France’s Loi Bertrand vs. Italy’s Sunshine Act: Similarities and Divergences
Author
May Khan leads the Compliance Services team at Vector Health, a SaaS company specializing in life sciences compliance. Her experience includes global transparency reporting, Sunshine Act strategy, and HCP risk monitoring. At Vector, she coordinates cross-functional teams dedicated to data integrity, customer service, and regulatory alignment.
Vector Health Compliance
Il principale partner in Italia per la conformità al Sunshine Act
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France has been publishing even the smallest €10 meal given to a doctor since 2014. Italy, on the other hand, sets a much higher bar, focusing only on payments above €100. Same principle, two very different approaches. So which one is stricter?
When France introduced Loi Bertrand in 2011, it became a pioneer in Europe. After more than a decade, Italy is joining the movement with its own registry, Sanità Trasparente. At first glance they may look similar, but beneath the surface, both laws have key differences that matter, especially for life science companies that deal with cross-border relationships in Europe.
Similarities Between France and Italy’s Sunshine Laws
- Shared objective: Both seek to prevent conflicts of interest and increase public trust in healthcare.
- Disclosure scope: Both require companies to report contracts, remunerations, and in-kind benefits provided to HCPs and HCOs.
- Public platforms: Each country mandates a centralized, public, searchable database (France’s Transparence Santé and Italy’s Sanità Trasparente).
- Data retention: In France, submissions are made semi-annually and retained for five years from publication, subject to privacy protections. Publications in Italy also remain public for five years before deletion.
- Semi-annual reporting: Both laws follow a semester-based or semi-annual reporting cycle with fixed reporting windows and deadlines.
- Wide coverage of stakeholders: Both laws extend beyond HCPs to include organizations, associations, and other healthcare-related entities.
Key Differences Between French and Italian Sunshine Acts
1. Thresholds for Reporting
- France: Requires disclosure of any benefit or remuneration equal to or above €10. This very low threshold means even small meals and token benefits are captured.
- Italy: Uses higher thresholds, €100 per individual (or annual > €1,000) and €1,000 per organization (or annual > €2,500).
Impact: France produces more granular but larger datasets, while Italy filters out smaller transactions and focuses on higher-value interactions.
2. Breadth of Coverage
- France: From the outset, Loi Bertrand has covered a wide range of stakeholders, including HCPs, students, associations, media involved in health communication, and even prescription software providers. Judicial rulings and decrees expanded the scope over time.
- Italy: Also very broad, covering individuals and organizations (such as hospitals, research institutions, professional associations, and patient groups), with additional reporting obligations like shareholdings. However, the higher monetary thresholds reduce the volume of reported items.
3. Sanctions and Enforcement
- France: Non-compliance can lead to administrative penalties and, in some cases, criminal fines under the French Anti-Gift law.
- Italy: The Italian Sunshine law establishes clearer and stricter fines, omissions can trigger a base fine of €1,000 plus 20x the amount omitted, with ranges from €5,000–€100,000 for false reporting. Sanction decisions themselves are also published.
4. Data Privacy and Reuse
- France: Balances transparency with CNIL and GDPR’s data privacy guidance, such as restrictions on external search engine indexing of sensitive information.
- Italy: Italian Sunshine Act mostly aligns with GDPR, allowing publication while limiting data retention to five years and controlling how the data may be reused.
The French Anti-Gift Law: Another Transparency Decree
In addition to transparency reporting, France enforces a strict anti-gift law designed to prevent undue influence over healthcare professionals. This law prohibits companies from giving, and professionals from accepting, gifts or advantages of any kind unless they are covered by a formal written agreement that meets defined requirements. Permitted transfers must stay within strict thresholds—such as capped remuneration per hour or per agreement—and include all related expenses like travel and lodging. These agreements must also be declared or authorized depending on their value, and they are published under the transparency regime.
Violations can result in criminal penalties, including fines of up to €75,000 and up to one year of imprisonment, as well as professional bans or confiscation of unlawful benefits. The recent €1 million+ fine against a pharmaceutical company illustrates the high stakes of non-compliance. Together, the Sunshine Act and the anti-gift law ensure that relationships between industry and healthcare remain transparent and ethically sound.
