Japan has made big strides in bringing new measures to increase the transparency of regulatory and policy decision-making in the health care sector and implementation of plans to substantially speed new drug introductions.
According to the sixth annual report of the US-Japan Regulatory Reform and Competition Policy Initiative, moves by Japan to continue its programme of regulatory reform foster new business opportunities and stimulate competition in the sector.
The report, produced jointly by the two governments to detail progress made on the recommendations for reform which they have exchanged each year since the initiative began six years ago, noted that Japan has achieved remarkable transparency specifically in the area of pharmaceutical pricing.
Japan's Ministry of Health, Labour and Welfare (MHLW) has pledged to "consider rewarding" the development of innovative medicines during fiscal 2007 by:
■ Continuing to select suitable candidates, irrespective of nationality, to serve as members of the Central Social Insurance Medical Council (Chuikyo) Drug Pricing Expert Subcommittee;
■ Ensuring that, ahead of meetings with the Drug Pricing Organization (DPO), the MHLW's Economic Affairs Division discusses fully with drugmakers the issues being considered by the Health Insurance Bureau;
■ Providing industry with opportunities to express its views on proposals to reform Japan's drug pricing system, and to consider those views; and
■ Discussing with industry how to improve rewards for innovation.
The MHLW said it would ensure that drugmakers have the opportunity to contribute to any official discussions on the frequency of reimbursement price revisions. It will also continue to discuss with industry the issue of re-pricing criteria for market expansion.
By extending the standard length of the re-examination period for medicines with new active ingredients from six to eight years on April 1 this year, it has, in effect, extended the data protection period.
Normally, innovative medicines are introduced into Japan years after the USA and Europe, and the government is keen to eliminate these lags by strengthening R&D, stimulating clinical trials and streamlining reviews.
MHLW will also ensure that the Pharmaceuticals and Medical Devices Agency (PMDA) achieves its target of increasing the number of its reviewers by 236 by March 31, 2010, through hiring 58 new reviewers in FY2007, 80 in FY2008 and 98 in FY2009, funded by the user-fee increases which took effect last April 1. The MHLW and PMDA will continue to exchange views on PMDA's performance status with interested parties, including US drugmakers.
In April this year, the MHLW published draft guidelines clarifying Japan's regulations for global clinical trials and announced a five-year plan to stimulate clinical trials in the country. In addition, it established plans to reduce, by end-FY2011, the pre-application drug lag by 1.5 years and the application review period by one year, thus reducing the total development-to- approval period by 2.5 years. Moreover, the PMDA has pledged, by March 31, 2009, to cut consultation waiting times from approximately three months to around two months.
The PMDA has reduced its New Drug Application backlog from 139 when it was set up in April 2004 to 20 at March 31, 2007.
The agency with MHLW, is making "all possible efforts to ensure reviews are carried out properly and promptly and to attain the mid-term target of completing 80% of applications in 12 months of administrative time by March 31, 2009," the report said.