[New Wave] The Necessity of Enacting Vaccine Law for Advancing to the Top 5 Vaccine Powers

Published 17 Aug.2021 14:25(KST)

Jeong Yuntaek, Director of the Pharmaceutical Industry Strategy Institute

The government announced its plan to advance as one of the top five global vaccine powers, emphasizing the importance of vaccines in overcoming the COVID-19 pandemic and anticipating increased future vaccine demand. To this end, it unveiled the ‘K-Global Vaccine Hub Vision and Strategy’ and plans to invest approximately 2.2 trillion KRW in resources.

One of the major shifts in the future medical paradigm is the transition from treatment to prevention. Vaccines prevent diseases through human immunity, reduce severe cases and mortality rates, promote healthy lives, and help reduce medical expenses.

Recently, preventive and therapeutic vaccines for various diseases such as cancer have been developed, breaking previous stereotypes. The messenger ribonucleic acid (mRNA) vaccine platform introduced the concept of gene therapy into vaccines and successfully commercialized it. Vaccines are expected to play an increasingly significant role as innovative therapeutics in overcoming diseases.

Korea has also made efforts toward vaccine sovereignty through domestic production. However, among 28 vaccines?including 19 national (regular) immunization vaccines, 5 other preventive vaccines, and 4 vaccines for pandemic and bioterrorism preparedness?only 14 have achieved self-sufficiency. In past crises such as Severe Acute Respiratory Syndrome (SARS), novel influenza A (H1N1), and Middle East Respiratory Syndrome (MERS), vaccines received concentrated attention and support, but once the crises ended, they were repeatedly forgotten amid other issues.

The first reason for difficulties in securing vaccine sovereignty is a fragile ecosystem. There is insufficient participation from venture companies, manufacturing, and clinical trial outsourcing agencies, with a few companies handling the entire process from candidate material discovery to product development. The second reason is the severe shortage of shared research infrastructure and support centers compared to global companies. Lastly, companies avoid research and development (R&D) investment due to poor profitability caused by low domestic market prices, unstable supply and demand from declining birth rates, and high overseas dependence.

This is why the ‘Vaccine Act’ must be enacted to realize the government’s policy will. Based on past experiences, efforts to leap into the top five vaccine powers must be implemented through legal grounds. Although various laws such as the Infectious Disease Control and Prevention Act, Pharmaceutical Affairs Act, and Health and Medical Technology Promotion Act exist, a special law is necessary. The Vaccine Act should cover not only infectious diseases but also various diseases such as cancer, proposing measures to overcome diseases and expanding the National Immunization Program (NIP) for children to adults to alleviate future disease cost burdens.

It is also important to specialize the safety management system for vaccine side effects and approvals to establish an immediate and timely response system. Furthermore, to support research and development, the legal basis for establishing a Korean-style public vaccine development and support center should be included, drawing on operational examples such as the Vaccine Research Center (VRC) under the U.S. National Institute of Allergy and Infectious Diseases (NIAID), the Vaccine Research and Development Center (VRDC) under Taiwan’s National Health Research Institutes (NHRI), and Japan’s National Institute of Biomedical Innovation, Health and Nutrition (NIBIO).

To achieve the policy goals of the comprehensive plan for the next five years to become one of the top five vaccine powers, enacting the Vaccine Act as a special law should be considered to provide legal grounds not only for vaccine development support but also for comprehensive support and management.