Ministry Of Health, Labour And Welfare Research Articles

Current status and legal/ethical problems in the research use of the tissues of aborted human fetuses in Japan.

To date, there is no law regulating the research use of human aborted fetuses in Japan. The aim was to review the current status with historical background and legal/ethical problems limiting the research use of the tissues of aborted human fetuses. We reviewed literature via PubMed, Web of Science, Scopus, Japana Centra Revuo Medicina and CiNii, reports from various committees and research groups from Ministry of Health, Labour and Welfare (MHLW), and domestic books. Aborted human fetal tissues used for research purposes were first documented in the 1920s. The first guideline, the Peel Code was released in 1972. Since then, in Western countries, the research use of aborted fetuses has been less restricted compared with that of embryos, due to the following guidelines outlined by expert groups. Currently, aborted fetal tissues are commercially available for research purposes in the United States. In Japan, only four indications are presented in "a public statement permitting research use of deceased fetuses' and 'neonates' organs, etc." (1987). In the 2000s, expert committees of the MHLW concluded that research use of human aborted fetuses should be discontinued, and that comprehensive rules and independent regulations should be implemented. This issue has not been discussed in the Japanese legislature since 2003. Establishment of laws and guidelines for this issue is insufficient not only in Japan but also in other countries. It is important to secure transparency for making laws and guidelines and in obtaining public understanding.

Clinical characteristics and social productivity levels of patients with malignant rheumatoid arthritis based on a nationwide clinical database in Japan: annual survey from 2003 to 2013

Objectives Malignant rheumatoid arthritis (MRA) is defined as rheumatoid arthritis (RA) with systemic vasculitis or other severe extra-articular manifestations. Japan has a nationwide database for MRA. We analyzed the characteristics of Japanese patients with MRA based on data from the Ministry of Health, Labour and Welfare (MHLW). Methods We were permitted to use data on 43,108 patients who were registered in the MHLW database from 2003 to 2013. Results Median age was 65 (interquartile range, 57–72) years. Patients consisted of 71% females. Proportions of patients who had or had experienced interstitial pneumonia and pleuritis were increased, episcleritis was stable, and other MRA manifestations were decreased over time. The number of positive symptoms per patient also decreased over time. The median dose of glucocorticoid, percentage of patients undergoing surgery, and use of non-steroidal anti-inflammatory drugs and apheresis decreased year by year. Steinbrocker stage and class improved over time. Median C-reactive protein levels and erythrocyte sedimentation rate also decreased. Regarding social productivity levels of patients with MRA, the proportion of patients who were working or working from home increased and the proportion of patients recuperating or hospitalized decreased. Conclusion In patients with MRA, disease activity decreased and social productivity improved from 2003 to 2013.

Cancer genomic medicine in Japan.

Advances in cancer research have revolutionized the way cancer is diagnosed and treated. Any cancer is now known to be an amalgamation of many subtypes, each carrying its specific cancer-causing gene or oncogene. It is also evident that a given oncogene is often present across a wide range of cancer subtypes, albeit at different frequencies. These lines of information have brought cancer genomic medicine (CGM) to the clinic, where genetic information is used to optimize therapeutic intervention. In 2017, the Expert Meeting for Cancer Genomic Medicine Promotion Consortium in the Ministry of Health, Labour and Welfare (MHLW) of Japan submitted a blueprint for the CGM platform in Japan. Accordingly, the MHLW designated a total of 206 hospitals that conduct cancer gene panel testing under the national health insurance system and established the Center for Cancer Genomics and Advanced Therapeutics to store genomic/clinical information of cancer patients. Since June 2019, the CGM officially started in Japan.

Current coronavirus (SARS-CoV-2) epidemiological, diagnostic and therapeutic approaches: An updated review until June 2020.

Coronaviruses are a group of enveloped viruses with non-segmented, single-stranded, and positive-sense RNA genomes. In December 2019, an outbreak of coronavirus disease 2019 (COVID-19) caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), in Wuhan City, China. The World Health Organization (WHO) declared the coronavirus outbreak as a global pandemic in March 2020. Fever, dry cough and fatigue are found in the vast majority of all COVID-19 cases. Early diagnosis, treatment and future prevention are keys to COVID-19 management. Currently, the unmet need to develop cost-effective point-of-contact test kits and efficient laboratory techniques for confirmation of COVID-19 infection has powered a new frontier of diagnostic innovation. No proven effective therapies or vaccines for SARS-CoV-2 currently exist. The rapidly increasing research regarding COVID-19 virology provides a significant number of potential drug targets. Remdesivir may be the most promising therapy up till now. On May 1, 2020, Gilead Sciences, announced that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the investigational Remdesivir as a potential antiviral for COVID-19 treatment. On May 7, 2020, Gilead Sciences, announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval of Veklury® (Remdesivir) as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19 acute respiratory syndrome, under an exceptional approval pathway. Also, Corticosteroids are recommended for severe cases only to suppress the immune response and reduce symptoms, but not for mild and moderate patients where they are associated with a high-risk side effect. Based on the currently published evidence, we tried to highlight different diagnostic approaches, side effects and therapeutic agents that could help physicians in the frontlines.

