National Health Service Act 1977

Part IIE+W+S General Medical, General Dental, General Ophthalmic, and Pharmaceutical Services

General medical servicesE+W+S

29Arrangements and regulations for general medical services.E+W+S

[F1(1)It is the duty of every [F2Health Authority], in accordance with regulations, to arrange as respects their [F3area] with medical practitioners to provide personal medical services for all persons in the [F3area] who wish to take advantage of the arrangements.

(1A)The services so provided are referred to in this Act as “general medical services”.]

(2)Regulations may provide for the definition of the personal medical services to be provided and for securing that the arrangements will be such that all persons availing themselves of those services will receive adequate personal care and attendance, and the regulations shall include provision—

(a)for the preparation and publication of lists of medical practitioners who undertake to provide general medical services;

F4(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F4(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d)for the issue to patients or their personal representatives by medical practitioners providing those services of such certificates as may be prescribed being certificates reasonably required by them under or for the purposes of any enactment;

(e)for the removal from the list of medical practitioners undertaking to provide general medical services for persons in any [F5area] of the name of any one in whose case it has been determined in such manner as may be prescribed that he has never provided, or has ceased to provide, such general medical services for persons in that [F5area].

[F6(f)for the making of arrangements for the temporary provision of general medical services [F7in the area of a Health Authority];

(g)for the circumstances in which a name added to the list by virtue of subsection (6) below may be removed from it.]

(3)Regulations under subsection (2) above may provide for the personal medical services there mentioned to include the provision of, and services connected with, any such advice, examination and treatment as are mentioned in paragraph (b) of section 5(1) above.

[F8(4)The remuneration to be paid under the arrangements mentioned in subsection (1) above to a practitioner who provides general medical services shall not, except in special circumstances, consist wholly or mainly of a fixed salary which has no reference to the number of patients for whom he has undertaken to provide such services.]

[F9(5)Regulations shall—

(a)include provision for the making to a medical practitioner providing general medical services of payments in respect of qualifying services provided by a spouse or other relative of his; and

(b)provide that the rates and conditions of payment and the qualifying services in respect of which the payments may be made shall be such as may be determined by the Secretary of State after consultation with such bodies as he may recognise as representing such medical practitioners.]

[F10(6)The persons with whom arrangements for the temporary provision of general medical services in [F11an area] may be made by virtue of regulations under subsection (2) above include medical practitioners who are not on the list of medical practitioners providing such services in [F12the area], and the power to prepare and publish lists of medical practitioners conferred by paragraph (a) of that subsection accordingly includes power to add the names of medical practitioners with whom such arrangements are made to the list.

(7)Regulations may provide that this Act and any regulations made under it shall apply in relation—

(a)to the making of arrangements for the temporary provision of general medical services; and

(b)to the provision of general medical services in pursuance of any such arrangements,

subject to such modifications as may be specified in the regulations.

(8)Where the registration of a medical practitioner in the register of medical practitioners is suspended—

(a)by a direction of the Health Committee of the General Medical Council under [F13section 37(1) or (2) of the M1Medical Act 1983] (unfitness to practice by reason of physical or mental condition);

(b)by an order of that Committee under [F13section 38(1)] of that Act (order for immediate suspension); or

(c)by an interim order [F14under section 42]of that Act,

the suspension shall not terminate any arrangements made with him for the provision of general medical services, but he shall not provide such services in person during the suspension.]

[F15(9)Where the registration of a medical practitioner in the register of medical practitioners is suspended by a direction of the Committee on Professional Performance of the General Medical Council—

(a)under section 36A of the Medical Act 1983 (professional performance),

(b)under section 38(1) of that Act (order for immediate suspension), or

(c)under rules made by virtue of paragraph 5A(3) of Schedule 4 to that Act (procedure of committees),

the suspension shall not, except in so far as is provided by or determined in accordance with regulations under subsection (2) above, terminate any arrangements made with him for the provision of general medical services; but he shall not provide such services in person during the suspension.]

[F1629A Medical lists.E+W+S

(1)A Health Authority may not, under section 29, arrange with a medical practitioner for him to provide general medical services for persons in the Authority’s area unless his name is included in the Authority’s medical list.

(2)A medical practitioner is entitled to be included in a Health Authority’s medical list only if—

(a)he is eligible for inclusion in the list; and

(b)he is nominated or approved, in accordance with regulations under section 29B, for appointment to fill a vacancy which relates (whether wholly or in part) to the area of the Authority.

(3)[F17Subject to any provision made under section 43C] a medical practitioner is eligible for inclusion in a medical list if—

(a)he has not attained the age specified in regulations under section 8 of the M2Health and Medicines Act 1988 (retirement age for practitioners); and

(b)he is not disqualified, or treated as disqualified, from inclusion in the list by virtue of a direction of the Tribunal constituted under section 46 or any corresponding tribunal in Scotland or Northern Ireland.

(4)Regulations may make provision in relation to delaying a person’s inclusion in a medical list in prescribed circumstances.

(5)This section is subject to section 29(6) (temporary provision of general medical services) and any provision of, or made under, an enactment relating to the right of a medical practitioner to transfer to a medical list.

(6)In this Act “medical list”, in relation to a Health Authority, means the list of medical practitioners undertaking to provide general medical services for persons in their area, kept by the Authority under regulations made under section 29(2)(a).]

[F1829B Vacancies for medical practitioners.E+W+S

(1)Regulations may make provision in relation to the filling of vacancies for medical practitioners to provide general medical services.

(2)The regulations may, in particular, include provision for—

(a)references by a Health Authority to the Medical Practices Committee as to whether there is, or will be, a vacancy for a medical practitioner in a locality;

(b)the determination of such references by the Medical Practices Committee;

(c)the determination by the Medical Practices Committee of conditions of practice to be imposed on any medical practitioner who fills a particular vacancy;

(d)the determination by a Health Authority of whether a vacancy is to be filled by a member of a partnership or by a sole practitioner;

(e)the nomination by a Health Authority of a medical practitioner for appointment to fill a vacancy as a sole practitioner;

(f)the approval by a Health Authority of a medical practitioner for appointment to fill a vacancy as a member of a partnership.

