Survey on Drug Lag in Japan Current Situation and Challenges Based on a Survey of Pharmaceutical Companies
Keita Ishibashi, Senior Research Fellow, Pharmaceutical and Industrial Policy Research Institute
(No.40: Published in June 2008)
A questionnaire survey was conducted from October to December 2007 among pharmaceutical companies in Japan to clarify the current situation and factors behind the drug lag (difference in the timing of new drug launches compared to Europe and the U.S.) and to identify issues that need to be addressed in order to eliminate the drug lag.
Of the 158 drugs containing new active ingredients approved in Japan between 2000 and 2006, 104 were marketed in the U.S. or Europe. Of these, the drug lag for the 97 products for which developers responded to the questionnaire was approximately 4 years compared to the U.S. and Europe. A detailed analysis of this lag revealed that the extent of the lag varied greatly depending on the country of origin, the target disease, and the development history of the product. As elements of the drug lag, this study focused on the differences in "clinical trial start-up period," "clinical development period," and "review period" between Japan and overseas. The difference in clinical trial start-up time was around two years compared to Europe and the U.S. However, as with drug lag, the degree of difference in start-up time differed greatly when divided by category, such as development history. The clinical development period and review period also took longer in Japan than in the U.S. and Europe. In terms of factors contributing to the drug lag from the viewpoint of developers, the most frequent response was the delay in domestic introduction and initiation of clinical trials, followed by the impact of the length of domestic review and clinical trials.
In terms of issues to be addressed to eliminate the drug lag, the pharmaceutical companies indicated that they consider "implementation of international joint clinical trials including Japan" and "review of the timing of starting clinical trials in Japan" to be important. In addition, from the viewpoint of pharmaceutical companies, medical institutions want "securing incentives for clinical trials" and regulatory authorities want "enhancement of consultation systems" and "clarification of review criteria".
One important point to note about this study is that approximately 90% of the items analyzed were of foreign origin as a result. In other words, the drug lag in Japan was greatly affected by the late introduction of foreign-origin items to Japan. In considering how to solve the drug lag problem, it is also necessary to consider possible future drug lags (i.e., items that have been launched in Europe and the U.S. but are not currently available in Japan) and the situation where some drugs cannot be taken due to differences in indications even though they have been launched in Japan. In addition, there are some drugs that have been launched in Japan but cannot be administered due to differences in the indications.