Implementing an Effective Global Anti-Bribery Program
Elaine Murphy, MBA Director 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, MPH Covington & Burling LLP, Washington, DC, USA
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
7 Key Elements of an Effective Compliance Program
7. Response to 1. Written Policies detected problems & & Procedures corrective action initiatives 6. Enforcement & Disciplinary Guidelines Elements 2. Assigned Compliance Officer & Committees
of an Effective Compliance Program
5. Monitoring & Testing 4. Communication
3. Training & Education
Compliance Office
Source: Adapted from various models & tools
1. Written Policies & Procedures
7. Response to 1. Written Policies detected problems & & Procedures corrective action initiatives 6. Enforcement & Disciplinary Guidelines Elements 2. Assigned Compliance Officer & Committees
of an Effective Compliance Program
5. Monitoring & Testing 4. Communication
3. Training & Education
Compliance Office
Source: Adapted from various models & tools
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
2. Assigned Compliance Officer & Committees
7. Response to 1. Written Policies detected problems & & Procedures corrective action initiatives 6. Enforcement & Disciplinary Guidelines Elements 2. Assigned Compliance Officer & Committees
of an Effective Compliance Program
5. Monitoring & Testing 4. Communication
3. Training & Education
Compliance Office
Source: Adapted from various models & tools
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
Leadership - Key Success Indicator
“Tone at The Top” Walk the Talk Openness & honesty Regular updates to, & buy-in from, Audit & Governance Committees
3. Training & Education
7. Response to 1. Written Policies detected problems & & Procedures corrective action initiatives 6. Enforcement & Disciplinary Guidelines Elements 2. Assigned Compliance Officer & Committees
of an Effective Compliance Program
5. Monitoring & Testing 4. Communication
3. Training & Education
Compliance Office
Source: Adapted from various models & tools
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
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
4. Communication
7. Response to 1. Written Policies detected problems & & Procedures corrective action initiatives 6. Enforcement & Disciplinary Guidelines Elements 2. Assigned Compliance Officer & Committees
of an Effective Compliance Program
5. Monitoring & Testing 4. Communication
3. Training & Education
Compliance Office
Source: Adapted from various models & tools
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 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
5. Monitoring & Testing
7. Response to 1. Written Policies detected problems & & Procedures corrective action initiatives 6. Enforcement & Disciplinary Guidelines Elements 2. Assigned Compliance Officer & Committees
of an Effective Compliance Program
5. Monitoring & Testing 4. Communication
3. Training & Education
Compliance Office
Source: Adapted from various models & tools
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
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
6. Enforcement & Disciplinary Guidelines
7. Response to 1. Written Policies detected problems & & Procedures corrective action initiatives 6. Enforcement & Disciplinary Guidelines Elements 2. Assigned Compliance Officer & Committees
of an Effective Compliance Program
5. Monitoring & Testing 4. Communication
3. Training & Education
Compliance Office
Source: Adapted from various models & tools
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
7. Response to Detected Problems & Correct Action
7. Response to 1. Written Policies detected problems & & Procedures corrective action initiatives 6. Enforcement & Disciplinary Guidelines Elements 2. Assigned Compliance Officer & Committees
of an Effective Compliance Program
5. Monitoring & Testing 4. Communication
3. Training & Education
Compliance Office
Source: Adapted from various models & tools
7. Response to Detected Problems & Correct Action
Risk Management process Incident response team & plan Detective controls From “lessons learned” develop training & education tools
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?
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
Thank you
Elaine Murphy, MBA Director 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, MPH Covington & Burling LLP, Washington, DC, USA