Revisiting the Term "Compassionate Use" and Leadership of the World Health Organization in Resolving Confusion in the Age of COVID-19 and Beyond.

We discuss the term "compassionate use" (CU) as an example of terminology having a huge impact on drug regulation. CU is used in many confusing situations, and its meaning varies significantly. We ethically affirm the necessity of CU. We insist that CU should be properly placed in exceptional status. The regulation of CUs is much more lenient than that of clinical trials because of the difference in the purpose. Whether consciously or unconsciously, abuse results in confusion and is never acceptable. The World Health Organization (WHO) proposed not to use the previous term CU but to replace it with another one. WHO also proposed the term MEURI (monitored emergency use of unregistered and experimental interventions). However, this was extremely incomplete, and WHO used the term CU subsequently. The main purpose of the proposal needs to be thoroughly implemented. In the context of the COVID-19 pandemic and beyond, expectations regarding WHO's role and leadership in global health issues are rising. We hope that WHO will play a major role in promoting research ethics preparedness while discontinuing the use of confusing terms such as CU and will develop alternative terms and their content. We discuss the evaluation of MEURI, the Japanese version of CU, and appropriate and inappropriate terminology related to the therapeutic use of unapproved drugs. We also discuss the expected appearance of CU including its name. It is appropriate to target group/cohort patients and unapproved drugs in the late stage of development. It is also important to solve the problem of incentives for CUs of pharmaceutical companies that are rushing to obtain marketing approval. The UK's Early Access to Medicine Scheme has provided many suggestions. We believe that our opinion can contribute to WHO's efforts to resolve the confusion and promote research ethics preparedness in health emergencies.

[Ethical, legal and social issues in regenerative medicine].

Regenerative medicine, currently on the stage of research, implies important ethical issues. Current main stream is the embryonic stem cell research which implies destruction of embryo in order to derive ES cells. Is such a use (destruction) of a human embryo, which is called a "germ of human life" in Japanese Society, ethically permitted or not? If yes, in which conditions? Expected clinical use of ES cells and differentiated cells thereof requires therapeutic cloning, on which arises also the ethical permissibility. Such heavy ethical obstacle leads researchers to the utilization of adult stem cells. Recent appearance of iPS cell (induced pluri-potential stem cell) does not escape from ethical issues, although the destruction of embryo is avoided.

Experts' attitudes towards medical futility: an empirical survey from Japan.

UNLABELLED: BACKGROUND The current debate about medical futility is mostly driven by theoretical and personal perspectives and there is a lack of empirical data to document experts and public attitudes towards medical futility. METHODS: To examine the attitudes of the Japanese experts in the fields relevant to medical futility a questionnaire survey was conducted among the members of the Japan Association for Bioethics. A total number of 108 questionnaires returned filled in, giving a response rate of 50.9%. Among the respondents 62% were healthcare professionals (HCPs) and 37% were non-healthcare professionals (Non-HCPs). RESULTS: The majority of respondents (67.6 %) believed that a physician's refusal to provide or continue a treatment on the ground of futility judgment could never be morally justified but 22.2% approved such refusal with conditions. In the case of physiologically futile care, three-quarters believed that a physician should inform the patient/family of his futility judgment and it would be the patient who could decide what should be done next, based on his/her value judgment. However more than 10% said that a physician should ask about a patient's value and goals, but the final decision was left to the doctor not the patient. There was no statistically significant difference between HCPs and Non-HCPs (p = 0.676). Of respondents 67.6% believed that practical guidelines set up by the health authority would be helpful in futility judgment. CONCLUSION: The results show that there is no support for the physicians' unilateral decision-making on futile care. This survey highlights medical futility as an emerging issue in Japanese healthcare and emphasizes on the need for public discussion and policy development.

[Ethical questions of the human embryonic stem cells research].

With the "Guidelines for Derivation and Utilization of Human Embryonic Stem Cells" of September 2001, Japan has become one of few countries that officially permit the research on human ES cells. The decision to permit such research is based on a well balanced consideration between the advantages towards the new medicine and the disadvantages of destroying the embryo who has a potential of life. The main ethical concern is the respect for human dignity and human rights. The whole ethical consideration comes from this standpoint, and the Guidelines set out the conditions to be respected in each research project. Because of its potential for human life, the embryos for the derivation of human ES cells, for which only frozen supernumerary embryos may be used, should be treated with full respect of its dignity. The ES cells themselves should also be used with full respect accordingly. Obtaining informed consent from the donors with possibility of withdrawal is the most important procedure. The import of human ES cells is also possible if similar conditions are fulfilled in the country of derivation. Each research project is put under a double check system, first by the IRB and then the Experts Committee on governmental level.