TOKYO -- After lagging far behind European countries and the United States on COVID vaccine development, Japan has set about amending regulations that previously slowed it down, with renewed strategies to be unveiled in March.

Five years have passed since the coronavirus pandemic began. Japan has lost momentum in creating conditions to confront unknown infectious diseases with domestic technology. Will the regulatory revisions make any difference?

Regulations that inhibited research and development

On Jan. 30, 2020, the World Health Organization (WHO) declared COVID-19 a pandemic. Researchers at one Japanese company were frustrated. At the beginning of the month, Chinese authorities had released the entire genome of the novel coronavirus, and the researchers were on the verge of commencing vaccine development.

However, they were unable to get off to a running start as they had to conform to procedures in line with the Cartagena law, which aims to prevent the spread of genetically modified plants and animals. The law had drawn attention following the arrest in 2023 of five men suspected of the unauthorized breeding and sale of Japanese rice fish, commonly known as "medaka," with genes to make them glow red.

In the early days of vaccine development, researchers often synthesize artificial genes based on a virus' genomic information, or they may incorporate the genes into E. coli bacteria and grow them. But since the experiments for the coronavirus required steps to keep it contained, the law required researchers to get approval from the science ministry.

Around February 2020, the company began the process of applying for permission. But since the virus was new, the paperwork was time-consuming. The application was made in April and approved by the minister in May.

Lagging behind Europe and US

Little by little, researchers were becoming impatient and they partly contracted research out to organizations overseas that weren't bound by legal restrictions, but even this took time and effort. Around the time their application procedures were finished, U.S. and European firms had already progressed to vaccine clinical trials. One researcher painfully recalled, "Ministerial permission is a system particular to Japan."

Yoshihiro Kawaoka, a virology professor and head of the University of Tokyo's Pandemic Preparedness, Infection and Advanced Research Center (Utopia Center), pointed out, "Differences between legal procedures in Japan and those in the U.S., where only approval within research institutions is required, delayed research and vaccine development at universities and companies in Japan."

Kawaoka revealed that he had called on domestic companies to develop a COVID-19 vaccine in mid-January 2020. "A crisis management system that could respond immediately in the event of a pandemic was needed," he said.

System 'not designed to handle emergencies'

According to the science ministry documents, each year there are around 200 to 300 requests for ministerial approval under the Cartagena law. However, in fiscal 2019 when the new virus appeared, there were 334, and the figure rose to 449 the fiscal year after that.

Hiroshima University molecular biology professor Nobukazu Tanaka, who is familiar with related legislation, noted that the science ministry has doubled the frequency of review committee meetings from roughly four times a year. Despite that, he pointed out, "It's said that the workload became too much to cope with, and there were many waiting lists and delays in confirmations. The system was not designed to handle emergencies."

Toward development within 100 days

In 2024, the ministry began full-scale work to update the regulations. The rules for enforcing the Cartagena law were revised at the end of the year, and the ministry will update its ministerial ordinance on the matter in March.

Under the revised enforcement rules, in the event of a pandemic or other emergency, a green light from the ministry is not needed for research involving infectious diseases for which a government task force has been established based on a relevant special measures law.

Reviews will rather be conducted by committees established by each university, company or other organization. However, this is a special operation only while the task force is in place, and research will be limited to that leading to treatment, prevention and diagnosis.

Under the proposed ministerial ordinance amendments, even if the virus genome is placed into E. coli, if research shows that it is not associated with onset of illness or infectiousness, ministry permission will be unnecessary regardless of whether the task force has been set up. Some have said that this would have the advantage of allowing research to begin using genomic information before a pandemic occurs.

The Group of Seven (G7) supports the 100 Days Mission of the International Pandemic Preparedness Secretariat which aims to see vaccines achieved within the first 100 days of a future pandemic. The simplification of the research process seems to have been a step toward achieving the mission's international commitments.

Securing budgets and other mounting challenges

Tanaka said highly of the amendments, "Research will proceed in a timely fashion." On the other hand, he contended, "The duty of the committee reviewing applications is critical. There are concerns that disease proliferation countermeasures could be inadequate when a low-quality committee conducts a review, for example."

Tanaka emphasized that the government will have to act early in emergencies to analyze the nature of a new disease and to release targets for fighting it.

"In the case of a completely unknown virus, there remain outstanding issues such as whether a committee can make a proper call by itself, and whether judgements could differ from one committee to another."

Naturally, delays for the research and development of domestic vaccines are not due to laws alone. The Utopia Center was established based on national strategies for vaccine development. But in reality, Kawaoka said, "It is commendable that a budget was secured based on the strategies. On the other hand, it is essential to secure an ongoing budget for a framework to train staff and rapidly link vaccine candidates generated in the lab to clinical studies."

(Japanese original by Ryo Watanabe and Rikka Teramachi, Lifestyle, Science & Environment News Department)