Legalize / United Kingdom / Wales / Welsh-Statutory-Instrument

The National Health Service (Pharmaceutical Services) (Wales) Regulations 2020

Type Welsh-Statutory-Instrument

Publication 2020-09-29

Last updated 2026-03-28

State In force

Jurisdiction Wales

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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(i) if the NHS appliance contractor provides an appliance under an electronic prescription, provide the patient, if the patient so requests, with a written record of the appliances ordered on that prescription and, in the case of an electronic repeatable prescription, of the number of occasions on which it may be dispensed,

(j) maintain records of repeatable prescriptions in such a form as to provide a clear audit trail of supplies under the repeatable prescription (including dates and quantities supplied),

(k) destroy any surplus batch issues relating to appliances—

(i) which are not required, or

(ii) where a patient is refused an appliance pursuant to paragraph 9,

(l) ensure that where a person is refused appliances pursuant to paragraph 9(1)(b), (2) or (3), the patient is referred back to the prescriber for further advice;

(m) where a patient is provided with appliances under a repeatable prescription, notify the prescriber of any clinically significant issues arising in connection with the prescription and keep a record of that notification,

(n) notify the prescriber of any refusal to provide appliances pursuant to paragraph 9(3), and

(o) when providing specified appliances, comply with the additional requirements set out in paragraph 11.

(2) Where, on presentation of a prescription form or repeatable prescription in connection with the dispensing of appliances under paragraph 4, an NHS appliance contractor is unable to provide an appliance, or stoma appliance customisation is required and the NHS appliance contractor is unable to provide that, the NHS appliance contractor must—

(a) if the patient consents, refer the prescription form or repeatable prescription to another NHS appliance contractor or to an NHS pharmacist, or

(b) if the patient does not consent to a referral, provide the patient with contact details of at least two people who are NHS pharmacists or NHS appliance contractors who are able to provide the appliance or stoma appliance customisation (as the case may be), if these details are known to the NHS appliance contractor.

Additional requirements in relation to specified appliances

11

(1) This paragraph sets out the additional requirements referred to in paragraph 10(1)(o) relating to the provision of specified appliances.

(2) An NHS appliance contractor who dispenses specified appliances in the normal course of business must provide a home delivery service in respect of those appliances and, as part of that service—

(a) the NHS appliance contractor must offer to deliver the specified appliance to the patient’s home,

(b) if the patient accepts that offer, the delivery must be made with reasonable promptness and at such time as is agreed with the patient,

(c) the specified appliance must be delivered in a package which displays no writing or other markings which could indicate its content, and

(d) the manner of delivery of the package and any supplementary items required by sub-paragraph (3) must not convey the type of appliance being delivered.

(3) In any case where a specified appliance is provided (whether by home delivery or otherwise), the NHS appliance contractor must provide a reasonable supply of appropriate supplementary items (such as disposable wipes and disposal bags) and—

(a) must ensure that the patient may, if the patient wishes, consult a person to obtain expert clinical advice regarding the appliance, or

(b) if the NHS appliance contractor believes it is appropriate to do so, must—

(i) refer the patient to a prescriber, or

(ii) offer the patient an appliance use review service.

(4) If the NHS appliance contractor is unable to provide an appliance use review service in accordance with sub-paragraph (3)(b)(ii), they must give the patient the contact details of at least two people who are NHS pharmacists or NHS appliance contractors who are able to arrange for the service to be provided, if these details are known to the NHS appliance contractor.

(5) Where an NHS appliance contractor provides a telephone care line in respect of the dispensing of any specified appliance, they must ensure that during out of hours periods—

(a) advice is made available to patients through that telephone care line, or

(b) the telephone number of NHS Direct Wales, or the website address of NHS Direct Wales, are made available to patients through the telephone care line.

(6) For the purposes of this paragraph—

“expert clinical advice” (“cyngor clinigol arbenigol”), in relation to a specified appliance, means advice which is given by a person who is suitably trained and who has relevant experience in respect of the appliance;

“out of hours periods” (“cyfnodau y tu allan i oriau”), in relation to each of the premises from which an NHS appliance contractor has undertaken to provide pharmaceutical services, means the periods outside the periods during which the NHS appliance contractor is obliged to provide pharmaceutical services by virtue of paragraph 13.

Signposting

12

(1) Where, on presentation of a prescription form or repeatable prescription, an NHS appliance contractor is unable to provide an appliance or stoma appliance customisation because the provision of the appliance or customisation is not within their normal course of business, the NHS appliance contractor must—

(a) if the patient consents, refer the prescription form or repeatable prescription to another NHS appliance contractor or to an NHS pharmacist, and

(b) if the patient does not consent to a referral, provide the patient with contact details of at least two people who are NHS pharmacists or NHS appliance contractors who are able to provide the appliance or stoma appliance customisation (as the case may be), if these details are known to the NHS appliance contractor.

(2) The NHS appliance contractor must, in appropriate cases, keep and maintain a record of any information given or referral made under sub-paragraph (1) and that record must be in a form that facilitates—

(a) auditing of the provision of pharmaceutical services by the NHS appliance contractor, and

(b) follow-up care for the person who has been given the information or in respect of whom the referral has been made.

Opening hours: general

13

(1) An NHS appliance contractor must ensure that pharmaceutical services are provided at each of the premises from which they have undertaken to provide pharmaceutical services—

(a) for not less than 30 hours each week,

(b) if the Local Health Board in whose pharmaceutical list the NHS appliance contractor is included, or on appeal the Welsh Ministers, have directed (either under this Schedule or Schedule 5 to the 2013 Regulations), that the NHS appliance contractor may provide pharmaceutical services at the premises for fewer than 30 hours per week, provided that those services are provided at set times and on set days, at the times and on the days so set,

(c) if the Local Health Board in whose pharmaceutical list the NHS appliance contractor is included, or on appeal the Welsh Ministers, have directed (either under this Schedule or Schedule 5 to the 2013 Regulations), that the NHS appliance contractor must provide pharmaceutical services at the premises for more than 30 hours per week, and at set times and on set days, at the times and on the days so set, or

(d) if the Local Health Board in whose pharmaceutical list the NHS appliance contractor is included, or on appeal the Welsh Ministers, have directed under this Schedule that the NHS appliance contractor must provide pharmaceutical services at the premises for more than 30 hours each week—

(i) for the total number of hours each week required by virtue of that direction, and

(ii) as regards the additional hours for which the NHS appliance contractor is required to provide pharmaceutical services by virtue of that direction, at the days on which and times at which the NHS appliance contractor is required to provide pharmaceutical services during those additional hours, as set out in that direction,

but a Local Health Board may, in appropriate circumstances, agree a temporary suspension of pharmaceutical services for a set period, where it has received 3 months’ notice of the proposed suspension.

(2) At each of the premises from which an NHS appliance contractor has undertaken to provide pharmaceutical services, an NHS appliance contractor must exhibit a notice specifying the days on which and times at which the premises are open for the provision of appliances.

(3) An NHS appliance contractor must, on request, submit a return to the Local Health Board setting out—

(a) the days on which and times at which pharmaceutical services are provided at each of the premises from which the NHS appliance contractor has undertaken to provide pharmaceutical services (including times at which they are providing pharmaceutical services when not obliged to do so by virtue of sub-paragraph (1), which are referred to in these Regulations as “supplementary opening hours”), and

(b) the pharmaceutical services which the NHS appliance contractor ordinarily provides at each of those premises.

(4) Where an NHS appliance contractor changes—

(a) the days on which or times at which pharmaceutical services are to be provided at premises from which they have undertaken to provide pharmaceutical services, or

(b) the pharmaceutical services which they are ordinarily to provide at those premises,

the NHS appliance contractor must supply the Local Health Board with a return informing it of the change.

(5) Subject to sub-paragraph (6), where an NHS appliance contractor is prevented by illness or other reasonable cause from complying with its obligations under sub-paragraph (1) the NHS appliance contractor must, where practicable, make arrangements with one or more NHS appliance contractors, NHS pharmacists or providers of local pharmaceutical services under a pilot scheme whose premises are situated in the neighbourhood for the provision of pharmaceutical services or local pharmaceutical services during that time.

(6) An NHS appliance contractor may make an arrangement with a provider of local pharmaceutical services under a pilot scheme under sub-paragraph (5) only where that provider provides local pharmaceutical services which are of a similar description, and a similar extent to, the pharmaceutical services which the NHS appliance contractor ordinarily provides.

