Assessing Regenerative Medicine in Japan: an interdisciplinary approach
- Yoshimi YASHIRO
Professor, Kanagawa University of Human Services
The main objectives of the research on costs are as follows. Firstly, to collect via a uniform method basic data on development costs, manufacturing costs and clinical benefits as they are currently proposed within regenerative medicine research across a range of medical fields. Secondly, to bring together wide ranging calculations of economic the effects using input-output analysis in order to, thirdly, propose novel frameworks to accurately evaluate policies aimed at promoting innovations in regenerative medicine that take into account the perspectives of the public and the nation.
The year 2014 saw the first clinical trials of iPS cells transplanted into humans. In Japan, there have been very few First in Human medical trials, and hence these trials were received attention from all over the world. As a problem to be developed medical practice, researchers have studied safety and efficacy top priority. However, as a result of the research that we conducted earlier, the point that society considers as a problem while regenerative medicine is approaching clinical research is not only the risk but also the interest from the viewpoint of cost and medical expenses is growing. In this regard, as research expands the realm of what is technically possible, the different beliefs concerning the medical costs held by the research community and the wider public may become a barrier to achieving broad acceptance of new, innovative technologies that will affect the society and its values about life. In terms of RRI, which has been looked at closely over recent years, researchers and policymakers must bear the responsibility of providing explanations to the community in light of its needs, and should provide information to society about the image of these technologies after they have been made possible so that regenerative medicine might be more easily accepted. The term ‘regenerative medicine’ of course entails a number of different approaches, and there have not been many studies that have looked at all the relevant costs involved or which have performed cost-benefit analyses. Accordingly, we decided to pursue research that would look in detail at the costs of regenerative medical technologies from their earliest stages, that would consider how insurance systems might sustainably provide regenerative medicine to the broadest section of society possible, and that would look for policies to expand the scope of the regenerative medical industry and extend the impacts of regenerative medicine across society as a whole.