Prime Minister Han Duck-soo Presides Over 1st Innovation Committee Meeting
Discusses Operational Plans and Investment Strategies
Regulatory Improvements Expected to Be First Step
The long-awaited pan-ministerial industry promotion control tower, the 'Biohealth Innovation Committee,' which has been a hope for the pharmaceutical, bio, and healthcare industries, has finally set sail. Starting with the abolition of the '7 Major Killer Regulations,' which have been cited as obstacles to industrial development, attention is focused on whether it will address the industry's long-standing issues, such as presenting large-scale research and development (R&D) investment plans and training physician-scientists.
Prime Minister Han Duck-soo is delivering a greeting at the 1st Biohealth Innovation Committee held at the Government Seoul Office on the morning of the 22nd. [Photo by Yonhap News]
On the morning of the 22nd, the government announced that it held the 1st Innovation Committee meeting at the Government Seoul Office, presided over by Prime Minister Han Duck-soo. The meeting discussed the Innovation Committee's operational plan, including ▲measures to eliminate regulatory barriers ▲innovation R&D investment plans ▲strategies for training physician-scientists.
The Innovation Committee will first identify seven major killer regulations and proceed with specific improvements. The foremost among these is the market early access and post-evaluation system for innovative medical devices. Digital therapeutics (DTx) and artificial intelligence (AI) medical devices, even after approval, must undergo a de facto double approval process, such as new medical technology assessments, to be used in practice. Accordingly, the Innovation Committee plans to implement a system starting this month that allows non-invasive innovative medical technologies to enter and be used immediately in medical settings. Institutional improvements supporting substantial changes, such as establishing an innovation account, extending usage periods, and shortening publication periods, will also be carried out.
The irony that drugs that prolong patients' lives longer find it difficult to be covered by health insurance will also disappear. Currently, drugs like 'Enhertu' fail to pass the insurance reimbursement threshold because their incremental cost-effectiveness ratio (ICER) is higher than existing drugs. Going forward, drugs with such 'innovation' will be allowed to exceed the ICER threshold, giving preferential economic evaluations to innovative new drugs. Additionally, the scope of price premiums for domestic new drugs and the targets of risk-sharing agreements (RSA) will be expanded, actively responding to the industry's attempts at innovative growth.
Furthermore, regulatory improvements will be made to ▲expand patient access to advanced regenerative medicine ▲expand the list of permitted production items within advanced medical complex zones ▲resolve export regulatory barriers ▲establish contract manufacturing hubs ▲approve digital medical products. R&D investments for innovation, such as the Korean-style Advanced Research Projects Agency for Health (ARPA-H) and the Boston-Korea project, will also be carried out centered on the Innovation Committee. To lead future technology development, the goal is set to train physician-scientists at about 3% of medical school graduates, and inter-ministerial cooperation will be strengthened to achieve this.
The launch of this Innovation Committee is an achievement realized about a year and a half after President Yoon Suk-yeol's transition committee promised last April to establish an innovation committee directly under the Prime Minister. The Innovation Committee is composed of 30 members, including the Prime Minister as chairman, 12 heads of central administrative agencies, and 17 private sector members from various fields.
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