Advice on appropriate pharmaceutical marketing

Medicines information – Neutral distribution of information

• Distribution of objective information without the purpose of promoting the sale of a medicinal product:
  • Summary of product characteristics
  • Package leaflet
  • Medicinal product database
  • Dosage and safety instructions
  • Price list
  • Press article
  • Press release
  • Health information campaign

Borderline cases – Purpose and content are crucial

• Prohibited:
  • Stealth marketing
  • Communication aimed at indirectly increasing the sales of a medicinal product

Pharmaceutical marketing – Promotion of sales

• Clearly identifiable marketing under the name of the medicinal product:
  • Brochures and advertisements
  • Trade event materials
  • Outdoor advertising
  • Video and audio advertisements
  • Banners and digital advertisements
  • Email marketing

1. A medicinal product that does not have a valid marketing authorisation or registration in Finland may not be marketed.
2. The pharmaceutical marketing is not inappropriate, it does not attract unnecessary use of the medicine or target children.
3. The pharmaceutical marketing is identifiable and transparent.
4. The pharmaceutical advertisement complies with the requirements of either a standard or reminder advertisement.
5. The indication of the medicinal product is clearly presented.
6. The minimum information and safety information are presented in an appropriate and clear manner.
7. The information provided in the marketing is compatible with the summary of product characteristics.
8. The claims are correct and verifiable.
9. The marketing of prescription medicinal products is only permitted to persons entitled to prescribe or supply the medicinal product.
10. An over-the-counter medicine may be marketed to the general population, but the restrictions on the information content must be taken into account.

The Finnish Medicines Agency Fimea requires that all marketing materials for medicinal products subject to additional monitoring under European Commission Regulation (EC) No 726/2004 (art. 23) display the symbol (inverted black triangle) specified in European Commission Regulation (EC) No 198/2013 and the accompanying, standardised explanatory sentence. 

It is Fimea's view that the additional monitoring of medicinal products in accordance with the regulations referred to above, including the the relevant markings, represents information necessary to the correct and safe use of a medicinal product referred to in Section 91 a of the Medicines Act, and essential information on the medicinal product and its use referred to in Section 91 b of the Medicines Act. 

The presentation of the inverted black triangle must comply with the specifications given in the Annex to regulation (EC No 198/2013), and each side must be at least 5mm long.   Smaller triangles may not be used. The text of the explanatory sentence must be easy to read and proportionate to the size of the triangle, as indicated below. Both the triangle and the standardised explanatory sentence must be enlarged as required to make them proportionate to the font size used elsewhere in the material. 

The inverted triangle is always black. No other colours are permitted. 

The triangle and the accompanying standardised explanatory sentence must be separated from other text.  The triangle and the sentence may not be separated from each other, nor should any other text or other elements be placed in their immediate vicinity. It is, however, permitted to add explanatory sentences used in the summary of product characteristics (This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. )after the standardised explanatory sentence. 

The triangle is not to be part of the product logo. 

In the case of electronic materials, the minimum recommendation is to place the black triangle and the explanatory sentence on the page on which the name of the medicinal product is displayed for the first time (usually the front page) and on the page containing product information, if this is a separate page. It is recommended that the same principle be followed in the case of other materials in which the product information is provided on a separate page. 

The inverted black triangle and the standardised explanatory sentence are not required in any reminder advertisements for the medicinal products in question. 

Sample triangle and explanatory sentence: 

In Finnish:  Tähän lääkkeeseen kohdistuu lisäseuranta.

in Swedish:  Detta läkemedel är föremål för utökad övervakning.

In English:  This medicinal product is subject to additional monitoring.

Regulation: Medicines Act, section 91

The marketing must not involve means such as lotteries, competitions, offers or free gifts that may lead to unnecessary or inappropriate use of over-the-counter medicines.

Regulation: Medicines Act, section 91

The marketing must clearly indicate that it concerns a medicinal product. Fimea recommends that the advertisement include the information “medicine” or “over-the-counter medicine”, as Fimea believes that the average consumer cannot be expected to identify a pharmaceutical advertisement without a corresponding clear expression.

Hidden or covert advertising is not acceptable. Advertising must be clearly distinguishable from editorial content. Disease or health communication aimed at the general population must not even indirectly market a specific medicinal product.

Regulations: Medicines Decree, sections 25 and 25b; Consumer Protection Act, chapter 2, section 4

Medicines may be marketed in two ways: by means of an advertisement containing detailed product information or a reminder advertisement, which may only contain the name of the medicinal product, the active substance and the marketing authorisation holder. Even short claims are not allowed in a remarketing advertisement. The following sections apply to a standard pharmaceutical advertisement.

Regulation: Medicines Act, section 91a

A medicinal product may only be marketed for an approved indication in the summary of product characteristics. Marketing in which the indication is presented inaccurately or as broader than the approved indication is a typical target of supervision. It is important to clearly indicate the approved indication of the over-the-counter medicine in the advertisement so that marketing claims can be understood in the right context.

