Citation, commencement, extent and application

1.—(1) These Regulations may be cited as the National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2024.

(2) These Regulations come into force on 1st September 2024.

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

Amendment of regulation 91A of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013

2.—(1) Regulation 91A of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013( 3) (zero or nominal product reimbursement for coronavirus vaccines and antivirals) is amended as follows.

(2) In its heading, omit “coronavirus”.

(3) In paragraph (2)—

(a) in sub-paragraph (a), omit “(“a coronavirus vaccine”)”;

(b) omit “or” at the end of sub-paragraph (a); and

(c) after sub-paragraph (a) insert—

“(aa) a drug or medicine which is used for vaccinating or immunising people against respiratory syncytial virus, if the conditions set out in paragraph (3) are satisfied;

(ab) a drug or medicine which is used for vaccinating or immunising people against measles, mumps and rubella, if the conditions set out in paragraph (3) are satisfied; or ”.

(4) In paragraph (3)—

(a) in sub-paragraphs (a) to (c), for “coronavirus” substitute “the”at each place where it occurs (three times); and

(b) in sub-paragraph (d), omit “coronavirus”.

(5) After paragraph (3), insert—

“(3A)  The references in paragraph (3) to vaccines or the vaccine in question are references to the drugs or medicines in respect of which the conditions set out in paragraph (3) are to be satisfied by virtue of paragraph (2)(a) to (ab). ”.

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (“ the PLPS Regulations”). The PLPS Regulations govern the arrangements in England, under Part 7 of the National Health Service Act 2006 (“ the 2006 Act”), for the provision of NHS pharmaceutical and local pharmaceutical services.

The scheme for paying for NHS pharmaceutical and local pharmaceutical services is predicated on the basis that pharmaceutical remuneration that relates to prescription items will ordinarily include an amount which is in respect of (but ordinarily slightly more than) the price that a service provider paid when they purchased a prescription item that they go on to supply or administer. However, there are powers in Part 7 of the 2006 Act to enable alternatives to these ordinary remuneration arrangements in some circumstances. Regulation 2 amends the alternative arrangements that already allow a zero or nominal NHS reimbursement price to be set for centrally purchased coronavirus vaccines so that they also apply to centrally purchased respiratory syncytial virus vaccines and centrally purchased measles, mumps and rubella vaccines.

An assessment of the effect of this instrument was undertaken and it was deemed that a full impact assessment would not be proportionate. These Regulations are expected to have no or no significant impact on the public and voluntary sectors, and only a limited impact on the private sector, below the threshold for undertaking a full impact assessment.