Importance of Regulations for Advertising Medicines and Medical Devices

Healthcare regulations safeguard public health by ensuring accurate information and ethical marketing. They prevent misleading claims, promote responsible advertising, and require scientific evidence for product claims. This empowers patients with reliable information and protects them from misuse of medications. Regulations also ensure fair competition within the industry.

1. Which are applicable laws regarding advertising of medicines and medical devices in Brazil?

• Health Surveillance Law (Law No. 6360/1976): Provides for health surveillance of medicines, pharmaceutical products, cosmetics, sanitizers, and related products.
• Regulatory Decree (Decree No. 8077/2013): Regulates the Health Surveillance Law.
• ANVISA Law (Law No. 9782/1999): Establishes the National Health Surveillance Agency (ANVISA) and its responsibilities, including advertising oversight.
• Law on Medicines Advertising Restrictions (Law No. 9294/1996): Specifies restrictions on advertising of medicines and is regulated by Decree No. 2018/1996.
• Consumer Defense Code (Law No. 8078/1990): Provides consumer protection rules applicable to advertising.
• Health Surveillance Sanctions Law (Law No. 6437/1977): Establishes violations and penalties for health surveillance breaches.
• ANVISA RDC No. 96/2008: Defines advertising and publicity for medicines and establishes guidelines for promotional practices.
• CFM Resolution No. 1974/2011: Regulates medical advertising by doctors. This will be replaced by CFM Resolution No. 2236/2023 and CFM Resolution No. 2217/2018 as of March 11, 2024.

Specific Regulations for Medicines

• Law No. 5991/1973: Defines medicines as pharmaceutical products intended for prophylactic, curative, palliative, or diagnostic purposes.
• RDC No. 60/2009 (amended by RDC No. 768/2022): Regulates production, dispensing, and control of free medicine samples.

Specific Regulations for Medical Devices

• ANVISA RDC No. 751/2022: Defines medical devices and establishes risk classification, notification, registration, labeling, and instructions for use.
• Exclusions: Used or refurbished devices (RDC No. 579/2021), customized devices (RDC No. 305/2019), and in vitro diagnostic devices (RDC No. 36/2015 as amended by RDC No. 423/2020).

2. Are there any additional legislative frameworks, such as self-regulatory codes of conduct, that control the advertising of pharmaceuticals and medical devices?

Medicines

• Brazilian Advertising Self-Regulation Council (CONAR):
  • Enforces the Brazilian Advertising Self-Regulation Code (CBAP)
  • Issues Digital Influencer Advertising Guidelines (Influencers’ Guide)
  • Acts as an overall advertising watchdog respected beyond its members
• Industry Associations with Codes of Conduct:
  • SINDUSFARMA – Trade Union for the Pharmaceutical Industry
  • INTERFARMA – Pharmaceutical Research Industry Association
  • ACESSA – OTC Medicines Industry Association

Medical Devices

There are currently no specific self-regulatory bodies in Brazil dedicated to regulating the advertising of medical devices.

3. What are the Licenses, Approvals, and Fees for advertising medicines and medical devices?

There is no requirement for prior authorization or payment of fees for advertising medicines and medical devices. However, only products approved and registered with ANVISA and published in the Union Official Gazette (DOU) may be advertised.

4. Does Brazilian law govern the advertisement of prescription and over-the-counter medications differently?

General Rules

• No prior authorization or fees are required for advertising.
• Only ANVISA-approved and registered products may be advertised.

Over-the-Counter (OTC) Medicines

Regulated primarily by RDC No. 96/2008, Articles 22 to 26.

Prescription-Only Medicines

Advertising is restricted to media exclusively intended for healthcare professionals in accordance with Article 58(1) of the Health Surveillance Law and RDC No. 96/2008, Articles 27 to 32.

