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. Applicable Laws Regarding Advertising of Medicines and Medical Devices in Mexico

General Health Law (Ley General de Salud – GHL)
Regulations of the General Health Law regarding Advertising (Reglamento de la Ley General de Salud en materia de Publicidad – HLR)
Federal Consumer Protection Law (Ley Federal de Protección al Consumidor – LFPC)
Regulations of the Federal Consumer Protection Law (Reglamento de la Ley Federal de Protección al Consumidor)
Mexican Official Standards (Normas Oficiales Mexicanas – NOMs)
Law for Transparency, Prevention, and Combat of Unduly Practices in Publicity Hiring (Ley para la Transparencia, Prevención y Combate de Prácticas Indebidas en Materia de Contratación de Publicidad)

2. Self-Regulatory Codes of Conduct

In addition to legal regulations, self-regulatory codes of conduct from various industry associations play a significant role in the advertising of medicines and medical devices:

2.1 Medicines

Council of Ethics and Transparency of the Pharmaceutical Industry (CETIFARMA):
- Code of Ethics and Transparency of the Pharmaceutical Industry
- Code of Good Practices of Promotion (Code of GPP)
- Regulates interactions between the pharmaceutical industry and patient organizations
National Advertising Council (CONAR):
- Establishes ethical advertising standards across various sectors
- Focuses on ethical advertising practices, including pharmaceuticals
Over-the-Counter Medicines Association (AFAMELA):
- AFAMELA Advertising Ethics Code for OTC medicines

2.2 Medical Devices

Companies in the medical device sector adhere to CETIFARMA and CONAR codes, ensuring their advertising practices align with ethical and transparent standards.

3. Licenses, Approvals, and Fees

3.1 Medicines

Over-the-Counter Medicines (OTC): Advertising to the general public is permitted but requires a permit from COFEPRIS.
Prescription Medicines: Advertising is restricted to healthcare professionals and requires a notice to be filed with COFEPRIS.

3.2 Medical Devices

General Public: Typically restricted unless specific permission is obtained during the premarket clearance process, demonstrating no risk to public health.
Healthcare Professionals: Generally allowed with a notice filed to COFEPRIS, and premarket clearance details must be included.

Fees for Advertising Permits

COFEPRIS charges fees for different media formats such as TV, radio, print, and outdoor advertising. These fees apply to both medicines and medical devices and vary based on the media used.

4. Prescription-Only vs. Over-the-Counter Medicines

Prescription-only Medicines: Can only be advertised to healthcare professionals to prevent misuse and protect public health.
Over-the-Counter Medicines: Can be advertised to the general public to inform about product characteristics, usage, and therapeutic properties.

5. Restrictions on Advertising to the General Public

5.1 Medicines

Advertising cannot present the product as a definitive solution unless explicitly proven.
Advertisements must not suggest uses beyond those approved by COFEPRIS.
Promotions through draws, competitions, or offering additional products are prohibited.
Misleading statements or unsupported testimonials are not allowed.
Advertisements must include preventive messages, especially for products with potential health risks.

Penalties for Non-Compliance

Violations can result in fines ranging from $83,000 to $110,666.66 USD.

5.2 Medical Devices

Advertising must not promote unsafe practices or claim to be a definitive treatment without proof.
Must include warnings about potential health risks if misused.

6. Advertising to Healthcare Professionals

Advertisements can only be published in specialized medical media and must align with approved prescription information. Websites targeting healthcare professionals must restrict access to authorized users and require a notice to COFEPRIS.

7. Information Required in Advertisements Directed to Healthcare Professionals

7.1 Medicines

Distinctive and generic names
Pharmaceutical form and formulation
Indications, pharmacokinetics, and pharmacodynamics
Contraindications and precautions
Adverse reactions, drug interactions, and dosage
Manufacturer details and COFEPRIS clearance number

7.2 Medical Devices

COFEPRIS premarket clearance number
Supporting scientific references

8. Advertising Requirements

8.1 Medicines

Must align with COFEPRIS-approved indications
Include precautionary messages and the advisory “Consult your physician”

8.2 Medical Devices

Advertisements must be clear, concise, and easy to understand
Should contribute to health education
Must highlight health risks associated with the product

9. Scientific Data Requirements

All claims must be supported by scientific data that adheres to clinical research regulations. Such data should be presented only to audiences capable of understanding it professionally. Compliance with the General Health Law Rules for Clinical Research is mandatory.

10. Comparative Advertising

Comparative advertising is allowed if it is factual, fair, and not misleading or exaggerated. Legal provisions under the Industrial Property Law and the Federal Consumer Protection Law may be invoked against harmful practices.

11. Internet and Social Media Advertising

There are no specific provisions for internet or social media advertising. General advertising regulations apply, and all online advertisements must comply with the HLR definition of advertising.

12. Enforcement and Legal Consequences

COFEPRIS monitors and enforces compliance through surveillance programs
PROFECO may collaborate with COFEPRIS in certain cases
Penalties may include suspension of advertising, product seizures, and fines ranging from $27,666.66 to $221,333.33 USD

13. Future Developments in Mexico

NOM-241-SSA1-2021 enforces Good Manufacturing Practices for Medical Devices and has been in effect since June 2023.
Decree of May 10, 2023 amends the General Health Law, broadens the definition of medical devices, recognizes low-risk devices, and introduces criminal provisions for violations.