Citation, commencement and interpretation

1. —(1) These Regulations may be cited as the National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2016 and—

(a) apart from regulations 4(2) and 5(2), come into force on 1st April 2016;

(b) regulations 4(2) and 5(2) come into force on 1st July 2016.

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

Amendment of regulation 75 of the principal Regulations

2. —(1)Regulation 75 of the principal Regulations (voluntary and automatic removal of listings: change of ownership, relocation, temporary provision and voluntary closure) is amended as follows.

(2) In paragraph (2)—

(a) in sub-paragraph (a), for “regulation 67(4)(b)” substitute “regulation 67(4)”; and

(b) in sub-paragraph (b)(ii), for regulation 67(4)(a)(ii), substitute “regulation 67(4)”.

Substitution of regulation 121 of the principal Regulations

3. For regulation 121 of the principal Regulations (review of these Regulations) substitute the following—

“ Review of these Regulations

121. —(1) The Secretary of State must, in accordance with paragraphs (2) to (4)—

(a) carry out reviews of these Regulations;

(b) set out the conclusions of each review in a report; and

(c) publish each report.

(2) Each report must in particular—

(a) set out the objectives intended to be achieved by these Regulations;

(b) assess the extent to which those objectives have been achieved;

(c) assess whether those objectives remain appropriate; and

(d) if those objectives remain appropriate, assess the extent to which they could be achieved in another way which involves less onerous regulatory provision.

(3) The first report under this regulation must be published before the end of 31st August 2017.

(4) Each subsequent report must be published before the end of the period of five years beginning on the day on which the previous report was published. ” .

Amendment of Schedule 4 to the principal Regulations

4. —(1) Schedule 4 to the principal Regulations( 3 ) (terms of service of NHS pharmacists) is amended as follows.

(2) In paragraph 7 (preliminary matters before providing ordered drugs or appliances), after sub-paragraph (3) insert the following sub-paragraph—

“ (3A) In any case where no satisfactory evidence, as required by sub-paragraph (3), is produced to P, P must ensure before the drugs or appliances are provided that the person who was asked to produce that evidence is advised, in appropriate terms, that checks are routinely undertaken to ascertain entitlement to—

(a) exemption under the Charges Regulations ( 4 ) ; or

(b) remission of charges under the Remission of Charges Regulations ( 5 ) ,

where such entitlement has been claimed, as part of the arrangements for preventing or detecting fraud or error in relation to such claims. ” .

(3) After paragraph 29 (professional standards), insert the following paragraph—

“ Accessing summary care records

29A. —(1) If an NHS pharmacist (P) is providing pharmaceutical services to or in respect of a patient and has access to the summary information that comprises a summary care record of that patient, P must access that summary information where the conditions in sub-paragraph (2) are satisfied.

(2) The conditions are that—

(a) in P’s clinical judgment it is in the best interests of the patient to do so; and

(b) in doing so P is acting in accordance with the guidance known as “The NHS Care Record Guarantee”, published in the document entitled “The Care Record Guarantee – Our Guarantee for NHS Care Records in England” that was published by the National Information Governance Board for Health and Social Care in January 2011 ( 6 ) .

(3) In this paragraph, a “summary care record” and “summary information” mean a summary care record and summary information within the meanings given in—

(a) regulation 68 of the GMS Regulations ( 7 ) (summary care records); and

(b) regulation 61 of the PMS Regulations ( 8 ) (summary care records). ” .

Amendment of Schedule 7 to the principal Regulations

5. —(1) Schedule 7 to the principal Regulations( 9 ) (mandatory terms for LPS schemes) is amended as follows.

(2) In paragraph 5 (preliminary matters before providing ordered drugs or appliances), after sub-paragraph (3) insert the following sub-paragraph—

“ (3A) In any case where no satisfactory evidence, as required by sub-paragraph (3), is produced to C, C must ensure before the drugs or appliances are provided that the person who was asked to produce that evidence is advised, in appropriate terms, that checks are routinely undertaken to ascertain entitlement to—

(a) exemption under the Charges Regulations ( 10 ) ; or

(b) remission of charges under the Remission of Charges Regulations ( 11 ) ,

where such entitlement has been claimed, as part of the arrangements for preventing or detecting fraud or error in relation to such claims. ” .

(3) After paragraph 13 (professional standards), insert the following paragraph—

“ Accessing summary care records

13A. —(1) If an LPS chemist (C) is providing local pharmaceutical services to or in respect of a patient and has access to the summary information that comprises a summary care record of that patient, C must access that summary information where the conditions in sub-paragraph (2) are satisfied.

(2) The conditions are that—

(a) in C’s clinical judgment or the clinical judgement of a registered pharmacy technician employed or engaged by C, it is in the best interests of the patient to do so; and

(b) in doing so C or the registered pharmacy technician is acting in accordance with the guidance known as “The NHS Care Record Guarantee”, published in the document entitled “The Care Record Guarantee – Our Guarantee for NHS Care Records in England” that was published by the National Information Governance Board for Health and Social Care in January 2011 ( 12 ) .

(3) In this paragraph, a “summary care record” and “summary information” mean a summary care record and summary information within the meanings given in—

(a) regulation 68 of the GMS Regulations ( 13 ) (summary care records); and

(b) regulation 61 of the PMS Regulations ( 14 ) (summary care records). ” .