June 16, 2014

Jez Moulding, Chairperson, EFPIA Japan
EFPIA Views on a Yearly NHI Drug Price Revision
The Council on Economic and Fiscal Policy is currently discussing whether tointroduce a yearly NHI drug price revision. At present, drug prices are revised by theNHI every other year and drug prices are further reduced by various drug pricepolicies. Introducing a yearly NHI drug price revision will have unintended
consequences on Japanese patients by possibly hurting long-term access to vital, lifesaving medications, and injecting an unnecessary delay in the Japanese healthcare
system. EFPIA Japan strongly objects to a yearly NHI drug price revision for thefollowing reasons:
1. The drug market itself is controlled by the NHI drug price revision performed biyearly and by the periodical reviews related to various drug price-suppressingpolicies. An NHI drug price revision conducted yearly will weaken efforts bypharmaceutical companies to develop and provide innovative new drugs. EFPIA
Japan cannot support a NHI drug price revision conducted annually.
2. A precise survey of drug price is necessary to perform an NHI drug price revision.
However, if the NHI drug price revision is conducted yearly, it is likely that theactual market price will not be accurately reflected for many newly marketeddrugs and add an increased burden to stakeholders and wholesalers who aredependent upon these surveys and price negotiations. We fear that the pricerevision will not be based on the actual market price, which would increase therisk of even further delaying the establishment of new prices, and create more
confusion in the system. Further, confusion in the market will renew the drug lag,create long-term access problems for patients, and ultimately deviate from the__________________________________________________________________
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fundamental purpose of the NHI drug pricing system. The lack of predictability
and stability will adversely affect wholesalers, patients, industry and other keystakeholders.
3. Owing to the government’s various policies such as restructuring the clinical trial
framework, improving the efficiency of regulatory reviews, and reorganizing theNHI drug pricing system to maintain the price during a patent period, amongst
others, Japanese patients are gaining access to new drugs at the same level as
patients in Western countries. This improved environment has also increased thelikelihood that in the near future, a new drug will be approved first in Japan
before elsewhere in the world. However, implementing a yearly NHI drug pricerevision will cause concern for investors, particularly foreign-capitalized
pharmaceutical companies, who will be hesitant to invest in the Japanese drugmarket.
4. The medical fee reimbursement revision is performed every other year, and thenumber of drugs included in the medical fee reimbursement system is increasing.
If the NHI drug price revision is conducted yearly, the balance between it and thebi-yearly medical fee reimbursement revision will be disrupted.
Contact information:
Tetsu Owari, Chairman of Public Relations Committee, EFPIA Japan
Boehringer Ingelheim Japan, Inc.
2-1-1 Ohsaki Shinagawa-ku, Tokyo 141-6017
Phone: 03-6417-2223
E-mail: tetsuya.owari@boehringer-ingelheim.com

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