The government has set a goal of creating two global blockbuster innovative drugs with annual sales of more than 1 trillion won ($768 million) by innovating the biohealth industry and doubling exports in the biohealth sector.
To this end, it also will train 3 percent of medical school graduates as physician-scientists.
To support this product, the government will launch the Biohealth Innovation Committee, a public-private control tower, removing relevant regulations and providing field-oriented support.
The government decided to do so by holding the first Biohealth Innovation Committee meeting, chaired by Prime Minister Han Duck-soo, on Friday.
The Biohealth Innovation Committee was launched to leap to the global center of biohealth and secure global competitive advantages and wide gaps in the biohealth industry, as announced at a strategic meeting chaired by President Yoon Suk Yeol in February.
Its inaugural meeting discussed the operation plan of the BioHealth Innovation Committee, the R&D investment plan for biohealth innovation in 2024, plans to remove regulatory barriers for biohealth innovation, and strategy to foster physician-scientists.
Biohealth Innovation Committee to focus on substantive changes in the field
Based on the voices of the field, the committee plans to discover problems that government departments can solve together and solve them to the end. The committee will operate to become a panel that can bring practical changes and help the field by going beyond the rigid limitations of the existing committee.
Specifically, the committee will discuss supporting a comprehensive policy package that industrial sites can experience, creating innovation results by expanding excessive R&D investment, discovering new growth engines in the digital transformation era, fostering biohealth talents that drive the future, and building legislation and infrastructure to foster the industry.
Through this, the government and the private sector will combine their capabilities to achieve specific goals, including creating two global blockbuster innovative drugs with annual sales of more than 1 trillion won, doubling biohealth exports such as pharmaceuticals and medical devices, achieving 82 percent of the technology level compared to leading countries, building and opening 1 million bio research big data, and fostering 110,000 biohealth core talents to become a global center.
An expert advisory group under the committee and a working group between related ministries will be organized and operated to support this. The government will promote the preparation of a basic law for the biohealth sector to clarify the basis and role of the committee, currently stipulated by a presidential decree.
Committee will conduct various R&D projects
The meeting also discussed plans for biohealth innovation R&D investment. The Ministry of Health and Welfare has prepared a strategy to promote the “Korean ARPA-H Project effectively,” “Boston-Korea Project,” “National Integrated Bio Big Data,” and “Physician-Scientist Life Cycle Support Program, as major tasks for biohealth innovation R&D investment in 2024.
More specifically, it plans to promote challenging R&D worth about 2 trillion over the next 10 years through the Korean ARPA-H Project, which supports mission-oriented, challenging, and innovative research.
Through this, it plans to solve the five most urgent health challenges, such as health security and overcoming unconquered diseases, and to fundamentally improve people's health and quality of life by securing core technologies.
The Boston-Korea Project, a collaboration between three ministries -- the Ministry of Health and Welfare, the Ministry of Science and ICT, and the Ministry of Trade, Industry and Energy -- to secure super-gap technologies, will break away from the narrow domestic-centered R&D system and focus on research that utilizes the strengths of our bio-health ecosystem, including excellent medical personnel and data.
Through the National Integrated Bio Big Data Project, the three ministries and the Korea Disease Control and Prevention Agency will jointly build and open up bio big data, a key strategic asset for the future, to strengthen the innovation foundation of biohealth research and industry, including precision medicine, new drugs, and medical devices.
Accordingly, to establish 1 million bio big data, 770,000 participants will be recruited for five years in the first phase of 2024 to collect and link specimens and data.
Fostering 3% of medical school graduates to become physician-scientists
The government also proposed a full-cycle support system for medical scientists who can innovate the entire research and industry ecosystem.
First, a target level for the scale of physician scientist training was established. It will strengthen systematic cooperation among ministries to gradually expand the number of physician-scientists from 1.6 percent of medical school graduates to 3 percent, the level of advanced countries.
In addition, the government will expand support for undergraduate, resident, and full-time doctoral programs for physician-scientists and establish research support tracks for each stage of their careers to provide a stable and long-term support system.
To create a research ecosystem, it plans to lay the foundation for establishing a virtuous cycle of clinical, research, and biohealth industries centered on research-centered hospitals.
In particular, the government plans to initiate cross-ministerial discussions on improving various systems to foster physician-scientists and promote research.
Accordingly, it will review how to improve the military specialized research personnel system so that they can complete their doctoral programs and how to reduce medical treatment time and secure research time for physician-scientists.
To this end, it will establish a career-specific research support track to provide 92 physician-scientists with the opportunity to devote themselves to research every year and will set up the “Physician Scientist Training Office” to operate support programs systematically, such as global training and joint research.
Improving 7 'killer regulations' requested by the field
There was a consensus that the biohealth sector is a typical area where the system has not kept up with technological advancement and that speedy regulatory improvements are needed to secure competitiveness in the global market.
In response, the committee plans to play the role of a good offspring of regulatory innovation that scratches industrial site itch and continues to remove regulatory barriers.
To this end, it decided to establish the “tentatively named Biohealth Industry Site Regulatory Reform Yard” to collect voices from the field regularly and discover regulations restricting business activities while quickly resolving the discovered regulations through the committee.
At the meeting, seven “killer regulations” were identified among the recommendations consistently requested by the field, including rapid use of innovative medical devices and ensuring the value of new drug innovation, and participants discussed specific improvement measures.
First, it will improve the first-to-market and post-market evaluation system of innovative medical devices. Through this, it plans to continuously improve the innovative medical device market entry and post-evaluation system, including simplifying unnecessary administrative procedures to facilitate market entry of innovative medical devices, easing clinical trials, and temporary health insurance registration.
Regarding the reward for the innovation value of new drugs and stabilizing the supply of essential drugs, the government will give priority to the economic evaluation of new drugs, ease the conditions for preferential drug prices for pharmaceutical companies with a high proportion of R&D, provide preferential drug prices for the use of domestic raw materials for national essential drugs, and simplify procedures for cost conservation of drugs with insecure supply and demand.
Other measures include expanding patient access to advanced regenerative medicine, expanding permitted items for production in high-tech medical complexes, resolving export regulatory barriers through expanded global cooperation, improving the system to become a hub of biopharmaceutical contract manufacturing and revitalizing exports, and innovating digital (convergence) medical product approval and clinical trial regulations.
"Countries worldwide are already engaged in fierce competition at the national level to preempt the biohealth market, which will lead the future industry," Prime Minister Han said. "Through the Biohealth Innovation Committee, a joint public-private control tower, we will strive to achieve fundamental changes felt in the field and leap forward as a global center for bio and digital health."