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

• (1) For the purposes of these Regulations, an appliance is listed in a Drug Tariff if the appliance is listed—

• (a) in Part IX of the Drug Tariff (England) for the given month,

• (b) in Part IX of the Drug Tariff (Wales) for the given month,

• (c) in Part II, VI or IX of the Drug Tariff (Scotland) for the given month, or

• (d) in Part III of the Drug Tariff (Northern Ireland) for the given month.

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—excluding value added taxes, andafter the deduction of—all discounts and payments, andthe value of all payments or benefits in kind,given in connection with the supply of those products;

• “pharmaceutical services remuneration”—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;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;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;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.

SCHEDULE 3 — Calculation of daily penalty

Interpretation of Schedule 3

1

• (1) In this Schedule, “net NHS sales income”, “qualifying Health Service chemist” and “qualifying NHS hospital purchaser” have the meanings given in paragraph 2 of Schedule 2.

• (2) In this Schedule, “relevant financial year”

• (a) in relation to a UK producer who is liable to pay a penalty under regulation 32(4) for failing to comply with a compliance notice relating to an original request under regulation 23, means the producer's last complete financial year ending before the day on which the producer was given the original request;

• (b) in relation to a UK producer who is liable to pay a penalty under regulation 32(4) for any other reason, means the last complete financial year ending before the day on which the producer is given the penalty demand.

Daily penalty payable by UK producers who are small producers

2

The daily penalty payable by a UK producer who is a small producer is—

• (a) £250 per day for—

• (i) the day on which the contravention occurs, and

• (ii) each of the next following 13 days on which the contravention continues;

• (b) £500 per day for the fifteenth day and each subsequent day on which the contravention continues.

Daily penalty payable by UK producers who are not small producers

3

• (1) The daily penalty payable by a UK producer who is not a small producer is—

• (a) the column 2 amount per day for—

• (i) the day on which the contravention occurs, and

• (ii) each of the next following 13 days on which the contravention continues;

• (b) the column 3 amount per day for the fifteenth and each subsequent day on which the contravention continues.

• (2) In this paragraph—

• “column 2 amount”, in relation to a producer, means the amount specified in column 2 of the Table which corresponds to the relevant financial threshold;

• “column 3 amount”, in relation to a producer, means the amount specified in column 3 of the Table which corresponds to the relevant financial threshold;

• “relevant financial threshold”, in relation to a producer, means the financial threshold specified in column 1 of the Table into which the producer's relevant income falls.

• (3) For the purposes of this paragraph, a producer's relevant income is—

• (a) the producer's net NHS wholesale income in the relevant financial year, if—

• (i) the producer is a primary medical services provider,

• (ii) the producer is a Health Service chemist and—

• (aa) is also a medicines wholesaler or a medical supplies wholesaler, and

• (bb) in the relevant financial year, is paid pharmaceutical services remuneration of an amount less than the producer's net NHS wholesale income in that year, or

• (iii) the producer is an NHS hospital purchaser and—

• (aa) is also a medicines wholesaler or a medical supplies wholesaler, and

• (bb) in the relevant financial year, has net NHS expenditure of an amount less than the producer's net NHS wholesale income;

• (b) the producer's pharmaceutical services remuneration in the relevant financial year, if the producer is a Health Service chemist and either—

• (i) is not a medicines wholesaler or a medical supplies wholesaler, or

• (ii) is a medicines wholesaler or a medical supplies wholesaler with net NHS wholesale income in the relevant financial year which is equal to or less than the amount the producer is paid as pharmaceutical service remuneration in that year;

• (c) the producer's net NHS expenditure in the relevant financial year, if the producer is an NHS hospital purchaser and either—

• (i) is not a medicines wholesaler or a medical supplies wholesaler, or

• (ii) is a medicines wholesaler or a medical supplies wholesaler with net NHS wholesale income in the relevant financial year which is equal to or less than the producer's net NHS expenditure in that year;

• (d) the producer's net NHS sales income in the relevant financial year, if the producer is not a UK primary medical services provider, a UK NHS chemist or an NHS hospital purchaser.