(3)The regulations may also make provision in relation to—

(a)criteria to be applied in making decisions under the regulations,

(b)the variation or revocation of such decisions (including appeals to the Secretary of State on points of law), or

(c)vacancies relating to the area of one Health Authority which also relate to the area of another Health Authority or a Health Board,

and may contain such transitional provisions as the Secretary of State considers appropriate.

(4)Regulations which make provision about vacancies which relate partly to the area of a Health Board may, in particular, provide that section 29A(2)(b) is to have effect in prescribed circumstances as if the reference to regulations under this section were a reference to regulations under section 19B of the M3National Health Service (Scotland) Act 1978.

(5)In this section—

• “conditions of practice” means conditions—

  (a)

  specifying, by reference to one or more prescribed conditions relating to hours or the sharing of work, the provision of general medical services for which a person is entitled to be remunerated; and

  (b)

  specifying the locality in which a person is entitled to provide general medical services;

• “Health Board” has the same meaning as in the National Health Service (Scotland) Act 1978;

• “locality”, in relation to a Health Authority, means the Authority’s area or a particular part of their area; and

• “sole practitioner” means a medical practitioner providing general medical services otherwise than in partnership with one or more other medical practitioners.

(6)This section does not affect the power to make regulations under section 29.]

F1930. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E+W+S

31 Requirement of suitable experience.E+W+S

[F20(1)Regulations under section 29B must secure that a medical practitioner is not nominated or approved by a Health Authority for appointment to fill a vacancy unless he is suitably experienced.]

(2)For the purposes of this section a medical practitioner is “suitably experienced” if, but only if, he either—

(a)has acquired the prescribed medical experience, or

(b)is by virtue of regulations made under section 32 below exempt from the need to have acquired that experience, and “medical experience” includes hospital experience in any specialty.

32 Regulations as to s. 31.E+W+S

(1)Regulations may for the purposes of section 31 above provide—

(a)for prescribing the medical experience needed to satisfy paragraph (a) of section 31(2);

(b)as to the documents which an applicant may or must produce as evidence that he is suitably experienced or has acquired medical experience of any particular kind;

(c)for requiring an applicant who claims to have acquired the prescribed experience to submit particulars of his experience to a prescribed body, and for requiring that body, if satisfied that he has acquired the prescribed experience, to issue him a certificate (a “certificate of prescribed experience”) to that effect;

(d)for enabling an applicant without the prescribed experience who considers that the medical experience which he has acquired is, or ought to be regarded as, equivalent to the prescribed experience to submit particulars of that experience to a prescribed body, and for requiring or enabling that body, if satisfied that the applicant’s medical experience is so equivalent, to issue him a certificate (a “certificate of equivalent experience”) to that effect;

(e)for treating an applicant who holds a certificate of equivalent experience as satisfying paragraph (a) of section 31(2);

(f)as to the circumstances or conditions in or subject to which a medical practitioner is exempt from the need to have acquired the prescribed experience;

(g)for conferring on an applicant who is refused a certificate of prescribed experience or a certificate of equivalent experience a right of appeal to a body constituted by the Secretary of State, and for any matter for which it appears to the Secretary of State to be requisite or expedient to provide in consequence of the conferring of that right;

(h)for anything authorised or required by section 31 to be prescribed or otherwise provided for by regulations.

In this section—

• [F21“applicant” means a medical practitioner who is seeking to be nominated or approved by a Health Authority in accordance with regulations under section 29B for appointment to fill a vacancy;]

• “the prescribed experience” means the medical experience for the time being prescribed for the purposes of paragraph (a) of section 31(2).

(2)Regulations under this section shall be framed so as to allow the prescribed experience to be acquired without undertaking whole-time employment.

(3)Any power under this section to make regulations—

(a)may be exercised so as to make different provision for different [F22areas] or different periods of time or in relation to different cases or different circumstances;

(b)includes power to make such incidental or supplemental provision in the regulations as the Secretary of State considers appropriate.

33 Distribution of general medical services.E+W+S

F23(1). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F24(1A)The Secretary of State may by order specify—

(a)the maximum number of medical practitioners with whom, in any year, all the [F25Health Authorities for areas] in England, taken as a whole, may enter into arrangements under section 29 above for the provision of general medical services; and

(b)the maximum number of medical practitioners with whom, in any year, all the [F26Health Authorities for areas] in Wales, taken as a whole, may enter into such arrangements.

(1B)An order under subsection (1A) above may contain such incidental and consequential provisions (including provisions amending this Part of this Act [F27or any regulations made under this Part of this Act]) as appear to the Secretary of State to be appropriate including, in particular, provisions as to the basis on which [F28references under regulations made under section 29B are to be determined] in order to secure that any maximum number specified in the order is not exceeded.]

[F29(1C)An order under subsection (1A) may, in particular, make provision as to the extent to which account is to be taken under the order of medical practitioners whose ability to carry out remunerated work is limited by virtue of conditions of practice which relate to remuneration and are determined under regulations made under section 29B.]

(2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F30(2A). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F30(3). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F30(4). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F30(5). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F30(6). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F31

F30(8). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

34 Regulations for Medical Practices Committee.E+W+S

[F32(1)] Regulations may make provisions for conferring or imposing on the Medical Practices Committee such additional functions in relation to arrangements for the provision of general medical services as may be prescribed; and regulations shall provide—

[F33(a)for requiring [F34Health Authorities] to make to the Medical Practices Committee, at such times and in such manner as may be prescribed, reports as to—

(i)the number of medical practitioners required to meet the reasonable needs of their [F35areas] and the different parts of those [F35areas];]

General dental servicesE+W+S

35 Arrangements for general dental services.E+W+S

[F37(1)It is the duty of every [F38Health Authority], in accordance with regulations, to make as respects their [F39area] arrangements with dental practitioners under which any person in the [F39area] for whom a dental practitioner undertakes in accordance with the arrangements to provide dental treatment and appliances shall receive such treatment and appliances.

(1A)The services so provided are referred to in this Act as general dental services.]

