Contributed By Santillana Hintze Abogados, S.C.
In México, the General Health Law (GHL) is the federal legislation that regulates advertising in connection with medicines as well as other medical products, including devices. This federal law is grounded by the Mexican Constitution (Constitución Política de los Estados Unidos Mexicanos); Article 4 of the country’s constitution establishes healthcare protection as a human right.
The Mexican healthcare law system is based on the principle that the protection of people’s health is a human right. Provisions related and applicable to advertising on medicines are part of the GHL; this law has several similar regulations that apply to different aspects and issues related to healthcare (such as: research, regulatory matters, healthcare services, etc). Therefore, in addition to the dispositions of the GHL, there is a particular regulation on advertising of healthcare products (Reglamento de la Ley General de Salud en Materia de Publicidad). In certain cases, such as pricing the provisions of the consumer protection law, it might apply. Issues related to the accuracy of the information submitted to consumer are regulated by the Federal Law of Consumer Protection (Ley Federal de Protección al Consumidor).
The National Chamber of the Pharmaceutical Industry (CANIFARMA) groups pharmaceutical companies in México. Its members must comply with several codes, for example, the Ethics and Transparency Code; the Good Promotional Practices Code; and the Code of Interactions with Patient Associations, including those that apply to advertising of medicines. Such regulations only apply to members of CANIFARMA – compliance with their terms is not binding, pursuant to the terms of Mexican legislation; they contain precise obligations with respect to advertising practices.
CANIFARMA codes apply only to members of the chamber – their dispositions do not apply to healthcare professionals (HCPs) or third parties that are not members of such association. CANIFARMA is a Mexican commerce and industrial chamber, the affiliation to which is strictly voluntary. Companies of the pharmaceutical industry are not obliged to join it under the terms of Mexican law. In order to be admitted to such association, the members must accept compliance with all its codes, including the ones applicable to ethics and Good Promotional Practices.
CANIFARMA codes are not mandatory pursuant to the terms of the Mexican constitution; nor the GHL or any other legal provision. For Mexican pharmaceutical companies being members of CANIFARMA is logical due to its visibility before the Mexican government as well as with other industries and sectors. CANIFARMA is the official link and representative of the pharmaceutical industry. With the above factors in mind, being a member and complying to the terms of its regulations is valuable to its members. It is important to mention that breach of such codes does not automatically represent a breach of Mexican legislation. One key provision of such codes is the members’ duty to comply with the terms of Mexican law.
The regulation of the GHL includes two concepts: one is advertising; the other is the definition of advertising or 'commercial':
Under the terms of the GHL and its regulations, the difference between advertising and information is that information related to a healthcare product is considered advertising; conversely, information about healthcare in general and/or general awareness of illnesses is not considered as advertising. The regulations of the GHL are clear to determine that information of healthcare products is considered promotional activity even if there are not advertising phrases and/or suggestions to use such products. Information about good healthcare practices or disease awareness are not considered as advertising. The Mexican regulatory authority has interpreted that information that mentions a product even by its generic name is considered as advertising and is therefore subject to the applicable legal terms and limitations.
Under the terms of the GHL there is a clear distinction about the advertising activities that could be performed depending on the target audience. Any information related to medicines that requires a medical prescription in order to be sold (Rx pharmaceutical products) can only be delivered to HCPs. This restriction includes the information that contains either the generic and/or the trade mark of the correspondent product. Advertising and Information related to over-the-counter (OTC) products can be directed to the general public with a prior permit from the regulatory authority.
The specific law/regulation regarding promotional activities mandates that the same must be grounded and supported. No information on Rx pharmaceutical products could be used or released to the public. If a company owner of a pharmaceutical product launches a campaign to such general audience, it assumes full responsibility to comply with the terms of the applicable law, being the holder of the correspondent marketing authorisation. In the case of Rx, products can only be directed to an HCP.
