Issues and Future Developments of Pediatric Drugs in Japan: From a Survey on Pediatric Drug Development in Japan

Abstract

While the need for pediatric drugs has increased in Japan, their development has not been accelerated, resulting in what is called “drug lag” or “drug loss”. As part of our research to identify the causes of the lack of progress in pediatric drug development, we conducted a questionnaire survey of Japanese pharmaceutical companies and drug discovery ventures regarding pediatric drug development. The dominant reasons not to conduct the pediatric drug development were identified as “unprofitable”, “difficulty in conducting clinical studies” and “pediatric indication is not mandatory”. Questionnaires were used to evaluate the current seven systems that could contribute to pediatric drug development. The most common opinion held by 79.1% of companies, was to appreciate the NHI additional fee for pediatric drugs, while all other current systems are affirmed by more than 60% of companies. Fifteen new proposals to extend the benefits of the current system were evaluated. The four proposals for which most respondents (83.6% to 92.5%) voted were “further extension of the maximum patent extension (currently up to 5 years),” “extending the pediatric pricing benefit to adult indications if the drugs are approved for pediatrics,” “extending the reexamination period (exclusivity)” and “promoting acts for disease background research and registries”. Of the questionnaires received, 65.7% had positive opinions (including the opinions that highlighted some issues those need to be resolved) about the introduction of foreign pediatric drug development promotion systems into Japan. However, the survey also identified some problem with our new incentive proposals and the introduction of foreign systems, suggesting that further considerations, including understanding and resolution of these problem, may be necessary for the future pediatric drug development.