In Mexico, the General Health Law (GHL) is the federal legislation that regulates advertising in connection with medicines as well as other medical products, including devices. This federal law is grounded in the Mexican Constitution (Constitución Política de los Estados Unidos Mexicanos), Article 4 of which establishes healthcare protection as a human right.

The Mexican healthcare law system is based on the principle that the protection of people’s health is a human right. Provisions related and applicable to advertising of medicines are part of the GHL; this law has several similar regulations that apply to different aspects and issues related to healthcare (such as research, regulatory matters and healthcare services). In addition to the dispositions of the GHL, there is a particular regulation on advertising of healthcare products (Reglamento de la Ley General de Salud en Materia de Publicidad). In certain cases, such as pricing, the provisions of Mexican consumer protection law might apply. Issues related to the accuracy of information submitted to consumers are regulated by the Federal Law of Consumer Protection (Ley Federal de Protección al Consumidor).

The National Chamber of the Pharmaceutical Industry (CANIFARMA) groups pharmaceutical companies in Mexico. Its members must comply with several codes, including:

• the Ethics and Transparency Code;
• the Good Promotional Practices Code; and
• the Code of Interactions with Patient Associations.

Such regulations only apply to members of CANIFARMA; compliance with their terms is not binding pursuant to the terms of Mexican legislation. They contain precise obligations with respect to advertising practices.

CANIFARMA codes apply only to members of the chamber – their dispositions do not apply to healthcare professionals (HCPs), healthcare institutions or third parties that are not members of such association. CANIFARMA is a Mexican commerce and industrial chamber, affiliation with which is strictly voluntary. Pharmaceutical companies are not obliged to join it under the terms of Mexican law. In order to be admitted to such association, the members must accept compliance with all its codes, including those applicable to ethics and good promotional practices.

CANIFARMA codes are not mandatory pursuant to the terms of the Mexican Constitution, nor the GHL or any other legal provision. For Mexican pharmaceutical companies, being members of CANIFARMA makes sense due to its visibility before the Mexican government as well as other industries and sectors. CANIFARMA is the official link to and representative of the pharmaceutical industry. With the above factors in mind, being a member and complying with the terms of its regulations is valuable to members. It is important to note that breach of such codes does not automatically represent a breach of Mexican legislation; however, one key provision of such codes is the duty of its members to comply with the terms of Mexican law.

The regulation of the GHL includes two concepts. One is “advertising”, and the other is “commercial”.

Advertising

As defined by the GHL, “advertising” encompasses the entire creation process, planning, execution and diffusion of commercials in the media, with the purpose of promoting the sale and consumption of products and services.

Commercial

This is defined by the GHL as a message directed at the public, or at a segment of it, with the purpose of informing it of the existence or the characteristics of a product, service or activity for that product’s commercialisation and sale or to create a reaction.

Under the terms of the GHL and its regulations, the difference between advertising and information is that information relating to a healthcare product is considered advertising; however, information about healthcare in general and/or general awareness of illnesses is not considered advertising. The regulations of the GHL clearly determine that information about healthcare products is considered promotional activity even if there are no advertising phrases and/or suggestions to use such products. Information about good healthcare practices or disease awareness is not considered advertising. The Mexican regulatory authority has interpreted information that mentions a product even by its generic name as advertising, which is therefore subject to the applicable legal terms and limitations.

Distinction Between Target Audiences

There is a clear distinction concerning the advertising activities that may be performed depending on the target audience. Any information relating to medicines that require a medical prescription in order to be sold (Rx pharmaceutical products) may only be delivered to HCPs. This restriction includes information that contains either the generic name and/or the trade mark of the corresponding product. Advertising and information relating to over-the-counter (OTC) products may be directed at the general public with a prior permit from the regulatory authority.

