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Advertisement of Medicines Directed to the Public

The advertisement of medicines pertains to a market that is very different from that of other consumer products, and as such, it is subject to a special regime. This is justified both by the priority given to the consumers’ interest over the advertiser’s interest and by the impact that constitutional principles such as the right to health or the principle of consumer protection can have in these cases. All this results in specific regulations aimed at ensuring that this type of advertising is informative and truthful.

Royal Legislative Decree 1/2015, of July 25, which approves the revised text of Law 29/2006, of July 26, on guarantees and the rational use of medicines and health products, specifies in Article 80.3 that:

“The advertisement of non-prescription medicines will not require prior administrative authorization, although the competent health authorities will carry out the necessary controls to ensure that the advertising content complies with the applicable legal and regulatory standards and faithfully adheres to the scientific and technical conditions stated in the marketing authorization.”

Since this regulatory amendment does not establish any other prior administrative control system for this type of advertisement, the Ministry of Health, Consumer Affairs, and Social Welfare, considering the importance of conveying information about human medicines to the public, has established mechanisms to evaluate advertisements directed to the public. The Ministry of Health, Consumer Affairs, and Social Welfare collaborates with other organizations involved in this process, such as the “Association for the Self-Care of Health (anefp)” and the “Association for the Self-Regulation of Commercial Communication (AUTOCONTROL),” which are the economic operators involved in the advertisement of human medicines directed to the public. This collaboration has resulted in the signing of an Agreement between all parties. Its purpose is to ensure that the advertising messages comply with each and every condition imposed by the legal framework in this matter, without prejudice to the exercise of administrative powers that may apply. Its main objective is to promote self-regulation in the advertisement of human medicines directed to the public.

In particular, anefp offers a voluntary technical-health advisory service (Seal of Guarantee) and AUTOCONTROL provides a voluntary prior advertising control service (Copy Advice®). Additionally, AUTOCONTROL addresses complaints related to advertising messages directed to the public about human medicines through the Advertising Jury.

Specific Principles of Advertising of Human Medicines Directed to the Public

The advertising of medicines must adhere to all the general principles established in the following section, as well as to other more specific principles of medicine advertising outlined in the current legislation on this matter, which are detailed in section B:

A.- General Principles of Advertising Law

1. Principle of Legality: Advertising must comply with current laws, especially the values, rights, and principles recognized in the Constitution.
2. Principle of Social Responsibility: The advertising message must not suggest any form of discrimination, incite violence, or encourage illegal, unlawful, or socially unacceptable behavior.
3. Principle of Truthfulness: All content in the message must be adequately justified and, in the case of medicines, conform to what is authorized by the competent authority. The design and presentation of the advertisement must be clear and easily understandable by the intended consumer. Written notes must be in a font size that is easily readable.
4. Principle of Honesty: The advertising message must not abuse the trust of consumers or take advantage of their lack of information, inexperience, fears, anxieties, or superstitions.
5. Principle of Objectivity: Advertising must contain precise, balanced, honest, and objective information, and be sufficiently complete to allow the recipient to make the most appropriate choice for their needs.

B.- Specific Principles of Medicine Advertising

1. Adequacy of Content: All elements of a medicine advertisement must conform to the information provided in the technical data sheet or, failing that, the approved leaflet.
2. Promotion of Rational Use of Medicines: Medicine advertising must promote rational use in any case, presenting it objectively and without exaggerating its properties.
3. Principle of Health Loyalty: Medicine advertising must adhere to the following rules:

• If it refers to components of other legally authorized preparations, it must not highlight their absence or suggest they are less safe.
• It must not claim as exclusive any general characteristics that similar medicines comply with or should comply with.
• It must not rely on recommendations or testimonials from health professionals nor suggest that consulting them is unnecessary.
• It must not contain statements or illustrations guaranteeing a cure, nor create fear of suffering a more severe illness or contracting it by not using the advertised preparation. It should not imply that normal health can be improved by using the product.
• It must never be directed at children under 16 years old, nor suggest or recommend that the product be applied to them, unless the product’s marketing authorization and registration expressly allow it.
• It must not suggest that the product’s value or safety comes from being a natural product.

