Distribution and marketing of drugs in Brazil: overview
A Q&A guide to distribution and marketing of drugs law in Brazil.
The Q&A gives a high level overview of distribution and marketing of drugs law, including pre-conditions for distribution; licensing; wholesale distribution; marketing to consumers; marketing to professionals and engagement with patient organisations.
To compare answers across multiple jurisdictions, visit the Distribution and Marketing of Drugs Country Q&A Tool.
This Q&A is part of the global guide to Distribution and Marketing of Drugs.
Pre-conditions for distribution
The distribution of medicinal products is regulated by the National Sanitary Surveillance Agency (ANVISA).
Pharmaceutical products can be marketed and distributed if the following requirements are met:
They are registered with ANVISA.
Their price is approved by CMED (Chamber of Drug Market Regulation).
They are manufactured or imported by establishments duly authorised by the federal government.
They are manufactured or imported by establishments duly licensed by the local authorities (municipal or state government).
To receive approval to launch and distribute drugs on the market, the applicants must submit to ANVISA regulatory data of the potential candidate, such as details of the manufacturing process, clinical trial results, safety and efficacy data. If all data is in accordance with the requirements established by ANVISA, marketing authorisation is eventually granted, therefore formally allowing the medicinal products to enter the market.
Exceptions to the requirement for a marketing authorisation exist, for example, if the new drug is intended to be exclusively used in a clinical trial or if it is required to meet the prescription for a specific patient. In these cases, it can be supplied and imported in Brazil without being previously approved, if the importation is formally authorised by ANVISA.
The National Sanitary Surveillance Agency's (ANVISA) RDC No. 38 of 13 August 2013 sets out pathways through which patient access to experimental drugs is provided before these drugs are officially approved and available for purchase.
In the compassionate use programme, ANVISA provides authorisation for individual access to an experimental drug without agency registration for the treatment of patients with serious or rare diseases. The expanded access pathway is an alternative that provides group access to an experimental drug. These specific pathways comprehend the possibility of importing new, unregistered drugs, if needed.
According to ANVISA, the authorisation approval for the compassionate use is evaluated, depending on the severity of the illness. The absence of satisfactory treatment alternatives available for the patient's condition is assessed before issuing an authorisation. The patient's doctor must submit a formal request to obtain the drug from the entity funding the programme and the entity places a corresponding request with ANVISA.
The entity funding the treatment provides for the complete treatment and medication at no cost for the patient under the expanded access, compassionate use or post-study programmes (chapter VIII, section 18, RDC No. 38/2013).
Licensing of a drug is mandatory before its widespread use.
Licences are only granted if predefined standards of safety and quality are met, covering the whole development and manufacturing process of a drug.
To be granted a licence, the drug must be developed and tested.
The health surveillance over products and services is conducted by the National Sanitary Surveillance Agency (ANVISA), which covers the regulation of processes, used ingredients and applied technologies (Law No. 9782, 26 January 1999).
According to Law No. 9782/1999, ANVISA is the only authority responsible for granting licences for medicinal drugs and other health-related products.
When dealing with a drug with a foreign licence, marketing authorisation from the National Sanitary Surveillance Agency (ANVISA) is still required. However, some over-the-counter drugs can be marketed by only giving notice to ANVISA, regardless of any previous licences held abroad.
With imported drugs and active pharmaceutical ingredients, in addition to the usual registration requirements, the applicant must also show evidence proving that the product is already registered in the country of origin (Article 18, Law No. 6360, September 23, 1976) and further complies with the good manufacturing practices (GMP) standards in that country.
Regarding parallel imports, a product manufactured in accordance with a process or a product patent that has not been placed on the internal market directly by the patentee or with his consent can represent a violation of the patent holder's exclusive rights, therefore allowing the patent holder to enforce its exclusive rights (section 43, item IV, Brazilian Industrial Property Law). Whether implicit consent can avoid the parallel importer's liability for patent infringement is always a hot topic before the courts, so all situations must be examined on a case-by-case basis and bear in mind their own particularities.
The sale of drugs through the internet can only be undertaken by accessing websites from pharmacies and drugstores with fixed commercial establishments, which are open to the public.
The services provider must also provide for a direct and immediate method of communication between the patient and a pharmacist.
Drugs subject to special control (Ordinance No. 344, 12 May 1998) cannot be sold on the internet.
Brazil-based pharmacies can attend online orders with some restrictions. According to the law, only licensed Brazilian pharmacies can sell prescription drugs online. An internet pharmacy must post its National Sanitary Surveillance Agency's (ANVISA) authorisation number on its website. Personal importation of medicine is legal where the patient has a valid prescription and where the frequency and quantities are clearly limited in the prescription signed by the medical doctor.
