If your company is developing a new medicine and you’re looking at France as part of your European launch, you might wonder:
👉 “Is it possible for patients in France to access our drug before we get full marketing authorisation?”
The good news: yes, it is possible — thanks to two special early access pathways.
These programs help patients with serious diseases get much-needed treatments earlier, while allowing companies to start building visibility and evidence in France.
Let’s walk through them — in simple terms.
1️⃣ What is Compassionate Use? (Accès Compassionnel)
Compassionate Use (in French: Accès Compassionnel, or AAC) is a case-by-case authorisation to use your drug before it’s officially approved.
It’s designed for patients who:
- Have a serious or rare disease,
- Have no other treatment options,
- And who can benefit from your drug based on the data you already have.
There are two main forms:
- Named-patient use (AAC): For one individual patient.
- Cohort AAC: For a small group of patients with the same condition.
These authorisations come from the French health authority (ANSM), and they’re temporary — usually while your trials and MA process are still ongoing.
2️⃣ What is Accès Précoce? (AAP)
AAP (Accès Précoce Autorisation) is France’s new Early Access Program.
It was introduced to simplify and improve the old ATU system.
AAP is given when:
- Your drug shows promising results (but is not yet fully approved).
- The disease is serious or rare, and no alternatives exist.
- You’ve started the MA process but need more time to complete it.
Unlike Compassionate Use, AAP is for broader, planned patient access — not just individual requests.
AAP is valid for 1 year and can be renewed. You’ll need to provide ongoing data on safety and efficacy.
Why Should You Care?
Early access programs are not only good for patients — they’re also good for your company:
✅ Patients benefit earlier.
✅ You collect real-world data to strengthen your MA application.
✅ You engage earlier with French payers and authorities on pricing & reimbursement.
✅ You build awareness of your product in the French medical community.
How We Can Help
Navigating these pathways isn’t always easy. The rules are strict, the paperwork is detailed, and timing is crucial.
At Elliogen, we’ve helped international pharma and biotech companies successfully:
- Choose between AAC and AAP.
- Prepare the necessary documentation for ANSM.
- Coordinate with local Exploitant partners.
- Align early access with your overall market access strategy.
If you’re thinking about bringing your product to France — even before approval — let’s discuss your options.
📩 Contact us at hello@elliogen.com
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