Nowadays the use of social media platforms is common, if they allow access to the public, the only messages that could be performed are the ones related to OTC products.
Press releases are considered an advertising activity and are therefore subject to the applicable regulations; the specific law/regulation regarding promotional activities mandates that the same must have the scientific and technical information that support the message. No information on Rx pharmaceutical products could be used or released though press releases if the same are directed to the public and/or have public access, regardless if the intention was only to refer to an HCP. If a company owner of a pharmaceutical product launches a campaign on social nedia, he or she assumes full responsibility to comply with the terms of the applicable law, being the holder of the correspondent marketing authorisation. The regulations on marketing of healthcare products defines as broadcast or public medium ('medio de difusion') as those used to disseminate marketing ads to the public including TV, movies, radio, press, magazines, public ads in streets as well any other means of communication whether electronic or any other IT technology. If the social media platform is accessible by the public, the only messages that could be broadcast are the ones related to OTC products, no matter if the message is made through a press release.
Even though comparative advertising for medicines is not specifically forbidden, making comparisons between medicines might be considered as a trade mark administrative infraction, since the intention of such an advert might be intended to damage the reputation and image of one of the products being compared.
Mexican law requires a marketing authorisation for a medicine to be manufactured, distributed and used. These activities include advertising. Due to the above, advertising of unauthorised medicines or new non-authorised indications is not permitted.
As mentioned above, Mexican law requires a marketing authorisation for a medicine to be manufactured, distributed and used. These activities include advertising. If the medicine is not authorised the information cannot be provided at a scientific conference of HCPs.
If the medicine is not authorised the information cannot be provided to HCPs.
If the medicine is not authorised the information cannot be provided, this applies to healthcare institutions.
Mexican legislation allows only marketing ads or information related to OTC pharmaceutical products. In the case of Rx, products can only be directed to HCP. In my opinion if any media platform allows access to the public, the only messages that could be presented are the ones related to OTC products.
The classification of a medicine being an OTC product or a prescription-only medicine is given by the regulatory authority when analysing and approving a marketing authorisation. The classification of for sale to the public is as follows:
Following a ruling published in the Official Federal Gazette on 27 May 2010, the Ministry of Health determined that antibiotic medicines may only be sold after a medical prescription is presented, which will be retained by the pharmacy at the end of the treatment.
Note: All the above medicines are considered prescription-only medicines.
The main legal principles of advertising of medicines pursuant to the terms of the GHL and the applicable regulation are:
The Advertising of Medicines and Dissemination Materials have a Basic Legal Division
To the public in general: medicines or other health products that for their sale do not require a medical prescription (ie OTC medicines, protheses, orthoses, medical device functional aides, etc).
Advertising directed to health professionals.
Referring to medicines and other products that require a prescription for their sale (medical prescription).
Comply with the marketing authorisation and authority prior specific permit to perform the advertising.
Not be deceptive, exaggerated or tendentious.
Only to health professionals.
Comply with the terms granted within the marketing authorisation and the information to prescribe, approved by the Federal Commission to Prevent Sanitary Risks (Comision Federal para la Protección Contra Riesgos Sanitarios [COFEPRIS]) (summary of the medicine’s information known as information for prescribing [IPP] is the acronym in Spanish).
The information that can be used in advertising of medicines is the one included and approved by the regulatory healthcare authority during the process of the review and analysis of the correspondent marketing authorisation. Only the approved information and therapeutic indications of a medicine can be used in advertising. The price of a medicine can be advertised. The information about the security, efficacy and quality of a medicine must be have the technical and scientific support, as well as be approved be approved by the Mexican healthcare authority. The key document for purposes of advertising activities is the marketing authorisation.
There is not a specific legal restriction for interactions patients, patients’ organisations and industry. The limitations will be with public institutions as well as public servants.