Strategic Insights from French Transparency Data
Experience with France’s transparency reporting shows that the data is not just a compliance requirement, but also a strategic resource. Analysis of the Transparence Santé database, especially when enriched with external datasets, allows companies to benchmark their spending against competitors, identify which key opinion leaders (KOLs) receive the highest levels of engagement, and spot regional or institutional trends.
Advanced analytics can also reveal unusual patterns, such as disproportionate hospitality or consulting fees, that act as early warning signs for compliance risk. At the same time, data quality challenges such as inconsistent beneficiary names or broad spending categories mean companies need to invest in cleaning and standardizing information before meaningful insights can be drawn.
These lessons from France are directly relevant for Italy: while Italy’s higher thresholds may reduce reporting volume, companies will still face the same need for robust data governance and analytic capabilities to turn transparency obligations into competitive and compliance advantages.
Evolution and Implementation Lessons from France
France’s Sunshine Act has not remained static since its introduction in 2011. Legal and regulatory updates in 2016 and 2017 clarified and extended obligations, making it clear that all remunerations and fees above €10 must be reported, not only agreements. The reforms also required companies to include far more detail in reported contracts, such as subject matter, dates, amounts, and direct as well as indirect beneficiaries.
The scope of beneficiaries was deliberately expanded to include students, education programs, prescription software editors, and medical media, reflecting France’s comprehensive approach. Importantly, these obligations are tightly linked with broader ethical and anti‑bribery rules, which means that non‑compliance carries multiple layers of legal risk.
The implementation process itself highlighted that even when the official Transparence Santé platform was being updated, companies remained responsible for meeting deadlines and complying with new requirements. These lessons illustrate both the maturity of the French system and the challenges Italy may face as it builds and enforces its own registry.
Practical Takeaways
For compliance teams, France demands the capture of even small-value items, while Italy allows more focus on higher-value engagements. For analysts, France offers richer but noisier datasets, whereas Italy provides leaner but cleaner transparency records. From a public perception standpoint, France’s low threshold may generate more reputational exposure, while Italy’s higher thresholds spotlight larger financial ties.
France has been publishing even the smallest €10 meal given to a doctor since 2014. Italy, on the other hand, sets a much higher bar, focusing only on payments above €100. Same principle, two very different approaches. So which one is stricter?
When France introduced Loi Bertrand in 2011, it became a pioneer in Europe. After more than a decade, Italy is joining the movement with its own registry, Sanità Trasparente. At first glance they may look similar, but beneath the surface, both laws have key differences that matter, especially for life science companies that deal with cross-border relationships in Europe.
Similarities Between France and Italy’s Sunshine Laws
- Shared objective: Both seek to prevent conflicts of interest and increase public trust in healthcare.
- Disclosure scope: Both require companies to report contracts, remunerations, and in-kind benefits provided to HCPs and HCOs.
- Public platforms: Each country mandates a centralized, public, searchable database (France’s Transparence Santé and Italy’s Sanità Trasparente).
- Data retention: In France, submissions are made semi-annually and retained for five years from publication, subject to privacy protections. Publications in Italy also remain public for five years before deletion.
- Semi-annual reporting: Both laws follow a semester-based or semi-annual reporting cycle with fixed reporting windows and deadlines.
- Wide coverage of stakeholders: Both laws extend beyond HCPs to include organizations, associations, and other healthcare-related entities.
Key Differences Between French and Italian Sunshine Acts
1. Thresholds for Reporting
- France: Requires disclosure of any benefit or remuneration equal to or above €10. This very low threshold means even small meals and token benefits are captured.
- Italy: Uses higher thresholds, €100 per individual (or annual > €1,000) and €1,000 per organization (or annual > €2,500).
Impact: France produces more granular but larger datasets, while Italy filters out smaller transactions and focuses on higher-value interactions.
2. Breadth of Coverage
- France: From the outset, Loi Bertrand has covered a wide range of stakeholders, including HCPs, students, associations, media involved in health communication, and even prescription software providers. Judicial rulings and decrees expanded the scope over time.
- Italy: Also very broad, covering individuals and organizations (such as hospitals, research institutions, professional associations, and patient groups), with additional reporting obligations like shareholdings. However, the higher monetary thresholds reduce the volume of reported items.