(2)The remuneration to be paid under such arrangements to a dental practitioner who provides general dental services elsewhere than at a health centre shall not consist wholly or mainly of a fixed salary unless either—

(a)the remuneration is paid in pursuance of arrangements made under section 56 below, or

(b)the services are provided in prescribed circumstances and the practitioner consents,

and it shall be the Secretary of State’s duty, before he prescribes any circumstances for the purposes of paragraph (b), to consult such organisations as appear to him to be representative of the dental profession.

[F40(3)Where the registration of a dental practitioner in the dentists register is suspended—

(a)by an order under [F41section 32 of the M4Dentists Act 1984] (interim suspension); or

(b)by a direction or [F42an order of the Health Committee under] that Act (health cases),

the suspension shall not terminate any arrangements made with him for the provision of general dental services, but he shall not provide such services in person during the suspension.

(4)Regulations may provide for the making of payments in consequence of suspension to a dental practitioner whose registration is so suspended.]

36Regulations as to s. 35.E+W+S

[F43(1)]Regulations may provide as to the arrangements to be made under section 35 above, and shall include provision—

(a)for the preparation and publication of lists of dental practitioners who undertake to provide general dental services;

(b)for conferring a right, subject to [F44[F45subsections (2) and (3)] below [F46to any provision made under section 43C below] and to] the provisions of this Part of this Act relating to the disqualification of practitioners [F47and to section 8 of the Health and Medicines Act 1988 and regulations under that section], on any dental practitioner, who wishes to be included in any such list, to be so included;

F48(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d)for the removal from the list of dental practitioners undertaking to provide general dental services for persons in any [F49area] of the name of any one in whose case it has been determined in such manner as may be prescribed that he has never provided, or has ceased to provide, such general dental services for persons in that [F49area].

[F50(2)No dental practitioner who is a national of a member State and is registered by virtue of a qualification granted in a member State shall be entitled to have his name included in the list kept by any [F51Health Authority] unless he satisfies [F51the Health Authority] that he has that knowledge of English which, in the interests of himself and his patients, is necessary for the provision of general dental services in the [F51Health Authority’s area].]

[F52(3)Regulations may make the exercise of the right conferred by virtue of paragraph (b) of subsection (1) above subject to any provision made by or under the regulations, and, in such cases as may be prescribed, may confer a right of appeal to a prescribed body in respect of a refusal to include a dental practitioner on such a list as is referred to in paragraph (a) of that subsection.]

37 Dental Estimates Board.E+W+S

[F53(1)]Regulations providing as to the arrangements to be made under section 35 above shall include provision—

(a)for constituting a Board, to be called the Dental Estimates Board, of whom the chairman and a majority of the members shall be dental practitioners, for the purpose of carrying out such duties as may be prescribed with respect to . . . F54 dental treatment and appliances, and to the remuneration of dental practitioners providing general dental services;

(b)for providing in relation to that Board for any of the matters for which, in relation to [F55a Health Authority], provision is or may be made by or under Part III of Schedule 5 to this Act.

[F56(1A)Regulations may empower the Dental Practice Board—

(a)to direct a dental practitioner to submit to the Board, in relation to treatment which he has carried out or contemplates carrying out or to a description of such treatment specified in the direction, such estimates and information and such radiographs, models or other items as may be prescribed; and

(b)to direct a dental practitioner not to carry out treatment, or a description of treatment specified in the direction, without first obtaining approval of an estimate from the Board.

(1B)If regulations include any such provision as is mentioned in subsection (1A)(b) above, regulations shall confer on a dental practitioner in whose case a direction such as is mentioned in that pargraph has been given a right of appeal against the direction to a prescribed person or body, but before making regulations conferring such a right the Secretary of State shall consult such organisations as appear to him to be representative of persons providing general dental services.

(1C)Regulations may be made authorising or requiring the Dental Practice Board to carry on any such additional activity relating to the provision of general dental services as may be prescribed and, without prejudice to the generality of this subsection, to conduct or commission surveys or other research relating to the provision of such services.]

General ophthalmic servicesE+W+S

38 Arrangements for general ophthalmic services.E+W+S

[F57(1)][F58It is the duty of every [F59Health Authority], in accordance with regulations, to arrange as respects their [F60area]] with medical practitioners having the prescribed qualifications, [F61and ophthalmic opticians for securing the testing][F62by them of the sight—

(a)of a child;

(b)of a person whose resources fall to be treated under the regulations as being less than his requirements or as being equal to his requirements; or

(c)of a person of such other description as may be prescribed.

(2)In this section—

• “child” means—

(a)a person who is under the age of 16 years; or

(b)a person who is under the age of 19 years and receiving qualifying full-time education; and

• “qualifying full-time education” means full-time instruction at a recognised educational establishment or by other means accepted as comparable by the Secretary of State, and for the purpose of this definition—

(a)“recognised educational establishment” means an establishment recognised by the Secretary of State as being, or as comparable to, a school, college or university; and

(b)regulations may prescribe the circumstances in which a person is or is not to be treated as receiving full-time instruction.

(3)Regulations under this section may direct how a person’s resources and requirements are to be calculated and, without prejudice to the generality of this subsection, may direct that they shall be calculated—

(a)by a method set out in the regulations;

(b)by a method described by reference to a method of calculating or estimating income or capital specified in an enactment other than this section or in an instrument made under an Act of Parliament or by reference to such a method but subject to prescribed modifications;

(c)by reference to an amount applicable for the purposes of a payment under an Act of Parliament or an instrument made under an Act of Parliament; or

(d)by reference to the person’s being or having been entitled to payment under an Act of Parliament or an instrument made under an Act of Parliament.

(4)Descriptions of persons may be prescribed for the purposes of subsection (1) above by reference to any criterion and, without prejudice to the generality of this subsection, by reference to any of the following criteria—

(a)their age;

(b)the fact that a prescribed person or a prescribed body accepts them as suffering from a prescribed medical condition;

(c)the fact that a prescribed person or a prescribed body accepts that a prescribed medical condition from which they suffer arose in prescribed circumstances;

(d)their receipt of benefit in money or in kind under any enactment or their entitlement to receive any such benefit; and

(e)the receipt of any such benefit by other persons satisfying prescribed conditions or the entitlement of other persons satisfying prescribed conditions to receive such benefits.

