Document Type : Original Article
Authors
1
Medical Governance Research Institute, Tokyo, Japan
2
Department of Research and Academics, Kathmandu Cancer Center, Bhaktapur, Nepal
3
Department of Internal Medicine, Soma Central Hospital, Fukushima, Japan
4
Department of General Practice, Royal College of Surgeons in Ireland, University of Medicine and Health Sciences, Dublin, Ireland
5
Department of Social and Policy Sciences, University of Bath, Bath, UK
6
NIHR Newcastle Patient Safety Research Collaboration, Newcastle University, Newcastle upon Tyne, UK
7
Navitas Clinic Kawasaki, Kanagawa, Japan
8
Breast and Thyroid Center, Jyoban Hospital of Tokiwa Foundation, Iwaki, Japan
Abstract
Background
Financial relationships between the medical device industry and healthcare providers have raised concerns about conflicts of interest (COIs). However, these relationships remain poorly characterized in Japan, despite the country’s large medical device market, which was valued at ¥4.41 trillion ($33.3 billion) as of 2021. This study examined the scale, composition, and temporal patterns of payments from the medical device industry and evaluated current transparency practices.
Methods
We analyzed publicly disclosed payment data from 117 medical device companies predominantly affiliated with the Japan Federation of Medical Devices Associations (JFMDA) from 2019 to 2022. Payment categories included research and development, academic research support, lecture and consulting fees, information-provision–related expenses, and other payments to healthcare professionals (HCPs) and healthcare organizations (HCOs). We assessed payment magnitude, category composition, company-level concentration, year-to-year changes, and disclosure transparency using an adapted proforma previously applied to European pharmaceutical payment data.
Results
Total payments amounted to $942.3 million over four years. Academic research support expenses constituted the largest share (33.0%, $310.7 million), followed by information provision–related expenses (25.2%, $237.5 million) and research and development expenses (21.7%, $204.8 million). Payments were highly concentrated, with the top 10 companies accounting for approximately 58% of total amounts. Using 2019 as the pre-pandemic baseline, total payments declined by 30.2% in 2020 and remained below pre-pandemic levels in 2021 (-24.0%), before partially recovering in 2022 (-11.6%). Category-specific trends diverged during the pandemic, with consulting, lecturing, and manuscript-related fees exceeding pre-pandemic levels by 2022, while information provision–related expenses remained substantially reduced. Transparency was limited: 78.6% of companies disclosed payment data with limited standardization, searchability, or data download functionality.
Conclusion
This multi-year analysis revealed substantial financial relationships between the medical device industry and healthcare stakeholders in Japan, alongside persistent shortcomings in transparency of disclosures. Introducing legally mandated disclosure would improve oversight and align Japan’s system with international best practices.
Keywords
