첨단재생의료법안 도입의 주요쟁점

Issues in the Introduction of the Advanced Regenerative Medicine Act

The Advanced Regenerative Medicine Act includes both support and regulations, focusing on the implementation of advanced regenerative medicine(ARM). This is the result of considering that it is an industrial sector that needs to enhance national competitiveness and also an advanced medical sector that has unknown risk. Comparatively reviewing the ATMP Regulation(EU), Regenerative Safety Act(Japan), and 21st Century Cures Act(US), some similarities can be found, although the regulatory situations in each country are not the same. They share the problem that regulations such as clinical trials based on conventional drugs cannot properly regulate ARM. Therefore each country has developed new regulations and introduced new concepts such as ATMP, regenerative medical technology, and the Regenerative Advanced Thermography. It is also similar to the fact that the government does not rely solely on the role of regulators, but rather on the role of an expert group in the field of ARM. Although the role of expert groups in each country s regulatory system is different, they are required to play a certain role in deliberating such matters as scientific validity, safety and ethics on ARM and establishing regulatory standards. The proposed ARM Act is similar in this respect. The Act provided that the concept of ARM, and that the providing ARM could be carried out through the deliberation of a group of peer experts. The Act also provides risk-benefit analysis based on the risk of ARM and sets different procedures depending on the degree of risk. Furthermore, it is assessed that a regulatory system has been prepared to ensure the safety of all processes from before implementation to after. However, legislation alone does not solve the problem of regulating ARM. However, the fact that specific policy details and procedures should be determined by this purpose is an issue that needs further study.