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Pharmaceutical services and local pharmaceutical services

Provision of pharmaceutical services

Section 80(1) of the National Health Service (Wales) Act 2006 (NHSWA 2006) provides that each Local Health Board (LBH) must make arrangements, in accordance with regulations made by the Welsh Ministers, for the provision to persons in the LHB’s area of:

  • proper and sufficient drugs and medicines and listed appliances which are ordered for those persons by a medical practitioner in pursuance of his or her health functions,
  • proper and sufficient drugs and medicines and listed appliances which are ordered for those persons by a dental practitioner in pursuance of his or her health functions,
  • such drugs and medicines and such listed appliances as may be determined by the Welsh Ministers and which are ordered for those persons by a description of person prescribed in the Welsh Ministers’ regulations in pursuance of health functions, and
  • such other services as may be prescribed.

Section 80(2) provides that the Welsh Ministers must make regulations for the purposes of section 80(1). Section 80(4) provides that the descriptions of persons which may be prescribed by the Welsh Ministers for the purpose of the regulations are:

  • persons registered in the register maintained under article 5 of the Health and Social Work Professions Order 2001,
  • registered pharmacists,
  • persons who are registered in the dental care professionals register established under section 36B of the Dentists Act 1984,
  • optometrists,
  • registered osteopaths,
  • registered chiropractors,
  • registered nurses or midwives,
  • persons not mentioned above who are registered in any register maintained under an Order in Council under section 60(1) of the Health Act 1999, and
  • any other description of persons which appears to the Welsh Ministers to be a description of persons whose profession is regulated by or under an Act of the Scottish Parliament or the Northern Ireland Assembly. 

Sections 83 and 84 of NHSWA 2006 provide further detail on the regulations that the Welsh Ministers are required to make under section 80.

Section 83(1) provides that the Welsh Ministers’ regulations must provide that arrangements made by a LHB under section 80 will:

  • enable persons for whom drugs, medicines or appliances are ordered to receive them from persons with whom such arrangements are made, and
  • ensure the provision of any other services that are prescribed by the Welsh Ministers under section 80(3)(e) by persons with whom such arrangements have been made.

The regulations must include provision:

  • for the preparation and publication by a LHB of one or more lists of persons, other than medical practitioners and dental practitioners, who undertake to provide pharmaceutical services from premises in the LHB’s area. This list is known as the ‘pharmaceutical list’,
  • that an application to a LHB for inclusion in a pharmaceutical list be made in a manner prescribed by the regulations and must state the services the applicant will undertake to provide and the premises from which he or she will undertake to provide them,
  • that, except in prescribed cases, an application for inclusion in a pharmaceutical list when not already included, and an application by a person already included in a pharmaceutical list for inclusion also in respect of services or premises other than those already listed in relation to him, may be granted only if the LHB is satisfied, in accordance with the regulations, that it is necessary or expedient to grant the application in order to secure in the neighbourhood in which the premises are located the adequate provision by persons included in the list of the services, or some of the services, specified in the application, and
  • for the removal of an entry in respect of premises from a pharmaceutical list if it has been determined in the prescribed manner that the person to whom the entry relates has never provided from those premises, or has ceased to provide from them, the services which that person is listed as undertaking from them.

Section 83(3) provides that the regulations may prescribe the extent to which the provision of local pharmaceutical services must be taken into account in determining whether to grant an application for inclusion in a pharmaceutical list.

Sections 83(4) and (5) provides that the regulations may provide for the method of determination where two or more applications are received in relation to the same neighbourhood, and they are considered together by the LHB, and the LHB would be satisfied that the applications would be approved by the LHB as being necessary or expedient if they were taken on their own, but the LHB is not satisfied that, taken together, they are necessary or expedient. In such cases, regulations may provide that the LHB may take into account proposals in the applications for the sale of drugs and other products, otherwise than by way of pharmaceutical services or by private prescription.

Further, section 83(6) provides that the regulations may make provision:

