Health products, whether regular or irregular, are objects of consumption. Just as there are medications whose consumption is restricted, we also face tightly constrained legislation.
Regarding the advertising of health products, our legal system includes the General Health Law No. 42-01 of March 8, 2001, the General Consumer or User Protection Law No. 358-05 of September 19, 2005, and the Drug Regulation No. 246-06 of June 9, 2006.
The legislator has been forced to include in these health provisions and those regulating consumer rights, aspects related to the advertising of health products due to their impact on public health.
Medications that may be advertised are those whose consumption does not have serious health effects and are therefore not subject to strict controls or medical prescriptions.
While it is necessary to provide information to the consumer public, the promotional support and marketing of these types of health products should not be directed directly at the end recipients or users, but should operate through healthcare professionals authorized to prescribe. In the case of products that can cause harm, our legislation has established an authorization regime for the purpose of placing a medicine on the market and appropriately advertising it.
The danger or harmfulness of certain products justifies advertising controls. Once these medications have been classified, a medical prescription is required for their use.
Likewise, there are other health products, such as objects, utensils, devices, equipment, materials, or methods beneficial to health, whose advertising is restricted in accordance with current special legislation.
In accordance with the provisions of article 40, literal a), of the General Health Law No. 42-01 dated March 8, 2001, it is the responsibility of the Ministry of Public Health and Social Assistance, together with other specialized institutions in the matter, to issue regulations aimed at preventing and combating drug addiction, among other actions, through research on the cause, habit of drug consumption (medicines), and
on the effects of advertising on increasing consumption.
Likewise, Article 109, paragraph a), of the aforementioned legal text places the Ministry of Public Health and Social Assistance in charge of controlling the promotion and advertising of medicines, personal hygiene products, toxic substances that pose a health risk, and the materials used in their manufacture, among others.
What do we call “health products”?
They include health products, medicines, foods for medical use, biomaterials, health care equipment, cosmetics and personal hygiene products, pharmaceutical products, dental products, prosthetics, surgical materials, psychoactive substances, among others.
What is health product advertising?
Firstly, it should be noted that in accordance with the spirit and letter of the General Law on Consumer or User Protection No. 358-05, dated September 19, 2005, advertising in the general sense is any form of communication carried out directly or indirectly " by a natural or legal person, public or private, in the exercise of a commercial, industrial, artisanal or professional activity, in order to inform, motivate or induce the acceptance and/or acquisition of the offer of goods and services ."
Specifically, Article 273 of Drug Regulation No. 246-06 of June 9, 2006, defines drug advertising or propaganda as "any form of informational offering intended to promote the prescription, dispensing, sale, or consumption of drugs, whether through publications, projections, or transmissions of notices, labels, signs, or any other means of dissemination."
Form requirements for advertising health products
Any company operating in the health product sector that intends to develop advertising campaigns for pharmaceutical products aimed at the public must apply, through the owner or technical director of the establishment or registered product, for authorization from the General Directorate of Drugs and Pharmacies of the Ministry of Public Health and Social Assistance, the body with exclusive jurisdiction for these purposes. This application must be accompanied by the corresponding advertising project.
Consequently, individuals or legal entities engaged in the design and distribution of advertising may not provide their services until the interested party presents the corresponding authorization issued by the General Directorate of Drugs and Pharmacies.
Below are the main formal requirements that all health product advertising must meet:
- The text of the advertisement must be written in Spanish;
- The infallibility of a medication should not be accepted, nor should its application to symptoms for which it is not indicated in the registration documentation;
- The actions, degree of relief and benefit of the medication should also be
correspond to what is authorized by the competent authority;
- You may not attribute false virtues or mislead about the qualities of the medicine;
- It must be consistent with the audience it is intended for;
- You may not indicate or suggest that the advertised medicine is
recommended by the Ministry of Public Health and Social Assistance;
- It should not encourage people to avoid seeking medical treatment and/or undergo diagnostic or rehabilitation procedures.
Specific prescriptions
Pursuant to the provisions of Article 245 of Drug Regulation No. 246-06 of 2006, advertising shall be carried out in accordance with the regulations established in said legal text, as well as in General Health Law No. 42-01 and in the complementary regulations that the Ministry of Public Health and Social Assistance deems appropriate to develop.
The aforementioned Regulation governs, among other things, the advertising of medicines, medical devices, personal hygiene products, and pharmaceutical products of natural origin marketed for therapeutic purposes, among others.
Thus, it assigns to the General Directorate of Drugs and Pharmacies of the Ministry of Public Health and Social Assistance the role not only of issuing authorizations for drug registration applications, provided they meet the legally established health and marketing conditions, but also of establishing the marketing conditions for each product regarding its advertising.
Pursuant to Article 16 of the aforementioned Regulation, "Medicines shall be classified, based on their advertising, as: a) Medicines authorized for advertising to the general public; b) Medicines authorized for advertising to professionals.
In this regard, Article 35, paragraph n), establishes three conditions regarding the advertising of medicines: 1. Advertising to the general public; 2. Advertising to professionals; 3. Non-advertising.
So we necessarily have to talk about two types of medicines: those whose advertising is permitted or authorized (aimed at consumers or health professionals), and those whose advertising is prohibited.
When the recipient of the advertising is a consumer (general public)
Drug Regulation No. 246-06 of June 9, 2006, provides in Article 246 that advertising "may only be used for those drugs whose active ingredient is included in the list of over-the-counter drugs for sale, and whose advertising rights are recognized by the owner within the registration process." That is, express authorization from the General Directorate of Drugs and Pharmacies is required for advertising purposes.
When advertising is prohibited
According to Article 247 of the Medicines Regulation, all types of public advertising of medicines that require a medical or dental prescription are prohibited. Advertising of psychotropic and narcotic drugs is prohibited.
Exception: when the recipient is a health professional
Advertising for the aforementioned medications may only be directed toward professionals. In the case of psychotropic and narcotic drugs, advertising may be authorized for health professionals provided their role is related to advertising, for example, a psychiatrist.
Offenses committed due to non-compliance with the formal requirements of advertising
In accordance with article 268, paragraphs 43, 60, 61 and 66 of the Drug Regulation No. 246-06, the following are considered irregularities or faults in the field of advertising of medicinal products:
a) Carry out promotion, information or advertising of unauthorized medicines such as
advertising;
b) Advertising, by the holder of the specialty, of promotional medicines without authorization, or not complying with the conditions established in the authorization for advertising dissemination, or with the provisions of the specific legislation and regulations, provided that the medicine is promotional and the advertising is made to the public;
c) Carry out, by the advertising company, whether in design or in dissemination, the work and actions required for the advertising of medicines without the author of the order presenting the approval for this advertising obtained from the General Directorate of Drugs and Pharmacies;
d) Advertising of magistral formulas or official preparations 1