(7) Where there is a temporary suspension in the provision of pharmaceutical services by an NHS appliance contractor for a reason beyond its control, the NHS appliance contractor will not be in breach of sub-paragraphs (1) and (2), provided that the NHS appliance contractor—

(a) notifies the Local Health Board of that suspension as soon as practicable, and

(b) uses all reasonable endeavours to resume provision of pharmaceutical services as soon as is practicable.

(8) Planned refurbishment of premises is neither a “reasonable cause” for the purposes of sub-paragraph (5) nor a “reason beyond its control” for the purposes of sub-paragraph (7).

(9) For the purposes of calculating the number of hours that premises are open during a week that includes Christmas Day, Good Friday, Easter Sunday or a bank holiday, it is deemed that the premises were open on that day at the times at which they would ordinarily have been open on that day of the week.

(10) In this Schedule, the “additional hours” for which an NHS appliance contractor is to be required to provide pharmaceutical services are those hours during which the NHS appliance contractor would not be providing pharmaceutical services, were the NHS appliance contractor subject to the condition set out in sub-paragraph (1)(a) and not the condition set out in sub-paragraph (1)(d).

(11) Notwithstanding the provisions of paragraphs 14 to 17, during an emergency requiring the flexible provision of pharmaceutical services, a Local Health Board may, on application from an NHS appliance contractor, permit a temporary change to the days on which or times at which the NHS appliance contractor is obliged to provide pharmaceutical services at the premises from which they have undertaken to provide pharmaceutical services, or permit temporary closure of those premises, if—

(a) the NHS appliance contractor gives at least 24 hours’ notice of the change or closure, and

(b) the reasons given by the NHS appliance contractor for the request are, in the opinion of the Local Health Board, adequate reasons.

(12) The Local Health Board need not approve the request referred to in sub-paragraph (11), in advance of the change or closure, and if it does not do so but decides subsequently that the NHS appliance contractor’s reasons are not, in its opinion, adequate reasons, then the days on which or times at which the NHS appliance contractor is obliged to provide pharmaceutical services at the premises are to revert to the overridden days and times, from the day after the date on which that decision is given to the NHS appliance contractor.

Matters to be considered when issuing directions in respect of opening hours

14

(1) Where a Local Health Board issues a direction setting any days or times under this Schedule, it must in doing so seek to ensure that the hours at which premises are open for the provision of pharmaceutical services are such as to ensure that pharmaceutical services are provided on such days and at such times as are necessary to meet the needs of people in the neighbourhood, or other likely users of the premises, for pharmaceutical services.

(2) In considering the matters mentioned in sub-paragraph (1), the Local Health Board—

(a) must treat any local pharmaceutical services being provided in that neighbourhood at the days and times in question as if they were pharmaceutical services being so provided, and

(b) may have regard to any pharmaceutical services that are being provided in that neighbourhood in circumstances where the person providing the pharmaceutical services is not obliged to provide those services.

(3) The Local Health Board may only direct that an NHS appliance contractor may provide pharmaceutical services at premises for less than 30 hours in any week if it is satisfied that the arrangements for the supply of appliances in the neighbourhood are likely to be adequate to meet the need for such services at times when the NHS appliance contractor is not providing pharmaceutical services.

(4) A Local Health Board may only direct that an NHS appliance contractor must provide pharmaceutical services at premises for more than 30 hours in any week if a Local Health Board is satisfied that the NHS appliance contractor will receive reasonable remuneration in respect of the additional hours for which they are required to provide pharmaceutical services (and any additional remuneration payable under the Drug Tariff in respect of those hours is “reasonable remuneration” for these purposes).

Determination of opening hours instigated by the Local Health Board

15

(1) Where it appears to the Local Health Board, after consultation with or having considered the matter at the request of the Local Pharmaceutical Committee, that the days on which or times at which premises are or will be open for the supplying of appliances will not, or no longer meet, the needs of—

(a) people in the neighbourhood, or

(b) other likely users of the NHS appliance contractor’s premises,

for the supply of appliances, it may carry out an assessment as to whether to issue a direction requiring the NHS appliance contractor to provide pharmaceutical services at the premises at set times and on set days (which may include Christmas Day, Good Friday, Easter Sunday and bank holidays).

(2) Before concluding the assessment under sub-paragraph (1) the Local Health Board must—

(a) give notice to the NHS appliance contractor of any proposed changes to the days on which or times at which the premises are to be open, and

(b) allow the NHS appliance contractor 60 days within which to make written representations to the Local Health Board about the proposed changes.

(3) After considering any representations made in accordance with sub-paragraph (2)(b), the Local Health Board must—

(a) issue a direction (which will replace any existing direction) which meets the requirements of sub-paragraphs (4) and (5), or

(b) confirm any existing direction in respect of the days on which and the times at which the NHS appliance contractor must provide pharmaceutical services at the premises, provided that the existing direction, whether issued under this Schedule or Schedule 5 to the 2013 Regulations, would meet the requirements of sub-paragraphs (4) and (5) if it were issued under this paragraph, or

(i) revoke (without replacing it) any existing direction in respect of the days on which and the times at which the NHS appliance contractor must provide pharmaceutical services at the premises, whether issued under this Schedule or Schedule 5 to the 2013 Regulations, or

(ii) in a case where there is no existing direction, issue no direction, in which case, by virtue of paragraph 13(1)(a), the premises must be open for not less than 30 hours each week.

(4) Where a Local Health Board issues a direction under sub-paragraph (3) in respect of premises that are to be required to be open—

(a) for more than 30 hours each week, it must set out in that direction—

(i) the total number of hours each week for which the NHS appliance contractor must provide pharmaceutical services at the premises, and

(ii) as regards the additional hours for which the NHS appliance contractor is to provide pharmaceutical services, the days on which and the times at which they are required to provide those services during those additional hours,

but it must not set out in that direction the days on which or times at which the NHS appliance contractor is to provide pharmaceutical services during hours which are not additional hours, or

(b) for less than 30 hours each week, it must set out in that direction the days on which and times at which pharmaceutical services are to be provided at those premises.

(5) The Local Health Board must not issue a direction under sub-paragraph (3) that has the effect simply of requiring premises to be open for 30 hours each week on set days and at set times (that is, the direction must have the effect of requiring premises to be open for either more or less than 30 hours each week).

(6) The Local Health Board must notify the NHS appliance contractor in writing of any direction issued or any other action taken under sub-paragraph (3), and where it sets new days on which or times at which the NHS appliance contractor is to provide pharmaceutical services at the premises, it must include with the notification a statement of—

(a) the reasons for the change, and

(b) the right of appeal of the NHS appliance contractor under sub-paragraph (7).

(7) An NHS appliance contractor may, within 30 days of receiving notification under sub-paragraph (6), appeal in writing to the Welsh Ministers against any direction issued or any other action taken under sub-paragraph (3) which sets new days on which or times at which the NHS appliance contractor is to provide pharmaceutical services.

(8) The Welsh Ministers may, when determining an appeal, either confirm the action taken by the Local Health Board or take any action that the Local Health Board could have taken under sub-paragraph (3).

(9) The Welsh Ministers must notify the NHS appliance contractor in writing of a determination under sub-paragraph (8) and must in every case include with the notification a written statement of the reasons for the determination.

(10) If the days on which or times at which an NHS appliance contractor is to provide pharmaceutical services at the premises have been changed in accordance with this paragraph, the NHS appliance contractor must introduce the changes—

(a) if they have not appealed under sub-paragraph (7), not later than 8 weeks after the date on which they receive a notification under sub-paragraph (6), or

(b) if they have appealed under sub-paragraph (7), not later than 8 weeks after the date on which they receive a notification under sub-paragraph (9).

Determination of opening hours instigated by the NHS appliance contractor

16

(1) An NHS appliance contractor may apply to a Local Health Board in writing with 90 days’ notice for it to change the days on which or times at which the NHS appliance contractor is obliged to provide pharmaceutical services at their premises, in a way that—

(a) reduces the total number of hours for which the NHS appliance contractor is obliged to provide pharmaceutical services each week, or

(b) keeps that total number of hours the same.

(2) Where an NHS appliance contractor makes an application under sub-paragraph (1), as part of that application they must provide the Local Health Board with such information as the Local Health Board may reasonably request in respect of any changes to the needs of the people in the neighbourhood, or other likely users of the premises, for pharmaceutical services that are material to the application.

(3) The Local Health Board must determine an application under sub-paragraph (1) within 60 days of receiving it (including any information required of the applicant in accordance with sub-paragraph (2)).

