French early access pathway shows strong uptake as HAS refines assessment criteria

Who is this relevant for?

• Manufacturers evaluating UK market entry
• Distributors monitoring sourcing opportunities
• Hospitals managing supply risk

France’s early access medicine pathway has moved from policy reform to active launch route in a short period. In the first 10 months after the scheme started in July 2021, close to 100 applications were submitted and 40 medicines reached patients. HAS and ANSM also reported average decision times of about 60 days, falling to 35 days for COVID-19 products.

For companies planning French access, that matters less as a headline than as a signal. France is showing that early access can operate at pace, but only where the sponsor arrives with a credible evidence package, a clear unmet need, and a workable supply plan.

Faster access, but with tighter discipline

The French model allows early availability and funding before standard reimbursement is in place. That creates a bridge between clinical development, marketing authorisation, and full commercial launch.

There are two routes:

• Pre-MA early access, where ANSM first reviews presumed efficacy and safety and the company must file for marketing authorisation within two years if access is granted
• Post-MA early access, which covers the gap between authorisation and completion of pricing and reimbursement negotiations

That structure is operationally useful. It gives manufacturers a route to funded use while regulatory and pricing processes continue. It also brings obligations forward. A company granted early access must be ready to supply patients within two months. That compresses planning across batch release, distribution setup, pharmacovigilance, and local market operations.

For rare disease and oncology products, where the treated population may be small but clinically urgent, this can accelerate uptake. It also raises the cost of weak preparation. A positive opinion is only valuable if product can move quickly and compliance systems are already in place.

HAS is sharpening the gatekeeping criteria

The latest update from HAS is less about expanding the scheme than refining how it decides borderline cases.

Two points stand out.

First, HAS has adjusted the way it judges whether an "appropriate treatment" already exists. Past application experience has pushed the agency to add more detail to this test. In exceptional cases, especially during a health emergency, a clinically relevant option may still fail to count as an appropriate treatment.

Second, HAS has clarified what it means by presumed innovation. The agency now expects three conditions to be met:

• a novel treatment approach likely to bring a substantial change for patients
• a development plan and clinical data that support a presumed patient benefit within the current treatment pathway
• an unmet or insufficiently met medical need

That refinement matters for access teams. The scheme is not a shortcut for products with modest differentiation or incomplete positioning. HAS is asking sponsors to show why the product changes treatment practice, not just why it deserves temporary availability.

Evidence planning starts earlier

For pharma companies, the French pathway now looks more like an evidence and launch-readiness test than a narrow regulatory filing.

A sponsor needs to align several elements early:

• the ANSM view on presumed benefit-risk
• the HAS case for no appropriate treatment or insufficient existing options
• the argument for innovation in the specific therapeutic context
• the operational ability to supply within the required timeline

That pushes market access work upstream. Clinical teams need to think beyond approval endpoints and prepare for comparative relevance in the French care setting. Access teams need a sharper narrative on unmet need. Supply teams need to plan for early demand under funded access before routine reimbursement is settled.

This is especially relevant in therapeutic areas where treatment pathways are crowded or evolving. If there is already a recognised standard of care, a sponsor will need stronger clinical and practical arguments to show why that option is not appropriate for the target patients.

The reimbursement gap is becoming a launch phase of its own

The post-MA route deserves close attention. In many European markets, the period after marketing authorisation but before reimbursement can stall uptake for months. France is using early access to keep eligible products moving during that interval.

That has two implications.

One is commercial. Launch in France no longer starts only when price negotiations conclude. For some products, the effective launch window opens earlier, under a different evidence and supply framework.

The other is financial and operational. Companies need to manage early funded demand, patient access commitments, and reimbursement submission requirements in parallel. That demands tighter coordination between headquarters, French affiliates, regulatory teams, and logistics partners.

Hospitals and supply teams should watch product flow, not just approvals

For hospitals, the French scheme can improve access to medicines in severe or rare conditions, but authorisation alone does not guarantee stable supply. Manufacturers still need to deliver within a short window and maintain continuity after the first patients start treatment.

That makes execution visible. Hospitals and procurement teams should track whether early access products are backed by reliable stock allocation, clear ordering channels, and realistic continuity plans through the shift to standard reimbursement.

Distributors should read the pathway in the same way. A faster assessment process can create short-notice demand spikes, especially for high-value specialist medicines. Distribution partners that understand French access timing can spot opportunities, but they also need to judge whether a manufacturer’s launch sequence is mature enough to support rapid deployment.

Patient group input is shaping decisions

HAS also highlighted the role of patient associations in the early decisions already issued. Written contributions were included in a substantial share of cases, and several associations were heard directly by the Transparency Committee.

That does not replace clinical evidence, but it does affect how unmet need and treatment urgency are framed. For manufacturers, it reinforces the need for a coherent access case that reflects real patient pathways, not only trial design.

France is building a more selective fast track

The early results are positive for sponsors that can meet the bar. Decision timelines are relatively short, authorisations have been granted in most completed cases, and the route is now embedded in pre- and post-MA planning.

At the same time, HAS is signalling that speed will sit alongside closer scrutiny. The updated doctrine narrows room for loose claims around innovation or lack of alternatives. Companies that treat early access as a disciplined launch route, with evidence, supply, and reimbursement planning built together, will be better placed to use it.

For international manufacturers, France remains one of the more active European markets for structured early access. The lesson from the latest HAS update is straightforward: rapid access is available, but only for sponsors ready to defend clinical relevance and execute at pace.