In Brazil, there are several laws that regulate pharmaceutical advertising, either laws that deal exclusively with the subject and laws that provide for rules in this regard among other rules, including:

• Law No. 6,360/76 (general rules regarding health surveillance);
• Law No. 6,437/77 (defines infractions of federal health legislation and respective sanctions);
• the Consumer Protection Code (Law No. 8,078/90);
• Law No. 9,294/96 (imposes restrictions on pharmaceutical advertising);
• Law No. 9,782/99 (organization of ANVISA – Brazilian Health Regulatory Agency –, granting to said agency the authority to establish infralegal rules in the field of health surveillance);
• SVS/MS Ordinance No. 344/98 (related to the Technical Regulation on substances and medications subject to special control).

Regarding regulation issued by ANVISA:

• the Collegiate Board Resolution of ANVISA (RDC) 768/2022 establishes the rules for drug labeling;
• RDC 96/2008 establishes the rules and restrictions applicable to pharmaceutical advertising; and
• RDC 60/2009 and the Ministry of Health’s SVS/MS Ordinance 06/1999 establish specific rules related to free drug samples.

With respect to healthcare professionals, there are restrictions on drug advertising in Resolution 2,217/2018 (Medical Profession Code of Ethics), and in Resolution 1,939/2010, both issued by the Federal Council of Medicine (CFM).

Yes, there are other Codes of Conduct that deal with pharmaceutical advertising, created by pharmaceutical industry associations, including the Pharmaceutical Employers Union of the State of São Paulo (SINDUSFARMA), the Brazilian Association of Research-Based Pharmaceutical Industries (INTERFARMA), and the Brazilian Association of Manufacturers of Non-Prescription Drugs (ABIMIP). Additionally, there is the Self-Regulation Advertising Code, created by the National Council of Self-Regulation in Advertising (CONAR), which refers to advertising in general and contains a specific chapter applied to over-the-counter drug advertising.

a. If there are any such codes, to whom do they apply (companies, or healthcare professionals, for example)?

R: All companies that are part of the group or association that approved the regulations must comply with their respective Codes of Conduct.

b. What is the legal status of the self-regulatory codes?

R: Although self-regulatory codes in Brazil don’t have legal force, their rules and principles guide the behavior of members of the category. However, this does not prevent those who violate articles of the code of conduct from being punished through administrative, civil, or even criminal proceedings.

Yes, the definition of advertising was established by ANVISA in RDC 96/2008, in which it is described as “a set of techniques and information and persuasion activities aimed at disseminating knowledge, making a specific product or trademark more widely known and/or highly regarded, with the goal of influencing the public through actions that promote and/or generate prescription, dispensing, purchasing, and use of a medicinal product.

a. What does the definition cover? – does it include patient information leaflets, for example, catalogues, disease awareness campaigns or correspondence, for example?

First, it is important to highlight that the only advertising allowed by  law for medicinal products is for the over the counter (OTC) medicines. For that matter, as per the definition of advertising, it is allowable to include product trademarks aiming to promote and persuade the public. However, the RDC 96/2008 allows for information about medications, without the distinction of trademarks, through disease awareness campaigns, catalogues, and others, without being considered as advertising.

This is not only allowed, but encouraged, as disease awareness campaigns play an important role in disease prevention and treatment. On the other hand, according to Article 44 of the RDC previously cited, if a pharmaceutical company conducts a public campaign, it should limit itself to discussing the company’s social responsibility, without mentioning the names of medicines or advertising these products.

b. Does the definition apply equally to all target audiences?

Yes, even though there may be different rules depending on who is providing the advertising and who is the target of it. The definition of advertising does not make a distinction as to whether the advertising will be target patients, the general public, private companies, or healthcare professionals.

Press releases are allowed in Brazil and are commonly employed, both by private companies and public entities, to provide information to industry professionals and the general public. To prevent their characterization as advertising, it is advisable to refrain from mentioning specific product names or trademarks.

No, there is no  legislation stating that pharmaceutical advertising must undergo regulatory approval before being placed in the media. However, according to RDC 96/2008, only pharmaceuticals that are registered and approved by ANVISA can be advertised or promoted. In other words, even though no authorisation is required for advertising placement, the pharmaceutical must go through the registration and approval process with ANVISA.

