Ministry Of Health, Labour And Welfare Research Articles

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.

Research evidence is essential for the development of family medicine as a discipline in the Japanese healthcare system

Japan is facing an extraordinary rapid ageing rate: approximately 40% of people will be ≥65 years of age in 2060.1 The Japanese Ministry of Health, Labour and Welfare (MHLW) have highlighted the importance of primary care physicians for coping with the ageing population and reducing healthcare expenditure.2 However, a range of stakeholders such as MHLW and the Japan Medical Association (JMA) have been debating the necessity of family medicine as a medical discipline in the Japanese healthcare system. We examined the necessity of family medicine based on the existing discussion in the Japanese healthcare system and propose future research in this area. The main characteristics of the healthcare system in Japan are universal health insurance and a free-access system, whereby patients are free to choose any healthcare facility, regardless of their insurance status or severity of illness.3 All residents of Japan including foreign nationals with a residence card are required by law to be enrolled in a health insurance programme.4 The free-access system allows patients to visit a hospital directly without referral from a family physician.3 Although the Japanese healthcare system has achieved better healthcare outcomes, such as long …

Evaluation of future cervical cancer risk in Japan, based on birth year

In 2013, following the Ministry of Health, Labor and Welfare (MHLW)'s announced suspension of its vaccine recommendation due to media reports of adverse events, HPV vaccination dropped to almost 0%. Here, we analyzed, by birth year, the cumulative vaccinations for girls up to age 16 (maximum age for public subsidies) and the results of cervical cancer screening in Matsuyama City. The incidence of CIN3 or worse was 0.09% (7/7872) for these unvaccinated generation born between 1991 and 1993, and 0.00% (0/7389) for the vaccination generation born between 1994 and 1996. This study is the first to show the significant reduction in incidence of CIN3+depending on birth year in Japan. We must keep in mind that the unacceptable high risk for cervical cancer has already begun for an entire new generation of unvaccinated girls born in or after 2000. This data encourages a resumption of MHLW's recommendation for HPV vaccination.

Evaluation of future cervical cancer risk in Japan, based on birth year

In 2013, following the Ministry of Health, Labor and Welfare (MHLW)’s announced suspension of its vaccine recommendation due to media reports of “adverse events”, HPV vaccination dropped to almost 0%. Here, we analyzed, by birth year, the cumulative vaccinations for girls up to age 16 (maximum age for public subsidies) and the results of cervical cancer screening in Matsuyama City. The incidence of CIN3 or worse was 0.09% (7/7872) for these unvaccinated generation born between 1991 and 1993, and 0.00% (0/7389) for the vaccination generation born between 1994 and 1996. This study is the first to show the significant reduction in incidence of CIN3+depending on birth year in Japan. We must keep in mind that the unacceptable high risk for cervical cancer has already begun for an entire new generation of unvaccinated girls born in or after 2000. This data encourages a resumption of MHLW’s recommendation for HPV vaccination.

Oseltamivir phosphate-Lifting the restriction on its use to treat teenagers with influenza in Japan.

In 2007, Ministry of Health, Labour and Welfare (MHLW) warned to refrain from prescribing oseltamivir for teenagers when two Japanese teenagers with influenza fell from a high-rise building after taking oseltamivir. Revisions of the warning texts of anti-influenza drugs were discussed by the Subcommittee of Pharmaceutical Affairs and Food Sanitation Council, MHLW, based on the studies and trends of anti-influenza medication over the last 10 years. The research group led by Dr Nobuhiko Okabe conducted nationwide survey since the 2007/2008 influenza season. The results of Japanese and foreign epidemiological and non-clinical studies of abnormal behaviors in influenza patients since 2009 were reviewed. Severe abnormal behaviors have been reported in influenza patients taking all types of anti-influenza drugs, as well as in untreated patients. There are some risks to patients whether treated with any anti-influenza drug, or non-treated though it is still not possible to rule out a potential causal relationship between abnormal behaviors and anti-influenza drugs. 70% of abnormal behaviors occurred within two days after the onset of fever. No difference was found between anti-influenza drugs treated and non-treated patients. In patients receiving oseltamivir and other anti-influenza drugs, the frequency of abnormal behaviors is not clearly different between teenagers and patients under 10 years old. The specific "boxed warning" and the restriction only for oseltamivir that should not be used for teenagers was lifted. Therefore, the labeling of all anti-influenza drugs carry a consistent warning about the potential for abnormal behaviors in Japan.