Retraction statement: National database study on the use of long-acting antipsychotic injections and hospital readmission proportions in patients with schizophrenia in Japan.

Usuki M, Kamiura Y, Okubo R, Yamanouchi Y. National database study on the use of long-acting antipsychotic injections and hospital readmission proportions in patients with schizophrenia in Japan. Psychiatry Clin. Neurosci. 2020; 74: 211-217. https://doi.org/10.1111/pcn.12970 The above article from Psychiatry and Clinical Neurosciences, published online on 3 February 2020 in Wiley Online Library (www.onlinelibrary.wiley.com), and in Volume 74, pp. 211-217, has been retracted by agreement between the authors, the Editors-in-Chief, Shigenobu Kanba and Tadafumi Kato, and John Wiley & Sons Australia Ltd. The retraction has been issued because the Ministry of Health, Labour and Welfare (MHLW) announced that the authors violated the guidelines on the use of the data from the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB Japan) in the article. REFERENCE: Usuki M, Kamiura Y, Okubo R, Yamanouchi Y. National database study on the use of long-acting antipsychotic injections and hospital readmission proportions in patients with schizophrenia in Japan. Psychiatry Clin. Neurosci. 2020; 74: 211-217. https://doi.org/10.1111/pcn.12970.

First approval of generic dry powder inhaler drug products in Japan.

The Japanese Ministry of Health, Labour and Welfare (MHLW) published the basic principles of bioequivalence evaluations for generic dry powder inhaler (DPI) drug products in March 2016. The basic principles were formulated to promote the development of effective and safe generic DPI drugs. Based on this document, the Pharmaceuticals and Medical Devices Agency (PMDA) advises generic companies on effective development through consultation meetings. The PMDA generally requires data from in vitro tests, pharmacokinetic studies, and pharmacodynamic or clinical endpoint studies for generic drug development. The MHLW approved the first generic version of the Symbicort Turbuhaler in 30- and 60-dose pack sizes in February 2019. This article presents the concrete data on the first approval of generic DPI drug products based on public information. Graphical abstract.

Analysis of Emergency Rescue Responses in Large-Scale Disasters in Japan

This study analyzed emergency rescue responses in large-scale disasters in Japan using White Paper on Japan Fire Service, White Paper on Japan Police, Defense of Japan (Annual White Paper), White Paper on Land, Infrastructure, Transport and Tourism in Japan, and Annual Health, Labour and Welfare Report published by the Fire and Disaster Management Agency (FDMA), the National Police Agency (NPA), the Ministry of Defence (MOD), the Ministry of Land, Infrastructure, Transport and Tourism (MLITT), and the Ministry of Health, Labour and Welfare (MHLW), to contribute to establishing emergency rescue responses during large-scale disasters in Korea. When the resources of disaster areas in Japan are inadequate for emergency response during a disaster due to its large-scale, prefectural governors request to mobilize the Emergency Fire Response Team (EFRT) of FDMA, the Inter-Prefectural Emergency Rescue Unit (IERU) of NPA, the Self-Defense Force of MOD, the Technical Emergency Control Force of MLITT, and the Disaster Medical Assistance Team of MHLW. These teams mobilized from the entire country perform emergency rescue activities through strong connection and collaboration under the command of prefectural governors.

