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, where product- and country-specific criteria are met, this may enable funded patient access before routine reimbursement. Availability, timing, price, volume and evidence value are not guaranteed.
The four core schemes
These mechanisms are not equivalent: some provide reimbursement (e.g., France Accès Précoce), some concern use or coverage within statutory frameworks (Italy Law 648/96; Germany SGB V §2(1a)), and some are case-by-case or exceptional reimbursement (Switzerland KVV Art. 71a–d). Compassionate use and named-patient access are separate routes and may require free supply. Switzerland is in Europe but not in the EU. Markets such as the UAE and Saudi Arabia are outside the EU and outside European early-access pathways.
| 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.