No, general pharmaceutical advertising in Brazil is not conditioned on any regulatory authorisation. However, if such advertising is to be displayed at scientific events, the event organisers must inform ANVISA three months in advance, providing the event’s date and location, as well as a list of the participating professional’s categories.

Yes, it is allowed as long as it follows the guidelines set forth in ANVISA’s RDC 96/2008. Regarding price comparison, it can only be done between medicines that are considered substitutes/interchangeable, as defined by Law No. 9,787/99. According to this law, substitute medicines are typically those that are therapeutically equivalent to a reference medicine, with essentially the same efficacy and safety. When it comes to direct or indirect comparison between medicines, the information provided should be based on comparative studies. Furthermore, comparative advertising must adhere to the principles of the CONAR Code, Law No. 9,279/96 (Intellectual Property Law), the Consumer Protection Code (Law No. 8,078/90), the Code of Ethics and Conduct of Pharmaceutical Industry Associations. None of these regulations prohibit comparative advertising, but they impose restrictions on it. For example, if a company provides false information about a competitor with the intent of gaining an advantage, it would constitute unfair competition under the Intellectual Property Law. In fact, CONAR not only prohibits comparisons that disparage the competitor’s brand or create confusion between products but also states that advertising should be based on objective aspects of the products, with the advertiser required to substantiate their claims.

RDC 96/2008 prohibits the provision of information about unauthorised drugs and/or unauthorised indications. However, some information may be shared in scientific events aimed at healthcare professionals or through press releases, but the use of the drug’s name or trademark should be avoided. The INTERFARMA Code of Conduct addresses this issue, confirming that such information can only be used in medical events (symposiums, congresses, and others) for the discussion of ongoing research and studies, limited to addressing technical matters. Under no circumstances should it mention drug names, as there is a risk of being considered advertising or encouraging the prescription of the medication.

In Brazil, advertising and promotion of prescription drugs are only allowed when directed at qualified healthcare professionals authorized to prescribe (doctors or dentists) or dispense (pharmacists) medications, as per Article 27 of ANVISA’s RDC 96/2008. In other words, advertising to the general public is only permitted for over the counter (OTC) medications, which do not require a prescription. Furthermore, according to Article 3 of the same RDC, for a drug to be the subject of advertising, it must be registered with ANVISA, although exceptions are made for those exempt from registration. In general, pharmaceutical advertising must provide consumers with complete information about the drug, consistent with the information registered with ANVISA, avoiding insinuations that the medication has only positive aspects without mentioning its side-effects.

For over-the-counter drugs, in addition to adhering to advertising guidelines, the advertisements must include the requirements outlined in Article 22 of ANVISA’s RDC 96/2008. These requirements include the drug’s brand name (if applicable), the active substance’s name, the ANVISA registration number with at least nine digits (with the exception of radio advertisements), and, for drugs subject to simplified notification, the statement: ‘SIMPLIFIED NOTIFICATION DRUG – ANVISA RDC No……../2006. AFE No: ……………………..,’ with the exception of radio advertisements. The advertisements should also include indications, the date of printing, and the warning: ‘IF SYMPTOMS PERSIST, CONSULT A DOCTOR.’

Moreover, advertising for over-the-counter drugs is prohibited from being broadcast during programs aimed at children or adolescents. In addition to this restriction, the advertising cannot:

• Use expressions like ‘demonstrated in clinical trials,’ ‘scientifically proven’;
• Suggest that the drug is the only alternative for treatment;
• Feature the name, image, and/or voice of a non-medical or non-pharmaceutical celebrity, asserting or suggesting that they use or recommend the drug;
• Use language that refers to the excessive consumption of alcohol or food;
• Use language that relates the use of the drug to a person’s enhanced physical, intellectual, emotional, sexual performance, or beauty;
• Present images of human body alterations caused by diseases in a sensational or deceptive manner;
• Include messages and images aimed at children or adolescents.

