Germany Tightens Rx Price Binding Sanctions: Personal Liability, Higher Fines
The German government is set to overhaul the sanctions mechanism for violations of the Rx price binding. The draft bill, if passed, will transfer the liability risk to contracting parties in equal parts. Fines for each violation could reach up to 50,000 euros, with a total contract penalty not exceeding 250,000 euros. This move comes amidst concerns raised by industry leaders and health ministers.
The Pharmacy Strengthening Act previously transferred the Rx price binding to the Social Security Code and established a joint arbitration panel for compliance. However, the new draft bill goes a step further by potentially holding DAV and GKV Association members personally liable for decisions on sanctions if later declared invalid by a court. This has sparked concern, with DAV chairman Dr. Hans-Peter Hubmann expressing worries about the responsibility for imposing penalties.
The bill also introduces severe penalties for violations, with fines up to 50,000 euros per violation. The total contract penalty is capped at 250,000 euros. In extreme cases, a temporary exclusion from the authorization for further supply is theoretically possible. Complete exclusion from the framework agreement, however, is only provided in connection with other violations, not solely for price breakers.
Health Minister Nina Warken has promised to improve the sanctions mechanism, while the Parity Office fears imposing penalties due to potential damages. Meanwhile, Dutch senders have shown little interest in the Rx price binding.
The draft bill aims to strengthen the sanctions mechanism for Rx price binding violations, with significant financial penalties and potential personal liability for decision-makers. While the bill seeks to deter violations, it has sparked concerns and debates among industry leaders and health ministers. The final form of the bill remains to be seen, pending further discussions and potential amendments.
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