Pharma Deutschland Criticizes New Drug Cost Legislation

The industry association Pharma Deutschland has sharply criticized the German government's proposed legislation for stabilizing statutory health insurance (GKV) drug costs. The association warns that the measures could significantly impair patient care, deter investment in new therapies, and harm Germany's position as a location for pharmaceutical innovation.

Key concerns include the introduction of a "dynamic manufacturer rebate" for patented medicines. Pharma Deutschland argues this creates planning uncertainty, burdens investment and location decisions, and complicates market access for new treatments. The proposal also allows health insurers to enter into rebate contracts for patented drugs, potentially leading to price competition, reduced reimbursement amounts, and a risk of market withdrawals if products become economically unattractive. The association suggests this could limit therapeutic diversity and increase rationing of medical options for patients.

Further, the legislation intends to tighten price-volume regulations, which Pharma Deutschland criticizes as imposing additional price pressure and reducing negotiation leverage. The association deems this unnecessary, as volume considerations are already mandatory. However, Pharma Deutschland welcomes the elimination of a complex "combination rebate" mechanism, while emphasizing the need for clear transitional rules.

The association also voices concerns regarding Digital Health Applications (DiGA). It fears that rigid volume thresholds and high rebates could make successful, widely used digital applications unattractive and hinder investment in digital innovation. Pharma Deutschland advocates for predictable, innovation-friendly reimbursement models to foster digitalization.

While the government aims to stabilize the GKV's finances, Pharma Deutschland believes the proposed savings come at the long-term expense of patients and risk undermining Germany's standing in medical research and development.