CONAR: A new arena for the pharmaceutical industry? Who is required to comply? What about foreign companies? How does this affect digital influencers?

CONAR: A new arena for the pharmaceutical industry? Who is required to comply? What about foreign companies? How does this affect digital influencers?

CONAR is not a government agency; it does not impose fines and has no police powers. However, a decision by its Ethics Council can take a campaign off the air instantly. For the pharmaceutical, food, cosmetics, and medical device industries, this decision adds to the oversight provided by ANVISA and the Consumer Protection Code.

This topic has been a recurring one due to a very important and strategic issue at present: companies in regulated sectors—especially those mentioned above—have been increasingly discussing the possibility of filing complaints with CONAR, given the unclear and even protracted landscape surrounding health regulations in this area, such as those governing the promotion and advertising of medications.

In this context as well, a recurring question from our clients is: Is our company required to comply? The answer depends on the advertiser’s status. Here, we address three situations: a CONAR-member company, a non-member domestic company, and a foreign company.

CONAR and Its Influence

CONAR is a private association created by the advertising market itself: advertisers, agencies, and media outlets. It enforces a code of ethics established by the industry. Its decisions may result in a warning, a recommendation to modify or correct an advertisement, a recommendation to media outlets to suspend the ad’s broadcast, or a public statement by the organization when an advertiser fails to comply with the recommended measures.

The strength of the system lies with the media outlets. Broadcasters, newspapers, magazines, and some digital platforms are members of CONAR and comply with suspension recommendations. The advertiser may disagree with the decision. The ad may cease to be displayed regardless.

The Member Company

Those who join voluntarily adhere to the bylaws and the Brazilian Code of Advertising Self-Regulation (“CBAP”). The relationship is associative and is legally binding between the parties. Thus, upon joining, the company assumes the duty to comply with the decisions of the Ethics Council, including preliminary injunctions to suspend advertising.

Three legal consequences warrant attention.

  1. Noncompliance constitutes a violation of the bylaws. It may lead to the member’s expulsion, subject to just cause and the right to a defense and to be heard.
  2. Membership does not preclude judicial review. Judicial review tends to focus on the regularity of the procedure and, to some extent, even on the merits (with some exceptions regarding ethical aspects).
  3. A CONAR decision does not preclude further liability. An acquittal by the Ethics Council does not prevent ANVISA from issuing a citation, sanctions by a consumer protection agency (SENACON and/or Procon), or legal action by a competitor.

Member companies also gain a tool: they can file complaints against competitors’ advertising and obtain a ruling within a timeframe that the courts—or even government agencies (such as ANVISA)—rarely provide.

The Non-Affiliated Domestic Company

Here lies a significant controversy.

On the one hand, no one is obliged to do or refrain from doing anything except by virtue of law, and no one may be compelled to join an association (Federal Constitution, Art. 5, II and XX). The CBAP is a private regulation and does not bind third parties. Legislating on commercial advertising is the responsibility of the Federal Government (Art. 22, XXIX). According to this line of reasoning, CONAR’s decision against non-members would, at most, amount to a technical opinion.

On the other hand, there are those who argue that the CBAP has indirect effect. The Code is said to express established practices and customs, as well as the ethical guidelines of the advertising market—a standard of interpretation theoretically recognized by Articles 113 and 422 of the Civil Code. It would also serve to define the concepts of misleading and abusive advertising (CDC, Art. 37) and unfair competition (Law No. 9,279/1996, Art. 195). Under this interpretation, an argument raised by industry professionals would be that the judge, when applying the law, could use the CBAP as a measure of due diligence.

Regardless of the approach taken, non-members remain vulnerable. CONAR processes complaints against third parties and even renders a decision, with or without a defense filed by the company, while member media outlets comply with the recommendation to suspend publication.

The greatest risk may lie outside CONAR. A company that does not recognize the system may ignore the decision, but it has no control over its outcome. CONAR itself may refer the case to other authorities, and the decision, once made public, may serve as a starting point for those with the power to impose sanctions, for example:

  • ANVISA and local health surveillance agencies, which can issue fines;
  • SENACON and Procons, which can impose sanctions and/or require counter-advertising;
  • the Public Prosecutor’s Office, which can launch investigations and propose legal action;
  • the competitor, who can submit the decision to the courts as evidence or use it for any other intended strategies.

The ethical recommendation that the company disregarded then resurfaces as an administrative or judicial proceeding before an authority whose jurisdiction it cannot refuse.

For this reason, a non-member must decide, on a case-by-case basis, whether to present a defense. Defending oneself does not equate to adhering to the system, and it is advisable to include this caveat in the submission itself.

The same reasoning applies to individuals. CONAR has begun to pursue complaints against individuals as well, notably digital influencers. The influencer is not a member of CONAR and is often unfamiliar with the system, but the advertising they post belongs to the advertiser. The company that hires influencers is, in practice, liable for what they publish, and it is recommended that this issue be addressed in the contract.

