Yoshio Mitsumori03.04.09
The Japanese government is breathing new life into an old plan. “Super Tokku” is a deregulation plan that was originally introduced in 2006 to encourage the development of cutting-edge medical technology within Japan which can then be sold to a wider global market.
A total of 24 projects have been nominated, including work in such areas as induced pluripotent stem cells, regenerative medicine, innovative medical devices and combination products. New medical technology often has been cited by the Japanese government as a driver for future growth of the country’s economy. Cutbacks in healthcare spending during the past few years, however, have forced a slowdown of the plan. It has been revitalized with the hope of once again driving the development of new medical technology.
Various industry stakeholders—researchers, physicians and technicians from academia, medical institutions and industry—are expecting special benefits, such as fewer mandates for conducting clinical trials and faster regulatory evaluation, for the development of new medical technology.
For example, the cultivation of tissue or cells for regenerative medicine at present only is allowed to be conducted by physicians in their respective medical institution for his or her clinical and therapeutic purpose. But if other scientific institutions or a private company is involved, the cultivation is regulated as a practice of medical performance by the Pharmaceutical Affairs Law (PAL). So, the tissue or cell cultivated by one institution cannot be used at the other institutions without very complicated regulatory procedures. Under current PAL definitions, however, the categories of medical products are pharmaceuticals and medical devices. There is no category for combination products such as those outlined by the U.S. Food and Drug Administration (FDA).
Apparently, PAL does not yet have a clear evaluation guideline for products that incorporate medical engineering and pharmaceuticals or biologics. Drug-eluting stent technology has been the only exception, and it was evaluated as a medical device. In 2006, the government named medical technology as a primary contributor for the future growth of the Japanese economy. The reality proved to be far more complicated. In 2008, the government cut reimbursement prices of pharmaceuticals and medical devices by a total of 5.2 percent.
As a result, many Japanese pharmaceutical companies moved from conducting domestic clinical trials to offshore options. According to a medical industry research organization, there were 195 new drugs released first to the Japanese market in 1996. By 2006, the number of novel drug therapies introduced first in Japan shrank to 73.
Despite political words of encouragement, Japan’s domestic medical industry substantially has declined year by year.
The medical device industry has seen similar results. The market size of medical devices in Japan is about $24 billion. Of that, imports surpass exports by about $6.3 billion. Most cardiovascular and therapeutic devices, such as pacemakers and angioplasty balloon catheters, mainly are imported, and most come from the United States. The deregulation plan is expected to turn around the situation for new medical technology development. The relevant regulations and legislation will be registered at the Diet (Japan’s legislative body) to materialize the plan in fiscal 2009. The question becomes the scope of the deregulation, particularly with respect to regulatory requirements. The Japanese regulatory system is known as one of the most difficult systems in the world. As such, scientists, physicians and industry are looking at the political progress with eager anticipation.
Yoshio Mitsumori is the president and CEO for Tokyo-based ADMIS, a consultant specializing in the medical device industry. He has more than 25 years of experience in the medical industry, including positions with the Itochu Corp., U.S. Surgical, National Medical Enterprises and Century Medical. A member of RAPS, he has spoken at many industry events and worked extensively in international trade of medical products and technologies. He can be reached at ymitsumori@admis.co.jp.