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 France?

1.1 Medicines

• Law No. 2011-2012 dated December 29, 2011
• Decree No. 2012-741 dated May 9, 2012

These provisions are codified in the French Public Health Code:

• Articles L.5122-1 to L.5122-16
• Articles R.5122-1 to R.5122-26

1.2 Medical Devices

• Law No. 2011-2012 dated December 29, 2011
• Decree No. 2012-743 dated May 9, 2012

These provisions are incorporated into the French Public Health Code:

• Articles L.5213-1 to L.5213-7
• Articles L.5122-1 and R.5213-1 to R.5213-11

2. Are there any self-regulatory codes of conduct?

2.1 Medicines

The National Agency for the Safety of Medicines and Health Products (ANSM) issues regulatory codes of conduct for advertising medicines. These guidelines cover advertising to the general public and healthcare professionals, specific therapeutic classes (such as antibiotics, vaccines, hypnotics, and anxiolytics), and different media supports including TV, radio, and the internet.

2.2 Medical Devices

The ANSM also provides guidelines for advertising medical devices, including general guidelines on medical device advertisement and policies on communication and promotion of healthcare products on the internet and e-media.

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

3.1 General Public

Medicines:

Advertising is allowed only for non-reimbursed medicines and medicines not subject to a medical prescription. Prior authorisation from the ANSM is required, known as an “advertising visa” or “visa GP.”

Medical Devices:

No prior approval is required for advertising medical devices, but ex-post control applies. Advertising for high-risk medical devices requires prior authorisation from the ANSM.

3.2 Healthcare Professionals

Medicines:

Since 2012, advertising to healthcare professionals requires prior authorisation by the ANSM, known as a “visa PM.”

Medical Devices:

No prior approval is required, but ex-post control applies. High-risk medical devices require prior authorisation from the ANSM.

3.3 Fees

A fee of €510 is required for the application for an advertising visa for both medicines and medical devices.

4. What is the difference in regulation between prescription-only and over-the-counter medicines?

Advertising to the general public is prohibited for prescription-only medicines. Advertising of such products is only authorised when directed to healthcare professionals.

5. What are the restrictions on advertising medicines and medical devices to the general public?

5.1 Medicines

Advertising to the public is allowed only for medicines that:

• Have marketing authorisation in France
• Are not under reassessment of their benefit/risk ratio
• Are not subject to medical prescription
• Are not reimbursed by compulsory health insurance schemes
• Do not have restrictions due to public health risks

Exceptions apply to tobacco cessation products and certain vaccines under specific conditions.

Prohibited Elements

• Suggesting medical consultation or surgery is unnecessary
• Claiming guaranteed effects or absence of side effects
• Implying improvement of normal health
• Suggesting health deterioration if not used
• Targeting children
• Using endorsements from scientists, healthcare professionals, or celebrities
• Comparing medicines to food, cosmetics, or consumer products
• Implying safety or efficacy due to natural origin
• Encouraging self-diagnosis
• Using misleading visual representations
• Presenting exaggerated claims
• Referring to healing certificates
• Emphasising marketing authorisation
• Offering bonuses or material benefits

5.2 Medical Devices

• Only CE-marked medical devices may be advertised
• Advertising reimbursed devices to the public is generally prohibited
• Low-risk devices (Class I and IIa) may be advertised
• Non-reimbursed devices may be advertised subject to ex-post control
• High-risk devices require prior authorisation

Similar prohibitions apply as for medicines, including misleading information, endorsements, targeting children, and exaggerated claims.

In Vitro Diagnostic Medical Devices

• Advertising is permitted subject to ex-post control
• High-risk devices require prior authorisation
• Only CE-marked devices may be advertised

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

6.1 Medicines

• Prior authorisation by the ANSM is required
• Advertisements must not misrepresent authority positions
• Free samples may be provided only upon request, excluding psychotropic or narcotic drugs, and must be marked “free sample”

6.2 Medical Devices

• Advertising is subject to ex-post control
• High-risk devices require prior authorisation

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

7.1 Medicines

• Name of the medicine
• Marketing authorisation or registration number
• Pharmacological properties
• Indications and contraindications
• Dosage and method of administration
• Adverse effects
• Warnings, precautions, and interactions
• Public sale price and reimbursement status
• Specific mentions for generic medicines

7.2 Medical Devices

• Commercial name or reference
• Use, characteristics, and claimed performance
• Medical device class
• Essential information for proper use
• Invitation to read instructions
• Reimbursement status

8. What are the advertising requirements for medicines and medical devices?

8.1 Medicines

• Clear identification as advertising
• Name of the medicine and INN
• Essential information for proper use
• Invitation to read the package leaflet
• Caution messages and advice to consult a doctor
• Specific rules for generic and radio advertising

8.2 Medical Devices

• Clear identification as advertising
• Name or commercial reference
• Intended use
• Essential information for proper use
• Invitation to read instructions
• Caution messages where applicable
• Mandatory statement: “Ce dispositif médical est un produit de santé réglementé qui porte, au titre de cette réglementation, le marquage CE.”

9. What are the requirements for scientific data in advertisements for medicinal and medical device products?

• Scientific references must be accurately reproduced with sources cited
• Only peer-reviewed and MA-compliant studies may be used
• Main study criteria must be highlighted
• Secondary criteria must be clearly identified
• Sub-population claims must be scientifically justified
• Comparative claims require robust, controlled studies or meta-analyses
• All claims must be supported by full bibliographical references

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

General Rules

• Must comply with French consumer law
• Comparisons must be objective and non-misleading

General Public

Comparisons are limited to economic aspects only and must not relate to therapeutic qualities.

Healthcare Professionals

• Comparisons must involve products with the same therapeutic purpose
• Must cover essential, relevant, and verifiable characteristics
• Cost comparison is preferred; price alone is insufficient except for generics

11. How to advertise medicines and medical devices on the internet and social media?

Online advertising must comply with general advertising rules and follow the ANSM’s Charter for Communication and Promotion of Health Products on the Internet and e-Media.

• Promotional pages must be clearly separated from institutional pages
• Comment moderation must be enabled
• Open social network promotion is generally prohibited
• HCP-only advertising must be restricted to professional access
• Interactive features such as likes and ratings must be disabled

12. Which are the enforcement mechanisms and legal consequences?

Medicines

• Criminal penalties: up to one year imprisonment and €150,000 fine
• Financial sanctions: up to 30% of product turnover, capped at €1,000,000
• Daily fines for continued non-compliance

Medical Devices

• Same criminal penalties as medicines
• Possible closure of establishments
• Financial sanctions up to €1,000,000

13. Are there any future developments in France?

Regulation (EU) 2017/745 on medical devices, initially applicable from May 26, 2020, had certain provisions postponed due to the COVID-19 pandemic. These provisions became fully applicable from May 26, 2021.

How can OMC help?

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