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UNIVERSITY OF ECONOMICS HO CHI MINH CITY
International School ofBusiness
Nguyễn Thị Thu Vân
The Lack of Effective Training Program in
Compliance Management
A case of a pharmaceutical company
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Dịch Vụ Hỗ Trợ Viết Thuê Tiểu Luận,Báo Cáo
Khoá Luận, Luận Văn
ZALO/TELEGRAM HỖ TRỢ 0973.287.149
MASTER OF BUSINESS ADMINISTRATION
Ho Chi Minh City – Year 2022
2
UNIVERSITY OF ECONOMICS HO CHI MINH CITY
International School ofBusiness
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 2022
3
SUPERVISOR’S REPORTON 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
1. General comments:
 Remarks on the student’s attitude:
.......................................................................................................................................
.......................................................................................................................................
 Remarks on the assignment’s academic quality:
.......................................................................................................................................
.......................................................................................................................................
2. Overall assessment:
 Meet requirement for submitting;
 Not meet requirement for submitting.
3. Other remarks:
- Did the student follow the report schedule?
 Yes  No  Other.......................................................................
- The Turnitin plagiarism percentage:

Supervisor’s signature
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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.
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CONTENTS
CHAPTER 1. BACKGROUND INFORMATION.........................................................9
1.1. Risk of compliance management in healthcare industry................................9
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 2. 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
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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
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CONTENTS OF FIGURES
Figure 1. Product lines ofMSD .........................................................................................11
Figure 2. Board of Management chart ............................................................................12
Figure 3. Marketing budget allocation ...........................................................................14
Figure 4. Number of promotion activities vs population.............................................17
Figure 5. Average number of attendees per meeting ...................................................17
Figure 6. Relationship of top management & individual behavior..........................21
Figure 7. Initial cause-effect map......................................................................................28
Figure 8. Updated cause-effect map - Justify the existence of problem...................31
Figure 9. 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 1. Listed repeat findings.............................................................18
Table 2. Scheme of risk definition....................................................... 19
Table 3. Briefprofiles of interviewees................................................22
Table 4. Cost estimated for half year training program.................46
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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 5 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 3 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.
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CHAPTER 1. 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 onthe risk ofcompliance
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
10
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
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vulnerable reputation, which is easy to damage by the complexity of market,
competition and stakeholders.
1.2. Overview of MSD Vietnam
1.2.1. MSD’s background and management structure
MSD Vietnam was establised in 1995 as a representative office, controlled by
MSD Hongkong Company Limited. By focussing on special treatment for
cardiovascular, diabetes, vaccines, infectious diseases, MSD Vietnam runs along 4 core
businesses: Primary Care (PC), Hospital (HS), Vaccine (VV) & Tender, which each has
different core products for different types of diseases or demands for improving quality
of human life.
Figure 1. Product lines of MSD
A particular characteristic in management structure of MSD Vietnam is that not
all support function is under management of Chief of Respersentative office (Managing
Director – MD), except Compliance manager, Director of Human resources, Director of
Finance. Other support functions are under management of regional board and also
report directly to regional person-in-charge. Together with 4 BUs and commercial
department, compliance department, which is identified as main function, dedicates to
12
Local IT
manager
Regional IT
director
Local supply
chainmanager
Regional supply
chaindirector
Local
procurement
manager
Regional
procurement
director
the smoothy in running business and in charge of all compliance matter of business
including tasks related to commercial regulations, legal issue or legitimacy ininteraction
with external stakeholders. Otherwise, not only report to MD, compliance manager have
to report to Regional Compliance Director to ensure a transparency and consistency in
controlling within company’s global network, also, ensure an independence against
business by tight collaboration and continuing discussion.
Businessfunctions
Supportfunctions
Figure 2. Board of Management chart
1.2.2. MSD’s compliance management strategy
As the leader in market about ethics and integrity, MSD commits to the highest
standard of transparency in all segments as well as in all interaction with stakeholders.
Operation policies and code of conducts were established consistently with
recommendations of Pharmaceutical Research and Manufactures of America (PhRMA),
International Federation of Pharmaceutical Manufactures & Associations (IFPMA) &
Foreign Corrupt Practices Act Law of US federal (FCPA 1977). The most priority of
company in controlling interaction with HCPs is to prohibit employees and all business
partners providing benefit in many kinds but out of scientific purpose. Prescribe of HCPs
Regional
Compliance
director
Compliance
Manager
Director of
finance
Managing
director
Director of
Medical
Director of
human resource
Director of
commercial
business
Director of
Tender business
Director of PC
business
Director of VV
business
Director of HS
business
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must be based on what benefit patients the most, but not based on relationship or
personal impression of HCPs about company. Otherwise, MSD strictly prohibits drug
promotion without guidance about caution for customer or consumer. All scientific
information company provide to HCPs – both advantages and disadvantages of
company’s products - must be carefully generated from researches of the most reliable
universities or sciences labs. Because of the clear direction, standards in operation
mostly focus on transferring these management’s perspective into business practices in
forms of guidance, processes and policies. To ensure all hospitalities and financial
supports provided to HCPs with scientific purpose, employees are asked to track all
expenses paid in approaching customer: meals in scientific meetings, sponsored air-
tickets in scientific symposia oversea, sponsored register fee for education courses, etc.,
for monitoring purposes. Moreover, before delivering to HCPs or the public, all
scientific information have to checked with high caution and be approved by medical
department. Policies related to each of management’s concerns were built, and,
continually updated and improved to follow business’s development.
1.2.3. MSD’s current practice in business
In Vietnam, according to business law, representative office (RO) is not allowed
directly producing, selling product or providing services. Thus, Vietnam MSD RO takes
role as the moderator for the parent company based in Hongkong to perform business.
In general, for a normal standard, MSD Vietnam conducts marketing activities, interacts
with healthcare professional, hospital and institution, receives orders from customer,
requests ships from Hongkong then arranges logistics which deliver products to
customers’ places. As a result, marketing activities, included meetings with customers
and sponsorships for Continuing Medical Education (CME), are the main activities of
MSD Vietnam RO. Also, marketing teams and sale teams account for the majority of
human resources of MSD Vietnam. In order to run marketing activities, each business
will receive budget annually from regional along with sales target. Marketing team of
each business then decides how much budget to keep in conducting major events and
sponsorship and how much budget to asign to sale team for conducting minor events.
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Figure 3. Marketing budget allocation
Activities by marketing team which involve many parties to co-organize such as:
medical team, procurement team, marketing team and sometimes, sales team. While as,
in minor events conducted by sales team, only salesman is the one who is in charge for
planning, contacting, booking, organizing and claiming expense for the company.
Salesperson can easy invite customers to join a meeting at restaurant and deliver his
speech during meal time. Therefore, the particular characteristics of this event’s type
also include many compliance risks because of unformal atmosphere, such as: allowing
HCPs to use alcohol in meetings, no scientific topic discussed in meetings,
entertainment or unnessary expense included in meetings, etc., In addition, the
maximum number of attendees in minor event is 25 and there is no requirement for pre-
booking that make the owner flexible in conducting event when he and the invitees are
available. Thus, this type of event is classified as the most risky type for company’s
reputation and operation.
Major events Over 25 attendees
Marketing team
Sponsorship
Marketing budget
Sponsor for
hospital/Healthcare
Institution
Sale team (Medical
representative-
MR)
Minor events
Less than 25
attendees
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CHAPTER 2. PROBLEM IDENTIFICATION
To scrutiny company’s potential problems, these steps were followed orderly for
a wide view of general picture:
-Collect result from annual compliance rating by Global Audit team, biannual
compliance self-assessments, Quarterly Compliance Management reviews and Monthly
Spot-check reports
-Collect data from systems, guidance, corporate’s regulation and business information
-Review literature in studies, researches in compliance, corporate regulation field
conducted by reliable specialist.
-Interview person in charge for practical perspective and experience: Mr. Huy,
compliance specialist of MSD; Mr. Kha, compliance specialist of Roche; Ms. Tu,
finance specialist of MSD – controlling and planning; Ms. Tram, sales manager of MSD,
Ms. Truc, process controller of FE Credit.
-Critically consider and connect data, literature, specialists’ perspective and actual
situation to identify problems
2.1. Symptoms analysis
There are 3 symptoms to be analysed in this part: high frequency of risk activities,
repeated types of noncompliance findings and being rated as “high risk in compliance”
in audit’s assessment.
2.1.1. High frequency of risk activities
Small meetings are traditional approach to reach HCPs in Vietnam. According to
current practice of doing marketing activities, small meetings – meetings with less than
25 invitees (as described before in section 1.2) are not hold professionally that be in
16
charged by 1-2 salesperson. Locations of small meetings are private room at restaurant
or meeting room at hospital. Customers who prefer this type of meetings are usually
busy and have no time for long lecture or formal meeting during working day. Actually,
in Vietnam – especially in big cities such as Ho Chi Minh and Ha Noi, HCPs as well as
healthcare professional organizations (HCOs) are now in overload of working pressure
due to economic situation, unbalance between qualification of HCPs in urban and rural
area, low average income level (we will not go much in detail of this area). In the other
hand, customers in other provinces also have reasons to prefer small meetings rather
than major meetings such as culture behavior of hesitating to share knowledge or
experience, difficulty in travelling. Thus, to reach customers Vietnam, the popular
methods used not only by our company but also by other rivals in the market are small
meetings – group discussion or presentation.
However, because of their particular features, small meetings are definied as
risky activities for reputation of pharma companies. In which, meals or hospitalities
provided for HCPs without (or little) sciencetific purpose can be reported as cases of
bribery or corruption. Due to small number of HCPs can be reached in this type of
meetings, not much resources are used in organizing to maximise the efficiency of
business’s cost. As a result, salesperson by themselves have to plan, monitor and control
all parts of meetings as a complete process. In the beginning, salesperson propose plan
and get approval from managers. At this step, MR have to make sure that the topic of
meeting is checked to be appropriate with the current business strategy of company and
the invitees list is not included HCPs who have irrelevant specialty or knowledge. All
expenses and meeting’s information have to logged on system for monitoring and
salesperson have to ensure that meeting will happen as planned. During meetings, no
entertainment or non-science activities is allowed and all meeting’s elements have to be
controlled within policy limit of amount and time. Therefore, a huge number of tasks in
controlling make small meetings more risky than any other types of marketing activities.
MSD allows business to conduct small meeting because of its benefits to
customers and also company, but not recommend this risky type. However, as can be
seen from the data – graph 1, Vietnam is in the top 3 that has the most number of small
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Number of meetings & Population in countries
1,600,000,000
1,400,000,000
2500
1,200,000,000
1,000,000,000
800,000,000
600,000,000
400,000,000
2000
1500
1000
500
200,000,000
- 0
India China Vietnam Thailand Myanmar Korea
Population Number of meetings
Averagenumber of attendees per meeting
160
140
120
100
80
60
40
20
0
India China Vietnam Thailand Myanmar Korea
meetings (lower than China & India). This phenomenon is unreasonable while consider
the population regarding with number of meetings. Also, Vietnam is the country with
lowest average number of attendees per event (as graph 2). In a different view,
conducting many meetings with few attendees increases the cost of organizing and
decrease efficiency of using resources. Thus, this symptom is the critical concern in
evaluating risk level of business in Vietnam.
Figure 4. Number of promotion activities vs population
Figure 5. Average number of attendees per meeting
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2.1.2. Repeated type of noncompliance findings
There are several type of compliance issues repeadedly reported in monthly
reports. The symptom began to be recorded in actual meetings by spot-check team since
February 2017. Before that, issues were discovered by document check after event
happened, in which, the most common issues were fake signatures of HCPs in attendant
list. Since spot-check applied in monitoring process, the most popular issue is the low
quality of lecture, which is too short or no related discussion is raised. The second
popular issue is the consumption of alcohol in meetings. Other issues less popular but
repeated throughout months were irrelevant attendees, last minute cancellation and
spend per attendees higher than policy’s limit.
Table 1. Listed repeat findings
Compliance findings Repeated months (from 1st
Jan 2017 – 31st Jul 2018)
Checking method
Signature concerns 6 Document check
Low quality lectures 13 Spot-check
Alcohol consumption 7 Spot-check
Irrelevant attendees 6 Spot-check
Last minute cancellation 12 Spot-check
Over-spend per attendees 5 Spot-check
Number of repeated months indicate the number of months in which, the findings were
reported. There were 19 months between 1st Jan 2017 and 31st Jul 2018, however, the
issue “low quality lectures” was figured out in 13 months by spot-check. On the other
hand, issue “last minute cancellation” - the decision to cancel event was made right
before the time event planned to happen – was repeated by different salesperson in 12
months. Other issues which were serious problem, also were involved in several months
despite of effort spent to educate or coach to sales team.
2.1.3. Being determined as “high risk in compliance” in audit’s assessment
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Vietnam was determined as level 3 in risk evaluation scheme by considering the
combination of the frequency of risk cases and the limit in solving risk completely,
through repeated issues. In which, there are 4 level of risk rated by global management
base on the implemetation of compliance controlling process, the violation of ethics &
compliance policies, the action plans to solve compliance issues and to reduce
compliance risks. There is global compliance team to establish guidance, control and
evaluate compliance risk in all countries that MSD run business.
Table 2. Scheme of risk definition
Ranking risk level Definition
Level 1 Low - All potential risks are recognized
and there are effective risk controlling
tools and the likelihood for risks to
happen is low and under organization’s
risk acceptance
Level 2 Medium - Majority of potential risks are
recognized and/or there are effective risk
controlling tools and the likelihood for
risks to happen is medium and under
organization’s risk acceptance
Level 3 – current rating High - Some of potential risks are
recognized and/or there are less effective
risk controlling tools and the likelihood
for risks to happen is high and/or over
organization’s risk acceptance
Level 4 Very High – Very rare of potential risks
are recognized and there is no effective
risk controlling tools and the likelihood
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for risks to happen is high and over
organization’s risk acceptance
2.2. Problem definition
By using literature framework and result from interview with specialist in this
field, the initial cause effect map was established with 5 potential problems: no effective
compliance training program, inappropriate compliance policies, great job pressure, low
ethical culture and wrong decision in recruitment.
2.2.1. Literature framework
In a general idea, a big picture of corporate violation was drew with its main
causes: capitalist culture, high risk business, organizational and situational factors,
conflict of association and low self-control (8). In which, culture and self-control canbe
negatively impacted by employees’ weak cognition and believe in legimitacy and justice
of compliance program, as a result, lead to bad attitude and non-compliance behavior
(9). The most critical reason for the lacking awareness about regulation is ineffective
compliance training which is a part of compliance program, as Trevino and her partners
stated in their research (10). This reason also reduce the willingness to look for
compliance advice, willingness to report compliance violation and the employees’
commitment to organization. Weaver and Trevino then in their another research, in
2001, also inputted that the lack of HR cooperation in compliance management of
organization is a potential cause in intentional compliance violations (11). In which, the
corporation with HR department help company to emphasize the importance of fairness
for archiving valuable compliance culture among employees. According to Weeks and
Nantel (12), bad communication about policies is claimed as potential cause of policies
violation, and account for low sales performance and job satisfaction. On the other hand,
Herrath and Rao scrutinized the importance of peer’s behavior and subjective norms in
21
salesperson’s non compliance behavior (13), in which, sharing knowledge and
compliance perspective within sales team and employees’ responsibility with company
help provide direction for employees’ behavior. Self-regulation, also studied by
Braithwaite in 1982 and Gray 2006, is a long-term management strategy which generate
either compliance violation or ethics culture in company (14) (8). By shifting the
centralization on individual responsibility, Gray believed that:
“This regulatory shift has resulted in a diffusion of
responsibility for safety risks as workers have increasingly
become individually responsible for enforcing regulation as
well as a target of regulation.” (8)
Differentially, Hu indicated in his research about managing employees’ compliance that
top management participant plays critical role in company’s compliance culture and
emloyees’ ethics behavior (9). The absence of top management in controlling the
implementation of corporate policies can make initiative, program or policies –
considered as extra work besides routine task of sales force - miss legitimacy
mechanism. In addition, the participant of top management is the signal of commitment
to the clear objective to all members of organization and also encourage rule adherence
(15).
Figure 6. Relationship of top management & individual behaviour
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2.2.2. Interview result
I conducted depth interview with 2 compliance officier (one from our company
– Mr. Huy, one from our competitor – Mr. Kha), a financial specialist – Ms. Tu, a sale
manager – Ms. Tram and a process controller – Ms. Truc to figure out what is the critical
cause of company’s current symptoms and problems. Interviews were placed in coffee
house in lunch time and interviewees were encouraged to express their perspective and
to share their own experience while dealing with compliance violation. Questions, from
questionaire, were used with different orders based on the flow of discussion.
