Implementing an Effective Implementing an Effective Global Anti-Bribery ProgramGlobal Anti-Bribery Program

Elaine Murphy, MBADirector Health Care Compliance

Johnson & Johnson Medical Devices & Diagnostics, UK

Sue Seferian, Esq.Assistant General Counsel, Worldwide Office of Health Care

Compliance, Johnson & Johnson, USA

Keith M. Korenchuk, JD, MPHCovington & Burling LLP, Washington, DC, USA

DiscussionDiscussion

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

Elements of an EffectiveCompliance Program

1. Written Policies & Procedures

7. Response to detected problems & correctiveaction initiatives

2. Assigned Compliance Officer & Committees

6. Enforcement &

DisciplinaryGuidelines

3. Training & Education

Compliance Office

Law D

epar

tmen

tInternal Audit

7 Key Elements of an Effective Compliance 7 Key Elements of an Effective Compliance ProgramProgram

Source:Adapted from various models & tools

5. Monitor

ing&

Testing 4. Communication

Elements of an EffectiveCompliance Program

1. Written Policies & Procedures

7. Response to detected problems & correctiveaction initiatives

2. Assigned Compliance Officer & Committees

6. Enforcement &

DisciplinaryGuidelines

Compliance Office

Law D

epar

tmen

tInternal Audit

1. Written Policies & Procedures1. Written Policies & Procedures

Source:Adapted from various models & tools

5. Monitor

ing&

Testing 4. Communication

3. Training & Education

1. Written Policies & Procedures1. 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

Elements of an EffectiveCompliance Program

1. Written Policies & Procedures

7. Response to detected problems & correctiveaction initiatives

2. Assigned Compliance Officer & Committees

6. Enforcement &

DisciplinaryGuidelines

Compliance Office

Law D

epar

tmen

tInternal Audit

2. Assigned Compliance Officer & 2. Assigned Compliance Officer & CommitteesCommittees

Source:Adapted from various models & tools

5. Monitor

ing&

Testing 4. Communication

3. Training & Education

2. Assigned Compliance Officer & 2. Assigned Compliance Officer & Committees, Roles & ResponsibilitiesCommittees, 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

Leadership - Key Success IndicatorLeadership - Key Success Indicator

“Tone at The Top” Walk the Talk Openness & honesty Regular updates to, & buy-in from, Audit &

Governance Committees

Elements of an EffectiveCompliance Program

1. Written Policies & Procedures

7. Response to detected problems & correctiveaction initiatives

2. Assigned Compliance Officer & Committees

6. Enforcement &

DisciplinaryGuidelines

Compliance Office

Law D

epar

tmen

tInternal Audit

3. Training & Education3. Training & Education

Source:Adapted from various models & tools

5. Monitor

ing&

Testing 4. Communication

3. Training & Education

3. Training & Education – Practical 3. Training & Education – Practical ConsiderationsConsiderations

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

Third Parties – A Critical ChallengeThird 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

Elements of an EffectiveCompliance Program

1. Written Policies & Procedures

7. Response to detected problems & correctiveaction initiatives

2. Assigned Compliance Officer & Committees

6. Enforcement &

DisciplinaryGuidelines

Compliance Office

Law D

epar

tmen

tInternal Audit

4. Communication4. Communication

Source:Adapted from various models & tools

5. Monitor

ing&

Testing 4. Communication

3. Training & Education

4. Communication 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

Implementing the Program: Effecting Implementing the Program: Effecting ChangeChange

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

Elements of an EffectiveCompliance Program

1. Written Policies & Procedures

7. Response to detected problems & correctiveaction initiatives

2. Assigned Compliance Officer & Committees

6. Enforcement &

DisciplinaryGuidelines

Compliance Office

Law D

epar

tmen

tInternal Audit

5. Monitoring & Testing5. Monitoring & Testing

Source:Adapted from various models & tools

5. Monitor

ing&

Testing 4. Communication

3. Training & Education

5. Monitoring & Testing Considerations5. 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

Challenges to Developing Effective Challenges to Developing Effective Monitoring & Testing FunctionsMonitoring & 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

Elements of an EffectiveCompliance Program

1. Written Policies & Procedures

7. Response to detected problems & correctiveaction initiatives

2. Assigned Compliance Officer & Committees

6. Enforcement &

DisciplinaryGuidelines

Compliance Office

Law D

epar

tmen

tInternal Audit

6. Enforcement & Disciplinary Guidelines6. Enforcement & Disciplinary Guidelines

Source:Adapted from various models & tools

5. Monitor

ing&

Testing 4. Communication

3. Training & Education

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

6. Enforcement & Disciplinary 6. Enforcement & Disciplinary GuidelinesGuidelines

Elements of an EffectiveCompliance Program

1. Written Policies & Procedures

7. Response to detected problems & correctiveaction initiatives

2. Assigned Compliance Officer & Committees

6. Enforcement &

DisciplinaryGuidelines

Compliance Office

Law D

epar

tmen

tInternal Audit

7. Response to Detected Problems & 7. Response to Detected Problems & Correct ActionCorrect Action

Source:Adapted from various models & tools

5. Monitor

ing&

Testing 4. Communication

3. Training & Education

7. Response to Detected Problems & 7. Response to Detected Problems & Correct ActionCorrect Action

Risk Management process Incident response team & plan Detective controls From “lessons learned” develop training &

education tools

Global Antibribery Policy: A Major Global Antibribery Policy: A Major ChallengeChallenge

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?

Global Antibribery Policy: A Major Global Antibribery Policy: A Major ChallengeChallenge

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

Thank youThank youElaine Murphy, MBADirector Health Care ComplianceJohnson & Johnson Medical Devices & Diagnostics, UK

Sue Seferian, Esq.Assistant General Counsel, Worldwide Office of Health Care Compliance, Johnson & Johnson, USA

Keith M. Korenchuk, JD, MPHCovington & Burling LLP, Washington, DC, USA