UNIVERSITY OF ECONOMICS HO CHI MINH CITY International School of Business Nguyễn Thị Thu Vân The Lack of Effective Training Program in Compliance Management A case of a pharmaceutical company MASTER OF BUSINESS ADMINISTRATION Ho Chi Minh City – Year 2019 UNIVERSITY OF ECONOMICS HO CHI MINH CITY International School of Business Nguyễn Thị Thu Vân The Lack of Effective Training Program in Compliance Management MASTER OF BUSINESS ADMINISTRATION SUPERVISOR: Phạm Phú Quốc Ho Chi Minh City – Year 2019 SUPERVISOR’S REPORT ON THE FINAL THESIS SUBMITTED FOR THE DEGREE OF MASTER of BUSINESS ADMINISTRATION Final thesis title: The Lack of Effective Training Program in Compliance Management Company Student name: Nguyễn Thị Thu Vân Supervisor name: Phạm Phú Quốc General comments: • Remarks on the student’s attitude: • Remarks on the assignment’s academic quality: Overall assessment:  Meet requirement for submitting;  Not meet requirement for submitting Other remarks: - Did the student follow the report schedule?  Yes  No  Other - The Turnitin plagiarism percentage:  Supervisor’s signature Acknowledgement I would like to take this chance to say a special thank to my thesis supervisor Pham Phu Quoc due to his huge contribution in supporting and encouraging me to complete my big project His advisory is one of most important sources of reference for me to realize the general picture of the problem and understand the requirement of school committee in evaluating Also, thanks to ISB for generating this study program with practical and effective methods in learning and working and gave us a golden opportunity to build by our own this meaningful project Thanks to my family and my dear friends: Truc & Huy in supporting me all the time CONTENTS CHAPTER BACKGROUND INFORMATION 1.1 Risk of compliance management in healthcare industry 1.2 Overview of MSD Vietnam 11 1.2.1 MSD’s background and management structure 11 1.2.2 MSD’s compliance management strategy 12 1.2.3 MSD’s current practice in business 13 CHAPTER PROBLEM IDENTIFICATION .15 2.1 Symptoms analysis 15 2.1.1 High frequency of risk activities 15 2.1.2 Repeated type of noncompliance findings 18 2.1.3 Being determined as “high risk in compliance” in audit’s assessment 18 2.2 Problem definition 20 2.2.1 Literature framework 20 2.2.2 Interview result 22 2.2.3 Initial cause-effect map .25 Chapter 3: Problem justification .29 3.1 Jusitfy the existence of problems: Updated cause-effect map 29 3.2 Justify the importance of solving problems 32 3.3 Causes of centralize problem 34 CHAPTER 4: ALTERNATIVE SOLUTIONS 36 4.1 Interview result 36 4.2 Literature framework .38 4.3 Proposed solutions: Building comprehensive training program .41 4.3.1 Who? 41 4.3.2 Where? 42 4.3.3 When? 43 4.3.4 How? 43 4.4 Considering factors 45 4.5 Action plan 46 CONTENTS OF FIGURES Figure Product lines of MSD 11 Figure Board of Management chart 12 Figure Marketing budget allocation 14 Figure Number of promotion activities vs population 17 Figure Average number of attendees per meeting 17 Figure Relationship of top management & individual behavior 21 Figure Initial cause-effect map 28 Figure Updated cause-effect map - Justify the existence of problem 31 Figure Updated cause-effect map - Justify the importance of problem .34 Figure 10 Cause for centralize problem 36 Figure 11 Key criteria in training program………… ………………… ……….45 Figure 12 Proposed solutions for key criteria in training program…………………………………………………………… ……………… 49 Figure 13 Action plan for improvement of training program…………………….50 CONTENT OF TABLES Table Listed repeat findings…………………………………….18 Table Scheme of risk definition……………………… …… 19 Table Brief profiles of interviewees…………………………….22 Table Cost estimated for half year training program…………46 EXECUTIVE SUMMARY The thesis is conducted to find solutions for the most centralize problem of compliance management of MSD: the lack of effective training program Initially, in focusing on examine operation of MSD – a pharmaceutical company with its headquarters bases in NJ, USA, three main symptoms of this problem were determined as high frequency of risky activities, repeated non-compliance findings and “high risk” rated by Global Audit team Through interviews and references from other researches and studies of experts in field, the initial list of problems was built with problems: no effective compliance training program, inappropriate compliance policies, great job pressure, low ethical culture in organization & wrong decision in recruitment Making decision is a process based on many factors of business and management, therefore, the consideration is also presented with the justification of problem’s existence, problem’s importance and the capability to solve the problem As a result, the problem of non-effective training program is indicated as centralize problem with main causes: no real cases discussion in training, no evaluation tools and no involvement of all members in organization In the final chapter of this report, solutions and action plan, which focus on solving main causes of problem in different criteria of a comprehensive program, are built with the result from interview and literature knowledge CHAPTER BACKGROUND INFORMATION For several decades, employee’s corporate violations have become the key challenge in running business among companies due to their damages cause in cost and