Table 3. Brief profiles of interviewees
Interviewees Summary profiles
Mr. Huy Compliance specialist, has worked at MSD for 4 year, 3 years
experience as auditor at EY Co., Ltd
Mr. Kha Compliance specialist, has worked at Roche (biggest
pharmaceutical company by revenue) for 5 year, 1 year experience
as compliance officier at MSD, 2 years experience as auditor at
Grant Thornton Co., Ltd
Ms. Tu Financial specialist, has worked at MSD for 3 year, 5 years
experience as risk consultant at Deloitte Co., Ltd
Ms. Tram Sale manager, has worked at MSD for 4 years, 3 years experience
as medical representative at AstraZeneca (pharmaceutical company
– ranked at 11th by revenue)
Ms. Truc Process specialist, has worked at Maritime for 3 years, 2 years
experience as Process specialist at FE Credit
The inappropriate policies guided by global management are rated as a reason for
symptom that the great frequency of interaction with customer by risk methods, in
interview with financial specialist – Ms. Tu - who used to work as consultant in KPMG
and spot-checker for event of Sanofi – our biggest competitor. In actual, other rivals in
market do not face with this symptom by application of restricted policies of minimum
limit number of attendees. Although our controlling process is the strongest and the most
23
optimistic in the market with massive requirements and standards implemented, our
policies are somehow flexible and allow salesperson to conduct meetings with their best
convenience. She recommended that if we apply the limit number of attendees per event
as 30 or more, instead of 8 in current, we will significantly decrease the number of small
meetings that also decrease management cost and risk generated from these meetings.
Ms. Tram has same perspective in this symptom and added that beside unstrictly
policies, mindset about effectiveness of salesperson may be different from management.
Indeed, salesperson think that it might be more effective and more comfortable to
provide information for group with less attendees rather than big groups. Thus, by
considering between pros and cons of several types of event, salesperson usually engage
with small meetings that give them more benefits. My colleague working in compliance
department – Mr. Huy, who used to work in Enrst & Young, inputted that salesperson
sometimes cannot acknowledge completely about compliance risk they could face in
small meetings and thus, there is no consideration about risk but only its convenience
when conduct so many meetings. This problem is claimed by the impractical training
that cannot help salesperson to aware all risky scenarios in their meetings, as he
mentioned: “Salesman do not have awareness of potential risks they will face while
interacting more frequently with high risk customers.”
Regarding to the symptom as repeadted noncompliance issue and high ratio of
number of findings and number of meetings, Ms. Tu proposed 2 circumstances that
employees might involve in breach: intention and unintention. Unintention in violation
compliance policies is caused by low effective training, while in intentional involvement
of breach, the problems are employees’ low ethics and employees’ low skills of
negotiation and communication with HCPs. She claimed that HCP’s noncompliance
requirement is belong to human nature and can be raised in any business circumstances.
On the other hand, nowadays, HCPs in Vietnam are group of citizen that have high level
education and usually attend professional education events, thus, HCPs can understand
the meaning of company’s compliance policies and also consider to protect their
reputation and images against public or their patients. Therefore, salesman with good
understanding can explain company’s policies with HCPs and deny to provide
inappropriate benefits or other noncompliance interaction with HCPs. On the other hand,
24
salesperson with unethical behavior that intentionally violate our regulations are not
suitable with our culture and requirement. Therefore, recruitment process is first
controlling stage in ensuring no unethical behaviors in our organization. Otherwise, Mr.
Huy’s perspective is different from Tu’s. In which, the problem engage with intentional
violation of policies is also one kind of lacking awareness – the longterm awareness. As
explained, salesperson understand compliance policies and implement as order from
their management but not understand the real meaning of these policies is to protect
company’s reputation and in long term, to creat a sustainable business with maximised
and long-last profitability. In contrast, a non-compliance events hold by MSD if be
captured or reported to the public, there would be not only a serious damage to company
reputation, but also to commercial business. Moreover, the operation of non-ethical
company can be restricted by laws and regulations of countries, industry as well as
business associations which it is now a member of.
One interesting viewpoint added by Mr. Kha that the serious level of issues can
also be used to define if that action is the result of intention or unintention. In which,
almost high risk issues – usually fraud – are involved intentionally, in opposite, low risk
issues – for example: missing documents, low quality lectures – can be classified as
either unintentional or intentional involvement. This point is very helpful in critisie the
importance of causes that should be focused on solving to minimise the risk of operation.
Mr. Kha also mentioned old practices in interaction with customer and sale pressure as
potential causes of intentional compliance mistakes. As regarding to the repeadted
issues, Ms. Tram suggested that the cause of this symptom is saleman’s practice in
getting compliance advisory, which is sharing and discussing within their team. In
actual, there are 3 compliance officier that salesperson can reach to get advise in several
methods: face to face, phone, email, chat. However, due to the hesitate feeling to
communicate with compliance department, salesperson usually seek advise from their
peers, seniors and managers – who sometimes not clearly understand all compliance
policies. This will lead to series of repeadted issues among employees. Ms. Truc, with
related point, claimed that the behavior of an employee can impact other employees’
work as an image of company in customer’s mind. Moreover, updating policies – which
happen regularly - also take long time to be implemented by sale force, in which, the
25
communication about policies and information is not really impacted, the old practice
in interaction with HCPs is hard to change and salesperson do not willing to update their
knowledge. Additionally, Ms. Tram suggested that language is also an important barrier
in effort to be compliance. Systems and document templates in English can make it
difficult for salesperson – who do not have good language skills – to understand and
learn.
“If that company evaluate ethic as a critical concern, it should
be included in assessment at recruitment process, as a fresh
raw material.” – Ms. Tu
In discussion about causes of both intentional and unintentional issues, one
critical key point that Ms. Tram, Ms. Tu and Mr. Huy agreed on is the inappropriate
compliance management program in many sections of management, such as low
effective discipline policies, weak corporation with other department, especially
recruitment or L&D, cursory evaluation of compliance implementation, no KPI
performance to measure level of compliance in business. Despite of effort incontrolling
and monitoring, a massively complicated process, without useful tools and guidance,
can be a reason for salesperson to miss compliance. One consideration of Mr. Kha about
compliance process is the selection of customers to engage with. Obviously, customers
who work with MSD have to ask to comply with MSD’s codes of conduct and operation
policies at the beginning, but in actual, customers sometimes ask to be provided
inappropriate benefits or attend MSD’s meeting with inappropriate behavior. As a result,
salesperson engaged in intentional violations of policies in order to satisfied customer’s
demand. However, the control process of this stage is ignored by salesperson and also
not strictly monitored by management.
2.2.3. Initial cause-effect map
Both literature and view of persons in charge agreed that employees’
noncompliance awareness is the most critical cause of policies violations. In a detailing
explanation, compliance violations are naturally considered as 2 types base on their
26
motivation in action: intention and unintention – lack of compliance awareness.
Intentional violation of policies is somehow easier for recognizing and examining its
causes due to the seriousness of particular issues. Deeper cause of intentional
noncompliance behavior are either employees’ miscontrolling nonethical behavior (8)
(14) or the requirement to adapt with noncompliance customer’s interest that was
firgured out significantly more than any other industry (8) (16) (17) (18) (19). This
motivation is generated not only by sales pressure, which is the combination of the
nature of this career kind (16) (20) and employees’ dissatisfaction raising from their job
(1); but also (a) the lack of communication skills to explain and convince customer to
respect company’s rules which is claimed as consequence of no effective compliance
training program- especially happen with juniors; and (b) a comprehensive compliance
management system with inpropriate policies as the totally agreement from different
organizational perspectives of Mr. Kha, Ms. Tram and Ms. Tu. In the other hand,
regarding to the management perspective, miscontrolling noncompliance behaviors are
claimed for unethical culture of organization (21) and the wrong decsion in recruitment
(11). In opposite, unintentional wrong-doing with its basic base is the lack of compliance
awareness. This issue can be devided into numerous more detail types: no idea about
potential issues may happen, no update policies perceived, misunderstanding about
policies, etc.,. These types of lacking awareness are the results of ineffective methods
used to spread out initiatives or updated policlies, according to Ms. Tram and Kharbili
and other authors stated in their research in 2008 (22), difficulty in reaching compliance
training materials and compliance advisory and employees’ unwillingness to reach these
resources – according to Ms. Tram (10), negative impact of peers and managers through
sharing experience and knowledge (1) (13) (as agreement of Ms. Tram & Ms. Truc). In
other words, no effective training program is the central problem of this mixture with its
consequence is determined as employsee’ noncompliance mindset that causes
compliance risks for company’s operation.
In summary, by combining the interview result and preference from previous
studies of specialists in compliance management field, list of problems of compliance
risks in organization was pointed out as below:
27
-No effective compliance training program
-Inappropriate compliance policies
-Great job pressure
-Low ethical culture in organization
-Wrong decision in recruitment
28
Figure 7. Initial cause-effect map
29
Chapter 3: Problem justification
In this part, the existence and importance of problems are considered rationally
to generate updated cause effect map with 2 central problems: no effective compliance
training and wrong decision in recruitment, and additionally, highlight the requirement
to pay effort in dealing with these problems.
3.1. Jusitfy the existence of problems: Updated cause-effect map
The idea about comprehensive compliance management and ethical culture are
certainly work well to improve effectiveness of controlling and prevent noncompliance
actions (8) (9) (23). However, because of being stated as leader in compliance
controlling in pharmaceutical pharmacy and defining integrity and transparency as most
important basement in business, MSD has a solid compliance system with highest
standards in controlling business, employee’s behavior and also stakeholder’s
interaction (Ms Tram and preference documents: Global Compliance Program &
Principles for Business Practices). Opetating with the spirit: “No rationale with fraud”,
MSD Vietnam as well as MSD Global acts with greatly aggressive attitude in
preventing, investigating and dealing with fraud. In addition, ethical culture of MSD
performs in all decision making process, not only personally but also organizationally.
In personal term, both effectiveness of salesperson’s activities and compliance in
working method are the critical point for their manager to consider whether the
salesperson showed outstanding performance or weak attention paid in working. Turn
to the organization term, important decision in MSD is not made by business’s leader
only, but by the concurence of relevant departments: finance, medical affair and
specially compliance. In several specific cases, General Director of the office and
Compliance Director are the final approval level, in which, the General Director
proposes the willing of business, the opportunities in reaching customers and raising
sales & the requirement to develop. In not clearly opposite side, Compliance Director
will show her opinion in relevant regulation, risks, scenarios of reputation’s damages
30
and restriction that company might face if involves in such of activites. Lastly, these
executive managers will try to balance the cost and benefit of company and come up
with the solutions to help grow business without breaking rules.
To be continually considered, the “Inappropriate compliance policies” problem
should be applied all above reason to examined and critizied. Furthermore, although
there are several issues were repeatedly involved by different salesperson, 2/3 of
salesperson have never involved in any breach (according to Finding’s owner report).
Of course any issue can be counted as ruinning company’s imagine, but the critical point
could be the evidence for the appropriateness of company’s policies and processes. One
more side of problems should be considered is the ability to deal with problems. Because
of being a member in giant MSD’s family expanding all over the world, MSD Vietnam
has to comply with standards in operation, vision in heading to and also process in
running business. Local laws and particular characteristics of local market certaintly
impact the practices of each MSD’s branch, however, these factors would be never a
reason to break the value in compliance and integrity that MSD Global established by
the contribution of all members in the network. As a result, a global standards and set of
policies are asked to be respected and commited by all countries in a group or a area.
Therefore, this potential problem should be eliminated according to company’s actual
situation.
As well, great job pressure is considered does not a suitable problem for company
to deal with due to the nature of this career type which is obviously more pressure and
difficulty in dealing with external stakeholders than any other jobs. In most of business
organizations or business areas, sales career is known for its particular way for people
to earn from: income bases mostly on sales performance. Not only because of the nature
of this job, excellent rating on working environment (preference: employer’s rankings)
and competitive C&B package offered by MSD are also reasons to eliminate this
problem out of potential list for company to deal with. In conclusion, list of potential
problems included 2 potential problems that indicated from company practices and
preference resources: no effective compliance training program and wrong decision in
recruitment.
31
Figure 8. Updated cause-effect map
32
3.2. Justify the importance of solving problems
“Is a gift just ever a gift?”, according to Wazana and numerous studies about
conflict of interest (COI) in pharma industry (24) (25) (4) (3) (2), the relationship
between companies and customers as well as consumers is examinied and restricted
carefully by public perception and government regulations. No promotion, gifts or any
interaction in order to attract customers by personal benefits provided are allowed.
Interest conflict in pharmaceutical industry must be avoided as a requirement in
enhacing company’s reputation and maintain the sustainable development in market. On
the other hand, focus on violations in business process should be set as priority but not
several internal process despite of its massive hamrful to operation cost of any
organization (21). As explaination in a research about compliance management of Ph.D.
Kharbili (22), “non-compliance at the level of business processes is critical because
business processes control all value adding activities of a company”, therefore,
compliance management in interactive activities between company and external
stakeholders should be focused and well controlled. The damages that non-compliance
behaviors of employees cause not only pointed out in several studies as above but also
made clear in company’s guidance of management, in which, country that cannot ensure
an integrity and low risk business and impacts negatively whole company’s reputation
and image, must be applied restricted strategy on its operation and even eliminated
completely by executive management’s decision to withdraw business from that
country.
Not only because of the worst scenario wherein the executive manager decide to
stop business in local market, the central list of problems also has critical rationale that
asks manager to pay aggressive effort to solve. Wrong decision in recruitment is claimed
as the deep problem of fraud as well as intentional non-compliance behavior, which is
less frequently happen. However, as Mr. Kha mentioned in his interview, the damage
causes by fraud is heavily which can not be defined and controlled by company, and
usually is because of inappropriate personal benefit. For instance, salesperson did not
hold scientific meeting with HCPs but used the budget to satisfied HCPs by financial
benefit. This scenario rarely happens, however, it not only ruins company’s reputation
the most but also generate negative perception of customers about company’s image.
33
Despite of these real consequence and importance of the problem “wrong decision in
recruitment”, knowledge and practical experience about this area are out of scope of
report writter. In addition, focusing on new recruitment and pay effort in controlling
future hired employees could only improve the level of compliance awareness of a small
group of employees but not a critical group who is now in charge the key business of
company which includes senior employees and managers. As a result, we focus heavily
in the next problem, which is defined as the main source of systematic issues and low
awareness of employees.
Unintentional involvement in noncompliance activities, in the opposite, is
acknowledged by management but because of both several subjective and objective
reasons, breaches still happen among organization and if these breaches are systematic
faults, there are issues in controlling and monitoring process to protect company and
employees against risks while interacting with customers. In field with “conflict of
interest”, espcially related to human health or human life, the inappropriate appearance
should also be avoided as well as the truly inappropriate behavior. Employees with no
awareness of restricted activities or the consequence of noncompliance activities could
involve in these breaches with the same appearance of an intentional one. Moreover, no
effective training program not only resulted in employees’ awareness but also in
employees’ work satisfaction. To be claimed as management’s voice and company’s
strategy, training program is the tool to establish compliance culture and to strengthen
employee’s believe in their executive manager. Therefore, enhancing an effective
training program can bring the company many improvement in such areas: compliance,
employee’s commitment, management and also business performance.
34
Figure 9. Final cause-effect map
3.3. Causes of centralize problem
Centralize problem – no effective training program is generated by 3 causes: no
involvement of different functions, no real cases discussion included in training and no
evaluation tools applied along with training session – which are also current practices
of training program.
3.3.1. No involvement of all employees
In actual, company’s compliance training program is now including 2 main
session: session in new-hired orientation and biannual updating session. With almost
time of each training session, compliance policies are read and explained traditionally
and unattractively - one by one - by compliance officier. New hired employees in this
way faces difficulty in raising questions, concerns or asking for more explaination (16)
(22). On the other hand, adequate awareness of compliance is also considered as the
attention of potential risks (as Mr Huy mentioned in his interview), which is now
missing from employee’s mindset. Solutions that would be discussed in next section
35
with the base of researches, studies and personal perspectives of interviewees must be
focussed on main causes of an ineffective training program. These causes which align
with current practices of company are indicated as: no involvement of all members in
organization (28), no real cases discussion (28) (29) and no evaluation tools applied
(30).
