Pharmaceutical Companies In Japan Research Articles

Cross‐sectional analysis of pharmaceutical industry payments to board‐certified breast cancer specialists in Japan

AbstractFinancial interactions between pharmaceutical companies and physicians introduce conflicts of interest among physicians, and can unduly influence physicians' clinical decision‐making, such as increased use of non‐recommended cancer treatments and higher healthcare expenditures. Breast cancer is the most common cancer for which there is a growing number of novel treatments. Nevertheless, the financial relationships between pharmaceutical companies and physicians treating patients with breast cancer remain unknown. Using payment data disclosed by major pharmaceutical companies in Japan between 2016 and 2020, this study examined size and trends in non‐research payments from the pharmaceutical companies to breast cancer specialists who were board‐certified by the Japanese Breast Cancer Society. A total of $17.2 million were made to 1349 or 77.8% of all board‐certified breast cancer specialists over the five years. Of all specialists, 41.9% to 55.5% received the payments each year. The median payments per specialist were $1,149–$1,371 annually. Only 5op 1% and 10% of all specialists received 24.7% and 70.3% of all payments to the specialists. The payments per specialist significantly increased by 9.9% (95% confidence interval: 6.713.1, p < 0.001) from 2016 to 2019, but decreased by 29.6% (95% CI: −34.4 to −24.5, p < 0.001) in 2020 when the COVID‐19 pandemic occurred. Given that even a small payment to physicians is associated with their clinical practice, it is imperative that these breast cancer specialists are more aware of the potential influence of payments on their decision‐making.

Real World Data Use in Pharmaceutical Companies in Japan： Current Status and Issues from Survey of Japan Pharmaceutical Manufacturers Association

Real World Data Use in Pharmaceutical Companies in Japan： Current Status and Issues from Survey of Japan Pharmaceutical Manufacturers Association

Association Between Gender and Payments Received From Pharmaceutical Companies Among Medical Professors and Associate Professors in Japan.

Introduction While prior research showed gender gaps in industry payments for medical professionals in the United States, there are limited data in Japan. So, this study seeks to investigate the potential gender gap in the receipt of pharmaceutical companies (PFCs) across all medical fields in Japan. Based on the results of previous studies, we developed a hypothesis that male doctors get more PFC than female doctors. Materials and methods Data from 92 pharmaceutical companies in Japan, covering 2016 to 2019, were analyzed. The analysis was conducted on professors and associate professors at all national and public medical universities in Japan, with gender as a factor variable and payments as an outcome variable, and variables that may have influenced the factor or outcome variables in previous studies, such as specialization, university type, region, rank and years since graduation, as control variables.Payments were converted to US dollars using the December 31, 2021, rate of 115 yen to the dollar for comparison purposes. Results Out of 1,825 subjects, 1,755 were males and 70 females. Males consistently received higher median payments from pharmaceutical companies (PFCs) than females across categories. In particular, among physicians specializing in internal medicine, the median PFC for men was $25 compared to $8 for women. For physicians affiliated with former imperial universities (the seven former imperial universities founded before World War II), the median PFC for men was $32compared to $5 for women. Multivariate analysis confirmed significantly higher total benefits for males from 2016 to 2019, with the gender gap widening during this period(incidence rate ratio (IRR) for 2016: 0.51, IRR for 2019: 0.44). Conclusions Japanese male professors and associate professors received significantly higher PFCs than their female counterparts, and this gender gap expanded from 2016 to 2019, highlighting persistent gender inequality in the medical field in Japan, similar to trends observed in the United States.

Nature and Trend of Pharmaceutical Payments to Japanese Board-Certified Neurologists Between 2016 and 2019: A Pre-emergence Analysis Amidst the Development of Next-Generation Alzheimer's Disease Drugs.