Specific Provisions

• Manipulated medicines: Articles 36 and 37 of RDC No. 96/2008
• Pharmaceutical sales representative visits: Article 38 of RDC No. 96/2008
• Advertising at scientific events: Articles 39 to 43 of RDC No. 96/2008
• Advertising in social campaigns is forbidden: Article 44 of RDC No. 96/2008

5. What are the primary limits on promoting drugs and medical devices to the public?

Medicines

• Promotion of indiscriminate or excessive use is prohibited
• Suggesting diagnoses or cures for diseases requiring medical supervision is forbidden
• Offering prizes encouraging unnecessary use is banned
• Images of people taking medicine are prohibited
• Misleading, fear-inducing, or exaggerated statements are forbidden
• Direct encouragement of consumption is prohibited
• Sedative effects must be clearly warned
• Participation in pharmacy loyalty programs is banned
• Advertising during children's television programming is prohibited

Medical Devices

• No specific audience restrictions exist
• Preventive or corrective field actions require notification to ANVISA

6. Which are the main restrictions applicable to the advertising of medicines and medical devices to healthcare professionals?

• Advertising must be limited to media aimed exclusively at healthcare professionals
• Online package inserts must be ANVISA-approved and non-promotional
• Special control drugs may only be advertised in technical medical journals
• Advertising must be factual and based on technical scientific publications
• Visual aids are allowed only for professional use

Relevant articles include RDC No. 96/2008, Article 29 (package inserts) and Article 32 (special control drugs).

7. What information is required in advertisements directed only at healthcare professionals for medicines and medical devices?

• Trade name of the medicine
• Active ingredient name (DCB or INN), at least 50% the size of the trade name
• ANVISA registration number (minimum nine digits)
• Indications for use
• Contraindications, interactions, cautions, and warnings
• Dosage instructions
• Prescription and dispensing classification
• Printing date of advertisements
• For vaccines, the number of doses required for full immunization

8. What information must appear in advertisements directed at the general public for medicines and medical devices?

Over-the-Counter (OTC) Medicines

• Mandatory health warnings as stipulated by the Ministry of Health
• Advice to consult a doctor if symptoms persist
• Doping warnings where applicable
• Scientific validation of claims
• Clear and legible presentation
• Trade name, active ingredient, and ANVISA registration number
• Disclosure for generic medicines as required by law

Medical Devices

Advertising must strictly comply with RDC No. 751/2022 and adhere to the information submitted to ANVISA during registration, as well as the principles of the Consumer Defense Code and CBAP.

9. Are there any constraints on the data used to support promotional claims?

• Claims must be based on published clinical studies with high levels of evidence
• Statements must be accurately reproduced with full bibliographical references
• Visual data must be truthful, complete, and non-misleading
• Bioavailability and bioequivalence claims must be based on ANVISA-approved studies

10. Are there any rules governing comparative advertising of drugs and medical devices?

Medicines

• Comparisons must be scientifically supported and transparent
• Biological medicines may not be compared
• Price comparisons are allowed only under specific conditions

Medical Devices

Comparisons must be accurate, verifiable, and consistent with ANVISA-approved information.

11. Are there special guidelines for advertising drugs and medical devices on the internet or social media?

• OTC medicines may be advertised to the general public online
• Prescription medicines must be restricted to healthcare professionals
• Medical devices must comply with ANVISA registration data
• Social media advertising must clearly disclose commercial intent using terms such as “ad” or “publipost”

12. Which bodies oversee compliance with the advertisement provisions, and what are the legal ramifications for noncompliance?

Regulatory and Supervisory Bodies

• ANVISA
• Public Prosecutor’s Office
• Consumer Protection Authorities
• CONAR

Penalties

• Warnings and fines
• Product seizure or destruction
• Suspension or prohibition of sale
• Deregistration of products
• Civil and criminal sanctions
• Reputational damage

13. Are there any future developments in Brazil?

• Bill No. 4340/2020 proposes limiting OTC medicine advertising to professional journals
• Bill No. 3415/2019 proposes increased penalties for abortifacient drug advertising
• Planned updates to package insert regulations, including digital formats
• Initiatives to improve accessibility, including Braille labeling for health products

How can OMC help?

• Professional review of marketing and advertising materials with reports
• Support in obtaining authority approvals where required
• Translation of marketing materials by a professional translation agency certified with ISO 17100