3.3.2. No real cases discussion
The negative result – high ratios of violations among activities, believed by sales
manager – Ms. Tram, is due to “no real cases discussion included in training” (11) that
help employees to raise awareness to avoid risk on working and be able to deal with
issues if any. Additionally, open discussion on daily routine tasks and difficulty in
working as well as appropriate right-doing also take a main contribution in a successful
compliance training program as a 2 ways or multiple ways communication. Regarding
the role of different parties in compliance education, the ethical culture is believed to be
built on strong commitment of all stakeholders within an organization, thus, as a spirit
value that make a heavy impact on performance of business and is controlled strictly by
several sets of regulations, compliance which lack of involvement of relevant parties’s
support in managing, discussing and making decision would be missed controls and
vulnerable in aggressive business environment.
3.3.3. No evaluation tools applied
In combining with other elements of a training program, assessment if applied
frequently as a compulsory performance and designed rationally could be used as
ingredient in building training content and evaluate the effectiveness of training without
real findings and issues happened on real field that cause harm for business of company.
Regarding to valuable sharing from Ms. Tu, knowledges if not is repeated by training
and testing would be easily erased in people’s mind. In the other hand, tesing is also a
tool not only to evaluate to understanding ability of studier but also an excellent tool to
measure the adaptiveness of training strategy in organization’s culture. Therefore,
assessment in pre & post training could help trainer to identify their student and mitigate
the gaps between trainer and learner. Because of all consideration, these causes with
36
deep analysis by interviews and literature framework in next section will finally come
up with solutions to enhance the effectiveness of training program.
Figure 10. Causes of centralize problem
CHAPTER 4: ALTERNATIVE SOLUTIONS
With the limited resources of human capital, finance and the current business
strategy at this time, central problem: The lack of Effective Training Program will be
chosen to solve as a long term strategy with a positive outcome: to develop the standard
level of compliance understanding and to build a compliance culture within
organization. This chapter is to gather interview result, idea from litterature framework
to come up with recommended solutions and action plans.
4.1. Interview result
Interviews about solutions to enhance the effectiveness of compliance training
were conducted base on the current practice of company and personal perspectives of
interviewees. As the current practice, orientation training is tool to communicate the
very first message of organization about most important topics. In compliance session,
key principles of interaction with HCPs and an overview of process of holding a
No involvement of
all employees
(in
No real cases
discussion
cluded executive
manager & other
functions)
No evaluation
tools applied
No
effective
compliance
program
37
promotion event are introduced to new comers. Then, employees will be asked to seek
advice or additional training from their manager or senior colleague in team meeting,
combined with other business topics. More compliance knowledge will be provided on
work or when issue are raised. According to compliance refreshment, biannually, cycle
meetings are hold for all BUs and compliance department is requested to update
compliance knowledge with specific topic “ordered” by each BU. In refreshment
session, compliance topic will be discussed with listed highlight information which is
popular findings involved by employees. As usual, compliance session will be ended
following an open discussion between compliance officer and sales person.
From the discussion, all interviewees agreed that training program is now not
approached as a comprehensive program that cover all essential contents to increase
employee’s compliance awareness. Basic elements were established and person in
charge for training program was assigned but there is no real connection between each
stage of the whole process. Ms Tram suggest that real case study should be discussed
frequently or guidance for correct decision should be made. In actual, training contents
in compliance refreshment session are consist of the written standard operation principle
(SOP) related to the topic, the guidance of the process need to follow and the message
“not to violate the rule” repeated times over times. Case study if can be analysed by
debate and examination between different parties: compliance, sales, executive
management, finance, and other operation function, will generate a cooperate result
which can be eliminate the gap between desires of sales team, management function and
company’s leaders. Also agreed with this suggestion, Mr Kha added that the practical
solutions, which all parties concurred, should be updated frequently by following the
dynamic flow of business. By doing this, difficulty of either sales person or controller
would be defined and got supports if it’s necessary. One more benefit from the
cooperation between different functions in compliance training is the commitment to
involve in implementation the policies seriously.
The cooperation among company could be also perform in the impact of peer and
manager in individual’s behaviour, regarding to the development of training content, Mr
Huy suggest that all employees include executive management and un-sales department
should be counted in compliance training with different point to focus on. Moreover, Mr
38
Huy proposed the awareness of potential risk before issue was raised should be treated
as important target to archive. Besides, not only awareness of “how to do right”, but also
the understanding of “why should do right” should be focused to enhance. Ms Truc, in
the discussion the same idea to enhance the quality of training program, suggested that
training should be designed to focus greatly in stages which is now missing the control
or cover many potential risks. Without wasting time in including all compliance
requirements in a short-time session, trainer should use data and observation to analyse
and determine the key point for gaining much more benefit. Furthermore, Ms Truc also
mentioned the importance of ability to recognize the risk and raise concern figured by
employees in controlling the implementation among company. This important skill, if
can be trained systematically and effectively, could become a useful merchandise for
executive management to create a solid compliance culture by using self-control ability
of employees. Besides the training content, measurement or valuation the result of
training program is now missing and requiring an effort to develop. By showed opinion
about this aspect, Ms Tu emphasized the critical role of measurement tools in improving
the effectiveness of training program. Tests, surveys are supposed to be essential for
education activities which can quickly generate and perform the short-term effectiveness
in enhancing understanding of employees. By this way, actions to fix issue in
communication or re-design training content could be immediately taken for next
session. Another key benefit for this practice is to determine the specific level of
understanding of employees to divide into several groups base on their weakness and
ask them to pay more effort in improving compliance awareness.
4.2. Literature framework
Training in researches by specialist or scientist in Operation Management field
was emphasized as an principal element in a comprehensive compliance program.
Designed to be the connection in communication between organization’s leader and
employees, training with its effectiveness can be establish a solid ethical culture in
company by the self-controlled ability of each individual. As suggested by Cairns and
Yarker in their study about maintaining compliance while interacting with HCPs,
compliance training should be conducted by a assigned team that take main
39
responsibility in training, also should be enforced by using not only compulsory tests as
a period reassessment, but also a clear evaluation system. Business ethics issues often
covered in training include breaches of confidence, falsifying records, conflict of
interest, abusing drugs or alcohol, misuse of organizational assets, discrimination, and
sexual harassment (26). To enhance to effectiveness of education and valuation,
company can use electronic education tool or online assessment, and use the result to
develop specific enhancing propram for individual. Also about this idea, Verschoor
agreed that customizing training content to particular demands of their business practice
is to maximize the effectiveness (27). In order to establish a unique training program
serves for individual’s demand, training team should focus on risk associated with
particular business area and should not focus much on exceptional case but the
application in daily routine and employee’s responsibility (28). Otherwise, there is
another opinion about differential learning content, in which, other researchers advised
that learning tasks should be personal for the learners (29). Besides compulsory training
program, learner can choose among set of topics that interest them and see the possible
consequence of their action. Not only tests, but also survey and interview to collect
opinion and class should be also divided by level of knowledge and type of job.
“If employees can participate in the initiation and
implementation of a code, then the values, commitments, and
beliefs of the company become a catalyst for the code’s
creation.”(28)
As required by the guildline (30), compliance training team have to ensure the
quality of education and ongoing communication about useful knowledge includes both
legal policies which begin with the development of code of ethics – also be the contents
of training program (28) and best practice sharing. Regarding content of training, case
studies in other organization and within company are suggested to be used to assess
employee’s understanding about real scenarios. No matter written policies or best
practice is shared, there are 4 principal ideas should be deeply acknowledged by the
employees:
1. “An ethical requirement in decision’s components.
2. Tools to address ethical issues.
40
3. Understanding of ethical situation’s ambiguity because of
their very nature (no completely correct decision which can be
debated both outside and inside the organization)
4. Awareness of importance of wrong ethical decision in
creating ethical culture within the firm.” (31)
One highlight in the study is the timeline indicated for required level of
knowledge and this information should be recorded in personel file. In application of
this concept, company should allow employee to have a time period to be familiar with
the full content of compliance program and standards before involving in a compulsory
test (30). Quantity of compliance training session or the frequency of training also takes
important role in enhancing effectiveness (29). Puhakainen & Siponen determined in
their study research that only one-off training course is not enough, it must be a
continuous activity. To be able to spend company’s resources in, an effective
compliance training program require great support from top management, such as
management review, management encouragement or involvement in training program.
Employees should get familiar with compliance definition, policies or compliance
processes by reminders from the top, frequency approach with compliance discussion
and feel the sense of compliance everywhere in organization. A key problem in
managing ethics program is to make ethics as a part of organization’s culture. Impacts
of manager and co-worker are determined as key element in implementing compliance
(28). Therefore, it is necessary to increase training at all level including senior
management and board of director (27). Regarding this idea, Ferrell indicated in his
research that: there is a need to cover all level of employees in training program to ensure
a consistent compliance awareness among organization (28). Most violation of policies
occur not because employees want to get benefit them-self and destroy the development
of company but because of 2 factors: opportunity and behaviour of peer and supervisor
(32). Almost the cases, employees try to benefit the company by the belief that corporate
objective is much more important than compliance requirement or ethical standards. The
conflict among individual value, organizational value and societal value leads to rule
violation. There is always the ambiguity in making right decision, only top management
and open discussion/debate can eliminate the mistake/issue. Training program should
41
be treated as any other core business function and conducted as a tool for open
discussion in organization. Turn to practice, an effective training program can be last for
about 2 or 3 hours but attract employee’s involvement and create open environment for
discussion. Furthermore, ethical issue should be discussed in relation with other business
activities such as a strategy kick off meeting quarterly or performance discussion inteam
meeting could be also an appropriate forum to identify compliance concerns engage with
the specific strategy or business goals.
“An issue, activity, or situation that can withstand open
discussion between many groups both in and outside the
organization and survive untarnished provides assurance that
the right decision was made.” (28)
Finally, the spirit of an effective training program which much more than legal
requirement or risk monitoring tool but a method to communicate company’s vision, is
to educate employee perform the mindset to share their responsibility in increasing
corporate ethical culture and the use of ethical understanding in making decision.
Training will be ineffective without full commitment of the whole organization to the
program and without the core infrastructure to guarantee the essential support of
manager to make the program succeed. Training is both to inform and to motivate, not
only understand the requirement but also be motivated to archive compliance
implementation’s target (28).
4.3. Proposed solutions: Building comprehensive training program
Solutions “building comprehensive training program” to increase the
effectiveness of compliance training should be built by 4 basic elements of a project:
who, where, when, how.
4.3.1. Who?
All level of organization should be the target audience of the program. As debate
of previous researchers and suggestion of Mr Huy, the compliance culture could only
be established by the participant of all members in organization (28) (27, 32). Current
program is now focusing on junior level salesperson but not a requirement for managers
42
or other functions. Thus, compliance session, especially open discussion, should cover
both executive management and related internal functions to get the concurrence of
appropriate operation within company. On the other hand, beside updating self-
knowledge, leaders have other responsibilities while participating a compliance training
program. These responsibilities are to support ethical discussion, to ensure a view from
top management, to behave as a compliance model and to get the commitment of
employees with company by believing in the ethic value painted by their executive
management (33). The role of other functions is also determined as critical element in
the success of training program because there is always an ambiguity in making correct
decision and the view from other side is valuable for the most appropriate solution. In
actual, compliance team does not gather issue or examine the operation themselves,
instead, data was provided by different team in charge of each stage in the process.
Therefore, by showing the working methods and discussing issue raise from operation,
salesperson could learn to eliminate mistake that usually recorded and to avoid risk in
their daily routine. Finance, supply chain, procurement are principal functions which
work closely with salesforce, should attend compliance session to get concurrence with
sales team.
4.3.2. Where?
The circumstances where training conducted are as important as the methods to
approach the program. At the first stage of comprehensive training program, during
orientation, in which no prescribe about operation was earned by salesperson, SOPs
should be discussed with key idea attached with a quick describe of working process
and real examples. In addition, compliance knowledge is provided together with
valuable discussion and inputted information could generate positive result in enhancing
compliance awareness of employees. In Mr. Kha’s opinion, compliance issues that could
be discussed in the view of business and follow business strategy, may be easier to come
up with best practice which benefit both business and compliance protection (31).
Besides official compliance training or compliance session inorientation or compliance
session in biannual business meeting, strategy meeting or business performance or
business kick off meeting need to cover compliance perspective (28). By this way, an
43
ethical culture would be established among company in all activities that compliance
involves.
4.3.3. When?
a continuous process, time to familiar with principal policies, monthly short
discussion, quarterly update (29). An ethic culture could only be built by the frequency
that ethical topics were discussed between relevant stakeholders. Obviously, increasing
awareness of all members in an organization is a continuous process with large amounts
of knowledge and information updated, changed, repeated regularly (29). Current
practice is now including orientation in first 2 months and updated session in business
meeting quarterly, this density is not meet the requirement for creating a compliance
climate due to the dynamic growth of business and the impact of repeated messages on
people behaviour. After orientation, monthly short discussion with team should be
conducted with noted issues or only hot message reminded. This message should be also
sent from top management monthly via email to all employees. Besides, in coordination
with the updated content of training, assessment should be conducted every 6 months
on the scale of company. In a different perspective of time requirement in training
program, it is necessary to allow employees having time to be familiar with regulation
before actual practice on working and on testing knowledge (30). It should be a
minimum time requirement as 2 months to internalize the vast majority of compliance
knowledge before working or interacting with HCPs. Testing for new joiners, by this
rationale, should be applied to ensure the quality of understanding after 2 months being
trained and educated.
4.3.4. How?
There are 4 topics discussed related to the content and methods to conduct
training program: measurement tools, requirement for updating content particularly,
requirement focusing on risk raised, requirement improving ability to identify risk.
Regarding measurement tools, pre-test and post-test should be applied to evaluate
44
compliance understanding before and after program launched, as suggested by Ms Tu.
Test should be designed to be fit with training content and different level of difficulty in
comparison of pre-test and post-test. In addition, annual test and quarter test are advised
to conduct on the scale of all company with the questions cover all compliance topics
with technology tools (27). As well, testing result could be used as a dimension in KPI
performance of individual and team, to force motivation of employees in learning and
enhancing compliance understanding. Turn to the demand of being educated personally
or base on different level of knowledge, testing result generated from evaluation and
performance recorded should be counted in the effort to divide salesperson into different
groups with the balance of literature and practice in the lesson (Ms Tram). Knowledge
offered to each group must be carefully designed and launched in training session at the
right time. Groups could be determined by level of experience or specific compliance
concerns, such as “controlling meeting”, “planning”, “documenting”, “systematic
controlling”, “making payment”, etc., On the other hand, there is suggestion to let
salesperson to choose the topic that interested themselves (29), however, this methods
could only applied with a balance between democratic and dictatorial. In which,
employees have the right to choose among several topics that required them to complete
within a period, employees could flexibly arrange their training plan and complete the
priority session that useful for their work. In discussion about increasing the ability to
identify potential risk (31) (28) (Mr Huy), employees should be provided full view from
different perspective about potential risk in scenarios they would face. A list of potential
risks for each type of promotional activities should be built for a very first image that
could happen and which kinds of behaviour or kinds of characteristic of activities would
lead to issue. By being acknowledging about future scenarios, not only ability to identify
risk would be increased because of bad scenarios determined, but also the guidance for
each situation would be rationally discussed between legal, compliance and business.
Along with objective to enhance employee’s ability in identifying potential risk, a
rationale concentration on risky activities should be approached to maximize the
effectiveness of company’s limit resources. Data could be gathered from monthly
reports and annual self-assessment result in order to define which are the tops of most
risky practice in the whole operational process (Ms. Truc)
45
WHO
• All levels of sales team
• Executive management
• Related functions
WHERE
• Discussion and brief
describe of process in
orientation training
• In business meeting:
strategy discussion,
business performance
HOW
• Apply measurement
tool
• Update content
particularly
• Focus on risky activities
• Enhance risk identified
ability
WHEN
• Orientation in first
month
• Monthly short
discussion
• Monthly message from
the top
• Time to be familiar: 2
months
Figure 11. Key criteria in training program
4.4. Considering factors
Human resources and time capability: There are now 3 head counts in compliance
team, 2 in Ho Chi Minh city office and 1 in Hanoi office. Besides, Compliance
Ambassador Team (CAT) which has 10 members who is representative of each Business
Unit commit to engage and support compliance development in organization. In the
main scope of compliance team, not only training, but controlling, testing, building
guidance, consulting and dealing with compliance case are also main activities to be
focused. Turn to CAT, all members are manager from sales and marketing department
who fully in charge of core business of company. CAT could support compliance team
in training session in biannually business meeting or when required. Most of the time,
compliance team is now having 1 hour for each session in business meeting with 2 hours
preparation prior to meeting.
