This study aims to articulate the problems of current stem-cell-based products regulation in Korea, and to suggest some improvements for reasonable regulation.
According to the current regulation in Korea, stem-cell-based products are regulated main...
This study aims to articulate the problems of current stem-cell-based products regulation in Korea, and to suggest some improvements for reasonable regulation.
According to the current regulation in Korea, stem-cell-based products are regulated mainly as pharmaceuticals. Thus product approval is a necessary condition for using stem-cell-based products, and only few of them may be used without the approval. This line of regulation, however, gives rise to a few significant problems with respect to patients protection, the protection being a highly important regulatory value. First of all, the regulation at issue lacks measures for ensuring patients’ safety in that they can use a stem-cell-based product without the approval. Moreover, under this regulation patients’ right to choose treatments they want can hardly be respected enough because there is no procedure for them to consider the alternatives. Lastly, the strict approval system tends to hinder advances in stem cell research.
In order to solve these problems, I consider the regulatory frameworks in other countries than Korea with regard to the two prominent values, protecting safety and respecting patients’ right to choice. The United States flexibly regulates stem-cell-based products by means of the existing biologics and cell products regulatory system to meet both the values; however, this system has a weakness that it is based on the drug approval system rather than on one tailored to stem-cell based products. European Union introduced and established a novel regulation for stem-cell-based products. Despite its reasonableness on its own, however, it is difficult to apply it directly to the Korea because the two social and cultural systems are structurally different from each other. Japan is arranging a whole new regulatory framework to regulate stem-cell-based therapies. To ensure safety of stem cell therapies and promote stem cell therapies in general, Japan adopted new procedures and rules, revising the approval system for stem-cell-based products.
These different regulatory frameworks in other countries adopted different approval systems to enure safety of the products, and special committees to consult with expertise for reasonable regulation of stem-cell-based products. Based on examination whether each framework is applicable in Korea, this paper proposes a reasonable regulation for stem-cell-based products appliable in Korea, which involves improvement of approval system, quality control of stem-cell-based products, setting up a special committee and activating clinical trials.