This country-specific Q&A provides an overview of Pharmaceutical Advertising laws and regulations applicable in Brazil.
What laws are used to regulate advertising on medicines in your jurisdiction?
A comprehensive regulatory scheme rules de advertising and promotion of drugs in Brazil.
The Brazil’s Health Surveillance Agency (the “ANVISA”) is the crucial regulator, but many others government self-regulatory authorities (for example, the local health surveillance agencies and a self-regulatory body so-called CONAR) and law enforcement actors (for example, the Public Prosecutor’s Office) also play key roles.
The key, in practice, is the ANVISA. Its regulatory oversight of drugs advertisement is fundamentally based on the ANVISA’s Resolution No. 96/2008, which in turn is complementary to Federal Law No. 6,360/76 and Federal Law 9,294/96.
Most of the ANVISA’S regulatory requirements set forth in ANVISA’s Resolution No. 96/2008 align with the principles established in the Brazilian body of law.
Even in recognizing the myriad of the laws and regulations that are used to regulate advertising on medicines in Brazil, this guidance will consider the multitude of advertising key concerns confronting life sciences companies nowadays but focusing primarily on the regulatory scheme rules that has been put in place by ANVISA.
The mere absence of specific mentions to other pieces of law or regulations shall not lead the reader to final conclusions in the sense that the advertising and promotion of drugs in Brazil are minimized or omitted altogether by any articles else.
Are there any self-regulatory or other codes of practice which apply to the advertising of medicines? a) If there are any such codes, to whom do they apply (companies, or healthcare professionals, for example)? b) What is the legal status of the self-regulatory codes?
ANVISA has primary jurisdiction over advertising of drugs. For example, ANVISA reserves the right to consider advertising to determine whether a company is promoting a drug outside its approved or generally recognized uses.
On the other hand, a self-regulatory body and law enforcement actors would focus the most on oversight on the myriad of the laws and regulations of the healthcare professions (for example, the Professional Board of Pharmacy’s rules, the Professional Board of Medicine’s rules, etc.) and companies’ responsibility for the advertising to the public at large (for example, the CONAR’s rules and the enforcement actions taken by the Public Prosecutor’s Office under the consumer law standpoint).
The precise boundary between the regulatory actors on advertising of medicines can blur, as the distinction is not specifically codified in statute or regulation, but in a circular fashion we would rely the distinction on the concerns at risk on each of the ends. For ANVISA, the key is the presence of “true statements” related to safety and efficacy when advertising of medicines, while for the self-regulatory and law enforcement actors this would be indeed narrowed to the ways in which an advertisement is delivered to consumers/audience and if it could somehow be considered per ser false, lacking in fair balance, or otherwise misleading, or violative of the law.
Certain industry codes of conduct (e.g., INTERFARMA, SINDUSFARMA, ABIMIP, Professional Boards, etc.) also bring best recommended practices on advertising of medicines.
a) If there are any such codes, to whom do they apply (companies, or healthcare professionals, for example)?
The broad and somewhat vague statutory provisions on how best to enforce advertising violations gives the regulators, the self-regulatory bodies, and the law enforcement actors significant and discretionary regulatory authority to impose to the extent applicable their requirements against each and every person (for example, a healthcare professional) and company in violation of the law.
One important comment on that is that we have been now experiencing an unprecedent enforcement environment, in which the failure to follow applicable requirements can lead not only to adverse regulatory action, but also prosecutions, competitor challenges, etc., triggering also reputational damage besides those pecuniary.
b) What is the legal status of the self-regulatory codes?
Very generally speaking, self-regulatory codes however cannot differ from the applicable law. For example, self-regulatory codes cannot prohibit a conduct permitted by the law or regulation, and vice-versa. The key for self-regulatory codes, in practice, is to put best recommended practices altogether.
Exceptions may apply. Therefore, special care should be taken when evaluating the Brazilian body of law, the regulatory framework, the nature of rules, and the division of responsibility between the different actors concerned by the regulatory oversight involved in the advertising of medicines.
Is there a statutory or generally accepted definition of “advertising”? a) What does the definition cover? – does it include patient information leaflets, for example, catalogues, disease awareness campaigns or correspondence, for example? b) Does the definition apply equally to all target audiences?
The definition of advertising is quite rudimentary.