46
Cost: Training program which includes physical training using internal material
and speaker without additional cost. However, opportunity cost raises by time being
spent in training sessions could be counted as significance cost to consider. Cost of
opportunity is not only come from trainer but also spent by trainee, in which, employees
have to cut down time for interacting with customers and time for discussing sales
strategy to participate in compliance session. Otherwise, refreshment and awards needed
for training also account for amount which is charged on general operation budget. As
can be seen from the cost plan as below, total cost is estimated for each half year (6
cycle) as 16 millions VND and for a full year as 32 millions VND.
Cost plan (for 6
months) x
1.000 VND
Cycle 1 Cycle 2 Cycle 3 Cycle 4 Cycle 5 Cycle 6
HR 4 x 200 6 x 500 4 x 200 4 x 200 4 x 200 4 x 2000
Refreshment
(Training &
Testing)
2000 2000 2000 2000
Awards
(Testing)
500
500
Total 3300 3000 800 2800 2800 3300
16000
Table 4. Cost estimated for bi-annual training plan
4.5. Action plan
By consideration between benefits of recommended solutions and cost
discussion, action plan would be built in the base of 4 criteria: who, where, when & how.
By the combination of all criteria of a comprehensive project, implementation would be
designed for each quarter and repeated through years. In actual, action plan is proposed
with predicted elements and additional inputs or modiration would be added whenever
required. In details, before program is launched, compliance committee should agree on
the program’s overview , timeline and approach plan. In which, a summary report about
compliance awareness includes popular findings, serious issues, difficulty in conducting
47
compliance process and employee’s expectation from compliance management would
be examined by compliance team to design the general training and initial test with the
focus on risky activities and concerns of employees in the first 3 weeks of December
2018. The program overview and initiation would be discussed with executive board of
manager to align the spirit as well as get support from leaders of organization in
communication. All preparation should be completed in December 2018, including
announcement, clarification and alignment with other related functions. Program will
be launched firstly in compliance session of national meeting in 1st week of Jan 2019,
with general training for all employees, followed by an initial test. In the 2nd week of
Jan 2019, compliance team will conduct scoring task and start to analyse date to figure
out which knowledge areas should be focused on improvement. Compliance team will
base on test result to make decision of how many groups that employees should be
divided into and propose this result to executive board of management for agreement.
In the meantime, training contents and agenda will be built with principle idea
highlighted and real case studies listed down for an open discussion. In the 3rd week of
Jan 2019, CAT team will send the test result and list of groups to their business unit and
leaders of each unit will make a voice to encourage their team members to join fully in
next particular training. All employees will have 2 weeks to prepare and register chosen
schedule for training course that will last about 3 hours for each topic. In the beginning
of February, training course will be conducted by compliance manager and to make the
use of the resources from quarterly business meetings. Next, in March, compliance
updating will be run for the demand of business or the necessary to run because of
current issues. This training session, because of its nature, is not a compulsory task must
be done, but a additional supporting from compliance program for teams who are facing
with compliance issue while doing business. In April, which is the beginning of a new
quarter, a periodic test will required to be completed with specific questions and case
studies for each groups, followed by the repeated process of scoring, analysing, group
dividing, training and updating from the previous quarter.
In July - the beginning of the 2nd half of the year, compliance team will hold a
general training for all employees in 2nd Cycle meeting with the participant of executive
board of management. In this general training, all topics that lack of appropriate
48
awareness will be mentioned to be discussed by all parties: managers, employees who
either good or bad at this topic, support functions and compliance. The training session
by groups will certainly launched, in along with cycle meeting’s activites. As a
continuing process, other steps will be applied as the same in 1st haf of the year. The art
work and process with specific timeline are indicated an overview of program to
enhance compliance awareness of employees, with modification might be inputted later
if required.
49
Where
(circumstances):
-Orientation
-Business meeting
-Meeting with
executive manager
and compliance
committee
-National meeting
Who (PIC):
-Compliance
manager
-Compliance officer
-CATteam
-Businessmanagers
-Executivemanager How (trainingcontents):
When(timeline):
Before implementation:
1st week in Dec 2018: collectingdataand
analysing
3rd week in Dec 2018: designinginitial test
1st weekinJan 2019: general trainingand
initially testing
2nd weekinFeb2019: analysingdataand
desginingtrainingcontents
3rd weekinJan2019: Testresultand groupswill
be announced,employees registerforschedule
1st weekinFeb2019: 1st trainingsession
3nd weekinFeb2019: testing
4nd weekinFeb2019: testresultannounced
-Testingtodevide employeesintogroups
by level of awareness
-Test'scontentshouldbe designedonthe
compliance backgroundof companyand
shouldbe focusedonpopularissues
gatheredfromrecentbusiness practice.
-Re-designingtrainingcontentforeach
groupsfrom the perspectiveof
compliance andbusiness
-Focuson riskyactivitesatparticular
business team
-Remindingonreal casesand potential
risks
Figure 12. Proposed solutions for key criteria in training program
50
1stweek in Jul
2019
•General
compliance
topics updating
•PIC:
Compliance
manager and
executive
manager
•Testing
•PIC:
Compliance
officer
•In cycle
meeting
2nd week in Jan
2019
•Analysing data
and designing
training
content for
each group
•PIC:
compliance
team
•with discussion
and
concurrence
with executive
manager
3rd week in Jul
2019
•Test resultand
listof groups
announced
•PIC: CAT &
business
managers
•In formal
strategy
meeting
quarterly
1stweek in Aug
2019
•Training by
groups
•PIC:
compliance
managers
•In business
meeting
monthly
1stweek in Sep
2019
•Updating
compliance
currentissues
•PIC:
compliance
officer &
business
managers
•In team
meeting in
which
compliance
issueraised
1stweek in Oct
2019
• Testing
• PIC:
Compliance
officer
• In orientation,
in business
meeting
monthy
• FOLLOWING
ACTIONS in 4th
QUARTER WILL
BE REPEATED
BY THE SAME
SCHEDULED IN
3rd QUARTER
Figure 13. Action plan for improvement of training program
1stweek in Apr
2019
• Testing
• PIC:
Compliance
officer
• In orientation,
in business
meeting
monthy
• FOLLOWING
ACTIONS in 2nd
QUARTER WILL
BE REPEATED
BY THE SAME
SCHEDULED IN
1st QUARTER
1stweek in Mar
2019
•Updating
compliance
currentissues
•PIC:
compliance
officer &
business
managers
•In team
meeting in
which
compliance
issueraised
1stweek in Feb
2019
•Trainingby
groups
•PIC:
compliance
managers
•In business
meeting
monthly
3rd week in Jan
2019
•Test resultand
listof groups
announced
•PIC: CAT &
business
managers
•In formal
strategy
meeting
quarterly
2nd week in Jan
2019
•Analysingdata
and designing
training
content for
each group
•PIC:
compliance
team
•with discussion
and
concurrence
with executive
manager
1stweek in Jan
2019
•General
compliance
topics updating
•PIC:
Compliance
manager and
executive
manager
• Testing
•PIC:
Compliance
officer
•In cycle
meeting
51
Supporting documents
Interview transcript
Ms. Tu - Financial specialist, has worked at MSD for 3 year, 5 years experience as risk
consultant at Deloitte Co., Ltd
Interviewer: Hi there, this is an interview for you to share your perspective about
compliance management, not only in our organization. I would like to hear your voice
base on experiences from other companies that you worked before. First of all, about
our particular outlier, what do you think is the reason for so much interactions with
customers that we rate as high risk?
Interviewee: In my experience, my previous company did not face with this issue. The
issue that salesperson interacted so much with high risk customers is particular for this
company.
Interviewer: So you think what is the main reason?
Interviewee: I think the reason is simply our policies allow that.
Interviewer: Can you please specific how our policies generate this issue?
Interviewee: In my previous company, the policies strictly limit the minimum number
of customers per meeting, that is 30 at least. But in our company, we allow meetings
with only 8 customers to happen. I also asked my manager about this speciality. She
said that is the global guidance and we do not have permission to change and somehow,
sale managers also feel comfortable to allow this.
Interviewer: If our policies are seemed to be flexible, salesperson have wide choice to
conduct meeting in various range number of attendees. But why they keep stuck on
meetings with few attendees?
Interviewee: I don’t really understand their thinking. I just guess that is because they
know their customers and only few customers can attend our meeting, I guess.
52
Interviewer: Do you think this issue is because our social or traditional norms, that
customers would like to join in small meetings to avoid a formal discussion with their
colleagues?
Interviewee: No, I don’t think so. Customers of my previous company do not feel any
uncomfortable feelings when joining big meetings. They are also our customers because
they are all doctors in our major hospitals. Even in a big meeting, there were 100 to 150
attendees attend without any inconvenience.
Interviewer: So customers also would like to join big meetings, why our salesperson do
not hold big meetings for lower cost management?
Interviewee: I think this is a question you can raise with board of management to update
our policies. Because policies always go after business so there is no requirement for a
“always” comprehensive policies. If it is not appropriate, it should be enhanced to cover
current business risk.
Interviewer: But why while our company so prouds of our integrity and compliance
system, we still have to face with this type of risk?
Interviewee: Not at all, our compliance system is strong because in each controlling
stage or I call “checking gate”, we have very specific requirement for salesperson to
comply. We care in many details in an interaction with HCPs in order to protect us
against risks. We have a very strictly clear system to approve for meeting incur and an
professional expense management also help us to tracking all amount paid for
interacting with HCPs. But we do have some policies in our process that still not catch
up with flow of business.
Interviewer: So do you agree that this issue will raise more risk for business?
Interviewee: Yes, because we can not check all events if they happen so frequently
because of the limit resource.
Interviewer: About intentional breach, what is the reason you think?
Interviewee: I think there are 2 main reasons, firstly, it is because of the compromise of
salesperson.
53
Interviewer: Do you think it is a particular characteristic of Vietnamese?
Interviewee: I don’t think so. I also saw some salesperson try their best to explain with
customers to not break company’s policies and customers also agreed because our
customers are at high level education. So they can understand if salesperson have their
voice.
Interviewer: What about the second case?
Interviewee: The second is about personal characteristic. This applies for people who
know clearly about policies and have ability to explain but they do not action because
their willing to enhance their relationship with customers.
Interviewer: So you think what is the reason for this unexpected behavior?
Interviewee: I think this is ethical problem, this person is absolutely not suitable with
our company. We should recheck our recruitment.
Interviewer: What you think should be improve in our recruitment task?
Interviewee: If that company evaluate ethic as a critical concern, it should be included
in assessment at recruitment process, as a “fresh raw material”. We have to choose
candidate with high value of ethic to avoid risk after.
Interviewer: In your opinion, what you think is the critical problem as our discussion so
far?
Interviewee: I think critical problem for non-compliance behavior is the awareness
problem.
Interviewer: Can you be more detailed?
Interviewee: I think both unintentional and intentional issues relate to awareness
problem, that salesperson do not aware of policies, potential risks and also awareness of
how to convince customers to comply with our policies.
Interviewer: What action you suggest to solve our these problem? Ethical problem?
Awareness? Policies?
54
Interviewee: We can easily add some element in our recruiting assessment, take
reference from our competitor’s or advisory agency to upgrade our policies and add real
cases in our training. Moreover, I think our discipline system is somehow not strong
enough to educate our employees, we can raise our case to regional management to
consider allow us to enhance level of disciplines.
Interviewer: that’s enough for our discussion, thanks for your sharing!
Mr. Huy - Compliance specialist, has worked at MSD for 4 year, 3 years experience as
auditor at EY Co., Ltd
Interviewer: Hi there, this is an interview for you to share your perspective about
compliance management, not only in our organization. I would like to hear your voice
base on experiences from other companies that you worked before. First of all, about
our particular outlier, what do you think is the reason for so much interactions with
customers that we rate as high risk?
Interviewee: This is because of lacking awareness of salesman. Salesman do not have
awareness of potential risks they will face while interacting more frequently with high
risk customers.
Interviewer: If lacking of awareness of risk, what is their concern while conducting such
meetings?
Interviewee: Gathering a small group of doctors is seemed to be more easier for them
and the convenience in working may be their consideration while choosing the method
when working.
Interviewer: What do you think is the reason for this problem?
Interviewee: Of course training is the cause, we trained a lots about standards, formal
policies but in real field, when salesman face with hundreds of cases and hundreds types
of people, we do not have clear guidance for them to solve or avoid bad scenarios.
55
Interviewer: In another case, if salesperson acknowledge about risk they may face, but
still willing to make it happen. What do you think is the reason in this intentional case?
Interviewee: Once again, I think it also because of awareness problem. People in this
case lack of “long term” awareness.
Interviewer: What do you mean “long term”?
Interviewee: While making decision, people just care about their immediate benefit but
not the opportunity cost in long term. They focus on rising the sale firgures but do not
understand that if there is compliance scandal happen with company, the reputation
would be down, business would be restricted and sale would be destructed.
Interviewer: In what way we can coach our sales team about this type of awareness?
Interviewee: We can show them clearly some example, such as, if a journalist, a staff
from competitor or more easier, a customer attend our meeting take a picture of drinking
beers in our event, you can imagine what is the consequence? What does public think
about us, about our products?
Interviewer: So training as you mentioned is an important reason for non-compliance
findings, any else?
Interviewee: I think our culture also take a part in these problems. Especially in province
area, where traditional living style is still popular, customers have the habit of drinking
alcohol during meals. Thus, salesperson who have their target customers in such areas
would face difficulty in ask customers to comply with our standards completely.
Interviewer: So you mean this is because of our customers?
Interviewee: Not really, our staff’s behavior is also counted as a contribution. On one
hand, they are far away from the office where their higher level managers base, thus the
training and coaching are not effective as they should be. Otherwise, working style can
not be impacted possitively by their professional manager so compliance culture of these
area is not well as the central. On the other hand, they are also impacted by the traditional
culture which perceive the alcohol assumption in a scientific event is a normal case and
they feel comfortable with it.
56
Interviewer: that’s enough for our discussion, thanks for your sharing!
Mr. Kha - Compliance specialist, has worked at Roche (biggest pharmaceutical
company by revenue) for 5 year, 1 year experience as compliance officier at MSD, 2
years experience as auditor at Grant Thornton Co., Ltd
Interviewer: Hi Kha, this is an interview for you to share your perspective about
compliance management, not from any particular company. I would like to hear your
voice base on experiences from other companies that you worked before. First of all,
about our repeated noncompliance cases reported?
Interviewee: I think it depends on level of seriousness of findings. In details, for serious
issues, the problem is mostly intentional involment while for issues with medium or
low risks, it depends again, on situation, awareness or personal gain. We cannot
conclude as a problem.
Interviewer: Let’s go detail in low risk first. Could you explain more about your opinion
as “depends”?
Interviewee: There are 2 cases for low risk issue. First, they knew about policies but
because of old practice or their compromise, they violated compliance. Second, they
missed information, missed understand about a complicated compliance controlling
process.
Interviewer: As you mentioned, they compromised customers so they had non-
compliance behavior? About old practice, this is practice of them or customers?
Interviewee: Of course the issue come from them, certaintly not customers. Compliance
is their responsibility despite of several types of customers they faced with, they have to
understand and comply with company’s policies. However, as a stage in our controlling
process, customers that engage with MSD have to be assessed and chosen based on lots
of elements. So, if we missed our controlling, we may have difficulty in dealing with
non-compliance customers.
57
Interviewer: Do you think sale pressure or nature of market impact salesperson’s
behavior?
Interviewee: I think sale pressure is popular with sales career and of course have a part
of contribution to the consequence. And also, not only us, our competitor also faced with
same kind of pressure because this pressure not only come from internal, but also come
from external factors, such as laws, government’s restrictment or trend of market…
Interviewer: Do you think our discipline is not strong enough to educate our employees?
Interviewee: I think the main reason is salesperson lack their skill while interacting with
customers, it not related to discipline. In actual, we also don’t know how to treat with
involver completely, we want that involvement in breach not happen, right?
Interviewer: What criteria you think we should focus on improving to raise employee’s
awareness?
Interviewee: People do wrong may be because of they do not know how to do it right.
We can provide them full guidance in practical situation that can happen while
interacting with customers. On the other hand, this guidance or solution in particular
case should be discussed between different point of views to reach the most reasonable
suggestion that satisfied all targets of different parties. On more benefit of this kind of
discussion that you can gain the commitment of high level manament for a compliance
culture in organization.
Interviewer: Very helpful and inresting! That’s enough for our discussion, thanks for
your sharing!