There is insufficient data on the financial relationships between Japanese neurologists and pharmaceutical companies prior to the advent of new-generation Alzheimer's disease drugs. The purpose of this study is to evaluate the magnitude, prevalence, and trend of the financial relationship between Japanese neurologists and pharmaceutical companies between 2016 and 2019. A cross-sectional study was undertaken to evaluate the financial relationships between all board-certified neurology specialists and pharmaceutical companies in Japan from 2016 and 2019. Descriptive statistics were applied to measure the magnitude and prevalence of payments among specialists, as well as their trends during the study periods. In a four-year analysis, 77 pharmaceutical companies disbursed a total of USD 36,869,204 across 50,050 payments to 2,696 neurologists in Japan, revealing a mean payment of USD 10,809 per specialist. Notably, the Gini index of 0.997 indicated a high inequality in payment distribution, with a minority of specialists receiving a substantial proportion of payments. Trends displayed irregularities, but an overall increase in total payments from 2016 to 2019, with a significant contribution from the top 10 pharmaceutical companies accounting for 74.2% of total payments, with Takeda Pharmaceutical and Eisai Company notably increasing payments in 2019. There were notable geographical variations in neurologist and payment distribution across 47 prefectures. Our analysis of neurologist payments from pharmaceutical companies in Japan showed a substantial financial relationship with overall increases, yearly varied increments, and payment inequality. Caution is warranted as financial ties may intensify with the continued development of next-generation Alzheimer's disease drugs.

Assessment of Financial Relationships Between Otorhinolaryngologists and Pharmaceutical Companies in Japan Between 2016 and 2019.

There are prevalent financial relationships between physicians and the pharmaceutical industry in medical specialties, including otorhinolaryngology. Although these relationships might cause conflicts of interest, no studies have assessed the size and contents of the financial relationships between otorhinolaryngologists and pharmaceutical companies in Japan. This study aims toevaluate the magnitude, prevalence, and trend of the financial relationship between Japanese otolaryngologists and pharmaceutical companies. Using payment data publicly disclosed by 92 pharmaceutical companies, we examined the size, prevalence, and trend in personal payments made to the otorhinolaryngologistboard certified by the Japanese Society of Otorhinolaryngology-Head and Neck Surgery (JSO-HNS) between 2016 and 2019 in Japan. Furthermore, differences in payments were evaluated by whether otolaryngologists were clinical practice guideline authors, society board members, and academic journal editors or not. Trends in payments were evaluated by generalized estimating equations. Of 8,190 otorhinolaryngologists, 3,667 (44.8%) were paid a total of $13,873,562, in payments for lecturing, consulting, and writing by 72 pharmaceutical companies between 2016 and 2019. The median four-year combined paymentper physician was $1,022 (interquartile range: $473-$2,526). Top 1%, 5%, and 10% of otorhinolaryngologists received 42.3% (95% confidence interval (95% CI): 37.2%-47.4%), 69.3% (95% CI: 65.9%-72.8%), and 80.6% (95% CI: 78.3%-82.9%) of overall payments, respectively. The median payments per physicianwere significantly higher among otorhinolaryngologists authoring clinical practice guidelines ($11,522), society board members ($22,261), and journal editors ($35,143) than those without. The payments and number of otorhinolaryngologists receiving payments remained stable between 2016 and 2019. This study demonstrates that a minority but a large number of otorhinolaryngologists received personal payments from pharmaceutical companies for the reimbursement of lecturing, consulting, and writing in Japan. Large amounts of these personal payments were significantly concentrated on a small number of leading otorhinolaryngologists.

Quality culture and knowledge management in the Japanese pharmaceutical industry - A cross-sectional study and case report.