To the extent applicable, ANVISA’s regulations describe advertising in a circular fashion way as “advertisements in published journals, magazines, other periodicals, and newspaper, and advertisements broadcast through media such as radio, television, telephone communications systems”.
Of course, the myriad of legal issues that the advertising of drugs faces in the region is wide ranging but the process of incorporating in full the best practices indicated in this guidance into business practices is still in early days. We believe much more development is to come.
a) What does the definition cover? – does it include patient information leaflets, for example, catalogues, disease awareness campaigns or correspondence, for example?
Patient information leaflets are likely to fall into the promotional labeling’s definition instead of advertising. Consequently, the target audience for this sort of promotion is the healthcare professionals only. Pharmacies, drug stores, and distributors of drug products can also be targeted for catalogue release.
For the sake of clarity, the case law and best doctrine provide that if there is a relationship between the text of the materials and the product – primarily that the materials explain or discuss the use of the product – the material is generally considered labelling, not advertising.
b) Does the definition apply equally to all target audiences?
All prescription drugs must be directed and contain adequate directions for licenced practitioners only, while OTC drugs advertisement can target general audience (direct-to-consumer communications).
Are press releases regarding medicines allowed in your jurisdictions, and if so what are the restrictions on these (bearing in mind the target audience)?
Press releases on approved drug products are subject to the same advertising rules described in this guidance – despite unusual, because of the regulatory risk exposure.
Press releases on unapproved drug products would be at first prohibited by regulators unless it is somehow done within certain parameters and a piece with emerging scientific data falls into the concept of institutional promotion or non-promotional communication or unsolicited information requests or scientific exchange, among others.
Are there any processes prescribed (whether by law or Codes of Practice) relating to the approval of advertising of medicines within companies?
Not specifically from a regulatory perspective. Company has freedom to operate, subject to the law.v
Do companies have to have material approved by regulatory bodies prior to release?
There is no requirement for submission or approval of advertising or promotional labelling prior to use. Company may voluntarily submit promotional pieces to ANVISA for advisory comments prior to use. Voluntary submissions are most frequently made for launch campaigns and direct-to-consumer television advertisements.
Is comparative advertising for medicines allowed and if so, what restrictions apply?
ANVISA allows the most for the comparison of price between drug products provided that the comparison is directed to healthcare professionals only, besides subject to very specific conditions (for example, to support a comparative claim to be directed to healthcare professionals regarding the cost of two drugs, it will be necessary to ensure that these two drugs fall into the interchangeable regulatory position and/or are built out of the same API).
Direct-to-consumer comparative claims in relation to the price of drug products are subject to even more strict conditions.
Also, apart from the price comparisons, any comparative claim between medicines must always be based on clinical data, otherwise it may even be seen as “misleading comparison”.
Is it possible to provide information on unauthorised medicines or unauthorised indications? Is it possible to provide information on unauthorised medicines or unauthorised indications during a scientific conference directed at healthcare professionals, or to send information to healthcare professionals?
ANVISA broadly prohibits the promotion of a drug for any use prior to approval.
Despite it falls into more of a gray area, we are of the view that exceptions may apply (for example, when done within certain parameters, the piece with emerging scientific data may fall into the concept of institutional promotion or non-promotional communication or unsolicited information requests or scientific exchange, among others).
Please provide an overview of the rules that apply to advertising to the general public for prescription only medicines and over the counter medicines, an indication of the information that must or must not be included.
Taken together, advertising of medicines must be supported with the product’s name, API, registration number with ANVISA, true statements, substantiation for claims, fair balance, brief summary, adequate directions for use, consistency with the approved prescribed information.
Regarding OTC drugs, the key concern relates to the substantiation as the failure to possess and rely upon a reasonable basis for DTC communications of OTC drugs constitute an unfair and deceptive practice. Also, the dissemination of the advertising must include the product’s name, API, registration number with ANVISA, adequate directions for use and certain disclaimers (for example, a mention to “SE PERSISTIREM OS SINTOMAS, O MÉDICO DEVERÁ SER CONSULTADO”).
As for the prescription drugs, all of the above must be taken into consideration (that is, insertion of all necessary indication and risk information on the medicine).
Are there any restrictions on interactions between patients or patient organisations and industry (e.g., consultation, sponsorship)? If so, please describe those briefly.