Requirements for Advertising Human Medicines Directed to the General Public

All advertisements for medicines aimed at the public must comply with the following general requirements:

1. The advertisement must be conducted in such a way that the advertising nature of the message is evident, and it must clearly specify that the advertised product is a medicine.
2. The advertisement must contain identifying data and recommendations as determined by the Ministry of Health, Consumer Affairs, and Social Welfare to prevent misuse and avoid the risks associated with normal use.
3. The advertisement must include essential information for the correct use of the medicine, and at a minimum:

• The name of the medicine, as well as the Spanish Official Denomination (DOE) or, failing that, the International Nonproprietary Name (INN), or the common or scientific name when the medicine contains a single active substance.
• A clear and visible invitation to read the instructions provided in the leaflet or on the external packaging, as appropriate, and the recommendation to consult the pharmacist for proper use.

d. The following text must be included in the advertisement message: “Read the instructions of this medicine and consult the pharmacist.”

e. All information included in the advertisement must be readable and perceptible, paying special attention to the font size, contrast with the background, and the duration the message remains visible.

Reminder Advertising

1. The advertising of a medicine aimed at the public may only include the name of the medicine, its INN or DOE, if available, or the brand name, provided the sole purpose is to remind the public of the name.
2. Optionally, besides the name/brand of the medicine, the advertisement may include the name and logo of the laboratory, the logo of the medicine (colors, typography, symbols, and/or elements that contribute to brand identification), and a phrase such as “in case of doubt, consult your pharmacist” or a similar expression.
3. Reminder advertising does not allow the inclusion of images, slogans, or other advertising elements.
4. A medicine is considered eligible for reminder advertising if it is sufficiently well-known by the public and has been included in promotional campaigns for at least two years, or if it has been on the market for less time, it can demonstrate that it is sufficiently well-known by the public based on the impact of the campaigns conducted.
5. Reminder advertising of multiple medicines on the same medium is permitted.

Prohibitions

The advertising of a medicine aimed at the public may not include any element that:

1. Attributes a superfluous nature to a medical consultation or surgical intervention, especially by offering a diagnosis or advising treatment by correspondence.
2. Suggests that its effect is guaranteed, that it has no side effects, or that it is superior or equal to another treatment or medicine.
3. Suggests that the user can improve their health by using it or that their health may be affected by not using it; this prohibition does not apply to vaccination campaigns regulated by Royal Decree 1416/1994. In particular, it is prohibited to suggest that the use or non-use of the advertised medicine generally improves or worsens health, although this prohibition does not extend to references about the efficacy of the medicine concerning the specific therapeutic indication for which it is authorized.
4. Suggests or indicates that its use enhances athletic performance.
5. Is directed exclusively or primarily at children.
6. Refers to a recommendation made by scientists, health professionals, or other persons who may, due to their notoriety, incite the consumption of medicines.
7. Equates the medicine to a food product, cosmetic, or any other consumer product.
8. Suggests that the safety or efficacy of the medicine is due to it being a natural substance.
9. May induce, through a detailed description or representation of the case history, a false self-diagnosis.
10. Refers abusively, alarmingly, or misleadingly to testimonials of cures.
11. Uses abusive, alarming, or misleading representations of body alterations caused by diseases or injuries, or the action of a medicine on the human body or parts thereof.

Mandatory elements that must appear in the Advertisement

The following elements must always appear in the advertisement, in a legible font size and in a visible position:

1. The name of the medicine and the active ingredient if it is a single-drug product.
2. The name and/or logo of the marketing authorization holder laboratory (provided it includes the name of the laboratory) or its local representative in Spain.
3. The authorized therapeutic indication, including the age of the recipients if it is part of the indication.
4. Contraindications, precautions, and important warnings, as currently incorporated and subject to future updates.
5. The phrase “Read the instructions of this medicine and consult the pharmacist” in a legible font size.

