The National Bioethics Committee (hereinafter referred to as the Bio Committee) was launched on the 23rd of last month. The National Bio Committee serves as the highest decision-making body for the bio field, overseeing policies related to the bio industry and research and development (R&D). It will organically connect related ministries and agencies, including the Ministry of Health and Welfare, the Ministry of Science and ICT, and the Ministry of Trade, Industry and Energy, and will play a role in consolidating public and private sector capabilities across all areas of bio, including health and medical care, food, resources, energy, and the environment.
The domestic bio industry has high expectations for the launch of the National Bio Committee. The bio industry faces stricter regulations compared to other fields. Given the significant impact the bio industry has on public health, regulation is indeed necessary. However, technologies that are already recognized as scientifically safe are often not permitted in Korea or face such strong restrictions that they hinder business.
Lee Sang-yeop, a leading authority in synthetic biology and metabolic engineering and the vice president of Korea Advanced Institute of Science and Technology (KAIST), has been appointed as the vice chairperson of the National Bioethics Committee. During a meeting at the KAIST campus in Daejeon on the 11th, Vice Chairperson Lee acknowledged this sentiment. He emphasized, "We have received many opinions from the industry, and the first task the National Bio Committee will discuss is regulatory improvement."
He said, "Technologies such as stem cells and gene therapies are extremely important, but the industry is somewhat lagging behind, as people are going to Japan for gene therapy." He continued, "To prevent these issues, we are looking to proactively examine what the problems are."
Japan has preemptively nurtured next-generation technologies such as stem cells and gene therapies, building global competitiveness. The number of patients who visited Japan for cell therapy in 2022 reached over 73,000. In 2014, Japan enacted legislation allowing cell therapies to be administered without restrictions in medical institutions, and the scientifically low-risk cell therapies were designated as "advanced regenerative medical products," allowing procedures to be conducted even before obtaining approval.
Korea has been hindered by regulations, leading to a brain drain of specialized personnel and a lack of new treatment approvals in the past decade. Starting this month, Korea will implement amendments to the "Act on the Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals" (the Advanced Regenerative Medicine Act), easing some regulations. The amendment allows the use of cell therapies and gene therapies for treatment purposes even in clinical stages.
While Vice Chairperson Lee emphasized the importance of improving regulations for the bio industry, he noted that it would not lead to indiscriminate regulatory changes. He pointed out that "the balance between regulation and promotion" is the most important factor.
Vice Chairperson Lee said, "Regulation and promotion need to be well balanced," adding, "especially in the red bio sector (biopharmaceutical industry), where dealing with human bodies means that if adverse effects arise from indiscriminate approvals, no one can take responsibility." He stressed that it shouldn’t turn into a gamble with the lives of citizens, emphasizing the need for a regulatory perspective guided by scientific evidence as the basic policy.
He also expressed a willingness to improve regulations on genetically modified organisms (GMO) and gene-edited organisms (GEO). GMOs and GEOs utilize technology to manipulate the genes of living organisms to obtain desired characteristics. They are gaining attention as next-generation technologies primarily in the pharmaceutical, biochemistry, and agriculture fields.
Vice Chairperson Lee said, "Due to issues with communication at the time of GMO's introduction domestically, many misunderstandings about safety have accumulated. While there are fields that require regulation, the problem is that there are absolutely no promotion policies."
He also expressed his intent to prioritize regulatory relaxation regarding gene editing methods that remove genes using CRISPR technology, due to its high safety. He stated, "We will gather experts from various fields, including the scientific community, to build consensus, and improve regulations through communication with the public."
He also presented a plan to secure indispensable technologies in the bio industry through basic research and development (R&D). He introduced a term, "NFTIPS (Non-Fungible Technology, Industry, Products, Service)" to denote the concept of indispensable technology and stated he would support the development of new technologies that other countries do not possess in the bio industry.
Vice Chairperson Lee remarked, "The recent tariff controversy in the U.S. and the sluggishness of the petrochemical industry, all stem from Korea's inability to possess indispensable technologies," stressing, "Just as there is no country that can replace Korea in the semiconductor industry, we must also achieve this capability in the bio industry."
In response to concerns that there are fewer industry officials than science and technology officials among the Bio Committee members, he stated that they would increase industry participation through subcommittees, special committees, and advisory bodies established under it. He mentioned, "We are also envisioning advisory bodies composed entirely of industry commissioners, and we will prioritize listening to the voices of the industry and reflecting them in policies."
Vice Chairperson Lee said, "The first goal of the Bio Committee is to achieve two visible outcomes within this year," adding, "We will create changes that the industry can feel with the establishment of the Bio Committee and foster an environment where more suggestions can be made in the future."