Medicines Act · 2024 Revised Edition · Part · Promotion of Sales of Medicinal Products and Medical Advertisements
52. False or misleading advertisements and representations
Official textFrom Attorney General's Chambers, unchanged
Subject to the following provisions of this section, any person who issues or causes another person to issue a false or misleading advertisement relating to medicinal products of any description is guilty of an offence.
Where a licence under Part 3 is in force which is applicable to medicinal products of a particular description and, in accordance with the
Medicines provisions of the licence, the purposes for which the medicinal products of that description may be recommended to be used are limited to those specified in the licence, then, subject to the following provisions of this section, any person who issues or causes another person to issue an advertisement relating to medicinal products of that description which consists of or includes an unauthorised recommendation is guilty of an offence.
Subject to the following provisions of this section, any person who makes a false or misleading representation relating to a medicinal product in connection with the sale of that product is guilty of an offence;
representation
“representation” means any statement or undertaking (whether constituting a condition or a warranty or not) which consists of spoken words falling within paragraph (a) or (b) of the definition of “advertisement”.
and any person who makes a false or misleading representation relating to medicinal products of a particular description —
to a practitioner for the purpose of inducing him to prescribe or supply medicinal products of that description;
to a patient or client of a practitioner for the purpose of inducing him to request the practitioner to prescribe medicinal products of that description; or
to a person for the purpose of inducing him to purchase medicinal products of that description from a person selling them by retail, is guilty of an offence.
Where, in the circumstances specified in subsection (2), any person who —
in connection with the sale of a medicinal product of the description in question, makes a representation relating to that product which consists of or includes unauthorised recommendations; or
for any such purpose specified in subsection (3)(a), (b)
and (c), makes a representation relating to medicinal products of that description which consists of or includes unauthorised recommendations, is subject to the following provisions of this section, guilty of an offence.
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Where a person is charged with an offence under this section, it shall be a defence for him to prove —
where the offence charged is under subsection (1) or (3), that he did not know, and could not with reasonable diligence have discovered, that the advertisement or representation was false or misleading;
where the offence charged is under subsection (2) or (4), that he did not know and could not with reasonable diligence have discovered, that the recommendations made by the advertisement or representation were unauthorised recommendations.
For the purposes of this section, an advertisement (whether or not it contains an accurate statement of the composition of medicinal products of the description in question) shall be taken to be false or misleading if —
composition
“composition”, in relation to a medicinal product, means the ingredients of which it consists and the proportions, and the degrees of strength, quality and purity, in which those ingredients are respectively contained in it;
it falsely describes the description of medicinal products to which it relates; or
it is likely to mislead as to the nature or quality of medicinal products of that description or as to their uses or effects, and any reference in this section to a false or misleading representation shall be construed in a corresponding way.
Any person guilty of an offence under this section is liable on conviction to a fine not exceeding $5,000, imprisonment for a term not exceeding 2 years or both.
In this section —
“false or misleading advertisement”
includes an advertisement which is not consistent with the information regarding a medicinal product that was approved during the medicinal product registration process under section 11;
“unauthorised recommendations”, in relation to the circumstances specified in subsection (2), means recommendations whereby medicinal products of a description to which the licence in question is applicable are recommended to be used for purposes other than those specified in the licence.
Medicines
Terms defined in this Act
composition
Defined · s 2“composition”, in relation to a medicinal product, means the ingredients of which it consists and the proportions, and the degrees of strength, quality and purity, in which those ingredients are respectively contained in it;
medicinal product
Defined · s 2“medicinal product” has the meaning ascribed to it by section 4;
practitioner
Defined · s 2“practitioner” means a medical practitioner, dentist or veterinary surgeon;
representation
Defined · s 51“representation” means any statement or undertaking (whether constituting a condition or a warranty or not) which consists of spoken words falling within paragraph (a) or (b) of the definition of “advertisement”.
Part