Changes in international legislation and trends in enforcement have continued to be a moving target for 2014 and 2015. In the area of FCPA enforcement, several trends provide guidance on what companies need to be conscientious about in the coming year. In the area of international regulations, there continues to be an upswing in the number of countries that have added new regulations or tightened requirements around existing legislation to send a message regarding their efforts to reduce corruption.
The OIG plan for 2015, re-released in May, with updates from the plan that was released in October 2014, demonstrates a pattern of what we have seen in the past, as well as the addition of a few new items. Of note, the OIG will continue its investigative actions focused around their strike force teams (formed in 2007) and the Health Care Fraud Prevention and Enforcement Action Team (HEAT) (started in 2009). The OIG highlighted that their strike force activities from October 1, 2014 to March 21, 2015 have resulted in more than $163 million in fines and charges against 69 individuals or entities. The OIG will also continue to investigate companies that manipulate payment codes and submit false claims, as well as review business arrangements that could violate the Anti-Kickback Statute.
In today’s market, pharmaceutical, medical device, and biotech companies straddle two worlds. In one world, they are driven by a public need to ensure access to a safe product at an affordable price. In another world, companies are driven by a competitive and capitalistic market to increase profit and market share while lowering costs. These two worlds do not have to be in conflict, but they sometimes are, and those conflicts can drive an ethical perception of an organization. The 2013 Harris poll in the United States indicated that American consumer perceptions of the pharmaceutical industry had gone down: only 10 percent of American consumers believed that the pharmaceutical industry was trustworthy (down from 13 percent in 2003), and were considered less trustworthy than other regulated industries, such as banking (18 percent) and public utilities (14 percent). In addition, 39 percent of survey respondents indicated that they wanted to see more government regulation in the pharmaceutical industry.
In today’s life sciences industry, mergers and acquisitions are becoming ever more prevalent as a means to ensure that strategic, operational, and financial goals are met, and that customers and patients have the products they need. The planning and execution of a partnership is often vetted thoroughly in terms of complementary product lines, financial goals, strategy for market presence, and access for those who need it.