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

I am a humanities researcher 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. Usually, I research the ethical, legal, and social issues (referred to as ELSI) involved in the development of 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 personally 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 (the activity of disseminating risk information and listening to the voices of those who receive it).

As of May 8, 2023, the classification of COVID-19 under the Infectious Diseases Act was changed from "New Influenza and Other Infectious Diseases" to "Class 5 Infectious Disease." 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-quarantine for COVID-positive individuals and close contacts based on the Infectious Diseases Act; 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 "Regarding the response after the transition of COVID-19 to Class 5 Infectious Disease"). Regarding vaccinations, they can be received without out-of-pocket costs until the end of this fiscal year, but eventually, self-payment will likely be required, just like other vaccines. The government task force has already disbanded, and many measures have ended. However, compared to other developed nations, this was a cautious easing of measures, delayed by about a year.

However, "Class 5 Infectious Disease" became a representation that went beyond its classification under the Infectious Diseases Act. 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 from the perspective of taking every possible step at the beginning of the pandemic when nothing was known, but which became unnecessary over time. It seems the label "Class 5 Infectious Disease" was convenient for ending ineffective measures and 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 the feeling that they no longer want to remember those three and a half years and want to forget them. Because of this, there is a concern about what will happen if we plunge 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.

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 medication. Therefore, 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, prioritization of who to treat first is unavoidable. Because the government did not seek the necessity and cooperation of citizens, 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 basic principles, the profile of patients to be prioritized differed by region. In some regions, priority was given to elderly people living alone with respiratory distress, while in others, 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 decisions must be made on whom 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, is it not necessary to exchange opinions with those close to us, keeping the next pandemic in mind? Doing so will also lead to helping the Japanese medical system.

The second challenge is visitation restrictions at medical institutions and facilities. There are likely places where these still continue today. It 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 consideration for 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 nosocomial infections, including for 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 suspension of thought saying "it can't be helped at a time like this" and indifference to the suffering of each individual may be allowing aimless visitation restrictions to persist (Mami Kodama (2023)).

To begin with, 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 fact-finding survey or the presentation of a policy by the government will be necessary. And we, too, should think that it is okay to be more angry, rather than just thinking it couldn't be helped.

The third challenge is the development of domestic vaccines. 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 the country 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 that draws 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 effectiveness of a treatment under development. In human challenge trials, it is necessary to promptly 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 COVID-19 vaccines, human challenge trials were conducted overseas, and the fact that efficacy could be confirmed quickly is said to have 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 will 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 often invisible. Unless we create an environment where volunteers are socially respected and their noble intentions are rewarded, along with systems for 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.