This country-specific Q&A provides an overview of the legal framework and key issues surrounding pharmaceutical advertising law in the Mexico.
This Q&A is part of the global guide to Pharmaceutical Advertising.
For a full list of jurisdictional Q&As visit http://www.inhouselawyer.co.uk/index.php/practice-areas/pharmaceutical-advertising
What laws are used to regulate advertising on medicines in your jurisdiction?
The main laws that regulates advertising on medicines are The General Health Law (Ley General de Salud) (“GHL”), and its Advertising Rules (Reglamento de la Ley General de Salud en materia de publicidad) (“HLR”). These norms are supplemented by The Federal Consumers Protection Law (Ley Federal de Protección al Consumidor), The Rules of the Federal Consumer Protection Law (Reglamento de la Ley Federal de Protección al Consumidor) and a variety of Mexican Official Standards (“NOMs”) covering specific technical issues such as manufacturing best practices, post – marketing controls, surveillance of labelling, among others.
The Federal Commission for the Protection against Sanitary Risks (“COFEPRIS”), is the agency in charge of the surveillance and authorization of medicines and medical devices advertisement.
Are there any self-regulatory or other codes of practice which apply to the advertising of medicines? a) If there are any such codes, to whom do they apply (companies, or healthcare professionals, for example)? b) What is the legal status of the self-regulatory codes?
Yes, industry associations have issued several Codes of Practices applicable to the advertising of medicines:
- The Council of Ethics and Transparency of the Pharmaceutical Industry (“CETIFARMA”); i) The Code of Ethics and Transparency of the Pharmaceutical Industry; ii) The Code of Good Practices of Promotion (Code of GPP); and iii) The Code of Good Practices of Interaction of the Pharmaceutical Industry with Patient Organisations (“CGCPI”).
- The Nacional Advertisement Regulation Council (“CONAR”): i) Advertisement Ethics Codes (“AEC”); and ii) Sectorial Ethics Code (“SEC”).
- The Over the Counter Medicines Association (“AFAMELA”): AFAMELA Advertisement Ethics Code.
Such codes apply to the company’s member of the industry associations that issue each one of them, only the healthcare professionals working for members are subject to these codes.
The legal status of the self-regulatory codes is private agreement between the members of each association.
Is there a statutory or generally accepted definition of “advertising”? a) What does the definition cover? – does it include patient information leaflets, for example, catalogues, disease awareness campaigns or correspondence, for example? b) Does the definition apply equally to all target audiences?
Pursuant article 2 section IX of HLR advertising is defined as “the activity comprehending any process of creation, planning, execution and circulation of ads in media channels which aims to promote the sales of consumption of products and services”.
The law distinguishes between general public and healthcare professionals, different rules and obligations arise depending on the targeted audience.
Are press releases regarding medicines allowed in your jurisdictions, and if so what are the restrictions on these (bearing in mind the target audience)?
Yes, press releases regarding medicines are allowed in Mexico. As long as it’s only contains the generic denomination, medical condition and general commercial information as introduction dates to the marked. Always excluding trademarks, logotypes, brands and approved prescribing information.
Are there any processes prescribed (whether by law or Codes of Practice) relating to the approval of advertising of medicines within companies?
No, in Mexico there are no processes prescribed relating to the approval of advertising of medicines within companies neither in Advertising Regulations nor Code of Practices.
Do companies have to have material approved by regulatory bodies prior to release?
Article 79 of HLR states that the advertisement of medicines to the general public requires a permit granted by COFEPRIS, while advertisement to health professionals, only require a notice to be filed before COFEPRIS. Promotional activities also only require a notice.
The advertisement authorisation is based on the classification made by the risk analysis of the product in the GHL. While over-the-counter medicines (“OTCs”) can be advertised to the general public, prescription medicines are limited to advertisements targeted only to healthcare professionals.
Is comparative advertising for medicines allowed and if so, what restrictions apply?
According to Mexican laws comparative advertising is permitted if the comparison is been made between equals, meaning same pharmaceutical dosage form and same therapeutics indications. Also, that the comparison is intended to inform the public, and it is not tendentious, false or exaggerated.
