Citation, commencement, application and interpretation

1. —(1) These Regulations may be cited as the National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021.

(2) These Regulations come into force on 1st March 2021.

(3) These Regulations extend to England and Wales and apply in relation to England only( 2 ).

(4) In these Regulations, “the PLPS Regulations” means the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013( 3 ).

Amendment of regulation 2 of the PLPS Regulations

2. In regulation 2(1) of the PLPS Regulations( 4 ) (interpretation), at the appropriate place insert—

“ “prescription item” means an item available on prescription, whether or not it is supplied in pursuance of a prescription or another basis for supply (for example a serious shortage protocol or a patient group direction); ” ; and

“ “PTPGD” means a pandemic treatment patient group direction, which is a patient group direction—

Amendment of Schedule 4 to the PLPS Regulations

3. —(1) Part 2 of Schedule 4 to the PLPS Regulations (terms of service of NHS pharmacists – essential services) is amended as follows.

(2) In paragraph 5B( 6 ) (supply in accordance with a PTP)—

(a) in sub-paragraph (1)(a), after “a PTP” insert “or a PTPGD”;

(b) after sub-paragraph (1) insert—

“ (1A) Where P considers—

(a) on the basis of a request for the supply of a drug in accordance with a PTP or a PTPGD that has been approved by the NHSCB as a basis for supply as part of pharmaceutical services;

(b) having made the appropriate checks; and

(c) having regard to what is reasonable and appropriate,

that a person is entitled to be supplied with the drug in accordance with the PTP or PTPGD as part of pharmaceutical services, P must, with reasonable promptness, provide the drug requested. ” ; and

(c) in sub-paragraph (2), after “sub-paragraph (1)(b)” insert “or (1A)”,

and in the heading of that paragraph, after “a PTP” insert “or a PTPGD”.

(3) In paragraph 8( 7 ) (providing ordered drugs or appliances)—

(a) in sub-paragraph (17), after “a PTP” insert “or a PTPGD”; and

(b) in sub-paragraph (18)—

(i) after “a PTP” insert “or a PTPGD”, and

(ii) after “particular PTP” insert “or PTPGD”.

(4) In paragraph 9( 8 ) (refusal to provide drugs or appliances ordered)—

(a) in sub-paragraph (5)—

(i) for “provide an order” substitute “fulfil an order or a request”,

(ii) after “a PTP” insert “or a PTPGD”, and

(iii) in paragraph (a), after “genuine order” insert “or valid request”; and

(b) in sub-paragraph (6)—

(i) after “a PTP” insert “or a PTPGD”,

(ii) after “an order” insert “or a request”,

(iii) after “with the PTP”, at both places, insert “or PTPGD”.

(5) After paragraph 22A( 9 ) (home delivery service while a disease is or in anticipation of a disease being imminently pandemic etc.) insert—

“ Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc.

22AA. —(1) Before dispensing a notified item on a prescription form or supplying it in accordance with a serious shortage protocol, a PTP or a PTPGD, an NHS pharmacist (P) must provide a home delivery option to eligible patients in respect of that item.

(2) For the purposes of this paragraph, a “notified item” is an item that, as a consequence of a disease being or in anticipation of a disease being imminently—

(a) pandemic; and

(b) a serious risk or potentially a serious risk to human health,

is the subject of an announcement made by the NHSCB, with the agreement of the Secretary of State, to the effect that, in order to assist in the management of the serious risk or potentially serious risk to human health, eligible patients are entitled to be provided with a home delivery option in respect of that item, if it is supplied to them as part of pharmaceutical services.

(3) Where P is to, or may be required to, dispense a notified item on a prescription form or supply it in accordance with a serious shortage protocol, a PTP or a PTPGD, P must ascertain from—

(a) an eligible patient—

(i) who has contacted P about the home delivery of a notified item, or

(ii) who is a person whom P considered, on the basis of an order or request for a notifiable item, might be an eligible person and accordingly, in the ordinary exercise of professional skill and judgement, made the appropriate checks and determined that they were; or

(b) a person who may make an application for pharmaceutical services on behalf of that eligible patient (a “duly authorised person”) who has contacted P about the home delivery of a notified item,

whether or not the item could be supplied via a duly authorised person, and if it could, then supplying the item via a duly authorised person is the home delivery option which P must provide.

