Kaori Muto: Considering the Ethical Challenges Remaining for the Next Pandemic

I am a researcher in the humanities who has been involved in COVID-19 countermeasures by the government and the Tokyo iCDC (Tokyo Center for Infectious Disease Control and Prevention) since the beginning of the outbreak. My daily research focuses on the ethical, legal, and social issues (referred to as ELSI) involved in developing new medical treatments, as well as creating environments where patients and citizens can contribute to creating better healthcare together (referred to as patient and public involvement). However, at 9:00 a.m. on February 3, 2020, I received a phone call from the Ministry of Health, Labour and Welfare, and became involved in COVID-19 countermeasures.

As someone who was neither a virologist nor a medical professional, I believe I was a unique presence, and I myself struggled with how I should conduct myself. However, I have tried to advise the government and the Tokyo Metropolitan Government on issues such as how to allocate limited ventilators, preventing prejudice and discrimination against infected individuals, their families, and healthcare workers, and risk communication (activities to disseminate risk information and listen to the voices of those who receive it).

As of May 8, 2023, the classification of COVID-19 under the Infectious Diseases Control Law was changed from "New Influenza and Other Infectious Diseases" to "Class 5 Infectious Diseases." This change means: (1) the government will no longer uniformly request basic infection control measures in daily life; (2) there will no longer be requests for self-isolation for COVID-positive individuals and close contacts based on the Infectious Diseases Control Law; (3) medical consultations will be available at a wide range of medical institutions; and (4) health insurance will apply to medical expenses, with a basic out-of-pocket cost of 10% to 30%, though public financial support will continue for a certain period (from the Ministry of Health, Labour and Welfare website "Response after the transition of COVID-19 to Class 5 Infectious Diseases"). Regarding vaccinations, they can be received without out-of-pocket costs until the end of this fiscal year, but eventually, out-of-pocket payments will likely be required, just like other vaccines. The government's response headquarters has already been disbanded, and many measures have ended. Compared to other developed countries, this was a cautious easing of measures, delayed by about a year.

However, "Class 5 Infectious Diseases" became a representation that went beyond a mere classification under the Infectious Diseases Control Law. As soon as it became "Class 5," the pandemic alert mode that had spread to every corner of society for about three and a half years was lifted all at once. This included self-restraint and measures that experts had recommended at the beginning of the pandemic when nothing was known—from the perspective of taking every possible step—but which became unnecessary over time. It seems that the label "Class 5 Infectious Diseases" was a convenient symbol for ending ineffective measures or self-restraint that raised concerns about long-term harm all at once.

Of course, even as a "Class 5 Infectious Disease," the virus and the disease do not disappear. However, many people are driven by a desire to no longer remember or to forget those three and a half years. Because of this, there is a concern about what will happen if we rush into the next pandemic as we are. This is because ethical challenges for the next pandemic have hardly been considered. In this article, I would like to list three concerns that I hope you will consider as your own business.

In other developed countries, the basic rule for getting the flu is to stay in bed at home. In contrast, Japan had a medical system rare among developed nations where, if you caught the flu, you could immediately visit any clinic and be prescribed anti-influenza drugs. Consequently, people had no tolerance for a situation where the medical consultations they had taken for granted were restricted, and criticism from the media was strong. The government also did not clearly declare the necessity of prioritization.

However, in the event of a rapid increase in patients where the medical delivery system may become strained, there is no choice but to prioritize who receives medical care first. Because the government did not ask citizens for their understanding and cooperation regarding this necessity, the judgment was left to each region or individual medical institution. Of course, final discretion should be left to the medical institutions. However, since the government did not clearly state a basic approach, the profile of patients to be prioritized differed by region. In some areas, priority was given to elderly people living alone with respiratory distress, while in other areas, priority was lowered depending on the patient's age or level of care required.

Furthermore, if a large number of severely ill patients occur at once, the intensive care delivery system will be limited, and a decision must be made on whose life to save. Various arguments can be made, such as whether to start with those with the highest survival rate, whether to go in the order of ambulance arrival, or whether to remove a ventilator from someone already using it if a later-arriving patient has a higher survival rate. Leaving such decisions to healthcare workers placed in harsh environments could create a sense of unfairness for patients and families and also places a heavy burden on the healthcare workers themselves.

