The Health Service Products (Provision and Disclosure of Information) Regulations 2018

Regulations 24, 31 and 32

SCHEDULE 2 Small producers

General

1.  This Schedule sets out the rules for determining whether a UK producer is a small producer for the purposes of regulation 24, 31 or 32.

Interpretation of Schedule 2

2.—(1) In this Schedule—

“net NHS sales income”, in relation to a producer, means the producer’s total income (in pounds sterling) from the supply of UK health service products—

(a)

excluding value added taxes, and

(b)

after the deduction of—

(i)

all discounts and payments, and

(ii)

the value of all payments or benefits in kind,

given in connection with the supply of those products;

“pharmaceutical services remuneration”—

(a)

in relation to a Health Service chemist who is an English NHS chemist, means remuneration for the provision of pharmaceutical or local pharmaceutical services under Part 7 of the 2006 Act;

(b)

in relation to a Health Service chemist who is a Welsh NHS chemist, means remuneration for the provision of pharmaceutical services under Part 7 of the 2006 Wales Act;

(c)

in relation to a Health Service chemist who is a Scottish NHS chemist, means remuneration for the provision of pharmaceutical care services under section 2CA(1) of the 1978 Act;

(d)

in relation to a Health Service chemist who a Northern Ireland HS chemist, means remuneration for the provision of pharmaceutical services under Part 2 or 6 of the 1972 Order;

“qualifying Health service chemist” means a Health Service chemist who, in the relevant financial year, is paid pharmaceutical services remuneration of £5 million or less;

“qualifying NHS hospital purchaser” means a NHS hospital purchaser who, in the relevant financial year, has net NHS expenditure of £5 million or less.

(2) For the purposes of this Schedule, “the relevant financial year”—

(a) in relation to a UK producer who receives a request under regulation 23, means the producer’s last complete financial year ending before the day on which the producer is given the request;

(b) in relation to a UK producer who—

(i) is given a compliance notice relating to an original request given under regulation 23, or

(ii) is liable to pay a penalty under regulation 32(4) for failing to comply with such a notice,

means the producer’s last complete financial year ending before the day on which the producer was given the original request under regulation 23;

(c) in relation to a UK producer who is liable to pay a penalty under regulation 32(4)—

(i) for failing to comply with regulation 25(4), or

(ii) in connection with a compliance notice other than one mentioned in paragraph (b)(i),

means the last complete financial year ending before the day on which the producer becomes liable to pay the penalty.

UK primary medical providers who are small producers

3.  A UK producer who is a UK primary medical services provider is a small producer if—

(a) the producer is not also a medicines wholesaler or a medical supplies wholesaler, or

(b) the producer—

(i) is a medicines wholesaler or a medical supplies wholesaler, but

(ii) in the relevant financial year, has net NHS wholesale income of £5 million or less.

Health Service chemists who are small producers

4.  A UK producer who is a qualifying Health Service chemist is a small producer if—

(a) the producer is not also a medicines wholesaler or a medical supplies wholesaler, or

(b) the producer—

(i) is a medicines wholesaler or a medical supplies wholesaler, but

(ii) in the relevant financial year, has net NHS wholesale income of £5 million or less.

NHS hospital purchasers who are small producers

5.  A UK producer who is a qualifying NHS hospital purchaser is a small producer if—

(a) the producer is not also a medicines wholesaler or a medical supplies wholesaler, or

(b) the producer—

(i) is a medicines wholesaler or a medical supplies wholesaler, but

(ii) in the relevant financial year, has net NHS wholesale income of £5 million or less.

Other UK producers who are small producers

6.—(1) A UK producer who is not a UK primary medical services provider, a Health Service chemist or an NHS hospital purchaser is a small producer if—

(a) the producer has net NHS sales income of £5 million or less in the relevant financial year,

(b) the producer receives—

(i) a request under regulation 23 during the producer’s first accounting reference period, or

(ii) a compliance notice in connection with such a request, or

(c) the producer becomes liable to pay a penalty under regulation 32(4) during the producer’s first accounting reference period.

(2) In this paragraph, “accounting reference period” had the meaning given in section 391 of the Companies Act 2006.