Pharmaceutical Advertising 2018
1.1 Laws and Self-Regulatory Codes
The laws and regulations that regulate advertising on medicines in Mexico are:
- General Health Law;
- Regulations of the General Health Law on advertising matters;
- Mexican Official Standard 072-SSA1-2011: labeling of medicines and herbalists remedies;
- Mexican Official Standard 001-SSA1-2012 – biotechnological medicines and its bio drugs: good manufacturing practices; characteristic technical and scientific techniques that must be followed to demonstrate safety, efficiency and quality; labelling; requirements to effectuate bio comparison and pharma surveillance studies.
1.2 Application and Legal Value of Regulatory Codes
Under a strict legal standpoint, self-regulatory provisions are not mandatory for others outside the ompany; they are only applicable internally. In some court cases a self-regulatory procedure can be used as evidence.
2. Scope of Advertising and General Principles
2.1 Definition of Advertising
In Mexico, advertising is defined as: “activity that encompasses the whole creation, planning, execution and diffusion process of an announcement in the media aimed at promoting the sale or consumption of products and services”.
2.2 Difference Between Information and Advertising
The difference between information and advertising resides in the fact that advertising promotes for sales. For this reason, disease awareness campaigns do not qualify as advertising.
2.3 Restrictions on Press Releases
There are two different types of medicine advertisements in Mexico. Firstly, those directed towards health specialists, comprising (a) information about the characteristics and use of the medicines, and (b) promotion for advertising purposes of medical and scientific information. Secondly, those directed towards the general population, comprising (a) promotion of medicines that do not require prescription for sale, and (b) promotion of herbal products.
Press releases, directed at the general population, regarding medicines that do not require prescription for sale and herbal products are allowed in the Mexican jurisdiction. Press releases regarding prescription medicines are not permitted.
There are restrictions on advertising medicines to the general population, which include:
- they must be adjusted to the indications approved by the Health Secretariat;
- they must include the clear message “Consult your doctor” and express due caution when the use/misuse of the medicine can be dangerous.
Medicine advertising directed at health specialists can only be broadcast through sector-specific media, including specialised publications and medical guides.
2.4 Comparative Advertising
In Mexico, comparative advertising for medicines is not forbidden.
3. Advertising for Unauthorised Medicines or Unauthorised Indications
3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications
In Mexico, it is not possible to provide information on unauthorised medicines or unauthorised indications. Advertisers must obtain the corresponding permit from the Health Secretariat.
3.2 Provision of Information During a Scientific Conference
In Mexico, it is not allowed to provide information on unauthorised medicines or unauthorised indications during a scientific conference directed at healthcare professionals.
3.3 Provision of Information to Healthcare Professionals
In Mexico it is not allowed to send information on unauthorised medicines or unauthorised indications during a scientific conference directed at healthcare professionals.
3.4 Provision of Information to Healthcare Institutions
In Mexico it is not allowed to send information on unauthorised medicines or unauthorised indications to healthcare institutions. All medicines, prior itheir commercial release, are required to have the authorised registry issued by the Health Secretariat.
4. Advertising to the General Public
4.1 Main Restrictions on Advertising to the General Public
First of all, it must be remarked that is not permissible to advertise medicines for which a prescription is required, only over-the-counter medicines. Secondly, such medicines would not be allowed to be advertised when:
- it is shown as the definitive solution in preventive, healing or rehabilitation treatment;
- it indicates or suggests a use for different symptoms to the ones expressed in the sanitary authorisation;
- it modifies the information about dosage previously authorised by the Health Authority;
- it promotes its consumption through raffles, contests, sweepstakes, and other suchlike events;
- it promotes its consumption by offering in return any other service or product;
- it uses statements or testimonies that might confuse the public or are not fully supported;
- it uses caricaturing techniques that might cause confusion in children;
- it is not adjusted to the indications approved by the Health Secretariat;
- it does not include the lclear message “Consult your doctor” and express the due caution when the use/misuse of the medicines can be dangerous.
4.2 Information Contained in Advertising to the General Public
The advertising of medicines that do not need a prescription must observe the restrictions aforementioned regarding the information prohibited (see above 4.1).
In general terms, any such advertisement must:
- -refer to the characteristics and properties of the drug in Spanish;
- provide sanitary information;
- provide sanitary precautions when it can cause health risks, pursuant to the following: provide information about the adequate use of the product, as well as the possible risks; put such information in a graphic image, in order to avoid any confusion in the patient; print in contrasting colors and in the sizes approved by the authority; draft in positive word forms the instructions for use; draftin negative word forms when the patient shall be warned about the risks.