(4) In determining the application, the Local Health Board must—

(a) issue a direction (which will replace any existing direction) which meets the requirements of sub-paragraphs (5) and (6) and which has the effect of either granting the application under this paragraph or granting it only in part,

(b) confirm any existing direction in respect of the days on which and the times at which the NHS appliance contractor must provide pharmaceutical services at the premises, provided that the existing direction, whether issued under this Schedule or Schedule 5 to the 2013 Regulations, would meet the requirements of sub-paragraphs (5) and (6), or

(i) revoke (without replacing it) any existing direction in respect of the days on which and the times at which the NHS appliance contractor must provide pharmaceutical services at the premises, whether issued under this Schedule or Schedule 5 to the 2013 Regulations, where this has the effect of granting the application under this paragraph or granting it only in part, or

(ii) in a case where there is no existing direction, issue no direction,

in which case, by virtue of paragraph 13(1)(a), the premises must be open for not less than 30 hours each week.

(5) Where a Local Health Board issues a direction under sub-paragraph (4) in respect of premises that are to be required to be open—

(a) for more than 30 hours each week, it must set out in that direction—

(i) the total number of hours each week for which the NHS appliance contractor must provide pharmaceutical services at the premises, and

(ii) as regards the additional hours for which the NHS appliance contractor is to provide pharmaceutical services, the days on which and the times at which they are required to provide those services during those additional hours,

but it must not set out in that direction the days on which or times at which the NHS appliance contractor is to provide pharmaceutical services during hours which are not additional hours, or

(b) for less than 30 hours each week, it must set out in that direction the days on which and times at which pharmaceutical services are to be provided at those premises.

(6) The Local Health Board must not issue a direction under sub-paragraph (4) that has the effect simply of requiring premises to be open for 30 hours each week on set days and at set times (that is, the direction must have the effect of requiring premises to be open for either more or less than 30 hours each week).

(7) Where the Local Health Board is considering taking action under sub-paragraph (4)(a) or (4)(c)(i), it must consult the Local Pharmaceutical Committee before determining the application.

(8) A Local Health Board must notify the NHS appliance contractor of any direction issued or any other action taken under sub-paragraph (4), and where this has the effect of refusing an application under this paragraph or granting it in part, it must send the NHS appliance contractor a statement setting out—

(a) the reasons for the refusal or, as the case may be, for granting the application only in part, and

(b) the right of appeal of the NHS appliance contractor under sub-paragraph (9).

(9) An NHS appliance contractor may, within 30 days of receiving a notification pursuant to sub-paragraph (8), appeal to the Welsh Ministers against any action under sub-paragraph (4) which has the effect of refusing an application under this paragraph or granting it only in part.

(10) The Welsh Ministers may, when determining an appeal, either confirm the action taken by the Local Health Board or take any action that the Local Health Board could have taken under sub-paragraph (4).

(11) The Welsh Ministers must notify the NHS appliance contractor in writing of its determination and must in every case include with the notification a written statement of the reasons for the determination.

(12) If the days on which or times at which the NHS appliance contractor is to provide pharmaceutical services at the premises have been changed in accordance with this paragraph, the NHS appliance contractor must introduce the changes—

(a) if they have not appealed under sub-paragraph (9), not earlier than 30 days after the date on which they receive a notification under sub-paragraph (4), or

(b) if they have appealed under sub-paragraph (9), not earlier than 30 days after the date on which they receive a notification under sub-paragraph (11).

Clinical governance

17

(1) An NHS appliance contractor must, in connection with all the services that they provide, participate, in the manner reasonably required by the Local Health Board on whose pharmaceutical list they are included, in an acceptable system of clinical governance.

(2) A system of clinical governance is “acceptable” if it provides for—

(a) compliance with the clinical governance components set out in sub-paragraph (3), and

(b) submission of an annual self-assessment of compliance (to an approved level) with those clinical governance components via approved data submission arrangements which allow the Local Health Board to access that assessment.

(3) The clinical governance components comprise of the following—

(a) a patient and public involvement programme, which includes—

(i) a requirement that the NHS appliance contractor should produce in an approved manner, and make available in an appropriate manner, a practice leaflet in respect of each of the premises from which they provide pharmaceutical services,

(ii) a requirement that the NHS appliance contractor publicises the NHS services that are available at or from the premises from which the NHS appliance contractor provides such services,

(iii) a requirement that where the NHS appliance contractor publicises the NHS services that are available at or from premises from which the NHS appliance contractor provides such services (whether they are producing their own publicity material or advertising services in material published by another person), the NHS appliance contractor does so in a manner which makes clear that those services are funded as part of the health service,

(iv) a requirement that the NHS appliance contractor should undertake an approved patient satisfaction survey annually, in an approved manner, including a requirement to publicise the results of the survey and any appropriate action the NHS appliance contractor intends to take,

(v) monitoring arrangements for appliances owed to patients but which are out of stock,

(vi) an approved complaints system (which meets the requirements of this Part),

(vii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(viii) a requirement that the NHS appliance contractor co-operates appropriately with any reasonable inspection or review that the Local Health Board or any relevant statutory authority wishes to undertake, ...

(ix) monitoring arrangements for compliance with the Equality Act 2010[^f00048], and

(x) a requirement that the NHS appliance contractor must have regard to the code of practice on access to premises prepared and published by the Welsh Ministers under section 19(1) of the Health and Social Care (Quality and Engagement) (Wales) Act 2020 (“the 2020 Act”) (so far as the code is relevant) in exercising any function that relates to the provision of health services or social services (within the meaning of those terms in section 21 of the 2020 Act),

(b) a clinical audit programme (normally of 5 days), which includes at least one premises-based audit and one multi-disciplinary audit agreed by the Local Health Board in each financial year,

(i) arrangements for ensuring that all stock is handled in an appropriate way,

(ii) arrangements for ensuring that all equipment used in the provision of pharmaceutical services is maintained appropriately,

(iii) an approved incident reporting system, together with arrangements for analysing and responding to critical incidents, which comprises of—

(aa) a patient safety incident log, and

(bb) a near-miss log,

(iv) arrangements, including record keeping arrangements, for dealing appropriately and timeously with communications concerning patient safety from the Welsh Ministers, the Medicines and Healthcare Products Regulatory Agency and NHS England,

(v) appropriate standard operating procedures, including standard operating procedures in respect of repeatable prescriptions and providing advice and support to people caring for themselves or their families,

(vi) appropriate waste disposal arrangements for clinical and confidential waste,

(vii) a clinical governance lead person for each of the premises from which the NHS appliance contractor provides NHS services, who is knowledgeable about both the procedures of the NHS appliance contractor and the other NHS services that are available in the locality,

(viii) appropriate child protection procedures, and

(ix) monitoring arrangements for compliance with the Health and Safety etc. Act 1974[^f00049],

(d) a clinical effectiveness programme, which includes arrangements for ensuring that appropriate advice is given by the NHS appliance contractor—

(i) in respect of the provision of appliances in accordance with a prescription form or repeatable prescription, or

(ii) to people caring for themselves or their families,

and arrangements for ensuring that the NHS appliance contractor, when giving advice to any patient on a matter mentioned in paragraph (d)(i), has regard to the details contained in the records maintained under paragraph 10(1)(f) in respect of the provision of appliances and the prescribing pattern relating to the patient in question,

(e) a staffing and staff management programme, which includes—

(i) arrangements for appropriate induction training for staff, including any locum,

(ii) appropriate training for all staff in respect of any role they are asked to perform,

(iii) arrangements for the checking of qualifications and references of all staff engaged in the provision of NHS services,

(iv) arrangements for identifying and supporting the development needs of all staff engaged in the provision of NHS services including continuing professional development for registered pharmacists and any necessary accreditation in respect of the provision of directed services,

(v) arrangements for addressing poor performance (in conjunction with the Local Health Board as appropriate), and

(vi) arrangements (which must include a written policy) for ensuring that all staff, including any locum who, arising out of their employment with the NHS appliance contractor—

(aa) make what is a protected disclosure within the meaning given in section 43A of the Employment Rights Act 1996[^f00050] (meaning of “protected disclosure”) have the rights afforded in respect of such disclosures by that Act, and

(bb) provide information in good faith and not for purposes of personal gain to the General Pharmaceutical Council or to a Local Health Board which includes an allegation of a serious nature which they reasonably believe to be substantially true, but disclosure of it is not a protected disclosure within the meaning given in section 43A of that Act, have the right not to be subjected to any detriment or to dismissal as a consequence of that act,

(f) an information governance programme, which provides for—

(i) compliance with approved procedures for information management and security, and

(ii) submission of an annual self-assessment of compliance (to an approved level) with those procedures via approved data submission arrangements which allow the Local Health Board to access that assessment, and

(g) a premises standards programme, which includes—

(i) a system for maintaining cleanliness at the premises from which the NHS appliance contractor provides NHS services which is designed to ensure, in a proportionate manner, that the risk to people at the premises of healthcare acquired infection is minimised, and

(ii) arrangements for there to be a clear separation between the areas of the premises which are an appropriate healthcare environment (where patients receive NHS services) and those areas that are a non-healthcare environment.

