The National Health Service (Pharmaceutical Services) (Wales) Regulations 2013

Explanatory Note

(This note is not part of the Regulations)

These Regulations revoke and replace the National Health Service (Pharmaceutical Services) Regulations 1992 (S.I.1992/662) (as amended) (“the 1992 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.

Part 2 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 3 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 2 to the Regulations. Rights of appeal to the Welsh Ministers in respect of decisions made by Local Health Boards are set out in Schedule 3.

Part 4 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 8 (applications to be included in or for amendment to a pharmaceutical list) and regulation 12 (applications for preliminary consent and effect of preliminary consent) applications can be granted only if the Local Health Board is satisfied that it is necessary or expedient to grant the application to secure in the neighbourhood in which the premises specified in the application are located, the 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 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 11 (locations in controlled localities that are reserved locations)).

Certain applications regarding pharmaceutical lists are not assessed in accordance with the necessary or expedient test or the prejudice test. A person already included in a pharmaceutical list can apply to relocate the premises from which he or she provides pharmaceutical services where the move can be considered to be a minor relocation. Regulation 13 (applications involving minor relocation within a Local Health Board’s area) sets out when a Local Health Board must grant such an application. Similarly, applications that fall within regulation 14 (applications involving minor relocation between neighbouring Local Health Board areas), regulation 15 (applications involving a temporary relocation) and regulation 16 (applications involving a change of ownership) are not assessed in accordance with the necessary or expedient test or the prejudice test. The procedures that a Local Health Board must follow in determining applications under Part 4 are set out in Schedule 2 to the Regulations, and rights of appeal to the Welsh Ministers in respect of decisions made by Local Health Boards are set out in Schedule 3.

Part 5 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 24 (outline consent and premises approval) and Local Health Boards must consider such applications in accordance with the necessary or expedient test, 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 20 (arrangements for the provision of pharmaceutical services by doctors). The procedures that a Local Health Board 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 Local Health Boards are set out in Schedule 3.

Part 6 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 31 and 32) together with an inclusion in a pharmaceutical list being subject to conditions (regulation 33). 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 six months, a Local Health Board must remove a person from a pharmaceutical list pursuant to regulation 35 (removal from a pharmaceutical list for other reasons).

Part 7 deals with payments to NHS pharmacists and NHS appliance contractors. Regulation 41 (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 42 (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 8 deals with miscellaneous matters, including transitional provisions for applications and appeals made under the 1992 Regulations before these Regulations come into force.

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, Social Services and Children, Welsh Government, Cathays Park, Cardiff, CF10 3NQ.