• (4) But where the Secretary of State cannot reasonably determine a producer's net NHS sales income for the relevant financial year, the producer's relevant income for that year is the producer's total UK sales for that year.

• (5) For the purposes of sub-paragraph (4), a producer's total UK sales are the total sales in the United Kingdom as shown in—

• (a) the producer's statutory audited accounts for the relevant financial year, or

• (b) if the producer does not have those accounts, the producer's individual accounts for the most recent complete financial year.

• (6) In this paragraph—

• “individual accounts” means accounts prepared in accordance with section 394 of the Companies Act 2006;

• “statutory audited accounts”—in relation to a producer whose individual accounts are required to be audited in accordance with Part 16 of the Companies Act 2006, means the producer's individual accounts audited in accordance with that Part;in relation to a producer whose individual accounts are exempt under section 477 of the Companies Act 2006 from audit under Part 16 of that Act, means the producer's individual accounts;in relation to a producer whose accounts individual accounts are exempt under section 479A of the Companies Act 2006 from audit under Part 16 of that Act, means the consolidated accounts of the parent undertaking on the same group as the producer (see section 479A(2)(a) of that Act).Column 1 – financial thresholdColumn 2 – daily penalty: first 14 daysColumn 3 – daily penalty: fifteenth and subsequent daysmore than £5,000,000 but less than £20,000,000£500£1,000£20,000,000 or more but less than £50,000,000£1,000£2,000£50,000,000 or more but less than £100,000,000£2,500£5,000£100,000,000 or more£5,000£10,000

SCHEDULE 4 — Disclosure of information under section 246B of the 2006 Act: prescribed bodies and prescribed purposes

1

• (1) The bodies specified in column 1 of Table 1, being bodies appearing to the Secretary of State to represent UK producers, are prescribed for the purposes of section 264B(1)(k) of the 2006 Act.

• (2) The purpose for which a body specified in column 1 of Table 1 may use confidential or commercially sensitive information disclosed to it under section 264B(1) of the 2006 Act is the purpose prescribed in the corresponding entry in column 2 of that Table.

Column 1 – Bodies	Column 2 – The purpose for which information disclosed under section 264B(1) of the 2006 Act may be used
Association of British Healthcare Industries;Association of Pharmaceutical Specials Manufacturers;British Association of European Pharmaceutical Distributors;British Generic Manufacturers Association;British Healthcare Trades Association;British In Vitro Diagnostics Association;Healthcare Distribution Association;NHS Pharmacy Production Committee;NHS Pharmaceutical Quality Assurance;Proprietary Association of Great Britain;Surgical Dressings Manufacturers Association Committee;Urology Trade Association.	The purpose is that of exercising functions connected with any of the matters specified in section 264A(3)(a) to (l).
Association of Independent Multiple Pharmacies;Company Chemists' Association;National Pharmacy Association.	The purpose is that of exercising functions connected with any of the matters specified in section 264A(3)(a) to (k).
BioIndustry Association;Ethical Medicines Industry Group.	The purpose is that of exercising functions connected with any of the matters specified in section 264A(3)(c), (e), (g), (i), (l) and (m).
Association of the British Pharmaceutical Industry	The purpose is that of exercising functions connected with any of the matters specified in section 264A(3)(c), (e), (g), (i) and (k) to (m).
British Medical Association;Dispensing Doctor's Association.	The purpose is that of exercising functions connected with any of the matters specified in section 264A(3)(a), (c), (d), (f), (g) and (i) to (k).
Pharmaceutical Services Negotiating Committee	The purpose is that of exercising functions connected with any of the matters specified in section 264A(3)(b) and (c).

2

• (1) The bodies specified in column 1 of Table 2 are prescribed for the purposes of section 264B(1)(l) of the 2006 Act.

• (2) The purpose for which a body specified in column 1 of Table 2 may use confidential or commercially sensitive information disclosed to it under section 264B(1) of the 2006 Act is the purpose prescribed in the corresponding entry in column 2 of that Table.