Current Status of &lt;i&gt;Campylobacter&lt;/i&gt; Food Poisoning in Japan

According to the annual food poisoning statistics compiled by the Ministry of Health, Labour and Welfare (MHLW) in Japan, Campylobacter replaced Salmonella and Vibrio parahaemolyticus as the leading bacterium responsible for food poisoning in 2003. Although in 2006 the number of cases of Campylobacter food poisoning was 3,439 on the basis of the MHLW statistics, it was estimated to be 1,545,363 on the basis of active surveillance, suggesting that passive surveillance yields an incidence about 450 times lower than that revealed by active surveillance. Epidemiological investigations of Campylobacter food poisoning in Japan have shown that chicken meat and its products are the most important sources of infection, as is the case in other industrialized nations. Over the last two decades, the consumption of fresh raw chicken meat and liver has been increasing in Japan. Although the MHLW recommends that chicken meat should only be eaten after thorough cooking, it is likely to account for much of the increased incidence of human campylobacteriosis. In response to this situation, the Expert Committee on Microorganisms/Viruses, Food Safety Commission of Japan, Cabinet Office, Government of Japan (FSCJ) has revised the previous risk profile of C. jejuni/coli in chicken meat by adding new findings for 2018. Moreover, the MHLW revised the Poultry Slaughtering Business Control and Poultry Meat Inspection Act in 2014 aiming at stepwise introduction of the Hazard Analysis Critical Control Point (HACCP) system into poultry processing plants. Subsequently, the Japanese government amended the Food Sanitation Act in 2018, requiring all food business operators to implement hygiene control based on HACCP principles as a general rule. This paper reviews the current status of Campylobacter food poisoning due to consumption of chicken meat in Japan and extracts the issues underlying each step of the food supply chain in order to examine the implementation of effective measures for risk management.

Aseptically Filled Tofu (Microorganisms and Viruses): Summary.

Aseptically filled Tofu was necessary to be refrigerated under the previous standards for tofu. Food Safety Commission of Japan (FSCJ) was requested by the Ministry of Health, Labour and Welfare (MHLW) to assess a food safety risk to human health on changing the standards to ambient temperature storage. Clostridium botulinum and Bacillus cereus can be significant hazards. Assuming that manufacturing procedures including sterilizing processes follow the MHLW-indicated condition, under a full hygienic control, C. botulinum and B. cereus would not exist in the final products. Therefore, FSCJ concludes that there are no substantial risks of human health irrespective of the change in the storage standard for aseptically filled Tofu.

Aluminium Ammonium Sulfate and Aluminium Potassium Sulfate (Food Additives).

Food Safety Commission of Japan (FSCJ) conducted a risk assessment of aluminium ammonium sulfate and aluminium potassium sulfate. This evaluation was requested from Ministry of Health, Labour and Welfare (MHLW) to revise the standards for use of additives. Aluminium ammonium sulfate and aluminium potassium sulfate as additives are assumed reasonably to behave as ions after dissociation, such as aluminium, ammonium, potassium, and sulfate ions, in digestive tract prior to their absorption. FSCJ thus evaluated the safety of aluminium ammonium sulfate and aluminium potassium sulfate used as additives, in considering the substances that are composed of ammonium ion, sulfate ion, potassium ion and aluminium ion. FSCJ concluded that there were no safety concerns of sulfate, ammonium and potassium ions as the use of aluminium ammonium sulfate and aluminium potassium sulfate for food additives. FSCJ specified the lowest no-observed-adverse-effect level (NOAEL) of 30 mg/kg bw/day for aluminium ion based on the reproductive developmental toxicity studies in rats. FSCJ also recognized no carcinogenicity of aluminium additives. FSCJ judged no clear relationship of dietary intake of aluminium with the influences on the bone, mainly due to the insufficient amounts of evidence. FSCJ judged no sufficient evidence to indicate a causal relationship between dietary intake of aluminium and neurological diseases including Alzheimer’s disease. FSCJ confirmed that no human data exist to indicate the clear association of the dietary intake with human health effects of aluminium. FSCJ specified this metal (Al) to be 1.0 mg/kg bw/week for the children (1 to 6 years) and 0.57 mg/kg bw/week for the general population. A safety factor of 100 was applied to the NOAEL of 30 mg/kg bw/day obtained in a developmental toxicity study in rats. Converting the value thus obtained to the aluminium intake per a week, FSCJ established a tolerable weekly intake (TWI) of 2.1 mg/kg bw/week (as Al) for aluminium.

Health Policy in Japan - Current Situation and Future Challenges.

