Germany - Briefings

The Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) is a key player in the access landscape, determining which healthcare services, including medicines, are covered, and assesses the comparative benefit provided by new drugs. Medicines showing a comparative benefit are launched at prices set by the manufacturer, who then negotiates the definitive price with the National Association of Statutory Health Insurance Funds, with the price applicable from six months after launch. Those without a comparative benefit are subject to national reference pricing.

Germany's healthcare system operates under a decentralised, statutory health insurance model offering universal access. Funding is primarily income-based, supplemented by private insurance and out-of-pocket payments. Healthcare services are provided by public, private, and non-profit institutions, with medicines regulated at national and European levels. Reimbursement policies balance comparative-effectiveness assessments with patient access.

In Germany, manufacturers can seek scientific advice separately from the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), the Federal Institute for Vaccines and Biomedicines (Paul-Ehrlich-Institut, PEI), and the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA). Alternatively they may opt for joint scientific advice to integrate regulatory and HTA perspectives. Choosing the right approach can streamline development, reduce risks, and optimise resource allocation.