Official Hearing on New Medical Research Act: Deutscher Bundestag

Our Managing Director, Professor Thomas Wilke, recently attended the official hearing by the ‘Deutscher Bundestag’ concerning their new medical research act. Below are his thoughts on the significant changes proposed by this legislation. 

Insights from the Official Hearing on the "Medizinforschungsgesetz" at the Deutscher Bundestag

I recently had the pleasure of participating in the official hearing of the Deutscher Bundestag regarding the new "Medizinforschungsgesetz."  This proposed law aims to introduce significant changes to how clinical studies are conducted in Germany. A particularly contentious aspect of the new legislation is the introduction of "secret rebates" in the AMNOG price negotiations, which pharmaceutical companies can request to keep confidential. This means that publicly communicated prices might no longer reflect the actual reimbursement prices in Germany. 

During the hearing, most speakers, including myself, expressed considerable scepticism about this change. The primary concern is the transparency upon which the German drug pricing system is built. Transparent, publicly available prices are crucial for maintaining the integrity and fairness of price negotiations and AMNOG assessments. Without access to these comparator prices, the future of these assessments becomes uncertain. 

Proponents of the secret rebates argue that they could reduce the likelihood of companies opting out of the German market, as current reimbursement prices often conflict with global reference pricing strategies. However, it is essential to note that there are already existing measures, such as price-volume agreements between pharmaceutical companies and the GKV-Spitzenverband, which effectively address the risk of drug opt-outs. These measures ensure that essential medications remain available to German patients without compromising the transparency of the pricing system. 

The hearing highlighted the need for careful consideration of the implications of these changes. While the goal is to make innovative drugs more accessible, it is crucial to preserve the transparency and fairness that the German healthcare system is known for. As the "Medizinforschungsgesetz" progresses, it is hoped that the input from this hearing will guide the legislation towards a balanced and effective outcome. 
 
If you would like to learn more or discuss further how these new laws may affect you then feel free to contact us.