(4) Where paragraph (3) does not apply, the home delivery option that P must provide must comprise—

(a) P delivering the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person (for example, a care home where the patient is temporarily residing);

(b) P arranging for an item dispensed by P to be delivered by another NHS pharmacist or by an LPS contractor to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person; or

(c) if P is unable to deliver the item or arrange for its delivery by another NHS pharmacist or by an LPS contractor, P arranging for the dispensing or supply of the item by another NHS pharmacist or by an LPS contractor who would be able to deliver the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person.

(5) Paragraph (1) does not apply where the eligible patient or a duly authorised person is already at P’s pharmacy premises for the purposes of being supplied with the notifiable item.

(6) Notwithstanding the foregoing provisions of this Part, in any case of a supply in accordance with a home delivery option, if but for this sub-paragraph that supply would need to be made with reasonable promptness, P may instead, in the exercise of professional skill and judgment, make the supply within a reasonable timescale.

(7) Where arrangements are in place which enable an NHS pharmacist to make a delivery as mentioned in sub-paragraph (4)(a) or (b) as part of a directed service, the NHS pharmacist must deliver the item as part of that directed service.

(8) This paragraph does not apply to an NHS pharmacist in respect of distance selling premises. ” .

Amendment of Schedule 6 to the PLPS Regulations

4. —(1) Schedule 6 to the PLPS Regulations (terms of service of dispensing doctors) is amended as follows.

(2) In paragraph 3B( 10 ) (supply in accordance with a PTP)—

(a) in sub-paragraph (1)(a), after “a PTP” insert “or a PTPGD”;

(b) after sub-paragraph (1) insert—

“ (1A) Where D considers—

(a) on the basis of a request for the supply of a drug in accordance with a PTP or a PTPGD that has been approved by the NHSCB as a basis for supply as part of pharmaceutical services;

(b) having made the appropriate checks; and

(c) having regard to what is reasonable and appropriate,

that a person is entitled to be supplied with the drug in accordance with the PTP or PTPGD as part of pharmaceutical services, D must, with reasonable promptness, provide the drug requested. ” ; and

(c) in sub-paragraph (3)—

(i) after “sub-paragraph (1)” insert “or (1A)”,

(ii) after “a PTP” insert “or a PTPGD”, and

(iii) after “particular PTP” insert “or PTPGD”,

and in the heading of that paragraph, after “a PTP” insert “or a PTPGD”.

(3) In paragraph 6( 11 ) (refusal to provide drugs or appliances ordered)—

(a) in sub-paragraph (5)—

(i) for “provide an order” substitute “fulfil an order or a request”,

(ii) after “a PTP” insert “or a PTPGD”, and

(iii) in paragraph (a), after “genuine order” insert “or valid request”; and

(b) in sub-paragraph (6)—

(i) after “a PTP” insert “or a PTPGD”,

(ii) after “an order” insert “or a request”,

(iii) after “with the PTP”, at both places, insert “or PTPGD”.

(4) After paragraph 7A( 12 ) (home delivery service while a disease is or in anticipation of a disease being imminently pandemic etc.) insert—

“ Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc.

7AA. —(1) Before dispensing a notified item on a prescription form or supplying it in accordance with a serious shortage protocol, a PTP or a PTPGD, a dispensing doctor (D) must provide a home delivery option to eligible patients in respect of that item.

(2) For the purposes of this paragraph, a “notified item” is an item that, as a consequence of a disease being or in anticipation of a disease being imminently—

(a) pandemic; and

(b) a serious risk or potentially a serious risk to human health,

is the subject of an announcement made by the NHSCB, with the agreement of the Secretary of State, to the effect that, in order to assist in the management of the serious risk or potentially serious risk to human health, eligible patients are entitled to be provided with a home delivery option in respect of that item, if it is supplied to them as part of pharmaceutical services.

(3) Where D is to, or may be required to, dispense a notified item on a prescription form or supply it in accordance with a serious shortage protocol, a PTP or a PTPGD, D must ascertain from—

(a) an eligible patient—

(i) who has contacted D about the home delivery of a notified item, or

(ii) who is a person whom D considered, on the basis of an order or request for a notifiable item, might be an eligible person and accordingly, in the ordinary exercise of professional skill and judgement, made the appropriate checks and determined that they were; or

(b) a person who may make an application for pharmaceutical services on behalf of that eligible patient (a “duly authorised person”) who has contacted D about the home delivery of a notified item,

whether or not the item could be supplied via a duly authorised person, and if it could, then supplying the item via a duly authorised person is the home delivery option which D must provide.

