Pharmaceutical Advertising 2023

Last Updated February 16, 2023

Mexico

Law and Practice

Author



Santillana Hintze Abogados, S.C. is based in Mexico City. Founded 15 years ago, its areas of expertise include health law, regulatory, advertising, licensing, black market issues and prosecution, anti-bribery compliance and personal data protection and compliance. It advises life sciences companies involved in the pharmaceutical and medical devices industry, as well as industry associations, on legal matters related to biotechnology. The practice group consists of 20 lawyers specialising in healthcare law, with a team dedicated exclusively to administrative litigation matters, including advising and litigating on public procurement and public tenders of pharmaceuticals and medical devices. The firm’s lawyers are experienced in health law, corporate law, personal data compliance, FCPA and competition matters, advising clients that are among the most prominent pharmaceutical and medical devices companies and demand highly specialised legal advice relating to the latest laws and regulations in this rapidly developing field.

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 on 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). Therefore, 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 the 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 industry companies are not obliged to join it under the terms of Mexican law. In order to be admitted to such an association, the members must accept compliance with all its codes, including the ones 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 is logical due to its visibility before the Mexican government as well as with other industries and sectors. CANIFARMA is the official link 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 members’ duty to comply with the terms of Mexican law.

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

Advertising

As defined by the GHL “advertising” incorporates 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 to the public, or to 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 related to a healthcare product is considered advertising; conversely, information about healthcare in general and/or general awareness of illnesses is not considered as 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 are not considered advertising. The Mexican regulatory authority has interpreted information that mentions a product even by its generic name as advertising and therefore subject to the applicable legal terms and limitations.

Distinction between Target Audiences

There is a clear distinction about the advertising activities that may be performed depending on the target audience. Any information related to medicines that requires a medical prescription in order to be sold (Rx pharmaceutical products) can only be delivered to HCPs. This restriction includes the information that contains either the generic and/or the trade mark of the correspondent product. Advertising and information related to over-the-counter (OTC) products can be directed to 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 could be used or released to the public. If a company owner of a 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 correspondent marketing authorisation. In the case of Rx, products can only be directed to an HCP.

Nowadays the use of social media platforms is common, if they allow access to the public, the only messages that could be performed are the ones related 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 for applicable self-regulatory codes, due to the following:

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

Finally, information about health and diseases is not considered as advertising, provided that the same does not directly or indirectly promote pharmaceutical products, or in any matter could be considered as subliminal information to provoke 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 the same must have the scientific and technical information that support the message. No information on Rx pharmaceutical products can be used or released though press releases if the same are directed to the public and/or have public access, regardless of if the intention was only to refer to an HCP. If a company owner of a pharmaceutical product launches a campaign on social media, they assume full responsibility to comply with the terms of the applicable law, being the holder of the correspondent marketing authorisation.

The regulations on marketing of healthcare products defines broadcast or public medium (medio de difusión) as those means used to disseminate marketing adverts to the public including TV, movies, radio, press, magazines, public adverts on streets as well any other means of communication whether electronic or any other technology. If a social media platform is accessible by the public, the only messages that can be broadcast are ones related to OTC products, no matter if the message is made 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 advert 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. Due to the aforementioned, advertising of unauthorised medicines or new non-authorised indications is not permitted.

It is not allowed to provide information about an unauthorised medicine or unauthorised Indications.

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 the information cannot be provided at a scientific conference of HCPs.

As a general rule, if the medicine is not authorised, the information cannot be provided to HCPs.

See 3.3 Provision of Information to Healthcare Professionals.

It is not allowed to publish the availability of compassionate use programmes. The same might be classified as advertising of a medicines and therefore subject to the terms of the GHL applicable to advertising of medicines.

Mexican legislation allows only marketing adverts or information related to OTC pharmaceutical products. In the case of Rx, products can only be directed to HCP. In the author’s opinion if any media platform allows access to the public, the only messages that could be presented are the ones related to OTC products.