The "Advance Care Planning" (ACP) recommended by the Ministry of Health, Labour and Welfare is an "initiative to think in advance about the medical care and support you desire for emergencies, and to repeatedly discuss and share this with your family and medical/care team." While we do not know when, where, or how we might fall ill and hover between life and death, medical resources are limited. Having experienced various things now, I believe it is necessary to exchange opinions with those close to us, keeping the next pandemic in mind. Doing so will also help support Japan's medical system.

The second challenge is visitation restrictions at medical institutions and facilities. There are likely places where these still continue today. This also raises fears that things may never return to the way they were. Visitation restrictions were written into the government's basic response policy in April 2020, but in January 2021, a note was added to consider the "QOL of patients and families," and in November 2022, this was changed to a consideration for having in-person visits. Currently, the situation is left to the judgment of individual medical institutions and facilities. Reasons cited for supporting visitation restrictions include: (1) the need to prevent hospital-acquired infections, including among inpatients; (2) the burden on medical professionals regarding visitation coordination; (3) the nature of the virus, which makes infection control difficult; and (4) the perspective of fairness to the public. However, considering (1) the perspective that there are things that cannot be obtained without visiting, (2) the importance of family in providing medical care and support, and (3) concerns about rigid responses, it can be said to be a serious ethical dilemma (Masayuki Tanaka (2022)). Especially for families caring for people with severe disabilities, visitation restrictions mean a significant drop in the quality of life for both the individual and the family. A paralysis of thought saying "it can't be helped at a time like this" and an indifference to the suffering of each individual may be allowing these visitation restrictions to continue idly (Mami Kodama (2023)).

In the first place, because visitation for inpatients and residents is not established as a right of the individual in Japan, the resolution of this dilemma is left to individual medical institutions and facilities. It is not desirable for this state to continue, and at some point, a factual investigation or the presentation of a policy by the government may be necessary. And I believe that we, too, should not just think it couldn't be helped, but that it is okay to be more angry.

The third challenge is the development of domestic vaccines. The COVID-19 vaccines were developed by overseas manufacturers, and the Japanese government negotiated to secure large-scale imports. Recently, the manufacture and sale of vaccines with fewer side effects, involving domestic companies, have been approved and have come into use. However, the fact that they could not be developed rapidly within Japan from the beginning of the pandemic remains a point of reflection.

When developing pharmaceuticals, clinical trials must be conducted to test the safety and efficacy of the drugs under development in humans. Clinical trials for pharmaceuticals are broadly divided into: (1) the stage of administering to healthy people to confirm safety, such as metabolism and toxicity in the body; (2) the stage of administering to a small number of patients to confirm efficacy; and (3) the stage of administering to a large number of patients to confirm efficacy. Volunteers who cooperate in these trials are essential.

A clinical trial method drawing attention in this context is the Controlled Human Infection Model (CHIM), where healthy people are intentionally made ill. For example, clinical trials are conducted where volunteers are exposed to large amounts of pollen to develop hay fever to confirm the effects of a treatment under development. In human challenge trials, it is necessary to quickly restore the health of volunteers who have been artificially made ill. Therefore, the principle is that they are only permitted when other treatments already exist.

In the development of vaccines for COVID-19, it is said that human challenge trials were conducted overseas, and the ability to quickly confirm efficacy led to early approval. However, even if it was an exceptional situation like a pandemic, clinical trials for vaccines that infected volunteers with the virus were conducted at a time when treatments had not yet been approved. Criticism of this remains strong even now.

However, what we must consider is that if we aim to develop domestic vaccines, there must be volunteers in Japan who are willing to cooperate in human challenge trials. In the development of COVID-19 vaccines, the discussion of whether human challenge trials should be organized domestically remained taboo, and we relied on overseas volunteers and the import of vaccines produced overseas. Can we really afford to rely entirely on overseas sources for the next pandemic as well?

In Japan, many clinical trials are conducted, and new pharmaceuticals are born. However, the volunteers who cooperated in those clinical trials are hard to see. Unless we create an environment where volunteers are socially respected and their noble intentions are rewarded, along with a system of generous compensation, we cannot expect rapid vaccine development in the next pandemic.

In this article, I have described three ethical challenges as concerns. While things are calm now that it has become a "Class 5 Infectious Disease," I hope you will consider these from your respective positions and prepare for the next pandemic.