Professional standards

18

An NHS appliance contractor must provide pharmaceutical services and exercise any professional judgment in connection with the provision of such services in conformity with the standards generally accepted in the pharmaceutical profession.

Inducements

19

(1) Neither an NHS appliance contractor nor any person employed or engaged by an NHS appliance contractor must give, promise or offer to any person any gift or reward (whether by way of a share of or dividend on the profits of the business or by way of discount or rebate or otherwise) as an inducement to or in consideration of them presenting an order for appliances on a prescription form or repeatable prescription.

(2) Promising, offering or providing a home delivery service is not a “gift or reward” for the purposes of sub-paragraph (1).

(3) Neither an NHS appliance contractor nor any person employed or engaged by an NHS appliance contractor may accept or receive any gift or reward in respect of only—

(a) providing contact details of alternative NHS pharmacists or NHS appliance contractors pursuant to paragraph 10(2)(b), 11(4) or 12(1)(b), or

(b) referring a prescription form or repeatable prescription to another NHS appliance contractor or NHS pharmacist pursuant to paragraph 10(2)(a) or 12(1)(a) and providing no additional service in connection with the item on that prescription.

Duty to provide information about fitness to practise matters as they arise

20

(1) Subject to paragraph 21, an NHS appliance contractor, and where the NHS appliance contractor is a body corporate every director of the body corporate, must, within 7 days of its occurrence, inform the Local Health Board in writing if the NHS appliance contractor or a director—

(a) is convicted of any criminal offence in the United Kingdom,

(b) is bound over following a criminal conviction in the United Kingdom,

(d) has, in summary proceedings in Scotland in respect of an offence, been the subject of an order discharging them absolutely (without proceeding to conviction),

(e) has accepted and agreed to pay either a procurator fiscal fine under section 302 of the Criminal Procedure (Scotland) Act 1995[^f00051] (fixed penalty: conditional offer by procurator fiscal) or a penalty under section 115A of the Social Security Administration Act 1992^f00052,

(f) is convicted elsewhere of an offence, or what would constitute a criminal offence if committed in England and Wales,

(g) is charged in the United Kingdom with a criminal offence, or is charged elsewhere with an offence which, if committed in England and Wales, would constitute a criminal offence,

(h) is notified by any licensing, regulatory or other body of the outcome of any investigation into their professional conduct, and there is a finding against them,

(i) becomes the subject of any investigation into their professional conduct by any licensing, regulatory or other body,

(j) becomes subject to an investigation into their professional conduct in respect of any current or previous employment, or is notified of the outcome of any such investigation and any finding against them;

(k) becomes the subject of any investigation by the NHS Business Services Authority in relation to fraud,

(l) becomes the subject of any investigation by another Local Health Board or equivalent body, which might lead to the removal from a relevant list, or

(m) is removed, contingently removed or suspended from, refused admission to, or conditionally included in, a relevant list on fitness to practise grounds,

and if so, the NHS appliance contractor must give details of any investigation or proceedings which were or are to be brought, including the nature of the investigation or proceedings, where and approximately when that investigation or those proceedings took place or are to take place, and any outcome.

(2) Subject to paragraph 21, if a person to whom sub-paragraph (1) applies is, or was at the time of the originating events, a director of a body corporate, the person must in addition inform the Local Health Board within 7 days if any such body corporate—

(a) is convicted of any criminal offence in the United Kingdom,

(b) is convicted elsewhere of an offence, or what would constitute a criminal offence if committed in England and Wales,

(c) is charged in the United Kingdom with a criminal offence, or is charged elsewhere with an offence which, if committed in England and Wales, would constitute a criminal offence,

(d) is notified by any licensing, regulatory or other body of the outcome of any investigation into its provision of professional services, and there is a finding against the body corporate,

(e) becomes the subject of any investigation into its provision of professional services by any licensing, regulatory or other body,

(f) becomes the subject of any investigation in relation to any fraud or is notified of the outcome of such an investigation where it is adverse,

(g) becomes the subject of any investigation by another Local Health Board or equivalent body, which might lead to its removal from a relevant list, or

(h) is removed, contingently removed or suspended from, refused admission to, or conditionally included in a relevant list on fitness to practise grounds,

and if so, that person must give the name and registered office of the body corporate and details of any investigation or proceedings which were or are to be brought, including the nature of the investigation or proceedings, where and approximately when that investigation or those proceedings took place or are to take place, and any outcome.

(3) A person to whom sub-paragraph (1) or (2) applies must consent to a request being made by the Local Health Board to any employer or former employer or licensing or regulatory body in the United Kingdom or elsewhere, for information relating to a current investigation, or an investigation where the outcome was adverse.

Home Local Health Board of bodies corporate

21

Where an NHS appliance contractor is a body corporate with a registered office in England and Wales, the information to be provided under paragraphs 20 and 24(3) to (6) may be provided instead to a home Local Health Board (as defined in regulation 60). When the NHS appliance contractor provides the information to its home Local Health Board, it must also provide the home Local Health Board with details of all the other Local Health Boards in whose pharmaceutical lists the NHS appliance contractor is included.

Complaints

22

An NHS appliance contractor must have in place arrangements which comply with the requirements of the National Health Service (Concerns, Complaints and Redress Arrangements) (Wales) Regulations 2011, for the handling and consideration of any concerns or complaints about a matter connected with the provision of pharmaceutical services by the NHS appliance contractor.

Directed services

23

An NHS appliance contractor with whom a Local Health Board makes an arrangement for the provision of any directed services must comply with the terms and conditions of the arrangement.

Information to be supplied

24

(1) An NHS appliance contractor must give written notice to the Local Health Board on whose pharmaceutical list the NHS appliance contractor is included within 28 days (or if this is impracticable, as soon as practicable thereafter) of—

(a) any occurrence requiring a change in the information recorded about the NHS appliance contractor in the pharmaceutical list which the NHS appliance contractor has not otherwise notified to the Local Health Board in accordance with these Regulations,

(b) in the case of an NHS appliance contractor who is an individual, any change of their private address, and

(c) in the case of an NHS appliance contractor that is a body corporate, any change to the address of its registered office.

(2) An NHS appliance contractor must give the Local Health Board, if it so requests, the name of any registered pharmacist employed by the NHS appliance contractor who is responsible for dispensing a particular prescription.

(3) Subject to sub-paragraph (6), an NHS appliance contractor that is a body corporate must give notice in writing to the Local Health Board within 28 days (or if this is impractical, as soon as practicable thereafter) of any changes to the names and addresses of its directors.

(4) Subject to sub-paragraph (6), if an NHS appliance contractor that is a body corporate appoints a director or superintendent that was not listed on the NHS appliance contractor’s application for inclusion in a pharmaceutical list, the NHS appliance contractor must give notice in writing to the Local Health Board within 28 days (or if this is impracticable, as soon as practicable thereafter) of the fitness to practice information about that person.

(5) Subject to sub-paragraph (6), an NHS appliance contractor or the director or superintendent of an NHS appliance contractor that is a body corporate must inform the Local Health Board—

(a) if they, or a body corporate of which they are a director or superintendent, applies to be included in any of another Local Health Board’s NHS performers or providers lists, and of the outcome of any such application, and

(b) if they become a director or superintendent of a body corporate which is on any of another Local Health Board’s NHS performers or providers list, or which applies to be included in such a list, and the outcome of any such application.

(6) Where an NHS appliance contractor is a body corporate with a registered office in Wales, the information to be provided under sub-paragraphs (3) to (5) may be provided only to the Local Health Board in whose area that registered office is located, if the NHS appliance contractor also provides that Local Health Board with details of all the other Local Health Boards in whose pharmaceutical lists it is included, and in these circumstances that Local Health Board must pass the information on to any other Local Health Board—

(a) in whose pharmaceutical list the NHS appliance contractor is included, or

(b) to whom the NHS appliance contractor makes an application to be included in its pharmaceutical list, that requests it.