operation (1) Obviously, the involvement of different stakeholder’s damanges in consequence of violations clearly requires greater effort of managers in controlling rather than circumstances that only company’s income is negatively impacted Indeed, company’s image, reputation, corporate social responsibilities or people relationship within company recently attract huge attention of business owner Along with this change in businessman’s perspective, concept of “conflicts of interest” in many areas are raised as concerns in researches, studies, debates and other kinds of discussion Turning into business practices, especially with health care section while that conflicts cause loss of public truth in scientific professional and be in charge of unethical problems in our society (2) (3) (4), the unique controlling tools to manage and diminish wrong-doing business practices of pharmaceutical company in health-care industry are established as corporate standards and policies in organizations world-wide In this report, there is not much focus on conflict of interest term but on the risk of compliance management in pharmaceutical company with the real case of MSD Vietnam – a member of MSD Global, one of top biggest pharmaceutical company in the world In which, the violations of regulations have particular motivations and causes, combine with management structure and practice of business that make controller more difficulty in recognizing and eliminating unexpected behaviors that damage pharma company’s most valuable asset: reputation 1.1 Risk of compliance management in healthcare industry Interest conflict in pharmaceutical industry was discussed in extensive amount of research as well as debates between policies makers, socialists, investigators and also health care professional In the past, HCP used to base on information of drug promotion or advertisement for prescribing However, due to FDA regulations of “Directed Print Advertisements and Promotional Labeling for Prescription Drugs”, limited information is allowed to transfer all useful knowledge to HCPs As a result, HCPs now is relying on pharmaceutical company to finance for continuing medical education (CME) for their better knowledge and enhancement of healthcare personal skills (5) (6) CMEs, are flexibly allowed to organize, can perform in different types of learning methods such as seminar, symposiums, expert information forum, online learning system, etc, This change is now influcing the relationship between pharmaceutical company and HCPs By collecting data about changes of behavior related to nature of human’ interest and interviewing about changes in mindset of HCPs, previous researches showed clear result that HCPs tend to bias in prescibing and advising treatment methods for patient after involving in a collaboration with a pharma company or receiving financial sponsorship of a company, even though they did not tend to be influent by these interactions (22) Moreover, interest conflict in pharma industry also due to the different stakeholders that company and HCPs are serving for The main stakeholders of HCPs are patient while main stakeholders of pharma company are shareholders In one side, HCPs try to bring the best treatment for patient or improvement for patient’s life quality However, in the other side, profit is the critical priority in running business of pharma company (7) Therefore, the changes in regulation, laws or business policies of industry may not affect strongly the objectives to promote product, increase market share and generate more profit of company’s manager For the purpose to against interest conflict, bias in prescribing and financial benefits provided by inappropriate purpose, regulations were required to build and implement not only at country level (by government), but also at institution and organization level In the other hand, pharma company’s reputation is the most critical company’s asset because of the particular nature of this field while the customer is not the consumer and the quality of product cannot be easy to measure or evaluate Doctors mainly base on the information of product provided by company, the company’s previous researches or other products as well as the reputation of company, and, their own science knowledge and judgement to make decision of treatment should be taken by patient Combining these business characteristics, pharma companies have to stick closely with compliance regulations and laws in running its business to protect their 10 Principle Apply good business judgment to all communications and documentation involving our interaction with the medical and scientific community, and ensure proper implementation of activities (e.g., training, documentation, tracking, reporting, and follow-up) Principle Conduct activities and interactions with the medical and scientific community in a manner that protects our intellectual property and respects that of others Principle Ensure that all communications shared with the medical and scientific community are based on accurate and balanced scientific information Principle 10 Ensure that selection of members from the medical and scientific community is based on their areas of expertise, experience, and other appropriate, objective criteria aligned with the stated purposes of the activity 66 Overview of Compliance Program – Merck Global website Leadership