Pharmaceutical compliance support in France
Local rules, connected to your global model.
Local compliance support for pharmaceutical and biotech companies working in France, from the anti-gift regime and Transparence Santé disclosure to Sapin II, led by a senior French ethics and compliance professional.
Discuss this service
What we can take on
Pharmaceutical compliance in France: scope of support
HCP and patient organisation engagement review
Local transparency and disclosure requirements
Promotional and non-promotional material review
Market-entry compliance assessment
Responsible person and local representative support
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
What shapes compliance in France…
A short guide to the main legal and self-regulatory frameworks. Each summary links to its official source below.
The anti-gift regime (loi anti-cadeaux)
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.
Transparency: the Loi Bertrand
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: ANSM visas
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.
Anti-corruption: Sapin II
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.
Industry ethics: LEEM
LEEM, the French pharmaceutical industry association, sets professional ethics rules for its members (Dispositions Déontologiques Professionnelles), overseen by its ethics committee, the Codeem.
Primary references
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
Alexandre Guillaume
Global Compliance Business Partner — Global & France
Meet the wider teamQuestions, answered
Pharmaceutical compliance in France FAQs
Which HCP engagements need declaring or authorising in France?
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.
Can you support Transparence Santé reporting?
Yes. We help build the data, process and review controls behind French transparency reporting, alongside EFPIA disclosure in other markets.
Does Sapin II apply to us?
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.
Tell us what is on your desk.
We will listen, ask a few questions and recommend the right scope—without obligation or pressure.
Start a conversation