(1) The Secretary of State may by regulations make, in relation to local pharmaceutical services arrangements or persons providing or assisting in the provision of services under such arrangements, provision corresponding (whether or not exactly) to enactments containing provision relating to—
(a) section 92 arrangements or section 107 arrangements, or
(b) persons who provide or perform services under section 92 or section 107.
(2) The regulations may, in particular, provide for the application of any such enactment with such modifications, if any, as the Secretary of State considers appropriate.
(3) The provision which may be made under this section includes provision amending, repealing or revoking enactments.
(4) “Local pharmaceutical services arrangements” means arrangements made under an LPS scheme or a pilot scheme.
147 Assistance and support: local pharmaceutical services
(1) A Primary Care Trust may provide assistance or support to any person providing local pharmaceutical services.
(2) Assistance or support provided by a Primary Care Trust under subsection (1) is provided on such terms, including terms as to payment, as the Primary Care Trust considers appropriate.
(3) “Assistance” includes financial assistance.
147A Performers of pharmaceutical services and assistants
(1) Regulations may make provision for the preparation, maintenance and publication by NHS England of one or more lists of—
(a) persons approved by NHS England for the purpose of assisting in the provision of pharmaceutical services which NHS England arranges;
(b) persons approved by NHS England for the purpose of performing local pharmaceutical services.
(2) The regulations may, in particular, provide that—
(a) a person of a prescribed description may not assist in the provision of pharmaceutical services which NHS England arranges unless the person is included in a list prepared by virtue of subsection (1)(a),
(b) a person of a prescribed description may not perform local pharmaceutical services unless the person is included in a list prepared by virtue of subsection (1)(b).
(3) The regulations may, in particular, also include provision as to—
(a) the preparation, maintenance and publication of a list,
(b) eligibility for inclusion in a list,
(c) applications for inclusion (including provision for the procedure for applications and the documents to be supplied on application, whether by the applicant or by arrangement with the applicant),
(d) the grounds on which an application for inclusion may or must be granted or refused or on which a decision on such an application may be deferred,
(e) requirements with which a person included in a list must comply (including the declaration of financial interests and gifts and other benefits),
(f) the grounds on which NHS England may or must suspend or remove a person from a list, the procedure for doing so, and the consequences of doing so,
(g) circumstances in which a person included in a list may not withdraw from it,
(h) payments to or in respect of a person suspended from a list (including provision for the amount of the payment, or the method of calculating it, to be determined by the Secretary of State or a person appointed by the Secretary of State),
(i) the supply to NHS England by an applicant for inclusion in a list, or by a person included in a list, of a criminal conviction certificate under section 112 of the Police Act 1997, a criminal record certificate under section 113A of that Act, an enhanced criminal record certificate under section 113B of that Act or up-date information within the meaning given by section 116A of that Act,
(j) the criteria to be applied in making decisions under the regulations,
(k) appeals against decisions made by NHS England under the regulations, and
(l) disclosure of information about applicants for inclusion, grants or refusals of applications or suspensions or removals,
and may make any provision corresponding to anything in sections 151 to 159.
(4) Regulations under this section may, in particular, also provide that approval for the purposes of either paragraph (a) or paragraph (b) of subsection (1) is to be treated for the purposes of this section as approval for the purposes of the other paragraph (and for lists prepared by virtue of that subsection to be read accordingly).
(5) Regulations under this section may, in particular, also provide for—
(a) a person's inclusion in a list to be subject to conditions determined by NHS England,
(b) NHS England to vary the conditions or impose different ones,
(c) the consequences of failing to comply with a condition (including suspension or removal from a list),
(d) the review by NHS England of decisions made by it by virtue of the regulations.
(6) The imposition of such conditions must be with a view to—
(a) preventing any prejudice to the efficiency of the services to which a list relates, or
(b) preventing any acts or omissions of the type described in section 151(3)(a).
(7) If the regulations provide under subsection (3)(f) or (5) that NHS England may suspend or remove a person (P) from a list, they must include provision—
(a) requiring P to be given notice of any allegation against P,
(b) giving P the opportunity of putting P's case at a hearing before NHS England makes any decision as to P's suspension or removal, and
(c) requiring P to be given notice of the decision of NHS England, the reasons for it and any right of appeal under subsection (8) or (9).
(8) If the regulations provide under subsection (3)(d) or (f) that NHS England may refuse a person's application for inclusion in a list, or remove a person from one, the regulations must provide for an appeal to the First-tier Tribunal against the decision of NHS England.
(9) If the regulations make provision under subsection (5), they must provide for an appeal by the person in question to the First-tier tribunal against the decision of NHS England—
(a) to impose conditions, or any particular condition,
(b) to vary a condition,
(c) to remove the person from the list for breach of condition,
(d) on any review of an earlier such decision of NHS England.
