Yoshio Mitsumori 05.06.06
In addition to the medical industry’s remuneration activity, the Japanese government also developed a plan to deregulate and privatize the industry over a period of three years. Proposed by the Deregulation and Privatization Enhancement Council last December, one segment of the plan focuses on medical devices.
In this plan, the council urges more research and investigation to help dissolve the disparity between domestic and foreign prices of medical devices. This is the first assessment made by the council with regard to the practical and specific issues of medical device industry.
In short, the plan contains the following recommendations:
• Investigate sources of increasing costs, such as the long time it takes for a product to be cleared for the market
• Dissolve unreasonable price gaps by comparing national prices with those of the foreign market
• Enable a smoother system for evaluation of medical devices—this includes enhancing the effectiveness of Pharmaceuticals and Medical Devices Agency evaluations (taking into account a medical device’s typically short life cycle), enlarging the certification system by third-party review, promoting external expert review, improving reviewer abilities, developing clear guidance on the acceptance of foreign clinical data and developing common standards between developers and reviewers and so on
• Enhance international harmonization of standards (such as judgment of clinical trial necessity), ease partial amendment procedures and promote preliminary face-to-face consultations more effectively
• Promote further differentiation and consolidation of medical institutions by function (knowing that widely dispersed medical institutions with fewer specialties and cases result in higher medical product costs and inefficient small quantity distribution)