The Abe administration is seeking to establish a new system for the nation’s medical research in which the government takes the lead in pushing large-scale projects in the development of new drugs and medical technology. While the administration will submit a bill to the current Diet session so that the planned organization will start operation in fiscal 2015, the plan needs to be carefully examined through deliberations in the legislature to ensure that it will serve its intended purpose.
The plan is part of the administration’s call for improving competitiveness in the medical sector as a new growth industry for Japan. Behind the initiative is a concern that basic research at universities and other institutions is not well connected to product development by medical firms, and that government support for medical research has been inefficient due to lack of communication and coordination among the various ministries involved.
Under the plan, part of the government budget for medical research funding currently allocated separately to the Education, Culture, Sports, Science and Technology Ministry; the Health, Labor and Welfare Ministry; and the Economy, Trade and Industry Ministry will be combined under a new research promotion headquarters to be led by a Cabinet member. An independent administrative body also will be established under the auspices of the headquarters to engage in the distribution of public funds among universities and research institutions, improve the research environment and introduce research results to medical businesses.
Through the new system, the administration plans to pursue a top-down approach to identify priority areas of research that will receive government support. Officials have indicated that among the targets will be large-scale projects such as trials on new medicines to cure intractable diseases or clinical research using induced pluripotent stem (iPS) cells.
One of the challenges will be limited funding and manpower for the plan. The plan was billed in its draft stage as creating a Japanese version of the United States’ National Institutes of Health. But the size of the budget allocation for the new system will be a far cry from that of the NIH.
Unlike the NIH, which is the primary agency of the U.S. government responsible for biomedical and health-related research, the new Japanese organization will have no research laboratories of its own and will basically work with existing universities and medical institutions to promote research.
Since the idea for the new system was unveiled last year, concern has been voiced from some academic circles that too much emphasis on commercial outcomes could result in neglect of basic research done on the free initiatives of researchers. Pursuit of commercialization of medical research also must not sacrifice safety assurance for new drugs or medical technology.
It needs to be carefully considered whether the government’s role in promoting certain projects could lead to bureaucratic rigidity in their identification as “national projects” irrespective of their scientific merits. Research can change course or stall depending on new discoveries, and flexibility for reassessing projects on scientific grounds will be needed as the government seeks to become more actively involved in medical research.