Contributed By Fukuma Advogados e Consultores Jurídicos
In Brazil, the requirements and rules related to advertising drugs are regulated by Law 6,360/76 and by RDC 96/08. These are related to IN 05/09, RDC 23/09 and RDC 60/09, issued by ANVISA (the National Health Surveillance Agency).
It is important to mention that drug advertising should follow the rules of the Consumer Protection Code (Law No 8,078/90), which provides for basic consumer rights as well as determining that the message must be true, clear, accurate, objective and in no way should the consumer be mislead.
Furthermore, the Advertising Self-Regulation Code, established by CONAR (the Brazilian Advertising Self-Regulation Agency) contains general advertising rules that also applies to OTC (over-the-counter) drugs advertising - the only category of drugs that allowed to be advertised.
Finally, pharmaceutical industries follow pharmaceutical industry compliance codes established by associations, such as the one defined by Interfarma (Pharmaceutical Research Industry Association) and applicable only for its members.
Self-Regulatory Codes (Internal Policies of the Companies)
The official codes are mandatory for all companies and should be applied for all companies that carry out activities with drugs in Brazil:
Self-Regulation Codes of Associations
In Brazil, according to Article 2 of RDC 96/2008 issued by ANVISA, advertising is defined as the techniques set and activities of information and persuasion in order to:
There is a tenuous line between information and advertising and it depends on the focus placed on the information provided. For example, “disease awareness campaigns” or “patient’s support programmes” do not qualify as advertising as long as it is restricted to disease information and does not mention any drug or induce any form of self-treatment. Once a drug is mentioned or a form of treatment is suggested, it becomes an advertising.
Another example is patient leaflets, which are not considered advertising as the main purpose is not to influence or induce drugs use. Rather, it is a piece of informative material and a mandatory part of medication packaging, which is not distributed proactively to healthcare professionals or general public.
It is worth mentioning that any campaigns or programmes that include information on or the advertising of prescription-only drugs should be aimed solely towards healthcare professionals. Only information or advertising regarding OTC drugs is suitable for the general public.
In Brazil, press releases regarding drugs are allowed as long as the information is duly scientifically proven, referenced and follows the rules established by regulation RDC 96/2008.
According to RDC 96/2008, press releases for drugs as prescription-only are allowed only when addressed to healthcare professionals. However, press releases regarding OTC drugs are allowed for the general public (patients).
In addition, the rules regarding mainstream media are set forth in Law No 9,294/96. All drugs advertisements must including warnings regarding possible symptoms and a recommendation to consult a doctor prior to usage.
Pursuant to Article 15 of RDC 96/2008, comparisons made directly or indirectly between any prescription-only and non-prescription (OTC) drugs are allowed as long as they are based on information from comparative studies that have been published in scientific publications.
Comparisons related to the bio-availability and bio-equivalence of active ingredients are allowed only if based on bio-availability and bio-equivalence studies approved by ANVISA.
It is important to note that customers usually choose a drug based on the price and, in light of this, the comparison of prices marketed to general public can only be performed between drugs that are interchangeable (ie, similar, generic, etc) based on Article 11 of Law 9787/99.
In addition, in accordance to Sections 1 and 2 of the above-mentioned Article 11, only healthcare professionals can receive comparative prices between drugs with the same active ingredient that are not interchangeable, based on market information. The comparison should be performed between treatment costs or, in the case of the continued use of drugs, between the defined daily doses. Regarding the advertising of biological drugs, price comparison is not allowed, even if they have the same active ingredients and/or effects.
According to Brazilian regulation, the advertising of unauthorised drugs or unauthorised indications are forbidden, based on Article 3.
It is worth noting that a drug is deemed authorised by ANVISA (and, therefore, allowed to be marketed in Brazil) only after the approval of its registration is published in the Official Gazette. Authorisation is never based on the receipt of registration application.
Furthermore, the RDC 96/2008 establishes in its Article 3, Section 2 that all claims related to action mechanism, indications, dosage, administration, adverse reactions, efficacy, safety, quality and other characteristics of the drug must be consistent with the information registered and approved by ANVISA.
The health surveillance regulation (RDC 96/2008) expressly prohibits the advertising of drugs unauthorised by ANVISA, even during scientific conferences.
However, scientific events for the dissemination of solely scientific information, without any reference to any specific drug and restricted to professionals, and which has no company’s sponsorship, advertising and commercial purposes, have been accepted.
