Pharmaceutical Advertising 2022

Last Updated February 02, 2022

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 by 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 the consumer protection law, it might apply. Issues related to the accuracy of the information submitted to consumer 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, the affiliation to which is strictly voluntary. Companies of the pharmaceutical industry 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 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 to the terms of its regulations is valuable to its members. It is important to mention that breach of such codes does not automatically represent a breach of Mexican legislation. 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

The activity that incorporates all creation process, planification, execution and diffusion of commercials in media, with the purpose of promoting the sale and consumption of products and services.

Commercial

The message directed to the public, or to a segment of it, with the purpose of informing about the existence or the characteristics of a product, service or activity for its 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 are clear to determine that information of healthcare products is considered promotional activity even if there are not advertising phrases and/or suggestions to use such products. Information about good healthcare practices or disease awareness are not considered as advertising. The Mexican regulatory authority has interpreted that information that mentions a product even by its generic name is considered as advertising and is therefore subject to the applicable legal terms and limitations.

Distinction between Target Audiences

There is a clear distinction about the advertising activities that could 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 trademark 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.

PSP Programmes

With respect to patient support programmes (PSP), in Mexico in the past years several pharmaceutical companies have developed programmes to support patients during their medical treatment. These programmes are sensitive from the 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 couching for a heathy life. Subscription to PSP's 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 a 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 could 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 as broadcast or public medium (medio de difusión) as those 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 IT technology. If the social media platform is accessible by the public, the only messages that could be broadcast are the 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 intended 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, therefore, are 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 my 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 being an OTC product or a prescription-only medicine is given by the regulatory authority when analysing and approving a marketing authorisation.

Prescription Medicines

  • Controlled medicines: the prescription is special and issued by the Ministry of Health.
  • Controlled medicines: 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.

It should be noted that all the above medicines are considered prescription-only medicines.

OTC Medicines

  • OTC medicines sold only in pharmacies that do not require a prescription to be shown.
  • 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.
  • 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.
  • Shall not attribute to them 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.
  • Indicate or suggest that the use or consumption of a product is a decisive factor for changing people’s behaviour.
  • 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

Provide health information on the use of the products and the providing of the services, which must correspond to any purposes indicated in the respective authorisation.

  • Indicate 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.
  • Avoid 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 have a basic legal division.

  • 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.

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; and
  • must omply 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) (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 the one 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 be have the 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 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 an 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. These data are submitted by the applicant of 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 a HCP is the one 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 on 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 heathcare matters and medicines information, in this case, the same must be in accordance to the one contained in the SmPC.

MSL 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 HLP 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, for not providing 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 procedure that regulates 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 medium (medio de difusion) as 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 HCP. If the IT platform allows access to the public, the only messages that could be performed are the ones related to OTC products, no information related to Rx products and their therapeutic indications should be published.

The same rules apply as to the internet. As mentioned above, 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 HCP. If the social media platform allows access to the public, the only messages that could be published are the ones related to OTC products. This includes Twitter, Facebook and WhatsApp. For legal purposes social media is considered a broadcast medium (medio de dufusión).

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

The 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 matter could be considered as subliminal information to provoke the use of pharmaceutical products. If a company projects to provide on-line disease awareness information, it is advisable to get an authority written ruling.

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 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 to give 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 or 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 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 relation 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 relation that might represent a conflict of interest with their public duties. The concept of conflict of interest applies to both individuals or public organisations.

A clear conflict of interest will be considered if the 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 included under the terms of their provisions 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.

As mentioned in the preceding paragraphs, the Federal Law of Administrative Responsibilities prohibit give 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 relation 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 HCP. The delivery must be made through administrative authorities of the healthcare institution.

In 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 to help 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 meeting as congresses, HCPs can attend. The main principle of 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 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 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 anti-trust regulations, for example, that the rebate is given under 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 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 get the benefit the company in an inadequate manner, such as:

  • influence the HCP to prescribe certain products;
  • buy or recommend them; or
  • damage the image of a product of a third party.

The payment should have a fair market value and be related only with 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 correspondent 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 anti-trust 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 my opinion such requests must be grounded and be specific to the cases, not being an open request of 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 are subject to the terms of the correspondent 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 a joint jurisdiction over an individual case, for example, advertising that is consider misleading 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 battle the case before federal courts and the right to a constitutional relief in case of a constitutional violation.

