Is there a statutory or generally accepted definition of “advertising”? a) What does the definition cover? – does it include patient information leaflets, for example, catalogues, disease awareness campaigns or correspondence, for example? b) Does the definition apply equally to all target audiences?
The definition of Art 86 Directive 2001/83/EC was implemented in the AMG: Advertising of medicinal products shall include any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products.
This definition does not apply to labelling and package leaflets, to correspondence needed to answer a specific question about a particular medicinal product (possibly accompanied by material of a non-promotional nature), trade catalogues and price lists (provided they do not contain information on medicinal products) and statements relating to human health or diseases, provided there is no reference, even indirect, to medicinal products.
This definition covers the advertising of medicinal products to the general public (‘lay advertising’) and to persons qualified to prescribe or supply them (‘professional advertising’).
Advertising for these purposes is “any form of door-to door information, canvassing activity or stimulation which is designed to promote the prescription, release, supply, sale or consumption of medicinal products” (article 9 AMP).
The above definition is extended by naming specific examples, such as provisions of samples, visits to healthcare professionals, sponsorships of scientific conferences and incentives to deliver or prescribe medicines by providing financial or in-kind benefits (article 2 §2 RDAMP).
Excluded from the definition are patient information leaflets, product labels and general information regarding health and disease areas with no direct or indirect reference to a medicinal product, including disease-awareness campaigns.
Moreover, the definition does not cover unsolicited medical information about a particular drug product given by a pharma company in reply to a patient’s or healthcare professional’s request, as long as such information is strictly necessary to answer said request and does not contain unsolicited promotional content.
See above under question 3.a.
The definition of advertising of medicines is provided in the Law on Pharmacy of the Republic of Lithuania. This advertising includes the spread among the general public, healthcare professionals and pharmaceutical specialists, in any form and by any means, of purposive information about medicinal products, the canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products. These activities include:
(i) visits by medical sale representatives to healthcare professionals;
(ii) distribution of free samples of medicinal products;
(iii) the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of a benefit or bonus, whether in money or in kind;
(iv) sponsorship of promotional or scientific events, attended by healthcare and pharmaceutical specialists and in particular payment of the travelling and accommodation expenses of the participants of such conferences;
(v) the support of radio, television broadcasts and/or programmes during which information about medicinal products is provided.
In practice, advertising of medicines is considered to be the presentation of branded medicine names, medicine package images, medicine filler images on the slides (whether in scientific reports or promotional messages).
The assessment of advertising is individual in each separate case and depends on an array of circumstances. For example, patient information leaflets are not advertising in themselves, but if excerpts from two patient information leaflets of competing medicines are provided by comparing the contraindications of these products with each other, it will be considered comparative advertising.
Yes, it applies to all groups of interest.
Pursuant article 2 section IX of HLR advertising is defined as “the activity comprehending any process of creation, planning, execution and circulation of ads in media channels which aims to promote the sales of consumption of products and services”.
The law distinguishes between general public and healthcare professionals, different rules and obligations arise depending on the targeted audience.
The 2007 Regulations define ‘advertising’ of a medicinal product as including any form of door to door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products and including in particular—
a) the advertising of medicinal products to the general public;
b) the advertising of medicinal products to persons qualified to prescribe or supply them;
c) visits by medical sales representatives to persons qualified to prescribe medicinal products;
d) the supply of samples of medicinal products;
e) the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind;
f) the sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products; and
g) the sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products and in particular payment of their travelling and accommodation expenses in connection therewith.
This definition is wide reaching and includes any material or act which would come under the scope of the definition of advertising above. The 2007 Regulations do provide the following exclusions:
a) the labelling of medicinal products and the accompanying package leaflets, where such labelling and package leaflets are in compliance with Regulation 16 of the Medicinal Products (control of placing on the market) Regulations 2007. For example labels and leaflets must contain the expiry date of the medicine, special storage requirements and a special warning if necessary;
b) correspondence, which may be accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product;
c) factual, informative announcements and reference material relating, for example, to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists, provided they include no product claims;
d) books, journals, periodicals and other publications that are imported into the State and which contain advertising which is not intended for or directed at persons resident in the State;
e) information relating to human health or diseases, provided there is no reference, even indirect, to medicinal products.
Health/disease awareness campaigns come within the scope of the exclusions provided they do not directly or indirectly refer to a medicinal product. Catalogues are excluded provided they make no product claims.
Yes, however, different advertising rules apply to different audiences.
