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Eunomia perspective · 2026-02-23 · HCP Engagement & Transparency Reporting, Regulatory Updates & Compliance News

Sunshine Act in France: Understanding the Transparency in Healthcare System

Published by Eunomia Pharma Services · Updated

What is the French Sunshine Act and who must report?

The French Sunshine Act, established under the Loi Bertrand, requires companies producing or marketing health products to publicly disclose agreements with, benefits given to and remuneration paid to healthcare stakeholders. Disclosures are published on the government-managed Transparence Santé database, making France one of the most stringent transparency regimes in Europe.

Getting French reporting right

  1. Identify every French recipient, including HCPs, HCOs, students and patient associations.
  2. Link each benefit and payment to its underlying agreement.
  3. Validate identifiers and amounts before submission.
  4. Plan to the French reporting calendar, separately from EFPIA disclosure.

The practical steps above are Eunomia’s operational guidance. See the source notes below for the scope of the external references.

Transparency in healthcare has become a cornerstone of compliance and ethical collaboration between pharmaceutical companies and healthcare professionals (HCPs). In France, this framework is governed by what is commonly referred to as the French Sunshine Act, established under the Loi Bertrand. This legislation created one of the most stringent and government-controlled transparency systems in Europe.

1. Legal Background: The French Sunshine Act

The French Sunshine Act was introduced in 2011 following the Mediator scandal and is codified under the French Public Health Code. The law requires companies producing or marketing health products to publicly disclose benefits and agreements granted to healthcare stakeholders.
Key milestones include: - 2011: Introduction of transparency requirements. - 2016 reform: Extension to include mandatory disclosure of remuneration amounts. - Creation of the national public database Transparency Santé. - Supervision by the French Ministry of Health.
Unlike industry self-regulation systems, France operates a government-managed disclosure platform.

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.

Sources and scope

  • Transparence Santé

    France’s public transparency database, managed by the Direction générale de la santé.

  • EFPIA: The EFPIA Code of Practice

    The European industry code for promotion and for interactions with HCPs, HCOs and patient organisations, implemented through national codes.

External sources accessed 30 September 2026. Check the applicable country rules and current source text for a specific engagement.

Put this into practice