Ms. Tram - Sale manager, has worked at MSD for 4 years, 3 years experience as
medical representative at AstraZeneca (pharmaceutical company – ranked at 11th by
revenue)
Interviewer: Hi Trâm, this is an interview for you to share your perspective about
compliance management, not only in our organization. I would like to hear your voice
base on experiences from other companies that you worked before. First of all, about
Luận Văn The Lack of Effective Training Program in Compliance Management
Luận Văn The Lack of Effective Training Program in Compliance Management
Luận Văn The Lack of Effective Training Program in Compliance Management
Luận Văn The Lack of Effective Training Program in Compliance Management
Luận Văn The Lack of Effective Training Program in Compliance Management
Luận Văn The Lack of Effective Training Program in Compliance Management
Luận Văn The Lack of Effective Training Program in Compliance Management
Luận Văn The Lack of Effective Training Program in Compliance Management
Luận Văn The Lack of Effective Training Program in Compliance Management
Luận Văn The Lack of Effective Training Program in Compliance Management
Luận Văn The Lack of Effective Training Program in Compliance Management
Luận Văn The Lack of Effective Training Program in Compliance Management
Luận Văn The Lack of Effective Training Program in Compliance Management
Luận Văn The Lack of Effective Training Program in Compliance Management
Luận Văn The Lack of Effective Training Program in Compliance Management
Luận Văn The Lack of Effective Training Program in Compliance Management
Luận Văn The Lack of Effective Training Program in Compliance Management
Luận Văn The Lack of Effective Training Program in Compliance Management
Luận Văn The Lack of Effective Training Program in Compliance Management
Luận Văn The Lack of Effective Training Program in Compliance Management
Luận Văn The Lack of Effective Training Program in Compliance Management
Luận Văn The Lack of Effective Training Program in Compliance Management
Luận Văn The Lack of Effective Training Program in Compliance Management

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Luận Văn The Lack of Effective Training Program in Compliance Management

  • 1. UNIVERSITY OF ECONOMICS HO CHI MINH CITY International School ofBusiness Nguyễn Thị Thu Vân The Lack of Effective Training Program in Compliance Management A case of a pharmaceutical company Tham khảo thêm tài liệu tại Baocaothuctap.net Dịch Vụ Hỗ Trợ Viết Thuê Tiểu Luận,Báo Cáo Khoá Luận, Luận Văn ZALO/TELEGRAM HỖ TRỢ 0973.287.149 MASTER OF BUSINESS ADMINISTRATION Ho Chi Minh City – Year 2022
  • 2. 2 UNIVERSITY OF ECONOMICS HO CHI MINH CITY International School ofBusiness 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 2022
  • 3. 3 SUPERVISOR’S REPORTON 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 1. General comments:  Remarks on the student’s attitude: ....................................................................................................................................... .......................................................................................................................................  Remarks on the assignment’s academic quality: ....................................................................................................................................... ....................................................................................................................................... 2. Overall assessment:  Meet requirement for submitting;  Not meet requirement for submitting. 3. Other remarks: - Did the student follow the report schedule?  Yes  No  Other....................................................................... - The Turnitin plagiarism percentage:  Supervisor’s signature
  • 4. 4 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.
  • 5. 5 CONTENTS CHAPTER 1. BACKGROUND INFORMATION.........................................................9 1.1. Risk of compliance management in healthcare industry................................9 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 2. 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
  • 6. 6 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
  • 7. 7 CONTENTS OF FIGURES Figure 1. Product lines ofMSD .........................................................................................11 Figure 2. Board of Management chart ............................................................................12 Figure 3. Marketing budget allocation ...........................................................................14 Figure 4. Number of promotion activities vs population.............................................17 Figure 5. Average number of attendees per meeting ...................................................17 Figure 6. Relationship of top management & individual behavior..........................21 Figure 7. Initial cause-effect map......................................................................................28 Figure 8. Updated cause-effect map - Justify the existence of problem...................31 Figure 9. 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 1. Listed repeat findings.............................................................18 Table 2. Scheme of risk definition....................................................... 19 Table 3. Briefprofiles of interviewees................................................22 Table 4. Cost estimated for half year training program.................46
  • 8. 8 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 5 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 3 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.
  • 9. 9 CHAPTER 1. 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 onthe risk ofcompliance 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
  • 10. 10 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
  • 11. 11 vulnerable reputation, which is easy to damage by the complexity of market, competition and stakeholders. 1.2. Overview of MSD Vietnam 1.2.1. MSD’s background and management structure MSD Vietnam was establised in 1995 as a representative office, controlled by MSD Hongkong Company Limited. By focussing on special treatment for cardiovascular, diabetes, vaccines, infectious diseases, MSD Vietnam runs along 4 core businesses: Primary Care (PC), Hospital (HS), Vaccine (VV) & Tender, which each has different core products for different types of diseases or demands for improving quality of human life. Figure 1. Product lines of MSD A particular characteristic in management structure of MSD Vietnam is that not all support function is under management of Chief of Respersentative office (Managing Director – MD), except Compliance manager, Director of Human resources, Director of Finance. Other support functions are under management of regional board and also report directly to regional person-in-charge. Together with 4 BUs and commercial department, compliance department, which is identified as main function, dedicates to
  • 12. 12 Local IT manager Regional IT director Local supply chainmanager Regional supply chaindirector Local procurement manager Regional procurement director the smoothy in running business and in charge of all compliance matter of business including tasks related to commercial regulations, legal issue or legitimacy ininteraction with external stakeholders. Otherwise, not only report to MD, compliance manager have to report to Regional Compliance Director to ensure a transparency and consistency in controlling within company’s global network, also, ensure an independence against business by tight collaboration and continuing discussion. Businessfunctions Supportfunctions Figure 2. Board of Management chart 1.2.2. MSD’s compliance management strategy As the leader in market about ethics and integrity, MSD commits to the highest standard of transparency in all segments as well as in all interaction with stakeholders. Operation policies and code of conducts were established consistently with recommendations of Pharmaceutical Research and Manufactures of America (PhRMA), International Federation of Pharmaceutical Manufactures & Associations (IFPMA) & Foreign Corrupt Practices Act Law of US federal (FCPA 1977). The most priority of company in controlling interaction with HCPs is to prohibit employees and all business partners providing benefit in many kinds but out of scientific purpose. Prescribe of HCPs Regional Compliance director Compliance Manager Director of finance Managing director Director of Medical Director of human resource Director of commercial business Director of Tender business Director of PC business Director of VV business Director of HS business
  • 13. 13 must be based on what benefit patients the most, but not based on relationship or personal impression of HCPs about company. Otherwise, MSD strictly prohibits drug promotion without guidance about caution for customer or consumer. All scientific information company provide to HCPs – both advantages and disadvantages of company’s products - must be carefully generated from researches of the most reliable universities or sciences labs. Because of the clear direction, standards in operation mostly focus on transferring these management’s perspective into business practices in forms of guidance, processes and policies. To ensure all hospitalities and financial supports provided to HCPs with scientific purpose, employees are asked to track all expenses paid in approaching customer: meals in scientific meetings, sponsored air- tickets in scientific symposia oversea, sponsored register fee for education courses, etc., for monitoring purposes. Moreover, before delivering to HCPs or the public, all scientific information have to checked with high caution and be approved by medical department. Policies related to each of management’s concerns were built, and, continually updated and improved to follow business’s development. 1.2.3. MSD’s current practice in business In Vietnam, according to business law, representative office (RO) is not allowed directly producing, selling product or providing services. Thus, Vietnam MSD RO takes role as the moderator for the parent company based in Hongkong to perform business. In general, for a normal standard, MSD Vietnam conducts marketing activities, interacts with healthcare professional, hospital and institution, receives orders from customer, requests ships from Hongkong then arranges logistics which deliver products to customers’ places. As a result, marketing activities, included meetings with customers and sponsorships for Continuing Medical Education (CME), are the main activities of MSD Vietnam RO. Also, marketing teams and sale teams account for the majority of human resources of MSD Vietnam. In order to run marketing activities, each business will receive budget annually from regional along with sales target. Marketing team of each business then decides how much budget to keep in conducting major events and sponsorship and how much budget to asign to sale team for conducting minor events.
  • 14. 14 Figure 3. Marketing budget allocation Activities by marketing team which involve many parties to co-organize such as: medical team, procurement team, marketing team and sometimes, sales team. While as, in minor events conducted by sales team, only salesman is the one who is in charge for planning, contacting, booking, organizing and claiming expense for the company. Salesperson can easy invite customers to join a meeting at restaurant and deliver his speech during meal time. Therefore, the particular characteristics of this event’s type also include many compliance risks because of unformal atmosphere, such as: allowing HCPs to use alcohol in meetings, no scientific topic discussed in meetings, entertainment or unnessary expense included in meetings, etc., In addition, the maximum number of attendees in minor event is 25 and there is no requirement for pre- booking that make the owner flexible in conducting event when he and the invitees are available. Thus, this type of event is classified as the most risky type for company’s reputation and operation. Major events Over 25 attendees Marketing team Sponsorship Marketing budget Sponsor for hospital/Healthcare Institution Sale team (Medical representative- MR) Minor events Less than 25 attendees
  • 15. 15 CHAPTER 2. PROBLEM IDENTIFICATION To scrutiny company’s potential problems, these steps were followed orderly for a wide view of general picture: -Collect result from annual compliance rating by Global Audit team, biannual compliance self-assessments, Quarterly Compliance Management reviews and Monthly Spot-check reports -Collect data from systems, guidance, corporate’s regulation and business information -Review literature in studies, researches in compliance, corporate regulation field conducted by reliable specialist. -Interview person in charge for practical perspective and experience: Mr. Huy, compliance specialist of MSD; Mr. Kha, compliance specialist of Roche; Ms. Tu, finance specialist of MSD – controlling and planning; Ms. Tram, sales manager of MSD, Ms. Truc, process controller of FE Credit. -Critically consider and connect data, literature, specialists’ perspective and actual situation to identify problems 2.1. Symptoms analysis There are 3 symptoms to be analysed in this part: high frequency of risk activities, repeated types of noncompliance findings and being rated as “high risk in compliance” in audit’s assessment. 2.1.1. High frequency of risk activities Small meetings are traditional approach to reach HCPs in Vietnam. According to current practice of doing marketing activities, small meetings – meetings with less than 25 invitees (as described before in section 1.2) are not hold professionally that be in
  • 16. 16 charged by 1-2 salesperson. Locations of small meetings are private room at restaurant or meeting room at hospital. Customers who prefer this type of meetings are usually busy and have no time for long lecture or formal meeting during working day. Actually, in Vietnam – especially in big cities such as Ho Chi Minh and Ha Noi, HCPs as well as healthcare professional organizations (HCOs) are now in overload of working pressure due to economic situation, unbalance between qualification of HCPs in urban and rural area, low average income level (we will not go much in detail of this area). In the other hand, customers in other provinces also have reasons to prefer small meetings rather than major meetings such as culture behavior of hesitating to share knowledge or experience, difficulty in travelling. Thus, to reach customers Vietnam, the popular methods used not only by our company but also by other rivals in the market are small meetings – group discussion or presentation. However, because of their particular features, small meetings are definied as risky activities for reputation of pharma companies. In which, meals or hospitalities provided for HCPs without (or little) sciencetific purpose can be reported as cases of bribery or corruption. Due to small number of HCPs can be reached in this type of meetings, not much resources are used in organizing to maximise the efficiency of business’s cost. As a result, salesperson by themselves have to plan, monitor and control all parts of meetings as a complete process. In the beginning, salesperson propose plan and get approval from managers. At this step, MR have to make sure that the topic of meeting is checked to be appropriate with the current business strategy of company and the invitees list is not included HCPs who have irrelevant specialty or knowledge. All expenses and meeting’s information have to logged on system for monitoring and salesperson have to ensure that meeting will happen as planned. During meetings, no entertainment or non-science activities is allowed and all meeting’s elements have to be controlled within policy limit of amount and time. Therefore, a huge number of tasks in controlling make small meetings more risky than any other types of marketing activities. MSD allows business to conduct small meeting because of its benefits to customers and also company, but not recommend this risky type. However, as can be seen from the data – graph 1, Vietnam is in the top 3 that has the most number of small
  • 17. 17 Number of meetings & Population in countries 1,600,000,000 1,400,000,000 2500 1,200,000,000 1,000,000,000 800,000,000 600,000,000 400,000,000 2000 1500 1000 500 200,000,000 - 0 India China Vietnam Thailand Myanmar Korea Population Number of meetings Averagenumber of attendees per meeting 160 140 120 100 80 60 40 20 0 India China Vietnam Thailand Myanmar Korea meetings (lower than China & India). This phenomenon is unreasonable while consider the population regarding with number of meetings. Also, Vietnam is the country with lowest average number of attendees per event (as graph 2). In a different view, conducting many meetings with few attendees increases the cost of organizing and decrease efficiency of using resources. Thus, this symptom is the critical concern in evaluating risk level of business in Vietnam. Figure 4. Number of promotion activities vs population Figure 5. Average number of attendees per meeting
  • 18. 18 2.1.2. Repeated type of noncompliance findings There are several type of compliance issues repeadedly reported in monthly reports. The symptom began to be recorded in actual meetings by spot-check team since February 2017. Before that, issues were discovered by document check after event happened, in which, the most common issues were fake signatures of HCPs in attendant list. Since spot-check applied in monitoring process, the most popular issue is the low quality of lecture, which is too short or no related discussion is raised. The second popular issue is the consumption of alcohol in meetings. Other issues less popular but repeated throughout months were irrelevant attendees, last minute cancellation and spend per attendees higher than policy’s limit. Table 1. Listed repeat findings Compliance findings Repeated months (from 1st Jan 2017 – 31st Jul 2018) Checking method Signature concerns 6 Document check Low quality lectures 13 Spot-check Alcohol consumption 7 Spot-check Irrelevant attendees 6 Spot-check Last minute cancellation 12 Spot-check Over-spend per attendees 5 Spot-check Number of repeated months indicate the number of months in which, the findings were reported. There were 19 months between 1st Jan 2017 and 31st Jul 2018, however, the issue “low quality lectures” was figured out in 13 months by spot-check. On the other hand, issue “last minute cancellation” - the decision to cancel event was made right before the time event planned to happen – was repeated by different salesperson in 12 months. Other issues which were serious problem, also were involved in several months despite of effort spent to educate or coach to sales team. 2.1.3. Being determined as “high risk in compliance” in audit’s assessment
  • 19. 19 Vietnam was determined as level 3 in risk evaluation scheme by considering the combination of the frequency of risk cases and the limit in solving risk completely, through repeated issues. In which, there are 4 level of risk rated by global management base on the implemetation of compliance controlling process, the violation of ethics & compliance policies, the action plans to solve compliance issues and to reduce compliance risks. There is global compliance team to establish guidance, control and evaluate compliance risk in all countries that MSD run business. Table 2. Scheme of risk definition Ranking risk level Definition Level 1 Low - All potential risks are recognized and there are effective risk controlling tools and the likelihood for risks to happen is low and under organization’s risk acceptance Level 2 Medium - Majority of potential risks are recognized and/or there are effective risk controlling tools and the likelihood for risks to happen is medium and under organization’s risk acceptance Level 3 – current rating High - Some of potential risks are recognized and/or there are less effective risk controlling tools and the likelihood for risks to happen is high and/or over organization’s risk acceptance Level 4 Very High – Very rare of potential risks are recognized and there is no effective risk controlling tools and the likelihood
  • 20. 20 for risks to happen is high and over organization’s risk acceptance 2.2. Problem definition By using literature framework and result from interview with specialist in this field, the initial cause effect map was established with 5 potential problems: no effective compliance training program, inappropriate compliance policies, great job pressure, low ethical culture and wrong decision in recruitment. 2.2.1. Literature framework In a general idea, a big picture of corporate violation was drew with its main causes: capitalist culture, high risk business, organizational and situational factors, conflict of association and low self-control (8). In which, culture and self-control canbe negatively impacted by employees’ weak cognition and believe in legimitacy and justice of compliance program, as a result, lead to bad attitude and non-compliance behavior (9). The most critical reason for the lacking awareness about regulation is ineffective compliance training which is a part of compliance program, as Trevino and her partners stated in their research (10). This reason also reduce the willingness to look for compliance advice, willingness to report compliance violation and the employees’ commitment to organization. Weaver and Trevino then in their another research, in 2001, also inputted that the lack of HR cooperation in compliance management of organization is a potential cause in intentional compliance violations (11). In which, the corporation with HR department help company to emphasize the importance of fairness for archiving valuable compliance culture among employees. According to Weeks and Nantel (12), bad communication about policies is claimed as potential cause of policies violation, and account for low sales performance and job satisfaction. On the other hand, Herrath and Rao scrutinized the importance of peer’s behavior and subjective norms in