Advertising of medicines is defined in article 150 (1) of Decree Law 176/2006 of August 30 as any form of information, prospection or incentive which scope or effect is the promotion of medicine´s prescription, dispense, sale, acquisition or consumption in any of the following circumstances:
(a) Before the public in general;
(b) Before wholesale distributors and healthcare professionals;
(c) Through the visit of medical sales representatives to healthcare professionals;
(d) Through the provision of samples or commercial bonus to wholesale distributors and healthcare professionals;
(e) Though the granting, offer or promise of pecuniary or in-kind benefits, except when its value is insignificant;
(f) Through the sponsorship of promotional meetings attended by healthcare professionals;
(g) Through the sponsorship of congresses or meetings of scientific nature attended/participated by healthcare professionals, namely through the direct or indirect payment of the respective hosting costs;
(h) Through the reference to the commercial name of a medicine.
The HWG does not provide a legal definition of advertising. Art. 86(1) of the Community Code (Directive 2001/83/EC) defines the concept of advertising as “any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products” and provides specific examples for such advertising. Under German law, advertising is generally understood in a very broad manner and captures any commercial act which is intended to promote the sale of goods and services. Thus, most communication by companies is considered as advertising.
As pointed out, the definition of advertising is very broad. It covers all product- or performance-related statements that are designed to promote the sale of the advertised medicinal product. It is not required that the promotion of sales is the only or main purpose of the communication. Instead, it is sufficient that the communication is inter alia suited to promote the sales. Against this background, also information provided in patient information leaflets, catalogues, correspondence or in case of disease aware campaigns are suited to qualify as advertising.
However, the mere provision of information in patient information leaflets, catalogues, correspondence is generally not subject to the restrictions of the HWG as long as such communication has no advertising purpose and the information contained in such communication is restricted to minimum necessary for fulfilling its respective purpose.
Yes, the definition for advertising equally applies irrespective of the targeted audience.
However, the statutory requirements for such advertising can then be different depending on whether the advertising is made to the general public or healthcare professionals.
The Consumer Act defines "advertisement" as prepared and through any form of mass medium, subsequently applied, disseminated or circulated advertising matter. "Advertising" means the business of conceptualizing, presenting or making available to the public, through any form of mass media, fact, data or information about the attributes, features, quality or availability of consumer products, services or credit.
Under the PPPMD Guidelines, promotion is the practice of giving temporary additional value to a brand, product or service to achieve specific marketing objectives, and this is distinguished by the FDA from advertisement which it considers as any representation by any means whatsoever for the purpose of promoting, directly or indirectly, the sale or disposal of any pharmaceutical product.
Yes. However, as will be discussed in the succeeding items, the materials and information that may be advertised will depend on the type of product that is subject of the advertisement and the target audience.
‘Advertising’ as such is not defined by statute in Sweden. ‘Marketing’ of medicinal products is defined in LVFS 2009:6. The definition implements and shall correspond to the definition in EU Directive 2001/83/EC according to the preparatory works to the Medicinal Products Act. This means that the concept of advertising of medicinal products shall be interpreted in conformity with EU law.
The definition of ‘Marketing’ covers:
- any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products. In particular it includes:
- advertising of medicinal products to the general public;
- advertising of medicinal products to persons authorised or entitled to prescribe or supply them;
- visits by medical sales representatives to persons authorised or entitled to prescribe medicinal products; and
- the supply of samples.
Package leaflets, correspondence with a non-commercial message required to respond to specific questions on certain medicinal products, and information on health and diseases such as disease awareness campaigns (under the prerequisite that they do not mention any medicinal product or active substances) are not covered by the definition.
Marketing of medicinal products is thus more narrowly defined than marketing in general under the Marketing Practices Act, where marketing is defined as advertising and other measures in commercial activities which are intended to promote the turnover of, and access to, products or services, including a trader's acts, omissions, or other measure or behaviour before, during or after the sale or delivery of products or services.
There is no separation between target audiences in relation to what constitutes marketing of medicinal products. However, there is a separation between target audiences when it comes to what constitutes permissible marketing of medicinal products. As such, it is not permissible to market medicinal products to children, and there are separate rules that apply to marketing to the general public and marketing targeting healthcare professional (‘HCP’)s and other professionals authorised or entitled to prescribe or supply medicinal products.
The law provides a definition of advertising for medicine. Advertising for medicines means any type of information, prospection and incentive, which aims at encouraging the prescription, the supply, the sale, the consumption or the use of medicines (Art. 2 let. a OAM). However, this definition does not include the packing material or medicine information, catalogues or price lists, insofar as they do not contain any medical data. General health or disease information is also excluded from this definition to the extent that it does not refer directly or indirectly to specific medicines (Art. 1 al. 2 OAM).
As explained above, it covers any type of information, which aim at encouraging the prescription, the supply, the consumption or the use of medicines. However, general information about illnesses (catalogues, disease awareness campaigns or correspondence) are not covered as long as they do not refer to a specific medicine directly or indirectly. It is considered that information about the origin and the nature of illnesses, general health advice or an advertisement-neutral list of all therapy options in the area of the illness discussed, are not covered by the definition of advertising. Swiss authorities evaluate the situation on a case-by-case basis, while taking the context into consideration.
