The government has named stem cells and gene therapy as "K-regenerative medicine" and established a basic plan to advance regenerative medicine over the next five years.

Under the plan, the government will review all advanced regenerative medicine clinical research and link the area to state health insurance to accelerate the regenerative medicine field and national benefits.

These and other policies were decided at the first meeting of the committee to deliberate policies to advance regenerative and biopharmaceutical medicines, presided over by Health and Welfare Minister Kwon Deok-cheol on Thursday.

The participants also discussed and approved a basic plan, which contained the prospects and strategies for the next five years from 2021 to 2025 to develop the advanced regenerative medicine field.

Korea has announced its plans to foster the regenerative medicine field over the next five years. (Getty’s Image)
Korea has announced its plans to foster the regenerative medicine field over the next five years. (Getty’s Image)

Full cycle of advanced regenerative medicine clinical research to be put under state control

The basic plan calls for the government to establish a national screening and management system concerning all advanced regenerative medicine clinical researches and reinforce the safety management throughout the entire cycle from study plan review to follow-up management from 2021.

To this end, a central deliberation committee composed of leading experts will deliberate on the suitability of a research plan and systematically collect research performance data by establishing a clinical research information system.

The committee will also record and manage the entire process from collection to supply of human cells, which is the raw material for advanced regenerative medicine, through the clinical research information system.

If necessary, advanced regenerative medical safety management institutions will spearhead long-term follow-up investigations, such as health status, treatment efficacy, adverse reactions, of the research subject, during or after the research from 2023.

Expanding access to treatment by making a connection to health insurance

The government also prepared a plan to expand access to treatment and clinical research in advanced regenerative medicine.

To revitalize the advanced regenerative medicine clinical research, the government will reinforce the foundation for clinical research by gradually expanding the designation of regenerative medical institutions from the general hospitals to the local hospital level.

Also, through the implementation of a preliminary feasibility study, the government will redouble its current annual clinical research budget of 12 billion won ($10 million) after 2023 while providing insurance benefits for such treatments.

Notably, the authorities plan to gradually expand access to treatment for technologies with proven safety and efficacy through clinical studies from 2022.

The plan is to actively utilize the innovative medical technology system to support rapid entry of technologies that can enter medical procedures in hospitals and review methods that are acceptable as limited procedures within the regenerative medical safety management system.

Health officials also aim to revitalize various public and private patient support programs and expand national budget support to provide additional financial resources and expand treatment opportunities for the underprivileged.

The government will also enhance social trust in advanced regenerative medicine by providing accurate and transparent information to the public.

To prevent the spread of inaccurate information on advanced regenerative medicine, the authorities will establish and operate a public information portal.

They also plan to reinforce management by preparing guidelines for major illegal procedures that harm public health, provide them to local governments, and conduct inspections with local governments, local drug safety administrations, and health insurance review and evaluation agencies.

Working out professional review system for advanced biopharmaceuticals

Regarding advanced biopharmaceuticals, the government plans to establish a specialized review and management system through the Ministry of Food and Drug Safety from 2021.

Accordingly, health authorities will establish a new business specializing in human cells and a quality control system differentiated from existing synthetic drugs.

Besides, health officials plan to establish a specialized permit review system that meets the international level by expanding permits and review manpower, introducing a joint review system, and recording and managing information systems according to quality evaluation of products after marketing long-term follow-up surveys.

It is also planning to establish a follow-up management system suitable for the characteristics of regenerative medicine and a policy support system that can meet the rapidly changing speed of advanced regenerative medical technology.

In line with the plans, the government will cooperate with the Korean Society for Regenerative Medicine and Korea Human Resource Development Institute for Health and Welfare to prepare and operate an educational program for human resources participating in clinical research.

To support developers of advanced biopharmaceuticals, the government plans to provide an integrated window to receive companies' complaints while providing professional consulting services to promote local technologies' commercialization.

Government to set aside ₩595.5 billion for this project over next decade

To build an innovative ecosystem for promoting technology, health officials will organize and operate a working group between industry, academia, and government to establish a one-stop regulation and support system and invest 595.5 billion won over the next decade.

"The final goal of the five-year plan is to provide better treatment methods to the people suffering from rare and incurable diseases by developing new treatment technologies," Minister Kwon said. "Through establishing a safety management system that the people can trust, we will advance our technology to a world-class level in the next five years."

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