Citation and commencement

1. These Regulations may be cited as the National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 and come into force on 1st April 2014.

Interpretation

2. In these Regulations, “the principal Regulations” means the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013( 2 ).

Amendment of regulation 13 of the principal Regulations

3. In regulation 13 of the principal Regulations (current needs: additional matters to which the NHSCB must have regard), for paragraph (1) substitute the following paragraph—

“ (1) If—

(a) the NHSCB receives a routine application and is required to determine whether granting it, or granting it in respect of some only of the services specified in it, would meet a current need for pharmaceutical services, or pharmaceutical services of a specified type, in the area of the relevant HWB; and

(b) the current need has been included in the relevant pharmaceutical needs assessment in accordance with paragraph 2(a) of Schedule 1,

in determining whether it is satisfied as mentioned in section 129(2A) of the 2006 Act ( 3 ) (regulations as to pharmaceutical services), the NHSCB must have regard to the matters set out in paragraph (2). ” .

Amendment of regulation 15 of the principal Regulations

4. In regulation 15 of the principal Regulations (future needs: additional matters to which the NHSCB must have regard), for paragraph (1) substitute the following paragraph—

“ (1) If—

(a) the NHSCB receives a routine application and is required to determine whether granting it, or granting it in respect of some only of the services specified in it, would meet a future need for pharmaceutical services, or pharmaceutical services of a specified type, in the area of the relevant HWB; and

(b) the future need has been included in the relevant pharmaceutical needs assessment in accordance with paragraph 2(b) of Schedule 1,

in determining whether it is satisfied as mentioned in section 129(2A) of the 2006 Act (regulations as to pharmaceutical services), the NHSCB must have regard to the matters set out in paragraph (2). ” .

Amendment of regulation 17 of the principal Regulations

5. In regulation 17 of the principal Regulations (improvements or better access to the current service: additional matters to which the NHSCB must have regard), for paragraph (1) substitute the following paragraph—

“ (1) If—

(a) the NHSCB receives a routine application and is required to determine whether granting it, or granting it in respect of some only of the services specified in it, would secure improvements, or better access, to pharmaceutical services, or pharmaceutical services of a specified type, in the area of the relevant HWB; and

(b) the improvements or better access that would be secured have or has been included in the relevant pharmaceutical needs assessment in accordance with paragraph 4(a) of Schedule 1,

in determining whether it is satisfied as mentioned in section 129(2A) of the 2006 Act (regulations as to pharmaceutical services), the NHSCB must have regard to the matters set out in paragraph (2). ” .

Amendment of regulation 18 of the principal Regulations

6. In regulation 18 of the principal Regulations (unforeseen benefits applications: additional matters to which the NHSCB must have regard), in paragraph (2)(b), at the end of paragraph (ii), for “and” substitute “or”.

Amendment of regulation 20 of the principal Regulations

7. In regulation 20 of the principal Regulations (future improvements or better access: additional matters to which the NHSCB must have regard), for paragraph (1) substitute the following paragraph—

“ (1) If—

(a) the NHSCB receives a routine application and is required to determine whether granting it, or granting it in respect of some only of the services specified in it, would secure improvements, or better access, in the future to pharmaceutical services, or pharmaceutical services of a specified type, in the area of the relevant HWB; and

(b) the improvements or better access that would be secured have or has been included in the relevant pharmaceutical needs assessment in accordance with paragraph 4(b) of Schedule 1,

in determining whether it is satisfied as mentioned in section 129(2A) of the 2006 Act (regulations as to pharmaceutical services), the NHSCB must have regard to the matters set out in paragraph (2). ” .

Amendment of regulation 24 of the principal Regulations

8. In regulation 24 of the principal Regulations (regulations that do not result in significant change to pharmaceutical services provision)—

(a) in paragraph (1)(c), for “is satisfied that granting the application would not cause” substitute “is not of the opinion that granting the application would cause”;

(b) in paragraph (2)(d), for “is satisfied that granting the application would not cause” substitute “is not of the opinion that granting the application would cause”; and

(c) in paragraph (3)—

(i) omit “or” at the end of sub-paragraph (b),

(ii) insert “; or” at the end of sub-paragraph (c), and

(iii) after sub-paragraph (c) insert the following sub-paragraph—

“ (d) are distance selling premises, unless—

(i) the premises to which the applicant is seeking to relocate are also distance selling premises, and

(ii) if the application was one to which regulation 25(1) applied, it would not be refused pursuant to regulation 25(2). ” .

Amendment of regulation 26 of the principal Regulations

9. In regulation 26 of the principal Regulations (change of ownership applications)—

(a) in paragraph (2)—

(i) in sub-paragraph (d), for “if Y had” substitute “had Y”, and

(ii) in sub-paragraph (e), for “if” substitute “in a case where”; and

(b) after paragraph (2) insert the following paragraphs—

“ (3) An application pursuant to paragraph (1) must be refused if it relates to distance selling premises, unless the application, if made pursuant to regulation 25(1), would not be refused pursuant to regulation 25(2).

