a provision includes a failure to comply with it, and
10
supplying medicines includes selling them.
Use of facilities in private practice
267
Permission for use of facilities in private practice
(1)
A person to whom this section applies who wishes to use any relevant health
service accommodation or facilities for the purpose of providing medical,
15
dental, pharmaceutical, ophthalmic or chiropody services to non-resident
private patients may apply in writing to the Secretary of State for permission
under this section.
(2)
Any application for permission under this section must specify—
(a)
which of the relevant health service accommodation or facilities the
20
applicant wishes to use for the purpose of providing services to such
patients, and
(b)
which of the kinds of services mentioned in subsection (1) he wishes the
permission to cover.
(3)
On receiving an application under this section the Secretary of State—
25
(a)
must consider whether anything for which permission is sought would
interfere with the giving of full and proper attention to persons seeking
or afforded access otherwise than as private patients to any services
provided under this Act, and
(b)
must grant the permission applied for unless in his opinion anything
30
for which permission is sought would so interfere.
(4)
Any grant of permission under this section is on such terms (including terms
as to the payment of charges for the use of the relevant health service
accommodation or facilities pursuant to the permission) as the Secretary of
State may from time to time determine.
35
(5)
The persons to whom this section applies are—
(a)
medical practitioners, registered pharmacists or other persons who
provide pharmaceutical services under Chapter 1 of Part 7,
(b)
chiropodists who provide services under this Act at premises where
services are provided under that Chapter,
40
(c)
persons providing primary medical services, primary dental services or
primary ophthalmic services under a general medical services contract,
a general dental services contract or a general ophthalmic services
contract, or in accordance with section 92 arrangements or section 107
arrangements.
45

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(6)
“Relevant health service accommodation or facilities”, in relation to a person to
whom this section applies, means—
(a)
any accommodation or facilities available at premises provided by the
Secretary of State by virtue of this Act, being accommodation or
facilities which that person is authorised to use for purposes of this Act,
5
or
(b)
in the case of a person to whom this section applies by virtue of
subsection (5)(b), accommodation or facilities which that person is
authorised to use for purposes of this Act at premises where services
are provided under Chapter 1 of Part 7.
10
Health service development
268
Persons displaced by health service development
(1)
Subsection (2) applies—
(a)
where the carrying out of a scheme for the provision by the Secretary of
State in pursuance of this Act of hospital accommodation or other
15
facilities will involve the displacement from any premises of persons
living in the premises, and
(b)
in so far as it appears to the Secretary of State that there is no other
residential accommodation suitable for the reasonable requirements of
those persons available on reasonable terms.
20
(2)
The Secretary of State may make arrangements with one or more of the bodies
mentioned in subsection (3) for securing the provision, in advance of the
displacement, of residential accommodation which becomes necessary as the
carrying out of the scheme proceeds.
(3)
The bodies are—
25
(a)
a local housing authority (within the meaning of the Housing Act 1985
(c. 68)),
(b)
a housing association or housing trust (within the meaning of the
Housing Associations Act 1985 (c. 69)),
(c)
a development corporation established under the New Towns Act 1981
30
(c. 64),
(d)
the Commission for the New Towns.
(4)
Arrangements under subsection (2) may include provision for the making of
payments by the Secretary of State to the body with whom the arrangements
are made.
35
Registration of information, etc
269
Special notices of births and deaths
(1)
The requirements of this section with respect to the notification of births and
deaths are in addition to, and not in substitution for, the requirements of any
Act relating to the registration of births and deaths.
40
(2)
Each registrar of births and deaths must furnish, to the Primary Care Trust the
area of which includes the whole or part of the registrar’s sub-district, such
particulars of each birth and death which occurred in the area of the Primary

National Health Service Bill [HL]
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Care Trust as are entered in a register of births or deaths kept for that sub-
district.
(3)
Regulations may provide as to the manner in which and the times at which
particulars must be furnished under subsection (2).
(4)
In the case of each child born—
5
(a)
the child’s father, if at the time of the birth he is residing on the
premises where the birth takes place, and
(b)
any person in attendance upon the mother at the time of, or within six
hours after, the birth,

must give notice of the birth to the Primary Care Trust for the area in which the
10
birth takes place.
(5)
Subsection (4) applies to any child which is born after the expiry of the twenty-
fourth week of pregnancy whether alive or dead.
(6)
Notice under subsection (4) must be given either—
(a)
by posting within 36 hours after the birth a prepaid letter or postcard
15
addressed to the Primary Care Trust at its offices and containing the
required information, or
(b)
by delivering within that period at the offices of the Primary Care Trust
a written notice containing the required information.
(7)
A Primary Care Trust must, upon application to it, supply without charge to
20
any medical practitioner or midwife residing or practising within its area
prepaid addressed envelopes together with the forms of notice.
(8)
Any person who fails to give notice of a birth in accordance with subsection (4)
is liable on summary conviction to a fine not exceeding level 1 on the standard
scale, unless he satisfies the court that he believed, and had reasonable grounds
25
for believing, that notice had been duly given by some other person.
(9)
Proceedings in respect of an offence under subsection (8) must not, without the
Attorney-General’s written consent, be taken by any person other than a party
aggrieved or the Primary Care Trust concerned.
(10)
A registrar of births and deaths must, for the purpose of obtaining information
30
concerning births which have occurred in his sub-district, have access at all
reasonable times to—
(a)
notices of births received by a Primary Care Trust under this section, or
(b)
any book in which those notices may be recorded.
270
Provision of information by Registrar General
35
(1)
The Registrar General may provide to the Secretary of State any information to
which this section applies.
(2)
Any information provided under subsection (1) must be provided in such form
as appears to the Registrar General appropriate for the purpose of assisting the
Secretary of State in the performance of his functions in relation to the health
40
service.
(3)
This section applies to any information—
(a)
entered in any register kept under the Births and Deaths Registration
Act 1953 (c. 20),