Companies are not allowed to send, proactively or reactively, any information on unauthorised drugs or unauthorised indications to healthcare professionals.
According to RDC 96/2008, Article 38, information must be restricted and consistent with the information and characteristics registered with/approved by ANVISA.
Based on RDC 96/2008 issued by ANVISA, companies cannot send any information on unauthorised drugs or unauthorised indications to healthcare institutions, as the registration dully approved by ANVISA is mandatory to start the dissemination of information on drugs.
After ANVISA’s approval, disclosure of data about efficacy, quality and safety of drugs is allowed.
There is no specific rule regarding the information/advertising of compassionate use programmes or other forms of early access. However, as it is an action related to the access to products that are not registered in Brazil, we should infer that it is not allowed.
To clarify, this kind of support program assumes the early access of patients to some drugs in order to preserve the life or life quality of patients should not be understand as a publicity of drugs not registered in Brazil.
Under Brazilian health surveillance regulation, the advertising of prescription-only drugs is restricted to healthcare professionals and should be performed according to rules established by RDC 96/2008, issued by ANVISA. It is prohibited to advertise prescription-only drugs to the general public.
Thus, if advertising of such category of drugs is performed on the Internet or other media, the company must have mechanisms to prevent the access to the content by non-healthcare professionals, by using an electronic registration system, with password and a disclaimer stating the legal restriction of access.
Advertising of OTC drugs to the general public is allowed as long as it follows the rules established by Article 8 of RDC 96/2008 and related thereto.
In general terms, regardless of the type of drug (prescription-only or OTC), advertising is forbidden if:
According to Article 22 of RDC 96/2008, the main information that that must be included in an advertising campaign for an OTC product, aimed at the General Public, includes:
However, according to Article 26 of RDC 96/2008, advertising to the general public is forbidden if it:
Related to advertising on price medicines, according to Article 11 of RDC 96/2008 the comparison of prices addressed to consumers can only be made between drugs that are interchangeable.
Pursuant to Article 38, Sections 1 and 2 of RDC No 96/2008, the pharmaceutical industry can only interact directly with healthcare professionals. The professional pharmaceutical representatives are not allowed to interfere with pharmaceutical care or patient care, emphasising that the visit cannot occur in the presence of patients or their companions and should be limited to healthcare professionals.
The interaction of pharmaceutical industry with patient and patient’s organisations can be carried out indirectly through advertising of OTC drugs (media) or directly through “disease awareness campaigns”; “patient’s support programmes” or even through sponsorship and lectures at patient’s organisations, as long as it does not mention any drug under prescribing drugs and does not induce self-treatment, as these kind of actions must be restricted to healthcare professionals.
Exclusively considering healthcare professionals, the mandatory information required in advertising comprises:
Additionally, based on Article 11, Sections 1 and 2 of Law 9,787/99, advertising can mention the price of the drug, which is not mandatory information.
The prohibited information is that which is related to the general rules for advertising, established in Article 8 of ANVISA RDC 96/2008, as mentioned in 4.1 Main Restrictions on Advertising to the General Public.
It is worth mentioning again that advertising for prescription-only drugs must be addressed solely to healthcare professionals.
According to Article 3 of ANVISA RDC 96/2008, advertising can refer to data on file or other clinical studies that are not included in the Summary of Product Characteristics, as long as the data or clinical studies are related and aligned with approved information. The mentioned reference (for OTC or prescription-only drugs) must be readily available to be provided by the company if it is requested by a member of the general public or a healthcare professional.
Advertising cannot refer to combination products or companion diagnostics that are not included in the Summary of Product Characteristics. As previously explained, advertising must be restricted to information approved by ANVISA.
It is important to explain that companies may provide reprints of indexed scientific journal articles to healthcare professionals because it is considered scientific material.
Nevertheless, any highlighting in the original article, advertising arguments, or any other information or images which have not been published in the scientific article will be considered advertisements and must comply with all requirements of the respective regulation in order to be shared.
In Brazil, MSLs (Medical Science Liaisons) are only permitted to discuss scientific information or indications regarding authorised drugs with healthcare professionals. This is because authorised drugs have had their quality, safety and efficacy duly evaluated and approved by the Health Authority.
Advertising for drugs is not subject to prior authorisation from, or notification to, the regulatory authority. However, when advertising becomes available, ANVISA may become aware of it through routine supervision and will evaluate if it meets the terms of RDC 96/2008 and other related rules. Where non-compliance occurs, it may notify the company, request adjustments and/or, if necessary, assess a penalty, including suspension and/or prohibition of advertising.