The specific law/regulation regarding promotional activities mandates that the same must be grounded and supported. No information on Rx pharmaceutical products may be released to the public. If a company that owns an OTC pharmaceutical product launches a campaign to such general audience, it assumes full responsibility to comply with the terms of the applicable law, being the holder of the corresponding marketing authorisation. In the case of Rx products, information may only be directed at HCPs.

Nowadays, the use of social media platforms is common. If those platforms allow access by the public, the only messages that may be communicated are those that relate to OTC products.

PSPs

With respect to patient support programmes (PSPs), in Mexico in the past years several pharmaceutical companies have developed programmes to support patients during their medical treatment. These programmes are sensitive from a legal point of view, as well as in view of the applicable self-regulatory codes, due to the following:

• the PSP must not directly or indirectly advertise Rx pharmaceutical products; and
• the only purpose of the PSP must be to provide support to the patient, including discounts, reminders of medical appointments, laboratory analysis, and coaching for a heathy life. Subscription to PSPs must be proposed directly by the HCP.

Finally, information about health and diseases is not considered advertising, provided that it does not directly or indirectly promote pharmaceutical products, or in any manner could be considered as subliminal messaging to encourage the use of pharmaceutical products.

Press releases are considered an advertising activity and are therefore subject to the applicable regulations; the specific law/regulation regarding promotional activities mandates that they must contain the scientific and technical information that supports the message. No information on Rx pharmaceutical products may be released though press releases if they are directed at the public and/or can be accessed by the public, regardless of whether the intention was only to reach out to HCPs. If a company that owns a pharmaceutical product launches a campaign on social media, it assumes full responsibility to comply with the terms of the applicable law, being the holder of the corresponding marketing authorisation.

The regulations on marketing of healthcare products define broadcast or public media (medios de difusión) as those means used to disseminate marketing advertisements to the public including TV, movies, radio, press, magazines and public advertisements on streets, as well as any other means of communication whether electronic or by use of any other technology. If a social media platform is accessible by the public, the only messages that may be broadcast are ones that relate to OTC products, irrespective of whether the message is sent through a press release.

Even though comparative advertising for medicines is not specifically forbidden, making comparisons between medicines might be considered as a trade mark administrative infraction, since the intention of such an advertisement might be to damage the reputation and image of one of the products being compared.

Mexican law requires a marketing authorisation for a medicine to be manufactured, distributed and used. These activities include advertising. For this reason, advertising of unauthorised medicines or new non-authorised indications is not permitted.

Providing information about an unauthorised medicine or unauthorised indications is not permitted.

As mentioned, Mexican law requires a marketing authorisation for a medicine to be manufactured, distributed and used. These activities include advertising; it is generally thought that if the medicine is not authorised, information regarding it may not be provided at a scientific conference of HCPs.

As a general rule, if a medicine is not authorised, information regarding it may not be provided to HCPs.

See 3.3 Provision of Information to Healthcare Professionals.

It is not permitted to publicise the availability of compassionate use programmes. This might be classified as advertising of a medicine and therefore be subject to the terms of the GHL applicable to advertising of medicines.

Mexican legislation allows only marketing advertisements or information relating to OTC pharmaceutical products. In the case of Rx, products can only be directed at HCPs. In the author’s opinion, if any media platform allows access by the public, the only messages that may be presented are those that relate to OTC products.

The classification of a medicine as an OTC product or a prescription-only medicine is made by the regulatory authority when analysing whether to approve a marketing authorisation.

Prescription Medicines

Prescription medicines fall into the following categories:

• controlled medicines where the prescription is special and issued by the Ministry of Health;
• controlled medicines where the prescription is retained by the pharmacy;
• medicines whose prescription is stamped three times and then retained the last time;
• medicines that for their sale require a medical prescription that is not retained; and
• antibiotics – following a ruling published in the Official Federal Gazette on 27 May 2010, the Ministry of Health determined that antibiotic medicines may only be sold after a medical prescription is presented, which will be retained by the pharmacy at the end of the treatment.

