The year 2024 has been turbulent for the healthcare industry, marked by ongoing conflicts between the medical community and the government over a policy to increase medical school admission quotas by 2,000. Tensions escalated further with the Dec. 3 martial law debacle. Many sectors within the healthcare industry faced significant challenges, with some reporting their worst year on record. Here, we highlight the top 10 healthcare news stories that defined this year. -- Ed.
The Korean biotech industry sees 2024 as the “year of advanced regenerative medicine.”
On Feb. 1, at a plenary session, the National Assembly passed an amendment to the Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals, or simply the Advanced Regenerative Bio Act. The revised law will be enforced from February 2025.
The revised act's core goal is to expand access to advanced regenerative medicine treatment opportunities. Patients with severe, rare, and incurable diseases who were previously only available to clinical trial participants will be able to receive treatment. In addition, cell and gene therapies in the clinical trial stage can be used for therapeutic purposes with the review committee's approval.
The biotech industry, including CHA Biotech, GI Cell, and CGBio, welcomed the news. “It will accelerate the clinical trials of therapies under development, including immune cell therapies, and shorten the commercialization period,” CHA Biotech said.
The industry also presented tasks to tackle. Safety and quality control were cited as top priorities. They called for prioritizing pipelines with proven safety in clinical trials and establishing a quality management system.
The medical community argued that review boards need to strengthen their expertise. They also suggested that clinical insights should be incorporated from the research design stage through collaboration with disease-specific experts.
The government has pledged institutional support for the development of advanced regenerative medicine.
The Ministry of Health and Welfare said it is investigating customized treatments using autologous cells and cost-mitigation measures for patients with rare diseases. Its goal is to provide more treatment opportunities for patients through flexible regulations and support that reflect the specificity of research and treatment.
Patient organizations have called for support from the government and society to ease the burden of treatment costs. Industry executives have presented views that improving reimbursement criteria for treating patients with rare and difficult diseases and expanding coverage are necessary.
Amid the challenges of securing safety, quality control, and easing the cost burden, the revised Advanced Regenerative Bio Act is expected to mark a new era in the development of the domestic biotech industry.