and Structure Merck has the appropriate resources in place to support our commitment to compliance • The Merck pharmaceutical and vaccine divisions that engage in sales and marketing activities in the United States have a Compliance Officer dedicated to support Merck’s culture of compliance within each division The US Compliance Officer (Compliance Officer) has responsibility for corporate wide activities in the United States and for those activities that US Healthcare Providers conduct on Merck's behalf outside of the US The Compliance Officer for the U.S pharmaceutical operating division reports to the President of Global Pharmaceuticals and periodically to the Company's Board of Directors • The Compliance Officer manages a department of Compliance Professionals who provide guidance and oversight for the processes, training, and implementation needed to ensure full compliance with the laws, regulations and policies that direct interactions with physicians and other customers in the U.S marketing and sales units • Merck is committed to ensuring that its Compliance Officer has the ability to effectuate change within the organization as necessary and to exercise independent judgment The compliance function has unrestricted access to information, executives and meetings related to business operations Written Standards The development and distribution of written standards of conduct, as well as written policies, procedures and guidelines has long been a key element of Merck’s Compliance Program • Merck’s Ethical Operating Standards (EOS) and the Merck Code of Conduct are our universal statement of the values, standards and ethical principles that guide our daily operations The EOS and Code of Conduct are available to all employees on 67 the Company’s intranet and applies to everyone conducting business on behalf of Merck • In addition to its EOS and Code of Conduct, Merck has corporate policies, procedures and guidelines that outline the specific behaviors required for day-to-day operations and outline how Merck employees are expected to conduct their activities Among other things, these policies, procedures and guidelines address potential risk areas such as those identified in the HHS-OIG Guidance For example, Merck has polices regulating: prescription drug sampling; Merck-led promotional and educational programs; financial support of independent continuing medical education; scientific research grants; consulting arrangements with healthcare professionals; service agreements with customers; and the provision of grants in support of healthcare-related initiatives sponsored by professional societies, patient advocacy groups, trade associations, charitable entities and other organizations • Merck’s policy relating to Field Based Employees (FBE) interactions with healthcare professionals provides that such interactions must focus on: (1) providing current, accurate, and balanced information about Merck products, (2) transmitting sound scientific and educational information, and (3) supporting medical research and education As a matter of policy, Merck Field Based Employees and Headquarter employees are prohibited from offering healthcare professionals items of personal benefit, such as tickets to sporting events, support for office social events, gift certificates to stores or golf outings • Under Merck policies, Merck Field Based Employees occasionally may provide healthcare professionals with approved educational or practice-related items that are not of substantial value These materials are intended primarily to benefit patients and may include items such as medical textbooks, medical journals, or anatomical models Items of minimal value may not be provided if they primarily are associated with a healthcare professional’s practice For example, items such as pens, notepads and similar “reminder items” with company logos may not be distributed Merck Policies have been developed to be consistent with the PhRMA Code and the HHSOIG Guidance 68 • Merck policy also permits informational presentations and discussions by Merck Field Based Employees or others speaking on Merck’s behalf These events provide high quality clinical, disease and drug therapy information, are in accordance with FDA regulations, and are specifically designed to provide the type of information practicing medical and healthcare professionals have indicated to Merck that they need and find most useful in the treatment of their patients In connection with such presentations or discussions, occasional modest meals may be offered to medical or healthcare professionals provided the meals occur in a venue and manner conducive to informational communication Policy measures are designed to ensure that these meals are provided in accordance with the PhRMA Code and the HHS-OIG Guidance • As required by California Health & Safety Code §§ 119400-119402, Merck has established an annual dollar limit on educational or practice-related items, items of minimal value and meals which Merck Field Based Employees are permitted to provide to medical or health professionals in California under Merck policy As of July 1, 2006, the annual limit of $2,000 applies prospectively to educational or practice-related items, items of minimal value, and meals associated with informational presentations or discussions provided to medical or health professionals in