In contrast to being the subject of enforcement actions by government authorities, companies are encouraged to self-report potential FCPA issues. The FCPA Enforcement Plan and Guidance pilot program was announced by DOJ on April 5, 2016. This program intends to provide more clearly defined incentives to encourage self-disclosure of potential FCPA issues. On the flip side, the pilot program also includes fairly rigorous requirements on making the self-disclosures in order to receive cooperation credit. As such, the net effect of the pilot program remains to be seen.

Of the nine SEC cases against the healthcare industry from July 2015 to September 2016, seven were related to China. It is increasingly critical and resource intense for pharmaceutical companies operating in China to meet compliance requirements.