Now, with respect to the industry codes (CANIFARMA), there is one specifically referred to the interactions between industry and patient organisations. This code contains rules an certain limitations for such interactions, including, in general terms the following:
When dealing with an HCP in Mexico an important division must be taken into consideration: HCP working for public institutions; an HCP with a private practice. Endorsements for medicines by HCP are not prohibited, if such an endorsement is to be performed by an HCP who is a public servant, this might represent a conflict of interest with his or her professional medical activity, particularly if the HCP takes part in a decision to: authorise a medicine – include it a public formulary – but the same through a public procurement procedure.
The information that can be directed to an HCP is the one approved by the healthcare authority and contained in the marketing authorisation, of which an important part is known as information for prescription. These data are submitted by the applicant of the marketing authorisation; the medicine will be approved together at the same time. Basically, the data is needed to prescribe the medicine, and includes generic and trade names, indications, manufacturer, formula, contraindications, possible adverse reactions and events. The price of a medicine can be informed to the HCP. The information that cannot be provided to a HCP is the one not approved by the authority, such as: non-approved indications and possible adverse reactions of a third product.
Basically, the advertising needs to refer to the Summary of Product Characteristics (SmPC/Información para Prescribir). If clinical or scientific information is used the same must coincide with the correspondent summary.
Companies can provide reprints of journal articles if the same contain information regarding diseases, general heathcare matters and medicines information, in this case, the same must be in accordance to the one contained in the SmPC.
The advertising approval system is as follows:
The competent authority for all regulatory healthcare matters is COFEPRIS.
Under the terms of the Mexican healthcare law, including GHL and its regulations, there are no legal requirements to have internal policies and/or standard operating procedure that regulates advertising activities.
In respect of these, the CANIFARMA codes contain certain obligations, including, for example: Written rules for the delivery of free samples, interactions with medical associations and control of promotional events.
There is not a specific law/regulation for the use of advertising on the internet. If the internet is used for messages or ads, the GHL and its regulations apply to information and publicity made with respect to goods, services and healthcare products that will be used by humans. This information should be accurate and not mislead the public, at the same time must be grounded and supported.
The regulations on marketing of healthcare products defines as broadcast and/or public medium (medio de difusion) as those used to disseminate marketing ads to the public including TV, movies, radio, press, magazines, public ads in streets as well any other mean of communication whether electronic or any other IT technology.
Such legislation allows only marketing ads or information related to OTC pharmaceutical products. In the case of Rx products they can only be directed to HCP. If the IT platform allows access to the public, the only messages that could be performed are the ones related to OTC products, no information related to Rx products and their therapeutic indications should be published.
The same rules apply as to the internet. As mentioned above, such legislation allows only marketing ads or information related to OTC pharmaceutical products. In the case of Rx products they can only be directed to HCP. If the social media platform allows access to the public, the only messages that could be published are the ones related to OTC products. This includes Twitter, Facebook, WhatsApp, etc. For legal purposes social media is considered as a broadcast medium (medio de dufusión).
If the information that will be submitted is intended for HCP, and is related to Rx medicines, the company must assure that the websites contain solid restrictions to prevent access to the general public.
The Mexican anti-bribery legislation is contained in a group of laws that are known as the national anti-corruption system. Within this mechanism there is one federal law – the Federal Law of Administrative Responsibilities. This legislation prohibits to give any benefit, gift or retribution to a public servant and applies to HCP working for public institutions. In addition, public servants need to avoid any relation that might represent a conflict of interest with their public duties. The concept of conflict of interest applies to both individuals or public organisations.
Under the terms of their provisions, CANIFARMA codes include the obligation of its members to avoid giving benefits, that is, contributions that might have the intention to get a benefit, in return, such as incentivising the prescription of a company’s medicines. These anti-bribery rules apply to relations with HCP or public or private sector organisations.
When dealing with an HCP in Mexico there must be taken in consideration an important division: HCP working for public institutions; HCP with a private practice.