The classification of a medicine as an OTC product or a prescription-only medicine is given by the regulatory authority when analysing and approving a marketing authorisation.

Prescription Medicines

These 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 the last time it is retained;
  • medicines that for their sale require a medical prescription that is not retained;
  • 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

These 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 regulation are as follows.

  • The information that is provided in the advertising must be verifiable – the information about the security, efficacy and quality of a medicine must previously be approved by the healthcare regulatory authority.
  • Advertising must be free of dialogues, texts, sounds, images and other descriptions that cause or could cause error or confusion because they are deceptive or abusive and 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 for changing people’s behaviour.
  • Advertising must refer to the real characteristics, properties and uses or those recognised by the Ministry, of the products, services and activities, in Spanish, in clear and easily understandable terms for the public to whom it is directed.

Purposes Requiring the Provision of Health Information

The following are compulsory when providing health information.

  • Providing health information on the use of the products and the providing of services, which must correspond to any purposes indicated in the respective authorisation.
  • Indicating the necessary precautions when the use, handling, storage, holding or consumption of the products 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.
  • The assertions that refer to the benefits derived from the purchase, use or consumption of a product, would be obtained immediately or in 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 the 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 used, or reference is made to studies, samples and/or tests, such information must be verifiable. Thus, avoiding the use of phrases such as “the best”, “the only”, “100% percent safe”, or others of a similar nature.
  • Avoid discrediting, by false assertions, other companies, products or 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 materials is divided into two categories based on the target audience.

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

Medicines

OTC medicines:

  • must comply with the marketing authorisation and authority prior specific permit to perform the 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 to prescribe, 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 information for prescribing (IPP is the acronym in Spanish).

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

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

There is not a specific legal restriction for interactions between patients, patients’ organisations and industry. The limitations will be with public institutions as well as public servants.

With respect to the industry codes (CANIFARMA), there is one specifically referred to the 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 in 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 pace 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 can be directed to an HCP is the one approved by the healthcare authority and contained in the marketing authorisation, of which an important part is known as information for prescription. This data is submitted by the applicant for the marketing authorisation; the medicine will be approved together at the same time. Basically, the data is needed to prescribe the medicine and includes generic and trade names, indications, manufacturer, formula, contraindications, possible adverse reactions and events.

The price of a medicine can be informed to the HCP. The information that cannot be provided to an HCP is that not approved by the authority, such as: non-approved indications and possible adverse reactions of a third product.

Advertising needs to refer to the Summary of Product Characteristics (SmPC/Información para Prescribir). If clinical or scientific information is used, the same must coincide with the correspondent summary.

It is not permitted to advertise combination products or companion diagnostics that are not included in the Summary or Product Characteristics, 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 can provide reprints of journal articles if the same contain information regarding diseases, general healthcare matters and medicines information, in this case, the same must be in accordance with the one contained in the SmPC.

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

The advertising approval system is as follows:

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

The competent authority for all regulatory healthcare matters is COFEPRIS.

Under the terms of the 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 not a specific law/regulation for the use of advertising on the internet. If the internet is used for messages or adverts, the GHL and its regulations apply to information and publicity made with respect to goods, services and healthcare products that will be used by humans. This information should be accurate and not mislead the public, at the same time must be grounded and supported.

The regulations on marketing of healthcare products defines as broadcast and/or public mediums (medio de difusion) those used to disseminate marketing adverts to the public including TV, movies, radio, press, magazines, public adverts in streets as well any other mean of communication whether electronic or any other IT technology.

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

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

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

Providing disease awareness information to the public is a sensitive matter, since it might be considered as advertising, therefore the same should not directly or indirectly promote pharmaceutical products, or in any way be potentially considered as subliminal information to provoke the use of pharmaceutical products. If a company plans to provide online disease awareness information, it is advisable to get 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 the information to be presented is in 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 the one approved by the health care authority as information for prescription. An event will be considered “national” if the same is organised and/or sponsored by a Mexican institution and/or company.