Demographics and disease structures have a great influence on medical service delivery systems and their finances. Japan has a rapidly aging population, with those aged 65 or over accounting for 27.4% of the population. Total Fertility Rate was 1.44 in 2016 and these combined factors, fertility rate and aging population, have seen the total population fall since 2006. Consequently, there is an increase in users of social and health services and a decrease in tax payers. This requires the Japanese government to reorganize its social security system.In order to reorganize the health service delivery system, the Ministry of Health, Labor and Welfare (MHLW) has started to collect data in the form of Diagnosis Procedure Combination data and the National Receipt Database. The former gathers around 11 million discharged cases from around 3,000 acute care hospitals annually. The latter gathers more than 1.7 billion claims data from all medical facilities each year. Using these methods, the Japanese government is trying to proceed with a data-driven health reform. As the principle of the Japanese healthcare system is a private dominant supply system under public financing, the existence of appropriate information regarding health needs is crucial for reliable administration.The success of this policy depends on strong leadership by politicians with a clear direction for the future. Additionally, it is necessary to improve the ability to utilize information in society as a whole. The author believes that strengthening the foundations of health service research is crucially important for public health administration in Japan.

What Drives Adoption of National Labels as Global Reference Labels? A Case Study With the JPI.

Pharmaceutical labeling describes the safe and effective use of an approved product. Such information may be provided to consumers and/or health care physicians, and available online or in the pack in a variety of different formats according to local or regional regulations. Depending on the Health Authority (HA), content within a nationally approved label is generally reliant on two primary sources, a Company Core Data Sheet (CCDS), and the text approved by the Health Authority. Content in the nationally approved label may differ from the CCDS for a variety of reasons. In some countries, HAs require the Marketing Authorization Holder (MAH) to base their national label on an already approved label in a "major market" economy, only approving changes to the label when there is evidence that the major market has already approved. In this paper, we examine recent steps taken by the Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) to change labeling regulation in Japan in the context of the recently communicated national strategy, and assess whether this may impact on uptake of the J-PI as a reference label. Decreases in approval times by PMDA for new products, development of basic principles on multiregional clinical trials, greater transparency of content on the PMDA website, and increasing outreach to other Asian Agencies in recent years are highlighted. Labeling harmonization across regions, particularly of safety-related information, represents a key factor in promoting patient safety and risk communication, and is a worthy topic for future ICH consideration.

PMD23 - Cost-Minimization Analysis of Vercise DBS System for Parkinson’s Disease in Japan

Deep brain stimulation (DBS) is considered a standard treatment option for patients with Parkinson’s disease who are responsive to drug therapies yet exhibit motor complications. In April 2016, Japan conducted a pilot cost-effectiveness evaluation for DBS, in line with methodological guidelines defined for cost-effectiveness analyses (CEA) by the Ministry of Health, Labour and Welfare (MHLW). Three DBS devices were considered in the evaluation including Vercise DBS system (rechargeable, Boston Scientific Corporation). Clinical evidence for the CEA evaluation was obtained from a systematic literature review (SLR). Activa SC (non-rechargeable, Medtronic) was set as a comparator. As equivalence of efficacy was suggested by the SLR between the treatment and comparator DBS systems, a cost-minimization analysis (CMA) was conducted from the perspective of the public healthcare payer. Hospitalization costs were calculated using the commercial database (Medical Data Vision Co Ltd.). Follow-up costs and treatment costs for implant-site infections were estimated based on expert opinions. Battery replacement costs after implantation were also included depending on the battery life of each product. The time horizon and discount rate were set as 10 years and 2% per year, respectively. Total estimated costs for DBS treatment by Vercise and Activa SC were JPY 5,370,928 and JPY 8,552,772, respectively. Cost reduction of JPY 3,181,844 per patient was expected when treated by Vercise. When a time horizon for 20 years was assumed, a cost reduction of JPY 8,030,314 by Vercise was expected. The robustness of the results was determined by sensitivity analyses. This is the first study that evaluated the cost-effectiveness of Vercise DBS system in Japan. The results suggested that Vercise was cost-saving compared with Activa SC. Significant patient benefit is also expected because Vercise is both rechargeable and has a longer lasting battery, and therefore reduces the total number of replacements per patient.