  • that an application may be granted in respect of some only of the services specified in it,
  • that an application relating to services of a prescribed description may be granted only if it appears to the LHB that the applicant has satisfied such conditions as may be prescribed in the regulations,
  • that an application by a person who qualified to have his or her name registered as a pharmacist in the register maintained under article 19 of the Pharmacy Order 2010 by virtue of a qualification awarded in an EEA state other than the UK, or in Switzerland, may not be granted unless the applicant satisfies the LHB that he or she has the knowledge of English that is necessary for the provision of pharmaceutical services,
  • that a person’s inclusion may be for a fixed period,
  • that, where the premises from which an application states that the applicant will undertake to provide services are in an area of a prescribed description, the applicant may not be included in the list unless his inclusion is approved by the LHB by reference to criteria prescribed in the regulations,
  • that the LHB may give conditional approvals,
  • as to other grounds on which LHBs may or must refuse to grant an application,
  • as to information which must be supplied to a LHB by a person included, or seeking inclusion, in a list,
  • for the supply to a LHB by a person included, or seeking inclusion, in a pharmaceutical list, or who is on the controlling body of a body corporate included, or seeking inclusion, in a list, of a criminal conviction certificate, an enhanced criminal record certificate or up-date information,
  • for grounds on which a LHB may defer a decision,
  • for the disclosure by a LHB, to prescribed persons, of information of a prescribed description about applicants for inclusion in a pharmaceutical list, and refusals for applications,
  • as to criteria to be applied in making decisions under the regulations,
  • as to the making of declarations about financial interests, gifts above a prescribed value, and other benefits received.

Sections 83(7)-(9) provide that the regulations may provide for cases where the means of providing a service are such that the person receiving that services does so otherwise than at the premises from which it is provided. In such cases, the regulations require persons to be approved by the Welsh Ministers (or another person specified in the regulations) for the purposes of providing such a service, or require LHBs to make the approval subject to conditions prescribed in the regulations.

Appeals etc

Section 84(1) provides that regulations made by the Welsh Ministers under section 83 must include provision conferring on persons which are prescribed in the regulations rights of appeal from decisions made by virtue of section 83. In particular, if regulations made under section 83 provide that a LHB may refuse to grant an application, the regulations must also provide for an appeal to the First-tier Tribunal.

Section 1

The National Health Service (Pharmaceutical Services) (Wales) Regulations 2013 (SI 2013/898)

The National Health Service (Pharmaceutical Services)(Wales) Regulations 2013 (NHS PSR 2013) were made partly in exercise of the Welsh Ministers’ powers under sections 83 and 84 of NHSWA 2006. The Regulations govern the provision of pharmaceutical services as part of the National Health Service in Wales. The paragraphs below provide a summary of the main provisions.

Part 2 of NHS PSR 2013 requires each LHB to prepare and maintain for its area:

  • pharmaceutical lists of NHS pharmacists and NHS appliance contractors who undertake to provide pharmaceutical services from premises in the area,
  • dispensing doctor lists of doctors who undertake to provide pharmaceutical services from premises in the area.

Part 2 also sets out the terms on which persons are included in a pharmaceutical or dispensing doctor list and on which they undertake to provide pharmaceutical services.

Part 3 makes provision about ‘controlled localities’. It provides that a LHB may itself, or must on application by a Local Medical Committee or Local Pharmaceutical Committee, determine whether a particular area within the LHB’s area is, because it is rural in character, a ‘controlled locality’. The significance of being a controlled locality is that, in certain circumstances, dispensing doctors can provide pharmaceutical services to eligible patients. The procedures that a LHB must follow in determining whether an area is a controlled locality are set out in Schedule 2 to NHS PSR 2013. Schedule 3 provides for a right of appeal to the Welsh Ministers in this respect.

Part 4 of NHS PSR 2013  sets out the types of application for inclusion in, or amendment to, pharmaceutical lists and the tests which a LHB must apply to determine those applications. Regulation 8 (applications to be included in or for amendment to a pharmaceutical list) and regulation 12 (applications for preliminary consent and the effect of preliminary consent) applications can be granted only if the LHB is satisfied that it is necessary or expedient to grant the application to secure in the neighbourhood concerned adequate provision of all or some of the services specified in the application (the necessary or expedient test). In addition, the general position is that if the premises are located in a controlled locality, the LHB must be satisfied that granting 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 LHB to be in a reserved location under regulation 11.

Certain applications which involve minor changes to the list are not assessed in accordance with the necessary or expedient test or the prejudice test (see regulations 13 - 16).

The procedures that a LHB must follow in determining applications under Part 4 are set out in Schedule 2 to NHS PSR 2013, and Schedule 3 makes provision for rights of appeal to the Welsh Ministers in respect of decisions made by LHBs.

Part 5 sets out the application process for doctors wishing to provide pharmaceutical services to their patients in controlled localities. Doctors must apply for outline consent (under regulation 24) and LHBs must consider such applications in accordance with the necessary or expedient test, the prejudice test and have regard to the proximity of the premises from which the doctor wishes to provide pharmaceutical services to nearby pharmacies. The procedures that a LHB must follow in determining applications under Part 5 are set out in Schedule 2 to the Regulations, and rights of appeal to the Welsh Ministers in respect of decisions made by a LHB are set out in Schedule 3.

