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

PART 1 Introductory

Citation and commencement

1.—(1) These Regulations may be cited as the Health Service Products (Provision and Disclosure of Information) Regulations 2018.

(2) Subject to paragraphs (3) and (4), these Regulations come into force on 1st July 2018.

(3) Part 3 comes into force on 1st August 2018.

(4) Regulation 29 comes into force on 1st January 2019.

Interpretation: general

2.  These Regulations are to be interpreted in accordance with Schedule 1.

Application

3.  Nothing in these Regulations—

(a) requires a person who provides primary medical services under Part 4 of the 2006 Wales Act, or any person who provides services under Part 7 of that Act, to record, keep or provide information relating to any Welsh health service products(1) which are supplied by the person in providing the services in question;

(b) requires a person who provides primary medical services under section 2C(1) of the 1978 Act, or any person who provides pharmaceutical care services under section 2CA(1) of that Act, to record, keep or provide any information relating to any Scottish health service products(2) which are supplied by the person in providing the services in question;

(c) requires a person who provides primary medical services or pharmaceutical services under Part 2 or 6 of the 1972 Order to record, keep or provide information about Northern Ireland health service products(3) which are supplied by the person in providing the services in question.

Exception: products not known to be health service products

4.  Nothing in these Regulations requires a UK producer(4) to record and keep, or provide, information about a product if the producer could not reasonably have known, at the time the producer purchased or supplied the product, that it was, or was to be, a UK health service product(5).

Information required to be provided via an NHS digital online gateway

5.—(1) This regulation applies where a question arises as to whether any information required to be provided by, or under, these Regulations electronically via an NHS Digital online gateway has been so provided.

(2) For the purposes of these Regulations, it is to be presumed—

(a) that the relevant information has been successfully provided electronically via the relevant online gateway only if HSCIC has successfully recorded the information;

(b) that the relevant information was provided at the time it was recorded by the HSCIC;

(c) that the person providing the information is the person identified as such by the information recorded by HSCIC;

(d) that a return made on behalf of a body corporate is made with the authority of that body.

(3) The presumptions in paragraph (2) are rebuttable.

PART 2 Quarterly information about unbranded generic health service medicines

Meaning of “unbranded generic health service medicine” and listing of a presentation of unbranded generic health service medicine

6.—(1) In these Regulations, “unbranded generic health service medicine” means a health service medicine(6) the labelling of which includes the common name of the product, but does not include an invented name.

(2) For the purposes of paragraph (1)—

“invented name” means a name which—

(a)

is not the common name of the medicinal product, and

(b)

is not liable to be confused with that name;

“non-proprietary name” means a name which is, or is a permitted variation of—

(a)

an International Non-proprietary Name (INN),

(b)

an International Non-proprietary Name Modified (INNM),

(c)

a British Approved Name (BAN),

(d)

a British Approved Name Modified (BANM), or

(e)

an approved name.

(3) The names mentioned in paragraphs (a) to (e) of the definition of “non-proprietary name” (and their permitted variations) have the same meanings as in a list of names which has been prepared and published under regulation 318 of the 2012 Regulations and which is in force(7).

(4) For the purposes of this Part, a presentation of unbranded generic health service medicine is listed in a Drug Tariff if a price for that presentation is listed—

(a) in the Drug Tariff (England)(8) for the given month,

(b) in the Drug Tariff (Wales)(9) for the given month,

(c) in the Drug Tariff (Scotland)(10) for the given month, or

(d) in the Drug Tariff (Northern Ireland)(11) for the given month.

(5) For the purposes of determining whether a reimbursement price is listed for a presentation, any pack size specified in the relevant Drug Tariff is to be disregarded.

Information to be recorded and kept about supply of unbranded generic health service medicines: manufacturers and importers

7.—(1) A relevant producer must record the information mentioned in paragraph (3) for each presentation of unbranded generic health service medicine which—

(a) the producer manufactures, or imports, and supplies to any of the following—

(i) a UK primary medical services provider,

(ii) a Health Service chemist, or

(iii) a medicines wholesaler,

(b) is, in the month in which the producer supplies it, listed in a Drug Tariff, and

(c) if it is a liquid or a topical preparation, or is in tablet or capsule form, is in a pack not exceeding the maximum pack size.

(2) The relevant producer must keep the information recorded under paragraph (1) until it is provided to the Secretary of State in accordance with regulation 9.

(3) The information is—

(a) the number of packs supplied to persons mentioned in paragraph (1)(a)(i) to (iii), and

(b) the net sales income, or a reasonable estimate of the net sales income, from that supply.

(4) In this regulation, “relevant producer” means—

(a) a manufacturer(12), or

(b) a UK producer who is an importer.

Information to be recorded and kept about supply of unbranded generic health service medicines: medicines wholesalers

8.—(1) A UK producer who is a medicines wholesaler must—

(a) record the information mentioned in paragraph (2) for each presentation of unbranded generic health service medicine which the producer purchases for supply (including any purchase which requires the presentation to be imported into the United Kingdom) and—

(i) which is, in the month in which producer purchases it, listed in a Drug Tariff, and

(ii) if it is a liquid or a topical preparation, or is in tablet or capsule form, which is in a pack not exceeding the maximum pack size, and

(b) keep that information until it is provided to the Secretary of State in accordance with regulation 9.

(2) The information is—

(a) the number of packs purchased, and

(b) the net purchase amount, or a reasonable estimate of the net purchase amount, for that purchase.

