Novartis Pharma K.K. employees could have violated the privacy protection law by accessing patients' responses to a questionnaire for a clinical study led by the University of Tokyo, an investigative committee said Wednesday.
Some employees of the Japanese sales arm of Swiss pharmaceutical giant Novartis collected and kept the responses, which should have been faxed directly to the university's secretariat from hospitals, as the responding patients were told.
In an interim report last month, University of Tokyo Hospital said that all questionnaire responses were transferred to the Novartis Pharma side and that the firm was partially involved in analyzing the response data.
The committee, which has looked into the matter at the request of Novartis Pharma, said it has identified many cases of Novartis Pharma employees' inappropriate involvement in the study that started in 2012 on the side effects of a Novartis leukemia drug.
Novartis Pharma may have been aware of and tacitly tolerated the involvement, it said.
The committee also said the company's failure to notify the health ministry about information on the side effects could run counter to the pharmaceutical affairs law.
Prosecutors are currently investigating Novartis Pharma over a former employee's alleged manipulation of clinical research data on its Diovan blood pressure drug.