3. Sanctions and Enforcement
- France: Non-compliance can lead to administrative penalties and, in some cases, criminal fines under the French Anti-Gift law.
- Italy: The Italian Sunshine law establishes clearer and stricter fines, omissions can trigger a base fine of €1,000 plus 20x the amount omitted, with ranges from €5,000–€100,000 for false reporting. Sanction decisions themselves are also published.
4. Data Privacy and Reuse
- France: Balances transparency with CNIL and GDPR’s data privacy guidance, such as restrictions on external search engine indexing of sensitive information.
- Italy: Italian Sunshine Act mostly aligns with GDPR, allowing publication while limiting data retention to five years and controlling how the data may be reused.
The French Anti-Gift Law: Another Transparency Decree
In addition to transparency reporting, France enforces a strict anti-gift law designed to prevent undue influence over healthcare professionals. This law prohibits companies from giving, and professionals from accepting, gifts or advantages of any kind unless they are covered by a formal written agreement that meets defined requirements. Permitted transfers must stay within strict thresholds—such as capped remuneration per hour or per agreement—and include all related expenses like travel and lodging. These agreements must also be declared or authorized depending on their value, and they are published under the transparency regime.
Violations can result in criminal penalties, including fines of up to €75,000 and up to one year of imprisonment, as well as professional bans or confiscation of unlawful benefits. The recent €1 million+ fine against a pharmaceutical company illustrates the high stakes of non-compliance. Together, the Sunshine Act and the anti-gift law ensure that relationships between industry and healthcare remain transparent and ethically sound.
Strategic Insights from French Transparency Data
Experience with France’s transparency reporting shows that the data is not just a compliance requirement, but also a strategic resource. Analysis of the Transparence Santé database, especially when enriched with external datasets, allows companies to benchmark their spending against competitors, identify which key opinion leaders (KOLs) receive the highest levels of engagement, and spot regional or institutional trends.
Advanced analytics can also reveal unusual patterns, such as disproportionate hospitality or consulting fees, that act as early warning signs for compliance risk. At the same time, data quality challenges such as inconsistent beneficiary names or broad spending categories mean companies need to invest in cleaning and standardizing information before meaningful insights can be drawn.
These lessons from France are directly relevant for Italy: while Italy’s higher thresholds may reduce reporting volume, companies will still face the same need for robust data governance and analytic capabilities to turn transparency obligations into competitive and compliance advantages.
Evolution and Implementation Lessons from France
France’s Sunshine Act has not remained static since its introduction in 2011. Legal and regulatory updates in 2016 and 2017 clarified and extended obligations, making it clear that all remunerations and fees above €10 must be reported, not only agreements. The reforms also required companies to include far more detail in reported contracts, such as subject matter, dates, amounts, and direct as well as indirect beneficiaries.
The scope of beneficiaries was deliberately expanded to include students, education programs, prescription software editors, and medical media, reflecting France’s comprehensive approach. Importantly, these obligations are tightly linked with broader ethical and anti‑bribery rules, which means that non‑compliance carries multiple layers of legal risk.
The implementation process itself highlighted that even when the official Transparence Santé platform was being updated, companies remained responsible for meeting deadlines and complying with new requirements. These lessons illustrate both the maturity of the French system and the challenges Italy may face as it builds and enforces its own registry.
Practical Takeaways
For compliance teams, France demands the capture of even small-value items, while Italy allows more focus on higher-value engagements. For analysts, France offers richer but noisier datasets, whereas Italy provides leaner but cleaner transparency records. From a public perception standpoint, France’s low threshold may generate more reputational exposure, while Italy’s higher thresholds spotlight larger financial ties.
Author
May Khan guida il team Compliance Services di Vector Health, società SaaS specializzata nella compliance per il settore life sciences. La sua esperienza include il reporting sulla trasparenza a livello globale, la strategia legata al Sunshine Act e il monitoraggio dei rischi relativi agli HCP. In Vector coordina team interfunzionali dedicati all’integrità dei dati, al servizio clienti e all’allineamento normativo.
Vector Health Compliance
Il principale partner in Italia per la conformità al Sunshine Act
Cerchi supporto per la compliance al Sunshine Act?
Hai domande pratiche?
Dai un’occhiata alla nostra sezione Domande Frequenti per risposte chiare su scadenze, obblighi e strategie.