It is possible to proceed with an administrative appeal from denials on the granting of the licensing for a drug within ten days starting from the day immediately after the publication of the rejecting decision.
The appeal is filed before National Sanitary Surveillance Agency (ANVISA) and the authority that made the appealed decision has a five-day period to reconsider. If it upholds the decision, the appeal is subject to a formal analysis. Then, one of the five directors of ANVISA is assigned the appeal and acts as a case rapporteur when the appeal is heard by the board of directors.
The board of directors does not have a statutory maximum period to render its final administrative decision. However, parties often apply for an injunction (by filing a writ of mandamus) ordering the board of directors to decide within a specific deadline.
It is not possible to file a second administrative appeal from the final decision, issued by ANVISA's board of directors after analysis of the technical appeal, but such decisions may be subject to judicial control.
There are fees to be paid to the National Sanitary Surveillance Agency (ANVISA) to obtain the marketing authorisations. These fees vary depending on the type of product and on the size of the applicant (Ordinance No. 701 of 31 August 2015).
For example, considering a large company as the applicant, the costs can vary from BRL6,000 (generic drug) to BRL235,000 (new drug).
Distribution to consumers
For distribution to consumers, medicinal drugs can be classified into the following categories:
Drugs that can only be dispensed under a medical prescription (with retention).
Drugs that can only be dispensed under a medical prescription (without retention).
Drugs that can be sold without a prescription, known as "non-prescription products" or "over-the-counter drugs" (OTCs), which present a remote risk of causing side effects to patients.
Drugs exclusively used in hospitals.
Drugs subjected to special control, where the medical prescription must be notified to the health authority.
In considering whether a drug can be sold without the need for a prescription, the National Sanitary Surveillance Agency (ANVISA) takes into account, among other issues, whether the product is likely to, if incorrectly used:
Present a substantial risk to the patient.
Lead to addiction.
Be used for illegal purposes.
Prescription drugs are sold in licensed pharmacies, under medical prescription. This license is obtained from the National Sanitary Surveillance Agency (ANVISA).
Pharmacist technicians can perform activities that are not exclusive to pharmacists, including dispensing or selling prescription medicines (ANVISA's Resolution No. 44, 17 August 2009). However, the pharmacist technicians must be under direct supervision of the registered pharmacist technically responsible (or a substitute, also a pharmacist), whose presence is required during working hours of the commercial establishment. The sale of prescription medicines can only be made on the presentation of a prescription, issued by a registered physician.
Over-the-counter drugs are sold freely in licensed pharmacies, drugstores and some large supermarkets, without the need of a medical prescription.
Resolution No. 96/2008, dealing with advertising and promotion of drugs, does not expressly mention the possibility of using e-mails as a way to buy or sell drugs.
There are also no particular rules referring to marketing medicinal products by mail order. However, provided all requirements for the acquisition of a particular drug on the internet are met, this may be a possibility (see Question 5).
The regulation of the sector that distributes medicines is conducted on three levels:
The federal government.
The state governments.
The federal government enacts laws and regulations of general applicability, which are enforced and complemented by actions of the state governments and municipalities. At the federal level, the health and pharmaceuticals sectors are regulated and supervised by the Ministry of Health, through the National Sanitary Surveillance Agency (ANVISA).
The National Sanitary Surveillance Agency (ANVISA), and other authorities within the National Sanitary Surveillance System, can impose penalties if a regulated entity does not comply with the regulatory requirements (including in relation to distribution activities). Such penalties can be imposed in a preventive manner if the non-compliance represents a future risk of a breach, or after the breach has taken place.
In the event of a breach, the regulated entity is summoned with an infraction notice and a defence can be generally filed within ten or 15 days. However, this depends on the decision-making authority and the specific provision that had allegedly been breached.
A company can appeal a decision imposing any penalties within the same deadline set for a defence.
If the decision is maintained, it can be appealed to a superior authority at the government level within 20 days from the date the decision was acknowledged or from publication.
All legal deadlines are set out in Law No. 6437/1977 for federal procedures.
Distributors of pharmaceuticals must comply with the regulations (Good Distribution Practices) and hold the appropriate licences. Such distributors must obtain a:
Licence to operate.
Authorisation to operate.
Special authorisation for medicines under special control, if necessary.