There are three scenarios:

  • if the advertising infringements are any of regulatory healthcare provisions the company might file 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;
  • if in addition to the above if 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;
  • temporarily or definitive shutdown of the company;
  • seizure of a product or entire stock;
  • request to recall the correspondent products;
  • in case of an advertising material or 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 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 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 being medicines or having non-proven therapeutic effects. In the past, TV broadcast companies have allowed advertising of these products with the obvious damage to the consumer.

At the same time, the Federal Consumer Protection Attorney Office is active to prevent misleading advertising that might damage the consumer.

During 2021 there were not significant changes to the Pharmaceutical Advertising regulations in Mexico.

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 that marketing agencies and media companies might improperly control 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 kink of advertising and not only of pharmaceutical products.

Santillana Hintze Abogados, S.C.

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

+55 52 92 82 32

gsantillana@santillana-abogados.net www.santillana-abogados.mx
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Basham, Ringe y Correa is a full-service law firm with strong presence in Latin America. Established in 1912, it has more than 100 years of experience assisting clients in doing business throughout Mexico and abroad. The firm has four main offices in Mexico – in Mexico City, Monterrey, Queretaro and Leon – with a team of 120 lawyers. Basham’s clients include prominent international corporations, many of them on the Fortune 500 List, medium-sized companies, financial institutions and individuals. The firm’s lawyers actively participate in worldwide associations, as well as in international transactions. The firm provides regulatory counsel and litigation relating to manufacturing, import, distribution, marketing, labelling, and advertising of pharmaceutical products, medical devices, pesticides, fertilisers, cosmetics and household cleaning products, veterinary products, seeds, foods, beverages, alcohol and tobacco. Basham’s multidisciplinary practice team consists of lawyers, chemists and biologists, who ensure a comprehensive vision of client cases from a technical, regulatory and legal point of view through meaningful collaboration.

Pharmaceutical Advertising Regulations in Mexico

Overview

The pharmaceutical industry has become one of the most important sectors in the world, since medicines are part of our daily lives, used not only to cure or stop disease, but also to prevent and relieve symptoms. As most countries have regulatory mechanisms for this industry to protect against the pursuit of unnecessary, excessive or harmful consumption of medicines in general, this article aims to describe the general regulation of pharmaceutical products in Mexico from an advertising perspective. 

Introduction 

The regulation of advertising in Mexico is not a new issue, as for decades the competent authorities have legislated and issued various types of provisions and regulations in order to establish the guidelines that must be met by suppliers of products and services for the welfare of the consuming public.  

In general, Mexico has a Federal Consumer Protection Law (FCPL), which establishes the objectives of promoting and protecting the rights and culture of the consumer, seeking equity, clarity and legal certainty in relations between suppliers and the general public. 

Even though this law does not have a specific chapter regarding the guidelines that any product or service must comply with in terms of advertising, it establishes the general principle that information or publicity related to goods, products or services that are broadcast by any media or in any form must be truthful, verifiable, clear and free of text, dialogue, sounds, images, trademarks, designations of origin and other descriptions that lead or may lead to error or confusion due to misleading messages and abusive advertising practices. 

According to the FCPL, misleading or abusive information or advertising is understood as that which refers to characteristics or information related to any good, product or service that may or may not be true, misleads or confuses the consumer due to inaccurate, false, exaggerated, partial, artificial or tendentious content.  

Based on the foregoing, it is possible to say that the advertising of any product or service, regardless of its nature, field of application or characteristics, must comply with the principles of truthfulness and not mislead the consumer, rules which are equally applicable to to pharmaceutical products.  

Applicable Legislation  

In addition to the FCPL, there is a regulatory framework for the advertising of pharmaceutical products, which is mainly found in the following provisions: 

  • the General Health Law (GHL); 
  • the General Health Law Regulations regarding Advertising (RGHL); and
  • the Official Mexicans Standards (NOMs). 