Illicit pharmaceutical manufacturing, affecting the quality of drug products, has been frequently reported in Japan. Insufficient good manufacturing practice compliance and lack of quality culture in some pharmaceutical companies have been suggested as the underlying reasons for such cases. We aimed to focus on knowledge management and fostering of quality culture in pharmaceutical companies in Japan to understand their current situation and find a strategy for the availability of high-quality reliable pharmaceutical products. A wide-ranging questionnaire survey was conducted to understand the issues related to knowledge management and fostering of quality culture across pharmaceutical companies in Japan. A published investigation report on an illicit manufacturing case was closely examined by organizing the available facts using the diagram. Based on 395 responses to the questionnaire survey, we found that although pharmaceutical companies understand the importance of knowledge management and quality culture, issues exist in their operational methods. A total of 94% of the respondents agreed that they mentioned ″knowledge management″ as an enabler of the Pharmaceutical Quality System of ICH Q10, and 98% of the respondents accepted that insufficient fostering of quality culture leads to corporate risk. However, the survey revealed that many companies are struggling with this approach. Based on a report on an illicit manufacturing case, we analyzed the direct causes of misconduct and prepared a systematic summary that can be easily comprehended. Comparison of the illicit manufacturing case report with our questionnaire results suggests that many pharmaceutical companies do not regard the misconduct case as a situation that could occur in their company. With the revision of the Pharmaceuticals and Medical Devices Act and good manufacturing practice Ministerial Ordinance, we advocate the need for all employees of pharmaceutical companies to reconsider the priorities of their companies from the patient perspective.

Financial conflicts of interest between pharmaceutical companies and executive board members of internal medicine subspecialty societies in Japan between 2016 and 2020.

Pharmaceutical companies make payments to physicians such as compensations for lecturing or consulting. Of particular, financial relationships between pharmaceutical companies and leaders of professional medical societies are concern in medical community. However, little was known about them in Japan. This study aimed to evaluate the magnitude and prevalence of personal payments to executive board members (EBMs)of 15 medical associations representing different subspecialties within the Japanese Society of Internal Medicine. All EBMs of 15 medical associations representing internal medicine subspecialties were collected from each association webpage. Payments to the EBMs were extracted from the pharmaceutical companies belonging to the Japan Pharmaceutical Manufacturers Association between 2016 and 2020. We performed descriptive analysis on the payment data. Of the 353 different EBMs identified, 350 (99.2%) received one or more personal payments from the pharmaceutical companies over the 5 years. 99.2% (350) and 97.2% (343) of all EBMs received personal payments 3 years before and in the year of their board membership. A total of $70,796,014 were made to the EBMs over the 5 years. The median 5-year combined personal payments per EBM was $150,849 (interquartile range [IQR]:$73,412-$282,456). EBMs who were chairman or vice chairman of executive board received significantly larger median personal payments than those who were not ($225,685 vs. $143,885, p = 0.01 in the U test). Among the 15 societies, there were 12 (80.0%) societies with all (100%) EBMs receiving personal payments from the pharmaceutical companies. Although every society has their own conflicts of interest policy, none publicly discloses the financial relationships between pharmaceutical companies and their EBMs due to their privacy. This study demonstrated that nearly all EBMs of 15 medical associations representing internal medicine subspecialties had substantial financial relationships with the pharmaceutical companies in Japan over the past 5 years.

Pharmaceutical payments to Japanese board-certified dermatologists: a 4-year retrospective analysis of personal payments from pharmaceutical companies between 2016 and 2019

There are prevalent financial relationships between dermatologists and pharmaceutical companies in Japan. However, little was known about the extent of whole picture of the personal payments made to dermatologists by pharmaceutical companies. This study aimed to examine the personal payments to the board-certified dermatologists by the Japanese Dermatological Association from the pharmaceutical companies between 2016 and 2019. Using the publicly disclosed payments data by the pharmaceutical companies between 2016 and 2019, we evaluated the magnitude, prevalence, and trends in the personal payments made to all board-certified dermatologists for the lecturing, writing, and consulting compensations. The payments were descriptively analyzed overall and by dermatologist demographics. Additionally, the payment trends were assessed by generalized estimating equation models. Of 6883 active board-certified dermatologists, 3121 (45.3%) received a total of $33,223,806 personal payments between 2016 and 2019. The median per-physician payments and number of payments (interquartile range) were $1737 ($613–$5287) and 4.0 (2.0–10.0) over the 4 years, respectively. Only top 1%, 5%, 10% of dermatologists received 41.7% (95% confidence interval [CI] 38.2–45.1%), 76.9% (95% CI 74.7–79.1%), and 87.6% (95% CI 86.2–88.9%) of overall payments. The number of dermatologists receiving payments and per-dermatologist payments increased by 4.3% (95% CI 3.1‒5.5%, p < 0.001) and 16.4% (95% CI 13.5‒19.4%, p < 0.001) each year. The board-certification in dermatology-oncology, in cosmetic dermatology, and male sex were significantly associated with higher personal payments with relative monetary values of 2.29 (95% CI 1.65–3.19, p < 0.001), 3.16 (95% CI 1.89–5.26, p < 0.001), and 5.38 (95% CI 4.12–7.04, p < 0.001). Less than half of Japanese board-certified dermatologists received lower personal payments from the pharmaceutical companies than those to other specialists. However, these personal payments were increasingly more prevalent and greater over the 4 years.