Time-dependent changes of the intention of mothers in Japan to inoculate their daughters with the HPV vaccine after suspension of governmental recommendation

ABSTRACTIn Japan, the trend for cervical cancer at younger ages has been increasing. As a countermeasure, the HPV vaccine was introduced as a routine vaccination in April 2013. However, the Ministry of Health, Labour and Welfare (MHLW) announced a “Suspension of its active inoculation recommendation for HPV vaccine” in June 2013. In 2016, 32 months after that suspension, we conducted survey via Internet and compared the results with our previous ones conducted at 9 and 23 months after suspension (in 2014 and 2015, respectively). We examined the ‘time-dependent change’ of the ‘intention of mothers to inoculate their daughters with the HPV vaccine’ in terms of efficacy of external decision-making support. 17.5% of mothers in the first survey replied that they would inoculate their daughters under the current circumstances, 12.1% in the second survey, and 6.7% in the third, showing a consistent decrease in willingness over time (p = 0.03, p < 0.01). If the government recommendation were to be reintroduced, 22.5% of mothers in the first survey replied they would inoculate their daughters, 21.0% in the second survey, which indicated no significant difference (p = 0.65) over the first interval; however, this was significantly decreased to 12.2% in the third survey (p < 0.01). Our study revealed that the intention to inoculate their daughters has been declining among Japanese mothers over time triggered by the suspension.

REPRODUKSI WACANA METABO LAW DALAM PEMBENTUKAN STEREOTYPE FAT CHARACTER PADA ANIME JEPANG

(Title: The Reproduction Of Metabo Law Discourse In Constructing Fat Characters Stereotype In Japanese Animes) Japanese government through Ministry of Health, Labor and Welfare (MHLW) in 2008 issued the Metabo Law regulation, which is the standard of medical and health guidance that is done specifically with the purpose to decrease the number of obesity which cause the metabolic syndrome. This regulation put the body of each individual to be open to the public. Using Foucault’s perception, this study look how Metabo Law works and how the reproduction of Metabo Law discourses constructing stereotype of fat character in Japanese anime. This study took data from 14 fat character in 13 anime, airing in 2008’s until 2015’s. To complete the data, interview were conducted on 5 Japanese about their understanding about Metabo Law. This study shows that with the normalization process using yearly general checkup and the reproduction of Metabo Law discourses, Japanese government successfully change the Japanese mindset and their behavior in maintained a healthy life style and to stay slim. The stereotype of the fat character that emerge as the product of reproduction of Metabo Law discourses is greedy, careless, cowardly, shy/ have low self-confident, and an otaku.

Continuous improvement of fitness-for-duty management programs for workers engaging in stabilizing and decommissioning work at the Fukushima Daiichi Nuclear Power Plant.

Background: Numerous workers have participated in recovery efforts following the accident that occurred at the Tokyo Electric Power Company (TEPCO) Fukushima Daiichi Nuclear Power Plant after the Great East Japan Earthquake. These workers, belonging to various companies, have been engaged in various tasks since the accident. Given the hazards and stress involved in these tasks and the relatively long time required to transport sick or injured workers to medical institutions, it became necessary to quickly implement a more stringent management program for fitness for duty than in ordinary work environments. Case: It took considerable time to introduce and improve a fitness-for-duty program because of several concerns. Various efforts were conducted, sometimes triggered by guidance from the Ministry of Health, Labour and Welfare (MHLW), but the implementation of the program was insufficient. In April 2016, a new program was initiated in which all primary contractors confirmed that their subcontractors had achieved five conditions for workers' fitness for duty on the basis of guidance from the MHLW and occupational health experts. TEPCO confirmed that all primary contractors had implemented the program successfully as of the end of November 2016. Conclusion: Following a disaster, even though the parties concerned understand the necessity of fitness-for-duty programs and that companies in high positions have responsibilities beyond their legal requirements, it is highly possible that they may hesitate to introduce such programs without guidance from the government. It is necessary to prepare a governmental framework and professional resources that introduce these stringent management programs quickly.

Toward a Comprehensive Estimate of the Number of Foreign Workers in Japan

Foreign workers are playing an increasingly important role in Japan’s economy, but their total number is undetermined. The Ministry of Health, Labour and Welfare (MHLW) publishes an annual study on the number of foreign workers reported by employers; however, its data is not comprehensive or reliable because it ignores important categories of workers and does not include unreported employees due to the data collection process. In this article, a new method is proposed for providing a comprehensive estimate of the total number of foreign workers based on national census results and data on foreign residents issued by the Ministry of Justice. Estimates of the total number of workers are calculated for the years 2009 to 2016, and compared with the MHLW’s data. The estimates calculated with the proposed method are consistently above the MHLW’s figures over those years, and about 35% higher in 2016. The reasons for the differences are explained, and it is argued that the proposed method enables more credible and realistic data than the results of the MHLW’s annual study.