(10) Regulations making provision as to the matters referred to in subsection (3)(l) may, in particular, authorise the disclosure of information—
(a) by NHS England to the Secretary of State, and
(b) by the Secretary of State to NHS England.
147B Further provision about regulations under section 147A
(1) Regulations under section 147A may require a person (A) included in—
(a) a pharmaceutical list, or
(b) a list under section 132(3) (provision of drugs, medicines or listed appliances),
not to employ or engage a person (B) to assist A in the provision of the service to which the list relates unless B is included in a list mentioned in subsection (2).
(2) The lists are—
(a) a list referred to in subsection (1),
(b) a list under section 147A,
(c) a list under section 91, 106 or 123,
(d) a list corresponding to a list under section 91 prepared by NHS England by virtue of regulations made under section 145,
(e) a list corresponding to a list mentioned in any of paragraphs (a) to (d) prepared by a Local Health Board under or by virtue of the National Health Service (Wales) Act 2006,
or, in any of the cases in paragraphs (a) to (e), such a list of a prescribed description.
(3) If regulations do so require, they may, in particular, require that both A and B be included in lists prepared by NHS England.
(1) Regulations may provide—
(a) that if a person is included in a pharmaceutical list he is subject, while he remains included in the list, to conditions determined by NHS England,
(b) for NHS England to vary that person's terms of service for the purpose of or in connection with the imposition of any such conditions,
(c) for NHS England to vary the conditions or impose different ones,
(d) for the consequences of failing to comply with a condition (including removal from the list), and
(e) for the review by NHS England of any decision made by virtue of the regulations.
(2) The imposition of conditions must be with a view to—
(a) preventing any prejudice to the efficiency of the services in question, or
(b) preventing any acts or omissions within section 151(3)(a).
(3) If regulations provide for a practitioner's removal from the list for breach of condition—
(a) the regulations may provide that he may not withdraw from the list while NHS England is investigating whether there are grounds for exercising their power to remove him, or after NHS England has decided to remove him but before it has given effect to that decision, and
(b) the regulations must include provision—
(i) requiring the practitioner to be given notice of any allegation against him,
(ii) giving him the opportunity of putting his case at a hearing before NHS England makes any decision as to his removal from the list, and
(iii) requiring him to be given notice of the decision of NHS England and the reasons for it and of his right of appeal under subsection (4).
(4) If regulations provide as mentioned in subsection (1), they must also provide for an appeal by the person in question to the First-tier Tribunal against the decision of NHS England—
(a) to impose conditions, or any particular condition,
(b) to vary a condition,
(c) to vary his terms of service,
(d) on any review of an earlier such decision of NHS England,
(e) to remove him from the list for breach of condition,
and the appeal must be by way of redetermination of the decision of NHS England.
(5) The regulations may provide for any such decision not to have effect until the determination by the First-tier Tribunal of any appeal against it, and must so provide in relation to a decision referred to in subsection (4)(e).
(6) Regulations under this section may provide for the disclosure by NHS England, to prescribed persons or persons of prescribed descriptions, of information of a prescribed description—
(a) about persons whose inclusion in a pharmaceutical list is subject to conditions imposed under this section, and
(b) about the removal of such persons from a pharmaceutical list for breach of condition.
(7) In this Part, “terms of service” means the terms upon which, by virtue of regulations, a person undertakes to provide pharmaceutical services.
(1) The Secretary of State may by regulations provide that where a practitioner who provides pharmaceutical services under arrangements with NHS England breaches a term of those arrangements, NHS England may—
(a) by a notice require the practitioner to do, or not do, specified things or things of a specified description within a specified period, or
(b) in prescribed circumstances or for a prescribed period, withhold all or part of a payment due to the practitioner under the arrangements.
(2) Regulations under this section must include provision conferring on such persons as may be prescribed rights of appeal from decisions of NHS England made by virtue of this section.
(3) In this section—
“practitioner” means a person included in a pharmaceutical list, and
“specified” means specified in a notice under paragraph (a) of subsection (1).
(1) If it appears to NHS England that any of the conditions set out in subsections (2) to (4) is established in relation to a person included in a pharmaceutical list it may (or, in cases falling within subsection (5), must) decide to remove him from that list.
(2) The first condition is that the continued inclusion of the practitioner in the list would be prejudicial to the efficiency of the services which those included in the list undertake to provide (and such a case is referred to in this Chapter as an “efficiency case”).
(3) The second condition is that the practitioner—
(a) has (whether on his own or together with another) by an act or omission caused, or risked causing, detriment to any health scheme by securing or trying to secure for himself or another any financial or other benefit, and
(b) knew that he or the other was not entitled to the benefit,
(and such a case is referred to in this Chapter as a “fraud case”).
(4) The third condition is that the practitioner is unsuitable to be included in the list (and such a case is referred to in this Chapter as an “unsuitability case”).
(5) In unsuitability cases, NHS England must remove the practitioner from the list in prescribed circumstances.
