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 the Netherlands

1.1 Medicines

Medicines Act: The principal legislation governing the advertisement of medicines. It outlines the rules for promoting medicinal products to ensure they are not misleading and are safe for public consumption.
Dutch Civil Code (Articles 6:194–196): Addresses misleading and comparative advertising and applies to all types of advertising, including medicinal products.

1.2 Medical Devices

Medical Devices Act: Governs medical devices but does not contain specific advertising provisions. General advertising principles and self-regulatory codes apply.
Dutch Civil Code: Ensures that advertising of medical devices is not misleading or unfairly comparative.

2. Additional Legislative Frameworks and Self-Regulatory Codes of Conduct

2.1 Medicines

Code of Conduct on Pharmaceutical Advertising (Code PA): Sets detailed standards for ethical promotion and avoidance of misleading claims.
Code for Advertising of Medicinal Products to the General Public (Code AGP): Regulates advertising of non-prescription medicines to ensure clarity and truthfulness.

2.2 Medical Devices

Code on Advertisement for Medical (Self-Care) Devices (Code AMD): Establishes standards for advertising medical devices intended for consumer use without professional intervention.

3. Licenses, Approvals, and Fees

3.1 General Public

Medicines: Advertisements must have a valid authorization number from the Inspection Board for the Public Promotion of Medicines (KOAG).
Medical Devices: No specific licensing system exists; compliance with general advertising standards is monitored.

3.2 Healthcare Professionals

There is no formal licensing system for advertisements directed at healthcare professionals. Compliance with applicable laws and self-regulatory codes is expected.

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

Prescription-only Medicines: Cannot be advertised to the general public, including medicines listed under the Opium Act.
Over-the-Counter (OTC) Medicines: Classified as UA, UAD, and AV. Advertising is permitted unless substances regulated under the Opium Act are included.

5. Restrictions on Advertising to the General Public

5.1 Medicines

Prescription-only and Opium Act-listed medicines cannot be advertised to the general public.
Advertisements must align with the Summary of Product Characteristics (SmPC) and packaging information.
Promotional practices that do not promote rational use, such as free samples or conditional sales, are prohibited.

5.2 Medical Devices

Devices must comply with the Medical Devices Act and be advertised in line with their intended use.
Advertising must not be misleading regarding the device’s effects or usage.

6. Advertising to Healthcare Professionals

6.1 Medicines

Advertisements must accurately reflect authorized product information.
Misleading or deceptive advertising is prohibited.
Providing samples of substances listed under the Opium Act is not permitted.

6.2 Medical Devices

There is currently no specific legislation or code governing the advertisement of medical devices to healthcare professionals.

7. Information Required in Advertisements Directed to Healthcare Professionals

7.1 Medicines

Product name and marketing party
Active ingredients and pharmaceutical group
Therapeutic indications and adverse reactions
Contraindications and prescription status

7.2 Medical Devices

No specific requirements apply, but advertisements must follow general advertising principles and accurately represent the product.

8. Advertising Requirements

8.1 Medicines

Product name and active substance
Indications and contra-indications
Encouragement to read the package leaflet

8.2 Medical Devices

Product name and classification as a medical device
Main uses and situations where usage is discouraged
Instruction to read the provided user instructions

9. Scientific Data Requirements

Claims must align with authorized use and be supported by the latest scientific evidence.
Data must be accurate, verifiable, objective, and not misleading.
Exaggerated or unverifiable claims are prohibited.

10. Comparative Advertising Rules

Prescription-Only and Opium Act-Listed Medicines

Advertising must align with the government-approved SPC and promote rational use. Claims must be accurate, up-to-date, truthful, and verifiable, supported by proper scientific references.

Medicines Advertised to the General Public

Advertisements must objectively present facts and avoid misleading or exaggerated claims. The product must be clearly identified as a medicine and not equated with food, cosmetics, or other consumer goods.

Medical Devices in Pharmaceutical Form

Advertising must provide an objective representation of facts, clearly identify the product as a medical device, and avoid exaggerated claims. Products can only be advertised as “new” for up to two years.

11. Internet and Social Media Advertising

The same rules that apply to offline advertising also apply online. Social media advertising must comply with written and oral advertising standards and applies only to content accessible in the Netherlands and aimed at a Dutch audience.

General Rules

Advertising must always be recognizable as such
The sender or responsible party must be identifiable
The audience must be quantifiable
Advertisers are responsible for linked or referenced content

12. Enforcement and Legal Consequences

Compliance with the Medicines Act is monitored by the Inspection for Health and Youth Care. Sanctions for violations include:

Administrative fines of up to €450,000
Suspension or termination of product trade
Withdrawal of products from the market

The Code Commission (CGR), Advertising Code Committee, and Board of Appeal assess compliance with advertising codes and may impose reprimands, rectifications, recall orders, or publish decisions publicly.