The Industrial Property Law and the Federal Consumer Protection Law contains further provisions related to actions that can be filed against the party responsible for harmful comparative advertisement. In that sense, article 32 of the Federal Law for the Protection of Consumers penalises unfair practices in comparative advertisements.
Is it possible to provide information on unauthorised medicines or unauthorised indications? Is it possible to provide information on unauthorised medicines or unauthorised indications during a scientific conference directed at healthcare professionals, or to send information to healthcare professionals?
Providing information of unauthorised medicines or unauthorised medications is only permitted if it is targeted to healthcare professionals, and it is necessary to file the corresponding notice of advertisement.
According with GPP the information that is not contained in the approved prescribing information, either in the authorization issued by the Ministry of Health, must be strictly limited to scientific audiences.
This information must be based on scientific evaluation and in empirical evidence, it should not induce to distortion confusion, unjustified insistences, or any kind of omission.
Please provide an overview of the rules that apply to advertising to the general public for prescription only medicines and over the counter medicines, an indication of the information that must or must not be included.
In Mexico, prescription only medicines advertisement is limited to healthcare professionals, and is not allowed to be advertised to general public.
The advertisement of over the counter medicines (“OTCs”) directed to the general public shall comply with the indications approved by COFEPRIS in the premarket clearance of the product; and must include the message either in visual, print, hearing for radio, and print and hearing for cine and television the following caption: “Consult your physician” (Consulte a su médico), and also the precautions messages when the use of the medicine can represent any danger in the presence of a disease pattern.
According to article 44 of the HLR medicines advertisement will not be authorized to the general public when:
- It is presented as a definitive solution as preventive, curative or rehabilitative treatment of a certain disease;
- It indicates or suggest its use in relation to symptoms and conditions different that those expressed in the premarket clearance;
- Disrupt the information authorized by COFEPRIS;
- Promote its consumption through draws, raffles, competitions collectibles, or events in those who chance is involved;
- Promote consumption by offering any other product or service in return;
- Use statements or testimonials that may confuse the public or that are not supported.
- Use cartoons techniques that can confuse or induce minors to consume the products;
- Neglect the preventive messages command by regulation, when applicable.
Are there any restrictions on interactions between patients or patient organisations and industry (e.g., consultation, sponsorship)? If so, please describe those briefly.
Pursuant the GHL, HLR and CGCPI it’s forbidden any kind of promotion of prescribed medicines geared towards the Patients Organisations (“PO”), any kind of materials intended to increase the sales or use of medicines should require an advertisement permit.
The industry in any case should provide medical or diagnose information for patients or PO (e.g. call centre).
Which information must advertising directed at healthcare professionals contain, and which information is prohibited? For example can information about clinical trials, or copies of journal be sent?
According to article 42 of HLR the medicine advertisement for healthcare professionals, medicines advertisement shall include the following information:
- The distinctive denomination; if applicable
- The generic denomination;
- The pharmaceutical form and formulation;
- Therapeutic indications;
- Pharmacokinetics and pharmacodynamics;
- The contraindications;
- The general precautions;
- Restrictions of use during pregnancy and lactation;
- Secondary and adverse reactions,
- Alterations in the results of laboratory tests;
- Precautions regarding effects of carcinogenesis, mutagenesis, teratogenesis and on fertility;
- Dosage and administration route;
- Manifestations and management of overdose or accidental intake;
- The presentation or presentations;
- Storage and handling recommendations;
- Protection messages;
- Laboratory name and address;
- The premarket clearance number issued by COFEPRIS.
Additionally, according to NOM – 071 – SSA1-2012, controlled medicines shall contain obligatory captions as follows:
a. “Its sale or dispensation requires a prescription or special permit with barcode which will be retained at the pharmacy”.
b. “Its sale or dispensation requires a prescription, which shall be retained at the pharmacy” and if it applies “Prolonged use even at therapeutic doses may cause dependence”
c. “Its sale or dispensation requires a prescription which may be filled three times for a validity of six months” and if applies “Prolonged use even at therapeutic doses may cause dependence”.
Advertisements directed to healthcare professional can only be published in specialised media, and they must be based on the approved prescription information of the corresponding medicine. In all cases the premarket clearance number should be included. All the information in the guides to prescribe a medicine should be authorized previously in the medicine premarket clearance.