Column 1 – Bodies	Column 2 – Purpose for which information disclosed under section 264B(1) of the 2006 Act may be used
Any NHS foundation trust;Any NHS trust established under the 2006 Act;Any integrated care board.	The purpose is that of exercising functions connected with any of the matters specified in section 264A(3)(c).
Any NHS trust established under the 2006 Wales Act;Any Local Health Board.	The purpose is that of exercising functions connected with any of the matters specified in section 264A(3)(f).
Any Health Board constituted under section 2 of the 1978 Act	The purpose is that of exercising functions connected with any of the matters specified in section 264A(3)(i).
The Regional Health and Social Care Board established under section 7 of the Health and Social Care (Reform) Act Northern Ireland 2009	The purpose is that of exercising functions connected with any of the matters specified in section 264A(3)(k).

SCHEDULE 5 — Information about supply of unbranded generic health service medicines or special health service medicines: transitional provisions

General

1

This Schedule makes transitional provision in relation to—

• (a) the recording, keeping and provision of information about the supply of unbranded generic health service medicines by members of Scheme M and Scheme W (see paragraphs 2 and 3), and

• (b) the recording, keeping and provision of information about the supply of special health service medicines by members of the Specials MoU (see paragraphs 4 and 5).

Transitional provision: information about supply of unbranded generic health service medicines

2

• (1) A Scheme member is not required to comply—

• (a) with regulation 7 or 8 in any month which falls within a transitional quarter, or

• (b) with regulation 9 in respect of any transitional quarter.

• (2) But this paragraph is subject to paragraph 3.

• (3) In this paragraph and paragraph 3—

• “Scheme end date” means—in the case of a member of Scheme M, the day on which Scheme M ceases to operate following notice of termination being given by the Secretary of State in accordance with that Scheme;in the case of a member of Scheme W, the day on which Scheme W ceases to operate following notice of termination being given by the Secretary of State in accordance with that Scheme;

• “Scheme member” means a UK producer who, immediately before 1st July 2018, is a member of Scheme M or Scheme W;

• “transitional quarter” means a quarterly period (as determined in accordance with regulation 9(2)) which—begins on or after 1st July 2018, butbefore the Scheme end date.

• (4) For the purposes of this paragraph, it does not matter whether the Secretary of State gives notice of termination in accordance with Scheme M or Scheme W before, on or after 1st July 2018.

Circumstances in which transitional provision in paragraph 2 ceases to apply

3

• (1) This paragraph applies to a Scheme member—

• (a) who does not provide the Scheme information to the Secretary of State for a Scheme quarter within the submission period, or

• (b) who, before the Scheme end date, ceases to be a member of the Scheme.

Such a member is referred to in this paragraph as an “exiting member”.

• (2) An exiting member must comply with regulation 7 or 8 (or both, as the case may be) on and after the exit date.

• (3) An exiting member must also comply with regulation 9 in respect of each transitional quarter which begins on or after the exit date.

• (4) In addition, where the exit date falls during a transitional quarter, the exiting member must comply with regulation 9 in respect of the remaining part of that quarter.

• (5) In this regulation—

• “exit date”—in relation to an exiting member to whom sub-paragraph (1)(a) applies, means the day after the day on which the submission period ends;in relation to an exiting member to whom sub-paragraph (1)(b) applies, means the day on which the member ceases to be a member of the Scheme;

• “Scheme information” means—in the case of a member of Scheme M, the information which the member is required under Scheme M to provide to the Secretary of State for each Scheme quarter;in the case of a member of Scheme W, the information which the member is required under Scheme W to provide to the Secretary of State for each Scheme quarter;

• “Scheme quarter”—in the case of a member of Scheme M, means a quarterly period—which is specified in that Scheme as a period for which Scheme information is to be provided, andfor which the submission period ends after 1st July 2018;in the case of a member of Scheme W, means a quarterly period—which is specified in that Scheme as a period for which Scheme information is to be provided, andfor which the submission period ends after 1st July 2018;

• “submission period” means the period within which Scheme information must be submitted following the end of a Scheme quarter.

Transitional provision: information about supply of special health service medicines

4

• (1) A Specials MoU member is not required to comply—

• (a) with regulation 11, 12 or 13 in any month which falls within a transitional quarter, or

• (b) with regulation 14 in respect of any transitional quarter.

• (2) But this paragraph is subject to paragraph 5.

