PART 13 continued
(6) Consent under subsection (2)(a) must be given, or withdrawn, in the manner required by the Secretary of State.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,
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 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, 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.
(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 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.
(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
(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).
(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 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 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 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, 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.
(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
(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,
(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.
(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
(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.
(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 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), 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 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—
(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 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 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 sums mentioned in subsection (2).
(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
(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 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 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 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 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 (N.I.14)),
“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 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 supplying medicines includes selling them.
(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, 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 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—
(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 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.
(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,
(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.
(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, 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.
(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 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.
(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—
(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 (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.
(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.
(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 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—
(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 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 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 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 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 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.
(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 service.
(3) This section applies to any information—
(a) entered in any register kept under the Births and Deaths Registration Act 1953 (c. 20),
(b) entered in the Adopted Children Register maintained by the Registrar General under the Adoption and Children Act 2002 (c. 38), or
(c) which is kept by the Registrar General under any other enactment and relates to any birth or death.
(4) “Enactment” includes an enactment contained in subordinate legislation.