Online scientific meetings organisers must assure that all attendees are health care professionals, therefore each of them must provide with the correspondent information. Only health care professionals can attend such meetings, due to the fact that the information to be provided is not allowed to be shared to the general public.

Online meetings under the terms of Mexican law are not considered as international events. If the same 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 that are health care professionals, 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 a pre-registration that assure the participation of only of health care professionals.

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

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 giving any benefit, gift or retribution to a public servant and applies to HCPs working for public institutions. In addition, public servants need to avoid any relation 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 have the intention to get a benefit, in return, such as incentivising the prescription of a company’s medicines. These anti-bribery rules apply to relations with HCPs or public or private sector organisations.

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

  • 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 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 giving any benefit, gift or retribution 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. The 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 have the intention to get a benefit, in return, such as incentivising the prescription of a company’s medicines. These anti-bribery rules apply to relations with HCPs or public or private sector organisations.

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

In 2008, the Ministry of Health issued regulations that prohibit giving any goods to public HCPs. The 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, having their own medical practice – the CANIFARMA codes establish that it is possible to offer gifts that do not have a significant cost (ie, gimmicks).

In the case of public institutions, companies cannot 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;
  • provide samples in reasonable amounts for the purpose of helping the HCP to get familiar with the product and to initiate a medical treatment;
  • such samples must not be commercialised; and
  • strong control policies should be created, as well as personnel, that keep records and monitor these samples.

Companies can sponsor scientific meetings as congresses, HCPs can attend. The main principle regulating these activities is to keep them for educational and scientific purposes, not with the intention to motivate the participants to benefit a pharmaceutical company and 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 pace in adequate non-luxury sites not known for being for entertainment and must have a scientific purpose. The context and purpose of the event should be educational and not for the objective to entertain HCPs. The participation must be free of any influence or 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 administrative bodies of the institution and have the limits mentioned above. The participation must be free of any influence or given as an incentive to prescribe medicines or benefit a company in a public tender of public procurement procedure or to include certain product in a national formulary.

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

Companies in the pharmaceutical industry can provide grants and donations to healthcare institutions. The key factor in both the public and private sectors is to avoid conflict of interest and to use the monetary, equipment or services contribution to get back a benefit, such as:

  • prescriptions of medicines;
  • benefits or advantages in public tenders or public procurement procedures;
  • approvals of marketing authorisations; and
  • inclusions in national formularies.

Such restrictions do not necessarily apply themselves, the legal issue will come if the discount is granted to an HCP with a potential conflict of interest, such as getting prescriptions of medicines in exchange.

In the case of healthcare institutions, it is valid to give rebates and discounts in compliance with antitrust regulations, for example, that the rebate is 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, is important to establish the difference between professionals from the public and the private sector.

In the case of an HCP of the public sector, 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:

  • to include a medicine in a national formulary;
  • authorisation of 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 getting these types of services and the correspondent payment. The purpose or intention must not be to benefit the company in an inadequate 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 be related only to the service.

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

Samples of medicines as well as gimmicks to be given to a public HCP will need to be delivered to the administrative authorities of the healthcare institution, not directly to the HCPs. This is a matter that implies that before performing this activity, the corresponding internal body will need to approve the same.

Legally, pharmaceutical companies are not required to disclose, under regular or periodic basis, details of transfers of value to HCPs. The GHL, and not its regulations, establish such obligations. The possibility exists that an administrative or judicial authority might request such disclosure in case of a specific legal procedure or litigation – such a request must be legally grounded and be precise and detailed request of disclosure. 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, not being an open request for disclosure, nor an ongoing periodic obligation.

Transparency requirements from Mexican authorities apply to companies doing business in Mexico and such requirements are not related to having products in the market and are linked to their commercial activities.

In the case of CANIFARMA their 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 affect directly the consumer, the Federal Consumer Protection Agency 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 or a product, a company will have the right to content the case before federal courts and the right to constitutional relief in the case of a constitutional violation.

