HCP Engagement in France

When it comes to engaging with healthcare professionals (HCPs), France has one of the most rigorous regulatory frameworks in Europe. At the heart of this framework is a drive for transparency, integrity, and patient trust. Companies in the pharmaceutical, biotechnology, and medical device sectors cannot afford to treat French rules as just another compliance box, they fundamentally shape how industry and healthcare intersect.

So, what exactly does the French law require, and how should companies adapt their HCP engagement strategies? Let’s break it down.

The Legal Backbone: Loi Bertrand and Sapin II

The foundation of France’s rules is the French Sunshine Act, commonly known as Loi Bertrand (Loi n° 2011-2012 du 29 décembre 2011 relative au renforcement de la sécurité sanitaire du médicament et des produits de santé). This law, introduced after a series of health scandals, requires pharmaceutical and medical device companies to disclose any benefits or agreements with HCPs and healthcare organizations.

Later, the Sapin II law (Loi n° 2016-1691 du 9 décembre 2016 relative à la transparence, à la lutte contre la corruption et à la modernisation de la vie économique) strengthened France’s anti-corruption framework (AFA, compliance programs, whistleblowing) alongside the health-sector transparency regime, which itself is set in the Public Health Code and later implementing texts.

Together, these laws created one of the strictest HCP engagement frameworks in the world.

What Must Be Disclosed?

Under the French Sunshine Act, companies must disclose:

• Agreements with HCPs, students, associations, and healthcare institutions, even if no money changes hands. Examples include consulting contracts, research collaborations, and speaking engagements.
• Transfers of value of €10 or more, whether in cash or in kind. This includes meals, travel, accommodation, gifts, conference sponsorships, consulting fees, and research funding.

All of this information is submitted to the Ministry of Health and published online in the Base Transparence Santé, a public register accessible to anyone.

Key Rules for Engaging HCPs

1. Gifts are essentially banned Under the anti-gift rules (CSP L.1453-3 et seq.), offering or receiving advantages is prohibited unless a listed exception applies and, where required, a prior authorization or declaration has been made. With rare exceptions (like low-value scientific materials), gifts to HCPs are prohibited. The intent is clear: eliminate even the perception of undue influence.
2. Hospitality must remain modest Hospitality linked to scientific meetings must be reasonable and strictly professional; thresholds and procedures are set by decree/arrêté under the anti-gift rules (e.g., negligible-value and authorization thresholds since 1 Oct 2020).
3. Consulting requires real work Engagements like advisory boards or speaking arrangements must serve a legitimate, documented need. Compensation must be at fair market value and detailed in a written contract.
4. Conference sponsorships are tightly controlled Companies may cover costs such as registration, travel, and accommodation, but often funding must be directed to the event organizer rather than directly to the HCP. Venues must be professional, not recreational.
5. Research and educational grants are permitted — with transparency Support for research or training is acceptable but must be clearly documented and reported, and never tied to prescribing or purchasing decisions.

Enforcement and Penalties

Non-compliance is not taken lightly. Companies that fail to disclose agreements or benefits risk:

• Financial penalties of up to €45,000 for individuals and higher for legal entities (Article L. 1454-3 of the French Public Health Code).
• Reputational damage, since the transparency platform makes data publicly visible to journalists, patients, and NGOs.
• Regulatory scrutiny by bodies such as the Ministry of Health, the ANSM (National Agency for Medicines and Health Products Safety), and anti-corruption authorities.

Why This Matters

For life sciences companies, France’s approach underscores a simple truth: HCP engagement must be transparent, proportionate, and defensible. Unlike in some jurisdictions, where disclosure alone suffices, French law builds in substantive restrictions — banning most gifts, limiting hospitality, and scrutinizing the legitimacy of consulting arrangements.

In practice, this means companies must design compliance processes that go beyond reporting: they must ask whether the engagement would withstand public scrutiny if published online.

Final Thoughts

Engaging HCPs in France isn’t impossible, but it requires careful planning, airtight documentation, and a mindset rooted in transparency. By aligning with Loi Bertrand (2011), Sapin II (2016), and the obligations of the Base Transparence Santé, companies can build trust while avoiding regulatory pitfalls.

In a system where every meal, travel reimbursement, and consulting fee is open to public view, the guiding question for compliance teams should be: “Would this look appropriate if tomorrow’s headline highlighted it?”

References:

1. Loi n° 2011-12 du 5 janvier 2011 (adaptation de la législation au droit de l’Union européenne) — Legifrance
   https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000023367755 Marchés Publics+2Doctrine+2
2. Loi n° 2016-1691 du 9 décembre 2016 (Sapin II) — Legifrance / Agence Française Anticorruption
• Legifrance version: https://www.legifrance.gouv.fr/loda/id/JORFTEXT000033558528 Légifrance+1
• AFA summary page: https://www.agence-francaise-anticorruption.gouv.fr/fr/document/loi-ndeg2016-1691-9-decembre-2016-relative-transparence-lutte-contre-corruption-et-modernisation-vie Agence Française Anticorruption
3. Base Transparence Santé (Public transparency database for industry-HCP disclosures in France)
   https://www.transparence.sante.gouv.fr/pages/accueil/ Transparence Santé