A drugmaker that produces 30 per cent of the influenza vaccines used in Japan followed unapproved manufacturing procedures for vaccines and blood products for 40 years and systematically faked records to hide its wrongdoing, according to a scathing report compiled by a third-party committee.
Details of "serious illegal actions and an outrageous tendency for concealment" were contained in the report, which was prepared by a committee set up by the Chemo-Sero-Therapeutic Research Institute, a Kumamoto-based general incorporated foundation commonly called Kaketsuken (see below).
The Health, Labor and Welfare Ministry plans to impose an administrative penalty on the drugmaker for violating the Pharmaceuticals and Medical Devices Law, and is considering issuing a business improvement order.
The report's findings were submitted Wednesday to a meeting of experts at the ministry. Kaketsuken Director General Seiji Miyamoto announced at the meeting that he would resign effective that day, and all other directors would step down or be demoted.
According to the report, Kaketsuken has been including additives during the production process of some blood products since 1974 to help their manufacture proceed smoothly. This deviates from the manufacturing procedures that were approved by the government.
Kaketsuken was trying to quickly commercialize these products, so it did not re-apply for approval for the different methods. Until a whistleblower inside the institute exposed these unapproved methods in May 2015, Kaketsuken improperly manufactured blood products in 31 cases.
An investigation by the ministry confirmed similar wrongdoing in the making of influenza vaccines and other products.
The reports said that from 1995, in preparation for stricter inspections by the government, Kaketsuken maintained real production records and separately compiled fake production records containing information that matched the work it was authorised to do. Pages of the fake records were treated with ultraviolet rays to change their colour and make them appear to be past documents, and bogus figures of revenues and expenditures were kept to disguise the actual volume of additives kept in Kaketsuken's inventory.
The report slammed this conduct as "systematic, continuous concealment through extremely unscrupulous means."
When Kaketsuken reached a settlement with people who had filed lawsuits after contracting the AIDS virus from contaminated blood products in 1996, it promised to "continually make the utmost effort to prevent the occurrence of tragic suffering."
The report states that even at that time, Kaketsuken was covering up shady aspects of its product manufacturing. "The pledge made for this settlement was just a show. This strongly suggests the company fundamentally gave little consideration to patients and placed priority on its profits," it said.
Regarding the safety of the improperly manufactured blood products and vaccines, the report said, "We have not found any cases that clearly created fatal safety problems."
At a press conference held Wednesday evening, Miyamoto apologised for Kaketsuken's conduct. "I have known of this unforgivable 'negative legacy' that continued for many years, but it was difficult to correct because that would have had a massive impact," he said.
The committee was chaired by Shuichi Yoshikai, a former president of the Tokyo High Court.
Established in 1945 out of the research institute at the Kumamoto Medical College (now, Kumamoto University School of Medicine), Kaketsuken is one of three domestic makers of blood products using donated blood. It also holds a major share of Japan's market for the manufacture of vaccines. In the 1980s and '90s, Kaketsuken was a defendant, along with the central government and several other drugmakers, in lawsuits filed by people who contracted the AIDS virus through contaminated blood products. It admitted responsibility, reached a settlement with the plaintiffs and apologised. Total sales in the year through March 2015 were about ¥47.5 billion (S$5.4 million).