For more than a decade, Germany has been the gold standard for patient access to innovative medicines in Europe. A median of 56 days from regulatory approval to patient availability is the fastest on the continent. Immediate coverage by statutory health insurers from day one. A benefit assessment process that runs in parallel with treatment, not instead of it. Germany proved that it is possible to rigorously evaluate new medicines for value while patients are already benefiting from them. That is the principle at the heart of everything the Global Alliance for Patient Access stands for: Early is Better. Which is why what has been happening now in Germany deserves our attention.
The Evidence Is Not in Dispute
The case for early access is grounded in data, not aspiration. When patients receive effective treatments earlier in the course of disease, outcomes improve, survival extends, complications are avoided, and the costly downstream consequences of untreated or undertreated disease are reduced. Research has shown that even modest delays in access to innovative oncology medicines are associated with thousands of potential life-years lost.
In Germany, timely access to a single lymphoma therapy was associated with nearly €724 million in productivity gains. These are not abstract benefits; they are the measurable returns on a system designed to put patients first. Germany’s AMNOG framework was built around this logic. Price negotiations happen, but they happen after patients are on treatment, not before. That design choice is what separated Germany from its European peers.
A Troubling Direction
Despite this strong legacy, a series of policy measures adopted since 2022 have undermined early access for patients. The GKV Financial Stabilization Act halved the new therapy free-pricing window and introduced retroactive pricing. The 2024 Medical Research Act added a mandatory nine percent discount for pharmaceutical manufacturers who seek confidential pricing. Germany’s Constitutional Court upheld the resulting combined discount burden, now approaching twenty percent, as legally valid in May 2025, locking in the framework. And last month, the Bundestag raised the mandatory manufacturer rebate to fifteen and a half percent, effective January 2027.
No single measure is the breaking point. But together they form a pattern, and the pattern has a troubling direction.
Patients Are Already Paying the Price
The consequences are not theoretical. Research tracking medicines through the AMNOG process found that approximately one in ten new medicines launched in Germany was subsequently withdrawn following unfavorable pricing assessments. In 2024 alone, German patients loss access to three medicines, including treatments for blood cancer and kidney disease, that were withdrawn due to unfavorable outcomes and low-price potential. These are approved, safe and effective therapies that are no longer available to the German patients who need them.
The effect reaches clinicians too. A survey of German physicians found that two thirds factor the possibility of market withdrawal into their prescribing decisions. A doctor who is uncertain whether a therapy will remain available may not prescribe it even when it is the right clinical choice. Germany’s pricing system is no longer just shaping what is on the formulary. It is shaping what physicians are willing to prescribe.
The Choice Germany Faces
Germany still has structural strengths that most European health systems would benefit from replicating. The question is whether policymakers will protect those strengths or allow cost-containment pressures to erode them to the point where the model no longer functions as designed.
That choice will be made in the coming years by policymakers. But it is a choice that must be informed by the patient organizations, the clinicians, and the researchers who understand the value of access and the consequences of barriers to care. The best time to protect a system that works is before it stops working.
The evidence is clear: early access saves lives, reduces long-term costs, and delivers social and economic value that far exceeds the upfront cost of timely treatment. Germany has demonstrated that this is achievable. The task now is to ensure it stays that way and that Germany’s experience, both its achievements and its current pressures, informs the broader European conversation about what good access policy looks like.
Early is Better. For patients in Germany, that principle is increasingly at risk.