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Please answer the following questions based on the case below i) what activities/plans/initiatives could potentially constitute a legal violation? (e.g., ad board, speaker program, research

Please answer the following questions based on the case below

i) what activities/plans/initiatives could potentially constitute a legal violation? (e.g., ad board, speaker program, research grant, etc);

(ii) for each activity/plan/initiative identified, what specific facts contribute to making it a violation and explain your reasoning (e.g., ad board has 100 members which is far greater than needed, therefore intent seems to be to provide kickback to HCPs rather than gain needed advice).

(iii) for each activity/plan/initiative identified, what type of violation/problem is at issue (e.g, kickback, off-label promotion, performance pressure, privacy violation, bad governance, etc)?

the case:

In Brazil, a distributor hired by your LATAM Region General Manager, Enrique Iglesias, has been very actively engaged in scientific exchange. The distributor has excellent contacts in the medical community and with the reviewers at Anvisa (i.e., the Brazilian FDA). As a result, this region is much more prepared for launch than either India or China. For example, the distributor has been presenting your clinical trial data at scientific conferences in Brazil. It has also been visiting HCP offices, but it never proactively discusses clinical trial data or even mentions Super X during such visits. Rather, only disease awareness and corporate information about SuperTech is provided. Occasionally, a doctor who attended a scientific conference may ask an unsolicited question about SuperTech's clinical trial data. In these cases, the distributor makes the HCP sign a medical information request form before providing the requested information. In addition to all this excellent scientific exchange, the distributor has been working on the marketing application for Super X in Brazil. The cost of this work was originally quoted to you as $50,000 US. However, that was just an estimate. The distributor contacts Enrique with great news. Negotiations with Anvisa have accelerated. However, another $10,000 will be needed because the application involved more work than anticipated. If the money can be wired over quickly, the distributor can have the application submitted in a week. The distributor is vague on details and seems unwilling to spend the time to itemized invoice for the added cost at a time when things are finally moving: "look Enrique, if we don't move fast, we will lose ANVISA's attention and it could be months before they turn back to our application." Knowing the original quote was just an estimate and unwilling to lose the momentum with Anvisa, you wire an additional $10,000 to the distributor. Interestingly, several of the reviewers tasked with approving or rejecting your marketing application don't actually work for Anvisa. Nor are they HCPs. They are independent professors from state-owned universities who lend their expertise by volunteering their time. It is customary in Brazil to send each of these professors a box of local Brazilian chocolate to thank them for their time and review of the application. It would be rude not to do so. Unbeknownst to you and Enrique, your distributor sent the chocolates along with a bottle of wine to each reviewer with a thank you note stating: "greetings and thanks for your review of Super X from SuperTech."

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