Not specifically from a regulatory perspective.
Company has freedom to operate, subject to the law. For comments on the compliance arena, kindly refer to Q16-23.
Which information must advertising directed at healthcare professionals contain, and which information is prohibited? For example can information about clinical trials, or copies of journal be sent?
All ANVISA-approved supporting information and documentation in relation to the prescription drug can be directed to healthcare professionals.
May pharmaceutical companies offer gifts to healthcare professionals and are there any monetary limits?
It is possible to offer low-value gifts to healthcare professionals and it must not be used with the purpose of obtaining any undue advantage.
The ANVISA prohibits pharmaceutical companies from offering, promising, or distributing gifts, benefits or anything else of value to professionals who can prescribe, dispense or sell medicines.
According to INTERFARMA’s Code of Conduct, the following practices are also prohibited: (i) offering promotional aids of prescription drugs; (ii) offering gifts of a personal-use nature, including (but not limited to) electronic devices; and/or tickets to concerts, theatre, performances and sporting events; (iii) offering benefits in cash and/or equivalent, including (but not limited to) credit cards, gift certificates and/or gift vouchers; (iv) provide subscriptions to print and online magazines, even if they possess scientific contents. This prohibition does not apply to content made available without access restrictions on the Internet and/or any other free-access electronic platforms; (v) and make available products used in the routine management of a medical office, including (but not limited to) pens, pencil-holders, and notepads.
ABIMED’s Code of Conduct, on the other hand, provides that companies shall not offer gifts and any other benefits to healthcare professionals, even in the context of and marginally addressed in a legitimate interaction. It states that companies are only allowed to offer items of merely symbolic value, such as cards in culturally relevant dates, birthdays, and religious holidays.
There is no specific legislation that indicates the monetary limit of the gift.
The Brazilian Code of Conduct for the High Federal Administration (Code of Conduct) has been commonly used as a basis to set ethical parameters for private companies in Brazil. It states that the commercial value of the gift from the same company cannot exceed BRL 100 per year.
It is important to mention that special attention must be given to healthcare professionals that are classified as public officials. According to the Brazilian legal framework, a public official is anyone who holds, even if transitorily or without remuneration, a public function or employment, as well as anyone who holds a post, employment or function in government agencies, or in foundations, public companies and mixed economy companies, and other entities that are, directly or indirectly, controlled by the Public Administration.
Are pharmaceutical companies allowed to provide samples to healthcare professionals?
Pharmaceutical companies are allowed to provide samples to healthcare professionals, subject to very specific conditions. For example, ANVISA imposes restrictions such us: (i) the distribution of free samples of drugs shall be made exclusively to prescribing professionals, upon documented acceptance, and only at outpatient clinics, hospitals, doctors’ offices, and dental clinics; and (ii) the distribution of free samples of drugs must be registered before ANVISA.
If companies wish to provide free samples to healthcare professionals, they must follow ANVISA and INTERFARMA rules, especially keeping records of drugs handed out to prescribing healthcare professionals as free samples and not offering samples to prescribing professionals in exchange for the prescription or suggestion of products.
Is sponsorship of scientific meetings or congresses and/or attendance by healthcare professionals to these events? If so, which restrictions apply? Do additional restrictions apply to events taking place abroad?
ANVISA sets forth that any sponsorship, total or partial, to healthcare professionals to participate of scientific events, whether national or international, must not be conditioned to the prescription, dispense and/or advertising or publicity of any type of medication.
ANVISA also mandates that the sponsorship must be transparent and indicated in the event material.
The speakers of any scientific session that have any relationship with pharmaceutical laboratories or have any other financial or commercial interest must inform the event organizers of the potential conflict of interest.
Organizers of scientific events that allow the advertising or publicity of medicines must inform ANVISA, three months before the scientific event (national or international), including the location date, as well as the categories and other information related to the participants.
INTERFARMA’s Code of Conduct also sets forth rules on sponsorship, such as: (i) the invited healthcare professionals shall not receive, as a general rule, any type of remuneration, directly or indirectly, for the time invested to participate in the event; (ii) events with a touristic appeal that may corrupt the event’s technical-scientific character shall not be allowed (it includes but are not limited to: cruise ships, theme parks, hotels or hotel complexes recognized for their predominantly entertainment features).