May pharmaceutical companies offer gifts to healthcare professionals and are there any monetary limits?
According to statement 4.6.9 of GPP, in any case gifts of significant commercial value may not be offered to healthcare professionals, either any incentives of any kind as inducement to recommend a specific product.
The monetary limit is 40 dollars, set forth in the Federal Law of Public Officers Responsibilities (Ley Federal de Responsabilidades de los Administradores Públicos). This limit only applies for health professionals working at government health entities, however as there is not specific limit in the industry codes, this can be used as a reference for private practice.
Are pharmaceutical companies allowed to provide samples to healthcare professionals?
Yes, the HLR and industry codes states that healthcare professionals are allowed to receive samples for the sole purpose to get familiarized with the medicine; by no reason whatsoever market such samples.
According to several international agreements sign by Mexico, it is forbidden for companies to deliver samples that contains psychotropic or narcotic substances; companies also shall keep scrupulous and updated control of samples from their production, storage, delivery to regional coordinators until the delivery to doctors.
The breach of this statement it will be considered as a contravention of The Code of Ethics and Transparency of the Pharmaceutical Industry and The Code of Good Practices of Promotion.
Is sponsorship of scientific meetings or congresses and/or attendance by healthcare professionals to these events? If so, which restrictions apply? Do additional restrictions apply to events taking place abroad?
Yes, the sponsorship of scientific meetings or congresses shall have as it aims scientific exchange, medical education and detailed information about medicines or health supplies.
Any material that includes trademarks, logotypes or brands will be considered as advertising so it will be required an authorisation issued by COFEPRIS or notice file before COFEPRIS depending on the targeted audience.
On general basis, the companies must act responsibly regarding sponsorship, under no circumstances will funding be offered to influence decisions about the prescription of medications and health supplies.
No affiliate or adherent to GPP may organize or sponsor events, meeting or congresses aimed to health care professionals taking place abroad, unless:
a) More than the 80% of the invited healthcare professionals comes from other countries than Mexico and is logistically more convenient for most participants.
b) Safety and lower cost reasons.
What are the restrictions on the organisation of cultural, sports or other non-scientific events in relation to scientific conferences by pharmaceutical companies?
The events geared towards to healthcare professionals must be celebrated in suitable place; entertainment, sports or recreational activities may not prevail over scientific activities; these activities shall occupy at least the 80% of the scheduled time. Affiliates to GPP must not offer support or finance social, recreative, sports activities or any other nature than academic.
Is it possible to pay for services provided by healthcare professionals and if so, which restrictions apply?
Accredited healthcare professionals can be hired as consultants to provide health services and medical knowledge, such as help in medical development, participate in clinical research or any kind of investigations, to be speaker at presentations aimed to sales staff. Payment of such services shall follow local market criteria, be consistent with the time spent, the work done and the assumed responsibilities.
Under no circumstance healthcare professionals will be hired for an incentive to use, prescribe, buy or recommend any product.
Are pharmaceutical companies permitted to provide grants or donations to healthcare professionals or healthcare institutions? Does it matter if the grant or donation is monetary or in kind?
Yes, pharmaceutical companies are permitted to provide grants or donations to healthcare professionals and institutions.
Yes, it does, no gifts with significant commercial value may be offered to healthcare professionals either any incentive of any kind to use, prescribe, buy or recommend any product.
On general basis, nothing that could have an inappropriate influence on the prescribing practices of health professionals may be offered.
Books or technical material can be offered if the total amount does not exceed of 50 times the minimum wage (around 300 USD).
Are pharmaceutical companies required to disclose details of transfers of value to healthcare professionals or healthcare institutions? If so, please indicate whether this is a legal requirement or not, and describe briefly what the companies must report and how. Do these transparency requirements apply to foreign companies and/or companies that do not yet have products on the market?
In Mexico this is not a legal requirement, however the code of GPP requires members of CETIFARMA to record any valuable support given to healthcare professionals, institutions or patient organizations, additionally, members shall provide any information regarding donations granted available to the public in order to promote transparency.
As the interactions of pharmaceutical companies with healthcare professionals may generate a conflict of interest, in order to avoid these situations, CETIFARMA shall be consulted so they can advise and guide on the behavior to follow, providing supporting studies, invitations to conferences and promotional activities.