Advertising for prescription medicines is limited to healthcare professionals. Healthcare professionals are persons authorised to prescribe, supply or use medicinal products professionally and under their own responsibility (Art. 2 let. c OAM).
The type of advertising allowed depends on the audience:
- Advertising to healthcare professionals is allowed as follows (Art. 4 OAM):
- advertisements published in professional journals and other printed material for professionals;
- advertising on objects;
- advertising spread by electronic media (such as image, sound and data media) or by computer applications;
- advertising presented at scientific congresses or at promotional events;
- organising and financing promotional events, hospitality offered at scientific conferences or promotional events (from 1 January 2020 no more considered as advertising but as benefit subject to Art. 6 OITTP);
- advertising mailings and promotional material, visits by medical representatives and samples deliveries.
- Advertising to the general public is allowed as follows (Art. 15 OAM):
- advertisements published, in particular, in newspapers, magazines and books, leaflets, posters, circulars;
- advertising on objects;
- advertising spread by electronic media (such as image, sound and data media) or by computer applications;
- advertising presentations made at home or at conferences held in front of non-specialists;
- advertising made at doctors’ or veterinary surgery, and at places of delivery (showcases, sales containers) and samples deliveries.
Yes. Advertisement is broadly defined to be any act by any means which propagates information about medicine for commercial purpose. The Regulation of the Office of the Food and Drug Administration Regarding the Requirements on Advertising the Sale of Drug, B.E. 2545 (2002) (the "Regulation") issued under the Drug Act, elaborate further as follows:
i) "advertising the sale of drugs through general media" means advertising for the sale of drugs via radio, loudspeakers, television, picture projection, or film, through print, such as via a brochure, handbill, book, newspaper, magazine, bulletin, billboard, or other materials, or online.
ii) "advertising the sale of drugs directly to healthcare professionals ("HCPs")" means advertising the sale of drugs directly to medical and veterinary practitioners through any media, such as medical journals, brochures, handbills, billboards, posters, or other materials, or online.
Advertising is defined to include any printed matters, e.g. a brochure, handbill, book, newspaper, magazine, bulletin, billboard, or other materials, or online.
As there are two types of advertising the sale of drugs, each type of advertising has different requirements and restrictions pursuant to the Drug Act. For example, the advertisement for the sale of drug directly to the HCPs must also refer to a study or research that is reliable and in accordance with the international standard. In any case, the advertising information must not be false or exaggerated.
"Advertisement" is broadly defined in Article 7 (1) of the Regulations as "anything designed to promote the prescription, supply, sale or use of that product."
The Regulations specify that the definition of "Advertisement" includes:
- door-to-door canvassing;
- visits by medical sales representatives to persons qualified to prescribe or supply medicinal products;
- the supply of samples;
- the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except where the intrinsic value of such inducements is minimal;
- the sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products; and
- the sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products, including the payment of their travelling and accommodation expenses.
However, the Regulations clarify that "Advertisement" does not include:
- a medicinal product's package or package leaflet;
- reference material and announcements of a factual and informative nature, including:
a. material relating to changes to a medicinal product's package or package leaflet,
b. adverse reaction warnings,
c. trade catalogues, and
d. price lists, provided that no product claim is made; or
- correspondence, which may be accompanied by material of a non-promotional nature, answering a specific question about a medicinal product.
The ABPI Code does not define “advertising”, but uses the term “Promotion” instead. “Promotion” under the ABPI Code means “any activity undertaken by a pharmaceutical company or with its authority which promotes the administration, consumption, prescription, purchase, recommendation, sale, supply or use of its medicines” (Clause 1.2). The ABPI Code also provides a comprehensive list of specific activities which are considered to fall within the definition of Promotion and those which should not.
The PAGB Codes also contains detailed lists of examples of the various formats that advertising can take (again, a broad interpretation is adopted), together with lists to clarify what is not regarded as falling within the scope of the Code.
The Court of Justice of the European Union (“CJEU”) has provided some clarification on who is subject to the advertising rules under the statutory definition of "advertising". In the Damgaard case (C-421/07), the CJEU ruled that it is not necessary for the message to be disseminated by a person linked to the manufacturer and/or seller of the medicinal product or to be disseminated in the context of commercial or industrial activity in order for it to be held to be advertising. However, regarding the rules relating to inducements to prescribe, the CJEU has held that national public health authorities may lawfully offer incentives to doctors to prescribe certain medicines in preference to others when pursuing public health policy, including any policy on the public expenditure on pharmaceuticals (Case C-62/09 ABPI).
