METI in Japan launched a PE-guideline draft for MDD

Reported by Isao Kamae, Keio University, Japan

These two years, the Japanese Ministry of Economics, Trade and Industry (METI) has been interested in economic evaluations for medical device and diagnostics (MDD). In April of 2007, a draft document was released, “A Guideline Draft on Socio-economic Evaluation for Medical Device and Diagnostics”, by the METI Guideline Committee. The purpose of drafting is to clarify and define the expected standards for MDD development in terms of socio-economic evaluation in Japan. Such an action of METI may encourage and affect the MDD industries both domestic and international.

The degree of influence, however, will not be substantial since Ministry of Health, Labor, and Welfare (MHLW), not METI, is the house of regulatory power for MDD application to the government, and MHLW has not been actively involved with drafting the guideline by METI. Despite its limited role, Mr. Horiguchi, the chief officer of METI for the guideline committee, expressed his interest in developing the MDD industries and continuing the task force to boost technological innovations.

In the same month, independent of METI, the research group founded by MHLW, reported a guideline draft for pharmacoeconomic study after two-years discussions since 2005. The draft made a consensus among the renowned experts of pharmacoeconomis in Japan. It also described the scientific standards of the dossier for a new drug application to the government. The recommendations were addressed to comply with the thirty-two attributes for the international comparison in the ISPOR guideline matrix posted on its website. Dr. Isao Kamae, the primary investigator and President of the ISPOR Japan Chapter, said, “It is not a draft authorized by the government, but could be a prototype for the future involvement of the government.”

Although MHLW understands the potential need for employing pharmacoeconomic evidence for regulatory purpose, it appears to be more tentative in improving poor infrastructures of Japanese hospitals for conducting clinical trials. Last April, MHLW embarked on the first year of five-year project for promoting clinical trials in Japan, but their scope of interest still remains within the third hurdle, not taking the forth one into account.

One of the major reasons why the government addresses the promotion of clinical trials with the priority is a wide gap of availability in medical technologies between Japan and western countries. The international MDD companies, which share the recognition of the technology gap, came together on April 21st for attending the Medical Technology Leadership Forum at the good old Manpei Hotel in Karuizawa, the famous mountain resort of Japan. The purpose of the conference was to continue the dialogue initiated in May 2005 in Washington DC between the U.S. and Japanese health leaders, and to learn more about the health care systems of both countries. Serious concerns were raised from the international MDD companies that imposing more requirements on clinical trials by the government might not be helpful to diminish the gap, or even might get the situation much worse.

For the time being, under the pressure of the technology gap, METI and MHLW would struggle between increasing demands for quality improvement and the cost constraints in health care. It is obvious, however, that a new approach must be sought to attain sustainable reforms on the basis of “Value Economics in Health”, not just achieving the cost-containment. Careful attention should be paid for listening to the sound of reforms in Japan, a giant in Asia regarding the MDD market.

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