OTC Medicines

OTC medicines fall into the following categories:

• OTC medicines sold only in pharmacies that do not require a prescription to be shown; and
• OTC medicines sold in establishments that are not pharmacies, which do not require a prescription to be shown.

Legal Principles of Advertising Medicines

The main legal principles of advertising of medicines pursuant to the terms of the GHL and the applicable regulations are as follows:

• The information that is provided in the advertising must be verifiable – the information about the safety, efficacy and quality of a medicine must have previously been approved by the healthcare regulatory authority.
• Advertising must be free of dialogue, texts, sounds, images and other descriptions that would cause or could cause error or confusion because they are deceptive or abusive, and it should not mislead.
• The content must be for guidance and education.
• Advertising must not attribute to medicines preventive, therapeutic, rehabilitative, nutritional, stimulant or other types of qualities that do not correspond to their function or use as established in the applicable provisions or in the marketing authorisation granted by the authority.
• Advertising must not indicate or suggest that the use or consumption of a product is a decisive factor in changing people’s behaviour.
• Advertising must refer to the real characteristics, properties and uses or those recognised by the Ministry of Health, of the products, services and activities, in Spanish, in clear and easily understandable terms for the public at whom it is directed.

Requirements When Providing Health Information

The following are compulsory when providing health information:

• Providing health information on the use of a product and the provision of a service, which must correspond to any purposes indicated in the respective authorisation.
• Indicating the necessary precautions when the use, handling, storage, holding or consumption of a product may cause risk or harm to people’s health. The HCP and/or the patient should be warned about the potential effects and risks involved in the use of the medicine.

• Any assertions that refer to the benefits that would be derived from the purchase, use or consumption of a product, immediately or within a specified period, must have technical or scientific support that can prove them.
• Avoiding using categorical or superlative terms that encourage error or confusion for consumers with respect to the performance, characteristics or conditions of an advertised product. A categorical term will be understood as one that is asserted or denied absolutely. When, upon using these terms, objective assertions are also made, or reference is made to studies, samples and/or tests, such information must be verifiable. Thus, the use of phrases such as “the best”, “the only”, “100% safe” or others of a similar nature must be avoided.
• Avoid discrediting, by false assertions, other companies, other products or the industrial or commercial activity of any other person or company and its products, services, activities or circumstances or its brands, trade names or other distinctive signs through its content or in the form of presentation or dissemination.

Basic Legal Divisions

The advertising of medicines and dissemination of materials is divided into two categories based on the target audience:

• Advertising directed at the public in general – medicines or other health products that for their sale do not require a medical prescription (ie, OTC medicines, prostheses, orthoses and medical device functional aids).
• Advertising directed at health professionals.

Medicines

The advertising of OTC medicines:

• must comply with the marketing authorisation and have been authorised though a specific permit prior to that advertising; and
• should not be deceptive, exaggerated or tendentious.

Prescription medicines:

• may only be advertised to health professionals;
• must comply with the terms granted within the marketing authorisation and the information for prescription, approved by the Federal Commission to Prevent Sanitary Risks (Comision Federal para la Protección contra Riesgos Sanitarios, or COFEPRIS); and
• must contain a summary of the medicine’s information known as the Información para Prescribir (Summary of Product Characteristics, or SmPC).

The information that may be used in advertising of medicines is that which was included and approved by the regulatory healthcare authority during the process of review and analysis of the corresponding marketing authorisation. Only the approved information and therapeutic indications of a medicine may be used in advertising.

The price of a medicine may be advertised. The information about the safety, efficacy and quality of a medicine must have technical and scientific support, as well as be approved by the Mexican healthcare authority. The key document for purposes of advertising activities is the marketing authorisation.

There are no specific legal restrictions on interactions between patients, patients’ organisations and the industry. Those limitations that do apply will affect public institutions as well as public servants.

