UK Offence Report

Amendment of regulation 23 of the Advertising Regulations

regulation 8 of The Medicines (Advertising and Monitoring of Advertising) Amendment Regulations 1999

This offence was read from the text as made, and no revised version was available, so a later revocation could not be ruled out. Check the current text at legislation.gov.uk.

What the provision says

8 Any person who fails to comply with any requirement imposed on him under paragraph

6 shall be guilty of an offence and shall be liable on summary conviction to

a fine not exceeding level

5 on the standard scale.

Text as made, from legislation.gov.uk. © Crown copyright, reused under the Open Government Licence v3.0. This is the text as originally made; later amendments are not shown here.

Who it binds, and what has to be proved

Binds
a person
Conduct
failing to comply with a notice or direction
Fault element
Strict liability
Burden of proof
No statutory defence — prosecution proves everything

The prosecution must prove that the conduct happened. This is a strict liability offence as drafted: the provision uses no word of intention, knowledge, recklessness or negligence, so there is no need to show that a person meant to do it, knew about it, or was careless.

Intention, knowledge and carelessness are irrelevant to guilt. They may still matter a great deal to sentence.

The provision states no defence, so the prosecution bears the burden on every element of the offence.

Classifier’s reasoning: no word of intention, knowledge, recklessness or negligence in the offence or its provision.

What would breach regulation 8?

These are illustrations, not law. They are generated from the provision’s own words to show the shape of the offence. Whether any particular conduct is caught depends on the full text, on any amendment since, and on the facts.

  1. On these words an offence is committed where a person fails to comply with any requirement imposed on him under paragraph 6.
  2. Being served with a notice under the Medicines (Advertising and Monitoring of Advertising) Amendment Regulations 1999 and doing nothing by the date it specifies.
  3. Doing part of what the notice requires, where it required all of it.
  4. Disagreeing with the notice and ignoring it, rather than using whatever appeal the instrument provides.

Penalty

Mode of trial
Summary only — tried in a magistrates’ court
Maximum fine
£5,000
Standard scale
Level 5
Maximum prison (summary)
Not determined

this is the level 5 value when the instrument came into force (1999-04-05); the standard scale is keyed to the date the offence was committed, and for conduct today the same words mean an unlimited fine.

Sentencing

Offences of this kind are usually sentenced under the guidelines below. This is a mapping by subject, not a finding about this provision, and the links go to a search of the Sentencing Council’s own site.

Prosecution figures

No published per-offence figure was found for this provision, and it could not be matched to a Ministry of Justice offence code. Offences created by statutory instrument very largely do not have one. Absence of a figure is not evidence that the offence is unused.

Status and lifecycle

Current status
Status not determined
Made
5 February 1999
In force from
5 April 1999
Extent
Not stated

How this was established: read from the text as made; no revised version available, so later revocation could not be ruled out.

What the instrument is for

(This note is not part of the Regulations) — the explanatory note published with the instrument, © Crown copyright.

These Regulations amend the Medicines (Advertising) Regulations 1994 (“the Advertising Regulations”) and the Medicines (Monitoring of Advertising) Regulations 1994 (“the Monitoring of Advertising Regulations”). Those Regulations contain the legislative measures necessary for implementing Council Directive 92/28/EEC concerning the advertising of medicinal products for human use (“the Advertising Directive”), and these Regulations make further provision relating to the implementation of that Directive. Regulation 2 amends the interpretation provision of the Advertising Regulations, adding new definitions of “persons qualified to prescribe or supply” medicinal products and of “the Health Ministers”, and clarifying the scope of the existing definition of “relevant medicinal products”. Regulation 3 inserts a new regulation 3A into the Advertising Regulations which sets out general principles relating to the advertising of relevant medicinal products. These principles are based on article 2(2) and (3) of the Advertising Directive. Regulation 4 amends regulation 4 of the Advertising Regulations, including amongst the duties of holders of marketing authorizations responsibilities based on the first and fourth indents of article 13(2) of the Advertising Directive. These relate to samples of advertisements which must be kept available for the Health Ministers, and, to information and assistance which must be supplied to them to enable them to carry out their functions under the Advertising Regulations and the Monitoring of Advertising Regulations. Regulation 5 contains a revised version of regulation 12 of the Advertising Regulations, extending the prohibition (based on article 3(6) of the Advertising Directive) on sale or supply to the public of relevant medicinal products for promotional purposes. Regulations 6 and 9 change two of the headings in the Advertising Regulations to reflect more accurately the provisions to which they relate. Regulation 7 extends the application of regulation 20 of the Advertising Regulations to cover the activities of medical sales representatives who promote relevant medicinal products to persons qualified to supply such products. Regulation 8 contains technical amendments to the offences provision of the Advertising Regulations, making regulations 3A and 12 offences for the purposes of those Regulations and clarifying the applicability of the enforcement provisions of the Medicines Act 1968 to breaches of the Advertising Regulations. Regulation 10 contains a minor modification to the definition of “publication” for the purposes of the Monitoring of Advertising Regulations, and regulation 11 contains a minor modification of regulation 3 of the Monitoring of Advertising Regulations which arises as a consequence of the new Schedule to those Regulations inserted by virtue of these Regulations. Regulation 12 inserts two regulations into the Monitoring of Advertising Regulations: a regulation applying the enforcement provisions of the Medicines Act 1968 to breaches of the Monitoring of Advertising Regulations, and a regulation giving effect to the new Schedule inserted by virtue of these Regulations. Regulation 13 inserts a new Schedule into the Monitoring of Advertising Regulations. The Schedule contains a new notices procedure relating to the scrutiny of published or proposed advertisements for relevant medicinal products. This procedure is to be used by the Health Ministers for determining whether or not the advertisements, if published, would be in breach of the Advertising Regulations. There is an opportunity for written representations to be made to the Health Ministers before they reach their decision or determination. Breaches of the notices will, in certain circumstances, be offences.

Read the full note and every offence in this instrument

What Parliament said

Mentions of this instrument in Hansard. Parliamentary material is reused under the Open Parliament Licence v3.0.

Other offences in the same instrument

How this was identified as an offence

Everything above rests on the judgement that this provision creates a criminal offence, rather than mentioning one. That judgement is made by rule, from the words of the provision, and this is the rule that made it — with a confidence of 0.92.

Basis
the provision says a person is “guilty of an offence”; the provision states liability on summary conviction; the provision states a penalty in older drafting
Confidence
0.92 of 1.00

A provision that states a penalty for an offence created elsewhere can read very like one that creates an offence, and the rules can mistake the one for the other. If the text quoted above sets a penalty for something made an offence by another provision, treat the classification on this page with that in mind, and read the instrument.

Check the source