(5)Regulations which refer to an Act of Parliament or an instrument made under an Act of Parliament may direct that the reference is to be construed as a reference to that Act or instrument—

(a)as it has effect at the time when the regulations are made; or

(b)both as it has effect at that time and as amended subsequently.

(6)Regulations may provide that a person—

(a)whose sight is tested by a person who provides general ophthalmic services; and

(b)who is shown during the testing or within a prescribed time after it to fall within subsection (1) above,

shall be taken for the purposes of the testing to have so fallen immediately before his sight was tested; and the testing shall be treated—

(i)for the purposes of any arrangements under this section;

(ii)for the purposes of remuneration in respect of the testing; and

(iii)for any such other purpose as may be prescribed,

as a testing of sight under this Act.

(7)Regulations shall define the services for the provision of which arrangements under this section are to be made and the services so defined are in this Act referred to as “general ophthalmic services”.]

39Regulations as to s. 38.E+W+S

Regulations may provide as to the arrangements to be made under section 38 above, and shall include provision—

(a)for the preparation and publication of lists of medical practitioners, [F63and ophthalmic] opticians, respectively, who undertake to provide general ophthalmic services;

(b)for conferring a right, subject [F64to any provision made under section 43C below and] to the provisions of this [F65Part of this] Act relating to the disqualification of practitioners, on any medical practitioner having the prescribed qualifications, [F66or ophthalmic] optician who wishes to be included in the appropriate list, to be so included;

(c)for conferring on any person a right to choose in accordance with the prescribed procedure the medical practitioner or ophthalmic optician by whom his sight is to be tested, or from whom any prescription for the supply of optical appliances is to be obtained . . . F67;

(d)for the removal from the list of medical practitioners, [F68or ophthalmic] opticians undertaking to provide general ophthalmic services for persons in any [F69area] of the name of any one in whose case it has been determined in such manner as may be prescribed that he has never provided, or has ceased to provide, such general ophthalmic services for persons in that [F69area].

40 Medical practitioners with qualifications prescribed under s. 38.E+W+S

The power conferred by section 38 above (in relation to general ophthalmic services) to prescribe the qualifications to be possessed by any medical practitioner includes a power—

(a)to prescribe a requirement that the practitioner shall show to the satisfaction of a committee recognised by the Secretary of State for the purpose that he possesses such qualifications, including qualifications as to experience, as may be mentioned in the regulations; and

(b)to confer on a person who is dissatisfied with the determination of such a committee, a right of appeal to a committee appointed by the Secretary of State, and to provide for any matter for which it appears to the Secretary of State to be requisite or expedient to provide in consequence of the conferring of that right.

Pharmaceutical servicesE+W+S

41 Arrangements for pharmaceutical services.E+W+S

[F70It is the duty of every [F71Health Authority], in accordance with regulations, to arrange as respects their [F72area] for the [F73provision to persons who are in that [F72area] of]]

(a)proper and sufficient drugs and medicines and listed appliances which are ordered for those persons by a medical practitioner in pursuance of his functions in the health service, the Scottish health service, the Northern Ireland health service or the armed forces of the Crown (excluding forces of a Commonwealth country and forces raised in a colony; . . . F74

[F75(b)proper and sufficient drugs and medicines which are ordered for those persons by a dental practitioner in pursuance of the provision [F76of dental services by a Health Authority, a Special Health Authority or an NHS trust]; . . . F77

(c)listed drugs and medicines which are ordered for those persons by a dental practitioner in pursuance of the provision by him of general dental services.][F78and]

[F79(cc)listed drugs and medicines and listed appliances which are ordered for those persons by a prescribed description of registered nurse, midwife or health visitor in pursuance of functions in the health service, the Scottish health service or the Northern Ireland health service or the armed forces of the Crown (excluding forces of a Commonwealth country and forces raised in a colony); and]

[F80(d)such other services as may be prescribed.]

The services so provided are [F81, together with additional pharmaceutical services provided in accordance with a direction under section 41A, referred to in this Act] as “pharmaceutical services”.

In this section—

• “listed” means included in a list for the time being approved by the Secretary for the purposes of this section; and

• “the Scottish health service” and “the Northern Ireland health service” mean respectively the health service established in pursuance of section 1 of the M5National Health Service (Scotland) Act 1947 or any service provided in pursuance of Article 4(a) of the M6Health and Personal Social Services (Northern Ireland) Order 1972.

[F8241A Arrangements for providing additional pharmaceutical services.E+W+S

(1)The Secretary of State may—

(a)give directions to a Health Authority requiring them to arrange for the provision to persons in their area of additional pharmaceutical services; or

(b)by giving directions to a Health Authority authorise them to arrange for such provision if they wish to do so.

(2)Directions under this section may make different provision in relation to different services specified in the directions.

(3)The Secretary of State must publish any directions under this section in the Drug Tariff or in such other manner as he thinks appropriate.

(4)In this section—

• “additional pharmaceutical services”, in relation to directions, means such services (of a kind that do not fall within section 41) as may be specified in the directions; and

• “Drug Tariff” means the Drug Tariff published under regulation 18 of the M7National Health Service (Pharmaceutical Services) Regulations 1992 or under any corresponding provision replacing, or otherwise derived from, that regulation.]

[F8341B Terms and conditions etc.E+W+S

(1)Directions under section 41A may require the Health Authority to whom they apply, when making arrangements—

(a)to include, in the terms on which the arrangements are made, such terms as may be specified in the directions;

(b)to impose, on any person providing a service in accordance with the arrangements, such conditions as may be so specified.

(2)The arrangements must secure that any service to which they apply is provided only by a person whose name is included in a pharmaceutical list.

(3)Different arrangements may be made with respect to—

(a)the provision of the same service by the same person but in different circumstances; or

(b)the provision of the same service by different persons.

(4)A Health Authority must provide details of proposed arrangements (including the remuneration to be offered for the provision of services) to any person who asks for them.

(5)After making any arrangements, a Health Authority must publish, in such manner as the Secretary of State may direct, such details of the arrangements as he may direct.