As for prescription drugs, their advertising must include the information specified in Article 27 of the previously mentioned RDC. They must also observe the general restrictions for pharmaceutical advertising, established in Article 7 and Article 8 of the RDC, such as prohibiting the advertising from encouraging or recommending indiscriminate consumption of the medication, suggesting that the drug has a desirable taste, and using imperatives that influence drug consumption, such as ‘take,’ ‘have,’ ‘try,’ etc.

The SINDUSFARMA Code of Ethics, adhered to by the leading pharmaceutical companies in Brazil, permits contributions to patient associations with the aim of disseminating information about health and providing appropriate information on the prevention, diagnosis, and treatment of diseases.

In accordance with the Code just mentioned, companies are obliged to comply that “Such support must be institutional and formalized through written contracts, devoid of any conditions tying the sponsoring member company to interference, and explicitly prohibiting the inclusion of exclusivity clauses in said contracts” and “the association with patient organizations must be open, clear, and transparent, aligning with and adhering to the guidelines outlined in this Sindusfarma Code of Ethics and Behavior.”

This type of interaction is, therefore, allowed. Similarly, direct contact with patients to clarify questions about the correct use of products through appropriate channels is also permitted.

Advertising for medications in Brazil is regulated under two scenarios: medications with or without the requirement of a medical prescription. For products that require a medical prescription, advertising is restricted to healthcare professionals and is authorised by Article 11 of Decree 2,018/1996.

It must include essential information such as the commercial name of the medication (if applicable), the name of the active substance according to the DCB, and in its absence, with the DCI or botanical nomenclature. The registration number with ANVISA, indicating at least nine digits, is also required, along with indications, side-effects, precautions, and warnings (covering adverse reactions and interactions with medications, food, and alcohol), dosage, classification of the medication regarding prescription and dispensing, and the date of printing of the advertising materials (Resolution RDC 96/08, Article 27).

According to ANVISA RDC 96/2008, it is prohibited for health and pharmaceutical companies to promote, offer, or distribute gifts to those professionals that prescribe (doctors, dentists) or dispense (pharmacists) medications, and to the general public (article 5). However, the Federal Medicine Council (CFM) together with the Brazilian Medical Association (AMB), Brazilian Society of Cardiology (SBC), and INTERFARMA, established a best practice guide for the relationships between companies and physicians. Among the rules, associations have stipulated that gifts offered by pharmaceutical industries to medical professionals should:

1. Be related to medical practice, such as: publications, individual copies of scientific journals (excluding periodical subscriptions);
2. Carry symbolic value, with individual values not exceeding one-third of the current national minimum wage;

Also, everyday use products (pens, notepads, etc) are not considered items related to medical practice, and, therefore, cannot be distributed as gifts.

Yes, but companies are only allowed to provide samples to healthcare professionals that prescribe medicines in outpatient clinics, hospitals, medical offices, and dental offices, in accordance with Article 33, of RDC 96/2008. But not all medicines, such as biological drugs, magistral preparations and over-the-counter medications, can be provided as free samples. In addition, the packaging must not feature any promotional images or  and must include the phrase “FREE SAMPLE”. All free samples distributed by a pharmaceutical company must be listed in a report table, regularly updated, and made available to the National Health Surveillance Agency for a minimum period of two years.

Brazilian legislation does not prohibit the sponsorship of scientific meetings or congresses and/or attendance by healthcare professionals to these events, whether they are domestic or international. Article 42 of RDC 96/2008 establishes that the sponsorship should not be conditioned on the prescription, dispensing, or advertising of any type of medication. Nevertheless, the Interfarma Code prohibits the direct or indirect payment of compensation for time spent attending the event, unless the activities provided are part of a contractual obligation. Any payment made may only cover the costs of food, travel, and accommodation incurred by the professional during the event period and cannot be extended to their family members or companions. Regarding the event venue, it is not permitted  for it to be hosted in place that has a predominantly tourist or entertainment appeal that might distort the scientific and educational character of the event.

In the case of organizing cultural or sports events unrelated to scientific events, pharmaceutical companies may not use the names or trademarks of prescription-only drugs in promotional advertising.

Yes, healthcare professionals can be hired by clinics and hospitals to provide services for compensation, through a pre-established contract. Similarly, the same applies if these professionals are hired to teach or instruct in courses or lectures, and those services in Brazil may be regulated by various laws, depending on the type of contract and its context.

