1. GENERAL &NDASH; 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".
Ad means, 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 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 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 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 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 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.
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 of GPP 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 of GPP sets forth that when they are being published in specialised or widespread distribution magazines, pharmaceutical companies have to 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), this 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. main stream 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 of Ethics & Transparency 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 of GPP 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.
2.4 May such information be sent to healthcare professionals by the company? If so, must the healthcare professional request the information?
As mentioned above, the Code of GPP sets forth that information of medicinal products must be grounded on scientific evaluation and related empirical evidence, which must be kept at the disposal of healthcare professionals, if required.
When scientific information is provided that 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.
2.5 How has the ECJ judgment in the Ludwigs case, Case C-143/06, permitting manufacturers of non-approved medicinal products (i.e. products without a marketing authorisation) to make available to pharmacists price lists for such products (for named-patient/compassionate use purposes pursuant to Article 5 of the Directive), without this being treated as illegal advertising, been reflected in the legislation or practical guidance in your jurisdiction?
The above case law is not relevant to Mexico, as it is not an EU Member State.
2.6 May information on unauthorised medicines or indications be sent to institutions to enable them to plan ahead in their budgets for products to be authorised in the future?
With respect to private institutions, it is advisable to first obtain the medicine's approval before sending them information, in order to avoid this being perceived as advertising of an unauthorised medicine.
With respect to public institutions, they have to follow the National Formulary (Cuadro Básico de Insumos para la Salud) that is issued by the Ministry of Health. This is essentially a list of products that can be acquired by public insurers. To have a product listed in this formulary it is required to have been approved, among other requirements.
Such products are acquired mainly through public tender processes, unless they have to be directly acquired from exclusive rights holders, for example, in the case of patented products.
The Code of Ethics & Transparency requires members to fully and loyally comply with the precepts of the legal framework applicable to public tender processes. The Code mandates that during the acquisition process, through public bidding or any other procedure of government acquisition, there should be no attempt to either exert undue influence upon the decision-making process, or to gather confidential information from government officials acting on behalf of a government office or entity.
In addition, the Committee for the Negotiation of Drug Prices (CNDP) supports public acquisitions through a process of transparent negotiation between public insurers and pharmaceutical companies, particularly regarding patented products. The Committee evaluates the cost-benefits of new medicines and therapies in view of other comparable products in the market.
2.7 Is it possible for companies to involve healthcare professionals in market research exercises concerning possible launch materials for medicinal products or indications as yet unauthorised? If so, what limitations apply? Has any guideline been issued on market research of medicinal products?
The Code for GPP allows accredited healthcare professionals to be hired to participate in clinical trial studies and other research. The Code states that under no circumstances can healthcare professionals, whatever their accreditation, be hired in order to induce the use, prescription (products and/or indications), purchase or recommendation of a specific product or to influence the results of a clinical study. The standards mentioned below in question 5.4 would also apply.
3. ADVERTISEMENTS TO HEALTHCARE PROFESSIONALS
3.1 What information must appear in advertisements directed to healthcare professionals?
According to Article 42 of the HLR, advertisements directed to healthcare professionals can only be published in specialised media, and they must be based on the approved prescription information of the corresponding medicinal product.
However, in December 2017, COFEPRIS issued new guidelines regarding the advertising of prescription-only medicinal products. According to these guidelines, prescription-only medicinal products that can be purchased as many times as prescribed, can now be advertised in mass media, provided that these advertisements are transmitted within specialised programmes, informative capsules or their advertising breaks, which should be focused for professionals, technicians and auxiliaries of the health disciplines, or in another type of programming and/or means of communication, as long as it complies with the following characteristics:
- That within the advertising message there is a strong message that speaks of the consequences of self-prescription and microbial resistance, which should have an approximate duration of 10%–20% of the entire advertising message.
- Knowledge of innovative or generic medicines should be promoted.
- A caption should be included that says: "Exclusive information for health professionals, avoid self-medication" in accordance with the provisions of Article 10 of the HLR.
- Advertising on television or in electronic media must contain the following caption: "The use of this medicine requires a prescription" and must include at least one of the following disclaimers: "The improper and excessive use of antibiotics generates resistance and puts your health at risk", "Only use antibiotics when a health professional prescribes it", "Never use antibiotics that you have left over and do not share them with others", "Always take the complete prescription, even when you feel better", "Doctor: Prescribe and dispense antibiotics only when needed".
- The advertising notice must be made five days prior to its dissemination in any means of communication for the purpose that during that period the COFEPRIS will give its approval.
The Code of GPP states that the relationships between pharmaceutical industry personnel and healthcare professionals should encourage the development of a medical practice committed to patients' well-being, based on truthful and accurate information and tested and up-to-date scientific evidence in order to contribute to the appropriate use of approved medicines.
3.2 Are there any restrictions on the information that may appear in an advertisement? May an advertisement refer to studies not mentioned in the SmPC?
The Code of GPP requires that the medical and scientific departments of its members ensure that the information provided to healthcare professionals is accurate, balanced, fair and objective, and sufficiently complete to enable the recipients to form their own opinion of the therapeutic value of the medicine.
Members must take scientific and moral responsibility for the content of the information provided by them, or others by an agreement (outsourcing).