  • 21. 21 salesperson’s non compliance behavior (13), in which, sharing knowledge and compliance perspective within sales team and employees’ responsibility with company help provide direction for employees’ behavior. Self-regulation, also studied by Braithwaite in 1982 and Gray 2006, is a long-term management strategy which generate either compliance violation or ethics culture in company (14) (8). By shifting the centralization on individual responsibility, Gray believed that: “This regulatory shift has resulted in a diffusion of responsibility for safety risks as workers have increasingly become individually responsible for enforcing regulation as well as a target of regulation.” (8) Differentially, Hu indicated in his research about managing employees’ compliance that top management participant plays critical role in company’s compliance culture and emloyees’ ethics behavior (9). The absence of top management in controlling the implementation of corporate policies can make initiative, program or policies – considered as extra work besides routine task of sales force - miss legitimacy mechanism. In addition, the participant of top management is the signal of commitment to the clear objective to all members of organization and also encourage rule adherence (15). Figure 6. Relationship of top management & individual behaviour
  • 22. 22 2.2.2. Interview result I conducted depth interview with 2 compliance officier (one from our company – Mr. Huy, one from our competitor – Mr. Kha), a financial specialist – Ms. Tu, a sale manager – Ms. Tram and a process controller – Ms. Truc to figure out what is the critical cause of company’s current symptoms and problems. Interviews were placed in coffee house in lunch time and interviewees were encouraged to express their perspective and to share their own experience while dealing with compliance violation. Questions, from questionaire, were used with different orders based on the flow of discussion. Table 3. Brief profiles of interviewees Interviewees Summary profiles Mr. Huy Compliance specialist, has worked at MSD for 4 year, 3 years experience as auditor at EY Co., Ltd Mr. Kha Compliance specialist, has worked at Roche (biggest pharmaceutical company by revenue) for 5 year, 1 year experience as compliance officier at MSD, 2 years experience as auditor at Grant Thornton Co., Ltd Ms. Tu Financial specialist, has worked at MSD for 3 year, 5 years experience as risk consultant at Deloitte Co., Ltd Ms. Tram Sale manager, has worked at MSD for 4 years, 3 years experience as medical representative at AstraZeneca (pharmaceutical company – ranked at 11th by revenue) Ms. Truc Process specialist, has worked at Maritime for 3 years, 2 years experience as Process specialist at FE Credit The inappropriate policies guided by global management are rated as a reason for symptom that the great frequency of interaction with customer by risk methods, in interview with financial specialist – Ms. Tu - who used to work as consultant in KPMG and spot-checker for event of Sanofi – our biggest competitor. In actual, other rivals in market do not face with this symptom by application of restricted policies of minimum limit number of attendees. Although our controlling process is the strongest and the most
  • 23. 23 optimistic in the market with massive requirements and standards implemented, our policies are somehow flexible and allow salesperson to conduct meetings with their best convenience. She recommended that if we apply the limit number of attendees per event as 30 or more, instead of 8 in current, we will significantly decrease the number of small meetings that also decrease management cost and risk generated from these meetings. Ms. Tram has same perspective in this symptom and added that beside unstrictly policies, mindset about effectiveness of salesperson may be different from management. Indeed, salesperson think that it might be more effective and more comfortable to provide information for group with less attendees rather than big groups. Thus, by considering between pros and cons of several types of event, salesperson usually engage with small meetings that give them more benefits. My colleague working in compliance department – Mr. Huy, who used to work in Enrst & Young, inputted that salesperson sometimes cannot acknowledge completely about compliance risk they could face in small meetings and thus, there is no consideration about risk but only its convenience when conduct so many meetings. This problem is claimed by the impractical training that cannot help salesperson to aware all risky scenarios in their meetings, as he mentioned: “Salesman do not have awareness of potential risks they will face while interacting more frequently with high risk customers.” Regarding to the symptom as repeadted noncompliance issue and high ratio of number of findings and number of meetings, Ms. Tu proposed 2 circumstances that employees might involve in breach: intention and unintention. Unintention in violation compliance policies is caused by low effective training, while in intentional involvement of breach, the problems are employees’ low ethics and employees’ low skills of negotiation and communication with HCPs. She claimed that HCP’s noncompliance requirement is belong to human nature and can be raised in any business circumstances. On the other hand, nowadays, HCPs in Vietnam are group of citizen that have high level education and usually attend professional education events, thus, HCPs can understand the meaning of company’s compliance policies and also consider to protect their reputation and images against public or their patients. Therefore, salesman with good understanding can explain company’s policies with HCPs and deny to provide inappropriate benefits or other noncompliance interaction with HCPs. On the other hand,
  • 24. 24 salesperson with unethical behavior that intentionally violate our regulations are not suitable with our culture and requirement. Therefore, recruitment process is first controlling stage in ensuring no unethical behaviors in our organization. Otherwise, Mr. Huy’s perspective is different from Tu’s. In which, the problem engage with intentional violation of policies is also one kind of lacking awareness – the longterm awareness. As explained, salesperson understand compliance policies and implement as order from their management but not understand the real meaning of these policies is to protect company’s reputation and in long term, to creat a sustainable business with maximised and long-last profitability. In contrast, a non-compliance events hold by MSD if be captured or reported to the public, there would be not only a serious damage to company reputation, but also to commercial business. Moreover, the operation of non-ethical company can be restricted by laws and regulations of countries, industry as well as business associations which it is now a member of. One interesting viewpoint added by Mr. Kha that the serious level of issues can also be used to define if that action is the result of intention or unintention. In which, almost high risk issues – usually fraud – are involved intentionally, in opposite, low risk issues – for example: missing documents, low quality lectures – can be classified as either unintentional or intentional involvement. This point is very helpful in critisie the importance of causes that should be focused on solving to minimise the risk of operation. Mr. Kha also mentioned old practices in interaction with customer and sale pressure as potential causes of intentional compliance mistakes. As regarding to the repeadted issues, Ms. Tram suggested that the cause of this symptom is saleman’s practice in getting compliance advisory, which is sharing and discussing within their team. In actual, there are 3 compliance officier that salesperson can reach to get advise in several methods: face to face, phone, email, chat. However, due to the hesitate feeling to communicate with compliance department, salesperson usually seek advise from their peers, seniors and managers – who sometimes not clearly understand all compliance policies. This will lead to series of repeadted issues among employees. Ms. Truc, with related point, claimed that the behavior of an employee can impact other employees’ work as an image of company in customer’s mind. Moreover, updating policies – which happen regularly - also take long time to be implemented by sale force, in which, the
  • 25. 25 communication about policies and information is not really impacted, the old practice in interaction with HCPs is hard to change and salesperson do not willing to update their knowledge. Additionally, Ms. Tram suggested that language is also an important barrier in effort to be compliance. Systems and document templates in English can make it difficult for salesperson – who do not have good language skills – to understand and learn. “If that company evaluate ethic as a critical concern, it should be included in assessment at recruitment process, as a fresh raw material.” – Ms. Tu In discussion about causes of both intentional and unintentional issues, one critical key point that Ms. Tram, Ms. Tu and Mr. Huy agreed on is the inappropriate compliance management program in many sections of management, such as low effective discipline policies, weak corporation with other department, especially recruitment or L&D, cursory evaluation of compliance implementation, no KPI performance to measure level of compliance in business. Despite of effort incontrolling and monitoring, a massively complicated process, without useful tools and guidance, can be a reason for salesperson to miss compliance. One consideration of Mr. Kha about compliance process is the selection of customers to engage with. Obviously, customers who work with MSD have to ask to comply with MSD’s codes of conduct and operation policies at the beginning, but in actual, customers sometimes ask to be provided inappropriate benefits or attend MSD’s meeting with inappropriate behavior. As a result, salesperson engaged in intentional violations of policies in order to satisfied customer’s demand. However, the control process of this stage is ignored by salesperson and also not strictly monitored by management. 2.2.3. Initial cause-effect map Both literature and view of persons in charge agreed that employees’ noncompliance awareness is the most critical cause of policies violations. In a detailing explanation, compliance violations are naturally considered as 2 types base on their
  • 26. 26 motivation in action: intention and unintention – lack of compliance awareness. Intentional violation of policies is somehow easier for recognizing and examining its causes due to the seriousness of particular issues. Deeper cause of intentional noncompliance behavior are either employees’ miscontrolling nonethical behavior (8) (14) or the requirement to adapt with noncompliance customer’s interest that was firgured out significantly more than any other industry (8) (16) (17) (18) (19). This motivation is generated not only by sales pressure, which is the combination of the nature of this career kind (16) (20) and employees’ dissatisfaction raising from their job (1); but also (a) the lack of communication skills to explain and convince customer to respect company’s rules which is claimed as consequence of no effective compliance training program- especially happen with juniors; and (b) a comprehensive compliance management system with inpropriate policies as the totally agreement from different organizational perspectives of Mr. Kha, Ms. Tram and Ms. Tu. In the other hand, regarding to the management perspective, miscontrolling noncompliance behaviors are claimed for unethical culture of organization (21) and the wrong decsion in recruitment (11). In opposite, unintentional wrong-doing with its basic base is the lack of compliance awareness. This issue can be devided into numerous more detail types: no idea about potential issues may happen, no update policies perceived, misunderstanding about policies, etc.,. These types of lacking awareness are the results of ineffective methods used to spread out initiatives or updated policlies, according to Ms. Tram and Kharbili and other authors stated in their research in 2008 (22), difficulty in reaching compliance training materials and compliance advisory and employees’ unwillingness to reach these resources – according to Ms. Tram (10), negative impact of peers and managers through sharing experience and knowledge (1) (13) (as agreement of Ms. Tram & Ms. Truc). In other words, no effective training program is the central problem of this mixture with its consequence is determined as employsee’ noncompliance mindset that causes compliance risks for company’s operation. In summary, by combining the interview result and preference from previous studies of specialists in compliance management field, list of problems of compliance risks in organization was pointed out as below:
  • 27. 27 -No effective compliance training program -Inappropriate compliance policies -Great job pressure -Low ethical culture in organization -Wrong decision in recruitment
  • 28. 28 Figure 7. Initial cause-effect map
  • 29. 29 Chapter 3: Problem justification In this part, the existence and importance of problems are considered rationally to generate updated cause effect map with 2 central problems: no effective compliance training and wrong decision in recruitment, and additionally, highlight the requirement to pay effort in dealing with these problems. 3.1. Jusitfy the existence of problems: Updated cause-effect map The idea about comprehensive compliance management and ethical culture are certainly work well to improve effectiveness of controlling and prevent noncompliance actions (8) (9) (23). However, because of being stated as leader in compliance controlling in pharmaceutical pharmacy and defining integrity and transparency as most important basement in business, MSD has a solid compliance system with highest standards in controlling business, employee’s behavior and also stakeholder’s interaction (Ms Tram and preference documents: Global Compliance Program & Principles for Business Practices). Opetating with the spirit: “No rationale with fraud”, MSD Vietnam as well as MSD Global acts with greatly aggressive attitude in preventing, investigating and dealing with fraud. In addition, ethical culture of MSD performs in all decision making process, not only personally but also organizationally. In personal term, both effectiveness of salesperson’s activities and compliance in working method are the critical point for their manager to consider whether the salesperson showed outstanding performance or weak attention paid in working. Turn to the organization term, important decision in MSD is not made by business’s leader only, but by the concurence of relevant departments: finance, medical affair and specially compliance. In several specific cases, General Director of the office and Compliance Director are the final approval level, in which, the General Director proposes the willing of business, the opportunities in reaching customers and raising sales & the requirement to develop. In not clearly opposite side, Compliance Director will show her opinion in relevant regulation, risks, scenarios of reputation’s damages
  • 30. 30 and restriction that company might face if involves in such of activites. Lastly, these executive managers will try to balance the cost and benefit of company and come up with the solutions to help grow business without breaking rules. To be continually considered, the “Inappropriate compliance policies” problem should be applied all above reason to examined and critizied. Furthermore, although there are several issues were repeatedly involved by different salesperson, 2/3 of salesperson have never involved in any breach (according to Finding’s owner report). Of course any issue can be counted as ruinning company’s imagine, but the critical point could be the evidence for the appropriateness of company’s policies and processes. One more side of problems should be considered is the ability to deal with problems. Because of being a member in giant MSD’s family expanding all over the world, MSD Vietnam has to comply with standards in operation, vision in heading to and also process in running business. Local laws and particular characteristics of local market certaintly impact the practices of each MSD’s branch, however, these factors would be never a reason to break the value in compliance and integrity that MSD Global established by the contribution of all members in the network. As a result, a global standards and set of policies are asked to be respected and commited by all countries in a group or a area. Therefore, this potential problem should be eliminated according to company’s actual situation. As well, great job pressure is considered does not a suitable problem for company to deal with due to the nature of this career type which is obviously more pressure and difficulty in dealing with external stakeholders than any other jobs. In most of business organizations or business areas, sales career is known for its particular way for people to earn from: income bases mostly on sales performance. Not only because of the nature of this job, excellent rating on working environment (preference: employer’s rankings) and competitive C&B package offered by MSD are also reasons to eliminate this problem out of potential list for company to deal with. In conclusion, list of potential problems included 2 potential problems that indicated from company practices and preference resources: no effective compliance training program and wrong decision in recruitment.
  • 31. 31 Figure 8. Updated cause-effect map
  • 32. 32 3.2. Justify the importance of solving problems “Is a gift just ever a gift?”, according to Wazana and numerous studies about conflict of interest (COI) in pharma industry (24) (25) (4) (3) (2), the relationship between companies and customers as well as consumers is examinied and restricted carefully by public perception and government regulations. No promotion, gifts or any interaction in order to attract customers by personal benefits provided are allowed. Interest conflict in pharmaceutical industry must be avoided as a requirement in enhacing company’s reputation and maintain the sustainable development in market. On the other hand, focus on violations in business process should be set as priority but not several internal process despite of its massive hamrful to operation cost of any organization (21). As explaination in a research about compliance management of Ph.D. Kharbili (22), “non-compliance at the level of business processes is critical because business processes control all value adding activities of a company”, therefore, compliance management in interactive activities between company and external stakeholders should be focused and well controlled. The damages that non-compliance behaviors of employees cause not only pointed out in several studies as above but also made clear in company’s guidance of management, in which, country that cannot ensure an integrity and low risk business and impacts negatively whole company’s reputation and image, must be applied restricted strategy on its operation and even eliminated completely by executive management’s decision to withdraw business from that country. Not only because of the worst scenario wherein the executive manager decide to stop business in local market, the central list of problems also has critical rationale that asks manager to pay aggressive effort to solve. Wrong decision in recruitment is claimed as the deep problem of fraud as well as intentional non-compliance behavior, which is less frequently happen. However, as Mr. Kha mentioned in his interview, the damage causes by fraud is heavily which can not be defined and controlled by company, and usually is because of inappropriate personal benefit. For instance, salesperson did not hold scientific meeting with HCPs but used the budget to satisfied HCPs by financial benefit. This scenario rarely happens, however, it not only ruins company’s reputation the most but also generate negative perception of customers about company’s image.
  • 33. 33 Despite of these real consequence and importance of the problem “wrong decision in recruitment”, knowledge and practical experience about this area are out of scope of report writter. In addition, focusing on new recruitment and pay effort in controlling future hired employees could only improve the level of compliance awareness of a small group of employees but not a critical group who is now in charge the key business of company which includes senior employees and managers. As a result, we focus heavily in the next problem, which is defined as the main source of systematic issues and low awareness of employees. Unintentional involvement in noncompliance activities, in the opposite, is acknowledged by management but because of both several subjective and objective reasons, breaches still happen among organization and if these breaches are systematic faults, there are issues in controlling and monitoring process to protect company and employees against risks while interacting with customers. In field with “conflict of interest”, espcially related to human health or human life, the inappropriate appearance should also be avoided as well as the truly inappropriate behavior. Employees with no awareness of restricted activities or the consequence of noncompliance activities could involve in these breaches with the same appearance of an intentional one. Moreover, no effective training program not only resulted in employees’ awareness but also in employees’ work satisfaction. To be claimed as management’s voice and company’s strategy, training program is the tool to establish compliance culture and to strengthen employee’s believe in their executive manager. Therefore, enhancing an effective training program can bring the company many improvement in such areas: compliance, employee’s commitment, management and also business performance.