AB0494 CHARACTERISTICS OF THE PATIENTS WITH POLYARTERITIS NODOSA IN JAPAN

Background:Since the number of polyarteritis nodosa (PAN) patients is small not only in Japan but also in the world, the characteristics of PAN have not been fully clarified and appropriate treatment has not been established.Objectives:This study aimed to describe the epidemiological and clinical features and treatment of patients with PAN in Japan.Methods:We used the database of the Ministry of Health, Labour and Welfare (MHLW) in 2013 and 2014. Data of 178 patients who fulfilled the diagnostic criteria by MHLW and had registered within a year after onset of PAN was analyzed.Results:The analysis included 75 males and 103 females, with a mean age of 64.5 ± 20.3 years. PAN was diagnosed by clinical symptoms in 27.6% of the patients, 11.5% of the patients by pathological findings, and the rest of the patients by both. Pathological examination was performed in 71.3% of the patients, of whom 11.2% had evidence of necrotizing vasculitis of the small and medium arteries. As a systemic symptom, fever was observed in 55.2% of cases. As organ symptoms, muscle and joint symptoms (74.7%), skin symptoms (73.0%), neuropsychiatric symptoms (50.0%), respiratory symptoms (32.6%), and renal symptoms (19.7%) were common. Patients aged 65 or older had a higher rate of systemic, renal and respiratory symptoms, and lower rate of skin symptoms compared with the patients younger than 65. Patients with renal symptoms had a high prevalence of respiratory, cardiac and ocular symptoms, while those with respiratory symptoms had a high prevalence of systemic and cardiac symptoms. Laboratory findings showed that MPO- and/or p-ANCA positive rate was 30.5% and PR3- and/or c-ANCA positive rate was 11.0%. The Hepatitis B antigen positive rate was 3.9%. Angiography was performed in 20.7%, among which 27.0% were found to have multiple small aneurysms, wall irregularities and stenosis at the abdominal aortic branches. Glucocorticoids were used for treatment in all cases with an average maximum prednisolone dose of 32.5 mg/day. Concomitant immunosuppressants were used in 28.7%, half of which was cyclophosphamide. In other cases, azathioprine or methotrexate was used. Immunosuppressants have been used more frequently in patients with systemic symptoms and nasal and ear symptoms. Among the immunosuppressants, cyclophosphamide tends to be used for patients with higher CRP or patients with respiratory symptoms, and the maximum dose of glucocorticoids was significantly higher in patients who used cyclophosphamide compared to those who used other immunosuppressants.Conclusion:PAN developed in middle-aged and elderly people and exhibited various clinical symptoms. We found that common symptoms varied with age, and treatment options were determined depending on the types of organ symptoms and severity. Hepatitis B virus infection was rare in patients with PAN in Japan.

A survey of Japanese mothers on the effectiveness of the Ministry of Health, Labor and Welfare’s revised HPV vaccine leaflet

ABSTRACT Introduction: In June of 2013, Japan’s Ministry of Health, Labor and Welfare (MHLW) suspended its position of strong recommendation for the routine immunization of young girls against the Human Papilloma Virus (HPV) because of reports of adverse reactions after the vaccination. For the next four years, the MHLW’s website warned about the significance of these adverse events. In January of 2018, MHLW’s website was modified to reflect a less negative stance. We have studied public awareness of MHLW’s revised leaflet in Japanese women whose daughters were of the targeted age for receiving the HPV vaccine and how this awareness influenced their intentions to get their daughters vaccinated. Materials and Methods: From June to December of 2018, a survey was conducted through the Departments of Obstetrics and Gynecology at 14 different medical facilities. The questionnaire was distributed to women whose daughters were of the HPV–vaccine-targeted age. The survey measured their responses before and after being presented with the 2018-revised MHLW leaflet. Responses from 384 mothers were analyzed. Results: Before being presented with the leaflet, the survey found that the percentage of responder’s daughters already vaccinated was 6.5% (24/372). After reading the MHLW leaflet, an additional 6.9% (24/346) responded “I want to get my daughter vaccinated immediately”, and 37.6% (130/346) responded “I have positive feelings about HPV vaccination”. Discussion: By presenting the new MHLW leaflet at obstetrics and gynecology facilities, we expect to be able to effectively increase the HPV vaccination rate in Japan.

Provisional seven-item criteria for the diagnosis of polyarteritis nodosa.

