📢  Germany’s proposed “Location Clause” under the SHI Contribution Rate Stabilization Act (GKV-BStabG): What could change from 2027?

 

On 29 September, the expert committee responsible for the so-called “Location Clause” under § 130a SGB V published its report and proposal for the implementation of the additional manufacturer rebate. 🧭

Under the current framework, a total manufacturer rebate of 15.5 percentage points is envisaged from 2027 for the relevant medicines: 7 percentage points general rebate plus an additional 8.5 percentage points. 🚧

The committee’s proposal would allow the additional 8.5 percentage points to be reduced based on certain activities and investments in Germany.

 

The proposed approach consists of two steps:

1️⃣  Entry threshold

Companies would first need to meet a threshold of 2% of Phase I–III clinical trial participants enrolled at German sites, based on a three-year period including the exemption year. The threshold is proposed to increase to 4% at a later stage.

If the entry threshold is not met, the additional criteria would not result in a reduction of the additional rebate.

2️⃣  Additional criteria

Once the entry threshold is met, reductions could be achieved through one or more of the following:

🔹 Collective agreement: –2.0 percentage points

🔹 R&D expenditure in Germany: –3.0 percentage points

🔹 Investment / production in Germany: –3.5 percentage points

 

The reductions could be combined. If all three criteria are met, the additional 8.5 percentage-point rebate could be fully offset, leaving the general 7 percentage-point manufacturer rebate. 🔖

Importantly, the proposal would also represent a shift from the current product-specific 5% clinical trial participant rule for new active substances towards a potentially company-/portfolio-based approach. 🔄

For pharmaceutical companies, this could make the assessment of their German footprint and activities relevant not only at the level of individual products, but potentially across the broader portfolio. 💊

At this stage this remains a proposal. The main question is: What are the key practical questions pharmaceutical companies should already be considering in light of the proposed Location Clause?

🔔 Stay updated with us on the latest developments!