[Contribution] Collection of rebate investigation cases for pharmaceutical and medical device companies and implications
Attorney Daeryun Lee Il-hyung "steadily strengthened..Internal whistleblowing is the most common,Clues vary.-Multi-agency cooperation becomes routine"'HIRA prescription data analysis, Expected to use various investigative techniques, including use of tax investigation data" Regarding the rebate issue, CSO Introduction of reporting system, A series of rebate incidents occurred, And the new government's 'Pharmaceutical Industry Rebates' Special crackdown notice(2025year 7~10month)Tensions are increasing in the pharmaceutical and medical device industry as these overlap.. In this regard, the author 2025year 6The overall rebate regulation was covered in a monthly article in the Pharmaceutical Newspaper.. This time for practitioners 2015Summary of major cases related to rebates from 2008 to the recent past., Let’s take a look at the implications.. 1. 2015year Jhospital incident - Rebate using direct wholesale JThe hospital incident involved the hospital chairman, etc. 46The name is so-called ‘Direct wholesale’While operating 2011since 2015Pharmaceutical companies by year 18Rebate from anywhere 10This is a case where billions of won were received.. These are ‘Direct wholesale’and operates a pharmaceutical company and 'unit price contract'I received a rebate by signing a contract and pocketing the difference in drug price discount.. Meanwhile, in this case, clues to the investigation(Background on how the investigation began)go ‘the former’(Hospital direct wholesaler)It is unique in that it was reported by a pharmaceutical company employee who could not endure the abuse of power.. Another unusual thing is that the criminal and administrative measures were different.. The prosecution ‘The rebate is a small amount or the salesperson's personal deviant behavior’The pharmaceutical company was not indicted, including deferred prosecution, on the grounds that it appeared to be. However, this was also a controversial case as the Ministry of Food and Drug Safety announced that it would make its own judgment and take administrative action against some pharmaceutical companies.. 2. 2016year Nfour incident - Variant rebate using academic journals Nlive 2011since 2016Until 2018, we used medical journals and academic journals to hold round-table meetings in the name of advertising expenses and provide medicines to doctors. 25He was indicted on charges of providing bribes worth hundreds of millions of won.. The investigation into this case began with the revelation of an employee of a medical magazine., The investigation began in earnest with the Seoul Western District Prosecutors' Office conducting a search and seizure operation.. The prosecution ‘Roundtable discussions and academic journal production’In the end 'Variant Rebate' He claimed that, At the trial, controversy continued over whether there was organized collusion and recognition of illegality.. What is noteworthy about this case is that relatively heavy sentences were sentenced to working-level officials and professional academic journals., NThe company executives were declared not guilty and exempted.. Prosecutors claimed it was an organized kickback case at the company level, but, The court is a working group(PM) It was judged that there was insufficient evidence that executives or department heads were specifically reported to or were involved in the act.. In addition, some kickback activities were exempted as the statute of limitations had expired., He acknowledged that there was a possibility that the defendants were not aware of the illegality.. In particular, in the field of rare diseases and anticancer drugs, the need for academic events to improve disease awareness was also taken into consideration.. 3. 2018year ‘5dog pharmaceutical company’ case - Multi-agency joint investigation 2018year 9In January, the Board of Audit and Inspection conducted its own audit of the results of the integrated corporate and individual investigation by the Seoul Regional Tax Office., 5Total number of pharmaceutical companies 374After confirming the suspicion of providing monetary and in-kind kickbacks worth hundreds of millions of won to doctors and pharmacists., Ministry of Food and Drug Safety(Ministry of Food and Drug Safety)The need for investigation was notified to. Accordingly, the Central Investigation Team under the Ministry of Food and Drug Safety(Joongjodan)this 2018year 12month DThe investigation began in earnest with a search and seizure of the company's headquarters.. This incident ‘National Tax Service tax investigation → Board of Audit and Inspection Auditor → Ministry of Food and Drug Safety investigation → Sent to prosecution’It is characteristic in that it is a case of rebate detection linked to multiple institutions leading to. In addition, the Board of Audit and Inspection analyzes tax audit results to detect kickback suspicions and, It is noteworthy that the investigation was initiated after notification to the relevant agencies.. 4. 2024year Kpharmaceutical, 2025year DRecent pharmaceutical incidents 2024years and 2025There was also a rebate-related incident in 2012.. However, in both cases, the company denies the charges., As the facts have not been confirmed, I do not think it is appropriate to make specific comments.. Therefore, we would like to replace the above incidents with other press releases.. 5. 2024year medical device company GCompany case medical device company Glive 2016since 2022Drug-eluting stents for coronary arteries by(DES) Nationwide to expand sales 54gun in dog hospital 37Clinical research expenses worth billions of won, Academic activity fees, He was caught by the Fair Trade Commission on charges of providing advertising expenses..Gthanks DES Sales are 2016year 3From 100 million won 2022year 49In billions of won 16increased by more than twofold, Of these 90% It was confirmed that the above incident occurred at a hospital that had a rebate agreement.. The Fair Trade Commission 2024year GWith a correction order to Sasa 2100 million 8,700A fine of 10,000 won was imposed.. It is well known that some rebate practices exist in the medical device industry., Typically, its scale was relatively small compared to pharmaceutical companies.. However, in this case, despite being a medical device company, the rebate amount was relatively large., It is noteworthy that sanctions were imposed by the Fair Trade Commission, not by an investigative agency.. 5. Implications There were other big and small rebate incidents, but we ask for your understanding that we cannot tell you all about them due to space limitations.. If I get the chance, I will tell you more about the cases.. one side, If we consider the series of events, the following flow can be captured.. first, clues to investigation(Reasons for starting an investigation)As ‘whistle blowing’This is still the most.second, However, the clues in the above investigation are becoming more diverse..third, Multi-agency cooperation is becoming routine.fourth, In the future, HIRA's prescription data will be analyzed, It is expected that various investigative techniques will be used, including the use of tax investigation data..fifth, As I said in the previous article,, Government regulations continue to be strengthened. And it is expected that rebate regulations will continue to be strengthened in the future.. Summarizing the above, in the future ‘compliance’ The importance is bound to continue to grow., The industry also needs to prepare for this.. on the other hand, If you look closely at the cases above, the number of cases where the charges were acquitted is not less than you might think.. Therefore, if you are being unfairly misunderstood about rebates,, I would also like to tell you that there is an opportunity to resolve these difficulties if sufficient explanation is provided during the future investigation process.. [View full article]
[Contribution] Collection of rebate investigation cases for pharmaceutical and medical device companies and implications (link)