Part 6 of NHS PS 2013 deals with fitness grounds and inclusion in and removal from the pharmaceutical lists. It provides for the deferral and refusal of applications on fitness grounds (regulations 31 and 32), and for conditional inclusion on a list being subject to conditions (regulation 33). Regulation 35 provides that in some circumstances relevant to fitness, LHBs must remove a person from a pharmaceutical list (e.g. if they have been convicted of a criminal offence and sentenced to a term of imprisonment of over six months).

Part 7 deals with payments to NHS pharmacists and NHS appliance contractors. In particular, regulation 41 provides for the publication of the Drug Tariff, which is the main statement of the financial entitlements of NHS pharmacists and NHS appliances contractors. The Drug Tariff sets out the determinations made by the Welsh Ministers as determining authority. Regulation 42 makes provision for LHBs to be determining authorities where this is set out in the Drug Tariff. Part 7 of the regulations also deals with supplemental matters including overpayments and payments to NHS pharmacists and NHS appliance contractors. 

Section 2

Additional pharmaceutical services

Section 81 of NHSWA 2006 provides that the Welsh Ministers may give directions to a LHB requiring it to arrange for the provision to persons within or outside its area of additional pharmaceutical services, or authorising it to arrange for such provision if it wishes to do so. The directions may require or authorise a LHB to arrange for the provision of a service by means such that the person receiving the service does so otherwise than at the premises from which it is provided.

Section 82 provides that directions under section 81 may require the LHB, when making arrangements:

  • to include specified terms,
  • to impose specified conditions on any person providing a service in accordance with the arrangements.

Section 82(2) provides that the arrangements must secure that any service to which they apply is provided only by a person whose name is included in a pharmaceutical list in Wales, England or Northern Ireland, or who has entered into a pharmaceutical care services contract in Scotland.

A LHB must provide details of proposed arrangements for additional pharmaceutical services to any person who asks for them, and after making such arrangements, must publish, in such manner as the Welsh Ministers may direct details of the arrangements.

Power to charge for applications for inclusion in the pharmaceutical list

Section 85 of NHSWA 2006 provides that the Welsh Ministers may give directions to a LHB requiring it to charge a fee in cases specified in the directions to persons applying for inclusion in a pharmaceutical list, or persons who are already in the list but are applying in respect of premises or services other than those which are already listed in relation to that person. The Welsh Ministers must publish any directions they give under section 85.

Sections 85(2)-(3) provide that the Welsh Ministers may in the directions:

  • specify the fee themselves (after consulting organisations which represent persons providing pharmaceutical services and representing LHBs), or
  • require the LHB to determine the fee in accordance with requirements set out in the directions (having undertaken any consultation required by the directions). The LHB must publish the fee which it determines.
Section 3

Persons authorised to provide pharmaceutical services

Under section 86(1) of NHSWA 2006 except as provided for in regulations made by the Welsh Ministers, no arrangements may be made by a LHB with a medical practitioner or dental practitioner under which that practitioner is required or agrees to provide pharmaceutical services to any person to whom the practitioner is providing primary services.

Under section 86(2) except as provided for in regulations, no arrangements for the dispensing of medicines may be made under Chapter 1 of Part 7 of the NHSWA 2006 with persons other than persons who:

  • are registered pharmacists or persons lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968, and
  • undertake that all medicines supplied by them under the agreements will be dispensed either by or under the supervision of a registered pharmacist.

Sections 86(3)-(4) provide that regulations must provide for the preparation and publication by each LHB of one or more lists of medical practitioners who undertake to provide drugs, medicines or listed appliances under arrangements with the LHB. The regulations may, in particular, include provision:

  • as to the grounds on which a LHB may, or must, refuse to grant an application for inclusion in a list of medical practitioners who undertake to provide drugs, medicines etc,
  • as to information which must be supplied to a LHB by a medical practitioner included, or seeking inclusion, in such a list,
  • for the supply to a LHB by a medical practitioner who is included, or seeking inclusion, in such a list of a criminal conviction certificate, an enhanced criminal record certificate or up-date information,
  • for grounds on which a LHB may defer a decision whether or not to grant an application,
  • for the disclosure by a LHB to prescribed persons of information of a prescribed description about applicants for inclusion in such a list, and about refusals by the LHBs to grant such applications,
  • as to criteria to be applied in making decisions under the regulations.

Section 86(5) provides that if the regulations provide that a LHB may refuse to grant an application for inclusion in such a list, the regulations must also provide for an appeal to the First-tier Tribunal.

The regulations must also include provision for the removal of an entry from a list in prescribed circumstances.

