Changes may be made to the way clinical trials are financed, supervised and conducted following an inspection of 13 clinical hospitals by the Supreme Audit Office (NIK).
NIK's report drew attention to poor financial management as well as dishonesty in the way clinical trials were conducted. Its criticisms included improper management, insufficient supervision by the authorities and inconsistent regulation of aspects such as their conduct, financing and settlement.
As a result, the State Control Committee has demanded greater transparency in the rules governing the financing of clinical trials.
This is being considered by the Ministry of Health and the Ministry of Finance, and may also lead to changes in the way the State healthcare sector works with the pharmaceutical industry.
The irregularities revealed by the report may lead to corruption and other charges being brought by the Central Anticorruption Bureau and other prosecution bodes, in relation to certain aspects of the trials including the cooperation between pharmaceutical companies and medical sector companies with state healthcare representatives.
This article was written for Law-Now, CMS Cameron McKenna's free online information service. To register for Law-Now, please go to www.law-now.com/law-now/mondaq
Law-Now information is for general purposes and guidance only. The information and opinions expressed in all Law-Now articles are not necessarily comprehensive and do not purport to give professional or legal advice. All Law-Now information relates to circumstances prevailing at the date of its original publication and may not have been updated to reflect subsequent developments.
The original publication date for this article was 26/01/2011.
