The PharmaCertify™ Team
Set your phasers to “Woohoo” everyone, Star Trek: Into Darkness opens in just a few days!! Not a sci-fi or Star Trek nerd? You don’t have to be, if the first movie is any indication. Great storytelling is great storytelling, regardless of genre. If nothing else, you’ll like be treated to quite a fashion show if you attend the film on its opening day. While we here at the News Week in Review anxiously await the opening, we realize there is other news to cover. So, it’s “engines to full, Scotty,” as we blast off with this week’s News Week in Review.
The Chinese government appears ready to boldly go where it hasn’t gone before – into anti-bribery enforcement. While companies doing business in China are accustomed to dealing FCPA enforcement, the Chinese government is poised to add its own anti-bribery laws to the mix. China’s high court and highest enforcement agency published guidance on the country’s two anti-bribery laws, one criminal and one civil, at the end of 2012. The emphasis has been on the criminal aspect of bribery.
The laws are not specific as to what constitutes a violation, allowing for broad interpretation by enforcement agencies. The guidance also made clear that enforcement efforts would be directed against the person giving the bribe, whereas past enforcement had been directed at the person accepting the bribe. So far, multi-national corporations have avoided prosecution, but with the government’s current penchant for pursuing high-profile and scandalous cases, the first one against a multination corporation may not be in the distant future.
Conducting anti-corruption due diligence during an acquisition is about as easy as negotiating peace with the Klingons. Mintz-Levin developed five steps to help companies minimize their FCPA successor liability in an acquisition. The due diligence is critical since the acquiring company can be on the hook for the actions of the company it’s acquiring.
Could there be trouble on the communications deck at CVS? The drug company announced it will no longer send out refill reminders that are funded by pharma companies. The company cited upcoming changes in patient data privacy requirements of HIPAA as the reason for the change. The change in the law will restrict the use of money from pharma for “only the cost of labor, supplies and postage to make the communication.”
Legal experts say CVS may be acting from an abundance of caution, but even so other pharmacies may follow suit. Determining the cost of the communications could prove difficult, and if there is no profit in continuing these programs, pharmacies may be less inclined to do so. CVS says it will continue with its own reminder programs.
Is Dr. McCoy on the list? According to a study by the New England Journal of Medicine, one in four doctors in Massachusetts have received a gift of $50 or more from a pharmaceutical or medical device company over the past two years. During that time, $76 million worth of gifts was provided to HCPs, with $67 million of that being compensation for bona fide services. (Incidentally, Leonard “Bones” McCoy did not make the list. He’s from the South, by way of…well…outer space).
On the Sunshine front, the news around the law continues to move at warp speed, with CMS coming off a busy week. The agency released the list of Teaching Hospitals for 2013, and posted a call for comments on the burden of the data collection process as they seek to refine that process.
Well, that’s it in the compliance news galaxy for last week. Have a great week everyone and we’ll see you at the movies and the conventions! Hopefully, Shatner will go easy on us.