Brazil does not have specific legislations that deals with this matter. Yet, from a systemic point of view, the act of providing grants or donations to healthcare professionals or institutions would appear to be allowed, as long as is not made in exchange for advertisements, promotions, indications, medical prescriptions, or other things that violate health rules, regardless of whether the donation is monetary or of any other kind.

There is no legal obligation for healthcare professionals to disclose any transfers of value, nor their amount, nor the details of sponsorship. However, in case of a sponsorship, the health professionals should limit themselves to indicating it at the time of their presentation. Furthermore, according to §2 of article 42 of RDC 96/2008, speakers that establish relationships with pharmaceutical companies or that have other financial or commercial interests must disclose potential conflicts of interest to congress/event organisers. Transparency rules will not be applied to the donating foreign company; however, the healthcare professional beneficiary will be responsible for adopting them, if necessary.

ANVISA monitors pharmaceutical companies’ websites to ensure compliance with health regulations, and if any irregularities are found, sanctions may be applied by the agency, as appropriate. Like any other means of communication, the internet is subject to the rules and guidelines established by ANVISA and CONAR regarding the advertizing of medications. Therefore, in general, only over-the-counter medications can be advertized on the internet. On the other hand, limited advertizing of prescription medications is allowed, but only on  websites that can ensure restricted access to prescribing professionals.

The current Brazilian legislation does not provide specific anti-bribery regulation for communications between pharmaceutical companies and healthcare professionals or organisations. Nevertheless, some Brazilian laws may be applicable if the violation of pharmaceutical advertising rules occurs through acts of corruption or bribery. These laws include the Penal Code (Decree-Law No. 2,848/40), the Anti-Corruption Law (Law No. 12,846/13), which addresses the administrative and civil liability of legal entities (companies), and Law No. 8,429/92, which establishes sanctions for acts of misconduct committed by public servants.

The main rules regulating the offering of benefits and inducements to healthcare professionals are RDC No. 96/2008, which addresses the prohibition in a general manner, and more specifically, the Code of Medical Ethics.

The regulation, inspection, and eventual penalties for pharmaceutical advertising are carried out by ANVISA, specifically by the Management of Inspection and Health Supervision of Pharmaceuticals, as per Article 145 of RDC 585/2021. Therefore, the first attempt to rectify advertising irregularities should be made through the regulatory authority (ANVISA), which will initiate an administrative process if necessary. If the decision is not satisfactory or sufficient to rectify the issue, and if a competing company or a citizen wishes to seek an alternative outcome, they may turn to the Brazilian Judicial System. CONAR, as the regulator of advertising standards, can also be contacted to impose penalties such as warnings and recommendations for advertising alterations. Finally, self-regulatory authorities such as ABIMIP, INTERFARMA, and SINDUSFARMA can also impose penalties in accordance with their respective codes.

To initiate the process, there must be sufficient evidence that pharmaceutical advertising is in violation of the applicable legislation. ANVISA allows for anyone to report cases of advertising legislation violations. Therefore, the agency can start the process ex officio if the Agency itself identifies irregularities, or it can be initiated based on a complaint filed by any citizen or competing company.

Each regulatory body can impose different remedies in the event of a violation of pharmaceutical advertising rules. In general, if the advertising violates health legislation, ANVISA will assess the case and, depending on its severity, may impose sanctions including: warning, prohibition of advertising, sales suspension, imposition of a corrective message, suspension of advertising and promotion, and fines, with a minimum value of BRL 2,000 and a maximum of BRL 1.5 million.

The penalties imposed by the self-regulatory authority include verbal warning, written warning, suspension, dismissal without just cause, or dismissal for just cause. It is important to note that these sanctions are applicable only to members, and enforcement is limited.

On the other hand, judicial proceedings benefit from the authority of the State to ensure that decisions are enforced. Penalties in legal processes range from simple warnings and fines to the shutting down of companies in more severe cases.

The key distinction lies in the scope of decisions and enforcement mechanisms.

In the last two years, CONAR has issued several decisions addressing the potential encouragement, through advertising, of indiscriminate consumption of medications. Examples of such representations include 029/22, 151/2023, and 099/2023.