Moreover, companies associated with Interfarma (pharmaceutical association) may be supervised and/or reported by other companies associated with Interfarma where non-compliance occurs within the code of conduct applicable to its members.
There are no mandatory arrangements that companies must have in place for ensuring compliance with the rules on medicinal advertising. Nonetheless, most companies adopt an approval flow, which covers reviews from the marketing, medical, legal and regulatory affairs departments in order to ensure that material adheres to the internal code and to health regulations. Whilst this is not a mandatory standard, it is a trend complied with by pharmaceutical industry.
Internet advertising medicinal products is allowed as long as it follows the rules established by RDC 96/2008, see 4.1 Main Restrictions on Advertising to the General Public. For prescription-only drugs, all advertising should have access restricted solely to healthcare professionals.
For OTC drugs, advertisements addressed to the general public are allowed on social media as long as the regulations already mentioned are adhered to. Regarding prescription-only drugs, the company may advertise it on social media but the visibility of the advertisement must be limited exclusively to healthcare professionals. If not, regulatory penalties will be applicable (further fetailed in 11.3 Penalties for Violating Advertising Rules and Rules on Inducements to Prescribe.
Under Brazilian regulation, the internet advertising for medicinal products that is intended for healthcare professionals must have controlled/restricted access and be created in accordance with the current legislation.
For OTC medicinal products, the advertisements may be shared publicly, without restrictions, provided they are in compliance with the regulations in force.
The companies are allowed to provide online disease awareness information to patients. However, it is important to mention that if the disease requires a treatment using a prescription-only drug, the information provided to the patient must be restricted to the disease itself and shall not mention or suggest any product for treatment. This is because information regarding prescription-only drugs, and the prescription and use thereof, must be restricted to healthcare professionals. Furthermore, the patient must agree to receive the information according to Consumer Code (Law No 8,078/90) and Law of Protection Data No 13.709/2018.
Brazil has several laws aimed at preventing bribery, whether in the public or private sector, that are not specific to the pharmaceutical industry, but apply to this industry nonetheless.
According to the Criminal Code, both passive corruption (requesting or receiving any advantage for themselves or another, or promise of same, to act or instead refrain from acting as befitting their position) and active corruption (offering or promising a bribe) are considered crimes and for both the penalty is imprisonment for a period of two to 12 years and a fine. According to Article 49 of the penal code, the calculation of the fine is based on fine days and minimum wage. As of 2020 the minimum wage is BRL1039.00; the final fine amount can vary from BRL346.33 to BRL1,8 million.
There is also Law No 12,846/2013, which provides for the administrative and civil liability of legal entities, including foundations, entities or persons associations, or foreign companies that have their headquarters, a subsidiary or representation in the country, for the practice of acts against public administration, either Brazilian or foreign, such as:
Acts performed by a government official aimed at illicit enrichment of their tenure, position, job or task, etc, are known as acts of misconduct, are punished according to Law No 8,249/92. Among them we can mention receiving bonuses, commissions, economic advantages, etc. These are dealt with according to the severity, but can include the public official, besides having to fully refund the value of the damage, should lose their position, have their political rights suspended (for a period of three to five years), and ordered to pay a fine of up to 100 times the amount of compensation received by the official during their misconduct, notwithstanding any sanctions in the civil and criminal sphere.
According to Article 5 of RDC 96/2008, the companies cannot grant, offer, promise or distribute gifts, benefits or advantages for prescribing or dispensing to professionals, direct sales to the consumer or to the general public.
Moreover, according to RDC 96/2008, in Article 42, any total or partial support or sponsorship to encourage the participation of healthcare professionals in either Brazilian or international scientific events must not be subject to the prescription, dispensing and/or advertising of any kind of drug.
Non-compliance with this may result in penalties that will be further detailed in 11.3 Penalties for Violating Advertising Rules and Rules on Inducements to Prescribe.
In addition, the Federal Medical Ethic Code, issued by the Federal Professional Council of Physicians, prohibits physicians from participating in any advertisements or promotion of medical information for any promotional purposes. If a physician violates the Ethic Code, he or she will be subject to disciplinary action that may result in a some penalties, such as, in the worst scenario, having their professional practice licence suspended by a specific administrative procedure.
