The Japanese government has threatened Novartis with the suspension of its pharmaceuticals operations in the country for not reporting over 3,200 adverse effects cases.
The story first surfaced in the Japan Times which reported that the Ministry of Health, Labor and Welfare could order a business suspension of 15 for breaching the duty of reporting serious side effects in a timely fashion. The newspaper quotes sources as saying that Novartis will be given time to explain the situation before any sanction is finalised.
Following an internal investigation, Novartis admitted in December that sales reps failed to report 3,264 cases potentially caused by adverse effects from 26 of its drugs to the appropriate group in the company. The Japan Times notes that drugmakers are required to report significant side effects within 15-30 days.
Novartis spokesman Eric Althoff sent PharmaTimes a statement saying that the company has indeed “received a pre notification from the MHLW (but) we cannot give any further information at this time”. However the group “will take all necessary steps to ensure that Japanese patients are not adversely affected by any proposed business suspension order”.
Novartis concluded by saying it would need to evaluate the details of any order from the MHLW but “we believe that the financial impact will be manageable”.
Japan is a key market for Novartis, accounting for about 7% of turnover last year.