There are three scenarios:

  • if the advertising infringements are any of regulatory healthcare provisions the company might file a complaint before COFEPRIS;
  • if the infringement involves infractions to the Federal Law of Consumer Protection – ie, misleading advertising that might damage the consumer – an additional complaint might be filed before the Federal Consumer Protection Agency; and
  • if, in addition to the above, the advertising might affect a trade mark or reputation of a company there is an administrative recourse to claim the 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 regulation applicable to advertising of medicines might impose the following sanctions:

  • administrative preventions;
  • fines that 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 correspondent products;
  • in the case of an advertising campaign that might be considered to mislead the final consumer (ie, a deceptive ad), 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, in 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 to the sanctioned company.

In the case of a self-regulatory authority (CANIFARMA), the industry codes have procedures and sanctions that will be applicable only to members of such chamber. An infraction to 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.

In recent years COFERPIS has 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 can only be directed to 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 in the market pretending to be medicines or having non-proven therapeutic effects. In the past, TV broadcast companies have allowed advertising of these products, which poses an obvious danger to the consumer.

At the same time, the Federal Consumer Protection Attorney Office 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, Pharm chemicals, Pharmaceuticals, 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 avoiding misleading them (ie, a deceptive ad); and
  • the advertising must not discredit, by false assertions, other companies, 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.
Santillana Hintze Abogados, S.C.

Ricardo Castro No. 54-302
Col. Guadalupe Inn
C.P., 01020
Mexico

+55 52 92 82 32

gsantillana@santillana-abogados.net www.santillana-abogados.mx
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Trends and Developments


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Bello, Gallardo, Bonequi y García was established in 2001 and has become a significant player in the Mexican legal market, meeting the growing need for specialised legal services. The versatility of its lawyers allows BGBG to provide personalised services in each of its practice areas, including technology, media and telecommunications (TMT). BGBG was created as a boutique law firm for TMT practice, and since its formation has been providing ongoing legal services to all types of companies within the TMT, technology, media, entertainment and communications industries. The firm’s TMT practice, which handles all matters related to advertising and regulatory sectors, is one of the biggest standalone practices in Mexican law firms, and its team devotes almost all of its time to this specialised area. It has been recognised by independent national and international publications as a top-tier and leading practice.

Pharmaceutical advertising in Mexico can be categorised in terms of legal compliance, general compliance on consumer protection laws, and specific compliance due to the regulatory nature of pharmaceutical products and/or services.

However, before discussing the specific rules which may be applicable to such types of advertising, it is worth noting a fairly new pharmaceutical advertising topic due to a recently enacted law (currently being challenged) regarding paying for advertisements when there is an agency involved, and how the law intends to establish specific requirements and limitations on the manners for buying specific advertising products, such as pharmaceutical advertisements.

The Transparency Law

On 3 June 2021, the “Law for Transparency, Prevention and Combating Improper Practices in Advertising Contracting” (the “Transparency Law”) was published in the Official Daily and became effective on 1 September 2021. As mentioned, the purpose of the law is to prevent certain commercial practices by publishers, specifically practices which involve monetary considerations to the agencies (hired by advertisers), for such publishers to gain more business with such agencies.

Although the law is aimed at publishing activities which are carried out in Mexico, it contains an express prohibition which may have extraterritorial effect, as it mentions that any advertisement in Mexico paid for outside Mexico by a foreign company is subject to compliance with the Transparency Law. However, in the authors’ opinion, if there is an agreement not subject to Mexican law, or if the company is not a Mexican company and its services are understood to be provided through the internet, the Transparency Law would not be applicable.

A particular point of the Transparency Law is that sanctions due to breaches are imposed following an investigation procedure in accordance with Economic Competition Law procedures, and such investigation is also carried out by the Economic Competition Authority. The Transparency Law would thus be enforced taking into account economic competition procedures and principles, and breaches would only be investigated following a third-party claim.

