Germany is a federal republic comprising 16 states (Länder), each with its own government responsible for areas such as education and policing. The federal government, based in Berlin, handles national matters including foreign policy and defence. The healthcare system is a shared responsibility between the federal and state governments. It follows a universal multi-payer model, primarily funded through statutory health insurance (Gesetzliche Krankenversicherung), with contributions shared by employers and employees.
Approximately 88% of the population is covered by this statutory insurance, which provides a comprehensive benefits package. The remaining population is covered by private health insurance (Private Krankenversicherung). The insurance system is decentralised, with governance shared between federal and state levels, and self-regulated organisations of payers and providers.
Germany has established processes for health technology assessment that focus on evaluating the comparative benefit of new treatments. The results of this assessment inform price negotiations between the manufacturer and the health insurance bodies.
Each stage of the national access process is summarised via the dropdown menu visible to subscribers. Summaries contain links to more detailed briefings, which can also be found by selecting topics on the search page accessed by the button below:
Healthcare system
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. The decentralised structure ensures regional coordination through sickness funds, physician associations, and state governments.
Access landscape
Germany's healthcare system is decentralised, with statutory health insurance (SHI) covering approximately 90% of the population and private health insurance covering the remainder. The Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) is a key player in the access landscape. The G-BA determines 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.
Horizon scanning
German health authorities engage in horizon scanning to identify and evaluate emerging medicines and medical technologies before they enter regular care. The Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) systematically reviews clinical trial registries and scientific publications to detect innovations. Its findings are shared with decision-makers such as the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA), who use this information to support planning and reimbursement processes.
The national regulator, the Federal Institute for Drugs and Medical Devices (BfArM), also employs horizon scanning to identify emerging trends and innovations in healthcare. This process involves detecting early indicators of potential developments and assessing their potential impact on BfArM's responsibilities. The Innovation Office at BfArM actively engages in this method by researching and maintaining contact with innovators, such as start-ups and researchers, to pinpoint trends that are not yet widely discussed.
Scientific advice
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.