Cross-sectional analysis of pharmaceutical payments to Japanese board-certified gastroenterologists between 2016 and 2019

ObjectivesLimited evidence is available regarding the financial relationships between gastroenterologists and pharmaceutical companies in Japan. This study analysed the magnitude, prevalence and trends of personal payments made by major pharmaceutical...

Exploratory Analysis of Drug Lag in New Oncology Drugs Between Japan and the US.

Drug lag in Japan has greatly decreased over the past decades; however, new instances of drug lag have appeared along with changes in the circumstances of oncology drug development. We aimed to investigate the factors associated with the approval lag for new oncology drugs between Japan and the United States (US) over the past decade by comparing approval dates and modalities, lead indications, approval types, and phase I strategies for earlier approval in Japan. We descriptively evaluated the characteristics of 117 new oncology drugs approved in either Japan or the US from January 1, 2011, to December 31, 2020. Seventy-one drugs were approved in Japan, 112 in the US, five only in Japan, and 46 only in the US. Interestingly, new oncology drugs were predominantly developed by the top 20 pharmaceutical companies in Japan; however, the opposite was true for drugs that were not yet approved in Japan. However, no clear trend was observed in the relationship between drug lag and the studied factors, except for the phase I strategy. There was a numerical but clear trend in which a higher percentage of phase I multiregional clinical trials (MRCTs) in the drug development strategy was observed for drugs with earlier approval in Japan. Participation in global drug development during the early stages, such as during phase I MRCTs, is one of the keys to successfully minimizing this new instance of drug lag in Japan.

Evaluation of non-research payments from pharmaceutical companies to urologists in Japan between 2016 and 2019.

To evaluate the magnitude and trends in personal payments from pharmaceutical companies to urologists in Japan. This cross-sectional study examined the personal payments made to urologists by the major pharmaceutical companies in Japan between 2016 and 2019. Descriptive analyses were performed on the payment data. All urologists board-certified by the Japanese Urological Association as of March 2022 were included in this study. Trends in personal payments were assessed using the population-averaged generalized estimating equations with panel data of per-physician personal payments. Among 7016 active board-certified urologists, 4962 (70.7%) accepted 53,070 payments totaling $36,424,239 for reimbursement of lecturing, writing, and consulting compensations from 66 pharmaceutical companies between 2016 and 2019. The median payments per urologist receiving payments were $1714 [interquartile range(IQR): $700-$4583] in payment amounts and 4.0 (IQR: 2.0-10.0) in the number of payments. Only 1%, 5%, 10%, and 25% of top-paid urologists accepted 36.2%, 64.8%, 75.8%, and 90.1% of overall payments respectively. The payments per urologist and the number of payment contracts had annually increased over this period by 4.1% (95% CI: 2.3%-6.0%, p < 0.001) and 2.4% (95% CI: 1.2%-3.7%, p < 0.001), but there was no significant change in the number of urologists receiving payments, with a relative average annual change of 0.7% (95% CI: -0.15%-1.6%, p = 0.10) between 2016 and 2019. Most urologists received personal payments for lecturing, consulting, and writing compensations from pharmaceutical companies in Japan. The payments from pharmaceutical companies had been increasing over the 4-year period. These payments were substantially concentrated on a small number of urologists.

