The gist of the Bio-Health Industry Innovation Strategy announced by the Korean government on May 22 was to create an ecosystem in the entire cycle of the bio-health sector from R&D to licensing, manufacturing, and marketing.
The government is determined to nurture the bio-health sector as three future growth engines along with non-memory semiconductors and advanced cars. It plans to increase the global market share of Korean medicines and medical devices more than three-fold to 6 percent by 2030 from the current 1.8 percent and ramp up their exports to US$50 billion from current the US$14.4 billion.
First of all, the government has decided to create an environment where companies can freely focus on technology development. Five major big data platforms will be built as the foundation for bio-health innovation is data. The government has accepted the views of pharmaceutical companies that it is necessary to gather information about patients in order to treat unknown genetic diseases.
The core platform is the planned “National Bio Big Data.” The government plans to collect genomic, medical and health information from up to 1 million volunteers and use the collected information in developing patient-customized drugs. It will keep the collected information at the National Biological Resources Center. The government is planning to start the first phase of the project next year to collect information from 20,000 people by 2021. The whole project will be completed by 2029.
In order to utilize hospitals as innovation bases for a bio-health research ecosystem, the government has envisioned the establishment of medical technology cooperation groups and technology holding companies.
The government will significantly expand R&D investment and financial and tax support as well. It plans to dial up the amount of annual R&D investment in the biotech and healthcare sector to more than 4 trillion won by 2025 from 2.6 trillion in 2017. It will also provide 2 trillion won worth of policy loans a year for the next five years to Korean pharmaceutical companies to spur their development of new blockbuster drugs that can post more than one trillion won in annual sales. Regarding tax benefits, the government plans to expand the scope of tax exemptions from new drugs to biobetters, which refer to biological drugs that have the same target as the original biologics but are safer and more effective.
Also in the works is deregulation including shortening reviewing periods. The Ministry of Food and Drug Safety plans to double the number of reviewers within three years to shorten the time required for reviewing and permitting medicines and medical devices. Therefore, the reviewing period for approval of a new drug is expected to be shortened from the current average of 18 months to one year. According to the Ministry of Food and Drug Safety, the United States has up to 45 reviewers per biopharmaceutical item against Korea’s only five.
A high-priority and speedy review system will be introduced to facilitate market entry of innovative drug companies’ new drugs. The government has also decided to provide large-scale demonstration opportunities for products difficult to commercialize due to regulations by designating some specific areas as special regulation-free zones. Also on the drawing board is making obligatory short tandem repeat (STR) analyses and a long-term tracking and management system for patients who took advanced biopharmaceutical products.
Furthermore, the government will push forward with a plan to localize 30% of raw materials and equipment needed for biopharmaceutical production facilities within the next five years. Korea ranks second in production of biopharmaceuticals in the world but imports most of raw materials and equipment from consumables to production equipment.
Besides, the strategy includes how to export hospital systems, hospital information management solutions, medicines, medical equipment and stem cell plants among others which are positively recognized in the world for their excellence in packages.