Drug shortages are worsening worldwide [1, 2], and Japan is facing significant challenges due to a combination of factors. One major issue arises from the shift from brand-name to generic drugs, coupled with scandals involving poor manufacturing and development practices. These shortages affect access to essential treatments, prompting calls for action from pharmaceutical companies and the government.
In Japan, healthcare cost control has been a central policy issue. Over the past two decades, drug prices under the universal health insurance system have been consistently reduced. While this has lowered overall healthcare costs, it has also pressured pharmaceutical companies to cut corners, leading to scandals and reduced production quality.
A recent example involves Japan’s Sawai Group Holdings, which highlighted lapses in good manufacturing practice (GMP) compliance, particularly in the case of teprenone capsules 50 mg ‘Sawai’, where deficiencies in stability monitoring were found. This led to significant healthcare disruptions due to forced drug recalls and substitutions, exacerbating existing drug shortages [3].
To address this, Kinoshita and Kishimoto from Keio University School of Medicine in Tokyo suggest that the government introduce exceptional price reviews for unprofitable drugs in 2023 and 2024. However, the situation remains dire, as a 2024 report showed that 29.6%–100% of certain pharmaceutical products could become unprofitable [4].
Additionally, Japan's low drug prices and high clinical trial costs have deterred foreign pharmaceutical companies from entering the market, resulting in fewer new drugs being available. Kinoshita and Kishimotopropose alternative ways to reduce healthcare costs, such as adjusting patient co-payments and switching some drugs to over-the-counter status. Reevaluating drug pricing policies is crucial to prevent further disruption to essential medical care.
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References
1. GaBI Online - Generics and Biosimilars Initiative. UK NHS faces drug shortages [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 23]. Available from: www.gabionline.net/generics/general/uk-nhs-faces-drug-shortages
2. GaBI Online - Generics and Biosimilars Initiative. Drug shortages hit Japan and Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 23]. Available from: www.gabionline.net/generics/general/drug-shortages-hit-japan-and-europe
3. Hashimoto T, et al. The challenge for drug shortage: lessons learned from the quality issues of Japanese generic drug companies. Generics and Biosimilars Initiative Journal (GaBI Journal). 2024;13(3): Epub ahead of print.
4. Challenges introduced by Japan's drug pricing policy. S Kinoshita, T Kishimoto. The Lancet. https://www.thelancet.com/journals/lanwpc/article/PIIS2666-6065(24)00206-2/fulltext
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