If the details of clinical trial expenses are incorrect, you will be imprisoned... Pharmaceutical companies in ‘emergency’ [Daeryun’s Biz law forum]
Ministry of Health and Welfare, Pharmaceutical industry spending report released2Expenditure details of over 10,000 companies revealed for the first time in case of false information or missing data 1Imprisonment of up to one year Internal control inspection…The Ministry of Health and Welfare must preemptively prepare for strengthened regulations. 2month 11of the domestic pharmaceutical and medical device industry. 'Economic Benefit Expenditure Report'was revealed for the first time. The purpose was to increase transparency in the distribution of medicines and medical devices and block the eradication of illegal rebates..The expenditure report released this time is 2023It is based on the fiscal year. gun 2only178910 companies submitted data. The number of participating companies is 2023First survey of the year(1only1809dog) It has doubled since then. Pharmaceutical sales salesperson(CSO)It is analyzed that the new inclusion has a large impact..Ministry of Health and Welfare, Health Insurance Review and Assessment Service(HIRA)of 'Expense report management system'(KOPS)Through this, the general public can check the details of economic benefits provided by each company.. However, to protect personal information and trade secrets, the real name of the medical professional and specific clinical trial details were de-identified.. Direct searches for specific product names or beneficiaries are also restricted.. Information such as clinical trial support expenses is disclosed for the first time in the expenditure report by company. △Type and amount of economic benefits provided to medical personnel, etc. △Statistics such as number of offers and number of cases are included.. Items permitted by law include: 7Limited to branches, Statistics for each item were also provided in this release..① Samples provided : Minimum quantity required to confirm the dosage form and form of the relevant drug or medical device(Sample notation, no sales to patients). 1305total number of companies 1496Provide 10,000 medicines and medical devices to medical institutions.② Academic conference support : Academic conference participant(Presenter and moderator, debater)Actual costs for transportation, food, lodging, and registration fees. 391total number of companies 3155About the proposed academic conference 208billion won support.③ Clinical trial support : The quantity of medicines and medical devices for clinical trials and appropriate research funds required to conduct clinical trials.. 41310 companies research funding 5531billion won and 617Support for 10,000 products.④ Product information session : Transportation costs provided by attendees at actual cost, 5Souvenirs under 10,000 won, lodgment, food and drink(Amount excluding tax and service charge 1hall 10Limited to less than 10,000 won). medicine 2055billion won and medical devices 271Total, including billions of won 2326Provided 100 million won. 1Average amount of support per person 810,000 won.⑤ Post-marketing surveillance : Case reports provided to doctors, dentists, and oriental medicine practitioners participating in post-marketing surveillance 5Honoraria of less than 10,000 won(However, rare disease, When additional work, such as long-term follow-up, is required 30Less than 10,000 won). 101dog company 8only4000To write a case report 116100 million 300010,000 won support.⑥ Cost discount according to payment conditions : Cost discount according to transaction amount payment period(3within months 0.6% below, 2within months 1.2% below, 1within months 1.8% below). 1867total number of companies 2218Offers 10,000 cost discounts.⑦ Check medical device performance : Use of the minimum period of time necessary to verify the performance of the medical device(1Month/medical device field only). 311To check performance before purchasing 857dog items and 6only2630Dog medical equipment provided.Statistics show that a significant portion of the benefits provided to the economy(67.6%)Focused on supporting clinical trials. This suggests that research and development and academic purposes are the main spending drivers.. Also, among all drug suppliers, 18.5%, Among medical device suppliers 17.7%It was found that it provided economic benefits., This means that many small and medium-sized companies only fulfilled reporting obligations and made no or minimal economic provision.. There is a significant legal risk in case of non-compliance with the relevant laws and regulations. There is a significant legal risk in the case of non-compliance with the laws related to the economic profit and expenditure report.. If the report is false or related data is omitted or not stored, in accordance with the Pharmaceutical Affairs Act and the Medical Device Act. 1Imprisonment of up to one year or 1000A fine of up to 10,000 won may be imposed..Moreover, the government is likely to search for anomalies based on expenditure reports.. If excessive support is concentrated on specific medical institutions or medical staff, or if a pattern that deviates significantly from the general industry average appears, it may lead to a rebate investigation..With the release of the report, medical professionals can view the details of their economic interests, and procedures have been established to request corrections if necessary.. Accordingly, each company receives information from medical institutions and medical staff. 'Are the support details reported to you correct?' Please keep in mind that you may receive inquiries or correction requests.. Failure to respond here may lead to complaints or disputes.. For this reason, it is advisable to prepare internally accurate information management and rapid response processes.. As overall compliance policies are required to be reviewed, companies are expected to check their existing business practices and internal control systems while also taking preemptive measures to prepare for future strengthening of regulations.. This is because we cannot rule out the possibility that personal information and some trade secrets that were not disclosed this time will be included in the scope of disclosure in the future.. Specifically, the method of providing economic benefits and related contract documents, A review of the overall compliance policy is required.. The following countermeasures can be considered:.① Enhanced internal training and guidance : Thoroughly educate sales and marketing personnel on the types and limits of permitted economic benefits.. Distribute and continuously update internal guidelines on how to write expenditure reports and their importance.② Check the expenditure report preparation process : Check whether the information required to be included in the expenditure report is collected without omission.. Establish an internal system to thoroughly store documentary evidence for each expenditure item and manage it systematically during the legal retention period..③ Proactive monitoring and self-audit : Conduct quarterly or semi-annual self-audits to identify unusual spending patterns. Implement preemptive corrective action when problems are discovered.④ Establish procedures for responding to beneficiary requests : Establish an internal process to enable medical professionals and medical institutions to respond quickly when requested to confirm expenditure details reported to them..⑤ Monitor future policy changes : Reorganizing the legal and compliance department's response system, taking into account additional guidelines from relevant authorities such as the Ministry of Health and Welfare and the possibility of expanding the scope of disclosure.. Strengthen proactive measures such as maintaining transparent and sound practices in preparation for the possibility of detailed disclosure of individual beneficiaries or products in the future..Disclosure of expenditure reports is part of a policy to actively improve transparency in the pharmaceutical and medical device industry.. The government's strong will to establish a fair trade order is evident.. Companies in the field should not regard this as a simple regulation but strengthen their internal control systems., There is a need to use this as an opportunity to improve corporate trust..Ultimately, it must be kept in mind that establishing transparent and legal business activities is the best way to secure a company's reputation and sustainability.. In the future, continuous monitoring of government policy changes and systematic internal compliance management will become essential strategies for the industry.. [View full article]
If the details of clinical trial expenses are incorrect, you will be imprisoned... Pharmaceutical companies in ‘emergency’ [Daeryun’s Biz law forum] (Shortcut)