(6)In this section, “pharmaceutical list” means, subject to any provision of the directions in question, a list—

(a)published by the Health Authority concerned, or by any other Health Authority, in accordance with regulations made under section 42(2)(a) of this Act; or

(b)published by any body in accordance with regulations made under section 27(2)(a) of the M8National Health Service (Scotland) Act 1978 or Article 63(2A)(a) of the M9Health and Personal Social Services (Northern Ireland) Order 1972.]

[F8442Regulations as to pharmaceutical services.E+W+S

(1)Regulations shall provide for securing that arrangements made by a [F85Health Authority] under section 41 above will enable persons in the [F85Health Authority’s area] for whom drugs, medicines or appliances mentioned in that section are ordered as there mentioned to receive them from persons with whom such arrangements have been made.

(2)The regulations shall include provision—

(a)for the preparation and publication by [F86a Health Authority] of one or more lists of persons, other than medical practitioners and dental practitioners, who undertake to provide pharmaceutical services from premises in the [F86Health Authority’s area];

(b)that an application to [F86a Health Authority] for inclusion in such a list shall be made in the prescribed manner and shall 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

(ii)the premises from which he will undertake to provide those services;

(c)that, except in prescribed cases—

(i)an application for inclusion in such a list by a person not already included; and

(ii)an application by a person already included in such a list for inclusion also in respect of services or premises other than those already listed in relation to him,

(d)for the removal of an entry in respect of premises from a 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

(ii)has ceased to provide from them, the services, or any of the services, which he is listed as undertaken to provide from them.

(3)The regulations may include provision—

(a)that an application to a [F87Health Authority] may be granted in respect of some only of the services specified in it;

(b)that an application to a [F87Health Authority] relating to services of a prescribed description shall be granted only if it appears to the [F87Health Authority] that the applicant has satisfied such conditions with regard to the provision of those services as may be prescribed;

[F88(ba)that an application to a [F87Health Authority] by a person who qualified to have his name registered under the Pharmacy Act 1954 by virtue of section 4A of that Act (qualification by European diploma) shall not be granted unless the applicant satisfies the [F87Health Authority] that he has the knowledge of English which, in the interests of himself and persons making use of the services to which the application relates, is necessary for the provision of pharmaceutical services in the [F87Health Authority’s area;]]

(c)that the inclusion of a person in a list in pursuance of such an application may be for a fixed period;

(d)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 shall not be included in the list unless his inclusion is approved by [F89reference to prescribed criteria by the [F87Health Authority in whose area] those premises are situated; and]

(e)that [F87that Health Authority may give their] approval subject to conditions.

(4)The regulations shall include provision conferring on such persons as may be prescribed rights of appeal from decisions made by virtue of this section.

(5)The regulations shall be so framed as to preclude—

(a)a person included in a list published under subsection (2)(a) above ;and (b) an employee of such a person; from taking part in the decision whether an application such as is mentioned in subsection (2)(c) above should be granted or an appeal against such a decision brought by virtue of subsection (4) above should be allowed.]

43 Persons authorised to provide pharmaceutical services.E+W+S

(1)No arrangements shall be made by [F90a Health Authority] (except as may be provided by [F91or under] regulations) 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 general medical services or general dental services.

(2)No arrangements for the dispensing of medicines shall be made (except as may be provided by [F91or under] regulations) with persons other than persons who are registered pharmacists, or are persons lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968 and who undertake that all medicines supplied by them under the arrangements made under this Part of this Act shall be dispensed either by or under the direct supervision of a registered pharmacist.

[F92(2A)Regulations shall provide for the preparation and publication by a Health Authority of one or more lists of medical practitioners who undertake to provide drugs, medicines or listed appliances in the Authority’s area.

(2B)In subsection (2A) “listed” has the same meaning as in section 41.

(2C)The regulations shall include provision for the removal of an entry from a list in prescribed circumstances.]

[F93(3)No arrangements for the provision of pharmaceutical services falling within section 41(d) [F94, or additional pharmaceutical services provided in accordance with a direction under section 41A,] above shall be made with persons other than those who are registered pharmacists or are of a prescribed description.]

[F96 Indemnity cover]E+W+S

F9743C Indemnity cover.E+W+S

(1)Regulations may make provision for the purpose of securing that, in prescribed circumstances, prescribed Part II practitioners hold approved indemnity cover.

(2)The regulations may, in particular, make provision as to the consequences of a failure to hold approved indemnity cover, including provision—

(a)for securing that a person is not to be added to any list unless he holds approved indemnity cover;

(b)for the removal from a list prepared by a Health Authority of a Part II practitioner who does not within a prescribed period after the making of a request by the Health Authority in the prescribed manner satisfy the Health Authority that he holds approved indemnity cover.

(3)For the purposes of this section—

• “approved body” means a person or persons approved in relation to indemnity cover of any description, after such consultation as may be prescribed, by the Secretary of State or by such other person as may be prescribed;

• “approved indemnity cover” means indemnity cover made—

  (a)

  on prescribed terms; and

  (b)

  with an approved body;

• “indemnity cover”, in relation to a Part II practitioner (or person who proposes to provide Part II services), means a contract of insurance or other arrangement made for the purpose of indemnifying him and any person prescribed in relation to him to any prescribed extent against any liability which—

  (a)

  arises out of the provision of Part II services in accordance with arrangements made by him with a Health Authority under this Part of this Act; and

  (b)

  is incurred by him or any such person in respect of the death or personal injury of a person;

• “list” has the same meaning as in section 46 below;

• “Part II practitioner” means a person whose name is on a list;

• “Part II services” means general medical services, general dental services, general ophthalmic services or pharmaceutical services;

• “personal injury” means any disease or impairment of a person’s physical or mental condition and includes the prolongation of any disease or such impairment;

and a person holds approved indemnity cover if he has entered into a contract or arrangement which constitutes approved indemnity cover.

(4)The regulations may provide that a person of any description who has entered into a contract or arrangement which is—

(a)in a form identified in accordance with the regulations in relation to persons of that description; and

(b)made with a person or persons so identified,

is to be treated as holding approved indemnity cover for the purposes of the regulations.

