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

Explanatory Note

(This note is not part of the Regulations)

Section 264A of the National Health Service Act 2006 (“the 2006 Act”) provides for the Secretary of State to make regulations to require UK producers to record and keep information which the Secretary of State may require for the purpose set out in subsection (3) of that section and to provide that information to Secretary of State (section 264A(2) of the 2006 Act).

A “UK producer” is a person who manufactures, distributes or supplies any UK health service products (section 264A(1) of the 2006 Act). “UK health service products” are medicinal products, medical supplies and other related products used for any purposes of any of the health services in England, Wales, Scotland or Northern Ireland (section 264A(10) to (15)).

Section 264B of the 2006 Act sets out the persons to whom information provided by virtue of section 264A may be disclosed. That section imposes further restrictions on the use of any such information which is commercially sensitive or confidential. The persons to whom information may be disclosed include persons prescribed in regulations by the Secretary of State under section 264B(1)(k) or (l). The Secretary of State must also prescribe in regulations the purposes for which those bodies may use any commercially sensitive or confidential information.

These Regulations make provision for the purposes of sections 264A and 264B(1)(k) and (l) of the 2006 Act.

Part 1 of the Regulations U.K.

Part 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.

Regulation 2 and Schedule 1 are the general interpretation provisions for the Regulations. The terms defined here include “primary medical services provider”, “NHS chemist”, “importer”, “wholesaler” and “presentation of health service medicine”.

Part 2 of the Regulations U.K.

Part 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.

Manufacturers and importers of unbranded generic health service medicines must record and keep information about supplies of unbranded generic health service medicines in accordance with regulation 7. Wholesalers must record and keep information about their purchases and supply of unbranded generic health service medicines in accordance with regulation 8.

That information must be provided to the Secretary of State at quarterly intervals (regulation 9).

Part 3 of the Regulations U.K.

Part 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.

Manufacturers of made special health service medicines must record and keep information about their supply of those medicines in accordance with regulation 11. Wholesalers must record and keep information about their purchases and supply of made special health service medicines in accordance with regulation 12. Wholesalers and importers must record and keep information about their purchases and supply of imported special health service medicines in accordance with regulation 13.

That information must be provided to the Secretary of State at quarterly intervals (regulation 14).

Part 4 of the Regulations U.K.

Part 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.

Regulations 16 to 19 set out the information about the supply of health service medicines that is to be recorded and kept by UK producers.

Regulations 20 to 22 set out the information out the information that is to be recorded and kept by UK producers about the supply of certain appliances and borderline substances.

The Secretary of State may, by written request, require a UK producer to provide any of the information recorded and kept under any of regulations 16 to 22 (regulation 23).

A UK producer who is a small producer may provide any of the requested information in the form of existing documents such as invoices (regulation 24). Whether a UK producer is a small producer is determined in accordance with Schedule 2 to the Regulations.

Part 5 of the Regulations U.K.

Part 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.

The Secretary of State may, by information notice, require a producer to provide information about costs incurred in:

(a)

the manufacturing of a particular presentation of unbranded generic health service medicine or special health service medicine,

(b)

the distribution or supply of a particular presentation of health service medicine, or

(c)

the manufacturing, distribution or supply of a particular appliance.

(regulation 25).

“Information notice” is defined in section 264A(6) of the 2006 Act. A producer who receives an information notice under this regulation may appeal that notice (regulation 33).

The Secretary of State may, by request in writing, require that a producer provide information about costs other than those mentioned above in accordance with regulation 26.

Part 6 of the Regulations U.K.

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

Where the Secretary of State has reasonable grounds to suspect that a medicine is not available for supply to NHS chemists in England at the listed price, the Secretary of State may require manufacturers, importers or wholesalers of the medicine to provide information about the quantity available for supply in England and related prices. “The listed price” is the price listed for the medicine in Part VIII of the Drug Tariff (England) (regulation 27).

The Secretary of State may also require UK producers to provide information where the Secretary of State considers that there is a supply shortage of particular medicine (regulation 28).

Manufacturers and importers of health service medicines (other than medicines which are parallel imported or distributed) must notify the Secretary of State if:

(a)

they intend to stop manufacturing or supplying a medicine and they consider this could have an impact on patients, or

(b)

they consider there is likely to be a supply shortage of a medicine which could have an impact on patients.

(regulation 29).

Part 7 of the Regulations U.K.

Information 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 Regulations U.K.

Part 8 of the Regulations deals with enforcement and appeals.

If a UK producer does not comply with an obligation to provide information in or under the Regulations, or provides information which is incorrect or incomplete, the Secretary of State may give the producer a compliance notice (regulation 31). The notice must state the obligation that the Secretary of State considers the producer has not complied with, the information to be provided to remedy the failure and the period within which that information must be provided.

A UK producer who is given a compliance notice has a right of appeal against that notice (regulation 33).

If a UK producer does not comply with an information notice or a compliance notice, the producer becomes liable to pay a penalty to the Secretary of State (regulation 32). The amount of the penalty is to be calculated in accordance with regulation 32 and Schedule 3. There are different levels of penalty for UK producers who are small producers and those who are not. Whether a producer is a small producer is to be determined in accordance with Schedule 2.

The Secretary of State may issue a demand to a producer who is liable to pay a penalty requiring the payment of that penalty. A UK producer who is given such a demand has a right of appeal against the decision to require the payment of the penalty and also the amount of the penalty (regulation 33(6)). No daily penalty is payable for any day falling during the period for which the appeal is ongoing (regulation 32(10)).

Part 9 of the Regulations U.K.

Regulation 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 Regulations U.K.

Regulation 35 and Schedule 5 make transitional provision.

Regulation 36 provides for an annual review of the operation of the Regulations. The report setting out the first review of the Regulations must be published by 1st July 2019.

An impact assessment relating to these Regulations has been prepared and copies can be obtained from the Department of Health and Social Care, 39 Victoria Street, London, SW1H 0EU.