[Bio Story]①"Connecting Research, Approval, and Market Entry"... The Innovation Committee's First Hospital Director Gives a Field Diagnosis

Interview with Kim Yongwook, Director of Gangnam Severance Hospital ①


Joined the Investment Strategy Subcommittee of the National Bio-Innovation Committee

"Controlling the entire process—from regulatory approval to overcoming market entr

"When it comes to getting a single new drug candidate to patients, research, regulatory approval, and market entry all operate independently. I believe there is a clear role for hospitals in connecting these stages," he said.

Kim Yongwook, Director of Gangnam Severance Hospital, explained the background of his participation in the National Bio-Innovation Committee (the Innovation Committee) during an interview with this publication at Gangnam Severance Hospital in Gangnam-gu, Seoul, on June 30. Director Kim is serving as a member of the Investment Strategy Subcommittee on the Innovation Committee. The Innovation Committee was launched in April by integrating the previous National Bio Committee and the Biohealth Innovation Committee into a single body. This unified the bio-policy functions, which had previously been divided between the two committees, into one control tower. The Prime Minister serves as chairperson, and the ministers of 16 government departments participate as ex officio members. There are also 27 private sector members.

Kim Yongwook, Director of Gangnam Severance Hospital, is responding in an interview with this publication. Photo by Dongju Yoon

The driving force behind this major structural change lies in the longstanding structural fragmentation of the Korean bio industry. Until now, basic research has been handled by the Ministry of Science and ICT, industrialization by the Ministry of Trade, Industry and Energy, and clinical approval and reimbursement by the Ministry of Health and Welfare and the Ministry of Food and Drug Safety. For a technology in one field to reach the market from the research lab, it had to undergo new reviews and budget procedures each time it changed ministries. Even after research was completed, approvals could stall, and even with approval, reimbursement was often not provided. Director Kim commented, "Research, clinical trials, and commercialization all become disconnected," adding, "The Innovation Committee can address the entire cycle from R&D to market entry at a single table."

Beyond Advisory to Decision-Making Power... "A Driving Force to Overcome Ministerial Silos"

The government and industry are also placing high expectations on the Innovation Committee to fulfill its role as an integrated control tower. Director Kim said, "If previous organizations focused on providing advice, this time there is a clear intention to proceed to direct implementation through decision-making." While the previous organizations also included relevant ministers, the key difference now is the authority. With its elevation from a simple advisory body to a decision-making entity, the committee now has real momentum to overcome ministerial silos, according to his analysis.

Director Kim explained that this intention of the Innovation Committee is reflected in its meeting operations. Directors from each ministry attend the subcommittee meetings, and when issues such as investment strategies or regulatory matters are raised, they are addressed on the spot. The frequency of meetings has also changed. Unlike previous organizations, which met only once or twice a year, the new Innovation Committee is set to operate on a regular basis, with meetings scheduled every two months.

The changes proposed by the Innovation Committee are focused on addressing the issue most keenly felt at the industrial frontlines: the speed of market entry. Key initiatives include reducing the insurance listing period for rare disease treatments to within 100 days, establishing new reimbursement systems for AI and digital therapeutics, and easing regulations on the use of medical data—measures that are expected to have a tangible impact in the field. The regulatory rationalization roadmap includes 24 tasks, such as promoting advanced regenerative medicine. Until now, domestic bio companies that obtained approval from the Ministry of Food and Drug Safety often could not generate revenue because reimbursement systems were not established. The committee aims to resolve this bottleneck by linking approval and reimbursement in a single streamlined process.

The regulatory philosophy surrounding technology adoption has also come under scrutiny. Director Kim pointed out that the government has relied on a 'positive regulation' approach that only permits what is explicitly specified by law, stating, "In clinical settings, a more relaxed, negative approach—where entry is allowed first and oversight comes later—is needed." He explained that in a system where it takes years for new devices and treatments to reach commercialization, the very survival of companies is threatened. As a member of the Innovation Committee, Director Kim emphasized his commitment to contributing to the industry ecosystem. "Hospitals are the last gateway where research outcomes are translated into actual treatments and products," he said. "This is precisely where regulatory barriers are felt most acutely on the ground." He added, "It is our role as committee members to report and resolve the bottlenecks encountered in the field to the Innovation Committee."

This content was produced with the assistance of AI translation services.