Polyarteritis nodosa (PAN) is a potentially life-threatening systemic vasculitis, which predominantly involves medium arteries. However, it may be difficult to diagnose PAN in its early stage. The aim of our study was to investigate the sensitivity and specificity of the American College of Rheumatology (ACR) and the Japanese Ministry of Health, Labour and Welfare (MHLW) criteria for the diagnosis of PAN in a single-centre retrospective cohort in Japan and to develop simplified criteria with favourable diagnostic performance. All patients with "PAN" or "suspicion of PAN," as indicated on insurance forms, were included. The patient population was classified into PAN and non-PAN groups based on a retrospective chart review. The sensitivity and specificity of the ACR and MHLW criteria were calculated. Items that favourably discriminated the PAN group from the non-PAN group were determined and used as items for our provisional criteria. Thirteen cases of PAN and 24 cases without PAN were included in this study. The sensitivities of the ACR and MHLW criteria were 61.5% (8/13) and 30.8% (4/13), respectively, whereas the specificities were 79.2% (19/24) and 87.5% (21/24), respectively. We developed provisional criteria consisting of seven items, and found that a cut-off of ≥ 4 items had a sensitivity of 92.3% (12/13) and specificity of 91.7% (22/24) (p < 0.000001). The provisional seven-item criteria, developed in our real-world cohort of patients suspected of having PAN, had a high sensitivity and specificity and may be useful in the diagnosis of PAN, although it should be validated in additional patient populations.

Regulatory Perspective of International Agencies for Development of Biosimilar Products (Monoclonal Antibodies): An Overview.

Biopharmaceutical medicines are complex molecules obtained from a living organism (plant or animal cells) and may contain components of a living organism using biotechnology. Biosimilars are closely similar to already approved biopharmaceutical products that could form a new generation of medicines that are available widely at an affordable cost. The expiry of patent and data protection of Remicade (infliximab) aggravated biosimilar acceptance in the open market. Analysis of data package submitted for infliximab biosimilar and assessment reports published by agencies shows the importance of European Medicines Agency (EMA) product-specific guidelines (monoclonal antibodies) that are being followed by different regulatory agencies worldwide. Considering utilization of case-by-case basis for biosimilar development, infliximab biosimilar product evaluation assessment report suggests similarity in nature and extent of data required in analytical, nonclinical, and clinical studies even on utilizing cell lines different from the reference product's. Specific additional clinical study (phase III) is required for a biosimilar to be authorized by the Ministry of Health, Labour and Welfare (MHLW). US Food and Drug Administration and EMA widely accept the concept of extrapolation to other indications approved for the reference product. However, the Ministry of Health, Labour andWelfare, Japan shows a conservative approach for extrapolation to other indications in the absence of direct or indirect safety and efficacy data.

Epidemiologic Research on Healthy Life Expectancy and Proposal for Its Extension: A Revised English Version of Japanese in the Journal of the Japan Medical Association 2019;148(9):1781-4.

Healthy life expectancy is an indicator that represents a composite of data on mortality and health status and is defined as the average number of years that a person can expect to live at a certain level of health. To extend people’s healthy life expectancy, my colleague and I conducted a variety of epidemiologic research based upon community-based cohort studies and intervention trials. The findings from our prospective cohort studies included blood pressure reference values measured at home, green tea health benefit, Japanese dietary pattern, and feeling ikigai (a sense of life worth living) at daily life.Based upon these evidence, I have made some proposals toward extension of healthy life expectancy. In 2011, as the Chair of the Planning Committee for the Next National Health Promotion of Ministry of Health, Labor and Welfare (MHLW), I proposed that the Health Japan 21 (second term) should aim to extend healthy life expectancy to exceed the number of years extended in the total life expectancy, thus compressing the duration to be spent in an unhealthy state (compression of morbidity). In the interim evaluation of the Health Japan 21 (second term) in 2018, we were able to demonstrate that this goal is being achieved. Compared with 2010, in 2016, the increase in healthy life expectancy (1.72 years in men and 1.17 years in women) was higher than that of total life expectancy (1.43 years in men and 0.84 years in women). As a result, the duration to be spent in an unhealthy state was reduced by 0.29 years in men and by 0.33 years in women. It is important to note that Japan is the only country that has made progress in achieving compression of morbidity at the national level. We need to maintain this momentum of compressing morbidity.

Cattle Meat and Offal Imported from the United States of America, Canada and Ireland to Japan (Prions).

Food Safety Commission of Japan (FSCJ) was requested by the Ministry of Health, Labour and Welfare (MHLW) to conduct a risk assessment of cattle meat and offal imported from the United States of America (U.S.A.), Canada and Ireland. FSCJ assessed potential influences on bovine spongiform encephalopathy (BSE) risks to human health in cases of the alteration of cattle age to be allowed to import of cattle meat and offal from the three countries, from the current under 30 months of age to no age limitation, in line with the international standards for mitigating BSE risks. FSCJ judges that the control measures regarding “risks related to slaughtering and meat processing” are appropriately implemented in the three countries. FSCJ concludes that potential variations of BSE risks to human health by removing the age limit on cattle meat and offal excluding specified risk material (SRMs) imported from the three countries in line with the international standards is negligible.