(7) In this paragraph, “NHS performers or providers list” means—

(a) a pharmaceutical list, or

(b) a list maintained of approved performers or providers of primary medical, dental or ophthalmic services.

Withdrawal from pharmaceutical services

25

Where an NHS appliance contractor intends to withdraw from the pharmaceutical list in respect of particular premises, the NHS appliance contractor must notify the Local Health Board of this at least 3 months in advance of that date unless it is impracticable for the NHS appliance contractor to do so in which case the NHS appliance contractor must notify the Local Health Board as soon as it is practicable to do so.

Charges for appliances

26

Subject to regulations made under section 121 of the 2006 Act, all appliances provided under these terms of service must be provided free of charge.

Inspections and access to information

27

(1) An NHS appliance contractor must allow persons authorised in writing by the Local Health Board to enter and inspect any premises the NHS appliance contractor uses for the provision of pharmaceutical services at any reasonable time, for the purposes of—

(a) ascertaining whether or not the NHS appliance contractor is complying with the requirements of this Schedule;

(b) auditing, monitoring and analysing—

(i) the provision made by the NHS appliance contractor, in the course of providing pharmaceutical services, for patient care and treatment including any arrangement made with a person in respect of provision of appliances, and

(ii) the management by the NHS appliance contractor of the pharmaceutical services they provide, where the conditions in sub-paragraph (2) are satisfied.

(2) The conditions are that—

(a) reasonable notice of the intended entry has been given,

(b) the Local Pharmaceutical Committee for the area where the premises are situated have been invited to be present at the inspection, where this is requested by the NHS appliance contractor,

(d) the person authorised in writing does not enter any part of the premises used solely as residential accommodation without the consent of the resident.

(3) An NHS appliance contractor must, at the request of the Local Health Board or of a person authorised in writing mentioned in sub-paragraph (1), allow access to any information which the Local Health Board or that person reasonably requires—

(a) for the purposes mentioned in sub-paragraph (1), or

(b) in the case of the Local Health Board, in connection with its functions that relate to pharmaceutical services.

Welsh language

28

(1) Where an NHS appliance contractor provides pharmaceutical services through the medium of Welsh, the NHS appliance contractor must notify the Local Health Board on whose pharmaceutical list the NHS appliance contractor is included, in writing.

(2) An NHS appliance contractor must make available a Welsh language version of any document or form for use by patients and/or members of the public, provided by the Local Health Board.

(3) Where an NHS appliance contractor displays a new sign or notice in connection with pharmaceutical services, the text on the sign or notice must be in English and Welsh, and an NHS appliance contractor may utilise the translation service offered by the Local Health Board for this purpose.

(4) An NHS appliance contractor must encourage the wearing of a badge, provided by the Local Health Board, by those delivering pharmaceutical services who are Welsh speaking, to convey that they are able to speak Welsh.

(5) An NHS appliance contractor must encourage those delivering pharmaceutical services to utilise information and/or attend training courses and events provided by the Local Health Board, so that they can develop—

(a) an awareness of the Welsh language (including awareness of its history and its role in Welsh culture), and

(b) an understanding of how the Welsh language can be used in connection with the pharmaceutical services provided.

(6) An NHS appliance contractor must encourage those delivering pharmaceutical services to establish and record the Welsh or English language preference expressed by or on behalf of a patient.

SCHEDULE 7 — Terms of service for doctors providing pharmaceutical services

Interpretation

1

In this Schedule, drugs or appliances are to be taken to be requested or provided in accordance with a repeatable prescription even if the person who wishes to obtain pharmaceutical services does not present that prescription, as long as—

(a) the doctor has that prescription in their possession, and

(b) that person presents, or the doctor has in their possession, an associated batch issue.

Incorporation of provisions

2

Any provisions of the following affecting the rights and obligations of doctors who provide pharmaceutical services form part of the terms of service—

(a) the Regulations,

(b) the Drug Tariff in so far as it lists drugs and appliances for the purposes of section 80 of the 2006 Act (arrangements for pharmaceutical services),

(i) investigations made by the pharmaceutical discipline committee and the joint discipline committee and action which may be taken by the Local Health Board as a result of such investigations, and

(ii) appeals to the Welsh Ministers from decisions of the Local Health Board.

(d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Persons duly authorised to dispense on behalf of dispensing doctors

3

Where this Schedule imposes a requirement on a dispensing doctor in respect of an activity which they have duly authorised another person to undertake, if that other person undertakes that activity instead of the dispensing doctor—

(a) that other person must comply with that requirement, and

(b) that dispensing doctor must secure compliance with that requirement by that other person,

and references in this Schedule to a dispensing doctor are to be construed accordingly.

Dispensing of drugs and appliances ordered by another prescriber

4

(1) Subject to the following provisions of this Schedule, where any person presents to a dispensing doctor a prescription form which contains—

(a) an order for drugs, not being Scheduled drugs, or for appliances, not being restricted availability appliances, signed by a prescriber other than the dispensing doctor,

(b) an order for a drug specified in Schedule 2 to the Prescription of Drugs Regulations (drugs or medicines to be ordered only in certain circumstances), signed by a prescriber other than the dispensing doctor, and including the reference “SLS”, or

(c) an order for a restricted availability appliance, signed by a prescriber other than the dispensing doctor and including the reference “SLS”,

and the dispensing doctor is authorised or required by virtue of regulation 26 (arrangements for the provision of pharmaceutical services by doctors) of these Regulations to provide the drugs or appliances so ordered, the dispensing doctor must, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as they supply in the normal course of their practice or business.

(2) Subject to the following provisions of this Schedule, where—

(a) any person presents to a dispensing doctor a non-electronic repeatable prescription which contains—

(i) an order for drugs, not being Scheduled drugs or controlled drugs within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001 (which relate to controlled drugs excepted from certain prohibitions under those Regulations), signed by a prescriber other than the dispensing doctor who is a repeatable prescriber,

(ii) an order for a drug specified in Schedule 2 to the Prescription of Drugs Regulations, not being a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001, signed by a prescriber other than the dispensing doctor who is a repeatable prescriber and including the reference “SLS”,

(iii) an order for appliances, not being restricted availability appliances, signed by a prescriber other than the dispensing doctor who is a repeatable prescriber, or

(iv) an order for a restricted availability appliance, signed by a prescriber other than the dispensing doctor who is a repeatable prescriber, and including the reference “SLS”,

and also presents a batch issue, or

(b) the dispensing doctor receives an electronic repeatable prescription which contains an order of a kind specified in paragraph (a)(i) to (iv) and—

(i) any person requests the provision of drugs or appliances in accordance with that repeatable prescription, or

(ii) the dispensing doctor has previously arranged with the patient that they will dispense that repeatable prescription on receipt,

and the dispensing doctor is authorised or required by regulation 26 to provide the drugs or appliances so ordered, the dispensing doctor must, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as they supply in the normal course of their practice or business.

(3) For the purposes of this paragraph, a non-electronic repeatable prescription for drugs or appliances will be taken to be presented even if the person who wishes to obtain the drugs or appliances does not present that prescription, where—

(a) the dispensing doctor has that prescription in their possession, and

(b) that person presents, or the dispensing doctor has in their possession, an associated batch issue.

(4) Drugs and listed appliances provided under this paragraph must be provided in a suitable container.

Dispensing of drugs and appliances ordered by the dispensing doctor

5

In circumstances where paragraph 4 does not apply and subject to the following provisions of this Schedule, where a dispensing doctor is authorised or required by virtue of Part 6 of these Regulations to provide drugs or appliances to a person, the dispensing doctor must—

(a) record an order for the provision of any drugs or appliances which are needed for the treatment of the patient on a prescription form completed in accordance with a GMS contract which gives effect to paragraphs 49 and 50 of Schedule 3 to the GMS Regulations (other contract terms: prescribing),

(b) provide those drugs or appliances in a suitable container,

(c) provide for the patient a drug specified in Schedule 2 to the Prescription of Drugs Regulations only where the conditions in paragraph 55 of Schedule 3 to the GMS Regulations (restrictions on prescribing by medical practitioners) are satisfied, and

(d) provide for the patient a restricted availability appliance only if the patient is a person, or it is for a purpose, specified in the Drug Tariff.