It should be noted that even though these constitute the main legal framework for the advertising of pharmaceutical products, there are other laws and regulations that also apply. For instance, the Federal Law for the Protection of Industrial Property establishes the prohibition to use any denomination as a trademark that can cause confusion or mislead the consumer regarding the characteristics of the product. This obligation applies not only when the trademark is filed, but also if the trademark is registered, since at the moment of the declaration of use (applicable for trademarks filed after 10 August 2018) or renewal, it must be declared that the goods/services are non-deceptive and are free of bad faith. 

On the other hand, the Regulation in the Field of Medical Supplies, establishes that in addition to the fact that a trademark in pharmaceutical products cannot clearly or veiledly include the composition of the drug or its therapeutic qualities, it must be different from other trademarks in at least three letters of each word. 

The advertising of pharmaceutical products is not a matter regulated only by the government, but also associations formed by members of the pharmaceutical industry, such as:  

  • the National Chamber of the Pharmaceutical Industry (CANIFARMA); and
  • the Council of Ethics and Transparency (CETIFARMA). 

CANIFARMA and CETIFARMA have issued different codes of ethics and conduct to regulate this industry in the advertising field, namely: 

  • the Code of Ethics and Transparency of the Pharmaceutical Industry; 
  • the Code of Good Promotional Practices; and
  • the Code of Good Practices of Interaction of the Pharmaceutical Industry with Patient Organisations. 

Even when the regulations issued by the associations are not mandatory, if a member of the association does not comply with these codes, it can be suspended or excluded as a member of the chamber. 

Lastly, the Advertising Council is a public-service organisation which includes representatives from academia, the business sector, the scientific community, media and consumer groups and the Ministry of Health. This Council is focused on the issuance of different criteria and opinions for the optimal use of ethics in pharmaceutical advertising strategies. 

Advertising 

Advertising is defined as providing information with the intention to promote the sale or consumption of a product. Legally, it is “the activity comprehending any process of creating, planning, executing, and circulating of ads in media channels which aims to promote the sales or consumption of products and services”, according to Article 2 of the RGHL. 

This means that any activity that fulfils this description shall be regulated by the RGHL and other applicable regulations and, even when there is not a specific rule regarding electronic or online advertising, the activities through this media shall fulfil the general advertising rules in accordance with the RGHL. 

Any advertisement of a pharmaceutical product must be approved by the competent authorities, including the Federal Commission for Protection against Sanitary Risks (COFEPRIS), which is an agency linked to the Ministry of Health and with control of the advertising of pharmaceutical products.  

COFEPRIS is also the competent authority for regulating the authorisation of the manufacture and commercialisation of pharmaceutical products. The safety and efficacy of the products must be demonstrated by standard clinical trials, according to the rules established in the GHL, the Regulation of the RGHL and the NOMs related to the medicine manufacture in order to obtain the authorisation to sell the product and subsequently the advertising approval. 

If the product is not manufactured in Mexico, the import of drugs, health products or raw materials for drugs must be also approved by COFEPRIS for sale and marketing in our country. This means that parallel imports of medicinal products are not allowed in our legal system, since the import of medicinal products always requires authorisation. The exceptions to this rule are very limited for lab tests, clinical trials, special treatments for illnesses with low prevalence, personal use or donations. 

In addition to COFEPRIS, there are other authorities responsible for ensuring compliance with legal provisions, such as the Federal Agency for Consumer Protection (PROFECO), which is responsible for protecting and defending consumer rights, or the General Attorney Office (FGR), which is responsible for implementing measures against health crimes. 

Characteristics of Advertising in Pharmaceutical Products  

Advertising shall be consistent with the characteristics or specifications that establish the applicable provisions for pharmaceutical products, namely it shall not:  

  • attribute preventive, therapeutic, rehabilitative, nutritional, stimulating or other qualities, which do not correspond to their function or use; 
  • indicate or suggest that the use or consumption of the pharmaceutical product is a determinant factor to modify a person's behaviour; 
  • indicate or explicitly or implicitly lead to the belief that the pharmaceutical product has the ingredients or the properties it lacks; or 
  • encourage  or put at risk the physical or mental integrity or dignity of persons.  

