Stem Cell Laws in South Korea

Gong, J. R., Lee, D., Lim, K.-M. and Bae, S. (2020). Are newly evaluated drugs more likely to receive positive reimbursement recommendations in South Korea? 11 years of experience with the South Korean positive list system. Blinking. Ther. 42 (7), 1222-1233. doi:10.1016/j.clinthera.2020.05.006 Kim, M. (2005). An overview of the regulation and patentability of human cloning and embryonic stem cell research in the United States and anti-cloning legislation in South Korea.

Santa Clara Computer and High-Technology Law Journal, 21, 645-714. In South Korea, human stem cell research has been ongoing for many years. It was supported by the South Korean government, like other biomedical research. As in many other countries, human embryonic stem cell research, human adult stem cell research and iPS cell research were conducted in South Korea. The Bioethics and Safety Act is the most important piece of legislation governing human stem cell research. It entered into force on 1 January 2005. However, this law does not cover all areas of biomedical research and some provisions were not clear. After the Hwang scandal, there were heated debates over the revision of the law on bioethics and security. It has been revised several times and a new revised version is being revised.

An earlier version of this story stated that in South Korea, gene-editing tools such as CRISPRâCas9 cannot be used in cells inserted into humans. In fact, they can be used in cells introduced into the body, but under limited conditions. “We urgently need to revise relevant laws and institutions,” Jin-so Kim, a genomics engineer at the Institute of Basic Sciences in Daejeon, South Korea, said at the forum. He says the regulations were made before researchers started using gene-editing tools like CRISPRâCas9. In South Korea, such tools cannot be used in embryos, and only in extremely limited cases can they be introduced into the body under conditions that researchers consider impossible to fulfill. Given the technology`s potential to treat a range of diseases, clinical and embryonic testing is needed, he says. Gene-editing experiments on human embryos have been conducted in a number of countries, including China, the United States, Sweden and the United Kingdom. Takashima, K., Morrison, M., and Minari, J. (2021). Reflection on the enactment and impact of safety laws for regenerative medicine in Japan. 16 (6), 1425–1434.

doi:10.1016/j.stemcr.2021.04.017 For ethical discussions on research on somatic cell nuclear transfer between species, see Skene et al. [4]. Feng, Q., Lu, S.-J., Klimanskaya, I., Gomes, I., Kim, D., Chung, Y., et al. (2010). Human-induced haemangioblastic derivatives of pluripotent stem cells show limited expansion and early senescence. Stem cells, 28, 704-712. Lloyd-Williams, H., & Hughes, D. A. (2021).

A systematic review of economic evaluations of advanced therapy medicinal products. Br. J. Clin. Pharmacol. 87 (6), 2428–2443. doi:10.1111/bcp.14275 Lysaght, T., and Sugii, S. (2016). Uncertain monitoring of regenerative drugs in Japan under ASRM. stem cell 18 (4), 438-439.

doi:10.1016/j.stem.2016.03.007 In 2014, Lee1`s group reported cloning of human embryonic stem cells. However, the work was conducted at CHA`s satellite facilities in Los Angeles, California, using eggs collected for donor research purposes in the United States, where there are no federal legal restrictions on embryonic stem cell research. Lee wants South Korean laws changed so that Korean researchers can work with fresh donor eggs. Stem cells produced by cloning adult humans 2014-Apr-28 Sipp, D. (2015). Conditional approval: Japan lowers the bar for regenerative medicine products. Cell Stem Cell 16(4), 353-356. doi:10.1016/j.stem.2015.03.013 Jung, K. W. (2009). Perspectives on human stem cell research. Journal of Cellular Physiology, 220, 535-537.

More than a decade after a stem cell research fraud scandal rocked South Korea, scientists in the field are increasing pressure on the government to relax the country`s strict regulations on human embryo research — what many researchers are calling a ban. Jung, K. W. (2000). A legal discussion on the cloning of human embryonic stem cells by somatic nuclear transfer technique. J Korean Bioethics Assoc, 1, 21–39. South Korea has tried to restore its tarnished image on the ground after one of its stellar stem cell scientists, Woo Suk Hwang, convicted of embezzlement and bioethics violations in 2009 after falsifying results, was killed. The country has begun to regain trust through a series of successful research projects and is among the top ten research in the world on stem cells and regenerative medicine in terms of the number and quality of publications. The South Korean government believes the country can be a leading global competitor if the field receives enough support.

Hinrichs, C. S. and Rosenberg, S. A. (2014). Harnessing the healing potential of adoptive T-cell therapy for cancer. 257 (1), 56-71. doi:10.1111/imr.12132 “From the current atmosphere and research infrastructure, the government has estimated that stem cell studies are maturing now,” said Hyung Min Chung, chairman of Seoul-based biotech company Cha Bio and Diostech and an advisor to the budget plan. He adds that his company is particularly pleased that the government`s investment decisions to develop stem cell-based therapies are being made more quickly. In 2004, Woo Suk Hwang, then at Seoul National University, claimed to have made human stem cell lines from cloned human embryos. In response to public debate, a year later, in 2005, South Korea`s Bioethics and Biosafety Act came into effect, limiting research on human embryos to scientists licensed by the National Bioethics Commission. Initially, Hwangs was the only team to receive approval.

Then, in 2006, Hwang`s results turned out to be false and he was later convicted of embezzlement and bioethics violations, such as.dem buying human eggs in violation of the Bioethics Act. Takahashi, K., Tanabe, K., Ohnuki, M., Narita, M., Ichisaka, T., Tomoda, K., et al. (2007). Induction of pluripotent stem cells from adult human fibroblasts by defined factors. Cell, 131, 1-12. For more details on these types of human stem cell research, see Jung [2]. But many are still wary of these therapies. “Since the approval of three stem cell products last year, which I think surprised many industry observers, international attention has focused on what is happening in the Korean regenerative industry,” says Douglas Sipp, who works on stem cell policy and ethics at the RIKEN Center for Developmental Biology in Kobe.