Implementing%20an%20Effective%20Global%20Anti-Bribery%20Program%20%20Elaine%20Murphy,%20MBA%20Director%20Health%20Care%20Compliance%20Johnson%20

1
Implementing an Effective Global
Anti-Bribery ProgramElaine Murphy,
MBADirector Health Care ComplianceJohnson
Johnson Medical Devices Diagnostics, UKSue
Seferian, Esq.Assistant General Counsel,
Worldwide Office of Health Care Compliance,
Johnson Johnson, USAKeith M. Korenchuk, JD,
MPHCovington Burling LLP, Washington, DC, USA
2
Discussion

• Key Elements of an effective program,
  incorporating touch points on
• Roles Responsibilities, Structure/Organisation
  Factors
• Leadership
• Third Party Due Diligence
• Change Management
• Global Anti Bribery Policy A Major Challenge

3
7 Key Elements of an Effective Compliance Program
7. Response to detected problems
correctiveaction initiatives
Internal Audit
1. Written Policies Procedures
Law Department
Elements of an Effective Compliance Program
2. Assigned Compliance Officer Committees
6. Enforcement Disciplinary Guidelines
5. Monitoring Testing
3. Training Education
4. Communication
Compliance Office
Source Adapted from various models tools
4
1. Written Policies Procedures
7. Response to detected problems
correctiveaction initiatives
Internal Audit
1. Written Policies Procedures
Law Department
Elements of an Effective Compliance Program
2. Assigned Compliance Officer Committees
6. Enforcement Disciplinary Guidelines
5. Monitoring Testing
3. Training Education
4. Communication
Compliance Office
Source Adapted from various models tools
5
1. Written Policies Procedures

• Regional policies
• In country Standard Operating Procedures
• Local anti-bribery laws practice
• U.S. based laws (FCPA) procedures
• Cross-border interactions
• People follow people
• not paper policies processes

6
2. Assigned Compliance Officer Committees
7. Response to detected problems
correctiveaction initiatives
Internal Audit
1. Written Policies Procedures
Law Department
Elements of an Effective Compliance Program
2. Assigned Compliance Officer Committees
6. Enforcement Disciplinary Guidelines
5. Monitoring Testing
3. Training Education
4. Communication
Compliance Office
Source Adapted from various models tools
7
2. Assigned Compliance Officer Committees,
Roles Responsibilities

• Appropriate most effective reporting structure
• Governance
• Defining boundaries of Compliance vs.
• Legal
• Internal Audit
• Human Resources
• Finance
• Security
• Responsibility vs. Accountability
• Responsibility at country regional/global level

8
Leadership - Key Success Indicator

• Tone at The Top
• Walk the Talk
• Openness honesty
• Regular updates to, buy-in from, Audit
  Governance Committees

9
3. Training Education
7. Response to detected problems
correctiveaction initiatives
Internal Audit
1. Written Policies Procedures
Law Department
Elements of an Effective Compliance Program
2. Assigned Compliance Officer Committees
6. Enforcement Disciplinary Guidelines
5. Monitoring Testing
3. Training Education
4. Communication
Compliance Office
Source Adapted from various models tools
10
3. Training Education Practical Considerations

• Learning platforms what, how, who, when
• Tools to track global training education
  requirements
• Systems documentation methods ensure
  attendance comprehension
• Recipients
• Customisation/tailoring at local level
• Different languages challenges around
  translation of company policy training

11
Third Parties A Critical Challenge

• What standards should apply?
• How can Third parties demonstrate compliance?
• Level of due diligence required
• Use of contractual representatives warranties
• Practical relationship issues
• Ongoing monitoring

12
4. Communication
7. Response to detected problems
correctiveaction initiatives
Internal Audit
1. Written Policies Procedures
Law Department
Elements of an Effective Compliance Program
2. Assigned Compliance Officer Committees
6. Enforcement Disciplinary Guidelines
5. Monitoring Testing
3. Training Education
4. Communication
Compliance Office
Source Adapted from various models tools
13
4. Communication

• Management, anonymity, communication tracking
  at a global level of hotlines
• Effective communication across cultures
  languages
• Who is responsible for delivering the compliance
  message in various countries is it consistent
  with corporate standards?
• Use of confidential information

14
Implementing the Program Effecting Change

• Resistance to change implementing behaviour
  change
• Comprehensive review of core activities
  controls raises key issues that mirror global
  compliance challenges generally
• Resource constraints a time intensive activity,
  by activity process
• Ensuring company wide consistency of process a
  major challenge

15
5. Monitoring Testing
7. Response to detected problems
correctiveaction initiatives
Internal Audit
1. Written Policies Procedures
Law Department
Elements of an Effective Compliance Program
2. Assigned Compliance Officer Committees
6. Enforcement Disciplinary Guidelines
5. Monitoring Testing
3. Training Education
4. Communication
Compliance Office
Source Adapted from various models tools
16
5. Monitoring Testing Considerations

• Risk analysis
• Identify areas for potential monitoring testing
• Development of areas of focus
• Written protocols
• Development use of metrics
• Deployment of resources
• Utilisation of technology
• Effective communication of results

17
Challenges to Developing Effective Monitoring
Testing Functions

• Data quality
• Systems integration
• Under-developed key performance indicators
• Budget support/financial resources
• Resource for performing monitoring testing
• Training of personnel
• Collaboration across legal, internal audit, etc
• Follow-on investigations Corrective Action

18
6. Enforcement Disciplinary Guidelines
7. Response to detected problems
correctiveaction initiatives
Internal Audit
1. Written Policies Procedures
Law Department
Elements of an Effective Compliance Program
2. Assigned Compliance Officer Committees
6. Enforcement Disciplinary Guidelines
5. Monitoring Testing
3. Training Education
4. Communication
Compliance Office
Source Adapted from various models tools
19
6. Enforcement Disciplinary Guidelines

• Appropriate objectives set
• Consistency across disciplinary actions rules
  need teeth
• Reporting systems in place, e.g. telephone
  hotlines, well communicated understood
• Investigations conducted systematically
• Good working relationship with HR required

20
7. Response to Detected Problems Correct Action
7. Response to detected problems
correctiveaction initiatives
Internal Audit
1. Written Policies Procedures
Law Department
Elements of an Effective Compliance Program
2. Assigned Compliance Officer Committees
6. Enforcement Disciplinary Guidelines
5. Monitoring Testing
3. Training Education
4. Communication
Compliance Office
Source Adapted from various models tools
21
7. Response to Detected Problems Correct Action

• Risk Management process
• Incident response team plan
• Detective controls
• From lessons learned develop training
  education tools

22
Global Antibribery Policy A Major Challenge

• Local laws customs, applying local law on a
  global level
• Different country cultures languages, respect
  for autonomy differences
• Different organisational challenges, structures
  cultures
• Does one size fit all where do you set the
  bar high or low?

23
Global Antibribery Policy A Major Challenge

• Applying developed/developing country standards
  to an under developed country
• Competing resources priorities, organisational
  complexities
• Operational silos risk-based approach
• Consistency simplicity across functions
  geographies
• Effect on competition

24

• Thank you

Elaine Murphy, MBADirector Health Care
ComplianceJohnson Johnson Medical Devices
Diagnostics, UKSue Seferian, Esq.Assistant
General Counsel, Worldwide Office of Health Care
Compliance, Johnson Johnson, USAKeith M.
Korenchuk, JD, MPHCovington Burling LLP,
Washington, DC, USA