The Transparency Law has become relevant considering there are no other specific laws which establish other contractual requirements for marketing/advertising activities in Mexico. Because of this, the Transparency Law has been challenged by many players through “amparo” suits. Such challenges have been ruled in favour of the companies, and recently, in January 2023, the Supreme Court ruled on a specific procedure, deeming the Law unconstitutional. Although this consideration of the Transparency Law as being unconstitutional only applies to such amparo challenges, this is a precedent which may be taken into account by other jurisdictional authorities in Mexico. The Telecommunications Institute has also challenged the Transparency Law, stating that it gives the Economic Competition Authority too much power in overseeing matters normally given to the Telecommunications Institute only.

Because of the aforementioned issues, and all amparo procedures and rulings currently being challenged, in the authors’ opinion the Transparency Law will be ruled as unconstitutional by the Supreme Court, and will be requested to be repealed.  Meanwhile, and until it is repealed, some of the rules and requirements established by the Transparency Law are worth noting:

  • advertising spaces cannot be contracted by agencies on their own – such spaces should be contracted in the name and on behalf of the advertiser;
  • a specific type of agreement must be executed, in which it is understood that a specific and specialised power of attorney is granted to the agency for the agency to contract on behalf of the advertiser for such advertising spaces;
  • any rebate offered by the publisher to the agency must be replicated in the agreement between the advertiser and the agency;
  • neither the agency nor third parties used by the agency to provide services to the advertiser can receive remuneration, commission or considerations by the publisher;
  • an agency cannot provide services (simultaneously) to advertisers and to publishers;
  • although the agency is the party paying the publisher, the publisher must bill the advertiser directly;
  • an agency that buys programmatic digital advertising on behalf of the advertiser should inform the publisher of the identity of the advertiser and other information mentioned in the law after the broadcasting of the advertising;
  • an agency must inform the advertiser of any financial relationships between them (or their group) and the publisher; and
  • the economic sanctions arising from the Transparency Law may be 2% to 4% of the gross income of the infringer.

Consumer Protection for Pharmaceutical Advertising

It should be noted that there are no specific rules for the pharmaceutical advertising industry; however, the general rules regarding advertising are helpful for understanding how a pharmaceutical advertisement may be analysed or considered compliant by the Consumer Protection Agency (PROFECO) in charge of overseeing compliance with the Consumer Protection Law.

In general terms, pharmaceutical advertising must comply with the following rules:

  • the information or advertising related to products or services must be truthful, verifiable, clear and free of texts, dialogues, sounds, images and other descriptions that induce or may induce error or confusion due to being misleading or abusive; and
  • misleading or abusive information or advertising is that referring to characteristics or information related to a product or service that may or may not be true, and which induces error or confusion in the consumer due to the inaccurate, false, exaggerated, partial, artificial or biased manner in which it is advertised.

The authority of PROFECO in relation to advertising includes the following:

  • requesting a service provider to suspend the advertising that breaches the provisions of the Consumer Protection Law, wherever it is published; 
  • requesting correction of the advertising that breaches the provisions of the Consumer Protection Law; and
  • imposing economic sanctions, in accordance with the law.

Economic sanctions may range from USD9,500 to USD260,000, and, depending on how severe the breach was, may go as high as 10% of the gross income of the infringer.

Economic sanctions imposed by PROFECO take into consideration the following:

  • the damage caused to the consumer or to society in general;
  • the intentional nature of the breach;
  • whether it is a repeat offence; and
  • the economic condition of the provider.

Since the definition of misleading advertising and the elements that qualify for it are established in a broad manner in the Consumer Protection Law, PROFECO has issued certain guidelines to help understand what is covered by unlawful advertising, and identifies specific types of advertising which are not allowed, as follows.

