Japan lags behind its Western counterparts with respect to clinical, epidemiological, and basic research on the COVID-19 pandemic. The Science Council of Japan (SCJ) has released a report titled "The Current Status and Challenges of Clinical, Epidemiological, and Basic Research in Japan in Response to Infectious Disease Pandemics in Ordinary and Emergency Situations," calling for a drastic strengthening of the response to health crises.
The SCJ began considering this issue in August 2021. In March 2022, interviews were held with 14 experts from the fields of clinical, epidemiological and basic research, as well as informatics, law, administration, industry, among others. The interviews revealed the challenges in dealing with the COVID-19 pandemic across clinical, epidemiological, and basic research.
For instance, the regulations related to clinical research in Japan are fragmented in multiple laws and ethics guidelines depending on the purpose of research, the entity conducting it, and other factors. Among the regulations are the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, the Clinical Trials Act, and the Act on the Safety of Regenerative Medicine, each of which stipulate rather disparate measures.
Looking at Western countries, the legal regulation applicable to interventional clinical trials using pharmaceuticals is at least largely centralized. Problems deriving from Japan's inherent systems came to the fore in the response to the emergency brought about by the COVID-19 pandemic. Efficient clinical research implementation requires coordination in the application of multiple laws and regulations. Regarding the procedure of clinical research in an emergency, the rules for procedures enabling flexible and reasonable research, including the enactment of individual laws for the protection of personal data, should be set up during normal times.
Furthermore, even in ordinary situations, many of the medical institutions mainly providing medical care lacked human resources and systems necessary to conduct clinical trials and clinical research. Physicians on site, who were inundated with patients, were burdened with tasks ranging from the preparation for setting up of clinical research to data input. Meanwhile, in the UK, research nurses are assigned to hospitals under the National Health Service (NHS). The systems and personnel were set up during normal times to conduct clinical research across medical institutions. ICT is also being utilized for making databases of various medical data available to many researchers. This means that they do not have to collect and process large amounts of data when they may be busy treating patients. UK researchers used data from as many as 25 databases in conducting randomized controlled trials of treatment options for COVID-19. A notable result of these trials was the validation of the efficacy of dexamethasone, published within 100 days after the start of the randomized controlled trials.
In epidemiological research, Japan's lag in digitization became a tough challenge for researchers. Public Health Centers serve as gatekeepers to the active epidemiological investigation of infected persons as well as patient registration. However, the number of the Centers had halved from 847 to 468 in the past quarter century, and their human resources, including doctors and public health nurses, had been reduced as well. Consequently, responses at the Centers and related institutions were under strain. These matters are also highlighted in the recommendation made by SCJ in July 2020 entitled 'Establishment of a Permanent Organization to Prevent and Control Infectious Diseases.'
The law amended in December 2022 clearly stipulates the establishment of a system for providing health and medical care, including measures related to timely vaccination. The law also aims to ensure the effectiveness of broader measures, in the event of an outbreak or spread of infectious diseases. The April 2023 law revisions established the Cabinet Infectious Diseases Crisis Management Agency as a command post for national health crisis management. Hence, some matters identified in the recommendations are being resolved, but others, such as the use of information in emergencies, remain unsolved.
The development of COVID-19 vaccines in Japan lagged far behind that in the U.K. and the U.S. Both the U.K. and the U.S. began developing vaccines in January 2020 and approved them in December 2020. Japan has rarely felt any direct impact from overseas outbreaks of emerging infectious diseases over the past 20 years. This could explain the lacking sense of urgency among Japanese people against biological threats, as well as the modest support of initial funding for research by the government, which has caused the delay in the preparation for vaccine development and other countermeasures.
Challenges have also been highlighted with regard to regulations on the development of vaccines and therapeutics. In Japan, all genetic modification experiments for new pathogens, including even those involving a single gene, require approval from the Minister of Education, Culture, Sports, Science and Technology, which takes a lot of time. The Diet Supplementary Resolution on the revisions of the Act on the Prevention of Infectious Diseases and Medical Care for Patients with Infectious Diseases stated that vaccines shall be validated by clinical trials conducted in Japan. Therefore, vaccines produced based on the results of overseas clinical trials needed to undergo domestic clinical trials. This is because the government, pharmaceutical companies, and the public demand 'absolute safety' in vaccine development and vaccination that is 'unique to Japan.'
This article has been translated by JST with permission from The Science News Ltd. (https://sci-news.co.jp/). Unauthorized reproduction of the article and photographs is prohibited.