(6) NHS England must state which condition (or conditions) it is relying on when removing a practitioner from a list.
(7) “Health scheme” means—
(a) any of the health services under section 1(1) of this Act, section 1(1) of the National Health Service (Wales) Act 2006 (c. 42), or any enactment corresponding to section 1(1) of this Act and extending to Scotland or Northern Ireland, and
(b) any prescribed scheme,
and regulations may prescribe any scheme for the purposes of this subsection which appears to the Secretary of State to be a health or medical scheme paid for out of public funds.
(8) Detriment to a health scheme includes detriment to any patient of, or person working in, that scheme or any person liable to pay charges for services provided under that scheme.
(9) In this Chapter a “practitioner” means a person included in a pharmaceutical list.
(1) In an efficiency case or a fraud case, NHS England may, instead of deciding to remove a practitioner from its list, decide to remove him contingently.
(2) If it so decides, it must impose such conditions as it may decide on his inclusion in the list with a view to—
(a) removing any prejudice to the efficiency of the services in question (in an efficiency case), or
(b) preventing further acts or omissions within section 151(3)(a) (in a fraud case).
(3) If NHS England determines that the practitioner has failed to comply with a condition, it may decide to—
(a) vary the conditions, or impose different conditions, or
(b) remove him from its list.
(4) NHS England may decide to vary the terms of service of the person concerned for the purpose of or in connection with the imposition of any conditions by virtue of this section.
(1) Where the practitioner is a body corporate providing pharmaceutical services, the body corporate must be treated for the purposes of this Chapter as meeting a condition referred to in section 151(3) or (4) if any one of the body of persons controlling the body meets that condition (whether or not he first did so when he was such a person).
(2) A practitioner must be treated for the purposes of this Chapter as meeting the condition referred to in section 151(3) if—
(a) another person, because of an act or omission of his occurring in the course of providing any services mentioned in section 151(1) on the practitioner's behalf, meets that condition, and
(b) the practitioner failed to take all such steps as were reasonable to prevent acts or omissions within section 151(3)(a) occurring in the course of the provision of those services on his behalf.
(1) If NHS England is satisfied that it is necessary to do so for the protection of members of the public or is otherwise in the public interest, it may suspend a practitioner from its list—
(a) while it decides whether or not to exercise its powers under section 151 or 152 (other than in circumstances falling within paragraph (b)), or
(b) while it waits for a decision affecting the practitioner of a court or of a body which regulates—
(i) the practitioner's profession,
(ii) the profession of a person providing any of the services mentioned in section 151(1) on the practitioner's behalf, or
(iii) if the practitioner is a body corporate, the profession of one of its directors, or one of the body of persons controlling it or (if it is a limited liability partnership) one of its members,
or one of that regulatory body's committees.
(2) The references in subsection (1)(b) to a court or regulatory body are to a court or such a body anywhere in the world.
(3) In a case falling within subsection (1)(a), NHS England must specify the length of the period of suspension.
(4) In a case falling within subsection (1)(b), NHS England may specify that the practitioner remains suspended after the decision referred to there for an additional period which NHS England must specify.
(5) In either case—
(a) before that period expires it may extend, or further extend, the suspension for a further specified period, or
(b) if that period has expired, it may impose a further suspension, for a period which it must specify.
(6) The period of suspension (in a subsection (1)(a) case) or the additional period (in a subsection (1)(b) case), including in both cases the period of any further suspension imposed under subsection (5)(b), may not exceed six months in aggregate, except—
(a) in prescribed circumstances, when it may not extend beyond any prescribed event (which may be the expiry of a prescribed period),
(b) if, on the application of NHS England, the First-tier Tribunal orders accordingly before the expiry of the period of suspension, or
(c) if NHS England has applied under paragraph (b) before the expiry of the period of suspension, but the First-tier Tribunal has not made an order by the time it expires, in which case it continues until the First-tier Tribunal has made an order.
(7) If the First-tier Tribunal does so order, it must specify—
(a) the date on which the period of suspension will end, or
(b) an event beyond which it will not continue.
(8) The First-tier Tribunal may, on the application of NHS England, make a further order (complying with subsection (7)) at any time while the period of suspension pursuant to the earlier order is still continuing.
(9) The Secretary of State may make regulations providing for payments to practitioners who are suspended.
(10) Those regulations may include provision for the amount of the payments, or the method of calculating the amount, to be determined by the Secretary of State or by another person appointed for the purpose by the Secretary of State.
(1) This section applies if NHS England decides to remove a practitioner from a list under section 151.
(2) In such a case it may also decide to suspend the practitioner from the list pending any appeal by him, if it is satisfied that it is necessary to do so for the protection of members of the public or is otherwise in the public interest.
(3) If it does suspend the practitioner under this section, the suspension has effect from the date when NHS England gave him notice of the suspension.