With respect to the industry codes of CANIFARMA, there is one that specifically refers to interactions between industry and patient organisations. This code contains rules and certain limitations for such interactions, including:

• no promotion of Rx medicines to patients or their associations;
• keeping records of agreements, contributions and general interactions with these organisations;
• having internal policies that regulate the interactions;
• no editorial participation in sponsored publications;
• when sponsoring meetings or seminars, these should take place in adequate non-luxury sites not known for being only for entertainment purposes – such sponsorship should be reasonable; and
• paying the financial contribution to the association, not directly to a patient.

The information that may be directed at HCPs is that which is approved by the healthcare authority and contained in the marketing authorisation, an important part of which is known as the information for prescription. This data is submitted by the applicant for the marketing authorisation; the medicine will be approved together with this at the same time. Basically, the data is that which is needed to prescribe the medicine and includes generic and trade names, indications, manufacturer, formula, contraindications, and possible adverse reactions and events.

The price of a medicine may be informed to HCPs. Information that is not approved by the authority, such as non-approved indications and possible adverse reactions of a third product, may not be provided to HCPs.

Advertising needs to refer to the SmPC. If clinical or scientific information is used, it must coincide with the corresponding SmPC.

It is not permitted to advertise combination products or companion diagnostics that are not included in the SmPC; the company is only allowed to advertise the product itself with the indications that are approved by the Mexican regulatory authority in the marketing authorisation.

It is not permitted to advertise combination products or companion diagnostics that are not included in the SmPC; the company is only allowed to advertise the product itself with the indications that are approved by the Mexican regulatory authority in the marketing authorisation.

Companies may provide reprints of journal articles if they contain information regarding diseases, general healthcare matters and medicine information. In this case, the information must be in accordance with that which is contained in the SmPC.

Medical science liaisons (MSLs) are not clearly included in and regulated by the HCL or its regulations; however, they would follow the same pattern and principles of pharmaceutical advertising. Therefore, any information to be provided to HCPs even in scientific discussions must comply with the law and be limited to the approved information in the marketing authorisation as well as in the information for prescription. In the case of self-regulatory provisions, CANIFARMA includes terms and obligations for its members to not provide information relating to unauthorised medicines or indications to HCPs.

The advertising approval system is as follows:

• for advertisements or materials relating to OTC products, a prior permit must be obtained; and
• if the material refers to Rx products, a notice will need to be submitted before the advertisement is published/broadcast.

The competent authority for all regulatory healthcare matters is COFEPRIS.

Under the terms of Mexican healthcare law, including GHL and its regulations, there are no legal requirements to have internal policies and/or standard operating procedures that regulate advertising activities.

In respect of these, the CANIFARMA codes contain certain obligations, including, for example, written rules for the delivery of free samples, interactions with medical associations and control of promotional events.

There is no specific law/regulation for the use of advertising on the internet. If the internet is used for messages or advertisements, the GHL and its regulations apply to information and publicity with respect to goods, services and healthcare products that will be used by humans. This information should be accurate and not mislead the public, and at the same time must be grounded and supported.

The regulations on marketing of healthcare products define as broadcast and/or public media (medios de difusión) those used to disseminate marketing advertisements to the public including TV, movies, radio, press, magazines and public advertisements in streets, as well as any other means of communication whether electronic or by use of any other IT technology.

Such legislation allows only marketing advertisements or information relateing to OTC pharmaceutical products. In the case of Rx products, they can only be directed at HCPs. If the IT platform allows access by the public, the only messages that may be broadcast are those that relate to OTC products; no information relating to Rx products and their therapeutic indications should be published.

If the information submitted is intended for HCPs and relates to Rx medicines, the company must ensure that the websites contain solid restrictions that prevent access by the general public.

Companies are allowed to provide disease awareness information online, as long as there is no mention of the generic name and/or the brand of an Rx pharmaceutical product. If the company wishes to provide disease awareness information in which the generic name and/or brand of an OTC product is mentioned, the company needs prior authorisation that allows the provision of that information to the general public. Information relating to RX products is forbidden.