Local representative committeesE+W+S

44 Recognition of local representative committees.E+W+S

[F99(A1)A Health Authority may recognise a committee formed for their area which they are satisfied is representative of—

(a)the medical practitioners providing general medical services or general ophthalmic services in that area;

(b)those medical practitioners and the deputy medical practitioners for that area; or

(c)the medical practitioners mentioned in—

(i)paragraph (a) above; or

(ii)paragraph (b) above,

and the section 28C medical practitioners for that area,

(B1)A Health Authority may recognise a committee formed for their area which they are satisfied is representative of—

(a)the dental practitioners providing general dental services in that area;

(b)those dental practitioners and the deputy dental practitioners for that area; or

(c)the dental practitioners mentioned in—

(i)paragraph (a) above; or

(ii)paragraph (b) above,

and the section 28C dental practitioners for that area,

(1)Where [F100a [F101Health Authority are satisfied] that a committee formed for [F101their area] is representative]—

[F102(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

(c)of the ophthalmic opticians . . . F103 providing general ophthalmic services in that [F101area], or

(d)of the persons providing pharmaceutical services in that [F101area],

[F104the Family Health Services Authority] may recognise that committee; and any committee so recognised shall be calledF105. . . the Local Optical Committee or the Local Pharmaceutical Committee, as the case may be, for the [F101area] concerned.

(2)Any such committee may with the [F106approval of the [F107Health Authority]] delegate any of their functions, with or without restrictions or conditions, to sub-committees composed of members of that committee.

[F108(3)For the purposes of this section and section 45 below, a person who meets the condition in subsection (4) below—

(a)is a deputy medical practitioner for the area of a Health Authority if he is a medical practitioner who assists a medical practitioner providing general medical services in that area in the provision of those services but is not himself on a list;

(b)is a section 28C medical practitioner for the area of a Health Authority if he is a medical practitioner who provides or performs personal medical services in accordance with arrangements made under section 28C above by the Health Authority (whether with himself or another);

(c)is a deputy dental practitioner for the area of a Health Authority if he is a dental practitioner who assists a dental practitioner providing general dental services in that area in the provision of those services but is not himself on a list;

(d)is a section 28C dental practitioner for the area of a Health Authority if he is a dental practitioner who provides or performs personal dental services in accordance with arrangements made under section 28C above by the Health Authority (whether with himself or another).

(4)The condition referred to in subsection (3) above is that the person concerned has notified the Health Authority that he wishes to be represented under this section by the appropriate committee for their area (and has not notified them that he wishes to cease to be so represented).

(5)For the purposes of subsection (3) above—

(a)a person is to be treated as assisting a medical practitioner or dental practitioner in the provision of services if he is employed by that practitioner for that purpose or if he acts as his deputy in providing those services;and

(b)“list” has the same meaning as in section 46 below.]

45 Functions of local representative committees.E+W+S

[F109(1)Regulations may require Health Authorities—

(a)in the exercise of their functions under this Part of this Act to consult committees recognised by them under section 44 above,

(b)in the exercise of any of their functions which relate to arrangements under section 28C above to consult committees recognised by them under section 44(A1)(c) or (B1)(c) above,

on such occasions and to such extent as may be prescribed.

(1A)The power conferred by subsection (1) above is without prejudice to any other power to require a Health Authority to consult any committee recognised under section 44 above.

(1B)Committees recognised under section 44 above shall exercise such other functions as may be prescribed.

(1C)A committee recognised for an area under subsection (A1)(b) or (c) or (B1)(b) or (c) of section 44 above shall, in respect of each year, determine the amount of its administrative expenses for that year attributable —

(a)in the case of a committee recognised under subsection (A1)(b) or (c)(ii) of that section, to the deputy medical practitioners for the area;

(b)in the case of a committee recognised under subsection (A1)(c) of that section, to the section 28C medical practitioners for the area;

(c)in the case of a committee recognised under subsection (B1)(b) or (c)(ii) of that section, to the deputy dental practitioners for the area;

(d)in the case of a committee recognised under subsection (B1)(c) of that section, to the section 28C dental practitioners for the area.]

(2)The [F110Health Authority] may, on the request of any committee recognised under section 44 for their [F110area], allot to that committee such sums for defraying the committee’s administrative expenses [F111(including travelling and subsistence allowances payable to its members)] as may be determined by the [F110Health Authority] . . . F112

(3)Any sums so allotted shall be out of the moneys available to the [F110Health Authority] for the remuneration of persons of whom the committee so recognised is representative and who provide general medical services, general dental services, general ophthalmic services or pharmaceutical services, as the case may be, under this Part of this Act.

The amount of any such sums shall be deducted from the remuneration of those persons in such manner as may be determined by the [F110Health Authority] . . . F112

[F113(4)Where a committee has made a determination under subsection (1C) above, it shall apportion the amount so determined among the deputy medical practitioners, section 28C medical practitioners, deputy dental practitioners or section 28C dental practitioners, as the case may be, for the area and each such practitioner shall pay in accordance with the committee’s directions the amount so apportioned to him.

(5)References in this section to administrative expenses of a committee include references to travelling and subsistence allowances payable to its members; but the reference in subsection (2) above to a committee’s administrative expenses does not include so much of the committee’s administrative expenses as are determined under subsection (1C) above to be attributable to any practitioners mentioned in that subsection.]

Provisions as to disqualification of practitionersE+W+S

46 Disqualification of practitioners.E+W+S

(1)There shall be a tribunal (in this section and sections 47 to [F11449C] below referred to as “the Tribunal”) which shall be constituted in accordance with Schedule 9 to this Act to inquire into cases where representations are made in the prescribed manner to the Tribunal by [F115a Health Authority] or any other person that the continued inclusion of a person’s name in a list prepared under this Part of this Act—

(a)of medical practitioners undertaking to provide general medical services,

(b)of medical practitioners undertaking to provide general ophthalmic services,

(c)of dental practitioners undertaking to provide general dental services,

(d)of ophthalmic opticians undertaking to provide general ophthalmic services,

F116(e). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(f)of persons undertaking to provide pharmaceutical services,

would be prejudicial to the efficiency of the services in question.

The supplementary provisions contained in Schedule 9 apply in relation to the Tribunal.