(4) The suspension has effect until its revocation under subsection (5) or (6) or, if later, until the expiry of the period of 28 days referred to in section 158(1), or, if the practitioner appeals under section 158, until the First-tier Tribunal has disposed of the appeal.
(5) NHS England may revoke a suspension imposed under this section.
(6) If the practitioner appeals under section 158 against the decision of NHS England to remove him from the list, the First-tier Tribunal may also revoke a suspension imposed on him under this section.
(7) Subsections (9) and (10) of section 154 apply for the purposes of this section as they apply for the purposes of that.
While a practitioner is suspended (whether under section 154 or under section 155) he must be treated as not being included in the list from which he has been suspended even though his name appears in it.
(1) NHS England may, and (except in prescribed cases) if requested in writing to do so by the practitioner must, review a contingent removal or a suspension (other than a contingent removal or a suspension imposed by, or a suspension continuing pursuant to, an order of the First-tier Tribunal , or a suspension imposed under section 155).
(2) The practitioner may not request a review before the expiry of the period of—
(a) three months beginning with the date of the decision of NHS England to suspend or contingently remove him, or (as appropriate),
(b) six months beginning with the date of its decision on the previous review.
(3) On such a review, NHS England may—
(a) confirm the contingent removal or the suspension,
(b) in the case of a suspension, terminate it,
(c) in the case of a contingent removal, vary the conditions, impose different conditions, revoke the contingent removal, or remove the practitioner from the list.
(1) A practitioner may appeal to the First-tier Tribunal against a decision of NHS England mentioned in subsection (2) ....
(2) NHS England decisions in question are—
(a) to remove the practitioner from a list (under section 151 or 152(3) or under subsection (5)(b) of this section),
(b) to remove him contingently (under section 152),
(c) to impose any particular condition under section 152, or to vary any condition or to impose any different condition under that section,
(d) to vary his terms of service (under section 152(4)),
(e) any decision on a review of a contingent removal under section 157.
(3) The appeal must be way of redetermination of the decision of NHS England.
(4) On an appeal, the First-tier Tribunal may make any decision which NHS England could have made.
(5) If the First-tier Tribunal decides to remove the practitioner contingently—
(a) NHS England and the practitioner may each apply to the First-tier Tribunal for the conditions imposed on the practitioner to be varied, for different conditions to be imposed, or for the contingent removal to be revoked, and
(b) NHS England may remove him from its list if it determines that he has failed to comply with a condition.
(6) NHS England may not remove a person from a list, or impose a contingent removal—
(a) until the expiry of the period of 28 days referred to in subsection (1), or
(b) if the practitioner appeals within that period, until the First-tier Tribunal has disposed of the appeal.
(7) Regulations may provide for payments by NHS England to practitioners who are removed from lists pursuant to decisions of the First-tier Tribunal under this section, but whose appeals against those decisions are successful.
(8) Regulations under subsection (7) may include provision for the amount of the payments, or the method of calculating the amount, to be determined by the Secretary of State or by another person appointed for the purpose by the Secretary of State.
(1) If the First-tier Tribunal removes the practitioner from a list, it may also decide to disqualify him from inclusion in—
(a) the pharmaceutical lists prepared by NHS England,
(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(c) the lists under section 91, 106, or 123 prepared by NHS England,
(d) the lists under section 147A prepared by NHS England, or the lists corresponding to the lists under section 91 prepared by NHS England by virtue of regulations made under section 145,
(e) the lists corresponding to the lists mentioned in paragraphs (a) to (d) prepared by each Local Health Board under or by virtue of the National Health Service (Wales) Act 2006 (c. 42),
or only from inclusion in one or more descriptions of such lists prepared by NHS England and each Local Health Board, the description being specified by the First-tier Tribunal in its decision.
(2) A decision by the First-tier Tribunal to do what is mentioned in subsection (1) is referred to in this section as the imposition of a national disqualification.
(3) The First-tier Tribunal may also impose a national disqualification on a practitioner if it dismisses an appeal by him against the refusal by NHS England to include him in such a list.
(4) NHS England may apply to the First-tier Tribunal for a national disqualification to be imposed on a person after NHS England has—
(a) removed him from a list prepared by it of any of the kinds referred to in subsection (1)(a) to (d), or
(b) refused to include him in such a list.
(5) Any such application must be made before the end of the period of three months beginning with the date of the removal or of NHS England’s refusal.
(6) If the First-tier Tribunal imposes a national disqualification on a person—
(a) neither NHS England nor a Local Health Board may include him in a list of any of the kinds prepared by it from which he has been disqualified from inclusion, and
(b) if he is included in such a list, NHS England (if he is included in a list prepared by it) and each Local Health Board in whose list he is included must remove him from it.
(7) The First-tier Tribunal may at the request of the person upon whom it has been imposed review a national disqualification, and on a review may confirm it or revoke it.