CONAR itself has already signaled its stance on the matter. In 2021, it published the Guide to Advertising by Digital Influencers, which reinforces a central principle of the CBAP: advertising must always be identified as such. The problem, for the regulated sector, goes beyond transparency: an influencer who recommends a prescription drug, attributes therapeutic effects to a cosmetic product, or presents a dietary supplement as a solution for diseases goes beyond the ethical debate and also runs up against barriers established in health legislation.

But the discussion isn’t quite that simple, since the work of digital influencers goes far beyond simply promoting advertising campaigns and extends to spontaneous expressions and even their daily routines. Many of them attend all kinds of events and speak with professionals from different sectors; characterizing the publication of certain content as advertising per se—without considering the context or even the reality of the situation—leads to a completely erroneous interpretation. It also leads to a completely erroneous application of CONAR’s rules. And, to a certain extent, the very proceeding initiated at CONAR may already be marred by significant flaws and irregularities, which should be avoided from the outset.

When analyzing this situation—given the risk of poorly reasoned decisions, or even the risk that official letters may be sent to authorities and/or public agencies—the consequences are significant: the facts may reach ANVISA, SENACON, the state consumer protection agencies (Procons), or the Public Prosecutor’s Office already appearing to constitute a recognized violation. From that point on, the company must defend itself on multiple fronts against an allegation that should never have been accepted in the first place. Reputational damage, meanwhile, does not wait for any of these proceedings to conclude.

Foreign Companies and Territoriality

Digital advertising has, to some extent, broken the direct link between the location of the information provider and the location of the recipient. A company without a physical presence in Brazil can, in theory, provide information to a consumer of any nationality worldwide (including a Brazilian) via social media.

However, this does not mean that any information available on social media that reaches Brazilians is subject to the country’s rules and procedures. The correlation is neither automatic nor absolute. Accepting this premise as true would be tantamount to subjecting all content published on the internet by a company from any other country to CBAP regulations, simply because the content could be accessed from Brazil. Taken to the extreme, this would require a European pharmaceutical company to comply with ANVISA regulations regarding any information published on its official website simply because a Brazilian user encountered it in their social media feed. Simple logic, therefore, resolves the issue and demonstrates the fallacy of the premise.

Even so, specific cases may raise questions that warrant further discussion on this point—such as whether or not the company has a local presence through a subsidiary, distributor, agency, or influencer.

Life sciences: three layers of oversight

In the regulated life sciences and healthcare sector, advertising is subject to three layers of oversight, each of which asks a different question.

Health oversight asks whether the message corresponds to the product as approved and whether it reaches the intended audience. Consumer protection oversight asks whether the consumer was misled or subjected to abuse. CONAR asks whether the advertisement is ethical and fair, including in relation to competitors.

The first two are government-run and mandatory for all. The third is voluntary. An advertisement may pass one review but fail another, so internal approval processes tend to examine all three.

These regulatory bodies also communicate with one another. CONAR can be a faster route, which is why competitors typically initiate disputes there regarding comparative claims, claims of superiority, or claims of efficacy. Decisions made there can later inform the health authority and the consumer protection agency. In Life Sciences, it is not uncommon for advertising disputes to begin at CONAR and then proceed to other regulatory bodies.

What the company can do to mitigate risks:

  1. Understand its current position. Verify whether the company is a member and whether the agency and contracted media outlets are as well.
  2. Review contracts with advertising agencies and influencers. Define who is responsible for ensuring the ad’s compliance and who will lead the defense in the event of a complaint.
  3. Establish, before a crisis arises, a policy for responding to CONAR: who makes the decision, within what timeframe, and with what caveats.
  4. Within the international group, map out the global content that reaches the Brazilian audience and identify the local entity that will be responsible for it.
  5. Integrate CBAP guidelines into the internal approval process for materials, alongside ANVISA and CDC regulations.

It is always important to consider that a CONAR decision is significant for what it sets in motion: the ad is taken off the air, the competitor gains a precedent, and the regulatory authority receives a case to prosecute. Ignoring CONAR is, indeed, a right of those who have not joined the association. However, it is advisable to exercise that right (or not) with full awareness of the cost and consequences, including indirect ones.

References

  • 1988 Constitution of the Federative Republic of Brazil, Arts. 5, II, XX, and XXXV; 22, XXIX.
  • Law No. 8,078, of September 11, 1990 (Consumer Protection Code), Art. 37.
  • Law No. 9,279, of May 14, 1996, Art. 195.
  • Law No. 10,406, of January 10, 2002 (Civil Code), Arts. 57, 113, and 422.
  • NATIONAL COUNCIL FOR ADVERTISING SELF-REGULATION. Brazilian Code of Advertising Self-Regulation.

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This material is provided for informational purposes only and should not be relied upon solely for decision-making. Specific legal advice may be provided by one of our attorneys. Copyright is reserved by KESTENER VIEIRA TORRONTEGUY SPEGIORIN ADVOGADOS.

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