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

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Angela Merkel, the General Manager for the EuroPlus Region, can't afford to lose her job. She's taken out huge mortgages on two large villas, a main residence in London and a summer home in the south of France. She's determined to be the highest performing General Manager, but is currently tracking 8% below target. She is finding it hard to squeeze enough revenues out of Europe, but sees an opportunity in Russia. Although drug approval for Super X is taking longer than expected, she recently got very good advice from her former colleague, Vlad Putin, who runs the Russian Medicines Approval Agency (RMAA). Angela hired him as a consultant to explain the RMAA's complicated review and approval procedures and to learn if there is an accelerated pathway. Vlad was paid no more than fair market value for his services. During one of their calls, Vlad confirms there is no official accelerated pathway but states that the Russian government has recognized the need to fund registry studies to collect real world data on the safety of medicines used in Russia. Companies who are willing to fund such registry studies will be prioritized when it comes to both drug approval and reimbursement approval. In fact, for such companies, reimbursement discussions can parallel track approval discussions, such that Super X could be launched and reimbursed immediately upon approval. This was incredible news, because instead of the Russian launch of Super X being three months behind schedule (October launch), she could launch within a month (early May). Angela simply needs to make a $500k contribution to the registry study which Vlad indicates is currently being run by an organization called the Saints of Petersburg on behalf of the Russian government. Vlad sends Angela the paperwork and bank routing number associated with the safety study.

Now with the possibility of launching within a month, Angela needs to quickly get HCPs familiar with the incredible benefits of Super X in a country that is currently without treatment or competition. But she also needs to conduct market research on the prevalence of the Bad Disease in Russia. This involves going office-to-office to determine how many patients have been diagnosed with the disease at each office. This will greatly benefit both HCPs and patients because early identification of patients who could benefit from the medicine could have a significant impact on their health by slowing disease progression. The problem is that her

distributor who is conducting all field work is being turned away by many HCPs who do not have time to check the medical records of their patients to identify those with Bad Disease. It is agreed that going forward the distributor will offer to review charts and medical records on behalf of HCPs so these patients can be identified without burdening the HCPs and benefit from early identification and treatment