  • Misleading advertising by action – texts, dialogues, sounds, images, trade marks and other descriptions that induce or may induce error or confusion.
  • Misleading advertising by omission – advertising that is silent about characteristics of the good, product or service which are necessary for the consumer to have the appropriate information make a decision.
  • Misleading comparative advertising – comparing goods or services must, for obvious reasons, not be misleading, and must be considered lawful, since it should aim to provide the consumer with additional (and better) information.
  • Denigratory advertising – advertising that discredits a good, product or service of others. In this case, advertising will be unlawful or misleading when the information is not truthful, or is considered abusive since it will induce the consumer to change their consumption habits in an unlawful manner.
  • Adhesive advertising – advertising that induces or is likely to induce confusion with the goods, products or services of other suppliers. This is a type of misleading advertising to the extent that it takes advantage of the prestige acquired by another supplier, in such a way that the message makes the consumer believe that the advertised good or service corresponds to the type (characteristics) of those advertised by a competitor, taking advantage of the prestige of others.
  • Concealed advertising – a type of misleading advertising intended to hide its advertising nature, being hidden under an informative veil by means of which an attempt is made to make the consumer believe that they are being given an informative message of an objective nature, not vitiated by the persuasive and subjective interest that characterises the advertising message. The objective of this type of advertising is clear: to make the consumer/recipient of the concealed advertising give it the same credibility that they would give to an informative message, thus reducing consumer defences against advertising.
  • Exaggerated advertising – this may be considered as misleading advertising, and is unlawful since it constitutes subjective information that cannot be verified and is normally used as a technique to exalt goods, products or services. It corresponds to civil fraudulent misrepresentation, and does not contain objective information. Additionally, “overpromising” advertising which aims to surprise consumers and generate expectations is a classic example of the information provided with “miracle products”.

PROFECO will look for the following to determine if a specific type of advertising is in fact unlawful:

  • false information, when the information does not correspond to reality and may induce the consumer to make an erroneous decision, which they would not have made otherwise, as well as when the supplier does not deliver the good or perform the service in accordance with the terms and conditions offered or implied in the advertisement;
  • inaccurate, imprecise information in relation to the characteristics or qualities of the product, good or service;
  • exaggerated information which leads to deception of the consumer, where the consumer does not recognise such exaggeration at first sight and takes the advertising message seriously, and which may influence the consumer’s decision to consume;
  • partial information provided in an incomplete manner, where such omission relates to fundamental data required for a consumer’s proper decision; and
  • artificial or tendentious information where the advertising is intended to cautiously disguise the message sent – eg, inserting texts or legends that are not visible to the naked eye.

Rules for Pharmaceutical Advertising

For services and/or products of a pharmaceutical nature, there are two relevant laws establishing specific requirements and limitations: the General Health Law and the Regulations of the General Health Law on Advertising Matters. Their requirements and limitations as regards pharmaceutical advertising are discussed below.

Product advertisements

Cosmetic products cannot be attributed the same effects as medical products. The Ministry of Health must be notified when advertising cosmetic products, and advertising of any type of surgery must comply with all the requirements established in the General Health Law.

Any advertising related to health matters, disease treatments, rehabilitation of disabled people, health professionals and health products and services is subject to the prior authorisation of the Ministry of Health.

The advertising of raw materials for health, surgical materials, hygienic products and alcoholic beverages is also subject to the prior authorisation of the Ministry of Health.

The aforementioned advertising must adhere to the following principles:

  • the information contained in the message regarding quality, origin, purity, conservation, nutritional properties and use benefits must be verifiable;
  • the message must contain guiding and educational content;
  • the elements comprising the message, if applicable, must correspond to the characteristics of the respective health authorisation;
  • the message must not lead to behaviours, practices or habits which are harmful to physical or mental health, or imply a risk or threat to the safety, physical integrity or dignity of people, particularly women;
  • the message must not undermine or contravene the principles, provisions or regulations established by the Ministry of Health in prevention, disease treatment or rehabilitation matters; and
  • the message must be drafted according to the applicable legal provisions.