(8) Subject to subsection (9), the person may not request such a review before the end of the period of—
(a) two years beginning with the date on which the national disqualification was imposed, or
(b) one year beginning with the date of the First-tier Tribunal’s decision on the last such review.
(9) The Secretary of State may provide in regulations for subsection (8) to have effect in prescribed circumstances as if the reference there to “two years” or “one year” were a reference to a different period specified in the regulations.
Regulations may require NHS England to notify prescribed persons, or persons of prescribed descriptions, of any decision it makes under this Chapter, and of any information relevant to the decision which it considers appropriate to include in the notification.
Regulations may provide for circumstances in which a practitioner—
(a) whom NHS England is investigating in order to see whether there are grounds for exercising its powers under section 151, 152 or 154,
(b) whom NHS England has decided to remove from a list under section 151 or 152, or contingently remove under section 152, but who has not yet been removed or contingently removed, or
(c) who has been suspended under section 154,
may not withdraw from a list in which he is included.
162 Regulations about decisions under this Chapter
(1) Any decision by NHS England referred to in this Chapter must be reached in accordance with regulations about such decisions.
(2) The regulations must include provision—
(a) requiring the practitioner to be given notice of any allegation against him,
(b) giving him the opportunity of putting his case at a hearing before NHS England makes any decision affecting him under this Chapter,
(c) requiring him to be given notice of the decision of NHS England and the reasons for it and of any right of appeal which he may have.
(3) The regulations may, in particular, make provision as to criteria which NHS England must apply when making decisions in unsuitability cases.
163 Corresponding provisions in Scotland and Northern Ireland
(1) This section applies where it appears to the Secretary of State that there is provision in Scotland or Northern Ireland under which a person may be dealt with in any way which corresponds (whether or not exactly) with a way in which a person may be dealt with under this Chapter.
(2) A decision in Scotland or Northern Ireland to deal with such a person in such a way is referred to in this section as a “corresponding decision”.
(3) If this section applies, the Secretary of State may make regulations providing for the effect to be given in England to a corresponding decision.
(4) That effect need not be the same as the effect of the decision in the place where it was made.
(5) The regulations may not provide for a corresponding decision to be reviewed or revoked in England.
164 Remuneration for persons providing pharmaceutical services
(1) The remuneration to be paid to persons who provide pharmaceutical services under this Part must be determined by determining authorities.
(2) Determining authorities may also determine the remuneration to be paid to persons who provide those services in respect of the instruction of any person in matters relating to those services.
(3) For the purposes of this section and section 165 determining authorities are—
(a) the Secretary of State, and
(b) so far as authorised by him to exercise the functions of determining authorities, NHS England or other person appointed by him in an instrument.
(4) The instrument mentioned in subsection (3)(b) is called in this section an “instrument of appointment”.
(4A) An instrument of appointment—
(a) must be contained in regulations if it provides for the appointment of NHS England or other person as a determining authority in relation to the remuneration to be paid for providing services under section 126, and
(b) if paragraph (a) does not apply, may be contained in regulations.
(5) An instrument of appointment—
(a) may contain requirements with which a determining authority appointed by that instrument must comply in making determinations, ...
(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(6) Subject to this section and section 165, regulations may make provision about determining remuneration under this section and may in particular impose requirements with which determining authorities must comply in making, or in connection with, determinations (including requirements as to consultation and publication).
(7) Regulations may provide that determinations may be made by reference to any of—
(a) rates or conditions of remuneration of any persons or any descriptions of persons which are fixed or determined, or will be fixed or determined, otherwise than by way of a determination under this section,
(b) scales, indices or other data of any description specified in the regulations.
(8) Where regulations provide as mentioned in subsection (7)(b), they may provide that any determination which falls to be made by reference to a scale, index or other data may be made by reference to the scale, index or data—
(a) in the form current at the time of the determination, and
(b) in any subsequent form taking effect after that time.
(8A) Regulations may impose requirements in relation to remuneration in respect of any of the following—
(a) drugs or medicines used for vaccinating or immunising people against disease,
(b) anything used in connection with the supply or administration of drugs or medicines within paragraph (a),
(c) drugs or medicines, not within paragraph (a), that are used for preventing or treating a disease that, at the time the regulations are made, the Secretary of State considers to be a pandemic disease or at risk of becoming a pandemic disease,
(d) anything used in connection with the supply or administration of drugs or medicines within paragraph (c), or
(e) a product which is a special medicinal product for the purposes of regulation 167 of the Human Medicines Regulations 2012 (S.I. 2012/1916).
(8B) Such regulations may, for example, require determining authorities to ensure—
(a) that remuneration is to be calculated by reference to the outcome of prescribed procedures, or
(b) that determinations do not provide for or permit remuneration to be paid in prescribed circumstances.