Furthermore, the CJEU concluded that the dissemination of information that is a faithful and complete reproduction of the approved package leaflet or summary of product characteristics ("SPC") of a medicinal product is unlikely to be considered advertising, although a selection of extracts or rewriting of any such information, which can be explained only by an advertising purpose is prohibited (Case C-316/09 MSD).
The NPPM defines ADVERTISING as “every way of impersonal communication paid by a sponsor about a product, service and organization, transmitted to the public by means of a social mass media”; and PROMOTION as “every informative, for divulgation, persuasion and recordation activity, developed by manufacturers, distributors and representatives, with the aim of leading to the prescription, dispensation, supply, acquisition or utilization of such products”.
Yes, it´d be under the scope of the definition of promotion.
Neither the FD&C Act nor the FTC Act explicitly define “advertising,” and there is no one standard definition of the term. That said, “advertising” is generally interpreted broadly to include promotional materials disseminated to the consuming public, regardless of the format, manner or medium through which they are presented.
FDA regulations offer helpful guidance by specifying examples of materials it will regulate as “advertisements,” including print (for example, “published journals, magazines, other periodicals, and newspapers”) and broadcast (“media such as radio, television, and telephone communication systems”) advertising. See 21 C.F.R. § 202.1. “Advertising” is a legally distinct concept from promotional “labeling,” which is defined by the FD&C Act to mean “all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.” In practice, any industry promotional materials that do not fall within the FD&C Act definition of labeling should be considered “advertising.”
There is no statutory definition of "advertising" or "advertisement" in Australia; however, "advertise" is defined in relation to therapeutic goods in the TG Act as:
in relation to therapeutic goods, includes make any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation or design:
(a) is on the label of the goods; or
(b) is on the package in which the goods are contained; or
(c) is on any material included with the package in which the goods are contained.
The TG Advertising Code extends this by defining "advertiser" as:
a person who:
(a) advertises, by any means, therapeutic goods; or
(b) causes the advertising, by any means, of therapeutic goods.
The Medicines Australia Code defines "advertisement" with reference to the statutory definition of "advertise" in the TG Act.
The ASMI Code adopts an even broader definition of "advertisement/promotion" as:
any form of communication, including by means of:
(i) Any form of publication, display, notice, catalogue, leaflet, booklet, letter (whether circular or addressed to a particular person) or other document;
(ii) Any educational event or training material;
(iii) Any packaging materials (including labels, cartons, direction folders, and other packaging components bearing printed matter);
(iv) Any words inscribed on any article;
(v) Any exhibition of a photograph or film; and
(vi) Any sound recording, radio, television, digital media or spoken word.
Outside of the pharmaceutical sector, the AANA Code defines advertising or marketing communication as:
any material which is published or broadcast using any Medium or any activity which is undertaken by, or on behalf of an advertiser or marketer:
(a) over which the advertiser or marketer has a reasonable degree of control; and
(b) that draws the attention of the public in a manner calculated to promote or oppose directly, or indirectly a product, service, person, organisation or line of conduct.
The broad, purposive definition in the TG Act and TG Advertising Code covers all material intended to promote the use or supply of therapeutic goods and is not limited by the medium or type of communication used. The TG Act regulates the content of patient information leaflets. Whether materials are subject to the TG Advertising Code depends on the content and context of the materials. Depending on content then disease awareness campaigns can be captured and likewise catalogues.
The AANA Code excludes labels, packaging, corporate reports and media statements; however, the statutory and industry definitions specific to OTC and prescription medicines have been specifically broadened to ensure these types of materials are also regulated as advertisements.
The ACL applies to all forms of materials and has a broad prohibition on misleading and deceptive conduct together with more specific prohibitions.
The TG Advertising Code and the advertising provisions of the TG Act apply to all advertising of therapeutic goods, except those directed exclusively at health professionals or forming part of a public health campaign. The TG Advertising Code also does not apply to genuine news broadcast or published by certain, defined news agencies or broadcasters.
The Medicines Australia Code applies to advertising to both healthcare professionals.
The ASMI Code applies to advertising to healthcare professionals and consumers.
The ACL applies to all forms of materials to all target audiences. However the assumed knowledge level of the target audience (eg healthcare professional vs consumer) influences the determination of whether contravention has occurred.
 - Therapeutic Goods Act 1989 (Cth), s 3(1).
 - Therapeutic Goods Advertising Code (No. 2) 2018, s 4.
 - Therapeutic Goods Advertising Code (No. 2) 2018, s 6(2).
 - Therapeutic Goods Act 1989 (Cth), s 42AA(1); Therapeutic Goods Advertising Code (No. 2) 2018, ss 6(6)-(7).