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

n India, there is very little understanding of Bad Disease and no one other than the top three KOLs have heard of Super X. There are only about 20 KOLs in total for this large population, and these KOLs are mainly university professors who also have appointments at state-run university teaching hospitals. Jackie Chan, your Asia Region General Manager, is hoping drug and reimbursement approval for Super X will be wrapped up by October 1st. If so, he will have three months in which to book sales. It will be pedal-to-the-metal during those three months. The key to success will be to lay the groundwork by getting India's 20 KOLs as well as its 100 top HCPs knowledgeable about Bad Disease aware that a company called SuperTech will soon launch the first ever treatment for Bad Disease in India. Jackie was surprised to hear that the lowest ranked General Manager will lose their job if he or she comes in under target. But Jackie has a nice nest egg saved up and isn't so susceptible to threats. He is, however, susceptible to carrots. He has always wanted to be a chief commercial officer and would love to be listed as your successor. He is therefore very motivated to over-perform in India where there is high unmet need and a high prevalence of Bad Disease. So far, Jackie has spent most of his time and effort on the KOLs. Back in April he sent them to a four day scientific conference in Australia that presented the latest scientific information about Bad Disease. In the evenings, he would take them to dinner to gather their perspectives on the learnings coming out of the conference. One of the KOLs had asked for his return trip to be booked two days after the conclusion of the medical conference because he needed to meet with a manufacturer who is a supplier of medical devices to his hospital. Jackie was able to accommodate this extended return flight as well as two extra hotel nights for the HCP by staying an extra day himself to briefly meet with that KOL over dinner to discuss the market strategy for Super X in India.

During a trip to China, Jackie attended a meeting during which he met the social responsibility director of one of the state-run hospitals that promises to be a big prescriber of Super X. He learned of the hospital's struggles to combat a rare and devastating illness called epidermolysis bullosa ("EB"). Children with this devastating disease are called 'butterfly children,' because their skin can fall off as a result of even mild friction. After watching a video about these butterfly children, Jackie is deeply moved and determined to help them even though SuperTech does not sell any medicines related to EB. Sensing Jackie's empathy, the hospital's social responsibility director asks whether SuperTech could make a charitable contribution in the amount of $25,000 to the hospital's EB support group fund. Although this is only a small amount of money, and Jackie wishes he could do more, he knows he would not be able to justify a bigger donation to a disease disconnected to SuperTech and its treatments. He therefore provides the requested donation directly from his commercial budget to the hospital.