California; and incorporates the limitations and definitions contained in the statute • Consistent with California Law Merck’s annual dollar limit does not include drug samples given to physicians and healthcare professionals intended for free distribution to patients, financial support for continuing medical education forums, financial support for health educational scholarships and fair market value payments for legitimate professional services provided by healthcare or medical professionals In addition, the annual dollar limit does not include reprints, printed advertising or promotional materials, and items provided for distribution to patients (e.g., patientoriented health and disease management •The annual limit is not intended to serve as a spending objective or goal by Merck for all healthcare professionals in California Rather, it is intended to establish an 69 annual upper limit for those healthcare professionals with whom Merck employees interact across multiple therapeutic areas • Effective January 1, 2007 the reporting year is defined as the calendar year of January 1st through December 31st • The average annual expenditure by Merck for those medical or health care professionals is well below the established annual dollar limit • Some of the medical and healthcare professionals Merck calls on have practices spanning multiple therapeutic categories in which Merck has medicines and vaccines Merck’s pharmaceutical and vaccine line currently includes over 50 products that are actively promoted by Merck Field Based Employees Because of the breadth of topic areas that are relevant to these practitioners, a larger number of discussions and informational presentations occur between these individuals and Merck Field Based Employees It is in recognition of these instances that Merck’s annual upper limit on expenditures for medical and healthcare professionals is currently set at $2,000 (Collectively, these practitioners are referenced in the remainder of this document as the “Multi-Therapeutic Category Practitioners.”) The largest component of these expenditures is modest meals associated with informational presentations and discussions However, these expenditures also include the fair market value of educational and practicerelated items provided to medical and health care professionals as set forth above Education and Training Another critical element of our Compliance Program is the education and annual training of our Field Based and Headquarter employees on their legal and ethical obligations under Merck policy and the laws, regulations and guidelines that govern pharmaceutical marketing and selling activities in the United States • Merck is committed to taking all necessary steps to effectively communicate our standards and procedures to all affected Field Based and Headquarter personnel Merck’s Code of Conduct, corporate policies, procedures and guidelines are available to employees at all times through the Merck intranet 70 • All Merck Field Based and Marketing Headquarter employees are required to participate in annual training as a condition of their employment In addition, these employees will undergo periodic re-training and remedial training programs as necessary The training process is overseen by distinct training departments • The following training plan applies to all Field Based Employees New hires receive testing and certification on Merck’s Field Policy Letters, Merck's Ethical Operating Standards and general sales and product training This includes training to ensure compliance with federal laws and regulations that relate to pharmaceutical sales and marketing such as the Anti-Kickback Statute, the Prescription Drug Marketing Act, and FDA drug promotion regulations After this initial training, there is periodic training aimed at recertifying Field Based Employees on relevant policies Field-based employees in geographies with state or other region-specific legal or regulatory requirements also receive training specific to the local requirements • The following training plan applies to all U.S Headquarters employees (“HQ employees”) engaged in marketing and sales activities These employees receive annual training designed to ensure compliance with Merck's Policy Letters and Ethical Operating Standards and federal laws such as: the Anti-Kickback Statute, the antitrust laws, and FDA drug promotion regulations In addition, more specific training and testing is provided as needed to HQ employees consistent with their roles and responsibilities within the company • The content for all training is evaluated and updated annually to ensure it remains relevant and current Internal Lines of Communication As a matter of policy, employees are required to bring workplace issues of any type to the attention of management Merck strives to provide a work environment that encourages employees to communicate openly with management about all types of workplace issues without fear of retaliation or recrimination To support this concept, Merck has established the following resources: 71 • Merck encourages employees, as a first step, to seek out an immediate supervisor or manager to discuss workplace issues If the matter is not successfully resolved, an employee is encouraged to pursue the issue with his/her next level of management or Human Resources • The Merck Ombudsman Program, managed by the