In this Century, globalization has led to a very fragmented and fragile status of the world affairs, which in essence, have become 'Uncertain' with a new paradigm. This is due in part to rapidly advancing digital technology that seemingly follows the 'Moore's law'. Economic growth of OECD countries became stagnant, while world capital increased dramatically and the income disparity widens. Many now vividly see world affairs, excited, communicate and respond via smart phones. Arab Spring which began December 2010 to ISIS now, Tohoku Disaster-Fukushima nuclear accident of 2011, Ebola and many other major disasters are all captured wide viewers of the world. 'Innovation' is defined as 'creation of new social values' in this Uncertain Global World. Physical distance of the globe became shorter and information and capital move freely across any national boundaries in seconds. Corporate and NGOs became global and ignore national boundaries. While the nation state is a concept of past few centuries in Europe, our Uncertain Global World seems the beginning of the end of the nation state with the major issues being 'global'. Innovation came often than not, by out-of-norm compassionate thinker-doers. It is essential to embrace and value diversity and heterogeneity as innovation disregards national regulations and boundaries with faster and cheaper connecting world talents who share common goals.

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This special issue looks at the inconsistencies between law, regulation, and institutions on healthcare and promoting medical innovation, from the viewpoints of various professionals. First, this paper explains the factors fundamental to this issue. We then look at the agenda behind the promotion of medical innovations. The science and technology policy for medical sciences seeks to promote R&D, but the issue is that these innovations do not percolate to the general public, which is starved for access to latest medical care. Healthcare services inherently require more stringent safety standards, efficiency and equality-in-access. This paper discusses the economic characteristics of healthcare services, the contents and evaluative mechanisms of the national healthcare insurance system, the relationship between progress of medical technology and healthcare expenditure, the tradeoff between physical accessibility and economic accessibility to medical technology, and the inconsistencies between the science and technology policy for medical sciences and the healthcare policy.

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Since 2003, a number of policies and reforms have been implemented in relation to the promotion of research and development in the field of medical science. In the process of applying cutting-edge science and technology to society, clinical research, which is expected to produce findings that lead to social impact, is particularly important, but there are many challenges in Japan. Currently, clinical research is being globalized and conducted through international collaboration; it is necessary in Japan to standardize and introduce transparency to clinical studies as well as to develop infrastructure for enhancing them. The same is true when trying to spread new medical technology within Japan. Thus, there are "death valleys" between cutting-edge medical research and medical service. In April 2015, a new incorporated administrative agency, the Japan Agency for Medical Research and Development was launched to play the central role in implementing, supporting, and managing R&D in the medical field. It is expected to be instrumental in solving a variety of problems. It is inevitable to keep the function of Analysis and Research for evidence-based funding within this organization or, if necessary, to outsource them.

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I analyzed regulations and systemic burdens that act as barriers against the conduction of innovative drug/device development and against the promotion of high-quality clinical research and trials. Taking into account the wide range of these issues, I will propose a plan that will allow for both the promotion of innovation, clinical research, and clinical trials and the maintenance of the national healthcare system. By urgently completing this process of comprehensive systems-based planning, I hope to realize futuristic medicine (precision medicine and personalized medicine), which allows for genetic information to be used freely while maintaining the structure of the national health care system.

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The relationship of biomedical innovation and health care system including public health insurance is of critical significance, although this topic has not been discussed sufficiently in Japan. Currently, health care expenditures are growing very rapidly with aging population and the cutting-edge frontiers of scientific research are going into the domains of life sciences. In this article, the relationship of biomedical innovation and health care system is explored from broad perspectives with major attention to the cost-effectiveness of health care, allocations of health care resources and the sustainability of health systems.

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It is necessary to evaluate health technology from a multi-disciplinary point of view in relation to policy decisions in publicly-financed health care systems. Originally, health technology had been evaluated from clinical perspectives. As the various outcome measurements such as QOL were invented, the needs of economic evaluations were counted and equity in the allocation of healthcare resources were considered, social value judgements as well as scientific judgements have become very important. HTA encompasses several processes: analysis of the values of the health technology, an appraisal of analysis and policy judgements. In this article, social value judgements are discussed in detail in relation to each process of HTA. Adoption of one particular methodology sometimes brings with it implicit value judgements. This includes adoption of effectiveness measurements and the scope of cost considered. In the appraisal process, equity considerations are always issues. However, equity considerations are on a case-by-case basis, rather than based on objective evidence from social science. HTA is a newborn area in Japan. We need to establish methodologies considering implicit value judgments. Also, analysis of public preference and public discussions are necessary to capture social values.

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The environment of business development on regenerative medicine in Japan was drastically changed by the Pharmaceuticals and Medical Devices, etc. Act and the Regenerative Medicine Act that were enforced on November 25th, 2014. In parallel, the situation surrounding health and medical innovation in Japan is also changing. In this article we interviewed Professor Ryuichi Morishita, a member of the Council for Regulatory Reform, to discuss the trend of medical regulatory reform in Japan.

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