The Ministry of Health and Welfare promulgated the Regulations on the Implementation or Use of Medical Instruments for Examination Concerning Specific Treatment Technologies (hereinafter, the “Regulations”) as amended via the Wei-Bu-Yi-1071665803 Directive of September 6, 2018. Consisting of a total of 34 articles, the Regulations came into effect on the day of their promulgation except for Articles 23 through 27, which will come into effect on January 1, 2019. The highlights of the amendments pertain to relevant regulations of “autologous cell therapy” as discussed below:
For starter, Article 2 of the Regulations define the “cell therapy technology” as the technology for reconstructing the structure or functions of human body or for treating illnesses through blood transfusion, the use of blood products, bone marrow hematopoietic stem cell transplantation, peripheral blood stem cell transplantation, or artificial reproduction of human cell tissues and other human cell tissues which are not items announced by the central competent authority and which use unconjugated drugs.
In addition, Article 12 of the Regulations provides for the application procedure for implementing a cell therapy technology. To wit, a medical institution shall formulate an implementation plan and obtain an approval from the competent authority before the cell treatment technology may be implemented. Article 15 of the Regulations also stipulates that if the cell therapy technology involves cell processing, cultivation and storage, there shall be a cell preparation site that meets relevant requirements for excellent operation of human cell tissues or a cell preparation site that meets relevant requirements shall be retained.
In addition, Article 16 of the Regulations provides that in addition to medical records, a medical institution shall prepare relevant cell treatment records separately, which shall be retained for at least ten years. When a patient receives a cell therapy, if an unexpected adverse effect takes place, the competent authority shall be notified within seven days upon knowledge of the fact. In addition, Article 18 of the Regulations provides that after implementing a cell therapy technology, a medical institution shall provide a report on the implementation results three months after the end of each fiscal year or within the period required by the competent authority.
Finally, it is worth mentioning that with respect to the other specific medical treatment technologies under Article 30 of the Regulations, the competent authority added the “microbiota transplant therapy” by way of a schedule. To wit, the intestinal microflora of a healthy donor can be implanted in the intestinal system of a patient to achieve a therapeutic effect by restoring the balance of intestinal bacterial colonies. At present, the treatment method is available to patients suffering from clostridium difficile infection which is recurrent or for which regular treatment is difficult. Any medical center or any regional hospital qualified as a teaching hospital with qualified operators, facilities or equipment may implement such technology after obtaining an approval from the competent authority of its registration application.