On the other hand, the applicable regulation provides that medicine directed at the general public can include: description of the illness, diagnosis, treatment, preventions or rehabilitation information included in the sanitary authorisation. This information must always include the issuer’s name, with its trademark, and its corporate name.
4.3 Restrictions on Interactions Between Patients or Patient Organisations and Industry
In Mexico, neither the law nor the applicable regulations rule about possible restrictions on interactions between patients or patient organisations and industry.
4.4 Restrictions on Endorsements by Healthcare Professionals
Advertising of medicines that do not require a prescription for sale shall demonstrably correspond to the sanitary quality, origin, purity, conservation, nutrition properties and benefits of the product. Therefore, any endorsement by healthcare professionals (ie, “this medicine is endorsed by the Pediatric Association”) must ensure the demonstrability, quality, origin, purity, conservation, nutrition properties, etc, of the medicine.
5. Advertising to Healthcare Professionals
5.1 Restrictions on Information Contained in Advertising Directed at Healthcare Professionals
The content directed to healthcare professionals regarding advertisement ofmedicines comprises (a) information about the characteristics and use of the medicines, and (b) broadcast with advertising purposes of medical and scientific information.
The information pertaining to prescribed medicines shall be solely addressed to healthcare professionals. It must be approved prior to its disclosure and must include the following:
- distinctive name, if applicable;
- generic name;
- pharmaceutic form and formulae;
- therapeutic indications;
- pharmacokinetic and pharmacodynamics;
- adverse effects;
- general precautions ;
- pregnancy and lactation restrictions;
- secondary reactions;
- drug therapy interactions;
- alterations on the lab test results;
- precautions regarding the effects in terms of fertility;
- dosage and administration instructions;
- statements on and management of overdoses or accidental consumption;
- storage recommendations;
- protection legends;
- name and domicile of the lab;
- registry number.
Any information that does not follow the above requirements is prohibited.
5.2 Reference to Data Not Included in the Summary of Product Characteristics
Information on clinical trials, studies or other information related to patients’ files must be treated as confidential and therefore cannot be disclosed in the product’s summary.
5.3 Restrictions on Reprints of Journal Articles
Standard practice does not prohibit the provision of printed journals and articles to healthcare professionals; therefore, it is permitted, but subject to the applicable regulations.
6. Vetting Requirements and Internal Verification Compliance
6.1 Requirements for Prior Notification/Authorisation
To advertise medicines a prior permit issued by the competent authority is required. The competent authority is the Federal Commission Against Sanitary Risks (COFEPRIS). The main requirement to obtain the permit is to file the formal application, attaching the following information:
- name of the product or service;
- number of the sanitary registry;
- number of the sanitary license or operation notice;
- broadcast characteristics, including advertising media, advertisement duration, number of versions, advertising title and advertisement agency, the advertisement project, documentation that endorse the statements contained in the advertisement;
- sanitary permit of the product and its labels.
6.2 Compliance with Rules on Medicinal Advertising
In the medicinal advertising arena, no specific arrangements are provided by the applicable regulations, apart from medical services where the personnel attending the medical establishments must be trained persons.
7.1 Regulation of Advertising on the Internet for Medicinal Products
7.2 Advertising for Medicines on Social Media
The applicable regulations encompass within the general definition of “Broadcast Media” any electronic communication media, therefore, social media advertisement is allowed.
The restrictions for medicinal advertisement via social media are the same that apply for any type of broadcast media advertisement – see 4.1 Main Restrictions on Advertising to the General Public above.
The COFEPRIS has a department, which is called “Copy Advice”, whereby the interested party can submit a draft of the website’s advertisement to establish full compliance with the legal dispositions on the matter.
7.3 Access Restrictions on Websites
Any access restriction has been imposed by the applicable regulations to companies’ advertisement on its websites.
8. Inducement/Anti-bribery General
8.1 General Anti-bribery Rules
Anti-bribery provisions under Mexican legislation apply only to the existing relationship between a public officer and a private person, aiming to achieve an improper benefit for the individual or for his/her company.
Thus, in the sense of the abovementioned, no anti-bribery provisions exist between pharmaceutical companies and healthcare professionals.
8.2 Legislative or Self-regulatory Provisions
Any legal disposition regarding the offering of benefits to healthcare professionals exists. From this standpoint, the regulation of benefits to healthcare professionals can be regulated internally by the enterprise. In such regard, many companies are subject to the IPCCA (International Pharmaceutical Congress Advisory Association) that set forth the main guidelines to conduct benefits under ethical standards.