After many years of debate and discussion, in 2015 and 2016, as well as the creation of new legislation important amendments to the constitution were integrated into Mexican anti-bribery legislation to create a group of laws that are known as the national anti-corruption system. As mentioned above, this mechanism has the specific purpose to prevent and prosecute corruption. The Federal Law of Administrative Responsibilities prohibits giving any benefit, gift or retribution to a public servant. This limitation applies to HCP working for public institutions. This law clearly establishes the concept of conflict of interest between the professional activities of an HCP and the relation with the pharmaceutical industry.
In 2008 the Ministry of Health issued regulations that prohibited pharmaceutical companies directly giving any goods to public HCP. The invitation to participate in scientific activities and congresses must be approved by the administrative authorities. In addition, public servants need to avoid any relation that might represent a conflict of interest with their public duties. The concept of conflict of interest apply to both individuals or public organisations.
A clear conflict of interest will be considered if the HCP who has any interaction with the pharmaceutical industry participates in a decision-making process to approve a medicine. This applies also to a public procurement procedure or the analyses of its inclusion in a national formulary.
CANIFARMA codes included under the terms of their provisions the obligation of its members to avoid giving benefits, that is contributions that might have the intention to get a benefit, in return, such as: incentivising the prescription of a company’s medicines. These anti-bribery rules apply to relations with HCP or public or private sector organisations.
As mentioned in the preceding paragraphs, the Federal Law of Administrative Responsibilities prohibit give any benefit, gift or retribution to a public servant, this limitation applies to HCP working for public institutions. In addition, public servants need to avoid any relation that might represent a conflict of interest with their professional activities and their interaction with companies of the pharmaceutical industry. The Ministry of Health issued, in 2008, regulations that prohibit giving any goods to public HCP. The participation in scientific activities, including seminars must be scrutinised and approved by the administrative authorities. In addition, public servants need to avoid any relation that might represent a conflict of interest with their public duties.
In the case of HCP who act in the private sector – having their own medical practice – the CANIFARMA codes establish that it is possible to offer gifts that do not have a significant cost (ie, typically gimmicks).
In the case of public institutions, companies cannot directly provide samples to HCP. The delivery must be made through administrative authorities of the healthcare institution.
In case of HCP with private practices, CANIFARMA’s codes mandate the following:
Companies can sponsor scientific meeting as congresses, HCP can attend. The main principle of these activities is to keep them for educational and scientific purposes, not with the intention to motivate the participants to benefit a pharmaceutical company and encourage the prescription of medicines in exchange for the participation in such events.
In the case of HCP of private practice such events should take pace in adequate non-luxury sites not known for being for entertainment and must have a scientific purpose. The context and purpose of the event should be educational and not for the objective to entertain HCP. The participation must be free of any influence or given as an incentive to prescribe medicines or benefit a company.
In the case of HCP working for public institutions, the event should be authorised by administrative bodies of the institution and have the limits mentioned above. The participation must be free of any influence or given as an incentive to prescribe medicines or benefit a company in a public tender of public procurement procedure or to include certain product in a national formulary.
The cultural, sports or non-scientific events must not be the main objective and should not occupy more than 20% of the time conference.
Companies in the pharmaceutical industry can provide grants and donations to healthcare institutions. The key factor in both the public and private sectors is to avoid conflict of interest and to use the monetary, equipment or services contribution to get back a benefit, such as: prescriptions of medicines; benefits or advantages in public tenders or public procurement procedures; approvals of marketing authorisations; and inclusions in national formularies.
Such restrictions do not necessarily apply themselves, the legal issue will come if the discount is granted to an HCP with a potential conflict of interest, such as getting prescriptions of medicines in exchange.
In the case of healthcare institutions it is valid to give rebates and discounts in compliance with anti-trust regulations, for example: That the rebate is given under free competition basis and not with the specific intention to damage a third party or obstruct the free access to goods.
It is possible to contract services to be rendered by an HCP. As mentioned for other cases, is important to establish the difference between professionals from the public and the private sector.