• (3) In this paragraph and paragraph 5—

• “Specials MoU end date” means the day on which the Specials MoU ceases to operate following notice of termination being given by the Secretary of State in accordance with the MoU;

• “Specials MoU member” means a UK producer who, immediately before 1st August 2018, is a participating manufacturer for the purposes of the Specials MoU;

• “transitional quarter” means a quarterly period (determined in accordance with regulation 14(2)) which begins—on or after 1st August 2018, butbefore the day on which the Specials MoU end date.

• (4) For the purposes of this paragraph, it does not matter whether the Secretary of State gives notice of termination in accordance with the Specials MoU before, on or after 1st August 2018.

Circumstances in which transitional provision in paragraph 4 ceases to apply

5

• (1) This regulation applies to a Specials MoU member—

• (a) who does not provide the specials information to the Secretary of State for an MoU quarter within the submission period; or

• (b) who, before the Specials MoU end date, ceases to be a Specials MoU member.

Such a member is referred to in this paragraph as an “exiting member”.

• (2) An exiting member must comply with regulations 11, 12 and 13 on and after the exit date.

• (3) An exiting member must comply with regulation 14 in respect of each transitional quarter which begins on or after the exit date.

• (4) In addition, where the exit date falls during a transitional quarter, the exiting member must comply with regulation 14 in respect of the remaining part of that quarter.

• (5) In this regulation—

• “exit date”—in relation to an exiting member to whom sub-paragraph (1)(a) applies, means the day after the day on which the submission period ends;in relation to an exiting member to whom sub-paragraph (1)(b) applies, means the day on which the member ceases to be a member;

• “MoU quarter” means a quarterly period—which is specified in the Specials MoU as a period for which specials information is to be provided, andfor which the submission period ends after 1st August 2018;

• “specials information” means the information which a Specials MoU member is required under the Specials MoU to provide to the Secretary of State in respect of each MoU quarter;

• “submission period” means the period within which the specials information must be provided to the Secretary of State following the end of the relevant MoU quarter.

Signed

Signed by the authority of the Secretary of State for Health and Social Care.

O'Shaughnessy — Parliamentary Under-Secretary of State, — 2018-06-05

Explanatory note

(This note is not part of the Regulations)

Part 1 of the RegulationsPart 1 of the Regulations deals with citation and commencement of the Regulations (regulation 1), their application (regulation 3), exceptions (regulation 4) and presumptions which will apply if information is provided to the Secretary of State via an online gateway.

Part 2 of the RegulationsPart 2 of the Regulations deals with routine provision of information about the supply of unbranded generic health service medicines. “Unbranded generic health service medicine” is defined in regulation 6.

Part 3 of the RegulationsPart 3 of the Regulations deals with routine provision of information about the supply of made and imported special health service medicines. “Made special health service medicine” and “imported special health service medicine” are defined in regulation 10.

Part 4 of the RegulationsPart 4 of the Regulations deals with the provision on request of general information about the supply of UK health service products. The key terms used in this Part are defined in regulation 15.

Part 5 of the RegulationsPart 5 of the Regulations deals with the provision of information about costs incurred by UK producers in connection with the manufacturing, distribution or supply of UK health service products.

Part 6 of the RegulationsPart 6 of the Regulations deals with the provision of information about the price and availability of health service medicines.

Part 7 of the RegulationsInformation that UK producers are required to provide under the Regulations may, in certain cases, be provided in the form of a reasonable estimate, rather than an actual amount. Where a producer provides information on the basis of such an estimate, regulation 30 allows the Secretary of State to require the producer to explain why an estimate has been used and also the method used to calculate that estimate.

Part 8 of the RegulationsPart 8 of the Regulations deals with enforcement and appeals.

Part 9 of the RegulationsRegulation 34 and Schedule 4 prescribe bodies for the purposes of section 264B(1)(k) and (l) of the 2006 Act. Those provisions also prescribe, in accordance with section 264B(3)(g) of the 2006 Act, the purpose for which those bodies may use any confidential or commercially sensitive information disclosed to them under section 264B of the 2006 Act.

Part 10 of the RegulationsRegulation 35 and Schedule 5 make transitional provision.

Footnotes

Editorial notes