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Promotion of Authentic Healthcare Innovations and Treatments

In the constantly evolving landscape of healthcare, innovation is the driving force behind breakthrough treatments and solutions. However, not all innovations are created equal. It is crucial to distinguish between advances in healthcare that are truly replicable and authentic, and those that do not bring benefits to patients in a concrete way. Appropriate laws and regulations play a crucial role in this regard, ensuring that patients continue to benefit from high-quality and cost-effective treatments.

The GKV Financial Stabilisation Act (GKV-FSG) in Germany has a lot of potential to advance clinical research and the development of innovations in a targeted manner. One of the main benefits of the GKV-FSG is to promote financial support for clinical research. Closer cooperation with health insurance funds and sponsors enables more studies to be conducted in Germany under the highest standards, corresponding quality and efficiency.

The GKV-FSG reinforces and takes into account the cost-effectiveness of clinical research. Studies that demonstrate a clear benefit for patients receive more attention. With the focus on more efficiency, real-world data can be used to help provide more accurate data on the effectiveness of treatments in real-world situations.

The introduction of new laws and regulations, promote and improve the quality and safety of clinical research in Germany. For example, the GKV-FSG Act has introduced new requirements for adverse event reporting that can help improve patient safety and the overall quality of clinical research studies.

In total, the GKV-FSG entails an increased administrative burden. In terms of increased financial support, a stronger focus on cost-effectiveness and the introduction of new regulations, the quality and safety of clinical research studies in Germany will be improved still further. It becomes evident what impact the GKV-FSG will have on Germany, as an important, strategic research location, and on clinical research and development. The focus is on ensuring that patients continue to benefit from high-quality, cost-effective treatments.

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