China has monopolized global clinical trials in the field of genome editing technology that will dramatically change the bio industry, leading commercialization. With the China’s swift move, biotechnologically advanced countries, including the United States and Europe, have greatly eased gene-related regulations and are boosting efforts to research on commercialization. On the other hand, South Korea cannot even conduct basic research due to strict legal regulations, though it has global leading bio technology.
CRISPR-CAS9 is an enzyme protein that allows scientists to accurately cut off genetic segments that cause diseases. The segments that have been cut are replaced with normal DNA. It is considered one of the technologies that will bring innovation in the biomedical industry because it is so easy and accurate that anyone can use the technology if he or she gets a training session for few hours.
Citing clinical trial databases from the National Institutes of Health (NIH) in the U.S. on October 6, the journal Science said, “There are a total of ongoing 10 clinical trials related to CRISPER-Cas9 around the world. Nine out of the 10 are being conducted in China. The remaining clinical trial is for anemia treatment at the National Human Genome Research Institute (NHGRI) in the U.S.
Chinese scientists are applying the CRISPR-CAS9 technology to treat various incurable diseases ranging from leukemia to cervical cancer and acquired immune deficiency syndrome (AIDS). They are also testing a new technology that can deliver CRISPR-CAS9 on patients by applying it into the skin just like ointments to treat muscle pain for the first time in the world.
The journal Science said the Chinese government’s efforts to ease related regulations is a driving force of CRISPR-CAS9 technology commercialization. In China, any universities and hospitals can freely conduct clinical trials for gene editing technology when they get approval from their own ethics commissions. They can easily study basic research as well. China also succeeded in completing the CRISPR-CAS9 clinical trials on human fertilized egg in 2015 for the first time in the world. In the U.S., a research institute need to pass three stages of examination such as the NIH DNA advisory council, the Food and Drug Administration (FDA) and the Ethics Commission at the institute. It is true of Europe. Recently, the U.S. and Europe sought ways to relieve regulations for clinical trials and allowed CRISPR-CAS9 experiments on human fertilized egg for research purposes at the same time, prodded by China. Thanks to that, American and British scientists successfully cut off disease genes from human fertilized egg using the CRISPR-CAS9 technology in August and September.
In contrast, South Korea has led the development of the CRISPR-CAS9 technology along with the U.S. but lags far behind other countries in human studies and clinical trials. In early 2013, five research groups, including ones led by Professor Kim Jin-soo from Seoul National University and Harvard University, developed the CRISPR-CAS9 technology at about the same time. Professor Kim jointly succeeded in removing disease genes from human fertilized egg using CRISPR-CAS9 with American scientists in August and also found out about the genetic function that is essential for a fertilized egg to grow into a fetus in cooperation with British scientists in September. Kim said, “South Korea’s bioethics law prohibits from manipulating genes in human fertilized egg so we carried out all the experiments in other countries.”
With strong resistance from scientists, South Korea is also trying to reform the system. On the 11th, Shin Yong-hyun of the People's Party proposed a revised bioethics law that changes a positive method that labels which certain genetic treatment areas are allowed to a negative method that decides which areas are not allowed. The government has also decided to hold a biotechnology policy commission meeting under the presidency of Minister of Science, ICT and Future Planning Yoo Young-min on the 27th to give positive consideration to easing genome editing technology-related regulations. Professor Lee Dong-ryul from CHA Hospital said, “We are conducting all the clinical trials for human embryonic stem cell cloning and treatment in the U.S. It is time to relax regulations that tightens the bio industry.