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MERCOSUR Adopts Guidelines on Promotion, Advertising & Marketing of Pharmaceuticals
By Keith R | December 30, 2008
Topics: Advertising/Promotion, Health Issues, Pharmaceutical Issues | No Comments »
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I’ve said here many times that Latin American and Caribbean (LAC) nations tend to take seriously the recommendations, guidelines and other soft norms of the World Health Organization (WHO) on any issue involving public health and/or the environment, and I’ve tried to provide a few examples where WHO work has translated into national laws and norms.
At the end of November the Common Market of Southern Cone, better known as MERCOSUR or MERCOSUL, provided yet another concrete example, this time involving the marketing of pharmaceuticals. [Companies facing calls for WHO action on advertising food and beverages to children, take notes!] This new MERCOSUR rule will affect the pharmaceutical market in Argentina, Brazil, Paraguay and Uruguay, as well as Venezuela once ratification of its membership agreement is completed (although the impact may be felt less in Brazil, whcih just revised its own rules on this question).
MERCOSUR’s Common Market Group (GMC) adopted a binding resolution on MERCOSUR Guidelines for promotion, advertising and marketing of medicines that is explicitly based on WHO’s Ethical Guidelines for Medicinal Drug Promotion. The MERCOSUR guidelines call for:
- Advertising to promote the rational use of medicines;
- Advertising material to present the essential characteristics of the drug, such as active ingredient, brand name / trade indication, main precautions, contra-indications and warnings;
- The information provided to be reliable, accurate, true, current and capable of providing input for clinical decisions;
- The advertising elements to be accurate and verifiable, clearly and precisely identify source;
- The advertising not to lead to the indiscriminate, unnecessary, incorrect or inappropriate prescription, dispensing or use of medicines;
- Information in drug promotion to be disclosed in a balanced way, describing both the benefits and risks associated with their use;
- Medicine advertising directed at the general public to enable rational choices regarding the use of over-the-counter drugs, considering the legitimate right to information relating to health, without taking advantage of concerns related to it;
- No advertising of psychotropic or narcotic drugs to the general public;
- The information contained in marketing material not to induce mistaken interpretations capable of causing false interpretations, errors and/or confusion about the drug;
- Structuring any promotion or advertising of medicines in such a way as to make it clear the promotional nature of the message;
- Not using expressions with a strong emotional content, capable of causing fear or anxiety, or suggesting that health may be affected by the non-use of the drug;
- Medicine advertising not to include messages, images or symbols of any kind or be addressed to juvenile public;
- The propaganda not to suggest that a certain drug is safe or effective, or in those terms compared it with another drugs, except when the claims can be demonstrated in clinical studies or substantial evidence.
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