Search Legislation

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

What Version

 Help about what version
  • Latest available (Revised)
  • Original (As made)

Status:

This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

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

This section has no associated Explanatory Memorandum

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.

Back to top

Options/Help

Print Options

Close

Legislation is available in different versions:

Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.

Original (As Enacted or Made):The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

Explanatory Memorandum

Explanatory Memorandum sets out a brief statement of the purpose of a Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the Statutory Instrument accessible to readers who are not legally qualified and accompany any Statutory Instrument or Draft Statutory Instrument laid before Parliament from June 2004 onwards.

Close

More Resources

Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as enacted version that was used for the print copy
  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • correction slips
  • links to related legislation and further information resources
Close

Impact Assessments

Impact Assessments generally accompany all UK Government interventions of a regulatory nature that affect the private sector, civil society organisations and public services. They apply regardless of whether the regulation originates from a domestic or international source and can accompany primary (Acts etc) and secondary legislation (SIs). An Impact Assessment allows those with an interest in the policy area to understand:

  • Why the government is proposing to intervene;
  • The main options the government is considering, and which one is preferred;
  • How and to what extent new policies may impact on them; and,
  • The estimated costs and benefits of proposed measures.
Close

More Resources

Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as made version that was used for the print copy
  • correction slips

Click 'View More' or select 'More Resources' tab for additional information including:

  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • links to related legislation and further information resources