Week in Review, August 19, 2013

The PharmaCertify Team

Can you hear it? That low wail that’s bound to grow stronger over the next few weeks. Yes, it’s the cry of school children everywhere, as the end of summer vacation creeps closer. Yellow buses will soon populate the roadways, and the odor of freshly-sharpened number two pencils will fill the air… a wonderful time of year (unless of course you happen to be under the age of 18)! With those happy thoughts, let’s ring the bell on this week’s News Week in Review.

A new anti-corruption lesson plan is about to take effect in Brazil. The country’s president signed a new anti-corruption law that increases the country’s corruption prohibitions. The law imposes liability on corporate violators and increases fines, which can now be up to 20% of the violator’s gross revenue for the preceding year. The law, which covers corrupt payments to foreign or domestic officials, goes into effect at the beginning of 2014.

The Serious Fraud Office (SFO) appears to be handing out failing grades with the filing of the first charges under the U.K. Bribery Act. The agency filed fraud charges against four men for providing false information related to the selling of bio fuel investment products. The fraud is alleged to have occurred between April of 2011 and February of 2012, to the tune of 23 million pounds.

Time for some serious homework at SciClone, Inc. The company announced it had received a new subpoena in an ongoing investigation into potential violations of the FCPA. The subpoena was received in the last quarter of 2012. Both the DOJ and SEC have been investigating the company over operations in China since 2010. The company did not disclose the particulars of the latest subpoena, but did announce its board had opened a new investigation into matters related to the company’s acquisition of NovaMed Pharmaceuticals, FCPA violations and certain sales and marketing expenses.

Corporate employees are taking their hall monitor duties very seriously. According to a report from the Network and BDO Consulting, use of the company hotline has been steadily rising over the last two years for most companies. The report evaluated over 600,000 hotline incident reports from 2008 to 2012. The companies were divided into five groups, based on number of employees. Only the group made up of companies of 20,000 – 50,000 employees saw a decrease in incident rate. The report also showed that 72% of the people who made a report via a hotline did not report the issue to a manager first.

Transparency tutoring is now available from the Association of the British Pharmaceutical Industry (APBI). The group has launched a toolkit to help its members comply with the requirements for disclosing information from or about clinical studies. The toolkit, which includes practice guidelines, disclosure checklists and a template SO, will be updated regularly to include changing international requirements.

The final bell is about to ring on this week’s Review, but before we dismiss ourselves, we ask, have you thought about re-evaluating your compliance “lesson plans?” As the summer ends, this is a great time to think about new ways to engage you’re your learners with fresh compliance content and innovative training techniques.

Have a great week every one!

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