Is legislation to prevent genetic discrimination necessary in Japan? An overview of the current policies and public attitudes.

Genetic discrimination (GD) has not been discussed in East Asia as extensively as in Europe and North America. Influenced by UNESCO's universal declaration in 1997, the Japanese government took a stringent approach toward GD by releasing the Basic Principles on Human Genome Research in 2000. However, Japanese society has mostly been ignoring the prevention of GD for decades, and the principle of prohibiting GD was never adhered to in any of the Japanese laws. We conducted anonymous surveys among the general adult population in 2017 and 2022 to explore their experiences of GD and attitudes toward laws carrying penalties to prevent GD in Japan. In both years, approximately 3% of the respondents had experienced some unfavorable treatment regarding their genetic information. They showed higher recognition of the benefits of using genetic information and lower recognition of concerns about using genetic information and GD in 2022 than in 2017. However, the awareness regarding the need for legislation with penalties on GD had increased over the five-year period. In 2022, the framework of a bill to promote genomic medicine and prevent GD without any relevant penalties was released by the Bipartisan Diet Members Caucus. Considering that the absence of regulations may be a barrier to obtaining genomic medicine, as the initial step toward making the prohibition of GD more effective, legislation that no form of GD will be tolerated may stimulate education and awareness regarding respect for the human genome and its diversity.

General public's understanding of rare diseases and their opinions on medical resource allocation in Japan: a cross-sectional study.

BACKGROUND: Rare diseases (RDs) may impose a considerable financial burden on patients and their families. Public acceptance is essential to ensure sustainable public systems supporting RDs, especially in countries with universal healthcare coverage, such as Japan. This study aimed to explore the public's understanding of RDs and identify crucial factors associated with the public acceptance of prioritizing financial support for RDs in Japan. METHODS: An online questionnaire was sent to 131,220 Japanese residents aged 20-69 years. The items included in the questionnaire were general interest in medical science and medical care, general knowledge regarding RDs and health care systems, opinions on the cost of medical care, opinions on the research and development of RDs and common diseases, and individual characteristics. RESULTS: The responses of 11,019 respondents were analyzed. Several respondents agreed to partially cover the medication cost of adult and pediatric RDs (59.5% and 66.8%, respectively) with public funding. The major reasons for agreeing were the huge financial burden imposed on patients and their families, limited available treatment options, effects of RDs on the life planning of patients, and difficulties caused by RDs in the patient's social life. Furthermore, the respondents ranked RDs (56.0%) higher than common diseases (44.0%) for government funding for research and development. The reasons for supporting government-funded research and development for RDs included the lack of treatment options for numerous RDs (34.9%) and difficulty of studying RDs owing to the small number of researchers (25.9%). The chief reasons for supporting government-funded research and development for common diseases were the large number of affected patients (59.7%) and the possibility of more treatment options becoming available through the promotion of research and development (22.1%). CONCLUSIONS: The general public considers burdens associated with daily living or finance more than the epidemiological characteristics of RD while making funding decisions, demonstrating that rarity was less prioritized. A gap appears to exist between the general public and RD experts regarding the understanding of the epidemiological characteristics of RD and its thresholds. This gap should be bridged to ensure that prioritization of financial support for RDs is accepted by the society.

Public Attitudes toward COVID-19 Vaccinations before Dawn in Japan: Ethics and Future Perspectives.

Improving public understanding and acceptance are critical for promoting coronavirus (COVID-19) vaccination. However, how to promote COVID-19 vaccine programs remains controversial due to various ethical issues. This study, thus, aimed to survey the acceptance of COVID-19 vaccines among Japanese citizens and discuss relevant ethical issues. A cross-sectional survey was conducted via an online platform. An anonymous, quantitative, self-administered online questionnaire was sent to 6965 registered Japanese residents (20-79 years of age), which included questions regarding the respondent's general knowledge, experience, and opinions of vaccines, vaccine development, COVID-19, and COVID-19 vaccines. Of the 1569 respondents, 730 (46.5%) and 839 (53.5%) were categorized into the younger and older groups, respectively. Most of the respondents possessed general knowledge of COVID-19 vaccines and their features. Of the respondents, 57.8% definitely agreed (10.5%) or somewhat agreed (47.3%) to receive COVID-19 vaccines. The older group showed significantly greater willingness to receive vaccines and higher literacy regarding vaccines in general. Possible reasons for the older group's greater willingness to receive COVID-19 vaccines are a high risk of severe COVID-19 infection and their past accumulated experience of receiving various vaccinations. Although active public intervention could increase vaccination rates, most of the respondents did not agree with mandatory vaccination. Furthermore, a gap between the participants in the COVID-19 vaccine trials and the prioritized population in real-world vaccination should be adjusted in future vaccine development. Supplementary Information: The online version contains supplementary material available at 10.1007/s41649-022-00207-4.