In the case of HCP of the public sector, is possible to contract for such services if there is not a conflict of interest that might illegally benefit a company, for example: Services of an HCP who participates in the following decisions: To include a medicine in a national formulary; authorisation of a marketing authorisation; or granting a public contract to acquire a medicine or healthcare product.
In cases of an HCP with a private practice, CANIFARMA codes allow getting these types of services and the correspondent payment. The purpose or intention must not be to get the benefit the company in an inadequate manner, such as: Influence the HCP to prescribe certain products; buy or recommend them; or damage the image of a product of a third party. The payment should have a fair market value and be related only to the service.
In case of services to be contracted with public HCP a previous authorisation of the superior is required.
Samples of medicines as well as gimmicks to be given to a public HCP will need to be delivered to the administrative authorities of the healthcare institution, not directly to the HCP. This is a matter that implies that before performing this activity, the correspondent internal body will need to approve the same.
Legally, pharmaceutical companies are not required to disclose, under regular or periodic basis, details of transfers of value to HCPs. The GHL, and not its regulations, establish such obligations. The possibility exists that an administrative or judicial authority might request such disclosure in case of a specific legal procedure or litigation – such a request must be legally grounded and be precise and detailed request of disclosure. For example:
The CANIFARMA codes include transparency obligations, such as the obligation of companies to disclose upon request by the Ethics Council, contracts and payments or transfers of value to HCPs. Such requests must be grounded and be specific to the cases, not being an open request of disclosure, nor an ongoing periodic obligation.
Transparency requirements from Mexican authorities apply to companies doing business in Mexico and such requirements are not related to having products in the market and are linked to their commercial activities.
In the case of CANIFARMA their members already have products in the market; therefore, as members are subject to the terms of the correspondent codes.
The Mexican regulatory authority with legal responsibility to enforce all the applicable regulations on advertising is COFEPRIS.
In cases that involve prices as well as claims that might affect the consumer directly, the Federal Consumer Protection Agency might have a joint jurisdiction over an individual case. For example, advertising that is considered misleading to the consumer.
If a sanction is imposed, for example a fine and or a seizure or a product, a company will have the right to contest the case before federal courts and the right to constitutional relief in case of a constitutional violation.
There are three scenarios:
All the above proceedings have different instances that might end in litigation before federal courts, including constitutional reliefs.
The administrative authorities in charge of enforcing laws and regulation applicable to advertising of medicines might impose the following sanctions:
The procedures or measures taken by the self-regulatory authority and the procedures or measures taken by courts are not linked. Both types of authorities have their jurisdiction and forum. The Mexican Courts will act based on the terms of the Constitution; the GHL and its regulations as well as the consumer protection law. Their resolutions and final judgments will be binding to the sanctioned company. In the case of a self-regulatory authority (CANIFARMA), the industry codes have procedures and sanctions that will be applicable only to members of such chamber. An infraction to the self-regulatory codes does not imply an action of Mexican federal courts or administrative authorities. At the same time, a final judgment of a court will not automatically imply the initiation of a procedure for sanction before the CANIFARMA’s Ethics Council.
During 2017 COFERPIS issued a ruling that might be interpreted as an intention to allow advertising of Rx medicines to the general public; however, the law and the regulations must be changed, and the rules are currently still the same: Advertising of Rx medicines can only be directed to HCP.
The Mexican regulatory authority regularly prosecutes and sanctions advertising of medicines or products that purport to be medicines – without having a marketing authorisation – which do not have the claimed therapeutic effects or in worst-case scenario are not medicines at all.
COFEPRIS as well as the Ministry of Health has the clear intention to combat so-called 'miracle products' that are in the market pretending being medicines or having non-proven therapeutic effects. In the past, TV broadcast companies have allowed advertising of these products with the obvious damage to the consumer.
At the same time, the Federal Consumer Protection Attorney Office is active to prevent misleading advertising that might damage the consumer.