IntroductionGermany’s Pharmaceutical Pricing System:AMNOG and the Medical Research Act RevisionsHealthcare expenditures have been on the rise each year in Japan and Germany due to population aging and the introduction of advanced medical technologies. Japan, in particular, has one of the highest aging rates in the world, and Germany is likewise experiencing a steady increase in its elderly population. These demographic changes and technological advancements pose significant challenges for many developed countries.As shown in Right Figure (based on OECD Health Statistics), healthcare expenditures as a percentage of GDP in Japan and Germany have been trending upward since around 2010. This escalation in healthcare costs is a critical issue for both nations, which maintain universal health insurance systems; from the standpoint of insurance financing and taxation, it has reached a social impact that cannot be ignored.Against this backdrop, this article compares pharmaceutical pricing systems in Japan and Germany, focusing primarily on drug expenditures. I first examine the key In Germany, a system called AMNOG was introduced in 2011 to assess the medical value of new drugs and ensure sustainable healthcare spending. Under AMNOG, pharmaceutical companies are free to set prices for the first six months following the market launch of a new drug. After that period, price negotiations are conducted based on an assessment of the drug’s additional benefit. In this assessment, organizations called the G-BA (Federal Joint Committee) and IQWiG (Institute for Quality and Efficiency in Healthcare) collaboratively evaluate the added medical value of the new drug compared to existing treatment the various components of pharmaceutical expenditures, costs total Moreover, among healthcare (drug expenditures) occupy a particularly large share. According to data published by Japan’s Ministry of Health, Labour and Welfare, healthcare expenditures in Japan amounted to approximately 33.8 trillion yen in 2022, of which around 8 trillion yen were accounted for by pharmacy-dispensed medications. Pharmaceutical costs hold a considerable weight in overall healthcare spending. Notably, new drugs and biopharmaceuticals require substantial development costs, leading to a greater increase in drug expenditures as they become more widely adopted.characteristics of Germany’s pricing system, differences and challenges in Japan’s system, and finally consider future directions for managing healthcare and drug costs.options. Based on the results, the pharmaceutical company negotiates a reimbursement price with the GKV-SV (National Association of Statutory Health Insurance Funds). If they fail to reach an agreement, an arbitration committee determines the final price. This framework allows new drugs to enter the market quickly while simultaneously contributing to savings of billions of euros in healthcare spending.then explore 15Daiki WakabayashiGoethe University, Frankfurt am Main, GermanyComparing Pharmaceutical Pricing Systems in Japan and Germany
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