9. Gifts, Hospitality, Congresses and Related Payments
9.1 Gifts to Healthcare Professionals
The offering of gifts and other valuable benefits shall be regulated internally by the company (ie, self-regulation); no general legal disposition exists applicable to healthcare professionals in the private sector. A diifferent scenario exists when the healthcare professional is part of the public health system in Mexico – as such, they are considered as public officers, and the offer of any value to public officers is forbidden.
9.2 Limitations on Providing Samples to Healthcare Professionals
Provision of medicinal samples to healthcare professionals does not require a prior permit from COFEPRIS, but must comply with the requirements and specifications applicable for the original product and be provided in only a small number of units.
However, it is important to note that samples of restricted medicines are not allowed to be distributed to the general public.
9.3 Sponsorship of Scientific Meetings
Offering attendance/lodging to medical/scientific events, meetings or conferences abroad shall be regulated internally by the company (ie, self-regulation); therefore, no general legal restriction exists applicable to healthcare professionals in the private sector. However, when the healthcare professional is part of the public health system in Mexico they are considered as public officers, and an offer of any value to public officers is forbidden.
9.4 Sponsorship of Cultural, Sports or Other Non-scientific Events
See above, 9.1 Gifts for Healthcare Professionals, for rules regarding the private sector and the public health system; these also apply to sponsorship.
9.5 Grants or Donations to Healthcare Professionals or Healthcare Institutions
See above, 9.1 Gifts to Healthcare Professionals, for rules regarding the private sector and the public health system; these also apply to donations.
9.6 Restrictions on Rebates or Discounts to Healthcare Professionals or Healthcare Institutions
See above, 9.1 Gifts to Healthcare Professionals, for rules regarding the private sector and the public health system; these also apply to rebates/discounts.
9.7 Payment for Services Provided by Healthcare Professionals
There is no restriction in Mexico regarding the payment for services provided by healthcare professionals.
9.8 Prior Authorisations or Notifications
In certain jurisdictions anti-corruption regulations restrict the offering of gifts and hospitality-related benefits to healthcare professionals. However, this depends on the specific domestic region in which the business is intended to be developed. Under Mexican legislation, no anti-corruption restrictions exist in terms of offers to healthcare professionals in the private sector. It is important to underline that restrictions apply otherwise for healthcare professionals in the public sector.
10.1 Requirement to Disclose Details of Transfers of Value
Pharmaceutical companies are not required to disclose details of transfers of value to healthcare professionals or healthcare institutions in the private sector, which is self-regulated. Public healthcare professionalsy are considered as public officers, and an offer of any value to public officers is forbidden.
10.2 Foreign Companies and Companies That Do Not Yet Have Products on the Market
Transparency requirements apply to foreign companies in Mexico. If the company conducts business in a jurisdiction with regulations concerning corrupt foreign practices, then the specific case shall be analysed.
11.1 Enforcement Bodies
In Mexico, the bodies which are responsible for enforcing the rules on advertising and the rules on inducement are:
- the Federal Commission Against Sanitary Risks (COFEPRIS);
- the Federal Superior Audit Bureau (ASF) for cases in which public resources are compromised;
- the Federal Courts;
- the compliance department in pharmaceutical companies for cases of inducement of public officers of the public sector.
11.2 Initiating Proceedings for Advertising Infringements
If any person, whether a competitor or not, detects violations in the field of advertising, such person is entitled to file a complaint before the Federal Commission Against Sanitary Risks (COFEPRIS). If such a complaint does not proceed satisfactorily, then a claim alleging violations to the advertising regulations can be initiated before a court.
11.3 Penalties for Violating Advertising Rules and Rules on Inducements to Prescribe
Economic penalties can vary between MXN75,490 and MXN301,960. Additionally, damages can be claimed and imposed within a proceeding before a court.
11.4 Relationship Between Regulatory Authorities and Courts
There is no defined relationship between the procedures before or measures taken by the self-regulatory authority and the procedures before or measures taken by courts; however, in some court cases a self-regulatory procedure can be used as evidence.
11.5 Recent Enforcement Trends
Recently, COFEPRIS has looked towards those companies promoting so-called “miracle products” (eg, for weight loss), aiming to stop the commercialisation of those products considered prejudicial to health. In general terms, the authority will always seek that the advertisement of any product is ascertainable – in other words, that the advertisement matches with the properties and real characteristics of the product.
Mauricio Mondragon Velazquez