Darolutamide for treatment of castration-resistant prostate cancer.

Darolutamide is a novel, nonsteroidal androgen receptor (AR)-signaling inhibitor. It serves as a second-generation antiandrogen and is currently indicated for the treatment of patients with nonmetastatic castration-resistant prostate cancer (nmCRPC). The product was approved by the United States Food and Drug Administration (FDA) in July 2019 and by the Japanese Ministry of Health, Labour and Welfare (MHLW) in January 2020 for the treatment of men with nmCRPC, and is awaiting approval in the E.U. for the same indication. This review will cover the background, preclinical development, safety, pharmacokinetics, pharmacodynamics and clinical studies that led to the approval of darolutamide. The key clinical data, ongoing trials and future directions for darolutamide are also discussed herein.

Deoxynivalenol and Nivalenol (2nd edition) [Assuring the Maximum Level of Deoxynivalenol in Wheat] (Natural Toxins and Mycotoxins).

Food Safety Commission of Japan (FSCJ) was requested by the Ministry of Health, Labour and Welfare (MHLW) to conduct a risk assessment of deoxynivalenol (DON) to assure the maximal level for DON in foods. Previously, FSCJ had conducted a self-tasking risk assessment of DON and nivalenol (NIV) in 2010. In the current 2nd edition, only the assessment of DON has been revised. Grains contaminated with DON may be also contaminated with its derivatives, namely, 3-acetyldeoxynivalenol (3-Ac-DON), 15-acetyldeoxynivalenol (15-Ac-DON) and deoxynivalenol-3-glucoside (DON-3-glucoside). However, these substances orally ingested are rapidly biotransformed into DON. Therefore, FSCJ identified the total DON (sum of DON and its derivatives) to be assessed. The toxicity of DON was assessed based on the data of absorption-distribution-metabolism-excretion (ADME), acute toxicity, sub-acute toxicity, chronic toxicity, carcinogenicity, reproductive/developmental toxicity, genotoxicity, and immunotoxicity. DON was considered to have no significant genotoxic activity in vivo. The no-observed-adverse-effect level (NOAEL), based on the two-year chronic toxicity study in mice, was set at 0.1 mg DON/kg bw/day. By applying an uncertainty factor (UF) of 100, the TDI for DON was determined as 1 µg /kg bw/day. The average estimated exposure levels of total DON were 0.09 µg /kg bw/day and 0.22 µg/kg bw/day in the whole population and the 1-6 years group, respectively, by the Monte-Carlo method. The average exposure level in Japan was thus judged to be below the TDI, although a chance to exceed the TDI remains possible in the 1-6 years group depending on eating habits and DON contamination. For NIV, the genotoxic property was not able to be assessed due to the limited availability of the experimental data. No carcinogenic effect was observed in a two-year chronic toxicity study in mice, and the International Agency for Research on Cancer (IARC) also classifies Fusarium spp toxins including NIV to be in group 3. FSCJ thus judged that TDI can be set for NIV. Based on various toxicity studies, the TDI of NIV was determined at 0.4 µg/kg bw/day by taking into account of LOAEL 0.4 mg NIV/kg bw/day in a subacute toxicity study in rats with 90-day oral administration and UF of 1,000. The exposure level of NIV in Japan was estimated to be below the TDI. FSCJ judged it’s unlikely that NIV intake leads to adverse health effects in general population.

Lascufloxacin hydrochloride to treat bacterial infection.

Lascufloxacin hydrochloride (AM-1977) is a novel 8-methoxy fluoroquinolone antibacterial agent with a unique pharmacophore at the 1st and 7th positions of the quinoline nucleus developed by Kyorin Pharmaceutical Co., Ltd. (Tokyo, Japan). It has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) for treatment of respiratory tract and ear, nose and throat infections including community-acquired pneumonia and otorhinolaryngological infections, and shows great promise against fluoroquinolone-resistant strains of major pathogens which infect the respiratory tract. It is suitable for treating infections caused by Staphylococcus, Streptococcus, Pneumococcus, Moraxella (Branhamella) catarrhalis, Klebsiella, Enterobacter, Haemophilus influenzae, Legionella pneumophila, Prevotella and Mycoplasma pneumoniae that are sensitive to this drug.

Current Understanding of Food Safety Assessment Procedure for Stacked Trait Products Derived from Conventional Breeding among Approved GM Plants.

