Germany’s 5% clinical trial threshold: What pharmaceutical companies need to know for 2027
From 2027, the proportion of patients recruited at German clinical trial sites can have a direct financial impact on the launch of a new medicine in Germany. Pharmaceutical companies may qualify for an exemption from an additional 8.5% manufacturer rebate if at least 5% of participants in the relevant clinical trials were enrolled at study sites in Germany.
The 5% threshold itself is not new. Since January 2025, companies have had to report the participation of German study sites as part of the German AMNOG benefit assessment dossier. What changes from 1 January 2027 is where and why the threshold is assessed: the requirement will be removed from the AMNOG dossier and transferred to a separate application procedure administered by the Federal Institute for Drugs and Medical Devices (BfArM).
For international Market Access, Clinical Development and Regulatory teams planning a German launch, this creates a new connection between **clinical trial recruitment in Germany, launch planning and the statutory manufacturer rebate**.
Germany’s 5% clinical trial threshold from 2027: At a glance
• Clinical trial recruitment: At least 5% of participants in the relevant clinical trials must have been enrolled at study sites in Germany to meet the threshold.
• AMNOG dossier: The current reporting requirement in Section 3.6 of Module 3 will be removed from 1 January 2027.
• BfArM procedure: Companies seeking an exemption will instead have to apply separately to BfArM.
• Additional manufacturer rebate: Meeting the 5% requirement can provide the basis for exemption from an additional statutory rebate of 8.5%.
• Regular manufacturer rebate: The regular 7% manufacturer rebate generally remains applicable.
• Potential financial exposure: Without an exemption, the statutory rebate burden can amount to 15.5%, provided the medicinal product falls within the scope of the regulation and no statutory exception applies.
Why does Germany have a 5% clinical trial threshold?
Germany introduced the 5% threshold through the Medical Research Act as a measure intended to strengthen Germany as a location for clinical research. The provision links the German benefit assessment of new medicines to the participation of German study sites in the pivotal clinical trials supporting the product.
Since January 2025, pharmaceutical companies have therefore been required to report how many participants in the pivotal trials were enrolled at study sites in Germany. A proportion of at least 5% is considered relevant.
For this purpose, Section 3.6 and Table 3-11 were added to Module 3 of the German AMNOG benefit assessment dossier. Companies must report the relevant clinical trials and the number of study participants by country and study site.
Importantly, the criterion relates to **where patients were enrolled**, not to their nationality or place of residence. The relevant study sites must be located within the territorial scope of the German Social Code Book V (SGB V). Germany’s Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) assesses the proportion for the indication under benefit assessment, but not separately for individual patient groups.
What changes for the AMNOG dossier on 1 January 2027?
From 1 January 2027, the requirement to demonstrate the proportion of participants enrolled at German study sites will be removed from the benefit assessment under Section 35a SGB V.
The corresponding reporting requirement under Section 35a(1), sentence 3, no. 7 SGB V and the provision governing the assessment of the 5% proportion under Section 35a(1d) SGB V will cease to apply.
As a result, Section 3.6 of Module 3 will also disappear from the AMNOG benefit assessment dossier. Pharmaceutical companies will no longer submit information on German study-site participation to the G-BA as part of this section of the national benefit assessment dossier.
The important point for international teams is that the removal of Section 3.6 does **not** mean that the 5% threshold disappears. Its function changes.
How is the 5% threshold linked to Germany’s manufacturer rebate from 2027?
From 1 January 2027, the 5% threshold moves from the AMNOG dossier into a new regulatory and financial context.
An additional statutory manufacturer rebate of 8.5% of the pharmaceutical company's ex-factory price excluding VAT will take effect. This rebate generally applies in addition to the regular manufacturer rebate of 7%.
Certain medicinal products are excluded, including in particular off-patent products with the same active substance, biosimilars including their biological reference medicinal products, and products subject to a reference price. The legislation also provides for further exceptions and exemption options.
For medicinal products with new active substances first placed on the German market on or after 1 January 2027, pharmaceutical companies can apply for an exemption from the additional 8.5% rebate.
The 5% threshold becomes relevant at this point: **an exemption can be requested if at least 5% of participants in the relevant clinical trials were enrolled at study sites in Germany.
If the exemption is granted, the regular manufacturer rebate of 7% generally remains applicable. Without an exemption, the combined statutory rebate burden can reach 15.5%, provided that the medicinal product falls within the scope of the regulation and no statutory exception applies.
How will the new BfArM procedure work?