(4) Where paragraph (3) does not apply, the home delivery option that D must provide must comprise—

(a) D delivering the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person (for example, a care home where the patient is temporarily residing);

(b) D arranging for an item dispensed by D to be delivered by another dispensing doctor, or by an NHS pharmacist or an LPS contractor, to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person; or

(c) if D is unable to deliver the item or arrange for its delivery by another dispensing doctor, or by an NHS pharmacist or an LPS contractor, D arranging for the dispensing or supply of the item by another dispensing doctor, or by an NHS pharmacist or an LPS contractor, who would be able to deliver the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person.

(5) Paragraph (1) does not apply where the eligible patient or a duly authorised person is already at D’s listed dispensing premises for the purposes of being supplied with the notifiable item.

(6) Notwithstanding the foregoing provisions of this Schedule, in any case of a supply in accordance with a home delivery option, if but for this sub-paragraph that supply would need to be made with reasonable promptness, D may instead, in the exercise of professional skill and judgment, make the supply within a reasonable timescale. ” .

Amendment of Schedule 7 to the PLPS Regulations

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

(2) In paragraph 10A( 13 ) (home delivery service while a disease is or in anticipation of a disease being imminently pandemic etc.), in sub-paragraph (4), for “listed dispensing” substitute “chemist”.

(3) After paragraph 10A, insert—

“ Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc.

10AA. —(1) Before dispensing a notified item on a prescription form or supplying it in accordance with a serious shortage protocol, an LPS contractor (C) must provide a home delivery option to eligible patients in respect of that item.

(2) For the purposes of this paragraph, a “notified item” is an item that, as a consequence of a disease being or in anticipation of a disease being imminently—

(a) pandemic; and

(b) a serious risk or potentially a serious risk to human health,

is the subject of an announcement made by the NHSCB, with the agreement of the Secretary of State, to the effect that, in order to assist in the management of the serious risk or potentially serious risk to human health, eligible patients are entitled to be provided with a home delivery option in respect of that item, if it is supplied to them as part of local pharmaceutical services.

(3) Where C is to, or may be required to, dispense a notified item on a prescription form or supply it in accordance with a serious shortage protocol, C must ascertain from—

(a) an eligible patient—

(i) who has contacted C about the home delivery of a notified item, or

(ii) who is a person whom C considered, on the basis of an order or request for a notifiable item, might be an eligible person and accordingly, in the ordinary exercise of professional skill and judgement, made the appropriate checks and determined that they were; or

(b) a person who may make an application for pharmaceutical services on behalf of that eligible patient (a “duly authorised person”) who has contacted C about the home delivery of a notified item,

whether or not the item could be supplied via a duly authorised person, and if it could, then supplying the item via a duly authorised person is the home delivery option which C must provide.

(4) Where paragraph (3) does not apply, the home delivery option that C must provide must comprise—

(a) C delivering the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person (for example, a care home where the patient is temporarily residing);

(b) C arranging for an item dispensed by C to be delivered by another LPS contractor or by an NHS pharmacist to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person; or

(c) if C is unable to deliver the item or arrange for its delivery by another LPS contractor or by an NHS pharmacist, C arranging for the dispensing or supply of the item by another LPS contractor or by an NHS pharmacist who would be able to deliver the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person.

(5) Paragraph (1) does not apply where the eligible patient or a duly authorised person is already at C’s chemist premises for the purposes of being supplied with the notifiable item.

(6) Notwithstanding the foregoing provisions of this Schedule, in any case of a supply in accordance with a home delivery option, if but for this sub-paragraph that supply would need to be made with reasonable promptness, C may instead, in the exercise of professional skill and judgment, make the supply within a reasonable timescale. ” .

Amendment of the National Health Service (Charges for Drugs and Appliances) Regulations 2015

6. —(1)The National Health Service (Charges for Drugs and Appliances) Regulations 2015( 14 ) are amended as follows.

(2) In regulation 2( 15 ) (interpretation), in paragraph (1), at the appropriate place insert—

“ “prescription item” means an item available on prescription, whether or not it is supplied in pursuance of a prescription or another basis for supply (for example a serious shortage protocol or a patient group direction); ” .

(3) In regulation 13 (exemption from charges: risks to public health)—

(a) in paragraph (1), for “drugs”, at each place where it occurs, substitute “prescription items”;

(b) in paragraph (1)(b), for “protocols” substitute “a prescription form, a patient group direction, a serious shortage protocol or a protocol”; and

(c) in paragraph (2), for “drug”, at each place where it occurs, substitute “prescription item”.