The rules issued by ANVISA and INTERFARMA must also be followed during international events.
It is also recommended to conduct a background check on the healthcare professional to guarantee that the company is sponsoring a person that does not represent an integrity or reputational risk to the company. If the company has a compliance program in place, the anticorruption rules and code of conduct shall be extended to the healthcare professional, in order to avoid a misconduct practiced by him/her.
What are the restrictions on the organisation of cultural, sports or other non-scientific events in relation to scientific conferences by pharmaceutical companies?
Cultural, sports or other non-scientific events are generally allowed, however they cannot be organised by pharmaceutical companies using the names or trademarks of prescription drugs.
Companies should also select only events that are in accordance with the companies’ principles and values.
A background check in order to analyse any integrity or reputational risk to the company is also advisable.
Is it possible to pay for services provided by healthcare professionals and if so, which restrictions apply?
It depends whether the service provided violates any Brazilian legislation or the code of conduct that the healthcare professional is submitted to. If the healthcare professional is a public official (please refer to answer number 1) he/she must respect the article 37, item XVI, of the Brazilian Federal Constitution, in which it prescribes rules regarding the allowance for holding more than one public position.
Are pharmaceutical companies permitted to provide grants or donations to healthcare professionals or healthcare institutions? Does it matter if the grant or donation is monetary or in kind?
Pharmaceutical companies must not provide any grant or donation to healthcare professional with the purpose to obtain any undue advantage, especially in exchange for prescriptions of any product. It is recommended to provide grants or donations throughout a contract, indicating the date, amount, the purpose, conditions, and anticorruption clause (ex.: commitment not to violate anti-corruption laws, right to audit the use of the donations and to terminate the agreement in case of violation of the clause). It is also recommended to run a background check on the healthcare professional or institution in order to guarantee that the donation does not violate the internal compliance of the company or any applicable legislation.
The company shall refrain from making donations of any amount of money or valuable items to public officials or representatives of healthcare institutions, agencies, autarchies, foundations, or public companies, especially with the purpose of inducing the beneficiary to take or not take any action, in violation of its legal obligations.
The company must maintain all the appropriate records related to de grant/donation for at least 5 (five) years.
These records must contain description of the nature and scope of each project supported, value and/or benefit indication.
Also, donations/grants (monetary or not) shall be due to a legitimate interest and always focused to attend the needs of the community.
Are pharmaceutical companies required to disclose details of transfers of value to healthcare professionals or healthcare institutions? If so, please indicate whether this is a legal requirement or not, and describe briefly what the companies must report and how. Do these transparency requirements apply to foreign companies and/or companies that do not yet have products on the market?
As a general rule, there is no legal obligation on companies to disclose details of transfer of value to healthcare professionals or institutions. However, the Federal Decree 8,420/2015, that regulates the Brazilian Clean Company Act (Federal Law 12,846/13), stablishes “book and records” rules as a parameter of an effective compliance program. Also, this information can be requested by Brazilian authorities during their investigations and, if requested, the company will be obligated to disclose details of transfer of values of any type.
Furthermore, it is important to mention that Brazilian companies that are submitted to the Foreign Corrupt Practices Act (FCPA) are obligated to have Books and Records controls and, if requested by Brazilian or foreign public authorities, they must also disclose further details related to healthcare professionals and institutions.
When if at all with a competent authority have to get involved in authorising advertising? Is advertising on the internet (including social media) for medicinal products regulated, and if so, how? Should companies include access restrictions on websites containing advertising or other information intended for healthcare professionals?
As per widely described in this guidance, there is no specific requirement for submission or approval of advertising or promotional labelling prior to use. Company may voluntarily submit promotional pieces to ANVISA for advisory comments prior to use. Voluntary submissions are most frequently made for launch campaigns and direct-to-consumer television advertisements.
Advertising of medicines on the internet (including social media) is seem by ANVISA as equivalent to other forms of the advertisements in published journals, magazines, other periodicals, and newspaper and thus subject to the usual requirements (for example, true statements, substantiation for claims, fair balance, brief summary, consistency with the approved prescribed information, among others).
Companies should also include access restrictions on websites/social media websites containing advertising or other information intended for healthcare professionals only, including all necessary indication and risk information on the medicine.