  • 34. 34 Figure 9. Final cause-effect map 3.3. Causes of centralize problem Centralize problem – no effective training program is generated by 3 causes: no involvement of different functions, no real cases discussion included in training and no evaluation tools applied along with training session – which are also current practices of training program. 3.3.1. No involvement of all employees In actual, company’s compliance training program is now including 2 main session: session in new-hired orientation and biannual updating session. With almost time of each training session, compliance policies are read and explained traditionally and unattractively - one by one - by compliance officier. New hired employees in this way faces difficulty in raising questions, concerns or asking for more explaination (16) (22). On the other hand, adequate awareness of compliance is also considered as the attention of potential risks (as Mr Huy mentioned in his interview), which is now missing from employee’s mindset. Solutions that would be discussed in next section
  • 35. 35 with the base of researches, studies and personal perspectives of interviewees must be focussed on main causes of an ineffective training program. These causes which align with current practices of company are indicated as: no involvement of all members in organization (28), no real cases discussion (28) (29) and no evaluation tools applied (30). 3.3.2. No real cases discussion The negative result – high ratios of violations among activities, believed by sales manager – Ms. Tram, is due to “no real cases discussion included in training” (11) that help employees to raise awareness to avoid risk on working and be able to deal with issues if any. Additionally, open discussion on daily routine tasks and difficulty in working as well as appropriate right-doing also take a main contribution in a successful compliance training program as a 2 ways or multiple ways communication. Regarding the role of different parties in compliance education, the ethical culture is believed to be built on strong commitment of all stakeholders within an organization, thus, as a spirit value that make a heavy impact on performance of business and is controlled strictly by several sets of regulations, compliance which lack of involvement of relevant parties’s support in managing, discussing and making decision would be missed controls and vulnerable in aggressive business environment. 3.3.3. No evaluation tools applied In combining with other elements of a training program, assessment if applied frequently as a compulsory performance and designed rationally could be used as ingredient in building training content and evaluate the effectiveness of training without real findings and issues happened on real field that cause harm for business of company. Regarding to valuable sharing from Ms. Tu, knowledges if not is repeated by training and testing would be easily erased in people’s mind. In the other hand, tesing is also a tool not only to evaluate to understanding ability of studier but also an excellent tool to measure the adaptiveness of training strategy in organization’s culture. Therefore, assessment in pre & post training could help trainer to identify their student and mitigate the gaps between trainer and learner. Because of all consideration, these causes with
  • 36. 36 deep analysis by interviews and literature framework in next section will finally come up with solutions to enhance the effectiveness of training program. Figure 10. Causes of centralize problem CHAPTER 4: ALTERNATIVE SOLUTIONS With the limited resources of human capital, finance and the current business strategy at this time, central problem: The lack of Effective Training Program will be chosen to solve as a long term strategy with a positive outcome: to develop the standard level of compliance understanding and to build a compliance culture within organization. This chapter is to gather interview result, idea from litterature framework to come up with recommended solutions and action plans. 4.1. Interview result Interviews about solutions to enhance the effectiveness of compliance training were conducted base on the current practice of company and personal perspectives of interviewees. As the current practice, orientation training is tool to communicate the very first message of organization about most important topics. In compliance session, key principles of interaction with HCPs and an overview of process of holding a No involvement of all employees (in No real cases discussion cluded executive manager & other functions) No evaluation tools applied No effective compliance program
  • 37. 37 promotion event are introduced to new comers. Then, employees will be asked to seek advice or additional training from their manager or senior colleague in team meeting, combined with other business topics. More compliance knowledge will be provided on work or when issue are raised. According to compliance refreshment, biannually, cycle meetings are hold for all BUs and compliance department is requested to update compliance knowledge with specific topic “ordered” by each BU. In refreshment session, compliance topic will be discussed with listed highlight information which is popular findings involved by employees. As usual, compliance session will be ended following an open discussion between compliance officer and sales person. From the discussion, all interviewees agreed that training program is now not approached as a comprehensive program that cover all essential contents to increase employee’s compliance awareness. Basic elements were established and person in charge for training program was assigned but there is no real connection between each stage of the whole process. Ms Tram suggest that real case study should be discussed frequently or guidance for correct decision should be made. In actual, training contents in compliance refreshment session are consist of the written standard operation principle (SOP) related to the topic, the guidance of the process need to follow and the message “not to violate the rule” repeated times over times. Case study if can be analysed by debate and examination between different parties: compliance, sales, executive management, finance, and other operation function, will generate a cooperate result which can be eliminate the gap between desires of sales team, management function and company’s leaders. Also agreed with this suggestion, Mr Kha added that the practical solutions, which all parties concurred, should be updated frequently by following the dynamic flow of business. By doing this, difficulty of either sales person or controller would be defined and got supports if it’s necessary. One more benefit from the cooperation between different functions in compliance training is the commitment to involve in implementation the policies seriously. The cooperation among company could be also perform in the impact of peer and manager in individual’s behaviour, regarding to the development of training content, Mr Huy suggest that all employees include executive management and un-sales department should be counted in compliance training with different point to focus on. Moreover, Mr
  • 38. 38 Huy proposed the awareness of potential risk before issue was raised should be treated as important target to archive. Besides, not only awareness of “how to do right”, but also the understanding of “why should do right” should be focused to enhance. Ms Truc, in the discussion the same idea to enhance the quality of training program, suggested that training should be designed to focus greatly in stages which is now missing the control or cover many potential risks. Without wasting time in including all compliance requirements in a short-time session, trainer should use data and observation to analyse and determine the key point for gaining much more benefit. Furthermore, Ms Truc also mentioned the importance of ability to recognize the risk and raise concern figured by employees in controlling the implementation among company. This important skill, if can be trained systematically and effectively, could become a useful merchandise for executive management to create a solid compliance culture by using self-control ability of employees. Besides the training content, measurement or valuation the result of training program is now missing and requiring an effort to develop. By showed opinion about this aspect, Ms Tu emphasized the critical role of measurement tools in improving the effectiveness of training program. Tests, surveys are supposed to be essential for education activities which can quickly generate and perform the short-term effectiveness in enhancing understanding of employees. By this way, actions to fix issue in communication or re-design training content could be immediately taken for next session. Another key benefit for this practice is to determine the specific level of understanding of employees to divide into several groups base on their weakness and ask them to pay more effort in improving compliance awareness. 4.2. Literature framework Training in researches by specialist or scientist in Operation Management field was emphasized as an principal element in a comprehensive compliance program. Designed to be the connection in communication between organization’s leader and employees, training with its effectiveness can be establish a solid ethical culture in company by the self-controlled ability of each individual. As suggested by Cairns and Yarker in their study about maintaining compliance while interacting with HCPs, compliance training should be conducted by a assigned team that take main
  • 39. 39 responsibility in training, also should be enforced by using not only compulsory tests as a period reassessment, but also a clear evaluation system. Business ethics issues often covered in training include breaches of confidence, falsifying records, conflict of interest, abusing drugs or alcohol, misuse of organizational assets, discrimination, and sexual harassment (26). To enhance to effectiveness of education and valuation, company can use electronic education tool or online assessment, and use the result to develop specific enhancing propram for individual. Also about this idea, Verschoor agreed that customizing training content to particular demands of their business practice is to maximize the effectiveness (27). In order to establish a unique training program serves for individual’s demand, training team should focus on risk associated with particular business area and should not focus much on exceptional case but the application in daily routine and employee’s responsibility (28). Otherwise, there is another opinion about differential learning content, in which, other researchers advised that learning tasks should be personal for the learners (29). Besides compulsory training program, learner can choose among set of topics that interest them and see the possible consequence of their action. Not only tests, but also survey and interview to collect opinion and class should be also divided by level of knowledge and type of job. “If employees can participate in the initiation and implementation of a code, then the values, commitments, and beliefs of the company become a catalyst for the code’s creation.”(28) As required by the guildline (30), compliance training team have to ensure the quality of education and ongoing communication about useful knowledge includes both legal policies which begin with the development of code of ethics – also be the contents of training program (28) and best practice sharing. Regarding content of training, case studies in other organization and within company are suggested to be used to assess employee’s understanding about real scenarios. No matter written policies or best practice is shared, there are 4 principal ideas should be deeply acknowledged by the employees: 1. “An ethical requirement in decision’s components. 2. Tools to address ethical issues.
  • 40. 40 3. Understanding of ethical situation’s ambiguity because of their very nature (no completely correct decision which can be debated both outside and inside the organization) 4. Awareness of importance of wrong ethical decision in creating ethical culture within the firm.” (31) One highlight in the study is the timeline indicated for required level of knowledge and this information should be recorded in personel file. In application of this concept, company should allow employee to have a time period to be familiar with the full content of compliance program and standards before involving in a compulsory test (30). Quantity of compliance training session or the frequency of training also takes important role in enhancing effectiveness (29). Puhakainen & Siponen determined in their study research that only one-off training course is not enough, it must be a continuous activity. To be able to spend company’s resources in, an effective compliance training program require great support from top management, such as management review, management encouragement or involvement in training program. Employees should get familiar with compliance definition, policies or compliance processes by reminders from the top, frequency approach with compliance discussion and feel the sense of compliance everywhere in organization. A key problem in managing ethics program is to make ethics as a part of organization’s culture. Impacts of manager and co-worker are determined as key element in implementing compliance (28). Therefore, it is necessary to increase training at all level including senior management and board of director (27). Regarding this idea, Ferrell indicated in his research that: there is a need to cover all level of employees in training program to ensure a consistent compliance awareness among organization (28). Most violation of policies occur not because employees want to get benefit them-self and destroy the development of company but because of 2 factors: opportunity and behaviour of peer and supervisor (32). Almost the cases, employees try to benefit the company by the belief that corporate objective is much more important than compliance requirement or ethical standards. The conflict among individual value, organizational value and societal value leads to rule violation. There is always the ambiguity in making right decision, only top management and open discussion/debate can eliminate the mistake/issue. Training program should
  • 41. 41 be treated as any other core business function and conducted as a tool for open discussion in organization. Turn to practice, an effective training program can be last for about 2 or 3 hours but attract employee’s involvement and create open environment for discussion. Furthermore, ethical issue should be discussed in relation with other business activities such as a strategy kick off meeting quarterly or performance discussion inteam meeting could be also an appropriate forum to identify compliance concerns engage with the specific strategy or business goals. “An issue, activity, or situation that can withstand open discussion between many groups both in and outside the organization and survive untarnished provides assurance that the right decision was made.” (28) Finally, the spirit of an effective training program which much more than legal requirement or risk monitoring tool but a method to communicate company’s vision, is to educate employee perform the mindset to share their responsibility in increasing corporate ethical culture and the use of ethical understanding in making decision. Training will be ineffective without full commitment of the whole organization to the program and without the core infrastructure to guarantee the essential support of manager to make the program succeed. Training is both to inform and to motivate, not only understand the requirement but also be motivated to archive compliance implementation’s target (28). 4.3. Proposed solutions: Building comprehensive training program Solutions “building comprehensive training program” to increase the effectiveness of compliance training should be built by 4 basic elements of a project: who, where, when, how. 4.3.1. Who? All level of organization should be the target audience of the program. As debate of previous researchers and suggestion of Mr Huy, the compliance culture could only be established by the participant of all members in organization (28) (27, 32). Current program is now focusing on junior level salesperson but not a requirement for managers
  • 42. 42 or other functions. Thus, compliance session, especially open discussion, should cover both executive management and related internal functions to get the concurrence of appropriate operation within company. On the other hand, beside updating self- knowledge, leaders have other responsibilities while participating a compliance training program. These responsibilities are to support ethical discussion, to ensure a view from top management, to behave as a compliance model and to get the commitment of employees with company by believing in the ethic value painted by their executive management (33). The role of other functions is also determined as critical element in the success of training program because there is always an ambiguity in making correct decision and the view from other side is valuable for the most appropriate solution. In actual, compliance team does not gather issue or examine the operation themselves, instead, data was provided by different team in charge of each stage in the process. Therefore, by showing the working methods and discussing issue raise from operation, salesperson could learn to eliminate mistake that usually recorded and to avoid risk in their daily routine. Finance, supply chain, procurement are principal functions which work closely with salesforce, should attend compliance session to get concurrence with sales team. 4.3.2. Where? The circumstances where training conducted are as important as the methods to approach the program. At the first stage of comprehensive training program, during orientation, in which no prescribe about operation was earned by salesperson, SOPs should be discussed with key idea attached with a quick describe of working process and real examples. In addition, compliance knowledge is provided together with valuable discussion and inputted information could generate positive result in enhancing compliance awareness of employees. In Mr. Kha’s opinion, compliance issues that could be discussed in the view of business and follow business strategy, may be easier to come up with best practice which benefit both business and compliance protection (31). Besides official compliance training or compliance session inorientation or compliance session in biannual business meeting, strategy meeting or business performance or business kick off meeting need to cover compliance perspective (28). By this way, an
  • 43. 43 ethical culture would be established among company in all activities that compliance involves. 4.3.3. When? a continuous process, time to familiar with principal policies, monthly short discussion, quarterly update (29). An ethic culture could only be built by the frequency that ethical topics were discussed between relevant stakeholders. Obviously, increasing awareness of all members in an organization is a continuous process with large amounts of knowledge and information updated, changed, repeated regularly (29). Current practice is now including orientation in first 2 months and updated session in business meeting quarterly, this density is not meet the requirement for creating a compliance climate due to the dynamic growth of business and the impact of repeated messages on people behaviour. After orientation, monthly short discussion with team should be conducted with noted issues or only hot message reminded. This message should be also sent from top management monthly via email to all employees. Besides, in coordination with the updated content of training, assessment should be conducted every 6 months on the scale of company. In a different perspective of time requirement in training program, it is necessary to allow employees having time to be familiar with regulation before actual practice on working and on testing knowledge (30). It should be a minimum time requirement as 2 months to internalize the vast majority of compliance knowledge before working or interacting with HCPs. Testing for new joiners, by this rationale, should be applied to ensure the quality of understanding after 2 months being trained and educated. 4.3.4. How? There are 4 topics discussed related to the content and methods to conduct training program: measurement tools, requirement for updating content particularly, requirement focusing on risk raised, requirement improving ability to identify risk. Regarding measurement tools, pre-test and post-test should be applied to evaluate
  • 44. 44 compliance understanding before and after program launched, as suggested by Ms Tu. Test should be designed to be fit with training content and different level of difficulty in comparison of pre-test and post-test. In addition, annual test and quarter test are advised to conduct on the scale of all company with the questions cover all compliance topics with technology tools (27). As well, testing result could be used as a dimension in KPI performance of individual and team, to force motivation of employees in learning and enhancing compliance understanding. Turn to the demand of being educated personally or base on different level of knowledge, testing result generated from evaluation and performance recorded should be counted in the effort to divide salesperson into different groups with the balance of literature and practice in the lesson (Ms Tram). Knowledge offered to each group must be carefully designed and launched in training session at the right time. Groups could be determined by level of experience or specific compliance concerns, such as “controlling meeting”, “planning”, “documenting”, “systematic controlling”, “making payment”, etc., On the other hand, there is suggestion to let salesperson to choose the topic that interested themselves (29), however, this methods could only applied with a balance between democratic and dictatorial. In which, employees have the right to choose among several topics that required them to complete within a period, employees could flexibly arrange their training plan and complete the priority session that useful for their work. In discussion about increasing the ability to identify potential risk (31) (28) (Mr Huy), employees should be provided full view from different perspective about potential risk in scenarios they would face. A list of potential risks for each type of promotional activities should be built for a very first image that could happen and which kinds of behaviour or kinds of characteristic of activities would lead to issue. By being acknowledging about future scenarios, not only ability to identify risk would be increased because of bad scenarios determined, but also the guidance for each situation would be rationally discussed between legal, compliance and business. Along with objective to enhance employee’s ability in identifying potential risk, a rationale concentration on risky activities should be approached to maximize the effectiveness of company’s limit resources. Data could be gathered from monthly reports and annual self-assessment result in order to define which are the tops of most risky practice in the whole operational process (Ms. Truc)
  • 45. 45 WHO • All levels of sales team • Executive management • Related functions WHERE • Discussion and brief describe of process in orientation training • In business meeting: strategy discussion, business performance HOW • Apply measurement tool • Update content particularly • Focus on risky activities • Enhance risk identified ability WHEN • Orientation in first month • Monthly short discussion • Monthly message from the top • Time to be familiar: 2 months Figure 11. Key criteria in training program 4.4. Considering factors Human resources and time capability: There are now 3 head counts in compliance team, 2 in Ho Chi Minh city office and 1 in Hanoi office. Besides, Compliance Ambassador Team (CAT) which has 10 members who is representative of each Business Unit commit to engage and support compliance development in organization. In the main scope of compliance team, not only training, but controlling, testing, building guidance, consulting and dealing with compliance case are also main activities to be focused. Turn to CAT, all members are manager from sales and marketing department who fully in charge of core business of company. CAT could support compliance team in training session in biannually business meeting or when required. Most of the time, compliance team is now having 1 hour for each session in business meeting with 2 hours preparation prior to meeting.
