Author: Dr. rer. nat. Florian Stieglitz, Consultant, Germany
In a published press release, the German Association of Research-Based Pharmaceutical Companies (Verband Forschender Arzneimittelhersteller e. V., vfa) stated that there is a growing innovation backlog in Germany.
Gap Between Available Medicines
The vfa refers to the gap between the availability of medicines in Germany compared to the United States. Between 2015 and 2023, 15 drugs classified by the FDA as “very important” and 21 as “important” were approved in the US but are not available in Germany. As a solution to this innovation backlog, the vfa recommends not only strengthening research within Germany but also improving the AMNOG process and the reimbursement landscape.
Improvements by the Legislator?
Market access in Germany has become increasingly complex in recent years, primarily due to mounting financial pressure on statutory health insurers (SHI), and particularly following the enactment of the SHI Financial Stabilisation Act (GKV-FinStG) in 2022. With the introduction of the Medical Research Act (2024), the legislator has at least partially adjusted the regulatory framework.
However, the full effects of the GKV-FinStG will only become apparent in the medium to long term. In an international context, the German market remains attractive for now, but its position should not be put at risk by increasing restrictions and bureaucracy.
Why It Is Still Worth Launching in the German Market – If the Strategy Is Right
Reimbursement from Day One at the Manufacturer’s Launch Price: Innovative drugs are reimbursed by the statutory health insurance funds at the manufacturer’s launch price for six months following market entry. These favourable market conditions contribute to an average time-to-market of 151 days, compared to the EU27 average of 517 days. Germany—Europe’s largest pharmaceutical market—has held a leading position in this regard for many years.
Transparent and Efficient Evaluation Process: A clear, transparent, and structured procedure offers legal certainty and planning reliability. The entire process, including price negotiations, is typically completed within one year.
Pharmaceutical Company Hearing: The oral hearing enables the company and key opinion leaders to provide input on the benefit assessment and proactively address critical aspects. This is a unique feature compared to other European countries, ensuring the involvement of both the pharmaceutical industry and the medical community. The publication of a verbatim transcript adds an extra layer of transparency.
With comprehensive strategic planning, pharmaceutical companies have a real opportunity to launch innovative therapies in Europe’s most attractive market—Germany.
Kintiga is pleased to support you and your company as a reliable and experienced partner—both strategically and operationally—throughout every stage of the market access process in Germany, or during early strategic planning.
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