Regulations: Medicines Act, section 91; Medicines Decree, section 25b

An over-the-counter medicine advertisement targeted at the general population must indicate at least the following:

• name of the medicine
• generic name if the medicinal product contains only one active substance
• information necessary for the correct and safe use of the medicinal product
• an explicit and easily readable request to carefully read the separate instructions for the use of the medicinal product.

One of the most serious errors is shortcomings or errors in the most essential information related to correct and safe use. It is not enough to have the required information in the advertisement – if the text, sound or images cannot be read, heard or seen clearly enough, the advertisement may be non-compliant. Presenting important information in a manner that is easily accessible to the average consumer also supports the use of the medicine as indicated in the package leaflet. Advice on presenting information clearly:

• Make sure that the font size is large enough and that the text stands out from the background, preferably black text on a white background.
• Consider the reading distance and the appropriate reading height.
• Make sure that the information is visible in videos for a sufficiently long time.
• In advertisements containing speech, ensure that background sound does not interfere with comprehensibility.

Fimea considers that an advertisement may be multi-part, in which case the minimum information may be presented in another part of the advertisement. In this case, both parts of the ad must form a coherent whole that is available to the reader with equal effort.

• In print media, one page may contain the first part of the ad, which presents the narrower information and refers to the second part, which appears on a later page and provides the minimum information. Both parts of the ad appear in the same print product.
• In digital media, the reader can first see the first part of the ad (banner), which presents the narrower information, from which one click gets to the second part, which provides the minimum information.
• Information on an exhibition wall or roll-up cannot be replaced or supplemented with material available from, for example, the exhibition table, display stand or exhibition presenters. In this case, the minimum information would not be available with the same effort as the rest of the advertisement. The compliance of the pharmaceutical advertisement as a whole is assessed from the perspective of a passing attendee.

Regulations: Medicines Act, section 91a; Medicines Decree, section 25b

The information presented in the marketing of an over-the-counter medicine must be compatible with the approved summary of product characteristics. No new research data which conflict with the summary of product characteristics may be used in marketing. The company must keep the summary of product characteristics up to date with all relevant efficacy and safety information.

An advertisement for a over-the-counter medicine may only include the approved indication, dosage instructions and safety information for that medicine. References to prescription medicines are not permitted. The indication and dosage instructions for the over-the-counter medicine are provided in its package leaflet and on its packaging.

Claims concerning the efficacy and safety of an over-the-counter medicine, for example, must be precise, up-to-date, justified and not give a false impression of the medicine.

References to studies should give a truthful idea of the conclusion, scope or significance of the study. It is important to present the references correctly and precisely enough so that they can be traced.

Regulations: Medicines Act, section 91; Medicines Decree, section 25a; Consumer Protection Act, chapter 2, sections 6–7

There are more restrictions on the information content in the marketing of an over-the-counter medicine than in the marketing of prescription medicines. It is important to know the restrictions on the information content laid down in section 25b of the Medicines Decree. These include not proposing to the general population that the effects of the medicine are guaranteed or do not involve adverse effects, or that the effects are as good or better than another treatment or medication. Therefore, marketing aimed at the general population must not compare the effects of medicines. It must also be ensured that the medicinal product and its information cannot be confused with another medicinal product or a product of another product category, such as a medical device or a food product. Fimea emphasises that advertisements for different products must be clearly distinguishable.

Regulation: Medicines Decree, section 25b

Yes

• A marketing authorisation or registration valid in Finland
• Encourages appropriate use of the over-the-counter medicine
• Clearly identifiable as marketing
• Presents a realistic picture of the over-the-counter medicine, including its indication, composition, benefits and potential harms
• The minimum information required by law is clearly presented
• The information corresponds tocomplies with the approved summary of product characteristics and package leaflet of the over-the-counter medicine
• References to studies are truthful

No

• Attracts unnecessary use of the over-the-counter medicine, for example, by marketing the medicine with a free gift
• Targets children
• Minimum information, such as safety-related information, is incomplete, incorrect or presented in such a way that it cannot be clearly noticed
• Too much emphasis on the use of effective advertising methods that distracts attention from the information content about the over-the-counter medicine
• Contains information that cannot be legally presented to the general population, such as comparisons with the effects of another medication or treatment
• Contains inaccurate, misleading, or exaggerating information such as extension of the indication

Regulations: Medicines Act, sections 91, 91a; Medicines Decree, sections 25, 25a–b; Consumer Protection Act, chapter 2, sections 1–7

Regulation: Medicines Act, section 91

Marketing a prescription medicine to the general population is a serious pharmaceutical marketing error. A prescription medicine can only be marketed to persons entitled to prescribe or supply the medicine, e.g. doctors and pharmacists. Prescription medicines may be marketed to students when they are performing prescription or supplying tasks. Marketing of prescription medicines must be targeted at these professionals in pharmaceutical presentations or publications and media intended for them. The marketing must be carefully planned and implemented in a way that prescription medicine marketing is not available to the general population. Digital marketing must be protected in a way that it is only available to a legal target group.

Regulation: Medicines Act, section 91b
 

Hospitality must be reasonable, secondary to the purpose of the event and only target healthcare personnel. In addition, various benefits and gifts must have little financial significance and be related to professional activities.