(2)The Tribunal, on receiving representations from [F115a Health Authority] shall, and in any other case may, inquire into the case, and, if they are of opinion that the continued inclusion of that person’s name in any list to which the representations relate would be prejudicial to the efficiency of those services—

(a)shall direct that his name be removed from that list; and

(b)may also, if they think fit, direct that his name be removed from, or not be included in, any corresponding list kept by any [F115other Health Authority] under this Part [F117, and

(c)where they make a direction under paragraph (b) above, may also, if they think fit, declare that he is not fit to be engaged in any capacity in the provision of those services.]

F118(3). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F119(4)Subject to subsection (5) below, where the Tribunal direct that the name of any person be removed from or not included in any list or lists, the Health Authority or Health Authorities concerned shall remove the name of the person concerned from the list or lists in question.

(5)Subsection (4) above shall not apply—

(a)where no appeal is brought against the decision to make the direction, until the end of the period for bringing an appeal, and

(b)where an appeal is brought against that decision, until the appeal process has been exhausted.]

47 Removal of disqualification.E+W+S

(1)Any person whose name has been removed by a direction under section 46 above from any list or lists shall be disqualified for inclusion in any list to which that direction relates until the Tribunal F120. . . direct under this section to the contrary.

(2)For the purpose of deciding whether or not to issue a direction under this section (or under paragraph 8 of Schedule 14 to this Act), the Tribunal F121. . . may hold an inquiry.

48 Disqualification provisions in Scotland or Northern Ireland.E+W+S

Where—

(a)under any provisions in force in Scotland or Northern Ireland corresponding to the provisions of this Part of this Act a person is for the time being disqualified for inclusion in all lists prepared under those provisions of persons undertaking to provide services of one or more of the kinds specified in section 46(1) above, then

(b)that person shall, so long as that disqualifiction is in force, be disqualified for inclusion in a list prepared under this Part of persons undertaking to provide services of those kinds, and the name of that person shall be removed from every such list in which his name is included.

49 Regulations as to ss. 46 to 48.E+W+S

Regulations shall provide—

(a)for F122. . . inquiries F122. . . or the Secretary of State under sections 46 to 48 above [F123to be held in accordance with such procedure as may be prescribed by or determined under the regulations], and for the making and determining of appeals to the Secretary of State under that procedure, and, in particular for F122. . . any person who is the subject of such an inquiry [F124to have] an opportunity—

(i)of appearing, either in person or by counsel or solicitor or such other representative as may be prescribed, before the Tribunal and, in the case of an inquiry by, or appeal to, the Secretary of State before a person appointed by the Secretary of State, and

(ii)of being heard by the Tribunal or the person so appointed and of calling witnesses and producing other evidence on his behalf,

(b)for conferring on the Tribunal and on any person so appointed such powers as the Secretary of State considers necessary, and for that purpose to apply, with any necessary modifications, any of the provisions of section 250 of the M10Local Government Act 1972; and

(c)for the publication of the decisions of the Tribunal and the Secretary of State under this section and of the imposition and removal of any disqualifications imposed under section 48 above.

[F12549A Applications for interim suspension.E+W+S

(1)A Health Authority who have made representations under section 46 above may, at any time before the case is disposed of by the Tribunal, apply to the Tribunal for a direction to be made under subsection (2) below in relation to the person to whom the case relates.

(2)If, on an application under this section, the Tribunal are satisfied that it is necessary to do so in order to protect patients, they shall direct that subsection (3) below shall apply to the person concerned as respects services of the kind to which the case in question relates.

(3)A person to whom this subsection applies shall—

(a)be deemed to have been removed from any relevant list in which his name is included,

(b)be disqualified for inclusion in any relevant list in which his name is not included, and

(c)be deemed to be a person in relation to whom there is in force a declaration under section 46(2)(c) above concerning his fitness to be engaged in the provision of services of the relevant kind.

(4)A direction under subsection (2) above shall cease to have effect on the Tribunal’s disposing of the case in connection with which it is made.

(5)In subsection (2) above, the reference to patients is to persons to whom services of the kind to which the case in question relates are, or may be, provided under this Part of this Act.

(6)In the application of subsection (3) above to any person—

(a)“relevant list” means a list prepared under this Part of this Act of persons undertaking to provide services of the kind to which the direction applying the subsection to him relates, and

(b)“services of the relevant kind” means services of the kind to which that direction relates.]

[F12649B Continuation of suspension pending appeal.E+W+S

(1)Where—

(a)on disposing of a case under section 46 above, the Tribunal make a direction under subsection (2)(b) of that section, and

(b)the person to whom the direction relates is a person to whom section 49A(3) above would, apart from this section, cease to apply on the disposal of the case,

the Tribunal may, if they consider it necessary to do so in order to protect patients, direct that that provision shall continue to apply to him as respects services of the kind to which the direction under section 46(2)(b) above relates.

(2)A direction under subsection (1) above shall cease to have effect—

(a)where no appeal against the direction under section 46(2)(b) above is brought, at the end of the period for bringing an appeal, and

(b)where an appeal against that direction is brought, when the appeal process has been exhausted.

(3)Where the power conferred by subsection (1) above is exercisable by virtue of a direction which is not coupled with a declaration under section 46(2)(c) above, section 49(A)(3) above shall have effect, in relation to the exercise of that power, with the omission of paragraph (c).

(4)In subsection (1) above, the reference to patients is to persons to whom services of the kind to which the direction under section 46(2)(b) above relates are, or may be, provided under this Part of this Act.]

[F12749C Sections 49A and 49B: procedure etc.E+W+S

(1)Before making a direction under section 49A(2) or 49B(1) above in relation to any person, the Tribunal shall give him an opportunity—

(a)to appear before them, either in person or by counsel or solicitor or such other representative as may be prescribed, and

(b)to be heard and to call witnesses and produce other evidence.

(2)Regulations may—

(a)make provision for, or for the determination of, procedure in relation to determining applications under section 49A above or the exercise of the power conferred by section 49B(1) above, and

(b)provide for the functions of the Tribunal under section 49A or 49B above to be carried out, or to be carried out in prescribed circumstances, by the chairman or a deputy chairman of the Tribunal.]