(3) A UK producer who is a medicines wholesaler must also—

(a) record the information mentioned in paragraph (4) for each presentation of unbranded generic health service medicine (other than a presentation which the wholesaler has manufactured) which—

(i) the producer supplies to any UK primary medical services provider or Health Service chemist,

(ii) is, in the month in which the producer supplies it, listed in a Drug Tariff, and

(iii) if it is a liquid or a topical preparation, or is in tablet or capsule form, is in a pack which does not exceed the maximum pack size, and

(b) keep that information until it is provided to the Secretary of State in accordance with regulation 9.

(4) The information is—

(a) the number of packs supplied to persons mentioned in paragraph (3)(a)(i), and

(b) the net sales income, or a reasonable estimate of the net sales income, from that supply.

Requirement to provide information about supply of unbranded generic health service medicines

9.—(1) A UK producer must provide the information which the producer is required to record and keep under regulation 7 or 8 to the Secretary of State in accordance with this regulation.

(2) The information must be provided, in each year, for the following quarterly periods—

(a) 1st July to 30th September;

(b) 1st October to 31st December;

(c) 1st January to 31st March;

(d) 1st April to 30th June.

(3) The information for a quarterly period must be provided—

(a) in an electronic spreadsheet provided for that purpose by the Secretary of State, or

(b) if the Secretary of State does not provide such a spreadsheet, via the NHS Digital online gateway.

(4) The information for a quarterly period must be provided within the period of 28 days beginning with the first day of the month which begins immediately after the end of that quarterly period.

PART 3 Quarterly information about special health service medicines

Meaning of “special health service medicine”, “imported special health service medicine”, “made special health service medicine” and listing of a presentation of special health service medicine in a Drug Tariff

10.—(1) In these Regulations—

“imported special health service medicine” means a special health service medicine which is imported into the United Kingdom;

“made special health service medicine” means a special health service medicine which is manufactured in the United Kingdom;

“special health service medicine” means a health service medicine which is a special medicinal product (within the meaning of regulation 167(13) of the 2012 Regulations).

(2) For the purposes of this Part, a presentation of special health service medicine is listed in a Drug Tariff if a price for that presentation is listed—

(a) in the Drug Tariff (England) for the given month,

(b) in the Drug Tariff (Wales) for the given month,

(c) in the Drug Tariff (Scotland) for the given month, or

(d) in the Drug Tariff (Northern Ireland) for the given month.

(3) For the purposes of determining whether a reimbursement price is listed for a presentation, any pack size specified in the relevant Drug Tariff is to be disregarded.

Information to be recorded about supply of made special health service medicines: manufacturers

11.—(1) A manufacturer must record the information mentioned in paragraph (3) for each presentation of made special health service medicine which—

(a) the manufacturer manufactures and supplies to any of the following—

(i) a UK primary medical services provider,

(ii) a Health Service chemist, or

(iii) a medicines wholesaler, and

(b) is, in the month in which the manufacturer supplies it, listed in a Drug Tariff.

(2) A manufacturer must keep the information recorded under paragraph (1) until it is provided to the Secretary of State in accordance with regulation 14.

(3) The information is—

(a) the type of manufacture,

(b) the excipient formulations (if any),

(c) the quantity, by pack size, supplied to the persons mentioned in paragraph (1)(a)(i) to (iii), and

(d) the net sales income, or a reasonable estimate of the net sales income, from the supply.

Information to be recorded about supply of made special health service medicines: medicines wholesalers

12.—(1) A UK producer who is a medicines wholesaler must—

(a) record the information mentioned in paragraph (2) for each presentation of made special health service medicine which—

(i) the wholesaler purchases for supply, and

(ii) is, in the month in which the wholesaler purchases it, listed in a Drug Tariff, and

(b) keep that information until it is provided to the Secretary of State in accordance with regulation 14.

(2) The information is—

(a) the quantity, by pack size, purchased,

(b) the excipient formulations purchased (if any), and

(c) the net purchase amount, or a reasonable estimate of the net purchase amount, for the purchase.

(3) A UK producer who is a medicines wholesaler must also—

(a) record the information mentioned in paragraph (4) for each presentation of made special health service medicine (other than a presentation of such medicine which the wholesaler has manufactured) which—

(i) the producer supplies to any UK primary medical services provider or Health Service chemist, and

(ii) is, in the month in which the wholesaler supplies it, listed in a Drug Tariff, and

(b) keep that information until it is provided to the Secretary of State in accordance with regulation 14.

(4) The information is—

(a) the quantity, by pack size, supplied,

(b) the excipient formulations supplied (if any), and

(c) the net sales income, or a reasonable estimate of the net sales income, from the supply.

Information to be recorded and kept about supply of imported special health service medicines: medicines wholesalers and importers

13.—(1) A UK producer who is a medicines wholesaler or an importer must—

(a) record and keep the information mentioned in paragraph (2) for each presentation of imported special health service medicine—

(i) which the producer purchases for supply, and

(ii) which is, in the month in which the producer purchases it, listed in a Drug Tariff, and

(b) keep that information until it is provided to the Secretary of State in accordance with regulation 14.

(2) The information for a presentation is—

(a) the number of packs purchased, and

(b) the net purchase amount paid, or a reasonable estimate of the net purchase amount paid, for that purchase.

