Medical Research Act: Opportunities and Risks for Germany's pharmaceutical industry

Veröffentlicht:

Von:

Entdecken Sie die aktuellen Herausforderungen und Chancen des Medizinforschungsgesetzes in Deutschland. BPI-Hauptgeschäftsführer Dr. Kai Joachimsen beleuchtet die Auswirkungen auf Innovationen, klinische Studien und die Zusammenarbeit mit öffentlichen Einrichtungen. Erfahren Sie, wie bürokratische Hürden überwunden werden können und welche Bedingungen für die Zukunft der Arzneimittelentwicklung entscheidend sind.
Discover the current challenges and opportunities of the Medical Research Act in Germany. BPI general manager Dr. Kai Joachimsen illuminates the effects on innovations, clinical studies and cooperation with public institutions. Find out how bureaucratic hurdles can be overcome and what conditions are crucial for the future of drug development. (Symbolbild/MB)

Berlin, the German capital and heart of the innovation! Here it is the brand new Medical Research Act that could open the doors to a revolutionary health system. "The Medical Research Act is promising with regard to the innovation and study location in Germany," announces Dr. Kai Joachimsen, General Manager of the BPI, on the occasion of the decisive discussion in the Federal Council, which is already coming up tomorrow!

The excitement for the upcoming innovations is tangible! Scientists, companies and patients are ready to benefit from the accelerated approval and reduction in bureaucracy. But while the expectations are high, the planned implementation of the so-called AMNOG guidelines shocks shocking shadows!

Risks and opportunities in detail

In this way, drugs in which at least five percent of clinical exams were carried out in Germany are to be freed by the official “guidelines”. This could revolutionize the price negotiations and lead to higher reimbursement amounts! But stop, there is a double floor! The required proof of the research activity and control by the Federal Joint Committee (G-BA) could turn out to be a bureaucratic nightmare. "From the incentive to carry out clinical studies in Germany, a possible deterrent instrument becomes again," warns Joachimsen.

And that's not all! The entire regulation is under the Damocles sword of the limitation of only three years. However, most clinical studies need years to be completed! Medicines that now fall under the amnog could be left behind without the hoped -for benefits. A truly dramatic dilemma for the innovation landscape!

bureaucracy or innovation?

But most of the questions remain unanswered! The crucial point for the future of the industry is to prove cooperation with public institutions in research. These have to be designed as little bureaucratic as possible. "We have to establish expressive processes without endangering company secrets," warns Joachimsen. Access to existing tests and certificates could be the key to the solution! Is the turn for Germany's medical research?

The discussion remains hot and the coming days are crucial: will the health landscape change? The eyes of the entire industry are firmly directed to Berlin! It's time for a change - are we ready?