1. Legal Background: The French Sunshine Act
2. Who Must Report?
The obligation applies to:
- Pharmaceutical companies
- Medical device companies
- Cosmetic and other health product companies
These companies must disclose transfers of value provided directly or indirectly to:
- Healthcare Professionals (HCPs)
- Healthcare Organizations (HCOs)
- Students in health-related fields
- Patient associations
- Media representatives in the healthcare sector
2. Who Must Report?
The obligation applies to:
- Pharmaceutical companies
- Medical device companies
- Cosmetic and other health product companies
These companies must disclose transfers of value provided directly or indirectly to:
- Healthcare Professionals (HCPs)
- Healthcare Organizations (HCOs)
- Students in health-related fields
- Patient associations
- Media representatives in the healthcare sector
3. What Must Be Disclosed?
Transparency reporting in France is divided into three main categories:
A. Agreements (Conventions)
B. Benefits (Advantages)
C. Remuneration (Rémunération)
4. Where Is the Data Published?
All disclosures are published on the national public database Transparency Santé.
Key characteristics:
- Fully public access
- Searchable by HCP name, company name, benefit type, and date
- No consent required from HCPs (legal obligation overrides consent)
5. Reporting Timelines
Companies must report twice a year:
- H1 (January–June): Publication in October
- H2 (July–December): Publication in April of the following year
Strict deadlines apply, and late reporting may lead to penalties.
6. Key Compliance Challenges
1. Dual Reporting Structure: Agreements and financial amounts may require separate declarations.
2. Contract Linking: Benefits and remuneration must be linked to specific agreements where applicable.
3. Tax Handling: Amounts are reported gross, including applicable taxes.
4. Data Accuracy: Incorrect RPPS or FINESS numbers can create public discrepancies.
7. Penalties for Non-Compliance
Failure to comply may result in:
- Financial penalties
- Criminal sanctions
- Public reputational damage
- Regulatory investigations
French authorities treat healthcare transparency as a high-priority enforcement area.
8. Differences from EFPIA Reporting
Compared to EFPIA reporting systems:
- Reporting in France is a legal obligation and does not rely on HCP consent..
- All transfers of value must be disclosed at an individual level; aggregate reporting is not allowed.
- Disclosures are submitted twice yearly (H1 and H2), rather than on an annual basis.
- Data is published on a state-managed public database, rather than through industry association platforms.
9. Best Practices for Companies
- Maintain robust and validated HCP master data, including accurate RPPS and FINESS identifiers.
- Ensure contractual clarity, aligning each agreement with the appropriate disclosure category from the outset.
- Closely monitor the €10 disclosure threshold, including VAT considerations.
- Perform thorough financial reconciliation prior to submission to confirm completeness and accuracy.
- Implement structured pre-submission compliance reviews to identify discrepancies or data gaps.
- Establish a formal correction and amendment tracking process to manage post-publication updates efficiently.
Conclusion
Transparency reporting in France is more than a regulatory formality; it is a public accountability mechanism. The French Sunshine Act places disclosure responsibility under governmental oversight and requires operational precision, legal awareness, and strong data governance.
For pharmaceutical and medical device companies, compliance in France demands structured processes, accurate data management, and continuous monitoring to mitigate regulatory and reputational risks.