Are there any anti-bribery rules apply to communications between pharmaceutical companies and healthcare professionals or healthcare organizations?
As a best recommended practice, it is recommended to behave with integrity and transparency in all interactions with healthcare professionals and healthcare organizations. Companies should communicate in a precise and complete manner and maintain a record of all communications, especially if the healthcare is a public official / the healthcare is a public entity. In that case, communications should be conducted exclusively through official channels: (i) official e-mails, (ii) official phone numbers, (iii) official letters and others. Also, virtual and face-to-face meetings should have the participation of at least 2 members of the company and the existence of a previous agenda, with an indication of the meeting’s schedule, the matters to be discussed and the names of those who will participate of it. It is also recommended to draft minutes after the meeting, containing the topics discussed during the meeting, indicating the date, time, place, participants and also containing their signatures, if possible.
Those rules are not legally mandatory in Brazil, but it became a best recommended practice after the Car Wash Operation and the Brazilian Clean Company Act.
Prudent businesses must understand it as fast as they can in order to be well prepared for these rapidly coming changes – and, definitely, the less agile pack will end up challenged when these best practices on the compliance arena becomes a sound reality.
What are the rules (whether statutory or self-regulatory) which govern the offering of benefits or inducements to healthcare professionals?
The company must not offer benefits that could violate the Brazilian legislation or represent an undue advantage, direct or indirect, to the company.
Which bodies are responsible for enforcing the rules on advertising and the rules on inducement? Please include regulatory authorities, self-regulatory authorities and courts.
Public Prosecutor’s Office
Public at large (for example, the customers, competitors, trade associations, etc., as they can go to Court)
As mentioned before, the ANVISA is the crucial regulator, but many others government and self-regulatory authorities and law enforcement actors also play key roles.
On what basis and before which bodies or courts can companies initiate proceedings against competitors for advertising infringements?
Competitors may bring challenges for advertising infringements (for example, Unfair or deceptive practices, False or misleading advertisement, etc.) under any of the Brazilian body of law, the regulatory framework, the nature of rules, and the division of responsibility between the different actors concerned by the legal/regulatory oversight involved in the advertising of medicines. Claims can be directed to regulatory authorities (for example, the ANVISA) or even Courts.
What are the penalties, sanctions or measures that regulators or courts can impose for violating medicines advertising rules and rules on inducements to prescribe in your jurisdiction?
ANVISA typically engages in administrative actions in response to promotional activities it determines are improper, with potential fines of up to BRL 1,5million per offense.
Enforcement actions to be taken by law enforcement actors (for example, the Public Prosecutor’s Office) usually include seeking a court-ordered injunction to restrain ongoing and future violations, seizing the product involved, and civil (mostly indemnification claims) and criminal prosecution to the extent applicable.
Self-regulatory bodies may also impose penalties which are usually warning letters and minor fines.
What is the relationship between procedures before or measures taken by the self-regulatory authority and the procedures before or measures taken by courts/government competent authorities?
Enforcement actions are not co-dependent.
The same offense may trigger at the same time the administrative, civil and criminal liability and all of them could be prosecuted in parallel by the different actors concerned by the legal/regulatory oversight involved in the advertising of medicines.
Are there any recent enforcement trends in relation to pharmaceutical advertising in your jurisdiction? Please report any significant (publicly known) enforcement actions in the past two years.
Improper product promotion can trigger enforcement in a host of other venues in addition to ANVISA actions, which was the focus of this guidance.
The majority of the enforcement activity has centred on allegations of off-label drug promotion and product liability, with lawsuits building from competitor complaints or even whistle-blower allegations under Consumer’s Protection Code and ANVISA’s regulatory scheme.
In August 2021, for example, in a case concerning the drug Ivermectin (drug’s commercial name preserved on purpose) to fight against covid-19, the ANVISA and the Public Prosecutor’s Office have initiated enforcement actions against the pharmaceutical company that has published off-label and some other allegedly improper promotion of its product. The potential penalties in this case can be severe: the Public Prosecutor’s Office is seeking for an indemnification of approx. BRL 55 million, while ANVISA is likely to impose a fine of BRL 1,5million and require the pharmaceutical company to publish a note explaining to the public at large that the prior promotional pieces were false or misleading.
Estimated word count: 4309
Privacy & Cookies Policy