Section 83(7) provides that no arrangements for the provision of pharmaceutical services falling within section 80(3)(e) or additional services provided in accordance with a direction under section 81 may be made with persons other than those who are registered pharmacists or are of a prescribed description.

Finally, section 83(8) provides that where arrangements for the provision of pharmaceutical services have been made with a registered pharmacist, and the pharmacist’s registration is suspended by virtue of a direction or order under the Pharmacy Order 2010, that pharmacist may not provide pharmaceutical services in person during the period of the suspension.

Inadequate provision of pharmaceutical services

Section 87 of NHSWA 2006 applies where the Welsh Ministers are satisfied, after such inquiry as they consider appropriate, that as respects the area, or part of the area, of a LHB, the persons whose names are included in any pharmaceutical list are not such as to secure the adequate provision of pharmaceutical services, or for any other reason a considerable number of persons in the area are not receiving satisfactory services. In such cases, the Welsh Ministers may authorise the LHB to make such other arrangements as the Welsh Ministers may approve, or may themselves make such arrangements to provide adequate services. The Welsh Ministers may also dispense with any of the requirements of regulations made under Chapter 1 of Part 6 and Part 8 of NHSWA 2006 to meet exceptional circumstances and enable the arrangements to be made.

Section 4

Remuneration for persons providing pharmaceutical services

Section 88 of NHSWA 2006 provides that the remuneration to be paid to persons providing pharmaceutical services must be determined by the Welsh Ministers, or so far as they are authorised to do so by the Welsh Ministers by means of an ‘instrument of appointment’, a LHB or any other person. The instrument of appointment may contain requirements with which the determining authority must comply and may be contained in regulations. It must be contained in regulations in the circumstances provided for by section 88(4A). 

Section 88(6) provides that the Welsh Ministers may make regulations about determining remuneration for the providers of pharmaceutical services. Section 88(7) provides that the regulations may provide that determinations may be made by reference to:

  • rates or conditions of remuneration which are fixed or determined, otherwise than by way of determination under section 88 of NHSWA 2006,
  • scales, indices or other data of any description specified in the regulations.

Section 88(9) provides that the regulations may provide that the determining authorities may make determinations which have effect in respect of a period beginning before the date of the determination, but that they may only do so if, taking the determination as a whole, it is not detrimental to the persons to whose remuneration it relates.

Finally, section 89 provides that before the Welsh Ministers determine the level of remuneration which relates to all persons who provide pharmaceutical services, they must consult a body appearing to them to be representative of persons to whose remuneration the determination would relate, and may consult such other persons as they consider appropriate. Determinations may make different provision for different cases, including different provision for any particular case, class of case or area. 

Section 89(6) provides that the remuneration may be determined from time to time and may consist of payments by way of salary, fees, allowances and reimbursements. Section 89(10) provides for some of the relevant factors that the determining authority will be required to take into account, including:

  • the amount or estimated amount of expenses incurred in the past or likely to be incurred in the future in connection with the provision of pharmaceutical services,
  • the amount or estimated amount of any remuneration paid or likely to be paid to persons providing such services,
  • the amount or estimated amount of any other payments or repayments or other benefits received or likely to be received by such persons,
  • the extent to which it is desirable to encourage the provision, either generally or in particular places, of pharmaceutical services,
  • the desirability of promoting pharmaceutical services which are economic, efficient, and of an appropriate standard.

Part 7 of the National Health Service (Pharmaceutical Services) (Wales) Regulations 2013 makes provision about remunerating the providers of pharmaceutical services. The regulations were made partly in exercise of the Welsh Ministers’ power under section 88 of NHSWA 2006.

Regulation 41(2) of these Regulations provides that the Welsh Ministers’ determinations as to the remuneration to be paid to the providers of pharmaceutical services may be made by reference to scales, indices or formulae of any kind, and may take effect from a date earlier than the publication of the determination, but only if, taking the determination as a whole, it is not detrimental to the persons to whose remuneration it relates. The Welsh Ministers’ determination is included in the ‘Drug Tariff’, which is compiled on the Welsh Ministers’ behalf by the NHS Business Services Authority. The latest version of the Drug Tariff is available from the pharmacy services section of the NHS Wales website. 

Regulation 41(4) provides that any amendments to the Drug Tariff must be published by the Welsh Ministers in a consolidated version of the Drug Tariff that has the amendments included in it.

Regulation 42 provides that the Welsh Ministers may state in the Drug Tariff that the determining authority for a particular fee, allowance or other remuneration is to be the LHB. The Welsh Ministers have not exercised this power to make LHBs determining authorities.