Financial Relationships Between Pharmaceutical Companies and Rheumatologists in Japan Between 2016 and 2019.

Given the increasing number of novel and expensive drugs for rheumatoid diseases, the financial relationships between pharmaceutical companies and rheumatologists could be prevalent and substantial. However, little was known about the information in Japan. Using payment data publicly disclosed by 92 major pharmaceutical companies, we evaluated the financial relationships between pharmaceutical companies and rheumatologists who were board certified by the Japan College of Rheumatology between 2016 and 2019. The trends in payments were estimated by the generalized estimating equations with 4-year payment data. Differences in payments between general and leading rheumatologists including the board members, clinical practice guideline authors, and medical journal editors were assessed. Of the board-certified rheumatologists, 70.7% (3563 of 5038) received a total of $55,246,485 in personal payments for lecturing, writing, and consulting from 79 pharmaceutical companies between 2016 and 2019. The median payments per rheumatologist receiving payments were $3447 (interquartile range, $1124-$11,974) in payment amounts. There were increasing trends in the payments per rheumatologist and the number of rheumatologists with payments, with average yearly change rates of 5.9% (95% confidence interval, 3.9%-7.9%; p < 0.001) and 1.2% (95% CI, 0.3%-2.0%; p = 0.008). The leading rheumatologists such as the society board members, clinical practice guideline authors, and medical journal editors received much more payments than other rheumatologists. Most rheumatologists increasingly received personal payments for lecturing, consulting, and writing reimbursements from pharmaceutical companies in Japan. These payments were significantly concentrated on rheumatologists in authoritative and influential positions.

Nature and Trends in Personal Payments Made to the Respiratory Physicians by Pharmaceutical Companies in Japan between 2016 and 2019

Background: Financial relationships between healthcare professionals and pharmaceutical companies have historically caused conflicts of interest and unduly influenced patient care. However, little was known about such relationship and its effect in clinical practice among specialists in respiratory medicine. Methods: Based on the retrospective analysis of payment data made available by all 92 pharmaceutical companies in Japan, this study evaluated the magnitude and trend of financial relationships between all board-certified Japanese respiratory specialists and pharmaceutical companies between 2016 and 2019. Magnitude and prevalence of payments for specialists were analyzed descriptively. The payment trends were assessed using the generalized estimating equations for the payment per specialist and the number of specialists with payments. Results: Among all 7,114 respiratory specialists certified as of August 2021, 4,413 (62.0%) received a total of USD 53,547,391 and 74,195 counts from 72 (78.3%) pharmaceutical companies between 2016 and 2019. The median (interquartile range) 4-year combined payment values per specialist were USD 2,210 (USD 715–8,178). At maximum, one specialist received USD 495,332 personal payments over the 4 years. Both payments per specialist and number of specialists with payments significantly increased during the 4-year period, with 7.8% (95% CI: 5.5–9.8; p < 0.001) in payments and 1.5% (95% CI: 0.61–2.4; p = 0.001) in number of specialists with payments, respectively. Conclusion: The majority of respiratory specialists had increasingly received more personal payments from pharmaceutical companies for the reimbursement of lecturing, consulting, and writing between 2016 and 2019. These increasing financial relationships with pharmaceutical companies might cause conflicts of interest among respiratory physicians.

