compliance risk+assessment+ · principles of compliance programs for pharmaceutical manufacturers...
TRANSCRIPT
Compliance Risk Assessment the Heat Map
Tomasz Kruk / Istanbul / May 2011
Plan
1. The Risk Assessment vs The Effec3ve Compliance Program
2. The Heat Map – external sources
3. The Heat Map – internal sources
4. Discussion
SUBJECT: Elements for an Effec/ve Compliance Program
AUTHOR: Office of Inspector General / Dept. of Health & Human Services DOCUMENT TITLE: OIG Compliance Program Guidance for Pharmaceu/cal Manufacturers PUBLISHED: April 18, 2003 TARGET: reducing fraud and abuse in federal health care programs / At a minimum, a
comprehensive compliance program should include the following elements:
(5) The use of audits and/or other risk evaluaPon techniques to monitor compliance, iden/fy problem areas, and assist in the reduc/on of iden/fied problems;
Five approaches to effec2ve compliance program -‐ RISK ASSESSMENT -‐ I
Compliance Program Guidance for Pharmaceutical Manufacturers developed by the Office of Inspector General (OIG). Through this notice, the OIG is setting forth its general views on the value and fundamental principles of compliance programs for pharmaceutical manufacturers and the specific elements that pharmaceutical manufacturers should consider when developing and implementing an effective compliance program. - Compliance program guidance is a major initiative of the OIG in its effort to engage the health care community in preventing and reducing fraud and abuse in federal health care programs.
SUBJECT: Six Principles for Bribery Prevention
AUTHOR: Ministry of Jus/ce / UK DOCUMENT TITLE: Consulta/on on guidance about commercial organisa/ons preven/ng bribery PUBLISHED: Sept. 2010 TARGET: fighPng corrupPon
1/ Risk Assessment – this is about knowing and keeping up to date with the bribery risks you face in your sector and market;
Five approaches to effec2ve compliance program -‐ RISK ASSESSMENT -‐ II
Consultation on guidance about commercial organisations preventing bribery (section 9 of the Bribery Act 2010) Consultation Paper CP11/10 This consultation begins on 14 September 2010 This consultation ends on 8 November 2010 http://www.justice.gov.uk/consultations/docs/bribery-act-guidance-consultation1.pdf
SUBJECT: EFFECTIVE COMPLIANCE AND ETHICS PROGRAM (Nov.2010)
AUTHOR: United States Sentencing Commission DOCUMENT TITLE: United States Sentencing Commission -‐ Guidelines Manual PUBLISHED: Nov. 2010 TARGET: The existence of an effec/ve compliance and ethics program mi/gate the ul/mate
punishment of an organizaPon.
In implemen/ng the Program, the organiza/on shall periodically assess the risk of criminal conduct and shall take appropriate steps to design, implement, or modify each requirement set forth above to reduce the risk of criminal conduct iden/fied through this process.
Five approaches to effec2ve compliance program -‐ RISK ASSESSMENT -‐ III
The United States Sentencing Commission - Guidelines Manual, Chapter 8 Sentencing of Organizations, Part B Remedying Harm from Criminal Conduct and Effective Compliance and Ethics Program
SUBJECT: Good Practice Guidance for Companies
AUTHOR: OECD DOCUMENT TITLE: OECD Good Prac/ce Guidance for Companies PUBLISHED: Feb 18, 2010 TARGET: This “Guidance” is addressed to companies for establishing and ensuring the
effec/veness of internal controls, ethics, and compliance programmes or measures for prevenPng and detecPng the bribery of foreign public officials in their interna/onal business transac/ons (…)
Effec/ve internal controls, ethics, and compliance programmes or measures for preven/ng and detec/ng foreign bribery should be developed on the basis of a risk assessment addressing the individual circumstances of a company, in par/cular the foreign bribery risks facing the company (such as its geographical and industrial sector of opera/on).
Five approaches to effec2ve compliance program -‐ RISK ASSESSMENT -‐ IV
Good Practice Guidance on Internal Controls, Ethics, and Compliance Adopted 18 February 2010 This Good Practice Guidance was adopted by the OECD Council as an integral part of the Recommendation of the Council for Further Combating Bribery of Foreign Public Officials in International Business Transactions of 26 November 2009. http://www.oecd.org/dataoecd/5/51/44884389.pdf
SUBJECT: CORPORATE COMPLIANCE PROGRAM AUTHOR: The United States Department of Jus/ce, Criminal Division, Fraud Sec/on DOCUMENT TITLE: Prosecu/on Agreements PUBLISHED: Nov. 2010 TARGET: This is part of a few recent prosecu/on agreements where companies have been
obliged to develop and promulgate a clearly ar/culated and visible corporate policy against violaPons of the FCPA)
4. The Company will develop these compliance standards and procedures, including internal controls, ethics, and compliance programs on the basis of a risk assessment addressing the individual circumstances of the Company, in par/cular the foreign bribery risks facing the Company, including, but not limited to, its geographical organiza/on, interac/ons with various types and levels of government officials, industrial sectors of opera/on, involvement in joint venture arrangements, importance of licenses and permits in the company's opera/ons, degree of governmental oversight and inspec/on, and volume and importance of goods and personnel clearing through customs and immigra/on.
Five approaches to effec2ve compliance program -‐ RISK ASSESSMENT -‐ V
CORPORATE COMPLIANCE PROGRAM is a part of the Nov. 2010 PROSECUTION AGREEMENTS: United States vs. Panalpina Inc.: Plea Agreement http://www.justice.gov/opa/documents/panalpina-inc-plea-agreement.pdf or United States vs. Shell: Deferred Prosecution Agreement http://www.justice.gov/opa/documents/shell-dpa.pdf
Transparency Interna2onal INDEX -‐ the Heat Map (external sources)
Interna2onal Human Development INDEX -‐ the Heat Map (external sources)
http://hdr.undp.org/en/data/map/
OECD Conven2on on Comba2ng Bribery… -‐ the Heat Map (external sources)
Economic Freedom INDEX -‐ the Heat Map (external sources)
http://www.heritage.org/index/download
Number of legal en22es by country -‐ the Heat Map (internal sources)
12
Number of employees by country -‐ the Heat Map (internal sources)
13
Revenue by country -‐ the Heat Map (internal sources)
14
Discussion
15