From 2027, meeting the 5% threshold will no longer be assessed through Section 3.6 of the AMNOG dossier. Instead, pharmaceutical companies seeking exemption from the additional manufacturer rebate must submit a separate application to the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM).
The application can be submitted electronically at the earliest after the marketing authorisation application has been filed. Companies must provide appropriate evidence demonstrating the participation of German study sites.
BfArM will define the specific procedural requirements, supporting documentation and electronic templates in consultation with the Paul-Ehrlich-Institut (PEI). For medicinal products within the remit of the PEI, BfArM will determine in agreement with the PEI whether the 5% threshold has been met.
BfArM will issue its decision within three months of receiving the application. The exemption takes effect upon notification of the decision, but no earlier than the date on which the medicinal product is first placed on the German market. It is initially granted for three years.
An extension may be requested. The application must be submitted no earlier than 30 months and no later than 32 months after the start of the exemption or the previous extension.
One aspect is particularly relevant for launch planning: **the exemption does not apply retrospectively**. The timing of the BfArM application can therefore have a direct financial impact.
What does the 5% threshold mean for pharmaceutical companies planning a German launch?
The removal of Section 3.6 from the AMNOG dossier may initially appear to reduce the administrative burden. In practice, however, pharmaceutical companies will still need robust and verifiable data on recruitment at German study sites if they intend to apply for exemption from the additional manufacturer rebate.
Existing processes therefore remain relevant but will need to be adapted to the BfArM procedure.
For international teams, this creates a particularly important timing issue. The application needs to be coordinated with the regulatory pathway and planned German launch. Because the exemption does not apply retrospectively, a delayed application can result in the additional manufacturer rebate being payable temporarily.
For affected medicinal products, scenarios with and without an exemption should therefore be incorporated into revenue, budget and launch planning at an early stage.
Without an exemption, the statutory rebate burden generally increases from 7% to 15.5% of the pharmaceutical company's ex-factory price excluding VAT. This represents an increase of approximately 121% compared with the regular manufacturer rebate and may have considerable financial implications, particularly for high-revenue medicinal products.
Why the 5% threshold requires cross-functional preparation
The 5% threshold is not solely a German Market Access issue. The data required for the BfArM application originate much earlier in clinical development.
Clinical Development and Clinical Operations provide the underlying information on trials, study sites and participant recruitment. Regulatory Affairs, Market Access, Pricing and Finance then need to coordinate the application and assess its regulatory and financial implications.
Clear responsibilities for data preparation, application submission and deadline management should therefore be established early.
Looking further ahead, the threshold may also become relevant when planning global clinical development programmes. Companies may need to consider the potential financial benefit of meeting the German 5% threshold alongside the additional effort associated with greater participation of German study sites.
Preparing for Germany’s 5% threshold and the BfArM procedure
Pharmaceutical companies should prepare for the transition to the BfArM procedure early and integrate it into development, regulatory and German launch planning. The key priorities are identifying affected products, establishing a robust data basis and submitting the application in time.
Checklist for pharmaceutical companies
Identify affected German launches
Assess which medicinal products with new active substances will be placed on the German market for the first time on or after 1 January 2027 and fall within the scope of the regulation.
Determine German clinical trial recruitment
Centrally capture the relevant clinical trials, German study sites and participant numbers and document the calculation of the 5% proportion in a transparent and reproducible manner.
Adapt existing AMNOG processes
Processes already established for data collection and quality assurance under Section 3.6 of Module 3 can provide a basis for preparing the new BfArM procedure.
Coordinate the application with the German launch
Align the exemption application with the marketing authorisation procedure and planned market launch to minimise any temporary exposure to the additional manufacturer rebate.
Model the financial scenarios
Include scenarios with and without exemption in revenue, budget and launch planning.
Monitor BfArM requirements
Review the procedural details, evidence requirements and electronic templates once published and adapt internal processes accordingly.
From the AMNOG dossier to BfArM: why the 5% threshold remains relevant
The removal of Section 3.6 from the German AMNOG dossier does not make the 5% threshold irrelevant. Instead, the threshold moves from the benefit assessment dossier into a separate BfArM procedure and becomes directly connected to the level of the statutory manufacturer rebate.
For pharmaceutical companies planning German launches from 2027 onwards, the practical implication is clear: **data on German clinical trial recruitment remain relevant, but their purpose changes.**
Companies should therefore continue the underlying data processes and coordinate the BfArM application with German launch planning at an early stage.