Today, Assistant Attorney General Lanny Breuer gave a keynote address to the 10th Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum (see here for his address).
In addition, to talking about the unique FCPA compliance risks facing the pharmaceutical industry, Breuer also discussed general FCPA topics such as compliance and voluntary disclosure. Whether you are in the pharma industry or not, you probably want to take a look at what he had to say.
Here is what Breuer had to say about the “foreign official” element of an FCPA anti-bribery violation.
“…who exactly qualifies as a ‘foreign official’ in the context of a public health system, and what constitutes a corrupt offer or payment that violates the FCPA? Of course, the answers to those questions depend on the facts and circumstances of every case, and I can’t give you binding guidance from the podium today.”
Breuer also said:
“…consider the possible range of ‘foreign officials’ who are covered by the FCPA: Some are obvious, like health ministry and customs officials of other countries. But some others may not be, such as the doctors, pharmacists, lab technicians and other health professionals who are employed by state-owned facilities. Indeed, it is entirely possible, under certain circumstances and in certain countries, that nearly every aspect of the approval, manufacture, import, export, pricing, sale and marketing of a drug product in a foreign country will involve a ‘foreign official’ within the meaning of the FCPA.”
If I had attended the address, I would have raised my hand and asked these questions (perhaps someone did).
Why can’t the DOJ give binding guidance (or even just guidance) on the meaning of the “foreign official” element?”
You say that “doctors, pharmacists, lab technicians and other health professionals who are employed by state-owned facilities” are included in the range of “foreign officials who are covered by the FCPA.” However, isn’t that merely the DOJ’s interpretation of the statute, and an untested and unchallenged interpretation at that? Before companies are subject to an FCPA enforcement action based on this theory, shouldn’t there at least be some judicial acceptance of this theory? If you believe there has been, can you please provide the case cites? Is DOJ willing to make public its legal analysis and rationale for this theory?