(8C) Procedures prescribed by virtue of subsection (8B)(a) may include the person to whom remuneration is payable, a health service body or a determining authority—
(a) carrying out inquiries to ensure that remuneration is reasonable, or
(b) estimating an amount of remuneration that is reasonable (whether or not the estimated amount corresponds exactly to expenses in respect of which remuneration is to be paid).
(8D) Circumstances prescribed by virtue of subsection (8B)(b) may include circumstances in which anything within subsection (8A)(a) to (e) is made available to persons who provide pharmaceutical services under this Part—
(a) by a health service body, or
(b) under an arrangement for the supply of that thing, to which a health service body is a party.
(8E) In subsections (8A) to (8D)—
“health service body” has the meaning given by section 9(4);
...
(8F) Where regulations include provision made in reliance on subsection (8A)(c) or (d) and the Secretary of State considers that the disease to which it relates is no longer a pandemic disease or at risk of becoming a pandemic disease, the Secretary of State must revoke that provision within such period as the Secretary of State considers reasonable (taking into account, in particular, the need for any transitional arrangements).
(9) Regulations may—
(a) provide that determining authorities may make determinations which have effect in relation to remuneration in respect of a period beginning on or after a date specified in the determination, which may be the date of the determination or an earlier or later date, but may be an earlier date only if, taking the determination as a whole, it is not detrimental to the persons to whose remuneration it relates,
(b) provide that any determination which does not specify such a date has effect in relation to remuneration in respect of a period beginning—
(i) if it is required to be published, on the date of publication,
(ii) if it is not so required, on the date on which it is made.
(10) A reference in this section or section 165 to a determination is to a determination of remuneration under this section.
(1) Before a determination is made by the Secretary of State which relates to all persons who provide pharmaceutical services, or a category of such services, he—
(a) must consult a body appearing to him to be representative of persons to whose remuneration the determination would relate, and
(b) may consult such other persons as he considers appropriate.
(2) Determinations may make different provision for different cases, including different provision for any particular case, class of case or area.
(3) Determinations may be—
(a) made in more than one stage,
(b) made by more than one determining authority,
(c) varied or revoked by subsequent determinations.
(4) A determination may be varied—
(a) to correct an error, or
(b) where it appears to the determining authority that it was made in ignorance of or under a mistake as to a relevant fact.
(5) Determinations may, in particular, provide that the whole or any part of the remuneration—
(a) is payable only if the determining authority is satisfied as to certain conditions, or
(b) must be applied for certain purposes or is otherwise subject to certain conditions.
(6) Remuneration under section 164 may be determined from time to time and may consist of payments by way of—
(a) salary,
(b) fees,
(c) allowances,
(d) reimbursement (in full or in part) of expenses incurred or expected to be incurred in connection with the provision of the services or instruction.
(7) At the time a determination is made or varied, certain matters which require determining may be reserved to be decided at a later time.
(8) The matters which may be reserved include in particular—
(a) the amount of remuneration to be paid in particular cases,
(b) whether any remuneration is to be paid in particular cases.
(9) Any determination may be made only after taking into account all the matters which are considered to be relevant by the determining authority.
(10) Such matters may include in particular—
(a) the amount or estimated amount of expenses (taking into account any discounts) incurred in the past or likely to be incurred in the future (whether or not by persons to whose remuneration the determination will relate) in connection with the provision of pharmaceutical services or of any category of pharmaceutical services,
(b) the amount or estimated amount of any remuneration paid or likely to be paid to persons providing such services,
(c) the amount or estimated amount of any other payments or repayments or other benefits received or likely to be received by any such persons,
(d) the extent to which it is desirable to encourage the provision, either generally or in particular places, of pharmaceutical services or the category of pharmaceutical services to which the determination will relate,
(e) the desirability of promoting pharmaceutical services which are—
(i) economic and efficient, and
(ii) of an appropriate standard.
(11) If the determination is of remuneration for a category of pharmaceutical services, the reference in subsection (10)(a) to a category of pharmaceutical services is a reference to the same category of pharmaceutical services or to any other category of pharmaceutical services falling within the same description.
165A Pharmaceutical remuneration: further provision
(1) NHS England must provide the Secretary of State with such information relating to the remuneration paid by NHS England to persons providing pharmaceutical services or local pharmaceutical services as the Secretary of State may require.
(2) The information must be provided in such form, and at such time or within such period, as the Secretary of State may require.
(3) Schedule 12A makes further provision about pharmaceutical remuneration.
(1) Regulations may make provision for the purpose of securing that, in prescribed circumstances, prescribed persons included in a pharmaceutical list 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 must not be added to a pharmaceutical list unless he holds approved indemnity cover,
(b) for the removal from a pharmaceutical list prepared by NHS England of a person who does not within a prescribed period after the making of a request by NHS England in the prescribed manner satisfy NHS England 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—
on prescribed terms, and
with an approved body,
“indemnity cover”, in relation to a person included in a pharmaceutical list (or a person who proposes to provide pharmaceutical 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—
arises out of the provision of pharmaceutical services in accordance with arrangements made by him with NHS England, and
is incurred by him or any such person in respect of the death or personal injury of a person,
“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,
must be treated as holding approved indemnity cover for the purposes of the regulations.