It is necessary to pay to obtain these licences and to present a certificate of the technical responsibility of the responsible pharmacist. It is also necessary to undergo an inspection carried out by the local health authority. These distributors must obtain a document called "Certificate of Good Distribution Practices", which is issued by the National Sanitary Surveillance Agency (ANVISA) to operate legally. This certificate is a statement confirming that the distributor is in conformity with all the good practices established and allows the distributor to operate.
The distribution and promotion of medicinal products by the wholesale distributors are subject to the legal regulation of the National Sanitary Surveillance Agency (ANVISA).
ANVISA can issue legal provisions on human health issues (Article 24, section XII, Brazilian Constitution and Article 7, Law No. 9.782/1999). These enable the ANVISA to:
Proceed with the surveillance and regulation of medicines and medical goods.
Supervise the corresponding entities that manufacture and distribute them.
Provide the registration of medicinal products.
Companies that apply for permission to distribute drugs must comply with the requirements of Good Distribution Practice and Storage established by ANVISA. As per this regulation, the distributor must comply with certain procedures to control the quality and keep track of the medicinal products distributed.
Rights of appeal
The same procedure of appealing a distribution decision applies for wholesale distribution activities (see Question 14).
The main applicable legal instruments for marketing, advertising and promotion of medicinal products are:
The Brazilian Constitution of 1988 that provides the legal basis for advertisement regulations.
Law No. 6360 of 23 September 1976 (amended by Law No. 13,097 of 2015) that regulates the Sanitary Surveillance and describes general rules for the advertisement of drugs, medical products and other health-related products.
Decree No. 8,077 of 2013), which regulates Law No. 6360/1976 that provides further provisions concerning the advertisement of medicinal products.
Law No. 9294 of 15 July 1996 that regulates the advertisement of drugs.
Decree No. 2018 of 1 October 1996, which regulates Law No. 9294/1996.
Law No. 6437 of 20 August 1977 that defines violations of the federal health law and imposes the respective sanctions.
Resolution RDC No. 96 of 17 December 2008 (amended by RDC 023/2009) that regulates the advertising and promotional practices of prescription drugs and OTCs.
Normative Ruling No. 5, of 20 May 2009 that provides further clarifications concerning Resolution RDC No. 96/2008.
Resolution RDC No. 60 of 26 November 2009 that regulates free samples.
Ordinance No. 344 of 12 May 1998 that imposes specific restrictions on the advertising or promotion of medicinal products containing substances under special control such as anorexigenic drugs, immunosuppressant drugs and others.
Law No. 8078 of 11 September 1990 (Consumer Protection Code) (CDC) that contains general provisions for the advertisement of products in general.
Limits to marketing activities
To market medicines, the entities must have been granted the necessary authorisations by the sanitary authorities.
Besides the general prohibition on direct marketing of medical products under prescription, the legislation aims to keep the relationship between industry and healthcare professionals or medical institutions, transparent and fully documented.
Another principle regarding the promotion of medicinal products is that the advertisement of drugs cannot differ or exceed the information provided in the dossier of register submitted to the National Sanitary Surveillance Agency (ANVISA) for record-keeping and evidentiary purposes.
The Advertising Self-Regulation Code, enforced by the Advertising Self-Regulation Council (CONAR) and adopted in 1978 regulates ethical rules related to advertisements as well as defining rules to over-the-counter drugs (OTCs). CONAR's objective is to eliminate misleading advertisements and campaigns that may be offensive or abusive in content, or could, among other things, distort competition.
There is also the Codes of Conduct of Class Associations such as the Association of Research Based Pharmaceutical Industries (INTERFARMA).
Finally there are the Resolutions of the Federal Council of Medicine:
1931/2009 that is the Medical Profession Code of Ethics.
1939/2010 that prohibits participation of doctors in medicinal products campaigns.
1974/2011 that sets out the criteria for the participation of members of the medical profession in promotion and advertising.
The National Sanitary Surveillance Agency's (ANVISA) regulation on advertising drugs is not related to any self-regulatory bodies like CONAR or INTERFARMA, whose decisions are not made public. ANVISA investigates only matters that cannot be compliant with the law and its regulations but can use the decisions of any such self-regulatory body to support their decision.
Marketing to consumers
Generally, advertising is a non-regulated area, subject to the self-regulatory body, the Advertising Self-Regulation Council (CONAR). The limitations on advertisement to consumers are regulated by RDC No. 96/2008. Law No. 6360/1976 establishes that marketing of medicinal products is subject to authorisation by the Ministry of Health.
Only over-the-counter drugs (OTCs) can be directly advertised to end consumers in all types of media (Law No. 9294/1996). This law limits advertising prescription drugs to healthcare professionals.