Chief Ethics and Compliance Officer, complements Merck’s primary resolution mechanisms described above by providing an alternative channel for employees to address work-related concerns, including conduct inconsistent with Merck’s policies, practices, values and standards The Program is available to all employees and is designed to provide a “safe haven” where concerns can be addressed in confidence and without fear of reprisal All conversations with the Ombudsman are kept confidential unless they raise issues of potential harm to an individual or the Company The Ombudsman is a neutral party who will listen to and review concerns as an advocate for the Company’s values and standards The Ombudsman has a stand-alone office that is part of the Office of Ethics and independent of any Merck division • Merck also has a confidential outside telephone line made available to all employees who wish to anonymously raise concerns about potential unethical or illegal behavior or violations of Merck policies This telephone line is operated by an independent firm who will forward reported concerns to the Merck Office of Ethics for response or investigation The telephone line is available 24 hours a day, days a week • The Office of Ethics is accountable for ensuring appropriate review and follow-up with respect to issues raised to the Ombudsman or via the confidential telephone line Auditing and Monitoring Merck’s Compliance Program includes monitoring, auditing, and ongoing evaluation regarding compliance with the company’s policies and procedures In accordance with the HHS-OIG Guidance, the nature of our reviews as well as the extent and frequency of our compliance monitoring and auditing varies according to a variety of factors, including new regulatory requirements, changes in business practices, and other considerations Results of auditing, monitoring and evaluation are, as appropriate, followed up on specifically, 72 incorporated in training and communications strategies and considered when making choices in connection with ongoing general management of the business The primary responsibility for oversight is with line management To assist managers with this responsibility, Merck provides them with reports from tracking and oversight systems that capture key compliance indicators to aid them in monitoring compliance with company policy and investigating any potential violations of policy Management oversight is supplemented by audits Merck utilizes a combination of up-front planning, and monthly tracking and monitoring to comply with the annual dollar limit established pursuant to California Health & Safety Code §§ 119400119402 Hiring Merck is committed to hiring a workforce whose actions will reflect a high degree of integrity and ethics, recognizing that the ability to excel depends on the integrity, knowledge and skills of our people Accordingly, the Company invests significant resources in identifying and hiring highly qualified and skilled individuals In addition, prior to allowing the individual to commence employment with the Company, Merck performs a drug screening and background investigation of the individual The background investigation includes verification of employment history, and education Merck also performs a criminal background investigation that searches for any felony or misdemeanor on both a county and federal level and reviews all candidates against the Federal exclusions list If deemed appropriate to the position, checks also will be conducted of professional certifications and licenses, motor vehicle records and credit history Responding to Potential Violations A Compliance Program increases the likelihood of preventing, or at least identifying unlawful and unethical behavior However, HHS-OIG recognizes that even an effective Compliance Program may not prevent all violations As such, our Compliance Program requires employees to report and the company to respond promptly to potential violations of law or company policy, and take appropriate 73 disciplinary action Specifically, Merck’s Compliance Program includes a clearly defined violations process that sets out the potential consequences of violating the law or company policy Although each situation is considered on a case-by-case basis, Merck policy requires that consistent and appropriate disciplinary action be taken to address inappropriate conduct and deter future violations Merck also assesses whether identified violations are in part due to gaps in our policies, practices, or internal controls, and if so, takes appropriate action to prevent future violations Conclusion In summation, a copy of this document and/or Merck's written Declaration of the Company's adherence to the Comprehensive Compliance Program described above can be obtained by calling 1-800-672-6372 74 Employer’s rankings 75 MSD Vietnam - Breach Disciplinary Framework How should it be used? It should be used to inform decision-making on the appropriate disciplinary action to be taken into breaches of the Company policies It does not cover every possible scenario Neither does it cover conduct issues which are outside the scope of meeting activities A number of factors need to be considered when assessing the severity and the consequences arising from a breach The framework does not in any way restrict the company’s ability to take action it deems appropriate in light