Regulatory matters related to pharmaceutical advertising

Advertising must be consistent with the characteristics or specifications of the product or service, and it cannot:

  • attribute to the product or service preventative, therapeutic, rehabilitation, nutritious, stimulative or other qualities that do not correspond to its function or use;
  • indicate or suggest that the use or consumption of a product or service is a factor in determining a change of behaviour of individuals; or
  • indicate or lead to believe, explicitly or implicitly, that the product has ingredients or properties which it lacks.

Advertising which attempts to put at risk the security or physical or mental integrity of people is forbidden.

Disclaimers or sanitary messages appearing in the advertisements of products, services or activities are subject to the following:

  • written disclaimers in advertisements transmitted on TV should be shown for one quarter of the total length of the advertisement;
  • the disclaimer should appear in a contrasted colour;
  • the disclaimer should be located horizontally, with “Helvetic” font and in a size of 40 points per letter, proportional to a 14-inch TV screen;
  • audible disclaimers should be pronounced in the same rhythm and tone as the advertisement; and
  • for advertisements transmitted over the internet, the disclaimers should comply with the aforementioned obligations and principles.

Regulatory matters related to pharmaceutical products or services

For health services, the following applies:

  • health services advertisements should inform on the characteristics and purposes of the services, and the means to access them;
  • the advertisements cannot include techniques or treatments which are preventative, curative or rehabilitative, unless with the respective authorisation from the Ministry of Health; and
  • health professionals (as doctors) should, when they advertise, include within the advertisement the university where they obtained their degree and their professional ID number.

For food, food supplements and non-alcoholic beverages, the following applies.

  • Such advertising must not contravene the provisions on nutritional, hygienic and health education.
  • Food, food supplements and non-alcoholic beverages cannot be advertised as stimulants or as though they are able to modify the physical or mental state of individuals, unless with the respective authorisation from the Ministry of Health. 
  • Advertising of food, food supplements and non-alcoholic beverages may not:
    1. induce or promote harmful habits to health;
    2. state that the product fulfils by itself the nutritional requirements of a human being;
    3. attribute higher nutritional value to industrial food;
    4. perform comparisons aimed at disparaging the properties of natural foods;
    5. express or suggest, through real or fictional characters, that ingestion of these products provides people with extraordinary abilities or characteristics;
    6. be directly or indirectly associated with the consumption of alcoholic beverages or tobacco; and
    7. declare properties that cannot be verified, or imply that the products are useful in preventing, alleviating, treating or curing a disease, disorder or physiological state.
  • The advertising should include disclaimers about the condition of the products and messages promoting an equal alimentation and the promotion of healthy habits.
  • Advertising of baby milk formulas should:
    1. promote breastfeeding, for which they should clearly indicate the benefits thereof;
    2. expressly indicate that the use of baby formula is recommended only in certain cases; and
    3. include information on the correct handling of the formulas, their preparation and specific care.
  • Advertising of food supplements should include a disclaimer indicating the relevant authorisation of such food supplement.

Health supplies

Regulations provide a series of restrictions and rules related to the following products, which are considered health supplies.

Medicines

  • The advertising of medicines directed to the general population may include descriptions of human diseases, diagnosis, treatment, prevention or rehabilitation expressed in the terms of their sanitary registration and in language appropriate to the target public. These messages must always identify the issuer with the brand of the product or its corporate name.
  • The advertising should be in a visual form for printed material, and in audible form for radio, with the legend “Refer to your doctor” as well as express the corresponding precaution when the use of the medicine represents any danger in the presence of any coexisting clinical or pathological condition.

Herbal remedies

  • Herbal remedies should be limited to advertising a symptomatic effect based on the information expressed on the label, and should refrain from advertising them as curative.
  • In addition to the “Refer to your doctor” legend, they should also include the following additional precautionary legend which the Ministry of Health determines, based on the health risk that the product represents: “This product has not been scientifically proven to have preventative or curative properties.”