(3) A UK producer who is a medicines wholesaler or an importer must also—

(a) record the information mentioned in paragraph (4) for each presentation of imported special health service medicine which—

(i) the producer supplies to any relevant person, and

(ii) is, in the month in which the producer supplies it, listed in a Drug Tariff, and

(b) keep that information until it is provided to the Secretary of State in accordance with regulation 14.

(4) The information for a presentation is—

(a) the number of packs supplied to relevant persons, and

(b) the net sales income, or a reasonable estimate of the net sales income, for that supply.

(5) In this regulation, “relevant person”—

(a) in relation to a producer who is an importer, means—

(i) a UK primary medical services provider,

(ii) a Health Service chemist, or

(iii) a medicines wholesaler;

(b) in relation to a producer who is a medicines wholesaler, means—

(i) a UK primary medical services provider, or

(ii) a Health Service chemist.

Requirement to provide information about the supply of special health service medicines

14.—(1) A UK producer must provide the Secretary of State with the information which the producer is required to record and under regulation 11, 12, or 13 in accordance with this regulation.

(2) The information must be provided, in each year, for the following quarterly periods—

(a) 1st August to 31st October;

(b) 1st November to 31st January;

(c) 1st February to 30th April;

(d) 1st May to 31st July.

(3) The information for a quarterly period must be provided—

(a) in an electronic spreadsheet provided for that purpose by the Secretary of State, or

(b) if the Secretary of State does not provide such a spreadsheet, via the NHS Digital online gateway.

(4) The information for a quarterly period must be provided within the period of 28 days beginning with the first day of the month which begins immediately after the last day of that quarterly period.

PART 4 General information about supply of UK health service products

Categories of purchaser

15.  For the purposes of this Part—

(a) a person is in Category A if the person is a UK primary medical services provider or a Health Service chemist;

(b) a person is in Category B if the person is an NHS hospital purchaser or purchases UK health service products under an NHS framework contract;

(c) a person is in a Category C if the person—

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

(ii) is not in Category A or Category B;

(d) a person is in Category D if the person is not in any of Categories A to C.

Information to be recorded and kept about supply of imported special health service medicines: medicines wholesalers and importers

16.—(1) A UK producer who is a medicines wholesaler or an importer must—

(a) record the information mentioned in paragraph (2) for each purchase by the producer of a presentation of imported special health service medicine for supply, and

(b) keep that information for a period of four years beginning with the day on which it is recorded.

(2) The information is—

(a) the name of the person from whom the presentation is purchased,

(b) the quantity of packs purchased,

(c) the net purchase amount, or a reasonable estimate of the net purchase amount, for the purchase,

(d) the terms on which any discounts, payments, or payments or benefits in kind taken into account when calculating that amount were received, and

(e) the name of the person to whom the discounts, payments, or payments or benefits in kind were given, if that person is not the producer.

(3) A UK producer who is a medicines wholesaler or an importer must also—

(a) record the information mentioned in paragraph (4) for each supply of a presentation of imported special health service medicine by the producer, and

(b) keep that information for a period of four years beginning with the day on which it is recorded.

(4) The information is—

(a) the name of the person to whom the presentation is supplied (“the purchaser”),

(b) if known to the producer, whether the purchaser is in Category A, B, C or D,

(c) the quantity of packs supplied,

(d) the net sales income, or a reasonable estimate of the net sales income, for the supply,

(e) the terms on which the discounts, payments, or payments or benefits in kind taken into account when calculating that income were given by the producer,

(f) the name of the person to whom any of those discounts, payments, or payments or benefits in kind were given, if that person is not the purchaser, and

(g) if known to the producer, whether the presentation is an English health service product, a Welsh health service product, a Scottish health service product or a Northern Ireland health service product.

Information to be recorded and kept about supply of health service medicines other than imported special health service medicines: medicines wholesalers

17.—(1) A UK producer who is a medicines wholesaler must—

(a) record the information mentioned in paragraph (3) for each purchase by the producer of a relevant presentation of health service medicines for supply (including any purchase which requires the presentation to be imported into the United Kingdom), and

(b) keep that information for a period of four years beginning with the day on which it is recorded.

(2) The information is—

(a) the name of the person from whom the presentation is purchased,

(b) the quantity, by pack size, purchased,

(c) the net purchase amount, or a reasonable estimate of the net purchase amount, for the purchase,

(d) the terms on which the discounts, payments, or payments or benefits in kind taken into account when calculating that amount were given,

(e) the name of the person to whom the discounts, payments, payments or benefits in kind were given, if that person is not the wholesaler, and

(f) if it is a presentation of made special health service medicine, the excipient formulations purchased (if any).

(3) A UK producer who is a medicines wholesaler must also—

(a) record the information mentioned in paragraph (4) for each supply by the wholesaler of a relevant presentation of health service medicine, and

(b) keep that information for a period of four years beginning with the day on which it is recorded.

(4) The information is—

(a) the name of the person to whom the presentation is supplied (“the purchaser”),

(b) if known to the producer, whether the purchaser is in Category A, B, C or D,

(c) the quantity, by pack size, supplied,

(d) the net sales income, or a reasonable estimate of the net sales income, for the supply to the purchaser,

(e) the terms on which any discounts, payments, or payments or benefits in kind taken into account when calculating that income were given by the producer,

(f) the name of the person to whom any of those any discounts, payments, or payments or benefits in kind were given, if that person is not the purchaser,

(g) if it is a presentation of made special health service medicine, the excipient formulations supplied (if any), and

(h) if known to the producer, whether the presentation is an English health service product, a Welsh health service product, a Scottish health service product or a Northern Ireland health service product.

