The Moon Jae-in government has embarked on a grand project to nurture the biohealth industry as a major growth engine that will help the nation become a global powerhouse.
The government said it would spend 4 trillion won ($3.35 million) a year for the biohealth sector by 2025 and get rid of regulations that hamper the growth of pharmaceutical goods, medical devices and healthcare services.
President Moon Jae-in announced the plan himself during a visit to Osong, North Chungcheong Province, which has a cluster of biotech research firms, on Wednesday. His announcement showed the government’s commitment to innovation in the biohealth sector, observers said.
|President Moon Jae-in unveils the government’s plan to support the biohealth industry while chairing a meeting at an industrial park in Osong, North Chungcheong Province, on Wednesday.
Building ‘bio big data’ of 1 million people
One of the major tasks is to build a “state bio big data” of 1 million people, with the recognition that the global biohealth market is developing based on customized treatments such as targeted therapies and that data is the key for medical technology innovation.
To do so, the government will collect genome information, records of medical service use and health status of people who wish to participate. The data will be safely stored in the National Biobank of Korea and utilized for research and development of customized new drugs and innovative medical technologies.
The government will designate “data-centered hospitals” to make use of massive clinical data accumulated separately at each hospital to study diseases and new drugs.
“Korea’s clinical big data at hospitals are larger than those of 5.5 million total population of Finland. We should make sure that these data can be safely used for new drug and medical technology development within hospitals without a leak. So, we will start building a standard platform from next year,” the Ministry of Health and Welfare said.
To make new drug development more efficient, the government will also construct a platform using artificial intelligence (AI).
The government is to support hospitals to become a base for biohealth R&D as well.
Hospitals with excellent R&D infrastructure will be able to install “Future Medicine R&D Leading Project Team” to support biohealth-based technology research.
The government will encourage hospitals to open up their R&D infrastructure to innovative tech firms and expand support for joint research by hospitals, universities, companies, and research institutions.
Investing ₩4 trillion a year for new drug development
The government said it would increase its spending on R&D for innovative medicines and medical equipment.
The government’s annual R&D investment in the biohealth industry will go up from 2.6 trillion won to 4 trillion won by 2025.
The government will set up “Investment-linked R&D” division that selectively invests in promising substances, jointly with a private venture firm, to make new drug R&D more successful. The pan-government R&D collaboration and joint planning will also be expanded.
The government is also to enhance financial and tax support for the biohealth sector.
The government will utilize “Scale-up Fund,” a 15 trillion won fund to support the development of a local blockbuster drug with annual sales more than 1 trillion won, to spend over 2 trillion won for the biohealth sector over the next five years.
Deregulating drug approval procedures
For local biohealth businesses to actively engage in the overseas market, the government would ease regulations to the level of international standards.
The government said it would shorten the period of approval for drugs and medical devices. With the deregulation, the government will enhance the expertise of reviewers in the new technology sector and hire more professionals. It will also make it easier for companies to predict the chance of getting approval through early consultations and fast categorization of items from the initial stage of development of convergence products.
The government also plans to improve the drug management system to meet the needs of suppliers of regenerative medicine and biological drugs that use cells and genes.
To promote the output of biohealth firms, the government will collaborate with leading companies, startups, and venture firms for open innovation.
Under the cooperation, promising technologies of startups will be combined with leading firms’ capital and global network. Based on this, both startups and leading companies will hold a joint briefing overseas, the government said.
Supporting new techs’ market entry
The government also plans to promote the use of new technologies such as digital healthcare service at clinical scenes, to enhance doctors’ medical care quality and patient satisfaction.
The government will help clear uncertainties over the entry into the digital healthcare market by giving patient monitoring guidelines for devices such as home automated peritoneal dialysis machines. It will also support R&D for efficacy verification of innovative products.
As the Medical Device Support Act and Invitro Diagnostic Device Act take effect in May next year, the government will prepare a comprehensive measure to promote innovative medical devices.
The government will introduce a certification system for advanced devices for the treatment of rare diseases and give favors in approval review. If a medical device is being developed with a pharmaceutical drug, the government will review the device and the drug simultaneously.
“With the advancement of biohealth technologies, we can effectively meet the growing medical needs in the era of the population aging,” Health and Welfare Minister Park Neung-hoo said.
As Korea has excellent power in information and communication technologies, hospital systems, medical data, and talents, the nation can become a global powerhouse by using the full potentials, Park added.
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