Information on Advertising Activities

In accordance with the provisions of Article 21(b) of Royal Decree 1416/1994, of June 25, which regulates the advertising of human medicines, it is the obligation of the marketing authorization holder laboratory to submit an annual index of all advertising activities carried out during the year to the Ministry of Health, Consumer Affairs, and Social Welfare, specifically to the Directorate General of Basic Services of the SNS Portfolio and Pharmacy, Professional Information and Medicines Advertising. The submission of the annual activity index must be completed during the month of January following the reference period.

Code of Good Practices for Advertising Medicines to the Public

The code aims to establish principles, criteria, and recommendations to promote best practices in the advertising of over-the-counter medicines to the public. The main recommendations are highlighted below:

1. Compliance with the technical sheet: Advertising must adhere to the authorized technical sheet, avoiding technical terms incomprehensible to the average consumer, and, if necessary, the authorized leaflet.
2. Dosage information: When including graphical information about the dosage, it must be clear and in line with the leaflet.
3. General indications: The activity of the medicine can be mentioned instead of the specific indication, as long as it is understandable and aligned with the authorized indications.
4. Highlighting occasional nature: Emphasize the occasional nature of certain conditions such as insomnia or occasional constipation.
5. Speed of action: References to the speed of action of the medicine are allowed if supported by the technical sheet or leaflet.
6. Site of action: The site of action of the medicine must be accurate, using appropriate phrases such as “acts on the pain site”.
7. Active ingredient properties: These can be mentioned as long as they are related to the authorized indication and are understandable to the consumer.
8. Medicine characteristics: Characteristics related to the pharmaceutical form or excipients can be mentioned if justified.
9. Popular denomination: The popular name of the active ingredient can be used if it facilitates understanding of the advertising message.
10. Message focus: The message can focus on an authorized indication or a specific population group.
11. Fictitious packaging: Must represent the authorized packaging and include all mandatory information.
12. Comparative advertising: Allowed if done objectively between essential and verifiable characteristics of the medicines.
13. Prohibitions: Do not suggest that the effect of the medicine is superior or equal to another treatment or medicine.
14. Self-comparison: Not considered comparative advertising when between medicines from the same company.
15. Nicotine replacement therapy: Always include the importance of willpower.
16. Game-like advertising: Allowed if it does not trivialize the use of the medicine and is not mainly directed at children, justified in an educational context.
17. Combined advertising: Clearly identify the nature and purpose of each advertised product.

These recommendations aim to ensure that medicine advertising is clear, understandable, and compliant with authorized indications and regulations, promoting the rational and safe use of medicines.

Legal Framework

European Regulations:

1. Directive 2001/83/EC: Establishes a Community code on human medicines, particularly Articles 86-90 and 97-100.
2. Directive 2006/114/EC: Addresses misleading and comparative advertising.
3. Directive 2006/123/EC: Relates to services in the internal market.
4. Directive 2010/13/EU: Coordinates legal, regulatory, and administrative provisions among Member States regarding audiovisual media services.

National Regulations

1. Order of December 10, 1985: Regulates advertising messages for medicines and certain health products.
2. Law 14/1986: General Health Law, particularly Article 27.
3. Law 34/1988: General Advertising Law.
4. Law 3/1991: Law on Unfair Competition.
5. Royal Decree 1416/1994: Regulates the advertising of human medicines.
6. Circular 6/95: Provides clarifications to Royal Decree 1416/1994, amended by Circular 7/99.
7. Law 34/2002: Regulates information society services and electronic commerce.
8. Law 29/2005: Regulates Institutional Advertising and Communication, particularly Article 5.
9. Royal Decree 1345/2007: Regulates the authorization, registration, and conditions for dispensing industrially manufactured human medicines, particularly Article 25.
10. Royal Decree 1494/2007: Sets regulations for accessibility to information and communication technologies for people with disabilities.
11. Law 7/2010: General Audiovisual Communication Law.
12. Royal Decree 1624/2011: Develops regulations under Law 7/2010 related to television commercial communication.
13. Legislative Royal Decree 1/2015: Approves the consolidated text of the Law on Guarantees and Rational Use of Medicines and Health Products, specifically Article 80.