There is also the Interfarma’s Code of Conduct, applicable to its associated pharmaceutical companies, which prohibits the industry from making payments and/or donations of any kind, grant gifts, as well as performing any promotional instruments (sponsorship/events) aimed at health professionals in clinics, offices or outpatient clinics, among other entities (either public or private). Failure to comply with the Code of Conduct may result in the application of several penalties, including a company's exclusion from Interfarma’s membership and a fine, ranging from BRL5,000 to BRL1.6 million, depending on the severity of the breach.
Finally, important to mention is that, besides of legislation, each company should have its own internal self-regulation policies and penalties in place.
Pharmaceutical companies may only offer to healthcare professionals institutional gifts, which does not mention drug advertising and scientific articles, published technical books, scientific journals and publications used for updating professional knowledge.
In case of total or partial sponsorship for participation in Brazilian or international scientific events, meals or travel subsidies must be consistent with such events, and this may not be extended to family members or friends.
In general terms, according to RDC 60/09 from ANVISA:
Companies can sponsor any scientific events such as symposiums, congresses, meetings or conferences. However, all participants should be clearly informed of this sponsorship. Therefore, the information must be included in the registration form, on the event's website and in the congress's records, where existent.
The support or sponsorship for participation of healthcare professionals in Brazilian or international scientific events is allowed. However, it is strictly forbidden that such support or sponsorship is subject to the prescription, dispensing and/or advertising any kind of drug, which means that companies cannot request that professionals prescribe or dispense any kind of drug as a condition of the support offered. In addition, sponsorship should not be extended to the family members or friends of healthcare professionals.
Professionals who are sponsored by pharmaceutical companies can give lectures at scientific events. However, the lecturer of any scientific session who has relations with the pharmaceutical industry or who has any other financial or commercial interest, should inform potential organisers of the conflict of interests and provide indication of the relationship in the official programming and at the beginning of his or her lecture. Additionally, this should be contained in the congress’s records, where existent.
Pharmaceutical companies are allowed to organise or sponsor cultural, sport or other non-scientific events. However, these social actions cannot be related to drug names or drug advertising.
Initially, it’s important to note that any donation made to healthcare professionals or healthcare institutions cannot, in any way, bias or induce the beneficiary to act in a certain way in order to obtain an improper advantage that may feature, for example, a crime of corruption.
Under Brazilian rules, there is no clear definition of how a donation should be made, or its monetary limit. Regardless of this fact, donations made by the pharmaceutical industry to institutions and/or health professionals should not be linked to the name of any drugs nor to the advertising of these products. Furthermore, the donation cannot be linked in any way to the prescription or sale of drugs.
Finally, Interfarma’s code of conduct clearly prohibit companies from making donations to healthcare professionals or healthcare institutions with the purpose of inducing beneficiaries to act against their obligations.
Discounts offered to distributors, retailers or directly to the consumer is part of the relationship between the industry and its trading partners and it is carried out by companies in Brazil. Therefore, the granting of discounts is not prohibited as long as it is undertaken in compliance with the rules established by RDC 96/2008.
The hiring of health professionals to lecturer, research or participate in scientific events is not prohibited as stated in 9.3 Sponsorship of Scientific Meetings, but will not be subject or directly related to the prescription or dispensing of any drug or to any promotional disclosure.
In this kind of contract, a written agreement is recommended and should be signed by all participating parties. The contract should detail the service to be rendered and consideration offered in order to avoid any illicit practice. This recommendation is provided for in item 1.6 of Interfarma’s Code of Conduct and its contracting is provided for Section 6 of the Code.
Still, according to the resolution by Federal Council of Medicine, CFM No 1,974/2011, if the physician in interviews, provides information to the society or participates in public events, he or she should announce immediately any possible conflicts of interest that could perhaps compromise the understanding of his or her opinions or that could cause distortions with serious consequences for the individual or to collective health. The physician should strive for ethical correctness in work relations, and recommendation are made to not:
These actions are not tolerated, either for ones personal gain or for the benefit of others.
The activities described in 9 Gifts , Hospitality, Congresses and Related Payments are not subject to prior authorisation from, or notification to, the regulatory authority. However, it is worth clarifying that the distribution of free samples to health institutions or for professionals prescribing drugs, while authorisation is not required, should only take place upon documented acceptance in accordance with Article 3 of the ANVISA RDC 60/2009.
Moreover, regarding the sponsorship in congresses and/or scientific events, although employer’s authorisation is not mandatory for the physician attending a particular event being held by the pharmaceutical company, the transparency principle recommends an express authorisation from the health institution as well as written agreement, as indicated in 9.7 Payment for Services Provided by Healthcare Professionals.