Advertising will be guiding and educational, for which it must: 

  • refer to the characteristics, properties and effects, in Spanish, in clear terms which are easily understandable for the public to whom it is addressed; 
  • provide health information on the use of the pharmaceutical product, which must correspond, when appropriate, to the indicated purposes of the granted authorisation; 
  • indicate the necessary precautions when the use, handling, storage, possession or consumption may cause risk or damage to people’s health;  
  • contain information on the specifications for the proper use of the product, as well as the health damages that could be caused; and 
  • be written in negative literary forms when it comes to warning the consumer about the risks that the product may represent.  

Advertising shall be verifiable and therefore cannot:  

  • mislead the consumer; 
  • hide the necessary contraindications; 
  • exaggerate the features or properties of the pharmaceutical product; 
  • indicate or suggest that the use of the pharmaceutical product is a determinant factor of the individual’s physical, intellectual or sexual characteristics; and 
  • establish comparisons between products whose ingredients are different, which could lead to health risks or damage. 

The legends or health messages that must appear in the advertising of pharmaceutical products will be subject to the following provisions.  

  • In advertisements that are broadcast on television and in films, the written captions must appear for a minimum duration equivalent to a quarter of the total duration of the ad, appear in contrasting colours, be placed horizontally, with regular Helvetica font that is not condensed and equivalent to 40 points per letter in size, in proportion to a 14-inch television screen.   
  • The auditory legends must be pronounced in the same rhythm and at the same volume as the ad, in clear and understandable terms.  
  • In printed advertisements, the legends must have the characteristics referred to above and adhere to the following sizes:  
    1. for billboards measuring at least 1,290 mm x 360 mm, the legend will be 60 points high and must be adjusted in proportion to the size of the advertisment; 
    2. for any other print advertising, the text must be no smaller than 20 points high in proportion to a page that measures 21.5 cm x 28 cm; and  
    3. for electronic advertising, for every four spaces there must be one with the precautionary legend placed in a similar size and proportion to the product’s advertisement.  
  • In radio advertising, the legends will be an integral part of the advertisement and will be pronounced in the same rhythm and at the same volume as the voice of the latter, in clear and understandable terms. 
  • The legends and messages contained in Computer or telecommunication media advertising must comply with the  above regulations. 

If the authority so requires, any statements made in the advertising about the quality, origin, purity, conservation, nutritional properties and benefits of the pharmaceutical products must be verified, as well as the target group to which the publicity is directed. The advertising company responsible must present the technical and scientific information requested by the authority. 

Classification of Advertising 

For pharmaceutical products, advertising is classified as:  

  • Advertising aimed at health professionals, which includes:  
    1. information about the pharmaceutical product and its use; and 
    2. the diffusion of medical or scientific information for advertising or promotional purposes. 

In this case, the medical information shall be addressed to health professionals, through film, recorded or printed materials, by means of objective demonstrations, exposures or exhibitions on human diseases, and their prevention, treatment and rehabilitation.  

  • Advertising aimed at the general public, which includes the advertising of medicines that do not require a medical prescription to be purchased.   

Drug advertising aimed at the general public may include the description of diseases specific to human beings, diagnosis, treatment, prevention or rehabilitation expressed in the terms of the produts' health record and in language appropriate to the target audience. These messages must always identify the issuer with the product's trademark or its corporate name.  

Advertising aimed at health professionals may only be broadcast in the media for this sector, including dictionaries of pharmaceutical products and medication guides, and must be based on the information for the prescribed medications. 

The advertising of medicines aimed at the general public must:  

  • fulfil the indications approved by the health authorities in the authorisation of the product; 
  • include in the visual form for print, audio for radio, as well as the visual and audio forms for film and television, the legend: “Consult your doctor”, as well as express the corresponding precaution when the use of medications represents a danger in the presence of any co-existing clinical or psychological conditions; and 
  • in film and television, one of the legends can be included in visual form and the other in auditory form.  

Pharmaceutical product advertising will not be authorised when: 

  • it is showed as a definitive solution in the preventive, curative or rehabilitative treatment of a certain disease; 
  • it indicates or suggests its use in relation to symptoms other than those expressed in the health authorisation of the product; 
  • it promotes consumption through raffles, contests, collectibles, or other events in which luck is involved; 
  • it promotes consumption by offering any other product or service in exchange; 
  • it makes use of statements or testimonials that may confuse the public and are not properly supported; and 
  • it uses cartoon techniques that may confuse and induce minors to consume the products.  