Preliminary matters before providing ordered drugs or appliances

6

Before providing drugs or listed appliances recorded on a prescription form in accordance with paragraph 4, or in the circumstances set out in paragraph 7—

(a) the dispensing doctor must ask any person who makes a declaration that the patient does not have to pay the charges specified in regulation 4(1) of the Charges Regulations (supply of drugs and appliances by doctors) by virtue of either—

(i) entitlement to an exemption under regulation 8(1) of the Charges Regulations (exemptions), or

(ii) entitlement to remission of charges under regulation 5 of the Remission of Charges Regulations (entitlement to full remission and payment),

to produce satisfactory evidence of such entitlement, unless the declaration is in respect of entitlement to exemption by virtue of regulation 8 of the Charges Regulations or in respect of remission by virtue of regulation 5(1)(e) or 5(2)(e) or (f) of the Remission of Charges Regulations, and at the time of the declaration the dispensing doctor already has such evidence available to them, and

(b) if no satisfactory evidence, as required by sub-paragraph (a) is produced to the dispensing doctor, the dispensing doctor must endorse the form on which the declaration is made to that effect.

Provision of Scheduled drugs

7

(1) Subject to sub-paragraph (2), a dispensing doctor must not provide for a patient any Scheduled drug, except that, where the dispensing doctor or an independent prescriber has ordered a drug which has an appropriate non-proprietary name either by the name or by its formula, they may provide a drug which has the same specification notwithstanding that it is a Scheduled drug (but, in the case of a drug which combines more than one drug, only if the combination has an appropriate non-proprietary name).

(2) Nothing in this Schedule prevents a dispensing doctor providing, otherwise than under pharmaceutical services, a Scheduled drug or a restricted availability appliance for a patient.

Refusal to provide drugs or appliances ordered

8

(1) A dispensing doctor may refuse to provide the drugs or appliances ordered on a prescription form or repeatable prescription where—

(a) the dispensing doctor reasonably believes that it is not a genuine order for the person named on the prescription form or the repeatable prescription (for example, because the dispensing doctor reasonably believes that it has been stolen or forged), or

(b) it appears to the dispensing doctor that there is an error on the prescription form or on the repeatable prescription or its associated batch issue (including a clinical error made by the prescriber), or that, in the circumstances, providing the drugs or appliances would be contrary to the dispensing doctor’s clinical judgement.

(2) A dispensing doctor may refuse to provide the drugs or appliances ordered on a prescription form or repeatable prescription, or which they are otherwise authorised or required to provide by virtue of regulation 26, where—

(a) the dispensing doctor or other persons on the premises are subjected to or threatened with violence by the person presenting the prescription or repeatable prescription, or by any person accompanying that person, or

(b) the person presenting the prescription form or repeatable prescription, or any other person accompanying that person, commits or threatens to commit a criminal offence.

(3) A dispensing doctor must refuse to provide drugs or appliances ordered on a repeatable prescription where—

(a) the dispensing doctor has no record of that prescription,

(b) it is not signed by a repeatable prescriber,

(d) it would be the first time a drug or appliance had been provided pursuant to the prescription and the prescription was signed more than 6 months previously,

(e) if the repeatable prescription was signed more than 1 year previously,

(f) the expiry date on the repeatable prescription has passed, or

(g) where the dispensing doctor has been informed by the repeatable prescriber that the prescription is no longer required.

(4) Where the patient requests the supply of drugs or appliances ordered on a repeatable prescription (other than on the first occasion that the patient makes such a request), a dispensing doctor may only provide the drugs or appliances ordered if satisfied—

(a) that the patient to whom the prescription relates—

(i) is taking or using, and is likely to continue to take or use, the drug or appliance appropriately, and

(ii) is not suffering from any side effects of the treatment which indicates the need or desirability of reviewing the patient’s treatment,

(b) that the medication regimen of the patient to whom the prescription relates has not altered in a way that indicates the need or desirability of reviewing the patient’s treatment, and

(c) that there have been no changes to the health of the patient to whom the prescription relates which indicate the need or desirability of reviewing the patient’s treatment.

Fees and charges

9

(1) The terms of a GMS contract giving effect to regulations 21 and 22 of the GMS Regulations (fees and charges) apply in respect of the provision of any drugs or appliances by a dispensing doctor as they apply in relation to prescriptions for drugs and appliances.

(2) Where a dispensing doctor provides a drug or appliance under pharmaceutical services or provides any additional service associated with the dispensing of such drugs and appliances—

(a) in accordance with this Schedule or an agreement with the Local Health Board, and

(b) had the drug, appliance or additional service been provided by a contractor providing dispensing services under a GMS contract, the contractor would have been entitled by, by virtue of directions given by the Welsh Ministers under section 45 of the 2006 Act (GMS contracts: payments), to a payment—

(i) in respect of the drug or appliance, or

(ii) in respect of the additional service provision,

the Local Health Board will credit the dispensing doctor with the payment.

Complaints and concerns

10

(1) Where a dispensing doctor—

(a) is a GMS contractor, or is engaged or employed by a GMS contractor, the complaints procedure established in accordance with the terms of a GMS contract which give effect to paragraph 101 of Schedule 3 to the GMS Regulations (concerns and complaints);

(b) is an APMS contractor, or is engaged or employed by an APMS contractor, the complaints procedure established by the relevant APMS contract to deal with complaints in relation to the provision of primary medical services;

(c) is employed or engaged by a Local Health Board for the purposes of providing pharmaceutical services within an LHBMS practice, the complaints procedure established by that LHBMS practice to deal with complaints in relation to the provision of primary medical services,

applies in relation to any matter reasonably connected with the provision of pharmaceutical services as it applies as respects to services provided under that contract or agreement, or within that practice.

(2) Accordingly, a GMS contract which gives effect to 102 of Schedule 3 to the GMS Regulations (co-operation with investigations) also applies in relation to complaints or concerns notified about such matters.

Inspections and access to information

11

(1) A dispensing doctor must allow persons authorised by the Local Health Board to enter and inspect any premises that they use for the provision of pharmaceutical services at any reasonable time, for the purposes of—

(a) ascertaining whether or not the dispensing doctor is complying with the requirements of this Schedule;

(b) auditing, monitoring and analysing—

(i) the provision made by the dispensing doctor, in the course of providing pharmaceutical services, for patient care and treatment, including any arrangement made with a person in respect of provision of appliances, and

(ii) the management by the dispensing doctor of the pharmaceutical services the dispensing doctor provides,

where the conditions in sub-paragraph (2) are satisfied.

(2) The conditions are that—

(a) reasonable notice of the intended entry has been given,

(b) the Local Medical Committee for the area in which the premises are situated has been invited to be present at the inspection, where this is requested by the dispensing doctor,

(c) the person authorised in writing carries written evidence of their authorisation, which must be produced on request, and

(d) the person authorised in writing does not enter any part of the premises used solely as residential accommodation without the consent of the resident.

(3) A dispensing doctor must, at the request of the Local Health Board or of a person authorised in writing mentioned in sub-paragraph (1), allow it or that person access to any information which it or that person reasonably requires—

(a) for the purposes mentioned in sub-paragraph (1), or

(b) in the case of the Local Health Board, in connection with its functions that relate to pharmaceutical services.

Welsh language

12

(1) Where a dispensing doctor provides pharmaceutical services through the medium of Welsh, the dispensing doctor must notify the Local Health Board in writing.

(2) A dispensing doctor must make available a Welsh language version of any document or form for use by patients and/or members of the public, provided by the Local Health Board.

(3) Where a dispensing doctor displays a new sign or notice in connection with pharmaceutical services, the text on the sign or notice must be in English and Welsh, and a dispensing doctor may utilise the translation service offered by the Local Health Board for this purpose.

(4) Where a dispensing doctor is Welsh speaking, they are encouraged to wear a badge provided by the Local Health Board, to convey that the dispensing doctor is able to speak Welsh.

(5) A dispensing doctor is encouraged to utilise information and/or attend training courses and events provided by the Local Health Board, so that the dispensing doctor can develop—

(a) an awareness of the Welsh language (including awareness of its history and its role in Welsh culture), and

(b) an understanding of how the Welsh language can be used in connection with the pharmaceutical services provided.

(6) When delivering pharmaceutical services, a dispensing doctor is encouraged to establish and record the Welsh or English language preference expressed by or on behalf of a patient.

SCHEDULE 8 — Minor and consequential amendments

The National Health Service (Service Committees and Tribunal) Regulations 1992

1

In regulation 2 of the National Health Service (Service Committees and Tribunal) Regulations 1992[^f00054] (interpretation)—

(a) in paragraph (1), in the definition of “Pharmaceutical Regulations”, for “National Health Service (Pharmaceutical Services) (Wales) Regulations 2013” substitute “National Health Service (Pharmaceutical Services) (Wales) Regulations 2020”, and

(b) in paragraph (4)(c)[^f00055], for “paragraph 33 of Schedule 4 to, or paragraph 21 of Schedule 5 to” substitute “paragraph 33 of Schedule 5 to, or paragraph 22 of Schedule 6 to”.

