France remains one of the most attractive yet challenging pharmaceutical markets in Europe. With a highly regulated environment, price controls, and a centralised reimbursement system, successfully launching and sustaining your product in France requires a solid understanding of the market access landscape — and how it’s evolving in 2026.
Why France?
France’s single-payer system ensures universal access to medicines, but it also demands strict justification of clinical and economic value. The French market offers:
- A large patient population with high healthcare spending.
- Significant opportunities in rare diseases, oncology, and innovative therapies.
- Strong government focus on cost containment and generics.
Key steps to Market Access in France
1️⃣ Obtain Marketing Authorisation
Before anything else, a valid European Marketing Authorisation (EMA) or national ANSM approval is required.
2️⃣ Designation of an ‘Exploitant’
Non-French MA holders must appoint a local ‘exploitant’ (licensee) responsible for distribution and compliance in France — a mandatory step often overlooked by newcomers.
3️⃣ HAS Evaluation
Submit a reimbursement dossier to the Haute Autorité de Santé (HAS) for clinical benefit assessment (SMR/ASMR) of your product. This determines its reimbursement rate and relative positioning.
4️⃣ CEPS Pricing Negotiation
Negotiations with the Comité Economique des Produits de Santé (CEPS) establish the final price based on HAS assessment, European reference pricing, and budget impact.
5️⃣ Hospital Access
For hospital-only products, registration in the Liste en Sus or inclusion in hospital tenders is critical.
📈 What’s new in 2026?
✅ Accelerated pathways for ATUs/Early Access: Streamlined processes for innovative therapies with high unmet needs.
✅ Stricter budget impact controls: CEPS demands more robust pharmacoeconomic data.
✅ Push for digital health: Integration of digital therapeutics and companion apps into reimbursement discussions.
🚀 How Elliogen can help
At Elliogen, we help you navigate the intricacies of the French market, find the right Exploitant partner, and define best commercial strategies to maximise chances of success.
Let’s talk about your 2026 France launch strategy! Contact us at hello@elliogen.com
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