Authorisation  

The authorisation for the advertising of pharmaceutical products is granted by the Ministry of Health and shall be issued within 40 days of the application being filed. The Ministry of Health is able to request additional information or documents in order for the authorisation to be granted. The authorisation will implicitly be granted if a requirement or unfavourable response is not issued by the Ministry of Health after the above-mentioned term. 

The authorisation for the advertising of pharmaceutical products is indefinitely granted. Therefore, those responsible are not allowed to introduce any modification to the authorised advertising that would vary the characteristics that served as the basis for the granting of the authorisation, except if such modification is ordered by another authority, which must be made known to the Ministry of Health prior to it being broadcast.  

Authorisation will not be required for gift samples (understood as the copies of the products), which are used for the purpose of making them known through free distribution and which meet the requirements. The same  specifications apply as for the public sale of the original products, the only difference being the gif samples contain a smaller unit number.  

Sanctions 

The Ministry of Health and COFEPRIS are empowered to take the following actions against the advertising of pharmaceutical products: 

  • the suspension or withdrawal of the publication of an advertising activity in breach of the law within 24 hours;  
  • request that the accountable person modify the advertising that is presumably in breach of the legal regulations; 
  • conduct inspection visits to verify the enforcement of the legal regulations; and 
  • impose a fine from 2,000 up to 16,000 units of measurement (UMA = USD4.80).  

Even when these actions and penalties are only established in the RGHL, the legal framework foresees others, such as the seizure of advertising and products, additional fines, the suspension or closure of an establishment and even civil and criminal liability that can be executed by the Ministry of Health and COFEPPRIS and other authorities, eg, the Mexican Institute of Industrial Property, PROFECO and the Attorney General's Office (FGR).  

Conclusion  

While pharmaceutical products are a mechanism for preserving individual health and wellbeing, we must not forget that they are also merchandise. That is why any advertising for a health product, including drugs, plays a fundamental role in public information.   

The main objective of pharmaceutical advertising is to attract the greatest number of product consumers and, because it is directed to potential users who may be diminished by their sick condition, they are successful in accomplishing that goal without respecting the difference between medical publicity and that which is used for other products. Therefore, the government's role has to be primarily focused on the individual protection that is independent of the final user without ignoring the commercial purposes of the products. 

The legal framework allows enterprises in the sector to publicise their products in all media channels, however the particularity of this subject must be considered as well as the multiple regulations that cover these activities, including government legislation and the codes and other code-bodies of chambers and associations. 

COFEPRIS has played an important role in the monitoring and compliance of advertising regulations. This organism has executed agreements with pharmaceutical companies to implement the autoregulation principle in this sector and the execution of actions, enforcement, verification and imposition of fines to those companies that look to misinform consumers about the pharmaceutical product and its benefits and indications. 

Basham, Ringe y Correa S.C.

Paseo de los Tamarindos
400-A 9 Piso
Bosques de Las Lomas
Ciudad de México
Mexico

+52 55 5261 0600

+52 55 5261 0411

marketing@basham.com.mx www.basham.com.mx
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Law and Practice

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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.

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Basham, Ringe y Correa is a full-service law firm with strong presence in Latin America. Established in 1912, it has more than 100 years of experience assisting clients in doing business throughout Mexico and abroad. The firm has four main offices in Mexico – in Mexico City, Monterrey, Queretaro and Leon – with a team of 120 lawyers. Basham’s clients include prominent international corporations, many of them on the Fortune 500 List, medium-sized companies, financial institutions and individuals. The firm’s lawyers actively participate in worldwide associations, as well as in international transactions. The firm provides regulatory counsel and litigation relating to manufacturing, import, distribution, marketing, labelling, and advertising of pharmaceutical products, medical devices, pesticides, fertilisers, cosmetics and household cleaning products, veterinary products, seeds, foods, beverages, alcohol and tobacco. Basham’s multidisciplinary practice team consists of lawyers, chemists and biologists, who ensure a comprehensive vision of client cases from a technical, regulatory and legal point of view through meaningful collaboration.

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