Regulation: Medicines Act, section 92

When marketing a prescription medicine, it must be clear that it is a commercial message. Hidden or covert advertising is not acceptable. Advertising must be clearly distinguishable from editorial content. Disease or health communication aimed at the general population must not even indirectly market a prescription medicine.

Regulations: Medicines Decree, section 25; Consumer Protection Act, chapter 2, section 4

Medicines may be marketed in two ways: by means of an advertisement containing detailed product information or a reminder advertisement, which may only contain the name of the medicinal product, the active substance and the marketing authorisation holder. Even short claims are thus not allowed in a reminder advertisement. The following sections apply to a standard pharmaceutical advertisement.

Regulation: Medicines Act, section 91b

A medicinal product may only be marketed for an approved indication in the summary of product characteristics. Fimea recommends precision in the presentation of the indication, especially when the indication is restricted to a certain patient group or second-line treatment. Marketing of a prescription medicine in which the indication is presented as broader than the approved indication is a typical target of supervision.

Regulations: Medicines Act, section 91; Medicines Decree, sections 25a, 25e

Marketing material targeted at persons authorised to prescribe or dispense supply medicinal products shall always include:

1. the essential information, corresponding to the summary of product characteristics, relating to the indications and usage recommendations of the product and its efficacy and safety;
2. the legal conditions for the dispensing of the medicinal product;
3. health insurance reimbursement conditions, average treatment costs, where possible, and retail prices for different pack sizes; and
4. the date on which the communication was produced or revised.

Fimea requires that marketing materials for medicinal products subject to additional supervision include a black inverted triangle and a standard sentence explaining it on a white background.

It is not enough to have the required information in the advertisement – if the text, sound or images cannot be read, heard or seen clearly enough, the advertisement may be non-compliant. Advice on presenting information clearly:

• Make sure that the font size is large enough and that the text stands out from the background.
• Consider the reading distance and the appropriate reading height.
• In videos, make sure that the information is visible for a sufficiently long time.
• In advertisements containing speech, ensure that background sound does not interfere with comprehensibility.

Fimea considers that an advertisement may be multi-part, in which case the minimum information may be presented in another part of the advertisement. In this case, both parts of the ad must form a coherent whole that is available to the reader with equal effort.

• In print media, one page may contain the first part of the ad, which presents the narrower information and refers to the second part, which appears on a later page and provides the minimum information. Both parts of the ad appear in the same print product.
• In digital media, the reader can first see the first part of the ad (banner), which presents the narrower information, from which one click gets to the second part, which provides the minimum information.
• Information on an exhibition wall or roll-up cannot be replaced or supplemented with material available from, for example, the exhibition table, display stand or exhibition presenters. In this case, the minimum information would not be available with the same effort as the rest of the advertisement. The compliance of the pharmaceutical advertisement as a whole is assessed from the perspective of a passing attendee.

Regulations: Medicines Act, section 91b; Medicines Decree, section 25e

The information presented in the marketing of a prescription medicine must be compatible with the approved summary of product characteristics. No new research data conflicting with the summary of product characteristics may be used in marketing. Advertising may also include claims that are not part of the summary of product characteristics, provided that they clarify or reinforce its content, not distort or contradict it. The company must keep the summary of product characteristics up to date with all relevant efficacy and safety information.

Regulations: Medicines Decree, sections 25a, 25e

Claims concerning the efficacy and safety of a prescription medicine, for example, must be precise, up-to-date, verifiable and not give a false impression of the medicine or its therapeutic value. 

References to studies should give a truthful idea of the conclusion, scope or significance of the study. Citations, tables and graphs from medical publications must be accurately reproduced. References must be presented correctly and precisely enough so that they can be traced.

Fimea recommends special attention to detail in comparisons. The comparisons presented must be relevant to the pharmacotherapy, appropriately selected and clearly presented. Using superlatives or emphasising superiority does not belong to compliant marketing of prescription medicines.

Regulations: Medicines Act, section 91; Medicines Decree, sections 25a, 25e; Consumer Protection Act, chapter 2, sections 6–7

Yes

• A marketing authorisation valid in Finland
• Only targeted at legal target groups
• Clearly identifiable as marketing
• The minimum information required by law is clearly presented
• All information is compatible with the approved summary of product characteristics, is accurate, up-to-date, verifiable and sufficiently complete to form an understanding of the therapeutic value of the medicinal product
• Information from medical publications or studies has been accurately presented and sources have been precisely reported

No

• Encourages unnecessary use
• Marketed at the general population
• Too much emphasis on the use of effective advertising methods that distracts attention from the information content about the prescription medicine
• Minimum information, such as safety-related information, is incomplete, incorrect or presented in such a way that it cannot be clearly noticed
• Contains information which conflicts with the summary of product characteristics 
• Contains vague, misleading, or exaggerating information such as extension of the indication or inappropriate comparisons
• Regulations: Medicines Act, sections 91, 91b; Medicines Decree, sections 25, 25a, 25e; Consumer Protection Act, chapter 2, sections 4, 6–7