of the facts and circumstances of any particular alleged breach Local legislation takes precedence over these guidelines What factors need to be considered in determining appropriate disciplinary action in response to a breach? Aggravating and mitigating factors: Consideration will be given to any factors which could be significant in determining the appropriate action to be taken against the individuals involved The list of factors is not intended to be exhaustive As an example, the importance of each factor are weighted as points assigned to each of them Their relevance and relative weight should be judged depending on the circumstances in each case What disciplinary action would typically be appropriate in relation to breaches of the Companies policies? The following table provides examples of possible breaches with the typical sanctions that should be applied Aggravating and mitigating factors specific to the breach are also provided This is intended to guide decision making and it is important that each case is judged based on the individual circumstances *Verbal warning: coaching/counseling session from line manager *Written warning: receiving warning letter from HR/BU Managers, with or without effect to performance management *Up to Dismissal: following dismissal process of Company Potential Breach Severity Consequence Aggravating Factors Mitigating Factors Final consequence ZERO TOLERANCE TO ANY FRAUD ACTIVITY Get or create fake documents (itemized invoice, VAT invoice, receipt Motivation (+2) Motivation (-2) Final consequence: payment) to claim for an event that not happened - Deliberate breach - Accidental Subject to reviewing of all Create fake email approval for changing event - Willful disregard for rules - Avoidance of threat to person, consideration factors and/or High risk Up to Dismissal Create fake attendance list/ Falsify the attendee list - Undertake for personal gain injury … result of investigation Forge documents (itemized invoice, VAT invoice, receipt payment) to - Avoid the supervision of - No intention of personal gain inflated the event expense Compliance,… History (-2) Medium risk History (+2) - No previous involvement in >3: Increase the consequence - Repeated involvement in breaches by level Last minute cancellation w/o manager's approval breaches - Record of good service < -3: Decrease the consequence Presentation slides not approved by Medical Experience (+1) Experience (-1) by level Gifts or any benefit to HCP provided by MR personally - Senior level (from years) - Junior level (Less than Low risk Speaker: Attendee ratio 2: Increase the consequence Conduct the speaker meeting for an insufficient time (less than hour) Up to Written Medium risk and undertake required - Relevant training required has by level No business discussion during the event warning trainings not been provided < -2: Decrease the consequence Let HCPs bring their relatives (children, wife, husband) to the event w/o Reporting (+1) - Guidance sought and followed by level prevention actions - Failed to report the breach in good faith though incorrect Conduct an event without approval (including approval for change) despite being aware of it Report (-1) Access denial by MR for spot-check activity Admission (+1) - Bring the matter to the Failure to follow the required processes of conducting activities - Do not admit for the breach attention of management or - Blame someone for the breach Compliance & Ethics, Legal Access denial by HCP for spot-check activity Complicity (+1) Admission (-1) Using of alcohol at event during working day or exceed unit/ person - Ask or apply pressure on others - Acknowledge the occurrence of during other permissible time to undertake the breach breaches and co-operate with Input wrong info (location, time, attendee, vendor, supporting Low risk Verbal warning the investigation documents…) in system Complicity (-1) Only bussiness discusion (no presentation done) in an ISP event 76 - Subject to coercion or pressure Invite unrelevant person to join the event by management or peers Business meal is happenned separarely from the presentation Manager joint responsibility: MR have repeated breach LIST OF REFERENCE Gwen E Jones MJK An Experimental Examination of the Effects of Individual and Situational Factors on Unethical Behavioral Intentions in the Workplace Journal of Business Ethics 1996;15:511-23 ELLIOTT KC SCIENTIFIC JUDGMENT AND THE LIMITS OF CONFLICT- OF-INTEREST POLICIES Accountability in Research 2008;15:1-29 Elizabeth A Boyd P, Mildred K Cho, PhD, and Lisa A Bero, PhD Financial Conflict-of-Interest Policies in Clinical Research: Issues for Clinical Investigators ACADEMIC MEDICINE 2003;7(8) Friedman PJ The Impact of Conflict of 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Chi Minh City – Year 2019 SUPERVISOR’S REPORT ON THE FINAL THESIS SUBMITTED FOR THE DEGREE OF MASTER of BUSINESS ADMINISTRATION Final thesis title: The Lack of Effective Training Program in Compliance. ..UNIVERSITY OF ECONOMICS HO CHI MINH CITY International School of Business Nguyễn Thị Thu Vân The Lack of Effective Training Program in Compliance Management MASTER OF BUSINESS ADMINISTRATION... conducted to find solutions for the most centralize problem of compliance management of MSD: the lack of effective training program Initially, in focusing on examine operation of MSD – a pharmaceutical