[F12849D Suspension provisions in Scotland or Northern Ireland.E+W+S

(1)This section applies where, under any provisions in force in Scotland or Northern Ireland corresponding to section 49A or 49B above, a person (“the practitioner”) is disqualified for inclusion in all lists prepared under the provisions in force there corresponding to the provisions of this Part of this Act of persons undertaking to provide services of one or more of the kinds specified in section 46(1) above, other than those in which his name is included.

(2)The practitioner shall, while he is so disqualified—

(a)be disqualified for inclusion in any list prepared under this Part of this Act of persons undertaking to provide services of the same kinds (“relevant list”) in which his name is not included, and

(b)be deemed to have been removed from any relevant list in which his name is included.]

[F12949E Payments in consequence of suspension.E+W+S

(1)Regulations may provide for the making to persons to whom section 49A(3) or 49D(2) above applies of payments in consequence of the application of that provision.

(2)Regulations under subsection (1) above may provide for the determination by the Secretary of State in a prescribed manner of anything for which provision may be made by regulations under that subsection.]

[F143 The Family Health Services Appeal Authority]E+W+S

[F14449S The Family Health Services Appeal AuthorityE+W+S

(1)There shall be a body to be known as the Family Health Services Appeal Authority (“FHSAA”).

(2)The FHSAA shall be constituted in accordance with Schedule 9A to this Act, which also makes other provision in relation to the FHSAA.

(3)The FHSAA shall have such functions as are conferred on it by this Act or by any other enactment.

(4)The Secretary of State may direct the FHSAA to exercise any of his functions relating to the determination of appeals to him which are specified in the directions.

(5)Directions under subsection (4) shall be given by regulations or by an instrument in writing.

(6)The Secretary of State may make available to the FHSAA any facilities (including the use of any premises) provided by him or by a Special Health Authority or NHS trust for any service under this Act, and the services of persons employed by the Secretary of State or by a Special Health Authority or NHS trust.

(7)Subsections (1) to (3) of section 27 above apply in relation to the services of persons employed by a Special Health Authority and made available under subsection (6) as they apply in relation to the services of officers of Special Health Authorities to be made available under section 26 above.

(8)For the purposes of subsection (6)—

(a)the Secretary of State may give directions to an NHS trust requiring it to make facilities or the services of persons available as mentioned there; but

(b)subsections (1) and (2) of section 27 above apply in relation to the services of such persons as they apply in relation to the services of officers to be made available by virtue of section 26 above by a Health Authority, Special Health Authority or Primary Care Trust.]

Other provisions supplementary to Part IIE+W+S

50 Exercise of choice of practitioner in certain cases.E+W+S

Regulations may provide that, where a right to choose the person by whom [F145general opthalmic] services are to be provided under this Part of this Act is conferred by or under this Part, that right shall, in the case of such persons as may be specified in the regulations, be exercised on their behalf by other persons so specified.

51 University clinical teaching and research.E+W+S

[F146(1)] It is the Secretary of State’s duty to [F147exercise his functions under this Act and Part I of the M11National Health Service and Community Care Act 1990 so as to secure that there are made available] such facilities as he considers are reasonably required by any university which has a medical or dental school, in connection with clinical teaching and with research connected with clinical medicine or, as the case may be, clinical dentistry.

[F148(2)Regulations may provide for any functions exercisable by a Health Authority [F149Special Health Authority or Primary Care Trust] in relation to the provision of facilities such as are mentioned in subsection (1) above to be exercisable by the Health Authority [F149Special Health Authority or Primary Care Trust] jointly with one or more other relevant health service bodies.

(3)For the purposes of subsection (2) above the following are relevant health service bodies—

(a)Health Authorities;

(b)Special Health Authorities;

[F150(bb)Primary Care Trusts]; and

(c)NHS trusts.]

52 Use of accommodation.E+W+S

If the Secretary of State considers that any accommodation provided by him by virtue of this Act is suitable for use in connection with the provision of general medical services, general dental services, general ophthalmic services or pharmaceutical services he may make the accommodation available on such terms as he thinks fit to persons providing any of those services.

53 Immunisation.E+W+S

Where the Secretary of State arranges with medical practitioners for the vaccination or immunisation of persons against disease, he shall so far as reasonably practicable give every medical practitioner providing general medical services an opportunity to participate in the arrangements.

[F15154 Sale of medical practices.E+W+S

(1)It is unlawful to sell the goodwill of the medical practice of a person who has at any time—

(a)provided general medical services under arrangements made with any Council, Committee or Authority under the M12National Health Service Act 1946, the M13National Health Service Reorganisation Act 1973 or this Act, or

(b)provided or performed personal medical services in accordance with section 28C arrangements,

unless that person no longer provides or performs such services and has never carried on the practice in a relevant area.

(2)In this section—

• “goodwill” includes any part of goodwill and, in relation to a person practising in partnership, means his share of the goodwill of the partnership practice;

• “medical practice” includes any part of a medical practice; and

• “relevant area”, in relation to any Council, Committee or Authority by arrangement with whom a person has at any time—

  (a)

  provided general medical services, or

  (b)

  provided or performed personal medical services in accordance with section 28C arrangements,

  means the area, district or locality of that Council, Committee or Authority (at that time).

(3)Schedule 10 supplements the provisions of this section.]

55. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F152E+W+S

56 Inadequate services.E+W+S

If the Secretary of State is satisfied, after such inquiry as he may think fit, as respects [F153the area, or part of the area, of a Health Authority] that the persons whose names are included in any list prepared under this Part of this Act—

(a)of medical practitioners undertaking to provide general medical services,

(b)of dental practitioners undertaking to provide general dental services,

(c)of persons undertaking to provide general ophthalmic services, or

(d)of persons undertaking to provide pharmaceutical services,

are not such as to secure the adequate provision of the services [F154in question in that area or part, or that 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 Part, then—

[F155(i)he may authorise [F156the Health Authority] to make such other arrangements as he may approve, or may himself make such other arrangements, and]

(ii)he may dispense with any of the requirements of regulations made under this Part so far as appears to him necessary to meet exceptional circumstances and enable such arrangements to be made.