(5) In this regulation, “relevant presentation of health service medicine”, in relation to a producer, means a presentation of health service medicine other than—

(a) a presentation which the producer has manufactured, or

(b) a presentation of imported special health service medicine.

Information to be recorded and kept about supply of health service medicines other than imported special health service medicines: other UK producers

18.—(1) A UK producer must—

(a) record the information mentioned in paragraph (2) for—

(i) each supply by the producer of a presentation of relevant health service medicine which the producer has manufactured, and

(ii) each supply by the producer (otherwise than as a medicines wholesaler) of any presentation of relevant health service medicine, and

(b) keep that information for a period of four years beginning with the day on which it is recorded.

(2) The information is—

(a) the name of the person to whom the presentation is supplied (“the purchaser”),

(b) if known to the producer, whether the purchaser is in Category A, B, C or D,

(c) the quantity, by pack size, supplied to the purchaser,

(d) the net sales income, or a reasonable estimate of the net sales income, for the supply of the presentation to the purchaser,

(e) the terms on which any discounts, payments, or payments or benefits in kind taken into account when calculating the net sales income were given by the producer,

(f) the name of the person to whom those discounts were given, if that person is not the purchaser,

(g) if known to the producer, whether the presentation is an English health service product, a Welsh health service product, a Scottish health service product or a Northern Ireland health service product, and

(h) if it is a presentation of made special health service medicine, the excipient formulations supplied (if any).

(3) In this regulation, “relevant health service medicine” means a health service medicine other than an imported special health service medicine.

Information to be recorded and kept about supply of health service medicines to patients otherwise than by sale

19.—(1) This regulation applies to a UK producer who supplies health service medicines to patients.

(2) A UK producer to whom this regulation applies must—

(a) record the information mentioned in paragraph (3) for each presentation of health service medicine which the producer purchases for the purpose of supply to patients, and

(b) keep that information for a period of four years beginning with the day on which it is recorded.

(3) The information is—

(a) the invoice for the purchase of the presentation,

(b) if any discounts, payments, payments or benefits in kind given in connection with the purchase are not included in the invoice, a statement of those discounts, payments or payments or benefits in kind,

(c) the name of the person from whom the presentation is purchased,

(d) the quantity, by pack size, purchased,

(e) the net purchase amount, or a reasonable estimate of the net purchase amount, paid for the purchase, and

(f) the terms on which any discounts, payments, or payments or benefits in kind were given to the producer.

(4) In this regulation, “supply” means supply otherwise than by sale.

Information to be recorded and kept about supply of health service appliances: manufacturers and importers

20.—(1) A UK producer must—

(a) record the information mentioned in paragraph (2) for each supply by the producer of any appliance—

(i) which the producer has manufactured or imported,

(ii) which is a UK health service product, and

(iii) which is, in the month in which the producer supplies it, listed in a Drug Tariff, and

(b) keep that information for a period of four years beginning with the day on which it is recorded.

(2) The information is—

(a) the name of the person to whom the appliance is supplied (“the purchaser”),

(b) if known to the producer, whether the purchaser is in Category A, B, C or D,

(c) the number of appliances supplied to the purchaser,

(d) the net sales income, or a reasonable estimate of the net sales income, from the supply,

(e) the terms on which any discounts, payments, or payments or benefits in kind taken into account when calculating that income were given by the producer,

(f) the name of any person to whom any discounts, payments, or payments or benefits in kind are given, if that person is not the purchaser, and

(g) if known to the producer, whether the appliance is an English health service product, a Welsh health service product, a Scottish health service product or a Northern Ireland health service product.

Information to be recorded and kept about supply of listed health service appliances: medical supplies wholesalers

21.—(1) A medical supplies wholesaler must—

(a) record the information mentioned in paragraph (2) for each purchase by the wholesaler of any appliance (including any purchase which requires the appliance to be imported into the United Kingdom) which—

(i) is a UK health service product, and

(ii) is, in the month in which the wholesaler purchases it, listed in a Drug Tariff, and

(b) keep that information for the period of four years beginning with the day on which it is recorded.

(2) The information is—

(a) the name of the person from whom the appliance is purchased,

(b) the number of appliances purchased,

(c) the net purchase amount, or a reasonable estimate of the net purchase amount, paid for the purchase,

(d) the terms on which any discounts, payments, or payments or benefits in kind taken into account when calculating that amount were given, and

(e) the name of the person to whom they are given, if the person to whom they are given is not the producer.

(3) A medical supplies wholesaler must also—

(a) record the information mentioned in paragraph (4) for each supply by the wholesaler of any appliance (other than an appliance which the wholesaler has manufactured or imported) which—

(i) is a UK health service product, and

(ii) is, in the month in which the wholesaler supplies it, listed in a Drug Tariff, and

(b) keep that information for the period of four years beginning with the day on which it is recorded.

(4) The information is—

(a) the name of the person to whom the appliance is supplied (“the purchaser”),

(b) if known to the producer, whether the purchaser is in Category A, B, C or D,

(c) the number of appliances supplied,

(d) the net sales income, or a reasonable estimate of the net sales income, from the supply,

(e) the terms on which any discounts, payments, or payments or benefits in kind taken into account when calculating that income were given,

(f) the name of any person to whom they were given if the person to whom they were given is not the purchaser, and

(g) if known to the wholesaler, whether the appliance is an English health service product, a Welsh health service product, a Scottish health service product or a Northern Ireland health service product.

