The National Health Service (Pharmaceutical Services) (Amendment) (Wales) Regulations 2009

Explanatory Note

(This note is not part of the Regulations)

These Regulations further amend the National Health Service (Pharmaceutical Services) Regulations 1992 (“the principal Regulations”).

The principal Regulations govern the arrangements for the provision of pharmaceutical services under the National Health Service (Wales) Act 2006.

The amendments made to the principal Regulations by these Regulations make changes to the way that pharmaceutical services are provided in localities that have been determined to be rural in character, that is, “controlled” for the purposes of the principal Regulations. These Regulations also make consequential amendments.

The changes introduced by these Regulations include:

1.  Provision that prevents the grant of new applications for doctors to seek the right to provide pharmaceutical services to patients if there is a pharmacy within 1.6 kilometres of the premises from which the doctor wishes to provide such services. The rights of existing dispensing medical practices will not be affected.

2.  Local Health Boards will be required to establish a list of premises from which doctors provide pharmaceutical services within their respective area. The Local Health Board will also be required to give approval to the suitability of such premises to be used as dispensing premises (“premises approval”).

3.  Premises from which doctors are dispensing at the date of the coming into force of these Regulations, or which have had outline consent granted, will be required to secure premises approval from the Local Health Board within a period of three months of the coming into force of these Regulations.

4.  New provisions are introduced which permit an application to be made by a dispensing doctor to apply to relocate dispensing premises without being required to re-apply for outline consent and premises approval provided the Local Health Board is satisfied that the move constitutes a “minor relocation”.

5.  New provisions are introduced which will enable dispensing doctors to apply to relocate their premises or to open new premises. Such approval will only be given if the premises are more than 1.6 kilometres from any pharmacy and such approval will not take effect until 12 months after the grant of the application (to enable a pharmacy affected by the relocation an opportunity to apply to relocate).

6.  Provision is made to specify the procedure to be followed when a dispensing medical practice amalgamates with another, non-dispensing practice.

7.  Provision is included to introduce “reserved locations” within localities that have been determined to be controlled for the purposes of the principal Regulations. A reserved location is one in which the patient population (on all the patient lists) within 1.6 kilometres of the estimated or actual location of the proposed pharmacy premises is less than 2,750. Where a Local Health Board is satisfied that an area constitutes a reserved location, an application for inclusion in the pharmaceutical list in accordance with regulation 4(2) of the principal Regulations will not be subject to the “prejudice” test. Patients living within 1.6 kilometres of the new pharmacy, and who receive pharmaceutical services from a dispensing medical practice, will not lose their right to receive such services and will be able to exercise a choice as to whether to receive dispensing services from their doctor or pharmaceutical services from the pharmacy.

8.  Local Health Boards can remove (or refuse to apply) reserved location status in two circumstances:

• if the patient population exceeds 2,750, and

• if the patient population is below 2,750 but the Local Health Board considers that the needs of the patient population in the relevant location are such that they are similar to the needs in those areas with a larger population.

In such circumstances an application under regulation 4(2) of the principal Regulations will be subject to the “prejudice” test.

9.  Amendments are made to enable doctors and chemists who provide services in controlled localities to appeal to the Welsh Ministers when a Local Health Board makes a determination in respect of the rurality of a locality. Hitherto, only Local Pharmaceutical Committees and Local Medical Committees have had the right to appeal such a determination.

10.  The notification requirements are extended so that Local Health Boards are required to give notice of certain applications made under the principal Regulations to any patient, consumer or community group within its area that it considers has an interest in the provision of pharmaceutical services in the area.

11.  An amendment is made to remove an anomaly which failed to require the application of the “prejudice” test for all applications made under regulation 4(2) of the principal Regulations when the proposed premises was located in a controlled locality.

12.  The terms of service for doctors who provide pharmaceutical services under the principal Regulations are substituted. A new requirement within these terms of service is that all premises used by doctors for dispensing will be subject to inspection by the Local Health Board (a similar provision already applies in relation to community pharmacies).