The Drug Tariff should be consulted for full details of the remuneration to be paid to the providers of pharmaceutical services. Parts VIA and VIB make provision for essential services provided by pharmacy contractors and appliance contractors, and part VID makes provision for payments for advanced services to pharmacy contractors and appliance contractors.

Local Pharmaceutical Committees

Section 90 of NHSWA 2006 provides that a LHB may recognise a committee formed for its area, and that of one or more other LHBs, which it is satisfied is representative of the persons providing pharmaceutical services in that area. The recognised committee is called the Local Pharmaceutical Committee for the area.

The Welsh Ministers may make regulations to require a LHB to consult any committee recognised by it on such occasions and to such extent as may be prescribed, and a committee has such other functions as may be prescribed by the Welsh Ministers. The Welsh Ministers have not exercised their power to make regulations in this respect.

Section 5

Supplementary lists

Part 8 of the National Health Service Wales Act 2006 (NHSWA 2006) makes further provision about qualification to practise. Section 105 provides that the Welsh Ministers may make regulations providing for the preparation and publication by each LHB of one or more lists of persons approved by the LHB for the purpose of assisting in the provision of general ophthalmic services and pharmaceutical services. Such a list is known as a ‘supplementary list’. This is to be distinguished from the pharmaceutical list since a supplementary list relates to persons assisting in the provision of services (i.e. otherwise than as principals in their own right).

The Welsh Ministers’ regulations in this respect may, in particular, make provision for the matters listed in sections 105(3) and (4). They include the power to make provision about:

  • the LHB to which an application for inclusion in a supplementary list must be made,
  • the procedure for applying for inclusion,
  • grounds on which the LHB may, or must, refuse a person’s application,
  • requirements with which a person included in a supplementary list must comply,
  • grounds on which a LHB may, or must, suspend or remove a person from a supplementary list, the procedures for doing so, and the consequence of doing so,
  • payments to persons who are suspended from a supplementary list,
  • the supply to the LHB by an applicant of a criminal conviction certificate and/or an enhanced criminal record certificate,
  • circumstances in which a person included in a supplementary list may not withdraw from it,
  • criteria to be applied in making decisions under the regulations,
  • appeals against decisions of LHBs,
  • the disclosure by a LHB to prescribed persons of prescribed descriptions, of information of a prescribed description about applicants for inclusion in a supplementary list.

The regulations may also provide for:

  • conditions imposed by a LHB for a person’s inclusion in a supplementary list,
  • the LHB’s power to vary the conditions,
  • the consequence of failing to comply with a condition, and
  • the review by the LHB of its decisions.

If the regulations provide that a LHB may suspend or remove a person from a supplementary list, they must include provision requiring the LHB to give that person:

  • notice of any allegation against them,
  • the opportunity to put their case before the LHB at a hearing, and
  • notice of the LHB’s decision and the reasons for it and for a right of appeal to the First-tier Tribunal.

Finally, section 106 provides that regulations made by the Welsh Ministers under section 105 may require a person, ‘A’, included in a pharmaceutical list (or an ophthalmic list) not to employ or engage another person, ‘B’, to assist A in the provision of the service to which the list relates unless B is included in a list, including:

  • an ophthalmic or pharmaceutical list,
  • a supplementary list,
  • a medical or dental list.

If regulations are made to that effect, they need not require both persons A and B to be included in lists prepared by the same LHB, but may require both A and B to be included in lists prepared by LHB. The intention in this respect is to help those who work across LHB boundaries by normally requiring them to join one, rather than several, supplementary lists.

There are no regulations in force in relation to supplementary pharmaceutical services lists.

Section 6

Pilot schemes

Independent prescribers

Section 80 (3)(d) of NHSWA 2006 provides that each LHB is under a duty to make arrangements for, amongst other things, the provision to persons in the LHB’s area of such drugs, medicines and appliances as may be determined by the Welsh Ministers which are ordered for those persons by a prescribed description of person, known as independent contractors. Section 80(4) provides a list of the descriptions of persons that may be prescribed as being independent contractors. They include professions regulated under the Health and Social Work Professions Order 2001 (including podiatrists, chiropodists and physiotherapists), registered pharmacists, nurses, optometrists and dental care professionals.

The Welsh Ministers have exercised their power under section 80(3)(d) to provide that certain descriptions of persons may act as independent contractors. Most recently, the National Health Service (Physiotherapist, Podiatrist or Chiropodist Independent Prescribers) (Miscellaneous Amendments) (Wales) Regulations 2014 (SI 2014/2291) were made to provide that particular physiotherapists, podiatrists and chiropodists could act as independent prescribers.

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