(1) NHS England may recognise a committee formed for an area which it is satisfied is representative of—
(a) the persons providing pharmaceutical services from premises in the area for which the committee is formed (“pharmaceutical services providers”),
(b) pharmaceutical services providers and the persons to whom subsections (2) and (3) apply,
(c) pharmaceutical services providers and the persons to whom subsection (2) applies, or
(d) pharmaceutical services providers and the persons to whom subsection (3) applies.
(2) This subsection applies to each person who—
(a) is providing local pharmaceutical services ... under an LPS scheme made (whether with himself or another person) by NHS England, and
(b) has notified NHS England that he wishes to be represented by the committee (and has not notified it that he wishes to cease to be so represented).
(3) This subsection applies to each person who—
(a) is providing local pharmaceutical services ... under a pilot scheme made (whether with himself or another person) by NHS England, and
(b) has notified NHS England that he wishes to be represented by the committee (and has not notified it that he wishes to cease to be so represented).
(4) A committee recognised under this section is called the Local Pharmaceutical Committee for the area for which it is formed.
(5) Any such committee may delegate any of its functions, with or without restrictions or conditions, to sub-committees composed of members of that committee.
(6) Regulations may require NHS England, in the exercise of functions relating to pharmaceutical services or local pharmaceutical services, to consult committees recognised by it under this section on such occasions and to such extent as may be prescribed.
(7) Subsection (6) does not affect any other power to require NHS England to consult committees recognised by it under this section.
(8) A committee recognised under this section has such other functions as may be prescribed.
(9) NHS England may, on the request of any committee recognised by it under this section, allot to that committee such sums for defraying the committee's administrative expenses (other than any determined under subsection (12)) as may be determined by NHS England.
(10) Any sums so allotted must be out of the moneys available to NHS England for the remuneration of persons of whom the committee is representative under subsection (1)(a).
(11) The amount of any such sums must be deducted from the remuneration of those persons in such manner as may be determined by NHS England.
(12) A committee recognised under subsection (1)(b), (c) or (d) must, in respect of each year, determine the amount of its administrative expenses for that year attributable to the persons of whom it is representative under subsection (2) or (3).
(13) The committee must apportion the amount determined under subsection (12) among the persons of whom it is representative under subsection (2) or (3), and each such person must pay in accordance with the committee's directions the amount so apportioned to him.
(14) The administrative expenses of a committee include the travelling and subsistence allowances payable to its members.
168 Use of accommodation: provision of pharmaceutical services and local pharmaceutical services
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 pharmaceutical services or local pharmaceutical services, he may make the accommodation available on such terms as he considers appropriate to persons providing those services.
(1) The Secretary of State may direct the Board to exercise any of the Secretary of State's functions relating to services that may be provided as pharmaceutical services, or as local pharmaceutical services, under this Part.
(2) Subsection (1) does not apply to any function of the Secretary of State of making an order or regulations.
(3) The Secretary of State may give directions to the Board about its exercise of any functions relating to pharmaceutical services or to local pharmaceutical services (including functions which the Board has been directed to exercise under subsection (1)).
172 Charges for drugs, medicines or appliances, or pharmaceutical services
(1) Regulations may provide for the making and recovery in such manner as may be prescribed of such charges as may be prescribed in respect of—
(a) the supply under this Act (otherwise than under Chapter 1 of Part 7) of drugs, medicines or appliances (including the replacement and repair of those appliances), and
(b) such of the pharmaceutical services referred to in that Chapter as may be prescribed.
(2) Regulations under this section may in particular make provision in relation to the supply of contraceptive substances and appliances under paragraph 8 of Schedule 1.
(3) This section does not apply in relation to the provision of any relevant dental service (within the meaning of section 176).
(1) No charge may be made under regulations under section 172(1) in respect of—
(a) the supply of any drug, medicine or appliance for a patient who is resident in hospital,
(b) the supply of any drug or medicine for the treatment of sexually transmitted disease (otherwise than in the provision of primary medical services or in accordance with a pilot scheme established under section 134(1) of this Act or an LPS scheme),
(c) the supply of any appliance (otherwise than in pursuance of paragraph 8(d) of Schedule 1) for a person who is under 16 years of age or is under 19 years of age and receiving qualifying full-time education, or
(d) the replacement or repair of any appliance in consequence of a defect in the appliance as supplied.
(2) In subsection (1)(c) “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.
(3) For the purposes of subsection (2)—
(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 must, or must not, be treated as receiving full-time instruction.
(1) Regulations under section 172(1) may provide for the grant, on payment of such sums as may be prescribed, of a pre-payment certificate.