According to the Code of GPP, when promotional material refers to published studies, these must be faithfully reproduced or clear, easily accessible references must be given. A faithful reproduction is one that reflects the full meaning and content of the original source in an objective manner, without adding or excluding any information that could mislead or confuse the recipient.
3.3 Are there any restrictions to the inclusion of endorsements by healthcare professionals in promotional materials?
The Code of Ethics & Transparency requires members to refrain from taking undue advantage of their clients, or any product, individual, company, commercial brand or symbol, through mass media advertising.
3.4 Is it a requirement that there be data from any, or a particular number of, "head to head" clinical trials before comparative claims may be made?
There is no specific provision referring to head to head clinical trial data before comparative claims, however, the Code of GPP states that the information 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.
As mentioned above, when promotional material refers to published studies, these must be faithfully reproduced or clear, easily accessible references must be given. A faithful reproduction is one that reflects the full meaning and content of the original source in an objective manner, without adding or excluding any information that could mislead or confuse the recipient.
As an example of this, when the effectiveness and safety of different active principles are compared for advertising purposes, information such as the statistical appraisal of the results must not be omitted. Statistics, conclusions or any other data derived from different studies using different methodologies, must not be mixed or compared, unless resulting from systematic reviews or meta-analysis where the homogeneity criteria is specified. Adaptations that may introduce bias or confusion are unacceptable.
3.5 What rules govern comparative advertisements? Is it possible to use another company's brand name as part of that comparison? Would it be possible to refer to a competitor's product or indication which had not yet been authorised in your jurisdiction?
In December 2017, COFEPRIS issued new guidelines regarding the approval of ads for non-prescription medicinal products, where it is indicated that comparisons between medicines or active ingredients that have the same therapeutic purpose are valid as long as they do not demerit or present competitors in a situation of inferiority, adding that the comparisons should not question the quality of products that have marketing authorisation, no veiled or express comparisons are allowed with products of a different nature to the type of product to be advertised.
Comparative advertisements are further contemplated in both the Industrial Property Law and the Federal Law for the Protection of Consumers. Both of these laws contain provisions related to actions that can be filed against the party responsible for the comparative advertisement.
According to Article 213 subsection X of the Industrial Property Law, it is possible to use another company's brand name in advertising as long as the comparison is intended to inform the public, and it is not tendentious, false or exaggerated.
Article 32 of the Federal Law for the Protection of Consumers also penalises unfair practices in comparative advertisements, including unfair use of trademarks, and contemplates the possibility of filing a complaint before the Consumer's Bureau for such activities.
The Code of Ethics & Transparency calls members to compete fairly, avoiding unfair practices. Market competition must be fair and respect intellectual rights, or any other member's rights.
The above Code requires members to refrain from discrediting competitors or spreading any false or inaccurate information about their activities or products. The Code of GPP states that claims or comparisons while providing information shall not be included unless scientifically tested. All information, claims or comparisons included in promotional material must be substantiated and fair. In particular, any comparison between different medicines must be scientifically sustained and must comply with the regulations of fair competition standards. It must not be denigrating and comparisons must be grounded on equivalent elements and relevant evidence.
As to the referral to a competitor's product that has not been approved in Mexico, there are no clear specific provisions in this regard, provided that it does not have a well-known trademark in Mexico. Thus, our recommendation would be to submit the ad before COFEPRIS for an opinion or an authorisation, in order for it to determine whether the ad implies a risk to public health.
3.6 What rules govern the distribution of scientific papers and/or proceedings of congresses to healthcare professionals?
The Code of GPP sets forth guidelines for these activities. Public institutions may have their own particular guidelines.
The Code states that congresses, lectures, symposia, meetings and other similar scientific or educational events sponsored, financed or supported by pharmaceutical companies or any other third party must have, as a main purpose: scientific exchange; medical education; and/or information about medicines.
Whenever support for continuing education or independent educational programmes is being provided, the education of healthcare professionals should be encouraged, primarily, to improve their knowledge of patient care. In each case, programmes must comply with the guidelines of the applicable laws: they must have a strict scientific content sustained, if required, on clinical evidence; and, most importantly, they must be accredited and certified by the corresponding academic authorities.
Support in general will not be offered, under any circumstance, in order to have any kind of influence on the decision-making process involved in prescribing medicines or buying, including, excluding or modifying official product catalogues.
3.7 Are "teaser" advertisements (i.e. advertisements that alert a reader to the fact that information on something new will follow, without specifying the nature of what will follow) permitted?
Although there is no legal provision specifically forbidding teaser ads of medicinal products, the Code of Ethics & Transparency requires members, while providing information or advertising, to give accurate and objective explanations on the characteristics, functions, and advantages or disadvantages of the products or services.
In addition, the Code of GPP mandates that all promotional material, including advertising in printed, audio-visual or electronic media, must be legible and in strict accordance with the terms established in the marketing authorisation and with the ethical principles included in the Codes.
Therefore, there is a chance that teaser ads would be considered in breach of the Codes, as information to healthcare professionals must not induce confusion by means of distortion, unjustified pressure, omission or any other means and could be considered as misleading for the consumers.
Additionally, promotional activities to consumers should inform the patient or consumer about the properties of the medicines he/she is using, of the importance of concluding the treatment prescribed by the physician, and about the risks of substituting the prescribed medicine for another one without knowledge and proper medical supervision.
Originally published by The International Comparative Legal Guide to: Pharmaceutical Advertising 2018.
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.