Information to be recorded and kept about supply of appliances, food and dermatological products to patients otherwise than by sale

22.—(1) This regulation applies to any UK producer who supplies UK health service products which are not health service medicines to patients.

(2) A UK producer to whom this regulation applies must—

(a) record the information mentioned in paragraph (3) for each supply by the producer to patient otherwise than by sale of an appliance, food or dermatological product—

(i) which is a UK health service product, and

(ii) is, in the month in which the producer supplies it, listed in a Drug Tariff, and

(b) keep that information for a period of four years beginning with the day on which it is recorded.

(3) The information is—

(a) the invoice for the purchase of the appliance, food or dermatological product,

(b) if any discounts, payments or payments or benefits in kind given in connection with the purchase are not included in the invoice, a statement of those discounts, payments or payments or benefits in kind,

(c) the name of the person from whom the appliance, food or product is purchased,

(d) the number of appliances or quantity, by pack size, of product purchased,

(e) the net purchase amount, or a reasonable estimate of the net purchase amount, paid for the purchase,

(f) the terms on which any discounts, payments, or payments or benefits in kind taken into account when calculating that amount were given, and

(g) the name of the person to whom those discounts, payments or payments or benefits in kind were given, if that person is not the purchaser.

(4) For the purposes of paragraph (2), a food or dermatological product is listed in a Drug Tariff if the food or product is listed—

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

(b) in Part XV of the Drug Tariff (Wales) for the given month, or

(c) in Part X of the Drug Tariff (Northern Ireland) for the given month.

(5) In this regulation “supply” means supply otherwise than by sale.

Provision of information recorded and kept under this Part to the Secretary of State

23.—(1) The Secretary of State may by request in writing require a UK producer to provide such of the retained information as the Secretary of State requires for the statutory purpose.

(2) A written request must state the statutory purpose for which the Secretary of State requires the information.

(3) A UK producer who is given a written request must comply with the request within the period of 28 days beginning with the day on which the producer is given the request.

(4) A producer must provide the requested information—

(a) in an electronic spreadsheet provided for that purpose by the Secretary of State, or

(b) if the Secretary of State does not provide such a spreadsheet, via the NHS Digital online gateway.

(5) In this regulation, “retained information”, in relation to a UK producer, means the information which the producer is required to record and keep under this Part.

(6) This regulation is subject to regulation 24.

Provision of information: small producers

24.—(1) A UK producer who is a small producer may provide information in response to a request under regulation 23 in the form of an invoice or other existing document.

(2) For the purposes of this regulation, whether a producer is a small producer is to be determined in accordance with Schedule 2.

(3) A producer to whom paragraph 6(1)(a) of Schedule 2 applies must, when responding to the relevant request under regulation 23, provide the Secretary of State with information, in writing, setting out the producer’s net NHS sales income for the relevant financial year.

(4) The Secretary of State may, for the purposes of verifying any information provided under paragraph (3), request the producer who provided it to provide that information in audited form.

PART 5 Information about costs incurred in connection with the manufacturing, distribution or supply of UK health service products

Provision of information about costs incurred in connection with the manufacture or distribution of a particular health service medicine or appliance

25.—(1) If the Secretary of State requires the information for the statutory purpose, the Secretary of State may by information notice(14) require a UK producer to provide specified information in respect of any relevant costs incurred by the producer—

(a) in connection with the manufacturing of a particular presentation of unbranded generic health service medicine or special health service medicine;

(b) in connection with the distribution or supply of a particular presentation of health service medicine;

(c) in connection with the manufacturing, supply or distribution of a particular appliance which—

(i) is a UK health service product, and

(ii) is, in the month in which the request is made, listed in a Drug Tariff.

(2) But the Secretary of State may not require a UK producer to provide any information which the producer could not reasonably be expected to record and keep for the purpose of understanding the producer’s relevant costs.

(3) An information notice must specify the statutory purpose for which the specified information is required.

(4) A UK producer must comply with any information notice given to the producer.

(5) In this regulation—

“relevant costs”, in relation to a producer, means any costs (including, for example, manufacturing costs, supply costs, distribution costs, research and development cost, capital costs and business costs) other than costs which relate to any transaction between the producer and a UK producer for the relevant health service product;

“specified” means specified in an information notice.

Provision of general information about costs incurred in connection with the manufacture or distribution of health service medicines and appliances

26.—(1) If the Secretary of State requires the information for the statutory purpose, the Secretary of State may by request, in writing, require a UK producer—

(a) to provide information about any costs incurred by the producer—

(i) in connection with the manufacturing or distribution of a particular presentation of health service medicine, and

(ii) which relate to any transaction between the producer and a UK producer for that presentation;

(b) to provide information about any costs incurred by the producer—

(i) in connection with the manufacturing or distribution of a particular appliance which—

(aa) is a UK health service product, and

(bb) is, in the month in which the request is made, listed in a Drug Tariff, and

(ii) which relate to any transaction between the producer and a UK producer for that appliance;

(c) to provide information about any costs (other than supply costs) incurred by the producer in connection with the manufacturing, or distribution of—

(i) any health service medicine, or

(ii) any appliance which is—

(aa) a UK health service product, and

(bb) in the month in which the request is made, listed in a Drug Tariff.

