One of the most under-used levers in European market entry is early access: several major markets allow a therapy to reach patients — and in some cases generate chargeable revenue — before full marketing authorisation. For rare and ultra-rare diseases with high unmet need, this can mean first European revenue years earlier than a conventional launch timeline implies.
The four core schemes
| Country | Mechanism | Note |
|---|---|---|
| France | Accès Précoce (AP1 / AP2) | Chargeable; among the most structured early-access systems in Europe |
| Italy | Law 648/96 | Reimbursed use of medicines outside their authorised indication where no alternative exists |
| Germany | §2 SGB V | Access route within the statutory health insurance framework |
| Switzerland | Art. 71a-d KVV | Case-by-case reimbursement of non-listed medicines |
Why early access is strategic, not just tactical
Beyond the revenue itself, early-access programmes generate real-world evidence that strengthens the later HTA and pricing dossiers. A patient treated under France’s Accès Précoce today is also a data point that supports the AMNOG or HAS submission tomorrow. Sequenced correctly, early access and formal launch reinforce each other.
The risks of getting it wrong
Early-access pricing can anchor later negotiations and, through international reference pricing, leak across borders. This is why early access must be designed alongside the pricing corridor and IRP firewall — not bolted on opportunistically. FDA spillover effects into markets such as the UAE, KSA, Greece and Spain also need deliberate handling.