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 Ley General de Salud 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 Practice complement this regulation. The Council of Ethics and Transparency of the Pharmaceutical Industry (CETIFARMA) has issued the Code of Integrity, Ethics and Transparency of Health Care Supply Companies (Code, or CIETEMIS for its Spanish acronym). Affiliate members of the National Chamber of the Pharmaceutical Industry (CANIFARMA) are required to follow this Code. 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, promotion means any activity undertaken, organised, or sponsored by a pharmaceutical company or under its authority (subsidiaries, foundations, associations, institutes, agencies, etc.) that 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 requires members to strictly comply with the applicable legal provisions, and their personnel to have at least a broad knowledge of all 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 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 Code. These authorities must certify that the material's final form has been examined, that it abides by the provisions of the Code 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 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 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 the legal framework. This order must 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 that 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 times the minimum wage (around 21,000.00 USD to 165,000.00 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-the-counter 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 HL and the HLR, regarding advertising, both contemplate the possibility of a so-called "sanitary complaint", 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 empower CETIFARMA to supervise and impose monetary sanctions on 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 Code enforced by CETIFARMA. This self-regulatory 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 Federal Law for the Protection of Industrial Property 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 the Protection of Consumers establishes the possibility of filing a complaint before the Bureau of Consumer Protection (PROFECO) regarding false or tendentious advertising, which can impose a fine on the responsible party and an order to stop the specific advertising activities.
There is also the possibility of filing a civil action under Article 6 bis of the Commercial Law, which establishes the possibility of initiating civil actions derived from unfair competition acts. This action for unfair competition under the Commercial Law may be applicable for cases that cannot be claimed before an administrative authority and are not contemplated in the Federal Law for the Protection of Industrial Property.
2 Providing Information Prior to Authorisation of Medicinal Product
2.1 To what extent is it possible to make information available to healthcare professionals about a medicine before that product is authorised? For example, may information on such medicines be discussed, or made available, at scientific meetings? Does it make a difference if the meeting is sponsored by the company responsible for the product? Is the position the same with regard to the provision of off-label information (i.e. information relating to indications and/or other product variants not authorised)?
According to Article 42 of the HLR, prescribing information about products to healthcare professionals is subject to approval before publication. This information is approved while granting marketing authorisation for the corresponding product. Any publication should have the marketing authorisation number of this product.
The Code sets forth that information about medicinal products must be grounded on scientific evaluation and related empirical evidence, which must be kept at the disposal of healthcare professionals, if required. It must not induce confusion by means of distortion, unjustified pressure, omission, or any other means.
This Code also states that, when scientific information is provided and is not part of the prescribing information duly approved or authorised in the marketing authorisation of a product, it should be strictly limited to a scientific audience, avoiding the promotion, directly, indirectly or through a third party, of any unauthorised directions of use.
2.2 May information on unauthorised medicines and/ or off-label information be published? If so, in what circumstances?
With respect to results of clinical trials, the Code sets forth that when they are being published in specialised or widely distributed magazines, pharmaceutical companies must request the disclosure of any conflicts of interest from the authors.
With respect to scientific information that is not part of the prescribing information duly approved or authorised in the marketing authorisation of a product (off-label information), the Code requires that providing this information must be strictly limited to a scientific audience, avoiding the promotion, directly, indirectly or through a third party, of any unauthorised directions of use.
2.3 Is it possible for companies to issue press releases about unauthorised medicines and/or off-label information? If so, what limitations apply? If differences apply depending on the target audience (e.g. specialised medical or scientific media vs. mainstream public media), please specify.
According to the HLR, any advertising of medicinal products to the public should be approved by COFEPRIS. The product must have a marketing authorisation. The Code requires members to promote responsible prescription and discourage self-medication. It should be analysed, therefore, on a case-by-case basis, whether a press release is or is not an advertising activity.
The Code states that when a company, directly or indirectly, finances, sponsors, or organises the publication of promotional materials in journals or magazines, it must be expressly stated that the material is not presented as an independent editorial matter, and the sponsorship of the company must be clearly displayed.
In practice, it is possible for companies to issue press releases about unauthorised medicines and/or off-label information, yet guidelines should be considered within the HL and its regulations, as well as the Industry Code, in order to avoid any unlawful practice.
2.4 May such information be sent to healthcare professionals by the company? If so, must the healthcare professional request the information?
Such information may be sent to healthcare professionals by the company, if the healthcare professional requests the information, or if they have authorised the company to send scientific information.
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Originally published by ICLG.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.