보건복지부 영문홈페이지

July 27, 2022

By Relevant Ministries

Summary

Ⅰ. Significance of the biohealth industry

Ⅱ. Areas for growth

□ Investment to foster biohealth industry

○ Limited investments in vaccine and treatment development

* (AstraZeneca) KRW 2 trillion vs. (Korea) KRW 257.5 billion for vaccines and KRW 155.2 billion for treatments (2020-2022)

○ Korea lacking global leading companies in the biohealth industry due to insufficient private investments and experience developing blockbuster drugs

□ Regulatory reform for convergence-driven industries

○ Licensing/authorization and regulatory reform critically required to ensure timely development of vaccines and treatments

○ Increase in innovative products and services (digital devices, AI in healthcare, etc.) that cannot be assessed with existing systems

□ Increasing demand for biohealth specialists

○ Sharply increasing demand for specialists in R&D, licensing/ authorization, and manufacturing in the wake of accelerated technological innovation and rapid changes in the industry (synthetic medicine → biomedicine; convergence healthcare devices such as AI-based devices)

□ Global competition over healthcare big data and R&D

○ Intensifying global competition to make biohealth big data, which serves as the foundation for biohealth powerhouses, and the rapidly growing digital healthcare market

Ⅲ. Key measures

1. Promoting biohealth investments to remain prepared for pandemics

󰊱 Continued support for vaccine and treatment development

○ Providing focused support for securing vaccine candidates and key technologies for future pandemic preparedness

- (Candidates) Prioritizing the development of vaccine candidates for viruses with pandemic potential (COVID, MERS-CoV, Zika virus, etc.) to ensure a timely rollout of vaccines upon need

- (Key technologies) Providing focused support to help reach challenging targets set for key technologies for infectious disease response (mRNA vaccine platforms, antiviral agents, and universal vaccines)

○ Providing continued support for COVID-19 vaccine and treatment development

- (Vaccines) Supporting clinical trials for vaccine development (6 companies) and providing aid for WHO’s vaccine EUL/PQ (Emergency Use Listing/Prequalification) and efficacy assessment of booster dose for the first domestically developed vaccine

- (Treatments) Supporting clinical trials of 18 items (17 companies) and domestic CMOs of oral treatments developed abroad for low- and middle- income countries (3 domestic companies granted the waiver of patent protections for the production of oral treatments)

󰊲 Promoting private investments in biohealth

○ (Korea) Providing support for licensing/authorization, location selection, and foundation-building, as well as offering increased tax deductions and financial aid, to achieve total private investments of KRW 13 trillion by 2026

* KRW 8.7 trillion for Samsung Biologics, KRW 1 trillion for Lotte Biologics, KRW 0.5 trillion for SKBs, and KRW 0.1 trillion for EuBiologics

○ (Overseas) Expanding incentives* to secure vaccine ingredients, relevant equipment, and manufacturing techniques while attracting investments from globally renowned companies (USD 300 million from Sartorius of Germany and USD 50 million from Cytiva of the US)

* Providing cash grants of up to 50% and allowing a government funding ratio of up to 50% (20%p↑) for technologies selected as National Strategic Technologies

󰊳 Expanding private-public investments (i.e., K-Bio and Vaccine Fund)

○ (Global mega-fund) Creating K-Bio and Vaccine Fund this year to invest in pharmaceutical and biohealth companies for the domestic development of new medicines and vaccines

- Raising a fund of KRW 500 billion in 2022 in collaboration with the private sector and planning to expand the total to KRW 1 trillion in the future

○ (New medicine development) Investing KRW 2.2 trillion (KRW 1.5 trillion of government funding and KRW 0.7 trillion of private funding from 2021 to 2030) in R&D for medicine pipelines (Phase 2 clinical trial for identifying effective substances)

2.Biohealth regulatory reform

󰊱 Improving regulations for AI-based and digital healthcare devices

○ (Rapid application to the front lines) Revising regulations to allow the use of non-invasive AI-based and digital healthcare devices after licensing (not covered or selectively covered by National Health Insurance)

○ (Shortened evaluation period) Drastically shortening the evaluation period, required for application to the healthcare front lines for administrative measures after licensing, from 390 days to 80 days

* Simultaneously reviewing innovativeness and safety in the stage of designation as an innovative healthcare device and streamlining the technological evaluation

󰊲 Setting the direction for transparent regulatory reform

○ (Customized fast-track system) Redesigning regulations* to reflect the traits of state-of-the-art industries such as digital technology and biotechnology and providing intensive and strategic support for global advancement

* A plan to set up a legal framework for relevant regulations, customized to digital health devices, including clinical investigations, pre-market authorization and manufacturing, etc.