Providing disease awareness information to the public is a sensitive matter, since it might be considered as advertising; therefore, this should not directly or indirectly promote pharmaceutical products, or in any way be potentially considered as subliminal messaging to encourage the use of pharmaceutical products. If a company plans to provide online disease awareness information, it is advisable to obtain a written ruling from the regulatory authority.

There is no specific regulation for online scientific meetings in Mexico. Pharmaceutical companies are allowed to sponsor scientific meetings, provided that the information to be presented is within the scope of the specific marketing authorisation as well as the authorised information for prescription. The handbooks and related information to be provided must only be those approved by the healthcare authority as information for prescription. An event will be considered “national” if it is organised and/or sponsored by a Mexican institution and/or company.

Online scientific meeting organisers must ensure that all attendees are HCPs; therefore, each of them must provide the corresponding information. Only HCPsmay attend such meetings, due to the fact that the information to be provided is not allowed to be shared with the general public.

Online meetings under the terms of Mexican law are not considered international events. If they are organised by a Mexican institution or company, local regulations will apply.

There is no prior authorisation required, with the exception of online meetings organised inviting public servants who are HCPs. In this particular case, the prior authorisation of the public institution where the professionals render their services is needed. There must be rules of access, such as a pre-registration that ensures the participation of only HCPs.

The same rules apply for social media as for the internet. Such legislation allows only marketing advertisements or information relating to OTC pharmaceutical products. In the case of Rx products, they can only be directed at HCPs. If the social media platform allows access by the public, the only messages that may be published are those that relate to OTC products. This includes X, Facebook and WhatsApp. For legal purposes, social media is considered a broadcast medium (medio de difusión).

Influencers

Influencers’ campaigns in Mexico must comply with transparency and advertising accuracy requirements. The Federal Consumer Protection Agency (PROFECO) recommends (through an infographic issued in year 2023) using hashtags such as #PublicidadPagada, #Publicidad, #OpinionesPersonales and #Patrocinado (meaning that the influencer’s message is sponsored) to ensure clarity over sponsored content. In the healthcare sector, advertising must be based on verifiable information approved by the regulatory authority, avoiding misleading claims or attributes that do not correspond to the product’s actual function. Additionally, messages should be educational, in Spanish, and easily understandable by the target audience. It is prohibited to discredit competitors through false statements, and prescription drugs may only be advertised to HCPs. In our opinion, messages or dialogue produced and broadcast by influencers that are sponsored by pharmaceutical industries must follow the advertising legal provisions applicable to medicines and healthcare products.

Regarding geofencing in influencer campaigns, lack of geolocation controls could raise concerns from healthcare and consumer protection authorities, particularly if cross-border advertising involves products marketed in Mexico. In such cases, both the local healthcare authority and PROFECO may question a Mexican company about the dissemination of advertising originating abroad when it relates to a product sold in Mexico, even if the influencer is located abroad.

The Mexican anti-bribery legislation is contained in a group of laws that are known as the national anti-corruption system. Within this mechanism there is one federal law – the Federal Law of Administrative Responsibilities. This legislation prohibits the giving of any benefit, gift or remuneration to a public servant and applies to HCPs working for public institutions. In addition, public servants need to avoid any relationship that might represent a conflict of interest with their public duties. The concept of conflict of interest applies to both individuals and public organisations.

Under the terms of their provisions, CANIFARMA codes include the obligation of its members to avoid giving benefits, that is, contributions that might be made with the intention to get a benefit in return, such as incentivising the prescription of a company’s medicines. These anti-bribery rules apply to relationships with HCPs or public or private sector organisations.

When dealing with HCPs in Mexico, an important division must be taken into consideration, namely between:

• HCPs working for public institutions; and
• HCPs with a private practice.

The private sector is considered to be made up of companies as well as business projects that do not draw on public funds – ie, the investment does not come from the economic resources of any government institution.

