The National Health Service (Pharmaceutical Services) Regulations 2005

Explanatory Note

(This note is not part of the Regulations)

These Regulations replace the National Health Service (Pharmaceutical Services) Regulations 1992 which govern the provision of pharmaceutical services under Part 2 of the National Health Service Act 1977.

Primary Care Trusts are required to keep lists of persons providing pharmaceutical services in their area (regulation 4) and provide for applications to be made for inclusion in a list and for amendment to a list (regulation 5 and Schedule 4).

Regulation 5(1) sets out the different types of applications. Relatively straightforward applications are dealt with under their own provisions (regulation 6 (minor relocations within a Primary Care Trust’s area), regulation 7 (minor relocations between neighbouring Primary Care Trusts), regulation 8 (changes of ownership), regulation 9 (applications following suspension), regulation 10 (returning to the pharmaceutical list after providing local pharmaceutical services) and regulation 54 (the temporary provision of services during a period of suspension)). The grant or refusal of other applications (including applications to be included in the pharmaceutical list for the first time) are dealt with under regulations 11 and 13 to 21. The procedures for determining these applications are listed in regulation 22 and depend essentially on whether the application relates to a controlled locality (which is typically a rural area) or not.

Where the application does not concern premises in a controlled locality, it will be determined in accordance with the procedures set out in regulations 12(2) to (4), 22(4), and 23 to 30. Where the application does concern premises within a controlled locality, it will be determined in accordance with regulations 12(2) to (4), 22(4), 25, 26, 28, and 30 to 38.

Generally, applications will only be granted if the Primary Care Trust considers that it is necessary or desirable to do so in order to secure the adequate provision of pharmaceutical services in its area (regulation 12). However, in certain circumstances, applications will be granted without satisfying this requirement. These circumstances are:

(a) where the premises are in an approved retail area, which is essentially a large out of town centre shopping development (regulation 13(1)(a) and 15),

(b) where the premises will be open for at least 100 hours a week (regulation 13(1)(b)),

(c) where the premises are in a new one-stop primary care centre where a number of primary health care services are provided from a discrete building or site (regulation 13(1)(c) and 16), and

(d) where the pharmaceutical services are not provided at the premises, but are instead provided by the Internet or by mail order (regulation 13(1)(d)).

The Regulations allow the Primary Care Trust to consider the fitness to practise of applicants. The Primary Care Trust can refuse an application (regulation 19) or can impose conditions on the applicant’s entry in the list (regulation 21).

Once included in a pharmaceutical list or a dispensing doctors list, a chemist or doctor must provide pharmaceutical services in accordance with the terms of service. The terms of service for pharmacists are set out in Schedule 1. All pharmacists must provide the essential services described in Part 2 of that Schedule. The terms of service for dispensing doctors are set out in Schedule 2, and those for appliance contractors are set out in Schedule 3.

Part 3 of the Regulations concern matters arising after the applicant has been included in the pharmaceutical list and is primarily concerned with fitness to practise issues. It provides for the review of conditions imposed on fitness to practise grounds (regulations 42 and 43), removal from the pharmaceutical list (regulations 44 to 49), suspension from the pharmaceutical list (regulations 50 and 54), review of fitness to practise decisions (regulations 51 and 52) and withdrawal from the pharmaceutical list (regulation 53). The right of appeal against decisions in relation to fitness to practise matters is to the Family Health Services Appeals Authority.

Part 4 of the Regulations make provision for the payment of chemists (regulations 56 to 59).

Part 5 of the Regulations make provision for doctors to provide pharmaceutical services to patients in limited circumstances (regulations 60 to 69).

Part 6 of the Regulations makes miscellaneous provision regarding publication of particulars (regulation 70), the keeping of a list of chemists who provide an electronic prescription service (regulation 71), choice of chemist by patients (regulation 72) and transitional provisions (regulations 73 and 74). Regulation 75(1) and Schedule 5 make amendments to other legislation consequential on these Regulations and regulation 75(2) and Schedule 6 revoke legislation consequential on these Regulations.