This requirement only applies to members affiliated to CETIFARMA, whether or not they are foreign companies.
When if at all with a competent authority have to get involved in authorising advertising? Is advertising on the internet (including social media) for medicinal products regulated, and if so, how? Should companies include access restrictions on websites containing advertising or other information intended for healthcare professionals?
COFEPRIS is the agency in charge of the surveillance and authorization of medicines advertisement; the advertisement of medicines to the general public requires a permit granted by COFEPRIS, while advertisement to health professionals, only require a notice to be filed. Promotional activities also only require a notice.
The advertisement authorisation is based on the classification made by the risk analysis of the product in the GHL. While OTC’s can be advertised to the general public, prescription medicines are limited to advertisements targeted only to healthcare professionals.
Advertising on the internet for medical products shall comply with all the applicable regulation set in the HLR as the internet and other technologies used for advertising are considered as broadcasting medias by section VII of article 2 of HLR.
Yes, access restrictions on websites containing advertising or other information intended for healthcare professionals shall be implemented by companies, this security mechanism should be in record in case COFEPRIS may a request of information to the company.
Are there any anti-bribery rules apply to communications between pharmaceutical companies and healthcare professionals or healthcare organizations?
There are several anti-bribery rules contained in The Mexican Federal Constitution, The Federal Anticorruption Law for Government Procurement, the Federal Criminal Code, and the International anti-corruption conventions ratified by Mexico. Additionally, the industry codes state a variety of anticorruption, transparency, and data privacy provisions to prevent corruption practices.
What are the rules (whether statutory or self-regulatory) which govern the offering of benefits or inducements to healthcare professionals?
(i) Federal Law of Public Officers Responsibilities.
(ii) The industry Codes:
i) The Code of Ethics and Transparency of the Pharmaceutical Industry;
ii) The Code of Good Practices of Promotion.
Which bodies are responsible for enforcing the rules on advertising and the rules on inducement? Please include regulatory authorities, self-regulatory authorities and courts.
- Authorities: COFEPRIS and Federal Prosecutor for the Consumer Protection ("PROFECO”).
- Self-regulatory bodies CETIFARMA, CONAR and AFAMELA.
- Authorities: Anticorruption Ministry.
- Self-regulatory bodies CETIFARMA.
On what basis and before which bodies or courts can companies initiate proceedings against competitors for advertising infringements?
For Health Advertisement Rules infringements, the corresponding body to initiate a proceeding is COFEPRIS.
For commercial related infringement and/or comparative advertisement infringements the corresponding body to initiate a proceeding is PROFECO.
For intellectual property infringement the corresponding body to initiate a proceeding is Mexican Institute of Intellectual Property and the Federal Administrative Courts.
What are the penalties, sanctions or measures that regulators or courts can impose for violating medicines advertising rules and rules on inducements to prescribe in your jurisdiction?
In very specific cases COFEPRIS and PROFECO may coordinated actions against a violation of the corresponding laws and regulations.
Both authorities, may order the suspension of an advertising in breach of legal framework in order to modify such ads, if not modified or the modification is considered not to comply with legal provisions, COFEPRIS and PROFECO may suspend the advertising activities, seize the advertise product and/or impose a fines according to articles 110, 111 and 112 from the HLR which may vary from $9,000 to $73,000 USD depending on the severity of the violation.
What is the relationship between procedures before or measures taken by the self-regulatory authority and the procedures before or measures taken by courts/government competent authorities?
Government competent authorities’ procedures and measures are administrative acts to enforce the applicable laws and regulations.
Self-regulatory authorities, procedures and measures are based on commercial agreements.
Government authorities and self-regulatory authorities may coordinate in procedures and measures; however, this is not mandatory, nor their procedures or measures are legally bind between each other.
Are there any recent enforcement trends in relation to pharmaceutical advertising in your jurisdiction? Please report any significant (publicly known) enforcement actions in the past two years.
On June of 2019, COFEPRIS revoked the Advertisement Guidelines for internet health supplies advertisement and for OTC’s and prescription medicines. In the last quarter of 2019 COFEPRIS announced that the agency is working on new guidelines that should be published in 2020.