(2) But a request under paragraph (1)(a), (b) or (c) may not require a UK producer to provide any information which the producer could not reasonably be expected to record and keep for the purpose of understanding the producer’s relevant costs.

(3) In addition, a request under paragraph (1)(c) may not require a UK producer to provide any information to which regulation 25 applies.

(4) A UK producer who is given a written request under paragraph (1)(a), (b) or (c) must comply with the request.

(5) The producer must provide the requested information—

(a) in an electronic spreadsheet provided for that purpose by the Secretary of State, or

(b) if the Secretary of State does not provide such a spreadsheet, via the NHS Digital online gateway.

(6) The producer must provide the requested information within the period of 28 days beginning with the day on which the producer is given the request.

PART 6 Information about price and availability of health service medicines

Provision of information about English health service medicines which are not available at the reimbursement price

27.—(1) This regulation applies where the Secretary of State has reasonable grounds to suspect that a presentation of English health service medicine is, in a particular month, available for distribution or supply to English NHS chemists at a price which exceeds the listed price.

(2) Where this regulation applies, the Secretary of State may, by request in writing, require any of the following UK producers to provide the information mentioned in paragraph (3) for the relevant presentation—

(a) a manufacturer of the presentation,

(b) a person who distributes the presentation (whether by wholesale dealing or otherwise), or

(c) an importer of the presentation.

(3) The information is—

(a) the quantity, by relevant pack size, of the presentation which is available for distribution or supply by the producer in England,

(b) the net price or net prices, or a reasonable estimate of the net price or net prices, at which the producer would offer to distribute or supply those pack sizes in England,

(c) the quantity, by relevant pack size, of any branded equivalent which is available for distribution or supply by the producer in England, and

(d) the net price or net prices, or a reasonable estimate of the net price or net prices, at which the producer would offer to distribute or supply those pack sizes in England.

(4) A producer who is given a written request under paragraph (2), must comply with the request within the period of two working days beginning—

(a) with the day on which producer is given the request, if that day is a working day;

(b) otherwise, with the first working day after the day on which the notice is given to the producer.

(5) In this regulation—

“branded equivalent”, in relation to a presentation of English health service medicine, means a particular form of medicinal product—

(a)

to which a brand name has been applied that enables the medicine to be identified without reference to the common name, but

(b)

which has the same—

(i)

active ingredient or ingredients,

(ii)

strength,

(iii)

physical form,

(iv)

unit dose (if applicable),

(v)

method of administration (if applicable),

(vi)

freeness (if applicable), and

(vii)

type of packaging,

as the presentation;

“English health service medicine” means a medicinal product used to any extent for the purposes of the health service continued under section 1(1) of the 2006 Act;

“listed price”, in relation to a presentation of English health service medicine, means the price listed for that medicine in Part VIII of the Drug Tariff (England);

“net price”, in relation to a presentation, means the price after the deduction of—

(a)

all discounts and payments, and

(b)

the value of all payments or benefits in kind;

“relevant pack size”—

(a)

in relation to a presentation of English health service medicine which—

(i)

is a presentation of unbranded generic health service medicine, and

(ii)

is a liquid or a topical preparation or is in tablet or capsule form,

means any pack size which does not exceed the maximum pack size;

(b)

in relation to any other presentation of English health service medicine or a branded equivalent, means any pack size.

(6) For the purposes of this regulation—

(a) the definition of “presentation” in paragraph 2 of Schedule 1 applies as if any reference to pack size were omitted, and

(b) for the purpose of determining whether there is price listed in Part VIII of the Drug Tariff (England), any pack size specified in that Part is to be disregarded.

Provision of information about availability of health service medicines

28.—(1) This regulation applies where the Secretary of State considers that there is a supply shortage of a presentation of health service medicine (the “relevant presentation”).

(2) Where this regulation applies, the Secretary of State may by notice in writing require any of the following to provide the information mentioned in paragraph (3) about the relevant presentation—

(a) a manufacturer of the presentation,

(b) a person who distributes the presentation (whether by wholesale dealing or otherwise), or

(c) an importer of the presentation.

(3) The information is—

(a) the quantity (if any) of packs of the relevant presentation that is available for supply by the producer, and

(b) the quantity (if any) of any alternative presentation specified in the request that is available for supply by the producer.

(4) A producer who is given a notice under paragraph (2) must comply with the request within the period of two working days beginning—

(a) with the day on which producer is given the request, if that day is a working day;

(b) otherwise, with the first working day after the day on which the notice is given to the producer.

(5) In this regulation, “alternative presentation”, in relation to a relevant presentation, means a presentation of health service medicine which is used as a therapeutic alternative to the relevant presentation.

Requirement to provide information about discontinuation or anticipated supply shortage of certain health service medicines

29.—(1) This regulation applies where a designated producer of a notifiable presentation—

(a) intends to discontinue the manufacturing or supply of the presentation and considers that this is likely to have a direct impact on any patient who takes, or may need to take, the presentation for the prevention or treatment of a physical or mental illness, or

(b) considers there is likely to be a supply shortage of the presentation which will have a direct impact on any patient who takes, or may need to take, the presentation for the prevention or treatment of a physical or mental illness.

