부산대학교 도서관

On September 6, 107, the Ministry of health and welfare issued the revised provisions of the regulation of the measures for the administration of the implementation or use of special medical technology inspection and medical instruments (hereinafter referred to as the 'special measures'), in the hope of providing a new method of medical treatment for terminal cancer and special needs patients as early as possible. The purpose of this study is to understand the cognition and needs of patients and their families as the core, and how the regulation guide the development of the cell therapy industry, and to facilitate the cooperation between the hospital and the biotechnology industry, so as to open up a more comprehensive regenerative medical industry, and thus become a biotechnological center in Asia. In this study, 317 questionnaires were collected to investigate the cognition and demand of the respondents for the “special measures”. In addition, in-depth interviews were conducted with experts to examine the possible direction of the development of the “special measures” and the regenerative medical industry in Taiwan from different perspectives. The results show that, compared with Europe, the United States, Japan and China, the “special measures” is a legislation that reproduces the reality and future development. The health care system of Taiwan adopted two-track legislation to have medical technology implemented prior to that of medical products. This can accelerate the upgrading of industrial technology of cell therapy, in addition to fulfill the patients’ needs for early access to advanced treatment. However three key issues need to be paid attention to, which includ the delay approval of qualified treatment institutions under “special measures”, the high cost of treatment, and how to deal with medical disputes. The research of this study affirms that the 'special management' is a dynamic and advanced medical regulation, which can effectively promote the cooperation of industry and medical sector, in addition to giving early access to patients in need. In the future to speed up Taiwan's biomedical industry to become a world-class player. At the end of this study, four suggestions are raised to the competent authority as the reference for decision-making and implementation: first, it is necessary to accelerate the approval for the medical centers; second, it is necessary to help reduce the cost of the bio-companies to further reduce that of patients; third, it is necessary to strengthen advocacy and publicity; and finally, it is necessary to strengthen the mechanism of compensation for the medical accident of patients. As there’s no actual case published since the implementation of “Special Measures”, the effectiveness remains unclear. Researchers can look forward to follow-up on the basis of empirical cases to see if the legislation of“Special Measures” and the regenerative medical regulations of Taiwan work well in a more systematic way!