Comparative Assessment of Non-trial Access to Investigational Medical Products in the U.S. and Japan.

The U.S. and Japan have preapproval access systems for patients who have exhausted approved treatment options. We compare the systems of both countries and discuss some ethical concerns surrounding non-trial access to investigational drugs. Notable points of comparison of the two countries' systems include cost of non-trial access to investigational drugs and purpose of the non-trial access system. All stakeholders and the public must understand the ethical issues associated with non-trial preapproval access systems. The current non-trial access programs in both countries depends on pharmaceutical companies' voluntary decisions about whether patients get access to investigational products. Moreover, the potential for inequity of access raises ethical concerns. Non-trial preapproval access is an exceptional way to practice medicine with various ethical and safety concerns, so we suggest that the scope and eligibility for using these pathways should thus be limited.

Where Can Patients Obtain Information on the Preapproval Access Pathway to Investigational Treatment in Japan? A Survey of Patient Advocacy Organizations' Websites.

Investigational treatments are those that have been approved for testing in humans but are not yet available as an approved treatment option. For many patients with a terminal illness who have no approved treatment option and are not eligible for a clinical trial, investigational treatments are the last resort. However, not much is known about the dissemination of information by patient advocacy organizations (PAOs). We evaluated the quantity and quality of information on preapproval access to investigational therapies provided by Japanese PAO websites between January 24 and March 29, 2019. A total of 49 PAOs were identified. Of these, 16 (33%) provided no relevant information. The most frequent information provided was the PAO's own clinical trial finder or list of clinical trials (n = 15, 31%); of the 10 cancer-related PAOs, 5 (50%) provided this information. Nine (18%) PAOs had developed patient registries or provided a link to relevant registries. Only 1 PAO (2%) provided a link about the Ministry of Health, Labour, and Welfare trials that described the process and regulations of clinical trials. Our results indicate that PAOs do not disseminate adequate information on preapproval pathways. We suggest that the government involve PAOs in disseminating this information to both patients and physicians.

Ethical concerns on sharing genomic data including patients' family members.

BACKGROUND: Platforms for sharing genomic and phenotype data have been developed to promote genomic research, while maximizing the utility of existing datasets and minimizing the burden on participants. The value of genomic analysis of trios or family members has increased, especially in rare diseases and cancers. This article aims to argue the necessity of protection when sharing data from both patients and family members. MAIN TEXT: Sharing patients' and family members' data collectively raises an ethical tension between the value of datasets and the rights of participants, and increases the risk of re-identification. However, current data-sharing policies have no specific safeguards or provisions for familial data sharing. A quantitative survey conducted on 10,881 general adults in Japan indicated that they expected stronger protection mechanisms when their family members' clinical and/or genomic data were shared together, as compared to when only their data were shared. A framework that respects decision-making and the right of withdrawal of participants, including family members, along with ensuring usefulness and security of data is needed. To enable this, we propose recommendations on ancillary safeguards for familial data sharing according to the stakeholders, namely, initial researchers, genomic researchers, data submitters, database operators, institutional review boards, and the public and participants. CONCLUSIONS: Families have played significant roles in genetic research, and its value is re-illuminated in the era of genomic medicine. It is important to make progress in data sharing while simultaneously protecting the privacy and interests of patients and families, and return its benefits to them.

A review of Vietnam's healthcare reform through the Direction of Healthcare Activities (DOHA).