○ (Regulatory reform roadmap) Focusing on achieving regulatory transparency in new industries that cannot be assessed with existing systems to identify predictable regulations and come up with a reform roadmap

○ (Regulatory sandbox) Establishing a regulatory sandbox exclusive for biohealth, which is directly related to the lives and health of the public and reflects the latest changes in technologies and services

󰊳 Clarifying healthcare data utilization systems

* Pushing ahead with the enactment of the law to promote healthcare data utilization

○ (MyData for healthcare) Creating the ecosystem* for the sharing and utilization of healthcare data through the introduction of the right to data portability (transmission of healthcare data to a third party is allowed with request of transfer of data subject)

* Comprehensive regulation (entry, action, and expulsion) for all institutions that receive and utilize data

○ (Big Data) To activating big data utilization procedures, clearly defining the targets whose data will be pseudonymized to encourage research and legally mandating the establishment of a data review committee for each intitution

3. Creating advanced biohealth infrastructure

󰊱 Supporting the development of biohealth materials, parts, and equipment by startups and SMEs

○ (Materials, parts, and equipment) Supporting the development of technologies and their commercialization by biohealth materials, parts, and equipment companies (e.g., selecting priority items for localization and supporting relevant R&D from 2020 to 2025)

○ (Startups) Operating the Korea Biohealth Innovative Startup Center (KBIC) to provide customized support throughout the entire process from consultation to licensing/authorization and investment attraction

○ (SMEs) Ensuring easier access to manufacturing and quality assurance model-applied facilities (High-tech medical complex, etc.) for SMEs with inadequate production capacity and providing support for high-quality product manufacturing

󰊲 Fostering frontline biohealth personnel

○ (Frontline personnel) Ensuring the supply of experts required by companies and creating quality jobs

- (Pharmaceuticals) Pushing ahead with the cultivation of frontline personnel for production, clinical trial design, relaying research, etc., such as biomanufacturing personnel (NIBRT*) (from 2025)

* Korean NIBRT (National Institute for Bioprocessing Research and Training)

- (Regulatory science) Fostering regulatory affairs specialists (medicine, medical devices, etc.) and experts with advanced degrees equipped with evaluation technology development capability

○ (Advanced specialists) Fostering advanced specialists such as experts in AI for medicine and physician-scientists

- (AI and regenerative medicine) Operating a convergence course that engages the medical field, engineering field, and hospitals and promoting project-type training based on on-site needs

- (Physician-scientists) Providing comprehensive career support for physician-scientists and those engaging in medical science

* Project to foster physician-scientists (undergraduate course-residency-doctorate course)→ Project to support new physician-scientists (post-doctoral course)

󰊳 Building ‘PHR highway’ for people-centered services

○ (PHR highway system) Laying the foundation for customized data utilization by safely integrating and relaying dispersed personal health record (2023)

* (Present) Considerable amount of time and effort required to access individual health data (collection of dispersed data) → (Revised) Obtaining necessary data in an efficient manner (healthcare information highway)

○ (MyData for healthcare) Expanding the scope of patient-led everyday health management and promoting the development of platform-based services for the public

󰊴 Establishing healthcare big data to secure infrastructure for precision medicine

○ (Big Data) Promoting public health by establishing integrated national biohealth Big Data, which is essential for precision medicine R&D

* Collecting clinical and genomics data and connecting medical records and personal information with individuals’ consent

󰊵 Supporting the development of devices and services based on the convergence of healthcare and digital technologies

○ Supporting the development of optimization technologies (AI-based patient classification and management system, etc.) and key technologies (digital therapeutic devices, electroceuticals, etc.) in preparation for the possible emergence of more pandemics

4. Stronger biohealth global cooperation

󰊱 Taking firm root as a successful biomanufacturing training hub for WHO

○ (Operating system) Building an efficient and stable operating system consisting of the joint steering committee of WHO and Korea, working-level group, and advisory group

○ (Training) Conducting training on the production process of vaccines and biomedicine for low- and middle-income countries and establishing the relevant facility (tentatively named the Global Bio Campus) from 2026

󰊲 Expanding cooperation with international organizations and other countries

○ (World Bio Summit) Hosting the international summit to bring together heads of state (under discussion) and global pharmaceutical companies to share our expertise built on our experience of tackling COVID-19 (Oct. 25-26, 2022)

○ (International cooperation) Reinforcing cooperation with the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations by joining the concerted international efforts to remain prepared for future pandemics (participation in the decision-making body of ACT-A*, etc.)

* ACT-A (Access to COVID-19 Tools Accelerator): A global coalition formed in April 2020 under the leadership of WHO and the Bill & Melinda Gates Foundation to accelerate the development and production of COVID-19 vaccines and treatments

Ⅳ. Way forward

□ Providing full support to ensure timely and prompt investments in private equipment, etc.

○ Coming up with a roadmap for regulatory innovation, rapidly reforming regulations that directly concern on-site needs, and resolving issues and difficulties through close communication with those on the front lines