After many years of debate and discussion, in 2015 and 2016, alongside the creation of new legislation, important amendments to the Constitution were integrated into Mexican anti-bribery legislation to create a group of laws that are known as the national anti-corruption system. As mentioned, this mechanism has the specific purpose of preventing and prosecuting corruption. The Federal Law of Administrative Responsibilities prohibits the giving of any benefit, gift or remuneration to a public servant. This limitation applies to HCPs working for public institutions. This law clearly establishes the concept of conflict of interest between the professional activities of an HCP and the relationship with the pharmaceutical industry.

In 2008, the Ministry of Health issued regulations that prohibited pharmaceutical companies directly giving any goods to public HCPs. Any invitation to participate in scientific activities and congresses must be approved by the administrative authorities. In addition, public servants need to avoid any relationship that might represent a conflict of interest with their public duties. The concept of conflict of interest applies to both individuals and public organisations.

A clear conflict of interest will be considered if an HCP who has any interaction with the pharmaceutical industry participates in a decision-making process to approve a medicine. This applies also to a public procurement procedure or the analyses of its inclusion in a national formulary.

CANIFARMA codes include, under the terms of their provisions, the obligation for members to avoid giving benefits, that is, contributions that might be made with the intention to get a benefit in return, such as incentivising the prescription of a company’s medicines. These anti-bribery rules apply to relationships with HCPs or public or private sector organisations.

As mentioned in the preceding section, the Federal Law of Administrative Responsibilities prohibits giving any benefit, gift or remuneration to a public servant. This limitation applies to HCPs working for public institutions. In addition, public servants need to avoid any relationship that might represent a conflict of interest with their professional activities and their interaction with pharmaceutical companies.

In 2008, the Ministry of Health issued regulations that prohibit giving any goods to public HCPs. Participation in scientific activities, including seminars, must be scrutinised and approved by the administrative authorities. In addition, public servants need to avoid any relationship that might represent a conflict of interest with their public duties.

In the case of HCPs who act in the private sector – ie, who have their own medical practice – the CANIFARMA codes establish that it is possible to offer gifts that do not have a significant value.

In the case of public institutions, companies may not directly provide samples to HCPs. The delivery must be made through the administrative authorities of the healthcare institution.

In the case of HCPs with private practices, CANIFARMA’s codes mandate the following:

• not delivering free goods as an incentive or pressure to prescribe certain medicines;
• providing samples in reasonable amounts for the purpose of helping the HCP to become familiar with the product and to initiate medical treatment;
• such samples must not be sold; and
• strong control policies should be created, as well as personnel, that keep records and monitor these samples.

Companies may sponsor scientific meetings as congresses, and HCPs may attend. The main principle regulating these activities is that they should be kept for educational and scientific purposes, without any intention to motivate the participants to benefit a pharmaceutical company or encourage the prescription of medicines in exchange for the participation in such events.

In the case of HCPs in private practice, such events should take place in adequate non-luxury sites not known for being exclusively for entertainment and must have a scientific purpose. The context and purpose of such an event should be educational and not for the objective of entertaining HCPs. The participation must be free of any influence and not given as an incentive to prescribe medicines or benefit a company.

In the case of HCPs working for public institutions, the event should be authorised by the administrative bodies of those institutions and adhere to the limitations mentioned above. The participation must be free of any influence and not given as an incentive to prescribe medicines or benefit a company in a public tender of public procurement procedure or to include a certain product in a national formulary.

Cultural, sports or non-scientific events must not be the main objective and should not occupy more than 20% of the conference time.

Companies in the pharmaceutical industry may provide grants and donations to healthcare institutions. The key requirement in both the public and private sectors is to avoid conflict of interest and not to use a monetary, equipment or services contribution to receive a benefit in return, such as:

• prescription of medicines;
• benefits or advantages in public tenders or public procurement procedures;
• approvals of marketing authorisations; or
• inclusion in national formularies.

Restrictions on rebates and discounts do not necessarily apply, but a legal issue will arise if a discount is granted to an HCP with a potential conflict of interest, such as obtaining the prescription of medicines in exchange.