OBJECTIVE: This article provides a comprehensive review of the healthcare reform process driven by the Vietnamese Ministry of Health's Direction of Healthcare Activities (DOHA) scheme. METHODS: We reviewed policy documents relating to DOHA, along with historical literature and background information describing its formation. RESULTS: DOHA (Chi dao tuyen in Vietnamese) literally means guidance line or level in English. It requires healthcare facilities at higher government administration levels to support those at lower levels (the four levels being central, provincial, district, and commune), to help lower level hospitals to provide medical services for local communities in primary care settings and reduce the number of patients in higher level (central and provincial) hospitals. Since the 1990s, there have been too many patients attending higher level hospitals, and DOHA has therefore focused on technical skills transfer training to help alleviate this situation. Designated core central hospitals now provide technical skills transfer to provincial hospitals. Professional technical lists for each level of health facility have enabled strong commitment and proactive ownership of the process of training management in both higher and lower level hospitals. CONCLUSION: The DOHA scheme has accelerated the necessary up-skilling of healthcare at lower level public hospitals across Vietnam. These reforms are highly relevant for other countries with limited healthcare resources.

Discovery and informing research participants of incidental findings detected in brain magnetic resonance imaging studies: Review and multi-institutional study.

BACKGROUND: Brain imaging studies using magnetic resonance imaging (MRI) sometimes reveal incidental findings (IFs) that might be relevant to some of the health issues in research participants. Although professional communities have discussed how to manage these IFs, there is no global consensus on the concrete handling procedures including how to inform participants of IFs. METHODS: First, this study reviewed previous studies for the number of IFs discovered in brain imaging studies using MEDLINE. Second, a multi-institutional study determined the number of IF discoveries and evaluated the method of informing participants at multiple institutions, which participated in a national brain science project in Japan. RESULTS: Both the review and multi-institutional study showed that IFs with a high urgency level were discovered in 0-2.0% of participants, including healthy volunteers, and that the rate of IF discovery in general was higher in studies conducted in elderly population. Moreover, multi-institutional study suggested the criteria used to judge whether or not to inform participants of IFs may differ by institution. CONCLUSIONS: Our results suggest that in order to ensure informing the participants of high urgency IFs, physicians who are capable of interpreting brain images clinically should review all brain images, and the establishment of a support system is required for brain imaging studies at nonmedical institutions. Since the method of informing participants of IFs might affect their understanding and acceptance of IFs, which are related to managing risks of false "clean bill of health" or psychological impacts of informing IFs, further research focusing on communication of IFs is needed.

Handling incidental findings in neuroimaging research in Japan: current state of research facilities and attitudes of investigators and the general population.

BACKGROUND: To establish appropriate measures that deal with incidental findings (IFs), the neuroscience community needs to address various ethical issues. The current state of research facilities regarding IFs and investigator attitudes as well as potentially eligible research participants must be assessed prior to future discussions and before the development of policies and guidelines. To this end, we conducted two questionnaire surveys to clarify i) how IFs are addressed at neuroimaging research facilities in Japan and ii) the views of investigators and potential research participants regarding the handling of IFs. METHODS: Thirty-one principal investigators (PIs) involved in the Strategic Research Program for Brain Sciences (SRPBS), a government-funded project, were asked to fill out a questionnaire regarding ways IFs were handled at the facility. A total of 110 investigators engaged in SRPBS tasks, including 31 PIs who participated in the research facility survey and researchers conducting studies under the management of the PIs, and 500 individuals from the general public (i.e., general population) were asked to select the most appropriate way to deal with IFs in two scenarios, namely the medical school and humanities and social sciences department scenarios. RESULTS: More than 40% of PIs responded that they did not know or were unsure of what type of approach was employed to handle IFs at their research facilities. Nevertheless, they were willing to improve the current status if sufficient resources were provided. With regard to specialist involvement, 37.7% of investigators responded that it was appropriate to have a specialist check all images in the medical school scenario, whereas 13.3% responded that such involvement was appropriate in the humanities and social sciences department scenario. In contrast, 76.1% and 61.0% of the general population indicated that specialist involvement was appropriate in the medical school and humanities and social sciences department scenarios, respectively. These results show that expectations of the general population exceed those of investigators regarding measures to address IFs. Both investigators and the general population demanded more responsibility from PIs at medical institutions, compared to PIs at non-medical institutions. CONCLUSIONS: Based on our preliminary results, we recommended that a licensed physician perform a screening test to appropriately examine clear abnormalities. These recommendations were implemented by the SRPBS as guidelines for handling IFs in national research projects in Japan.