(2) Where this regulation applies, the designated producer must provide the following information to the Secretary of State—

(a) the name of the presentation,

(b) the licensed uses of the presentation which the producer is aware of,

(c) the unlicensed uses of the presentation which the producer is aware of,

(d) the reasons for which the manufacturing or supply is to be discontinued or, as the case may be, the producer considers there is likely to be a supply shortage,

(e) the quantity of the presentation which the producer has available for supply,

(f) where the producer considers there is likely to be a supply shortage—

(i) the anticipated duration of the shortage;

(ii) any steps taken by the producer to address it,

(g) the producer’s estimated share of the market,

(h) whether the presentation is made available under an NHS framework contract, and

(i) the name and contact details of a representative of the producer.

(3) The information must be provided—

(a) where the producer intends to discontinue the manufacturing or supply of the relevant presentation—

(i) at least six months before the day on which the manufacturing or supply will cease, or

(ii) where the decision to discontinue the manufacturing or supply is made less than six months before the day on which manufacturing or supply will cease, as soon as reasonably practicable after the producer makes the decision;

(b) where the producer considers there may be a supply shortage of the relevant presentation—

(i) at least six months before any anticipated impact on any patient who takes the presentation is realised, or

(ii) where the producer becomes aware of the likely supply shortage less than six months before the producer considers any anticipated impact will be realised, as soon as reasonably practicable after the producer becomes aware that there may be a supply shortage.

(4) In this regulation—

“notifiable presentation” means a presentation of health service medicine in respect of which a marketing authorisation has been granted other than a presentation of such medicine in respect of which a parallel distribution notice(15) with the United Kingdom as the Member State of destination has been given;

“designated producer”, in relation to a notifiable presentation, means—

(a)

the UK producer who holds the marketing authorisation for the presentation, if that producer manufactures the presentation;

(b)

otherwise, a UK producer who manufactures the presentation or imports the presentation and supplies it by way of sale;

“marketing authorisation” has the meaning given in regulation 8(1) of the 2012 Regulations.

PART 7 Information about reasonable estimates

Requirement to provide information about reasonable estimates

30.—(1) This regulation applies if a UK producer provides any information to the Secretary of State under or in accordance with these Regulations in the form, or on the basis, of a reasonable estimate.

(2) Where this regulation applies, the Secretary of State may by request in writing require the producer to provide the following information to the Secretary of State—

(a) the reasons for which the producer provided the original information in the form, or on the basis, of a reasonable estimate, rather than an actual amount, and

(b) the method used by the producer to calculate the reasonable estimate.

(3) A UK producer who is given a request under paragraph (2) must comply with the request within the period of seven days beginning with the day on which the producer is given the request.

PART 8 Enforcement and appeals

Compliance procedure

31.—(1) If the Secretary of State considers that a UK producer—

(a) has not complied with regulation 9, 14 or 29,

(b) has provided information under regulation 9, 14 or 29 which is incorrect or incomplete,

(c) has not complied with a written request given to the producer under regulation 23, 24, 26, 27, 28 or 30 (“the original request”), or

(d) has provided information in response to an original request which is incorrect or incomplete,

the Secretary of State may by notice in writing require the producer to provide any of the relevant information or to provide relevant information which is accurate.

Such a notice is referred to in these Regulations as a “compliance notice”.

(2) A compliance notice must—

(a) specify the provision of these Regulations or the original request to which the notice relates,

(b) specify the relevant information to be provided to the Secretary of State,

(c) state the additional compliance period within which that information is to be provided,

(d) state that the Secretary of State may demand a penalty from the producer if the information is not provided within that period, and

(e) state that there is a right of appeal against the compliance notice in accordance with the 2000 Regulations.

(3) For the purposes of paragraph (2), “additional compliance period”—

(a) in relation to a compliance notice which relates to regulation 9, 14 or 29, means the period of seven working days beginning—

(i) with the day on which the compliance notice is given to the producer, if that day is a working day;

(ii) otherwise, with the first working day after the day on which the compliance notice is given to the producer;

(b) in relation to a compliance notice which relates to an original request made under regulation 27 or 28, means the period of one working day beginning—

(i) with the day on which the compliance notice is given to producer, if that day is a working day;

(ii) otherwise, with the first working day after the day on which it is given to the producer;

(c) in any other case, means the period of 30 working days beginning—

(i) with the day on which it is given to the producer, if that day is a working day;

(ii) otherwise, with the first working day after the day on which it is given to the producer.

(4) But where the original request was made under regulation 23, the Secretary of State may, instead of the period mentioned in paragraph (3)(c), specify an additional compliance period of seven working days beginning—

(a) with the day on which it is given to the producer, if that day is a working day, or

(b) otherwise, with the first working day after the day on which it is given to the producer.

(5) A UK producer who is given a compliance notice must comply with that notice.

(6) If a UK producer—

(a) is given a compliance notice in relation to an original request, and

(b) the producer is a small producer in connection with that request,

the producer may provide any or all of the required information specified in the notice in the form of an invoice or other existing document.

(7) For the purposes of paragraph (6), whether a UK producer is a small producer is to be determined in accordance with Schedule 2.

(8) In this regulation, “relevant information”, in relation to a producer, means any of the information—

(a) the producer is required to provide to the Secretary of State under regulation 9, 14 or 29, or

(b) specified in the original request.

Penalties

32.—(1) This regulation applies where a UK producer contravenes regulation 25(4) or 31(5).

(2) Where this regulation applies—

(a) the producer is liable to pay a penalty to the Secretary of State, and

(b) the amount of the penalty is to be determined in accordance with paragraphs (3) and (4).