Law No. 6360/1976 limits the advertising and marketing of prescribed medicines to medical professionals and prohibits such activities in relation to consumers.
To avoid self-medication and the indiscriminate use of drugs, there are several provisions regulating the advertisement of over-the-counter drugs (OTCs).
Although it is not possible to advertise prescription drugs to the public, disease awareness campaigns are allowed. However, it is prohibited to mention any medicinal product.
It is possible to issue press releases concerning prescription products in non-scientific journals. In this case, the release cannot be "advertising" in its nature.
It is also possible to describe products and research initiatives in corporate brochures or annual reports.
Free samples can only be distributed by entities to prescribing professionals (doctors and dentists), exclusively in ambulatories, hospitals, clinics and medical offices.
The concession of discounts is not prohibited according to RDC No. 96/2008, however, the promotional material offering such discounts must abide by the regulation.
RDC No. 96/2008 has some specific regulations on internet advertising.
Entities are free to convey whichever information they wish to place on their websites, the exception being advertising or promotional materials related to prescription products, which are not permitted.
Online promotion of these medicines can only be accessible to professionals qualified to prescribe or distribute medicines. This is possible by means of an electronic registration system, and a liability statement setting out the legal restrictions on access must be provided.
The National Sanitary Surveillance Agency (ANVISA) often monitors sites of pharmaceutical companies, pharmacies, distributors, clinics and so on.
The National Sanitary Surveillance Agency (ANVISA) is the authority responsible for supervising advertising or promotional violations of marketing activities related to drugs.
The supervision of these activities is done by the ANVISA's department called the General Management of Inspection, Quality Monitoring, Control and Supervision of Raw Materials, Medicines and Products, Advertising and Publicity (GGIMP).
According to Resolution RDC No. 96/2008, ANVISA can also demand the issuance of a corrective statement.
Rights of appeal
Violators can appeal a decision of ANVISA that considered an advertisement or promotion as contravening the regulation or a decision to request the issuance of a corrective statement.
This appeal is decided by the ANVISA's board of directors and any final administrative decision can be subjected to a judicial procedure.
Law No. 6347/1977 establishes penalties for failing to comply with the rules governing the advertising of medicines. It is the National Sanitary Surveillance Agency's (ANVISA) responsibility to enforce these rules.
These penalties can vary from warnings to suspensions of sales, prohibition of advertising and corrective statements. They can be also accompanied by a fine, the value of which depends on whether the failure was considered by the authority as "light", "serious" or "very serious".
Infringers may also be subject to administrative procedures and penalties established by the Advertising Self-Regulation Council (CONAR).
Marketing to professionals
There are some restrictions related to marketing to professionals. For example, pharmaceutical companies cannot provide professionals with off-label information using the trademark of the product.
Additionally, advertising medicinal products that are not registered by the National Sanitary Surveillance Agency (ANVISA) is not permitted. A common practice used to overcome this prohibition is to promote campaigning with medical societies on the awareness and prevention of diseases, without specifically mentioning products.
The frequency of sales representatives' visits to medical doctors is not regulated by RDC No. 96/2008. However, health institutions can elaborate specific regulations establishing criteria for receiving sales representatives, provided that other conditions set out in RDC No. 96/2008 are respected.
Provision of hospitality
There is not a direct mention of hospitality in RDC No. 96/2008.
Any contribution, including travel expenses, meals and hospitality to support healthcare professionals' attendance at medical conferences and scientific events (national or international) is allowed. However, it is important that the relationship is clearly declared by the physician and the company, in the prospectus, brochure or leaflets of the seminar and in the application form.
The Association of Research Based Pharmaceutical Industries' (INTERFARMA) Code depicts some restrictive rules related to payments made to a professional whenever attending a scientific meeting.
The required information in advertising to healthcare professionals is regulated in RDC No. 96/2008. According to this resolution, the promotional material must contain the:
Brand name of the medicine.
Name of the active ingredient.
Number of the register granted by the National Sanitary Surveillance Agency (ANVISA).
Therapeutic indications, including the dosage.
Interactions and contraindications.
Warnings and precautions.
Proof of safety and efficacy by scientific sources.
The date of printing.
RDC No. 096/2008 sets out the rules for comparative advertising of medicinal products. Generally, comparative advertising is regulated by different legislations, including the Code of Ethics and the Advertising Profession and the Advertising Self-Regulation Code.
Products that are not authorised by the National Sanitary Surveillance Agency (ANVISA) cannot be mentioned in advertising.