Proposal for the revision of guidelines for clinical trials of vaccines to prevent infectious diseases in Japan

The development of vaccines against infectious diseases requires a different approach from that of therapeutics, because vaccines are inoculated into healthy individuals and have a preventive effect by activating the immunity of the inoculated human. In Japan, “The Guideline for Clinical Trials of Vaccines for the Prevention of Infectious Diseases” was published in 2010 before changes occurred in the vaccine development environment in Japan, such as the introductions of foreign vaccines and simultaneous global development. This study aimed to identify current challenges in vaccine development through a questionnaire-based survey of pharmaceutical companies in Japan and by comparing the domestic and international guidelines and surveying review reports of 35 vaccines approved in Japan between April 2010 and December 2020. Identified challenges included the requirement for protective efficacy trials, efficacy evaluation of combination vaccines, development of multiregional and foreign clinical trials, and immunization of older adults and immunocompromised patients. We propose that new vaccines against infectious diseases should be evaluated for the protective efficacy, preferably through multiregional clinical trials. Additionally, differences in the incidence of infectious diseases or in epidemic virus strains between regions may affect the trials, when multiregional clinical trials are conducted, but immunogenicity-based studies can be conducted if a correlation between protective efficacy and immunogenicity has been established. We suggest that licensed combination vaccines can be used as comparators when an antigen is added to a licensed combination vaccine. We also proposed that the efficacy of a vaccine in non-major subjects, such as older adults or immunocompromised patients could be evaluated by comparing immunogenicity in major subjects with the confirmed protective effects of the vaccine. It is expected that these revisions will lead to the rapid advancement of vaccine development, which should contribute to the improvement of public health.

Digital Transformation Challenges in the Sales of Pharmaceutical Companies in Japan

While the pharmaceutical industry is rated as having less digital maturity than other industries, the changing environment, especially due to the COVID-19 pandemic, has been giving momentum to the rise of digital transformation (DT). This study explored the current status and background of DT on sales and how DT has been promoted in Japan based on 20 interviews with leaders and consultants in the pharmaceutical industry. The results showed that while their DT was still at an early stage, DT had been driven by external factors, including the pandemic, with commitment from top management. We identified four changing external factors and nine initiatives in relation to the new activities: three in the practical stage and six in the developing stage. An interesting aspect was that regulations might both promote and hinder DT in this industry combined with COVID-19. As there has been limited domain-specific research in DT of the pharmaceutical industry in Asia, the study is considered to contribute to both academic research and practice in Asian business.

Financial and Intellectual Conflicts of Interest Among Japanese Clinical Practice Guidelines Authors for Allergic Rhinitis.

To elucidate financial and intellectual conflicts of interest (COIs) among clinical practice guideline (CPG) authors of allergic rhinitis in Japan and to evaluate the extent of transparency and accuracy in COIs by CPG authors of allergic rhinitis. A cross-sectional analysis of the payment data from all 79 pharmaceutical companies in Japan between 2016 and 2017. Japan. We considered all 27 CPG authors from 2 different versions of the most prominent CPGs for allergic rhinitis in Japan. Using payment data disclosed by 79 major pharmaceutical companies between 2016 and 2017, we assessed the magnitude and characteristics of financial COIs of CPG authors. We also evaluated the intellectual COIs of the CPG authors by counting self-citations of research articles related to CPG statements and recommendations. Of 27 CPG authors, 26 authors (96.3%) received at least 1 payment from a combined total of $1,333,552 between 2016 and 2017. The 2-year combined average and median monetary values per author were $49,391 (SD, $67,438) and $18,400 (interquartile range: $6,216-$72,494), respectively. Pharmaceutical companies with novel drugs predominantly made these payments. The percentage of citations with at least 1 CPG author relative to total citations was 47.6% in 2016 and 27.9% in 2020. There were no formal COI disclosure statements in either version. This study found that allergic rhinitis CPG authors had significant financial relationships with pharmaceutical companies, particularly those marketing novel drugs. In addition, CPG authors had relatively high self-citation rates, a potential marker of intellectual COIs. More rigorous and comprehensive COI management strategies are needed.

Evaluation of rapid drug safety communication materials for patients in Japan.

