Pharmaceutical Industry: Current Reimbursement Negotiation Model Deemed Impractical

Pharma Deutschland, the German pharmaceutical industry association, has criticized the existing regulation for confidential reimbursement amounts for new medicines, stating it is impractical and prevents timely patient access. The regulation, implemented in January 2025, allows for confidentiality in the reimbursement process for new active pharmaceutical ingredients under specific conditions.

However, the association argues that the mandatory nine percent discount, compensation for trade margins, and other additional burdens make the system economically unviable for pharmaceutical companies. Pharma Deutschland stated that this transforms the intended instrument into a "bureaucratic niche model" that fails to achieve its objectives.

"Confidential reimbursement amounts can be an instrument to enable market launches in Germany," said Dorothee Brakmann, CEO of Pharma Deutschland. She emphasized that to ensure early access to innovations in the future, Germany needs "many effective instruments," and the current regulation is too narrowly defined.

In response to the ongoing evaluation of the relevant legislation (§ 130b Absatz 11 SGB V), Pharma Deutschland is advocating for several key changes. These include the elimination of the mandatory nine percent discount, the abolition of trade margin compensation, the removal of restrictions limiting the scope to the first market introduction of a new active substance, and making the currently temporary regulation permanent. The ultimate goal is to create greater room for manoeuvre in negotiations and facilitate earlier access to innovative medicines for patients.