(4) An application pursuant to paragraph (2) must be refused if the existing pharmacy premises from which the applicant is seeking to relocate are distance selling premises, unless the premises to which the applicant is seeking to relocate are also distance selling premises (and this is in addition to the requirement that arises by virtue of paragraph (2)(d) that the application, if made pursuant to regulation 25(1), would not be refused pursuant to regulation 25(2)). ” .

Amendment of regulation 31 of the principal Regulations

10. In regulation 31 of the principal Regulations (refusal: same or adjacent premises), for paragraph (1) substitute the following paragraph—

“ (1) A routine or excepted application must be refused where paragraph (2) applies. ” .

Amendment of regulation 32 of the principal Regulations

11. In regulation 32 of the principal Regulations (deferrals arising out of LPS designations), for paragraph (1) substitute the following paragraph—

“ (1) A routine application must be refused where paragraph (2) applies to the relevant premises. ” .

Amendment of regulation 33 of the principal Regulations

12. In regulation 33 of the principal Regulations (refusal of applications for inclusion in a pharmaceutical list on fitness grounds)—

(a) before paragraph (1), insert the following paragraph—

“ (A1) In this regulation, “A” means, where an application for inclusion in a pharmaceutical list is made by a person who is—

(a) an individual, the individual making the application;

(b) a partnership, any partner in the partnership making the application; or

(c) a body corporate—

(i) except for the purposes of paragraphs (1)(a) and (b) and (3)(h)(i), the body corporate making the application, and

(ii) except for the purposes of paragraph (2)(b) and (e), any director or superintendent of the body corporate making the application. ” ;

(b) in paragraph (1)—

(i) omit “(A)”, and

(ii) in sub-paragraphs (a) and (b), omit “(or where A is a body corporate, any director or superintendent of A)”;

(c) in paragraphs (2)(c)(i) and (ii) and (d)(i) and (ii), and (3)(g) and (h), omit “(and where A is a body corporate, any director or superintendent of A)”; and

(d) in paragraph (3)(g) and (h), omit “(and where A is a body corporate, any director or superintendent of A)”.

Amendment of regulation 34 of the principal Regulations

13. In regulation 34 of the principal Regulations (deferral of consideration of applications for inclusion in a pharmaceutical list on fitness grounds)—

(a) before paragraph (1), insert the following paragraph—

“ (A1) In this regulation, “A” means, where an application for inclusion in a pharmaceutical list is made by a person who is—

(a) an individual, the individual making the application;

(b) a partnership, any partner in the partnership making the application; or

(c) a body corporate—

(i) except for the purposes of paragraph (1)(b), (c)(ii), (e), (g), (i) and (k), the body corporate making the application, and

(ii) any director or superintendent of the body corporate making the application. ” ; and

(b) in paragraph (1)—

(i) omit “(A)”,

(ii) in sub-paragraph (a)—

(aa) omit “(or where A is a body corporate, in respect of A or any director or superintendent of A)”, and

(bb) for “A’s removal from its pharmaceutical list, if A” substitute “the person’s removal from the pharmaceutical list, if the person”,

(iii) in sub-paragraph (b), for “A’s removal from its pharmaceutical list, if A” substitute “the person’s removal from the pharmaceutical list, if the person”,

(iv) in sub-paragraph (c)—

(aa) in paragraph (i), omit “(or where A is a body corporate, any director or superintendent of A’s)”,

(bb) in paragraph (ii), omit “(or where A is a body corporate, any director or superintendent of A)”, and

(cc) for “A from the pharmaceutical list if A” substitute “the person from the pharmaceutical list if the person”,

(v) in sub-paragraphs (d), (j) and (k), omit “(and where A is a body corporate, any director or superintendent of A)”,

(vi) in sub-paragraph (e), omit “(or where A is a body corporate, any director or superintendent of A)”,

(vii) in sub-paragraph (f)—

(aa) omit “(or where A is a body corporate, by A or any director or superintendent of A)”, and

(bb) for “A from the pharmaceutical list if A” substitute “the person from the pharmaceutical list if the person”,

(viii) in sub-paragraph (g)—

(aa) omit “(or where A is a body corporate, any director or superintendent of A)”, and

(bb) for “A from the pharmaceutical list if A” substitute “the person from the pharmaceutical list if the person”,

(ix) in sub-paragraph (h)—

(aa) omit “(and where A is a body corporate, any director or superintendent of A)”, and

(bb) for “A from the pharmaceutical list if A” substitute “the person from the pharmaceutical list if the person”,

(x) in sub-paragraph (i)—

(aa) omit “(and where A is a body corporate, any director or superintendent of A)”, and

(bb) for “A from the pharmaceutical list if A” substitute “the person from the pharmaceutical list if the person”, and

(xi) in sub-paragraph (l)(ii), for “A” substitute “the applicant”.

