On August 3, 2009, the Department issued its first FCPA Opinion Procedure Release (the “Opinion”) of the year.36 In that Opinion, a U.S. medical device manufacturer (the “Requestor”), proposed to provide $1.9 million in medical devices, related accessories and services to the government health centers in a foreign country. The Requestor represented that it learned about a foreign government’s plan to purchase medical devices for patients in need while meeting with a senior government official (“Senior Official”) from that country. The Senior Official informed the Requestor that all major manufacturers could participate in the tenders for these medical device purchases, but that the foreign government would endorse only those devices that it had favorably evaluated. Since the foreign government was not familiar with the Requestor’s product, the Senior Official asked the Requestor to provide sample devices for evaluation in order to receive the government’s endorsement. The Senior Official and the Requestor jointly determined the optimal evaluation sample size to be 100 devices distributed among 10 medical centers in the foreign country.

In seeking an Opinion from the Department, the Requestor represented that it would select the centers that would participate and that the medical centers would nominate candidates to receive the devices based on criteria provided by the Requestor and documentation of an inability to pay for the devices. The ultimate recipients would then be selected by a working group comprised of experienced health care professionals, together with the Requestor’s Country Manager, a physician who had received FCPA training. To ensure transparency, the Requestor represented that the recipients’ names would be published on a government agency website for two weeks following their selection.

In addition, as represented by the Requestor, close family members of government officials connected to the evaluation process would be ineligible to be recipients of the device unless it was determined that the government official could not influence the selection or evaluation process, they met the economic criteria, and the recipient relative was deemed a more suitable candidate than others whose selection was not based on this technical criteria. The Requestor’s Country Manager would also personally review the selection of such candidates to ensure strict adherence to the selection guidelines and forward his determination to the Requestor’s legal counsel. The Requestor would also report the selection of any such candidates to the Department.

The Requestor further represented that the evaluation of the medical devices would be based upon objective criteria which were provided to the Department. The Requestor proposed that its Country Manager, along with two medical experts, review the evaluation results and provide a report to a senior health official in the foreign country. That official would subsequently provide an assessment to the government agency, which would ultimately decide whether to endorse the Requestor’s device. The Requestor also represented that the foreign government advised that it would not promote any one qualified device over another. The Requestor further asserted that it did not have any reason to believe that the Senior Official who initially suggested providing the devices would personally benefit from the donation of products and services.

In its Opinion, the Department stated that it did not presently intend to take any enforcement action based upon the facts and circumstances as represented by the Requestor. Significantly, the Department noted that the conduct as described in the request, fell outside the scope of the FCPA, because the products and services would be provided “to the foreign government, as opposed to individual government officials,” for ultimate use by patient recipients selected in accordance with the guidelines outlined in the Opinion.37

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