Price comparison is only allowed between interchangeable products. If the products are not interchangeable, the price comparison can only be made to professionals, under specific conditions.
No incentives to prescribing professionals can be (or be understood as) an exchange for assuring the prescriptions of a particular product.
The restrictions for free samples are regulated in RDC No. 60/2009.
It is possible to provide professionals with sample of products, except for:
Products prepared in compounding pharmacies.
They can be distributed only in ambulatories, hospitals, medical and dentist's offices. The prescribing professional must sign a document indicating the receipt of the samples.
Generally, the amount offered in a free sample package must be 50% of the original and must clearly include the term "free sample".
Sponsorship of professionals
The scientist or physician must report to the conference organisation if they received financial support.
If a pharmaceutical company sponsors scientific events, this support must be made clear in all materials of communication.
RDC No. 096/2008 prohibits linking sponsorship of events (medical or health congresses, symposia, conferences and meetings) within assurance in prescribing or dispensing a medicine.
Other promotional items or activities
The advertisement and indirect sale or the granting, offer, promise or distribution of promotional gifts, benefits and advantages to professionals are prohibited.
Only institutional gifts that are not related to any specific product can be given to professionals.
The National Sanitary Surveillance Agency (ANVISA) is the authority responsible for supervising advertising and deciding on possible violations conducted on marketing activities related to drugs.
The supervision of these activities is done by ANVISA, as it is in marketing to consumers (see Question 25).
Rights of appeal
The rights of appeal are the same ones related to marketing to consumers (see Question 25).
The consequences are the same of non-compliance with consumers marketing laws (see Question 26).
Engagement with patient organisations
Generally, meetings with, and funding of, patient organisations are permitted and no specific requirements must be observed. Health authorities have been looking very closely at this issue.
RDC No. 096/2008 determines that the organisers of scientific events in which advertising and promotion of medicinal products are allowed must report to the National Sanitary Surveillance Agency (ANVISA) three months in advance of any such event indicating the date and place of the event and the professional categories that will participate in the event.
With regard to advertisement and distribution of drugs in Brazil, no changes in the regulation are expected for 2016, however, a review of RDC No. 096/2008 is scheduled to occur between 2017 and 2020.
There is an opinion from the Federal Attorney General's Office from 2009 indicating that most of the restrictions established in RDC No. 096/2008 are unconstitutional. Some stakeholders have successfully challenged attempts to enforce such provisions.
João Luis Vianna, Senior Partner
Professional qualifications. Admitted to the Brazilian Bar in 1999
Areas of practice. Life sciences; patent prosecution in the medical, pharmaceutical and biotechnology areas; patent applications, involving technical and administrative aspects; patent application drafting, foreign filing and prosecution abroad.
Non-professional qualifications. J.D., Law School, Candido Mendes University, Rio de Janeiro, 1998; Post-graduate in Immunopathology, Pontifical Catholic University of Rio de Janeiro; Medical Doctor, School of Medicine, Federal University of Rio de Janeiro (UFRJ), 1985; Master of Sciences in Immunology, King's College, University of London, 1991
Languages. Portuguese, English, French
Professional associations/memberships. Member of the Standing Committee for Patents, International Association for the Protection of Intellectual Property (AIPPI); Brazilian Association of Industrial Property Agents (ABAPI); Member of the Board of Directors, Brazilian Association of Intellectual Property (ABPI); American Intellectual Property Law Association (AIPLA); ABPI Biotechnology Commission.
Areas of practice. Regulatory affairs; sanitary surveillance of drugs and cosmetics; patent prosecution in the medical, pharmaceutical, and biotechnology areas.
Non-professional qualifications. Pharmacy, Federal University of Rio de Janeiro (UFRJ), 2007; Industrial Pharmacy qualification, Federal University of Rio de Janeiro (UFRJ), 2008; Post-graduation in Sanitary Surveillance in the Pharmaceutical Industry, Institute of Science, Technology and Industrial Quality (ICTQ), Rio de Janeiro, 2011.
Languages. Portuguese, English, French
Anderson Ribeiro, Partner
Areas of practice. Life sciences; patents; protection of plant varieties; trade secrets and confidential information; litigation and dispute resolution.
Non-professional qualifications. Graduated in Law (JD) at the State University of Rio de Janeiro (UERJ, 2005); Master of Laws (LL.M.) in Competition Law and Regulation, University of Lisbon (2012); Master of Laws (LL.M.) in Intellectual Property, Queen Mary University of London (2013)
Languages. Portuguese, English