The National Health Service (Indicative Amounts) Regulations 1997

2

In regulation 1(2) of the National Health Service (Indicative Amounts) Regulations 1997 (citation, commencement and interpretation)[^f00056], in the definition of “Drug Tariff”, for “regulation 41 (the Drug Tariff and remuneration of NHS pharmacists and NHS appliance contractors) of the National Health Service (Pharmaceutical Services) (Wales) Regulations 2013” substitute “regulation 55 (the Drug Tariff and remuneration of NHS pharmacists and NHS appliance contractors) of the National Health Service (Pharmaceutical Services) (Wales) Regulations 2020”.

The National Health Service (Payments by Local Authorities to Health Authorities) (Prescribed Functions) (Wales) Regulations 2001

3

In regulation 2 (prescribed functions of Health Authorities in Wales) of the National Health Service (Payments by Local Authorities to Health Authorities) (Prescribed Functions) (Wales) Regulations 2001[^f00057], in paragraph (2)(d)[^f00058], for “regulation 41 of the National Health Service (Pharmaceutical Services) (Wales) Regulations 2013” substitute “regulation 55 of the National Health Service (Pharmaceutical Services) (Wales) Regulations 2020”.

The National Health Service (General Medical Services Contracts) (Wales) Regulations 2004

4

(1) The National Health Service (General Medical Services Contracts) (Wales) Regulations 2004[^f00059] are amended in accordance with this paragraph.

(2) In regulation 2(1) (interpretation)—

(a) in the definition of “Drug Tariff”, for “regulation 41” substitute “regulation 55”, and

(b) in the definition of “Pharmaceutical Regulations”, for “National Health Service (Pharmaceutical Services) (Wales) Regulations 2013” substitute “National Health Service (Pharmaceutical Services) (Wales) Regulations 2020”.

(3) In Schedule 6 (other contractual terms)—

(a) in paragraph 47 (provision of dispensing services)—

(i) in sub-paragraphs (4)(b) and (9)(a), for “paragraph 6 of Schedule 2, paragraph 13 of Schedule 2 or paragraph 8(3) of Schedule 3 to”, in each place it occurs, substitute “paragraph 6 of Schedule 3, paragraph 13 of Schedule 3 or paragraph 8(3) of Schedule 4 to”, and

(ii) in sub-paragraph (9)(b)(ii), for “Part 2 of Schedule 3 to” substitute “Part 2 of Schedule 4 to”,

(b) in paragraph 48 (consent to dispense)—

(i) in sub-paragraph (2)—

(aa) for “regulation 24 of and Part 3 of Schedule 2 to” substitute “regulation 30 of, and Part 3 of Schedule 3 to,”, and

(bb) for “regulation 24” substitute “regulation 30”,

(ii) in sub-paragraph (4), for “regulation 24(9)” substitute “regulation 30(9)”,

(iii) for sub-paragraph (5) substitute—

(5) Regulation 30 of the Pharmaceutical Regulations will apply as if modified as follows: in paragraph (1), for “to provide pharmaceutical services to patients under regulation 26(1)(b) or (c) (arrangements for the provision of pharmaceutical services by doctors)” there were substituted a reference to the provision of dispensing services to patients under paragraph 47.

, and

(iv) for sub-paragraph (6) substitute—

(6) Part 3 of Schedule 3 to the Pharmaceutical Regulations will apply as if modified as follows: in paragraph 8(1)(a)(ii), for “dispensing doctor list made under Part 6 of these Regulations” there were substituted a reference to an application under sub-paragraph (1) of this paragraph.

, and

(c) in paragraph 49(8)[^f00060] (terms relating to the provision of dispensing services), in the words before paragraph (a), for “Schedule 6” substitute “Schedule 7”.

The National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007

5

In regulation 2(1) of the National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007[^f00061], in the definition of “Drug Tariff”, for “regulation 41 of the National Health Service (Pharmaceutical Services) (Wales) Regulations 2013 (the Drug Tariff and remuneration of NHS pharmacists and NHS appliance contractors)” substitute “regulation 55 of the National Health Service (Pharmaceutical Services) (Wales) Regulations 2020 (the Drug Tariff and remuneration of NHS pharmacists and NHS appliance contractors)”.

The Single Use Carrier Bags Charge (Wales) Regulations 2010

6

In paragraph 1(3) of Schedule 1 to the Single Use Carrier Bags Charge (Wales) Regulations 2010[^f00062], in the definitions of—

(a) “independent nurse prescriber”,

(b) “paramedic independent prescriber”,

(d) “podiatrist or chiropodist independent prescriber”, and

(e) “therapeutic radiographer independent prescriber”,

for “National Health Service (Pharmaceutical Services) (Wales) Regulations 2013” substitute “National Health Service (Pharmaceutical Services) (Wales) Regulations 2020”.

Signed

Vaughan Gething — Minister for Health and Social Services, one of the Welsh Ministers — 2020-09-29

Explanatory note

(This note is not part of the Regulations)

EXPLANATORY NOTE

These Regulations revoke and replace the National Health Service (Pharmaceutical Services) (Wales) Regulations 2013 (S.I. 2013/898) (“the 2013 Regulations”) as the Regulations which, in Wales, govern the provision of pharmaceutical services as part of the National Health Service under Part 7 of the National Health Service (Wales) Act 2006.

Part 1 contains introductory provisions, including setting different dates on which provisions come into force. Parts 1 to 4 and Parts 9 to 11 come into force on 1 October 2020. Parts 5 to 8 come into force on 1 October 2021.

Part 2 sets out the requirements relating to the production of pharmaceutical needs assessments (“PNAs”). A PNA is a statement of the assessment that each Local Health Board must make, at least every 5 years, of the needs in its area for pharmaceutical services provided as part of the National Health Service in Wales. This Part includes the consultation requirements that have to be fulfilled before a PNA is completed and published (regulation 7) and the matters to which a Local Health Board must have regard when producing a PNA (regulation 8) – and Schedule 1 thereafter sets out the information that must be included in PNAs. Pending full revision of a PNA, a Local Health Board may address, in a supplementary statement, changes to the availability of pharmaceutical services since the PNA was published (regulation 6). A Local Health Board is required to publish its PNA and any subsequent PNAs on its website (regulation 9).

Part 3 sets out the requirements for each Local Health Board to prepare and maintain for their area—

(a) pharmaceutical lists of NHS pharmacists and NHS appliance contractors who undertake to provide pharmaceutical services from premises in the area, and

(b) dispensing doctor lists of doctors who undertake to provide pharmaceutical services from premises in the area.

It also sets out the terms of service, which are the terms on which persons are included in a pharmaceutical or dispensing doctor list and on which they undertake to provide pharmaceutical services as part of the National Health Service.

Part 4 makes provision for a Local Health Board itself, or on application from a Local Medical Committee or Local Pharmaceutical Committee, to determine whether or not a particular area within the area for which the Local Health Board is established is, because it is rural in character, a controlled locality or part of a controlled locality. The significance of a locality being determined to be a controlled locality is that, in certain circumstances, doctors can provide pharmaceutical services to certain of their eligible patients (if those doctors are included in a dispensing doctor list). The procedures that a Local Health Board must follow in determining a question as to whether an area is a controlled locality or part of a controlled locality are set out in Schedule 3. Rights of appeal to the Welsh Ministers in respect of decisions made by Local Health Boards are set out in Schedule 4.

Part 5 sets out the types of applications in respect of inclusion in or amendment to pharmaceutical lists and the tests which a Local Health Board must apply to determine those applications. Under regulation 15 (applications to be included in or make amendment to a pharmaceutical list) and regulation 18 (applications for preliminary consent and effect of preliminary consent) applications can be granted only if the Local Health Board is satisfied that it would meet a need for pharmaceutical services, or pharmaceutical services of a specified type, in the area of the relevant Local Health Board and which have been included in the PNA of that Local Health Board. In addition, the general position is that if the premises are situated in a controlled locality, the Local Health Board must be satisfied that to grant the application will not prejudice the proper provision of primary medical, dispensing or pharmaceutical services in any locality (the prejudice test). The exception to the general position is where the premises specified in an application are determined by the Local Health Board to be in a reserved location (under regulation 17 (locations in controlled localities that are reserved locations)).

