1 General – Medicinal Products
1.1 What laws and codes of practice govern the advertising of medicinal products in your jurisdiction?
The primary legislation for the advertising of medicinal products is the General Health Law (Ley General de Salud) (HL), and its Regulations (Reglamento de la LGS en materia de Publicidad) (HLR). These norms are supplemented by guidelines published by the Regulatory Agency, the Federal Commission for Protection against Sanitary Risks (COFEPRIS). This agency is part of the Ministry of Health and controls the advertising of medicinal products. Industry Codes of Practices complement this regulation. The Council of Ethics and Transparency of the Pharmaceutical Industry (CETIFARMA) has issued the following self-regulatory instruments (the Codes):
- The Code of Ethics and Transparency of the Pharmaceutical Industry (Code of Ethics & Transparency).
- The Code of Good Practices of Promotion (Code of GPP).
- The Code of Good Practices of Interaction of the Pharmaceutical Industry with Patient Organisations (Code of GPI).
The latest versions of these Codes have been in force since April 1, 2013. Affiliate members of the National Chamber of the Pharmaceutical Industry (CANIFARMA) are required to follow these Codes. CETIFARMA supervises members' and adherents' compliance.
There are also opinions issued by the Advertising Council, which include representatives from the Ministry of Health, the academic and scientific communities, the business sector, the media and consumer groups.
Additionally, other general legislation may be relevant for the advertising of medicinal products, particularly, the Federal Law for the Protection of Consumers and the Industrial Property Law.
1.2 How is "advertising" defined?
Article 2 of the HLR defines advertising as, "the activity comprehending any process of creation, planning, execution, and circulation of ads in media channels which aims to promote the sales or consumption of products and services".
An advert is, according to this Article, "the message directed to the public or a section of the same, with the purpose of informing about the existence or characteristics of a product, service or activity for its commercialisation and sale or to motivate a conduct ".
For the Code of GPP, promotion means any activity undertaken, organised or sponsored by a pharmaceutical company or under its authority (subsidiaries, foundations, associations, institutes, agencies, etc.) which supports the prescription, dispensing, sale and acquisition or administration of its medicines, complying with applicable rules, regulations and standards.
1.3 What arrangements are companies required to have in place to ensure compliance with the various laws and codes of practice on advertising, such as "sign off" of promotional copy requirements?
The Code of Ethics & Transparency requires members to strictly comply with the applicable legal provisions, and their personnel to have at least a broad knowledge of all of the applicable provisions.
Concerning advertising and promotional activities, the above Code requires them to give accurate and objective explanations on the characteristics, functions, advantages or disadvantages of their products or services.
The Code of GPP requires that the information provided to healthcare professionals is accurate, balanced, fair and objective, and sufficiently complete to enable them to form their own opinion of the therapeutic value of the medicine.
Under no circumstances can promotional material be distributed in a final version, to which no further amendments will be made, if it has not been certified and authorised by the medical authorities of the laboratory and the person in charge of confirming its compliance with the Codes. These authorities must certify that the material's final form has been examined: that it abides by the provisions of the Code of GPP and by the applicable standards on advertising practices; and that it complies with commercial authorisations and, in particular, with the information of the marketing authorisation in effect. Presentations must be true and faithful to the medicine's stated characteristics.
1.4 Are there any legal or code requirements for companies to have specific standard operating procedures (SOPs) governing advertising activities or to employ personnel with a specific role? If so, what aspects should those SOPs cover and what are the requirements regarding specific personnel?
The Code of Ethics & Transparency requires members to act in accordance with sound trading practices and in strict compliance with the prevailing legislation. In this regard, members are required to establish the proper measures and monitoring procedures to verify that their associated members abide by the regulations applied to the different activities they perform.
1.5 Must advertising be approved in advance by a regulatory or industry authority before use? If so, what is the procedure for approval? Even if there is no requirement for prior approval in all cases, can the authorities require this in some circumstances?
Article 79 of the HLR sets forth that the advertisement of medicinal products must be approved. Approval applications should be filed before COFEPRIS. These applications must include all of the characteristics of the intended advertising.