In the case of healthcare institutions, it is permissible to give rebates and discounts in compliance with antitrust regulations; for example, the rebate must be given under a free competition basis and not with the specific intention to damage a third party or obstruct the free access to goods.

It is possible to contract services to be rendered by an HCP. As mentioned for other cases, it is important to set out the difference between professionals from the public and the private sector.

In the case of an HCP in the public sector, it is possible to contract for such services if there is not a conflict of interest that might illegally benefit a company, for example, services of an HCP who participates in the following decisions:

• whether to include a medicine in a national formulary;
• granting a marketing authorisation; or
• granting a public contract to acquire a medicine or healthcare product.

In case of an HCP with a private practice, CANIFARMA codes allow the receipt of these types of services and the corresponding payment. The purpose or intention must not be to benefit the company in an inappropriate manner, such as:

• influencing the HCP to prescribe certain products;
• buying or recommending them; or
• damaging the image of a product of a third party.

The payment should have a fair market value and relate only to the service.

In the case of services to be contracted with a public HCP, a previous authorisation from the superior is required.

Samples of medicines as well as small gifts to be given to public HCPs will need to be delivered to the administrative authorities of the healthcare institution, not directly to the HCPs. This implies that the corresponding internal body will need to give its approval beforehand.

Legally, pharmaceutical companies are not required to disclose, on a regular or periodic basis, details of transfers of value to HCPs. The GHL, and not its regulations, establishes such obligations. The possibility exists that an administrative or judicial authority might request such disclosure in the case of a specific legal procedure or litigation – such a request must be legally grounded and be a precise and detailed disclosure request. For example:

• the disclosure might be requested by the Secretariat of Public Function (in cases of corruption investigations);
• the Federal Economic Competition Commission (in cases of antitrust investigations); and
• some requests based on a tax audit.

The CANIFARMA codes include transparency obligations, such as the obligation of companies to disclose upon request by the Ethics Council, contracts and payments or transfers of value to HCPs. In the author’s opinion, such requests must be grounded and be specific to the case, rather than a general request for disclosure or an ongoing periodic obligation.

Transparency requirements from Mexican authorities apply to companies doing business in Mexico, and such requirements are related to having products in the market and are linked to their commercial activities.

In the case of CANIFARMA, its members already have products in the market; therefore, as members they are subject to the terms of the corresponding codes.

The Mexican regulatory authority with legal responsibility to enforce all the applicable regulations on advertising is COFEPRIS.

In cases that involve prices as well as claims that might directly affect the consumer, PROFECO might have joint jurisdiction over an individual case, for example, advertising that is considered to mislead the consumer.

If a sanction is imposed, for example a fine and/or a seizure of a product, a company will have the right to contest the decision before federal courts and the right to constitutional relief in the case of a constitutional violation.

There are three scenarios in relation to advertising infringements:

• if the advertising infringements are of any regulatory healthcare provisions, the company might file a complaint before COFEPRIS;
• if the infringement involves infractions of the Federal Law of Consumer Protection – ie, misleading advertising that might damage the consumer – an additional complaint might be filed before PROFECO; and
• if, in addition to the above, the advertising might affect a trade mark or the reputation of a company, there is an administrative recourse to claim infraction that could be filed before the National Institution of Industrial Property.

All the above proceedings have different instances that might end in litigation before federal courts, including constitutional reliefs.

The administrative authorities in charge of enforcing laws and regulations applicable to advertising of medicines might impose the following sanctions:

• administrative prohibitions;
• fines, which might be from approximately USD5,200 to USD55,000 per infraction;
• temporary or definitive shutdown of the company;
• seizure of a product or entire stock;
• request to recall the product in question;
• in the case of an advertising campaign that might be considered to mislead the final consumer (ie, a deceptive advertisement), there could be a fine of up to 10% of the company’s sales;
• media companies must ensure that the advertising transmitted has the corresponding permit or a notice has been filed with COFEPRIS; and
• COFEPRIS has the authority to order the media to immediately suspend, within 24 hours, the advertising of medicines that might be in breach of the GHL.

