日本の薬価制度～グローバル製薬企業から見える課題

抄録

Japan's drug pricing system is designed to control medical expenses and maintain appropriate prices for pharmaceuticals under the universal healthcare system. However, from the perspective of global pharmaceutical companies, this system presents several challenges.

First, Japan's drug pricing system, with its annual price revisions and the introduction of the market expansion re–pricing system, has resulted in a decline in price stability. This makes it difficult for global pharmaceutical companies to predict long–term revenues, thereby increasing risks related to investment in new drug development. Particularly in the case of high–cost biologics and advanced medical technologies, price uncertainty poses a significant barrier.

Second, Japan's criteria for drug pricing are unique. The prices of new drugs are determined based on comparisons with existing drugs and their clinical usefulness, which do not necessarily align with evaluation methods in global markets. Especially for innovative treatments and drugs for rare diseases, pricing that considers development costs and market size becomes challenging. While the drug pricing system to evaluate the innovativeness of new pharmaceuticals tends to be revised and improved annually, global pharmaceutical companies still need to engage in Japan–specific price negotiations and market strategies to secure profitability in the Japanese market.

Japan's drug pricing system must swiftly adapt to advancements in medical technology and changing patient needs. With the emergence of new therapies such as gene therapy and regenerative medicine, appropriate evaluation and pricing of these technologies are imperative. In the case of disease–modifying drugs, pharmaceutical companies are increasingly required to generate evidence related to cessation criteria, but limiting the duration of drug administration will significantly impact pharmaceutical expenditures. Global pharmaceutical companies expect a flexible drug pricing system that accommodates the characteristics of innovative treatments when introducing them to the Japanese market.

Finally, the Japanese government has been intensifying policies to promote the use of generic drugs. While this contributes to controlling medical expenses, it places greater emphasis on patented drugs as the driving force behind the pharmaceutical industry's growth. To secure sufficient revenue during the patent period, global pharmaceutical companies must focus on swift market entry and optimizing sales strategies.

This article will discuss how these challenges may impact market entry, as well as the development and supply of new drugs in the Japanese market.