How Germany is boosting Clinical Research: Part 4 – Reimbursement Benefits

Bringing a new drug to patients involves high costs for pharmaceutical companies. In 2024, the pharmaceutical industry spend around €55 billion for R&D in Europe¹. During the drug approval process, approximately 90% of drug candidates that enter clinical trials fail to receive marketing approval due to lack of clinical efficacy or safety concerns². The remaining 10% must be used to cover the companies‘ expenses.

Since 2011, the German Act on the Reform of the Pharmaceutical Market (AMNOG) has been the central instrument for this process and has fundamentally changed the landscape of drug pricing in Germany. The German approach guarantees patients immediate access to innovations, which distinguishes it from many other European systems. In Germany, the average time between approval and availability of drugs, including the reimbursement status of the new drug, was 128 days (as of January 5, 2025)³. Initially, market access is granted at a price set by the pharmaceutical manufacture. However, after six months at the latest, the negotiated reimbursement amount comes into effect, which is intended to reflect the actual value of the innovation. The AMNOG process follows the principle that the price of a drug must reflect its proven benefit. Drugs with significant added value over currently available therapies justify higher prices.

The AMNOG system is continuously being developed further. Since its introduction, legislators have made regular adjustments to maintain the balance between innovation and affordability. One of the government’s goals is to create additional treatment options for patients by encouraging pharmaceutical companies to conduct clinical studies in Germany. Various measures are taken to make Germany an attractive place for pharmaceutical companies to conduct clinical trials. The government recognizes the pharmaceutical industry as a key industry in Germany. Therefore, the German Medical Research Act allows pharmaceutical manufactures that have recruited at least 5% of participants in Germany to be exempt from additional discounts and price caps that were decided in 2022⁴. This exemption from the benefit assessment under AMNOG could be attractive to pharmaceutical companies, as the prices of new drugs would then no longer be measured so strictly against their added benefit compared to existing therapies. In this way, the government is sending an important signal to patients and research-active pharmaceutical manufacturers.

Thanks to various measures, Germany is once again establishing itself as the preferred destination for clinical trials. With regulatory clarity, speed, and scientific excellence, Germany is your ideal partner for clinical development.

As your partner for clinical trials, FGK can bring your study into life – efficiently and successfully.