There is also the possibility of submitting only a notice rather than an approval application when the advertising is only directed to healthcare professionals.
The regulations allow companies to have a previous opinion by an authorised expert. This opinion may be filed along with the approval application to speed up the process.
1.6 If the authorities consider that an advertisement which has been issued is in breach of the law and/or code of practice, do they have powers to stop the further publication of that advertisement? Can they insist on the issue of a corrective statement? Are there any rights of appeal?
COFEPRIS has specific authority to order the suspension of an advertising activity in breach of legal framework. This order has to be followed by both the responsible party and the media channel within a term of 24 hours.
COFEPRIS may warn companies with approved products to modify ads which are presumably in breach of the legal framework. If not modified, or the modification is considered to not comply with the legal provisions, COFEPRIS may suspend the advertising activities and impose a fine.
The decision and orders issued by COFEPRIS may be appealed before itself or the Federal Courts.
1.7 What are the penalties for failing to comply with the rules governing the advertising of medicines? Who has responsibility for enforcement and how strictly are the rules enforced? Are there any important examples where action has been taken against pharmaceutical companies? If there have not been such cases please confirm. To what extent may competitors take direct action through the courts in relation to advertising infringements?
The penalties for failing to comply with the rules related to advertising are the suspension of advertising activities ordered either to the responsible party or directly to the media, and the imposition of a fine to each one, which can range from 2,000 to 16,000 minimum wages (around 9,000.00 USD to 73,000.00 USD). The responsibility for imposing these penalties falls directly on the Ministry of Health, through COFEPRIS.
Regarding the strictness on the imposition of these fines, in our experience it has been steadily increasing. COFEPRIS constantly monitors advertising activities throughout the country, particularly regarding drug-like products. COFEPRIS has been directing the efforts of coordination agreements related to publicity, and the enforcement of the same.
There has also been a strong coordinated effort between COFEPRIS and pharmaceutical companies tending to the self-regulation of advertising, which is still monitored
As for any important examples where action has been taken against over-the-counter pharmaceutical companies, it is worth mentioning that COFEPRIS has imposed large fines against specific over-thecounter medication manufacturers for using misleading advertising related to its products, inciting the public to self-medicate and taking their products at the first symptom without consulting a doctor.
Regarding the possibilities for competitors to take direct actions related to advertising infringements, the General Health Law and the Regulations of the Health Law regarding advertising, both contemplate the possibility of a so-called "people's action", which is a complaint filed before COFEPRIS regarding a breach of the provisions of the law. Issues related to unfair competition will be directly addressed in question 1.9 below.
The Industry Code of Practice empowers CETIFARMA to supervise and impose monetary sanctions to members in breach of these Codes.
1.8 What is the relationship between any self-regulatory process and the supervisory and enforcement function of the competent authorities? Can and, in practice, do, the competent authorities investigate matters drawn to their attention that may constitute a breach of both the law and any relevant code and are already being assessed by any self-regulatory body? Do the authorities take up matters based on an adverse finding of any self-regulatory body?
COFEPRIS's supervisory and enforcement functions are supplemented by the Codes enforced by CETIFARMA. This selfregulatory process, therefore, does not preclude the statutory powers of COFEPRIS, which, at its discretion, may or may not take into account findings from the self-regulatory body
1.9 In addition to any action based specifically upon the rules relating to advertising, what actions, if any, can be taken on the basis of unfair competition? Who may bring such an action?
Actions based on unfair competition derived from advertising activities can be taken based on the provisions set forth by the Industrial Property Law.
Actions can be brought before the Mexican Institute of Industrial Property (IMPI) either by the directly affected party or by the authority itself.
If there is a firm unfair competition decision, the affected party can claim damages and lost profits before a civil court.
Additionally, Article 32 of the Federal Law for Consumer Protection establishes the possibility of filing a complaint before the Bureau of Consumer Protection (PROFECO) regarding false or tendentious advertising, which can impose a fine to the responsible party and order to stop the specific advertising activities.
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