Local compliance support for pharmaceutical and biotech companies working in France, from the anti-gift regime and Transparence Santé disclosure to Sapin II and Pharmacien Responsable governance, led by a senior French ethics and compliance professional.
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For pharmaceutical and biotech companies with French activities, global compliance teams adding France to a European model, and companies preparing their first French launch. French requirements are largely statutory, so the starting point is the legal regime rather than a code-only assessment.
In France, many HCP interactions need action before they happen: some advantages must be declared in advance or authorised under the anti-gift regime, and advertising needs a prior ANSM visa. Agreements and benefits must then be disclosed on Transparence Santé. Global processes built around after-the-event review and annual EFPIA disclosure often miss these timelines.
From requirements to action
Led by Alexandre Guillaume, we can map planned French engagements against the anti-gift regime, build declaration and authorisation timelines into your approval workflow, and set up the data and review controls behind Transparence Santé reporting. Where Sapin II applies, we can assess your anti-corruption programme against Article 17. Where French legal advice is required, we identify that need before delivery.
What we can take on
What this gives you
France requirements built into your global processes
A named local partner for questions and escalation
Local support without unnecessary fixed headcount
The rules in France
A short guide to the main legal and self-regulatory frameworks. Each summary links to its official source below.
Ordonnance n° 2017-49 of 19 January 2017 created Articles L.1453-3 and following of the Public Health Code (Code de la santé publique). It sets a general prohibition on healthcare companies offering, and healthcare professionals receiving, advantages in cash or in kind. Limited exceptions apply, and certain permitted advantages must be declared in advance or authorised by the relevant professional order or authority. The implementing decree (n° 2020-730) has applied since 1 October 2020.
Loi n° 2011-2012 of 29 December 2011, known as the Loi Bertrand or French Sunshine Act, requires companies producing or marketing health products to publicly disclose agreements with, and benefits provided to, healthcare stakeholders. Disclosures are published on the public Transparence Santé database, managed by the Direction générale de la santé.
Advertising of medicines requires a prior visa from the ANSM (Agence nationale de sécurité du médicament et des produits de santé): a visa PM for advertising aimed at healthcare professionals and a visa GP for advertising aimed at the general public.
Article 17 of Loi n° 2016-1691 of 9 December 2016 (Sapin II) requires companies with at least 500 employees and turnover above €100 million, including at group level, to put an anti-corruption programme in place. The Agence française anticorruption (AFA) checks compliance.
French Public Health Code Article L.5124-2 provides for a Pharmacien Responsable in the context of pharmaceutical establishments and assigns personal responsibility for compliance with provisions relating to the activity. The applicable entity, activities, eligibility and appointment requirements must be assessed for each organisation. Eunomia can support role mapping and compliance governance; this page does not offer or imply a statutory appointment.
LEEM, the French pharmaceutical industry association, sets professional ethics rules for its members (Dispositions Déontologiques Professionnelles), overseen by its ethics committee, the Codeem.
Your local partner
Alexandre is a senior Ethics & Compliance professional with over 25 years of experience with pharmaceutical and life sciences companies, as well as leading audit and consulting firms. He previously served as Head of Global Compliance at Servier for nearly three years and was a member of key industry ethics committees at IFPMA and EFPIA.
This overview is informational and does not constitute legal advice. Scope and application should be confirmed for the organisation, market, activity and counterparty in question. Sources checked September 2026.
Your named lead
Global Compliance Business Partner — Global & France
Meet the wider teamQuestions, answered
It depends on the type and value of the advantage. We map each planned engagement against the anti-gift regime, identify whether it falls under an exception, a declaration or an authorisation request, and plan the timelines.
Yes. We help build the data, process and review controls behind French transparency reporting, alongside EFPIA disclosure in other markets.
Article 17 applies above the employee and turnover thresholds, including at group level. Where it applies, we can help assess and strengthen the programme against it. Where it does not, its measures remain a useful benchmark for a proportionate programme.
The Pharmacien Responsable is a statutory responsible pharmacist role under the French Public Health Code for relevant pharmaceutical establishments. The legal entity, establishment, activity and appointment requirements determine how it applies. Eunomia can help map governance and responsibilities, but a formal appointment and eligibility must be confirmed for the specific organisation.
We will listen, ask a few questions and recommend the right scope—without obligation or pressure.
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