Ministry of Health, Labour and Welfare (MHLW) has conducted food safety assessment of the genetically modified (GM) plants generated by conventional breeding among approved GM plants (hereinafter called “stacked trait products”). Food safety assessment procedure of stacked trait products was revised in 2014. The safety assessment policies will continue to be updated, based on the collected knowledge and experience.

Optimal gestational weight gain for underweight pregnant women in Japan

We aimed to investigate the optimal range of gestational weight gain (GWG) for Japanese underweight (body mass index <18.5 kg/m2) women using the Japanese Birth Registry System. The study subjects included underweight women who were divided into groups according to the GWG recommendations of the Ministry of Health, Labour and Welfare (MHLW) (9–12 kg): <9.0 kg, group A; 9–12 kg, group B; and >12 kg, group C. The subjects were then classified according to the recommendations of the Institute of Medicine (IOM) (12.7–18.1 kg): <12.7 kg, group D; 12.7–18.1 kg, group E; and >18.1 kg, group F. In total, 148,135 cases were analysed. The frequencies of small for gestational age, preterm delivery, and caesarean delivery were as follows: 19.3%, 22.7%, and 28.5% for group A; 11.7%, 8.7%, and 22.8% for group B; 8.0%, 4.9%, and 21.5% for group C; 15.0%, 14.7%, and 25.2% for group D; 8.0%, 5.3%, and 21.5% for group E; and 7.0%, 5.5%, and 25.0% for group F, respectively. These results indicated that groups C and E had the best outcomes. Therefore, the IOM guidelines seem more appropriate than the MHLW guidelines. Therefore, the MHLW recommended GWG guidelines require revision.

The status of compliance with guidelines of cancer screening in Japan

Abstract Background The Ministry of Health, Labour and Welfare (MHLW) establishes screening recommendations specifying screening methods, age, and interval for gastric, colon, lung, breast, and cervical cancers. Screening programs are provided via local healthcare departments (LHD), who are responsible for managing programs and reporting the screening status through a survey annually. Methods We analyzed screening status provided by LHDs in fiscal 2017 in regards to appropriate screening age and interval. Briefly, current recommended screening age by MHLW is followed: colon, lung, breast cancer screening are age 40 years and older, and cervical cancer for aged 20 and older, and gastric cancer for aged 50 and older. Screening intervals are gastric, breast, and cervical cancer screening are two years, and colon and lung cancer screening are one year. Results The survey was completed by 1736 LHD (response rate: 99.9%). Regarding age-appropriate compliance, in cervical cancer, 96.4% of LHDs reported following recommended target age, while compliance was lower for lung, colon, breast, and gastric cancers at 79.4%, 75.7%, 60.2% and 4.2%, respectively. High compliance with recommendations for screening interval was identified for colon (99.7%) and lung (98.7%) cancers; this was substantially less for breast, cervical, and gastric cancer screening at 39.8%, 34.1%, and 4.6%, respectively. Conclusions In 2016, MLHW changed the starting screening age for gastric cancer from 40 to 50 years old, likely resulting in the lowest compliance in our analysis. Though it may take time for screening facilities to come into compliance with newer recommendations. Many LHDs provide screening without adhering to recommended starting ages, with a general tendency to provide screening at younger than recommended ages. This is a barrier to maximizing effectiveness and minimize harms of screening and warrants closer monitoring to promote efficiency in cancer screening programs. Key messages There is relatively low compliance with cancer screening guidelines in Japan. Establishing an environment of appropriate monitoring and support to achieve the goal of cancer screening is warranted.

Re-establishment of medical and healthcare systems for nuclear emergency workers based on the lessons learned from the 2011 Fukushima nuclear accident

In response to the Fukushima nuclear accident in 2011, the Ministry of Health, Labour and Welfare (MHLW) temporarily increased emergency dose limits from 100 to 250 mSv from March 14 to December 16, 2011, but there were many problems in medical and health care systems. Based on the lessons learned, in 2015, the MHLW deliberated for radiation protection and medical and health care systems to prepare for future nuclear emergencies. The paper aims to describe and share the experience gained in the process of setting medical and healthcare systems. The paper outlines the issues of: (a) on-site medical and health care systems; (b) health care during emergency work and; (c) long-term health care. For the deliberation, the MHLW had to find the way to keep a balance between the protection of the emergency workers and the prompt implementation of crisis response. The MHLW built a consensus among stakeholders by providing lifetime healthcare systems as compensation for the radiation health risks and by enhancing preparedness to eliminate confusion and disorder and improve the level of protection against health risks. The experience gained shows that acceptance of the health risks due to radiation exposure needs not only a scientific basis, but also social acceptance.