A person already included in a pharmaceutical list can apply to relocate the premises from which they provide pharmaceutical services. Regulation 19 (applications involving relocation within a Local Health Board’s area) sets out when a Local Health Board may grant such an application. Applications that fall within regulation 20 (applications involving relocation between neighbouring Local Health Board areas), regulation 21 (applications involving a temporary relocation) and regulation 22 (applications involving a change of ownership) will be assessed in accordance with the specific criteria set out in the provisions of those regulations. The procedures that a Local Health Board must follow in determining applications under Part 5 are set out in Schedule 3, and rights of appeal to the Welsh Ministers in respect of decisions made by Local Health Boards are set out in Schedule 4.

Part 6 sets out the applications which doctors can make in order to be able to fulfil the conditions on which they can then make arrangements with a Local Health Board to provide pharmaceutical services to their eligible patients in controlled localities. Doctors must apply for outline consent and premises approval under regulation 30 (outline consent and premises approval) and Local Health Boards must consider such applications in accordance with the prejudice test and the proximity of the premises from which the doctor wishes to provide pharmaceutical services to nearby pharmacies. A doctor who has been granted outline consent and premises approval may make arrangements with a Local Health Board to provide pharmaceutical services under regulation 26 (arrangements for the provision of pharmaceutical services by doctors). The procedures that a Local Health Board must follow in determining applications under Part 6 are set out in Schedule 3, and rights of appeal to the Welsh Ministers in respect of decisions made by Local Health Boards are set out in Schedule 4.

Part 7 deals with fitness grounds and inclusion in and removal from pharmaceutical lists. It provides for the deferral and refusal of applications for inclusion in a pharmaceutical list on fitness grounds (regulations 36 and 37) together with an inclusion in a pharmaceutical list being subject to conditions (regulation 38). For certain fitness matters, including where a person has been convicted in the United Kingdom of a criminal offence and has been sentenced to a term of imprisonment of over 6 months, a Local Health Board must remove a person from a pharmaceutical list pursuant to regulation 40 (removal from a pharmaceutical list for other reasons).

Part 8 sets out some conditions that are to be imposed on NHS pharmacists and NHS appliance contractors as part of their terms of service with the Local Health Board, which include requirements relating to co-operation with the Local Health Board over local resolution of disputes (regulation 49). These Part 8 conditions are in addition to the principal terms of service for NHS pharmacists, which are in Schedule 5, and NHS appliance contractors, which are in Schedule 6.

The terms of service in Schedule 5 include obligations to provide what are described as the essential services that must be provided at each pharmacy. These essential services include not only dispensing services but other services, for example disposal services in respect of unwanted drugs and promotion of healthy lifestyles. As well as providing essential services, NHS pharmacists are subject to other compulsory requirements by virtue of Schedule 5, for example with regard to having acceptable systems of clinical governance and providing information about fitness matters. The range of necessary services required of NHS appliance contractors in Schedule 6 is more limited, but also includes requirements with regard to dispensing and additional compulsory requirements with regard to clinical governance and providing information about fitness matters. Both of these types of provider of pharmaceutical services are also subject to detailed requirements with regard to their opening hours and changes to them. Schedules 5 and 6 also set out the NHS terms of service for NHS pharmacists and NHS appliance contractors in relation to Serious Shortage Protocols (SSPs), where when a SSP is in place, the NHS pharmacist or NHS appliance contractor must consider whether it is reasonable and appropriate to supply in accordance with the SSP rather than fulfilling the NHS prescription for that product.

Part 9 sets out the arrangements for dealing with breaches of terms of service by NHS pharmacists and NHS appliance contractors (breaches by dispensing doctors are dealt with under their parallel arrangements for providing primary medical services to registered patients, which they must have in order to be providers of pharmaceutical services). Where a dispute between an NHS pharmacist, or an NHS appliance contractor, and the Local Health Board cannot be resolved under the local dispute resolution procedures (or where that procedure may be by-passed), the NHS pharmacist or NHS appliance contractor faces the possibility of a breach or remedial notice, as a part of which there may be a payment withholding (regulations 50 to 52). In some cases, repeated failures to comply with terms of service, or failures with particularly serious consequences, may thereafter lead to the removal of an NHS pharmacist’s or NHS appliance contractor’s business premises from the relevant pharmaceutical list (regulation 53).

Part 10 deals with payments to NHS pharmacists and NHS appliance contractors. Regulation 55 (the Drug Tariff and remuneration of NHS pharmacists and NHS appliances contractors) provides for the publication of the Drug Tariff, the main statement of the financial entitlements of NHS pharmacists and NHS appliances contractors that sets out the determinations on such matters made by the Welsh Ministers as determining authority. Regulation 56 (Local Health Boards as determining authorities) makes provision for the Local Health Boards to be determining authorities where this is set out in the Drug Tariff. There are also provisions for supplemental matters including overpayments and payments to NHS pharmacists and NHS appliance contractors.

Part 11 deals with miscellaneous matters, including transitional provisions for applications and appeals made under the 2013 Regulations before and after these Regulations come into force, as well as setting out the different dates on which provisions within the 2013 Regulations are revoked.

The Welsh Ministers’ Code of Practice on the carrying out of Regulatory Impact Assessments was considered in relation to these Regulations. As a result, a regulatory impact assessment has been prepared as to the likely costs and benefits of complying with these Regulations. A copy can be obtained from the Department for Health and Social Services, Welsh Government, Cathays Park, Cardiff, CF10 3NQ.

Footnotes

[^f00001]: 2006 c. 42. See section 206(1) for the definitions of “prescribed” and “regulations”. Section 82A and section 203(6A) were inserted by section 111 of the Public Health (Wales) Act 2017 (anaw 2). Sections 83 and 84 were amended by section 112 of the Public Health (Wales) Act 2017.

[^f00002]: S.I. 1992/662, revoked by S.I. 2013/898 (W. 102).

[^f00003]: S.I. 2005/641, revoked by S.I. 2012/1909.

[^f00004]: S.I. 2013/898 (W. 102), amended by S.I. 2004/478 (W. 48).

[^f00005]: 1971 c. 80.

[^f00006]: S.I. 2007/121 (W. 11), amended by S.I. 2013/898 (W. 102).

[^f00007]: The definition of “electronic communication” was amended by the Communications Act 2003 (c. 21), Schedule 17, paragraph 158.

[^f00008]: S.I. 2010/231.

[^f00010]: S.I. 2002/254, amended by paragraph 2 of Schedule 2 to the Health Care and Associated Professions (Miscellaneous Amendments and Practitioner Psychologists) Order 2009 (S.I. 2009/1182). There are other amendments to the Order but none are relevant.

[^f00011]: 2002 c. 17, amended by the Health and Social Care Act 2008 (c. 14) and the Pharmacy Order 2010 (S.I. 2010/231). There are other amendments but none are relevant.

[^f00012]: S.I. 1992/664. The definition of “joint discipline committee” was inserted by S.I. 1996/703.

[^f00014]: 2006 c. 41. Section 159 has been amended by S.I. 2010/22 and the Health and Social Care Act 2012 (c. 7).

[^f00015]: S.I. 2005/2414, amended by S.I. 2006/632, S.I. 2007/1201, S.I. 2013/235, S.I. 2015/1862, S.I. 2017/959 and S.I. 2018/378.

[^f00016]: 1968 c. 67.

[^f00017]: The British Pharmacopoeia 2020 is the leading collection of standards for UK medicinal products and pharmaceutical substances and is available at www.pharmacopoeia.com.

[^f00018]: S.I. 2002/253, amended by S.I. 2009/1182 and S.I. 2018/838.

[^f00019]: 1989 c. 44, amended by S.I. 2005/848.

[^f00020]: S.I. 1992/664. The definition of “pharmaceutical discipline Committee” was inserted by S.I. 1996/703.

[^f00021]: S.I. 1976/1213 (N.I. 22).

[^f00022]: S.I. 2002/254, amended by S.I. 2009/1182.

[^f00023]: S.I. 2004/1022 (W. 119), amended by S.I. 2005/366 (W. 32), S.I. 2009/1838 (W. 166), S.I. 2009/1977 (W. 176), S.I. 2012/1916, S.I. 2013/683 (W. 81), S.I. 2014/109 (W. 09) and S.I. 2016/90 (W. 43).

[^f00024]: S.I. 2015/1989 (W. 299), amended by S.I. 2019/760 (W. 143).

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