Since 2011, pharmaceutical companies in Japan have been required to issue two types of documents regarding severe adverse drug reactions reported post-marketing, namely the Rapid Safety Communication Materials for Patients and the Related Materials. However, the adequacy of these documents has not yet been systematically assessed. The aim of this study was to evaluate the adequacy of these two types of materials. The Rapid Safety Communications for Patients were obtained from the Pharmaceuticals and Medical Devices Agency (PMDA) website. The Related Materials were obtained from pharmaceutical companies or the PMDA website. Three assessors independently scored the Rapid Safety Communication for Patients and the Related Materials using the Centers for Disease Control and Prevention Clear Communication Index (CCI). In addition, the contents and descriptions of the materials were analyzed. In total, 13 materials for seven drugs were assessed. Almost all materials contained the "main message" and "call to action". However, the average CCI scores for the Rapid Safety Communication for Patients and Related Materials for Patients were 68.8 and 74.3 (out of 100), respectively. Further, none of the evaluated materials were scored above the CCI threshold score (i.e., ≥ 90%). Descriptions regarding "language", "state of science", and "risk" were not adequate. In particular, the terminology used in materials seemed difficult for patients to understand. In conclusion, the Japanese Rapid Communication Materials for Patients require improvement. Furthermore, a system for evaluating these materials prior to publication should be established.

Significance and Practice of Medical Education Conducted by Medical Affairs of Pharmaceutical Companies in Japan

Significance and Practice of Medical Education Conducted by Medical Affairs of Pharmaceutical Companies in Japan

Pharmaceutical Company Payments to Japanese Government Drug Regulation Committee Members.

Little is known about the characteristics and distribution of financial conflicts of interest (FCOIs) in the drug regulation process, both in Japan and globally. This study aimed to identify the characteristics and distribution of pharmaceutical payments to members of Japanese government drug regulation committees, and to assess the accuracy of their FCOI statements. Among members who worked for either of the five committees of the Pharmaceutical Affairs and Food Sanitation Council (PAFSC), which is the advisory committee for pharmaceutical affairs in Japan, from April 1, 2017 to March 31, 2019, the extent of payments in 2016 from 78 major pharmaceutical companies in Japan and the accuracy of the self-reported FCOI disclosures were assessed. Of 108 members, 54 (50%) were medical doctors. The payments to the PAFSC members totaled ¥115,765,006 ($1,064,017), and the mean (SD) payment was ¥1,071,898 ($9,852) (¥2,272,520 ($20,887)). Fifty-one members (47%) received at least one payment from a pharmaceutical company in 2016; 32 members (30%) received more than ¥500,000 ($4,600). Of 8,530 declarations from five councils, 409 (4.8%) of the FCOIs self-reported by the committee members were inaccurate. Of those inaccurate disclosures, 112 of 409 inaccurate disclosures (27.4%) would have prevented the recipients from participating in the drug-approval decision-making processes had they been correctly disclosed. Almost half of drug regulation committee members in Japan received at least one payment from pharmaceutical companies in 2016. Moreover, several FCOIs they reported were inaccurate.

Reducing Reimbursement Drug Price Risk to Enhance R&D Incentives without Raising Drug Prices/Expenditures: Implications of Simulations Based on Questionnaire Survey of Pharmaceutical Companies in Japan

Due to severe financial conditions and unmet medical needs, the Japanese government must prioritize both R&D incentives and drug prices/expenditures. However, increasing reimbursement drug prices to strengthen R&D incentives also increases the financial burden on patients and the National Health Insurance, wherein virtually all prescription drugs are reimbursed, with prices determined and controlled by the government. Hence, it is important to find ways to achieve higher R&D incentives without raising drug prices/expenditures. To seek such policies, we focus on the reimbursement drug price risk of pharmaceutical firms. An original questionnaire survey is used to collect data on the price-risk attitudes of R&D-oriented pharmaceutical firms in Japan. With this data, we conduct numerical simulations to quantify the effect of reducing the reimbursement drug price risk on firms’ R&D incentives. Then, we check the robustness of our results. We find that many R&D-oriented pharmaceutical firms in Japan are risk averse. Thus, to enhance R&D incentives, reducing price risk is effective. The simulated impact of removing a ±10% price risk is equivalent to winning a 5% premium, which is substantial. These results are robust to changes in utility form, price/sales patterns and market size, while increased price risk enhances the simulated impact.