Perception of Japanese Physicians about Human Papillomavirus Vaccine

BackgroundCurrent vaccination coverage of Human Papillomavirus vaccine (HPVV) in Japan is less than 1% because the Ministry of Health, Labour and Welfare (MHLW) suspended its proactive recommendations for HPVV in 2013 after some reports of possible adverse events following immunization. We evaluated the perception of Japanese physicians about HPVV in order to consider the appropriate countermeasure to improve HPVV coverage in Japan.MethodsWe conducted a cross-sectional study using a postal questionnaire targeting 330 Japanese physicians (78 pediatricians, 225 internists and 27 obstetricians-gynecologists (OB-GYNs)) in Kawasaki, Japan in 2016. The questionnaire comprised questions about education frequency, physicians’ perception and recommendation behavior related to adolescent vaccines (HPVV, diphtheria tetanus toxoid (DT) and inactivated influenza vaccine (IIV)).ResultsValid responses were obtained from 148 (44.9%) physicians (pediatricians 80.8%, internists 31.6% and OB-GYNs 51.9%). Very few (8.0%) of physicians provided HPVV during the past month. Only 21.3% of physicians educated aggressively about HPVV, which was significantly less frequently than DT (61.7%) and IIV (88.6%). Similarly, 53.1% of physicians recommended HPVV aggressively, which was significantly less frequently than DT (83.1%) and IIV (80.3%). We found no significant differences in the frequency of HPVV education or recommendation by pediatricians, internists and OB/GYNs (22.4% vs. 16.9% vs. 35.7% and 54.8% vs. 47.9% vs. 71.5%, respectively). However, 90.0% of physicians answered that if MHLW were to reinstate its HPVV recommendation, they would more aggressively recommend HPVV for adolescents.ConclusionAlthough Japanese physicians were cautious about HPVV and infrequently provided education or made a recommendation for HPVV compared with other adolescent vaccines, our survey suggested such a passive attitude could be improved by the MHLW resuming its proactive recommendation in Japan.Disclosures All authors: No reported disclosures.

Price Comparison Of New Drugs In Japan, Eu And Us

Japan has the following pricing guidance: a premium is possible to be applied for an Orphan Designated drug if the premium has not been applied to its comparator. The objective of this study is to compare National Healthcare Insurance (NHI) prices of Orphan Designated drugs with Reference Countries' prices (listed in US: Red Book; UK: MIMS; Germany: Rote Liste; France: Vidal) at the time of NHI price listing. NHI price information was obtained from official websites of the Ministry of Health, Labor and Welfare (MHLW). We investigated if new drugs listed from April 2014 to December 2016 had reference countries' prices and Orphan Designation, and selected NHI prices of new drugs which have at least one or more reference countries' prices, in addition to Orphan Designation. We compared the selected NHI prices with "Foreign Average Price (FAP)", the average of all existing reference countries' prices the "EU Average Price (EUP)", the average of all existing prices of UK, Germany and France and the "US Price (USP)." A total of 181 new drugs were listed on the NHI price list from April 2014 to December 2016. Out of 181 drugs, 120 drugs (66%) had at least one or more reference countries' prices, of which 48 drugs (40%) received Orphan Designation. In addition, among the Orphan Designated drugs, 83%, 65% and 91% were priced lower than FAP, EUP and USP, respectively. For other drugs, 88%, 71% and 94% were priced lower than FAP, EUP and USP, respectively. In the past three years, NHI pricings for new drugs in Japan tended to be lower than Reference Countries' prices, even of new drugs for unmet medical needs. Further guidance to value new drugs, especially Orphan Designated drugs, would be necessary for the pricing system in Japan.

Assessment of Instructions on Protection Against Food Contaminated with Radiocesium in Japan in 2011.

The Japan Ministry of Health, Labour and Welfare (MHLW) has published instructions for radiological protection against food after the Fukushima Daiichi nuclear power plant accident in 2011. Following the instructions, the export and consumption of food items identified as being contaminated were restricted for a certain period. We assessed the validity of the imposed restriction periods for two representative vegetables (spinach and cabbage) grown in Fukushima Prefecture from two perspectives: effectiveness for reducing dietary dose and economic efficiency. To assess effectiveness, we estimated the restriction period required to maintain consumers' dose below the guidance dose levels. To assess economic efficiency, we estimated the restriction period that maximizes the net benefit to taxpayers. All estimated restriction periods were shorter than the actual restriction periods imposed on spinach and cabbage from Fukushima in 2011, which indicates that the food restriction effectively maintained consumers' dietary dose below the guidance dose level, but in an economically inefficient manner. We also evaluated the response of the restriction period to the sample size for each weekly food safety test and the instructions for when to remove the restriction. Stringent MHLW instructions seemed to sufficiently reduce consumers' health risk even when the sample size for the weekly food safety test was small, but tended to increase the economic cost to taxpayers.