Introduction

On December 20 2017 the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) published new guidelines for the authorisation of ad applications regarding prescription and over-the-counter drugs, herbal remedies and homeopathic medicines.(1)

The guidelines include several provisions that appear to be against the General Health Law and the Health Law Regulations on Advertisements.

Promotion of drugs in exchange for products or services

Section V(44) of the Health Law Regulations on Advertisements bans ads that promote the use of drugs by offering other products or services in exchange for such use.

However, the new guidelines allow for several promotional activities linking a non-prescription drug with other products, such as:

  • bottled water, sugar substitutes and energy foods and drinks;
  • personal care or hygiene products;
  • medical devices that do not require a prescription and are used for the same ailment as the non-prescription drug; and
  • general gifts, as long as they:
    • are related to consumers' health and wellbeing,
    • are aimed at the same age group as the non-prescription drug; and
    • do not constitute toys or objects that would induce irrational uses (eg, event tickets or kitchen or office appliances).

Television and internet ads

Under Article 310 of the General Health Law and Articles 40 and 42 of the Health Law Regulations on Advertisements, prescription drugs can be advertised only to health professionals via specialised media. These articles were previously enforced through a general ban on television and internet ads.

However, the new guidelines allow for television and internet ads, provided that specific requirements are met. For example, such ads must:

  • include a reference warning against self-prescription;
  • promote the existence of innovator and generic drugs; and
  • include a statement that the ad is aimed at health professionals.

Other changes

The new guidelines also regulate institutional ads and require mandatory warnings to be included in ads for homeopathic medicines and herbal remedies.

Comment

A number of interesting scenarios may arise from the new guidelines. For example, some companies may be inclined to take advantage of the broader permissions. However, others may face restrictive internal policies and may challenge authorisations granted by the COFEPRIS to competitors based on the abovementioned provisions.

The informal nature of these guidelines allows them to be modified or cancelled without undergoing a full regulatory process.

For further information on this topic please contact Juan Luis Serrano-Leets or José Alberto Campos Vargas at Sanchez-DeVanny Eseverri SC by telephone (+52 55 5029 8500) or email (jlserrano@sanchezdevanny.com or jacampos@sanchezdevanny.com). The Sanchez-DeVanny Eseverri SC website can be accessed at www.sanchezdevanny.com.

Endnotes

(1) The new guidelines are available on the COFEPRIS website.

This article was first published by the International Law Office, a premium online legal update service for major companies and law firms worldwide. Register for a free subscription.