Generic exchangeable drugs

Only pharmaceutical specialties included in the Catalog of Interchangeable Generic Drugs referred to in the Regulation of Health Supplies may use the following legends, acronyms, denominations and adjectives in their advertising:

  • the acronym “GE” (Generic Exchangable), its symbol or logo;
  • the denomination “interchangeable generic drug”, or the expressions “generic” or “interchangeable”; and
  • any other expression, word, image or symbol whose purpose is to induce in the consumer the idea that the advertised medicine is a substitute for the original or innovative product.

Medical equipment, prosthetics, orthotics, functional aids, diagnostic agents, dental supplies, surgical and healing materials and hygiene products

The Ministry of Health authorises the advertising of these types of products in accordance with the characteristics and purposes for which they have been registered, and they shall be subject to the indications or uses approved by the Ministry.

  • When granting or reviewing the registration of the product, the Ministry of Health shall specify in the advertising grounds whether it can be directed to the general population or only to health professionals or technicians.
  • The advertising of the product should include messages that avoid self-treatment, when required due to their characteristics.
  • Hygienic products may not be advertised when they:
    1. promote practices that are harmful to health due to the inadequate use of such products; and
    2. attribute preventative, therapeutic or rehabilitative qualities to the treatment of a certain disease, except in those cases where such circumstances have been fully proven.
  • In general, all advertisements should:
    1. be clear, concise and easily understandable for the sector of the public to which it is directed;
    2. contribute, by means of the use of legends, to hygiene education; and
    3. express in the precautionary message, if applicable, whether the use or consumption of the product represents a health risk.

It is important to mention that the following advertising always requires a specific advertisement permit issued by the Ministry of Health:

  • provision of health services;
  • food supplements and biotechnological products;
  • medications and herbal remedies; and
  • medical equipment, prosthetics, functional aids, diagnostic agents, dental supplies, surgical and healing materials, and hygienic products.

Conclusion

As can be seen from the topics discussed in this article, Mexico has strict regulatory requirements for pharmaceutical advertising. Because of this, it is always suggested that before carrying out any type of advertisement in this sector, the specific product and service is assessed in order to determine the relevant limitations and requirements.

Bello, Gallardo, Bonequi y Garcia

Downtown Santa Fe
Tower II
14 Floor Avenue
Santa Fe 428
Santa Fe
USA

+52 555 292 5232

cdiaz@bgbg.mx www.bgbg.mx
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Law and Practice

Author



Santillana Hintze Abogados, S.C. is based in Mexico City. Founded 15 years ago, its areas of expertise include health law, regulatory, advertising, licensing, black market issues and prosecution, anti-bribery compliance and personal data protection and compliance. It advises life sciences companies involved in the pharmaceutical and medical devices industry, as well as industry associations, on legal matters related to biotechnology. The practice group consists of 20 lawyers specialising in healthcare law, with a team dedicated exclusively to administrative litigation matters, including advising and litigating on public procurement and public tenders of pharmaceuticals and medical devices. The firm’s lawyers are experienced in health law, corporate law, personal data compliance, FCPA and competition matters, advising clients that are among the most prominent pharmaceutical and medical devices companies and demand highly specialised legal advice relating to the latest laws and regulations in this rapidly developing field.

Trends and Development

Authors



Bello, Gallardo, Bonequi y García was established in 2001 and has become a significant player in the Mexican legal market, meeting the growing need for specialised legal services. The versatility of its lawyers allows BGBG to provide personalised services in each of its practice areas, including technology, media and telecommunications (TMT). BGBG was created as a boutique law firm for TMT practice, and since its formation has been providing ongoing legal services to all types of companies within the TMT, technology, media, entertainment and communications industries. The firm’s TMT practice, which handles all matters related to advertising and regulatory sectors, is one of the biggest standalone practices in Mexican law firms, and its team devotes almost all of its time to this specialised area. It has been recognised by independent national and international publications as a top-tier and leading practice.

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