Drug pricing system
Since 2015, the predictability of the Japanese drug market and its attractiveness have declined significantly due to repeated revisions to drug pricing system, such as the introduction of off-year price revisions, fundamental reform of the drug pricing system in fiscal 2018, and the revision of the scope of price maintenance premium (PMP), etc. In addition, quality and supply problems of pharmaceuticals, mainly generic products, have had a significant impact on medical care and distribution. In this environment, an expert panel on comprehensive measures to realize a prompt and stable supply of pharmaceuticals was established within the Ministry of Health, Labour and Welfare from the perspective of early market launch of innovative drugs and drugs with high medical needs to Japan and stable supply of pharmaceuticals.
- With regard to the calculation rules for new drugs, innovation should be evaluated appropriately and a mechanism should be created to avoid Japanese drug prices to be significantly lower than those in Europe and the United States.
- After launch, drug prices should be maintained during the patent period, as in Europe and the United States.
- Since the current drug pricing system have become extremely complex due to repeated revisions, the system should be revised to be simple, easy to understand, and highly transparent.