The procedures or measures taken by the self-regulatory authority and the procedures or measures taken by courts are not linked. Both types of authorities have their jurisdiction and forum. The Mexican courts will act based on the terms of the Constitution, the GHL and its regulations as well as the consumer protection law. Their resolutions and final judgments will be binding upon the sanctioned company.

In the case of a self-regulatory authority (ie, CANIFARMA), the industry codes contain procedures and sanctions that will be applicable only to members of such chamber. An infraction of the self-regulatory codes does not imply an action of Mexican federal courts or administrative authorities. At the same time, a final judgment of a court will not automatically imply the initiation of a procedure for sanction before the CANIFARMA’s Ethics Council.

Advertising

In recent years, COFEPRIS issued a ruling that might be interpreted as an intention to allow advertising of Rx medicines to the general public; however, the law and the regulations must be changed, and the rules are currently still the same: advertising of Rx medicines may only be directed at HCPs.

The Mexican regulatory authority regularly prosecutes and sanctions advertising of medicines or products that pretend to be medicines – without having a marketing authorisation – which do not have the claimed therapeutic effects or, in the worst case scenario, are not medicines at all.

COFEPRIS as well as the Ministry of Health has the clear intention to combat so-called “miracle products” that are on the market and pretend to be medicines or to have non-proven therapeutic effects. In the past, TV broadcasting companies have allowed advertising of these products, which poses an obvious danger to the consumer.

At the same time, PROFECO is active in preventing misleading advertising that might damage the consumer.

During 2021 there were no significant changes to the pharmaceutical advertising regulations in Mexico.

Restrictions on Marketing Agencies Monopolising Media and Advertising Space

On 3 June 2021, a new law was enacted, related to transparency and the combat of improper activities, when contracting publicity (Ley para la Transparencia, Prevención y Combate de Prácticas Indevida en Materia de Contartación de Publicidad). The purpose of this new law is to prevent marketing agencies and media companies improperly controlling marketing means and spaces. Due to the above, as of the enactment of this law, pharmaceutical companies (among others), must directly contract and hire media companies to market their products in the different means and marketing spaces (such as TV, radio, newspapers, internet and social media). The marketing agencies cannot directly buy such marketing spaces for purposes to resell the same. Such agencies could only act on behalf of pharmaceutical companies. It must be noted that this Law applies to any kind of advertising and not only to pharmaceutical products.

In January 2023, the Mexican Supreme Court of Justice, issued a final judgment in a particular case, declaring the unconstitutionality of this law, due to the fact that prohibiting marketing agencies from contracting for marketing spaces directly with media companies limits their freedom to contract and develop their business. This judgment only applies to a particular case and at time of writing (March 2023) is not generally binding.

Advertising of veterinary medicines is not part of the Mexican GHL; the particular legislation that applies to such products is the Federal Law of Animal Health (Ley de Sanidad Animal). The official standard that regulates this advertising is the “Specifications for marketing of chemical, pharmaceutical, biological and food products for veterinary use” (NOM-059-ZOO-1997). This standard mandates that the information that is provided in the advertising must be verifiable, authentic and exact, and correspond to the approved characteristics of the veterinary medicines. The information provided in the advertising will need to correspond to the approved label, following the labelling rules contained in two official standards (NOM-012-ZOO-1993 and NOM-059-ZOO-1997). This advertising will need to comply with the principles of the Federal Law of Consumer Protection (Ley Federal de Protección al Consumidor):

• the information submitted to consumers must be accurate and avoid misleading them (ie, a deceptive advertisement); and
• the advertising must not discredit, by false assertions, other companies, or the products or industrial or commercial activities of any other person or company and its products, services, activities or its brands, trade names or other distinctive signs through its content or in the form of presentation or dissemination.