  • 46. 46 Cost: Training program which includes physical training using internal material and speaker without additional cost. However, opportunity cost raises by time being spent in training sessions could be counted as significance cost to consider. Cost of opportunity is not only come from trainer but also spent by trainee, in which, employees have to cut down time for interacting with customers and time for discussing sales strategy to participate in compliance session. Otherwise, refreshment and awards needed for training also account for amount which is charged on general operation budget. As can be seen from the cost plan as below, total cost is estimated for each half year (6 cycle) as 16 millions VND and for a full year as 32 millions VND. Cost plan (for 6 months) x 1.000 VND Cycle 1 Cycle 2 Cycle 3 Cycle 4 Cycle 5 Cycle 6 HR 4 x 200 6 x 500 4 x 200 4 x 200 4 x 200 4 x 2000 Refreshment (Training & Testing) 2000 2000 2000 2000 Awards (Testing) 500 500 Total 3300 3000 800 2800 2800 3300 16000 Table 4. Cost estimated for bi-annual training plan 4.5. Action plan By consideration between benefits of recommended solutions and cost discussion, action plan would be built in the base of 4 criteria: who, where, when & how. By the combination of all criteria of a comprehensive project, implementation would be designed for each quarter and repeated through years. In actual, action plan is proposed with predicted elements and additional inputs or modiration would be added whenever required. In details, before program is launched, compliance committee should agree on the program’s overview , timeline and approach plan. In which, a summary report about compliance awareness includes popular findings, serious issues, difficulty in conducting
  • 47. 47 compliance process and employee’s expectation from compliance management would be examined by compliance team to design the general training and initial test with the focus on risky activities and concerns of employees in the first 3 weeks of December 2018. The program overview and initiation would be discussed with executive board of manager to align the spirit as well as get support from leaders of organization in communication. All preparation should be completed in December 2018, including announcement, clarification and alignment with other related functions. Program will be launched firstly in compliance session of national meeting in 1st week of Jan 2019, with general training for all employees, followed by an initial test. In the 2nd week of Jan 2019, compliance team will conduct scoring task and start to analyse date to figure out which knowledge areas should be focused on improvement. Compliance team will base on test result to make decision of how many groups that employees should be divided into and propose this result to executive board of management for agreement. In the meantime, training contents and agenda will be built with principle idea highlighted and real case studies listed down for an open discussion. In the 3rd week of Jan 2019, CAT team will send the test result and list of groups to their business unit and leaders of each unit will make a voice to encourage their team members to join fully in next particular training. All employees will have 2 weeks to prepare and register chosen schedule for training course that will last about 3 hours for each topic. In the beginning of February, training course will be conducted by compliance manager and to make the use of the resources from quarterly business meetings. Next, in March, compliance updating will be run for the demand of business or the necessary to run because of current issues. This training session, because of its nature, is not a compulsory task must be done, but a additional supporting from compliance program for teams who are facing with compliance issue while doing business. In April, which is the beginning of a new quarter, a periodic test will required to be completed with specific questions and case studies for each groups, followed by the repeated process of scoring, analysing, group dividing, training and updating from the previous quarter. In July - the beginning of the 2nd half of the year, compliance team will hold a general training for all employees in 2nd Cycle meeting with the participant of executive board of management. In this general training, all topics that lack of appropriate
  • 48. 48 awareness will be mentioned to be discussed by all parties: managers, employees who either good or bad at this topic, support functions and compliance. The training session by groups will certainly launched, in along with cycle meeting’s activites. As a continuing process, other steps will be applied as the same in 1st haf of the year. The art work and process with specific timeline are indicated an overview of program to enhance compliance awareness of employees, with modification might be inputted later if required.
  • 49. 49 Where (circumstances): -Orientation -Business meeting -Meeting with executive manager and compliance committee -National meeting Who (PIC): -Compliance manager -Compliance officer -CATteam -Businessmanagers -Executivemanager How (trainingcontents): When(timeline): Before implementation: 1st week in Dec 2018: collectingdataand analysing 3rd week in Dec 2018: designinginitial test 1st weekinJan 2019: general trainingand initially testing 2nd weekinFeb2019: analysingdataand desginingtrainingcontents 3rd weekinJan2019: Testresultand groupswill be announced,employees registerforschedule 1st weekinFeb2019: 1st trainingsession 3nd weekinFeb2019: testing 4nd weekinFeb2019: testresultannounced -Testingtodevide employeesintogroups by level of awareness -Test'scontentshouldbe designedonthe compliance backgroundof companyand shouldbe focusedonpopularissues gatheredfromrecentbusiness practice. -Re-designingtrainingcontentforeach groupsfrom the perspectiveof compliance andbusiness -Focuson riskyactivitesatparticular business team -Remindingonreal casesand potential risks Figure 12. Proposed solutions for key criteria in training program
  • 50. 50 1stweek in Jul 2019 •General compliance topics updating •PIC: Compliance manager and executive manager •Testing •PIC: Compliance officer •In cycle meeting 2nd week in Jan 2019 •Analysing data and designing training content for each group •PIC: compliance team •with discussion and concurrence with executive manager 3rd week in Jul 2019 •Test resultand listof groups announced •PIC: CAT & business managers •In formal strategy meeting quarterly 1stweek in Aug 2019 •Training by groups •PIC: compliance managers •In business meeting monthly 1stweek in Sep 2019 •Updating compliance currentissues •PIC: compliance officer & business managers •In team meeting in which compliance issueraised 1stweek in Oct 2019 • Testing • PIC: Compliance officer • In orientation, in business meeting monthy • FOLLOWING ACTIONS in 4th QUARTER WILL BE REPEATED BY THE SAME SCHEDULED IN 3rd QUARTER Figure 13. Action plan for improvement of training program 1stweek in Apr 2019 • Testing • PIC: Compliance officer • In orientation, in business meeting monthy • FOLLOWING ACTIONS in 2nd QUARTER WILL BE REPEATED BY THE SAME SCHEDULED IN 1st QUARTER 1stweek in Mar 2019 •Updating compliance currentissues •PIC: compliance officer & business managers •In team meeting in which compliance issueraised 1stweek in Feb 2019 •Trainingby groups •PIC: compliance managers •In business meeting monthly 3rd week in Jan 2019 •Test resultand listof groups announced •PIC: CAT & business managers •In formal strategy meeting quarterly 2nd week in Jan 2019 •Analysingdata and designing training content for each group •PIC: compliance team •with discussion and concurrence with executive manager 1stweek in Jan 2019 •General compliance topics updating •PIC: Compliance manager and executive manager • Testing •PIC: Compliance officer •In cycle meeting
  • 51. 51 Supporting documents Interview transcript Ms. Tu - Financial specialist, has worked at MSD for 3 year, 5 years experience as risk consultant at Deloitte Co., Ltd Interviewer: Hi there, this is an interview for you to share your perspective about compliance management, not only in our organization. I would like to hear your voice base on experiences from other companies that you worked before. First of all, about our particular outlier, what do you think is the reason for so much interactions with customers that we rate as high risk? Interviewee: In my experience, my previous company did not face with this issue. The issue that salesperson interacted so much with high risk customers is particular for this company. Interviewer: So you think what is the main reason? Interviewee: I think the reason is simply our policies allow that. Interviewer: Can you please specific how our policies generate this issue? Interviewee: In my previous company, the policies strictly limit the minimum number of customers per meeting, that is 30 at least. But in our company, we allow meetings with only 8 customers to happen. I also asked my manager about this speciality. She said that is the global guidance and we do not have permission to change and somehow, sale managers also feel comfortable to allow this. Interviewer: If our policies are seemed to be flexible, salesperson have wide choice to conduct meeting in various range number of attendees. But why they keep stuck on meetings with few attendees? Interviewee: I don’t really understand their thinking. I just guess that is because they know their customers and only few customers can attend our meeting, I guess.
  • 52. 52 Interviewer: Do you think this issue is because our social or traditional norms, that customers would like to join in small meetings to avoid a formal discussion with their colleagues? Interviewee: No, I don’t think so. Customers of my previous company do not feel any uncomfortable feelings when joining big meetings. They are also our customers because they are all doctors in our major hospitals. Even in a big meeting, there were 100 to 150 attendees attend without any inconvenience. Interviewer: So customers also would like to join big meetings, why our salesperson do not hold big meetings for lower cost management? Interviewee: I think this is a question you can raise with board of management to update our policies. Because policies always go after business so there is no requirement for a “always” comprehensive policies. If it is not appropriate, it should be enhanced to cover current business risk. Interviewer: But why while our company so prouds of our integrity and compliance system, we still have to face with this type of risk? Interviewee: Not at all, our compliance system is strong because in each controlling stage or I call “checking gate”, we have very specific requirement for salesperson to comply. We care in many details in an interaction with HCPs in order to protect us against risks. We have a very strictly clear system to approve for meeting incur and an professional expense management also help us to tracking all amount paid for interacting with HCPs. But we do have some policies in our process that still not catch up with flow of business. Interviewer: So do you agree that this issue will raise more risk for business? Interviewee: Yes, because we can not check all events if they happen so frequently because of the limit resource. Interviewer: About intentional breach, what is the reason you think? Interviewee: I think there are 2 main reasons, firstly, it is because of the compromise of salesperson.
  • 53. 53 Interviewer: Do you think it is a particular characteristic of Vietnamese? Interviewee: I don’t think so. I also saw some salesperson try their best to explain with customers to not break company’s policies and customers also agreed because our customers are at high level education. So they can understand if salesperson have their voice. Interviewer: What about the second case? Interviewee: The second is about personal characteristic. This applies for people who know clearly about policies and have ability to explain but they do not action because their willing to enhance their relationship with customers. Interviewer: So you think what is the reason for this unexpected behavior? Interviewee: I think this is ethical problem, this person is absolutely not suitable with our company. We should recheck our recruitment. Interviewer: What you think should be improve in our recruitment task? Interviewee: If that company evaluate ethic as a critical concern, it should be included in assessment at recruitment process, as a “fresh raw material”. We have to choose candidate with high value of ethic to avoid risk after. Interviewer: In your opinion, what you think is the critical problem as our discussion so far? Interviewee: I think critical problem for non-compliance behavior is the awareness problem. Interviewer: Can you be more detailed? Interviewee: I think both unintentional and intentional issues relate to awareness problem, that salesperson do not aware of policies, potential risks and also awareness of how to convince customers to comply with our policies. Interviewer: What action you suggest to solve our these problem? Ethical problem? Awareness? Policies?
  • 54. 54 Interviewee: We can easily add some element in our recruiting assessment, take reference from our competitor’s or advisory agency to upgrade our policies and add real cases in our training. Moreover, I think our discipline system is somehow not strong enough to educate our employees, we can raise our case to regional management to consider allow us to enhance level of disciplines. Interviewer: that’s enough for our discussion, thanks for your sharing! Mr. Huy - Compliance specialist, has worked at MSD for 4 year, 3 years experience as auditor at EY Co., Ltd Interviewer: Hi there, this is an interview for you to share your perspective about compliance management, not only in our organization. I would like to hear your voice base on experiences from other companies that you worked before. First of all, about our particular outlier, what do you think is the reason for so much interactions with customers that we rate as high risk? Interviewee: This is because of lacking awareness of salesman. Salesman do not have awareness of potential risks they will face while interacting more frequently with high risk customers. Interviewer: If lacking of awareness of risk, what is their concern while conducting such meetings? Interviewee: Gathering a small group of doctors is seemed to be more easier for them and the convenience in working may be their consideration while choosing the method when working. Interviewer: What do you think is the reason for this problem? Interviewee: Of course training is the cause, we trained a lots about standards, formal policies but in real field, when salesman face with hundreds of cases and hundreds types of people, we do not have clear guidance for them to solve or avoid bad scenarios.
  • 55. 55 Interviewer: In another case, if salesperson acknowledge about risk they may face, but still willing to make it happen. What do you think is the reason in this intentional case? Interviewee: Once again, I think it also because of awareness problem. People in this case lack of “long term” awareness. Interviewer: What do you mean “long term”? Interviewee: While making decision, people just care about their immediate benefit but not the opportunity cost in long term. They focus on rising the sale firgures but do not understand that if there is compliance scandal happen with company, the reputation would be down, business would be restricted and sale would be destructed. Interviewer: In what way we can coach our sales team about this type of awareness? Interviewee: We can show them clearly some example, such as, if a journalist, a staff from competitor or more easier, a customer attend our meeting take a picture of drinking beers in our event, you can imagine what is the consequence? What does public think about us, about our products? Interviewer: So training as you mentioned is an important reason for non-compliance findings, any else? Interviewee: I think our culture also take a part in these problems. Especially in province area, where traditional living style is still popular, customers have the habit of drinking alcohol during meals. Thus, salesperson who have their target customers in such areas would face difficulty in ask customers to comply with our standards completely. Interviewer: So you mean this is because of our customers? Interviewee: Not really, our staff’s behavior is also counted as a contribution. On one hand, they are far away from the office where their higher level managers base, thus the training and coaching are not effective as they should be. Otherwise, working style can not be impacted possitively by their professional manager so compliance culture of these area is not well as the central. On the other hand, they are also impacted by the traditional culture which perceive the alcohol assumption in a scientific event is a normal case and they feel comfortable with it.
  • 56. 56 Interviewer: that’s enough for our discussion, thanks for your sharing! Mr. Kha - Compliance specialist, has worked at Roche (biggest pharmaceutical company by revenue) for 5 year, 1 year experience as compliance officier at MSD, 2 years experience as auditor at Grant Thornton Co., Ltd Interviewer: Hi Kha, this is an interview for you to share your perspective about compliance management, not from any particular company. I would like to hear your voice base on experiences from other companies that you worked before. First of all, about our repeated noncompliance cases reported? Interviewee: I think it depends on level of seriousness of findings. In details, for serious issues, the problem is mostly intentional involment while for issues with medium or low risks, it depends again, on situation, awareness or personal gain. We cannot conclude as a problem. Interviewer: Let’s go detail in low risk first. Could you explain more about your opinion as “depends”? Interviewee: There are 2 cases for low risk issue. First, they knew about policies but because of old practice or their compromise, they violated compliance. Second, they missed information, missed understand about a complicated compliance controlling process. Interviewer: As you mentioned, they compromised customers so they had non- compliance behavior? About old practice, this is practice of them or customers? Interviewee: Of course the issue come from them, certaintly not customers. Compliance is their responsibility despite of several types of customers they faced with, they have to understand and comply with company’s policies. However, as a stage in our controlling process, customers that engage with MSD have to be assessed and chosen based on lots of elements. So, if we missed our controlling, we may have difficulty in dealing with non-compliance customers.
  • 57. 57 Interviewer: Do you think sale pressure or nature of market impact salesperson’s behavior? Interviewee: I think sale pressure is popular with sales career and of course have a part of contribution to the consequence. And also, not only us, our competitor also faced with same kind of pressure because this pressure not only come from internal, but also come from external factors, such as laws, government’s restrictment or trend of market… Interviewer: Do you think our discipline is not strong enough to educate our employees? Interviewee: I think the main reason is salesperson lack their skill while interacting with customers, it not related to discipline. In actual, we also don’t know how to treat with involver completely, we want that involvement in breach not happen, right? Interviewer: What criteria you think we should focus on improving to raise employee’s awareness? Interviewee: People do wrong may be because of they do not know how to do it right. We can provide them full guidance in practical situation that can happen while interacting with customers. On the other hand, this guidance or solution in particular case should be discussed between different point of views to reach the most reasonable suggestion that satisfied all targets of different parties. On more benefit of this kind of discussion that you can gain the commitment of high level manament for a compliance culture in organization. Interviewer: Very helpful and inresting! That’s enough for our discussion, thanks for your sharing! Ms. Tram - Sale manager, has worked at MSD for 4 years, 3 years experience as medical representative at AstraZeneca (pharmaceutical company – ranked at 11th by revenue) Interviewer: Hi Trâm, this is an interview for you to share your perspective about compliance management, not only in our organization. I would like to hear your voice base on experiences from other companies that you worked before. First of all, about