Under the health regulations, there is no legal provisions requiring pharmaceutical companies to publicly disclose any amounts donated or paid to healthcare professionals or institutions. However, in practice, it is required that donations and payments are clearly identifiable and solidly justified and always supported by a written, signed agreement between the parties (with value clearly specified and including the date and purpose of the donation/payment).
As for companies associated to Interfarma, whose basic principle provided for in the Code of Conduct is that of transparency, companies are encouraged to make data of this sort public (item 10.4). It should be noted that, in accordance with item 4.4.4, donor companies must maintain appropriate records of sponsorships/donations and any other support (financial or otherwise) granted to patients’ associations.
As mentioned, considering that Brazilian legislation is silent as to the publication of data relating to donation values, in principle, the transparency requirements mentioned in 10.1 Requirement to Disclose Details of Transfers of Value only covers companies already established in Brazil.
However, we recommend that companies wishing to operate in Brazil also adopt the transparency principle in order to preserve their image and respectability before the health authorities, professional councils and their peers.
Considering government authorities, the advertising are regulated and monitored by:
For self-regulatory authorities, we indicate:
Finally, with respect to the courts, they will only be involved if the subject matter is raised within the legal scope.
In the public administrative procedure, companies can make complaints directly to the competent health authorities (ANVISA), the Consumer protection agencies or the Federal Prosecution Service. The authority shall decide whether to initiate an administrative proceeding. If an administrative proceeding is filed against the company and if a breach is recognised, it should appeal to the competent administrative court.
In the private sector, complaints should be addressed to Interfarma (if a member) or CONAR, informing either of the alleged violations. The relevant entity shall decide on the case and penalise the company in the way it feels is best suited to the complaint lodged.
In the courts, companies that feel harmed by an unfair competition should use the judiciary branch to resolve the issue. Depending on the complexity and diversity of the issues involved, it is impossible to cover all possibilities in this sphere.
Furthermore, it is noteworthy that it is still possible for consumer protection associations and the Federal Prosecution Service to file public civil actions to withdraw from market any advertising they consider deceptive or abusive and seek legal provision to penalise companies for such malpractice.
In the health area (RDC ANVISA 96/2008), violation of drug advertising rules will be considered a health breach and can be punished by:
In the consumerist context, the penalties are described in Article 58 of the Consumer Protection Code, emphasising that fines can reach approximately BRL10 million and be assessed solely or cumulatively.
In case of a violation of Interfarma’s Code of Conduct, it may result, for its members, in the application of several penalties including the exclusion of the company from Interfarma's membership and a fine ranging from BRL5,000 to BRL1.6 million, subject to the seriousness of the breach.
Finally, penalties by CONAR may include suspension and/or alteration of the advertising action and a warning to the offender.
Apparently, there is no interference between the procedures adopted by the administrative and judicial authorities (court), both of which can occur independently.
In our experience, under Brazilian law, the administrative proceeding must be exhausted before a judicial action is filed (with means both options are not carried out at the same time). It applies both to actions filed by the pharmaceutical industry and those subject to active supervision by the health authorities and/or consumer protection.
Considering that most of the specific rules on drugs advertising are issued by ANVISA (RDC 96/2008), generally the measures are adopted in the health area by the Agency or by whistle-blowers.
We know that, in the year 2017, out of 365 notices of violation issued by ANVISA, only three refer to drug advertising and only one Notice of Violation refers to the breach of Article 8, I, of RDC 96/2008, which prohibits drug advertising to encourage or induce the indiscriminate use of drugs. Regarding subsequent years, data was not available.
As it turns out, the assessments in the health regulatory framework relating to the advertising of drugs have been low.
It is worth mentioning that, in 2009, the Brazilian Association of Non-Prescription Drugs (ABIMP) filed lawsuit No 0018713-28.2009.4.01.3400 against ANVISA in order to exclude the application of certain legal provisions of the RDC 96/2008, to its members, in relation to non-prescription drugs. In low court, ABIMIP lost the lawsuit, however, the Federal Court of the First Region reformed the sentence, recognising the request of ABIMIP. As a result, ANVISA appealed and to date the decision does not have supersedeas effect. That is, until a decision is made otherwise, ABIMIP’s members are not obliged to comply with Articles 5, 33, Sections 3, 23, 24 and 48 to 50 of Exhibit I of the RDC 96/2008 of ANVISA.