(2) A pre-payment certificate is a certificate which confers on the person to whom it is granted exemption from charges otherwise chargeable under the regulations in respect of drugs, medicines and appliances supplied during such period as may be prescribed.
(3) Different sums may be prescribed in relation to different periods.
(1) Regulations may provide for the making and recovery, in such manner as may be prescribed, of such charges as the Secretary of State may determine in respect of the services mentioned in subsection (2).
(2) The services are such services as may be prescribed which are—
(a) provided under this Act, and
(b) provided in respect of such persons not ordinarily resident in Great Britain as may be prescribed.
(3) Regulations under this section may provide that the charges may be made only in such cases as may be determined in accordance with the regulations.
(4) The Secretary of State may calculate charges under this section on any basis that he considers to be the appropriate commercial basis.
(1) Regulations may provide for the making and recovery, in such manner as may be prescribed, of charges for relevant dental services.
(2) Regulations under subsection (1) may in particular include provision—
(a) specifying the amount, or maximum amount, of any charge (or aggregate charge in respect of the provision for two or more relevant dental services),
(b) for calculating the amount of any charge,
(c) for the variation of the amount, or maximum amount, of any charge in cases of a prescribed description,
(d) for any charge not to be payable in cases of a prescribed description,
(e) for power to direct that a charge is not payable in any particular case,
(f) for the repayment of any charge (including provision as to the persons by whom, and manner in which, repayments must be made).
(3) Regulations under subsection (1) may provide for sums which would otherwise be payable by NHS England to persons providing relevant dental services to be reduced by the amount of the charges authorised by the regulations.
(4) In this section and section 177 “relevant dental services” means—
(a) dental treatment provided—
(i) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(ii) under a general dental services contract, or
(iii) in accordance with section 107 arrangements, and
(b) the supply of dentures and other dental appliances under this Act.
(5) Any reference in this section or 177 to the supply of an appliance includes a reference to its repair, adjustment, refitting or replacement and, in the case of dentures, to their being relined or having additions made to them.
(1) No charge may be made under regulations under section 176(1) in respect of a relevant dental service provided for any person who at the prescribed time—
(a) was under 18,
(b) was under 19 and receiving qualifying full-time education,
(c) was pregnant, or
(d) had given birth to a child within the previous 12 months.
(2) No charge may be made under regulations under section 176(1) in respect of—
(a) the repair or replacement of any appliance,
(b) any appliance supplied to a patient who is resident in a hospital,
(c) the arrest of bleeding.
(3) Subsections (1) and (2)(a) do not apply in relation to—
(a) the repair or replacement of any appliance of a prescribed description,
(b) the repair or replacement of any appliance where it is determined in the prescribed manner—
(i) in any case, that the repair or replacement was necessitated by an act or omission of the person supplied, or
(ii) in a case where the person supplied was under the age of 16, that the repair or replacement was necessitated by an act or omission, occurring while that person was under that age, of a person having charge of him.
(4) Subsection (2)(b) does not apply where an appliance is supplied—
(a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(b) under a general dental services contract, or
(c) in accordance with section 107 arrangements.
(5) Regulations may provide, with respect to any exemption under this section, that it must be a condition of the exemption that—
(a) a declaration of the prescribed kind is made in the prescribed form and manner,
(b) a certificate or other evidence of the prescribed kind is supplied in the prescribed form and manner.
(6) In subsection (1)(b) “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.
(7) For the purposes of subsection (6)—
(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 must, or must not, be treated as receiving full-time instruction.
(8) In subsection (1)(d), “child” includes a still-born child (within the meaning of the Births and Deaths Registration Act 1953 (c. 20).
(1) Regulations may provide for the making and recovery, in such manner as may be prescribed, of charges for—
(a) local pharmaceutical services provided under pilot schemes, or
(b) local pharmaceutical services provided under LPS schemes.
(2) The regulations may in particular provide for—
(a) exemptions from charges,
(b) the liability to pay charges to be disregarded in prescribed circumstances or for prescribed purposes,
(c) section 192 (recovery of certain charges and payments) to apply also in relation to local pharmaceutical services (with or without modification),
(d) section 193 (penalties) to apply also in relation to local pharmaceutical services (with or without modification).
(3) The regulations must secure that the amount charged for any service is the same as the amount that would be charged for that service if it were provided under Chapter 1 of Part 7.
(1) Regulations may provide for the making and recovery, in such manner as may be prescribed, of charges in respect of the supply under this Act of optical appliances.
(2) The amount of the charges may be determined—
(a) in regulations, or
(b) by or in accordance with directions given by the Secretary of State.
(3) Regulations or directions may—
(a) vary the amount or maximum amount of charges, or
(b) provide that the charges are not payable.
(4) A reference to supply includes a reference to replacement.
(5) In this Act “optical appliances” means glasses and contact lenses, but regulations may provide for a different definition of optical appliances to have effect for the purposes of this Act.