Amendment of regulation 40 of the principal Regulations

14. In regulation 40 of the principal Regulations (applications for new pharmacy premises in controlled localities: refusals because of preliminary matters), after paragraph (3) insert the following paragraphs—

“ (4) Paragraph (2)(b) does not apply where the NHSCB is satisfied that there are reasonable grounds for believing the person making the refused application was motivated (wholly or partly) by a desire for that application to be refused.

(5) The refusal of an application pursuant to paragraph (2)(b), or regulation 40(2)(b) of the 2012 Regulations (applications for new pharmacy premises in controlled localities: refusals because of preliminary matters), is to be ignored for the purposes of the calculation of a 5 year period pursuant to paragraph (2)(b). ” .

Amendment of regulation 64 of the principal Regulations

15. In regulation 64 of the principal Regulations (distance selling premises: specific conditions), for paragraph (1) substitute—

“ (1) Paragraph (2) applies where—

(a) an application in respect of distance selling premises is granted under these Regulations; or

(b) an application was granted under the 2005 Regulations or 2012 Regulations in respect of premises which were, for the purposes of the Regulations under which the application was granted, distance selling premises. ” .

Transitional provision in relation to the application of regulation 64(3)(c) of the principal Regulations

16. —(1)Regulation 64(3)(c) of the principal Regulations (distance selling premises: specific conditions) does not apply to distance selling premises—

(a) which before 1st April 2014 were located, otherwise than in breach of the condition set out in regulation 64(3)(c) of the principal Regulations, on the same site or in the same building as the premises of a provider of primary medical services with a patient list; or

(b) where—

(i) before 1st April 2014 an application was granted under the principal Regulations to relocate the retail pharmacy business or appliance contractor business at those premises to the same site or into the same building as the premises of a provider of primary medical services with a patient list, and

(ii) on or after 1st April 2014 that business relocated to that same site or into that same building, and so the premises are distance selling premises of that business.

(2) Expressions used in this regulation which are defined in regulation 2 of the principal Regulations (interpretation) have the meanings given in that regulation.

Amendment of Schedule 2 to the principal Regulations

17. In Schedule 2 to the principal Regulations (applications in respect of pharmaceutical lists and procedures to be followed)—

(a) in paragraph 7 (additional information to be included with routine applications), in sub-paragraph (1)(b), for “Trust,” substitute “Trust),”;

(b) in the heading of paragraph 13 (which relates to the functions of the NHSCB in relation to fitness information relevant to applications, where it already holds fitness information that may be relevant to future applications), for “applications from bodies corporate” substitute “applications: aggregation of information”;

(c) in paragraph 31 (conditional grant of applications where the address of the premises is unknown), after sub-paragraph (3) insert the following sub-paragraph—

“ (3A) For the purposes of paragraph (3), premises are not within the range of possible locations covered by the estimate referred to in sub-paragraph (1)(b) if the granted application would have been refused pursuant to regulation 31 if the address of those premises had been included in that application instead of the estimate. ” ; and

(d) in paragraph 32 (changes to the premises specified in an application after its grant but before the listing of the premises), after sub-paragraph (3) insert the following sub-paragraph—

“ (3A) A notification under sub-paragraph (2) is not valid if the granted application would have been refused pursuant to regulation 31 if the address of those premises had been included in that application instead of the address mentioned in sub-paragraph (1)(b). ” .

Amendment of Schedule 4 to the principal Regulations

18. In Schedule 4 to the principal Regulations (terms of service of NHS pharmacists), in paragraph 12(5)(b) (additional requirements in relation to specified appliances), for from “the telephone number” to “on line” substitute “telephone or website contact details for providers of NHS services that may be consulted for advice regarding specified appliances during those periods”.

Amendment of Schedule 5 to the principal Regulations

19. In Schedule 5 to the principal Regulations (terms of service of NHS appliance contractors), in paragraph 11(5)(b) (additional requirements in relation to specified appliances), for from “the telephone number” to “on line” substitute “telephone or website contact details for providers of NHS services that may be consulted for advice regarding specified appliances during those periods”.

Amendment of Schedule 9 to the principal Regulations

20. In Schedule 9 to the principal Regulations (transitional provisions), in paragraph 11 (giving effect to listing decisions: pharmaceutical lists and dispensing doctor lists)—

(a) in sub-paragraph (1)(a), for “in pharmaceutical” substitute “in a pharmaceutical”; and

(b) in sub-paragraph (2)(a), for “in pharmaceutical” substitute “in a pharmaceutical”.