(3) If the producer contravenes regulation 31(5) by failing to comply with a compliance notice relating to regulation 27 or 28, the amount of the penalty is a single penalty of £1,000.

(4) If the producer contravenes regulation 25(4), or contravenes regulation 31(5) by failing to comply with any other compliance notice, the amount of the penalty is a daily penalty and is to be calculated—

(a) if the producer is a small producer, in accordance with paragraph 2 of Schedule 3;

(b) in the case of any other producer, in accordance with paragraph 3 of Schedule 3.

But this paragraph is subject to paragraphs (9) and (10).

(5) Whether a UK producer is a small producer is to be determined in accordance with Schedule 2.

(6) Where a producer is liable to pay a penalty under this regulation, the Secretary of State may by demand in writing require the producer to pay that penalty to the Secretary of State.

(7) A written demand under paragraph (6) must—

(a) specify—

(i) if the penalty payable by the producer is a single penalty, that the amount of the penalty is £1,000;

(ii) if the penalty payable by the producer is a daily penalty, the information mentioned in paragraph (8);

(b) give the Secretary of State’s reasons for imposing the penalty;

(c) specify the period within which the penalty is to be paid;

(d) state that the decision to require the producer to pay the penalty, and the decision as to the amount of the penalty, may be appealed under the 2000 Regulations.

(8) The information is—

(a) the date on which the contravention occurred,

(b) the amount of the daily penalty calculated in accordance with this regulation and Schedule 3 from that day up to and including the day on which the demand is made, and

(c) the daily rate at which the penalty continues to accrue in accordance with Schedule 3 until the producer complies with the relevant information notice or compliance notice (except to the extent that it is no longer to possible to meet a deadline because the deadline has passed).

(9) For the purposes of calculating the final amount of the daily penalty that is due, the day on which the producer starts to comply with the relevant notice is to be disregarded.

(10) If the producer makes an appeal to the tribunal against the decision under this regulation to require the producer to pay a daily penalty, or as to the amount of that daily penalty, in accordance with regulation 4 of the 2000 Regulations, any day falling within the appeal period is to be disregarded when determining the final amount of the penalty to be paid by the producer.

(11) For the purposes of paragraph (10), “appeal period” means the period—

(a) beginning with the day on which the tribunal receives the relevant notice of appeal, and

(b) ending with—

(i) the day on which the appeal is withdrawn, or

(ii) if the decision is upheld following the appeal, the day on which the appeal is finally determined.

Appeals

33.—(1) A UK producer has a right of appeal against a relevant enforcement decision in accordance with the 2000 Regulations.

(2) For this purpose, the 2000 Regulations apply in relation to relevant enforcement decisions as they apply to enforcement decisions (within the meaning of those Regulations) but with the modification specified in paragraph (3).

(3) The modification is that a reference to an enforcement decision is to be read as a reference to a relevant enforcement decision (within the meaning of this regulation).

(4) In this regulation “relevant enforcement decision”, in relation to a producer, means a decision of the Secretary of State—

(a) to give the producer an information notice under regulation 25,

(b) to give the producer a compliance notice,

(c) to require the producer to pay a penalty under regulation 32, or

(d) as to the amount of such a penalty.

PART 9 Disclosure of information

Disclosure of information

34.  Schedule 4—

(a) prescribes bodies for the purposes of sections 264B(1)(k) and (l) of the 2006 Act, and

(b) prescribes the purposes for which those bodies may use information disclosed under section 246B(1) of the 2006 Act.

PART 10 Miscellaneous

Transitional provisions

35.—(1) Until the coming into force of the repeal of section 27 of the 1978 Act by Schedule 3 to the Smoking, Health and Social Care (Scotland) Act 2005(16), any reference in these Regulations to pharmaceutical care services under section 2CA(1) of the 1978 Act is to be read as a reference to pharmaceutical services under section 27(1) of that Act.

(2) Schedule 5 makes transitional provision—

(a) in respect of the recording, keeping and provision of information about the supply of unbranded generic health service medicines by UK producers who are members of Scheme M or Scheme W, and

(b) in respect of the recording, keeping and provision of information about the supply of special health service medicines by UK producers who are participating manufacturers for the purposes of the Specials MoU.

(3) In this regulation—

“Scheme M” means the Scheme made by the Secretary of State and the British Generic Manufacturers Association which is dated March 2010 and known as the “Revised long-term arrangements for reimbursement of generic medicines (Scheme M)”(17);

“Scheme W” means the Scheme made by the Secretary of State, the British Association of Pharmaceutical Wholesalers and the British Association of Generic Distributors which is dated June 2005 and known as the “New long-term arrangements for reimbursement of generic medicines (Scheme W)”(18);

“Specials MoU” means the Memorandum of Understanding agreed by the Secretary of State and the Association of Commercial Specials Manufacturers for the purpose of the provision of information to inform Drug Tariff specials reimbursement prices.

Annual review

36.—(1) The Secretary of State must from time to time—

(a) carry out a review of the regulatory provisions contained in these Regulations,

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

(c) publish the report.

(2) The first report under these Regulations must be published before 1st July 2019.

(3) Subsequent reports must be published at intervals not exceeding one year.

(4) A report published under this regulation must, in particular—

(a) set out the objectives intended to be achieved by the regulatory provisions contained in these Regulations,

(b) assess the extent to which those objectives are 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 provisions.

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

O’Shaughnessy

Parliamentary Under-Secretary of State,

Department of Health and Social Care

5th June 2018