How Do Institutional Conflicts of Interest Between Pharmaceutical Companies and the Healthcare Sector Become Corrupt? A Case Study of Scholarship Donations Between Department of Clinical Anesthesiology, Mie University, and Ono Pharmaceutical in Japan

Abstract

Institutional conflicts of interest (ICOIs) with pharmaceutical companies can bias internal operation of healthcare organizations. Naturally, a scholarship donation—which is a donation scheme unique to Japan, provided to healthcare organizations and their subunits to encourage educational and academic activities related to the development of new drugs—fall into the ICOI category. While anecdotal evidence exists that scholarship donations have been used as bribes by pharmaceutical companies, there has been little case study research that would illuminate the workings of this “gray area” mechanism. From this perspective, we offer an in-depth analysis of a recent scandal involving the Department of Clinical Anesthesiology, Mie University and Ono Pharmaceutical, where a scholarship donation was used by a pharmaceutical company to increase the prescription of one of its key drugs at a hospital department. Available evidence also suggests that a professor based within the department originally requested a scholarship donation from the company, which became an initial trigger of the scandal. We argue that by scrutinizing scholarship donations we can gain insight into problems specific to ICOIs between the pharmaceutical companies and the healthcare sector in Japan. In addition, scholarship donations can be understood as a form of “gifts” which have been found to underpin certain forms of pharmaceutical companies' promotional activities in Japan but also in other countries. We conclude by highlighting potential institutional remedies, which may alleviate ICOIs and corrupt behavior affecting the healthcare sector.

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

“…The physicians working in national hospitals and national universities are considered as “deemed public servants” in Japan and are legally prohibited from receiving money or services in return for any favors from pharmaceutical companies in connection with the use of their public authorities. In the recent case in the Department of Clinical Anesthesiology, Mie University, a national university hospital in Japan, scholarship donations were made to the department by Ono Pharmaceuticals to increase the physicians' product prescriptions, and the physicians were arrested as the donations were considered as bribes in the first instance 31 . The payment disclosure scheme was based on self-regulatory approach of voluntary cooperation by the pharmaceutical companies in Japan.…”

International comparison of pharmaceutical industry payment disclosures in the UK and Japan: implications for self-regulation, public regulation, and transparency

“…We seek to compare the strengths and weaknesses of self-regulation of payment disclosure using two crucial case studies: the UK and Japan. While each country has been analysed separately, the focus has been on select payments to HCPs and HCOs [ 30 , 31 , 38 , 39 , 41 , 42 , 54 ]. Disparate research designs have further constrained possibilities for systematic analysis of the uniqueness and commonalities relative to other cases, reducing generalisable international policy learning [ 30 , 31 , 38 ].…”

“…Controversy has also been caused by the Japanese company Astellas’ illicit marketing, resulting in its temporary suspension from the ABPI [ 48 , 66 ]. In Japan, several well-publicised scandals have involved kickbacks to increase prescription [ 41 ] and data fabrication in clinical trials [ 44 , 67 – 71 ]. The ensuing criminal investigations have prompted policy discussions on transparency, leading to the development of the new Clinical Trials Act [ 44 , 72 , 73 ].…”

“…To some extent, these health-system level differences entail different patterns of the industry-healthcare sector interactions. Like in other major pharmaceutical markets [ 91 ], in the UK and Japan, industry marketing targets physicians, including medical Key Opinion Leaders (KOLs) [ 63 , 94 , 98 , 99 ] and hospitals [ 41 , 100 ]. The JPMA has also sought to regulate financial ties pertinent to Japan, such as extensive funding of physicians’ and university research [ 91 ].…”

Japan's valsartan clinical trials shambles; time for fundamental changes

“…20 The money was supposedly untied but with the tacit acceptance by both donor and recipient that it would be used to fund the trials. 21 The informed consent form signed by patients agreeing to participate in the trials labelled the funding source as "internal", 22 with any such misrepresentation or hiding the role of a corporate sponsor in this way not viewed as contravening ethical norms in Japan.…”