TOKYO -- A senior official at the Cabinet Legislation Bureau in 2016 leaked the contents of a clinical research bill prior to its release to a mid-sized pharmaceutical company, and received an admonitory warning for doing so, it has emerged.
The official, who had previously worked at the Ministry of Health, Labor and Welfare starting in 1992, sent the information via email to a former colleague who had entered the then Ministry of Health and Welfare the same year and who now serves as a board member of the pharmaceutical company. The official admitted to their actions in an internal investigation by the ministry, but the ministry had not publicly announced the incident.
When the information was leaked in January 2016, the official in question was on temporary assignment at the Cabinet Legislation Bureau -- a government body that undertakes the screening of bills, among other tasks -- as a counselor. The official is now posted at a research organization under the Health, Labor and Welfare Ministry.
Following the scandal of manipulated clinical research data on the blood pressure drug valsartan, sold under the trade name Diovan by Novartis Pharma, the Japanese wing of the Switzerland-based pharmaceutical giant Novartis International AG, the Clinical Trials Act made it a requirement for drug companies to disclose funding it provides to research organizations that conduct its clinical trials. The bill was submitted to the Diet in May 2016, and was enacted in April 2017.
According to those knowledgeable about the latest case, the official obtained the undisclosed bill information from a Health, Labor and Welfare Ministry official they knew, and emailed it to an executive at a mid-sized drug company. The official admitted to taking such action to the ministry, and explained, "The purpose was to hear the opinion of an expert on a controversial bill. I was not aware that I had an obligation of secrecy over the information, and there were no financial transactions." The official also admitted to leaking the contents of a bill to revise the Services and Supports for Persons with Disabilities Act to interested parties prior to their release.
There are differences in the contents of the bill of the Clinical Trials Act that the official leaked to the drug company and the bill that was ultimately submitted to the Diet, and the version that was leaked had stipulations holding pharmaceutical companies ethically accountable for clinical research. This provision had been eliminated when the bill was submitted to the Diet.
When questioned by the Mainichi Shimbun, the official declined to answer, saying, "I cannot respond."
The health ministry issued an admonitory warning to the official in December 2016 for violating a duty of confidentiality. But because the punishment was less serious than one based on the National Public Service Act, the ministry determined that it did not meet public dissemination standards. Officials can be fired or suspended in cases of intentional leaking of secrets that result in the serious interference of official duties. According to those connected to the case, however, the ministry concluded the draft bill contents were based on reports that had already been publicly released, and that while some regulations were beefed up during the screening process, ultimately, nothing the official did interfered with the carrying out of official duties.
(Japanese original by Masahiro Sakai, Lifestyle and Medical News Department)