Proactively Managing International and Foreign Corrupt ... · 0 Proactively Managing International...

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Proactively Managing International and Foreign Corrupt Practices Act Compliance Risks - The Third Annual FDA Regulatory

and Compliance Symposium

Gary F. Giampetruzzi, Pfizer IncAssistant General Counsel and Deputy

Compliance Officer

Keith M. KorenchukCovington & Burling LLP

Cambridge, Massachusetts, August 23, 2007

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Anti-Bribery/Anti-Corruption

(ABAC)

1. Real Life Lessons 2. What are the ABAC rules?3. The Compliance Framework

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How Companies Get in Anti-bribery/Anti-corruption Trouble: Real World Lesson #1

• Senior non-U.S. government regulator sought a charitable contribution from a U.S. company’s European subsidiary- The charity – the regulator’s favorite – is legitimate- The regulator has a lot of influence over the subsidiary’s business- He makes clear that it would be in the subsidiary’s interest if the

contribution is made

• Total contribution exceeds the manager’s authorization - So the contribution was made in several smaller payments- Not described properly in the accounting records

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Consequences:

• Anti-bribery/Anti-corruption VIOLATION: inaccurate accounting records

• Anti-bribery/Anti-corruption VIOLATION: inadequate internal controls

• FINE: $500,000

(Schering-Plough, 2004)

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Lesson:

Companies must have standard due diligence procedures and controls governing charitable contributions

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• Several subsidiaries of a U.S. healthcare company gave commissions and “gifts” to non-U.S. doctors– Cash, Computers, Digital cameras, Wine, Wristwatches– Leisure travel and sponsoring lavish social events

• Officers of the U.S. parent company knew about the gifts

• The gifts were not properly recorded– Recorded as capital or business expenses– On the books of a foreign subsidiary (enforcement was less strict)

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Consequences:• Anti-bribery/Anti-corruption VIOLATION: anti-bribery

provisions

• Anti-bribery/Anti-corruption VIOLATION: accounting and internal controls provisions

• FINES & PENALTIES: $2.5 million

• EXTERNAL Anti-bribery/Anti-corruption MONITOR

(Syncor, 2002)

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Lesson:

Companies must have clear policies and procedures governing gifts and entertainment provided to non-U.S. healthcare providers and other government officials

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• An U.S. manufacturer had a global distribution network of independent dealers

• One dealer paid bribes to government officials to avoid penalties for late delivery

• Executives of the manufacturer knew there was a high probability of bribery were paid, and took no action

– In one case, they even authorized payments that helped subsidize the dealer’s cost for paying the bribes

– They also knew there was a high probability that similar payments were made in other markets

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Consequences:• Anti-bribery/Anti-corruption VIOLATION: anti-bribery provision• Anti-bribery/Anti-corruption VIOLATION: inaccurate accounting

records, inadequate internal controls• DISGORGEMENT OF PROFITS: $618,000• CIVIL PENALTY: $500,000• MONITORING: External compliance monitor imposed on company

for two years• ENFORCEMENT ACTION: Sales Manager charged with Anti-

bribery/Anti-corruption violation; $65,000 fine(Invision, 2005)

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Lesson:

Companies must have standard due diligence procedures and controls for selecting, retaining and overseeing distributors, consultants, and other key third parties

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• A company was tendering in a developing country• Company sponsored “training” programs and travel for

several government employees who were responsible for evaluating the company’s offer

• Company paid all expenses and “per diem” payments to the government employees of $120-$200 per day– The average income in the government employees’ country was

under $800 per year– The “per diem” payments were distributed in cash from a paper

bag and were disguised using false invoices

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Consequences:• Anti-bribery/Anti-corruption VIOLATION: anti-bribery

provisions

• Anti-bribery/Anti-corruption VIOLATION: accounting provisions

• FINE: $13 million

• DISGORGEMENT: $15.5 million (Titan, 2005)

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Lesson:

Companies must have clear procedures that are designed to prevent and detect potentially improper sponsorship and travel expenditures

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Anti-Bribery/Anti-Corruption (ABAC)

What are the ABAC rules?

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The Global Regulatory Maze

• Foreign Corrupt Practices Act • OECD • The WHO Criteria• EU Directive 2001/83/EC• Association Codes (The IFPMA Code and

EFPIA Code• Specific Country Laws/Guidelines

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1. The FCPA: What is it?• US Foreign Corrupt Practices Act applies

WORLDWIDE • Prohibits bribery of foreign government

officials• Requires that public companies

– Maintain accurate books and records in all controlled entities

– Maintain an adequate system of accounting controls in all controlled entities

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1. The FCPA – prohibition on bribing of foreign government officials

• An offer, payment or gift of any money or thing of value is made

• To any foreign official or other person while knowing that some or all of the payment will be passed on to a foreign official

• For the purpose of obtaining or retaining business or obtaining any improper advantage

Payment

To foreignofficial

To obtain improper advantage

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A “Foreign Official” is anyone employed by a government agency, or by a government- owned commercial enterprise, including physicians or other healthcare providers

The “knowing”requirement will be satisfied if there is failure to make reasonable inquiry concerning the intentions or activities of an agent or other third-party payee

Foreign Official

“WhileKnowing”

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A payment is for the purpose of obtaining or retaining business if it is made to reward a foreign official for using or endorsing the company’s products

A payment is for the purpose of obtaining an improper advantage if it is made to obtain a favorable regulatory decision

Obtain orretain

business

Improper advantage

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1. The FCPA – books, records and appropriate control

A company and its subsidiaries must maintain accurate books and records

A company and its subsidiaries must maintain appropriate controls• Showing a bribe on the books as a payment for a

consulting arrangement is a violation• Supporting payment of bribe with an invoice for a

consulting arrangement is maintaining a false record

Accurate books and

records

Maintainappropriate

control

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1. The FCPA – Permitted Payments

• Payments legal under local country law

• Bona fide expenses of government officials for product promotion

• "Grease" or facilitating payments to expedite routine governmental action

– Permits, licenses, Visas, work papers– Police protection, mail pickup– Phone, power or water service– Loading cargo, protecting perishables

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2. OECD Convention

• OECD Convention on Combating Bribery of Foreign Public Officials in International Business Transactions (adopted 1997, entered into force 1999)

• 37 countries ratified as of June 2007

• Monitoring Phase I: Implementation -evaluates adequacy of a country’s legislation to implement the Convention

• Monitoring Phase II: Enforcement -assesses whether a country is applying its legislation effectively

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3. WHO Criteria for Medicinal Drug Promotion

• The World Health Organization guidance is endorsed by the World Health Assembly and may be voluntarily adopted by individual countries.

• The Guidance applies to prescription and non- prescription medicinal drugs as well as any other product promoted as a medicine. The Guidance offers ethical guidance on promotion; advertising; free samples; medical representatives; symposia; post-marketing studies; packaging and labeling; information for patients; and promoting exported drugs.

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4. Directive 2001/83/EC of the European Parliament and of the Council, as

Amended

• The European Union has adopted its own mandatory guidelines which apply to all Member States. These guidelines are found in Directive 2001/83/EC on The Community Code Relating to Medicinal Products for Human Use. It provides in part:– “Where medicinal products are being promoted to

persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of medicine or pharmacy.”

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5. Industry Codes

• International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Code of Pharmaceutical Marketing Practices (2007), Article 7

• European Federation of Pharmaceutical Industries and Associations (EFPIA) Code of Practice of the Promotion of Medicines, Article 10

• Association of the British Pharmaceutical Industry (ABPI) Code of Practice (2006), Clause 18.1

• Swedish Association of the Pharmaceutical Industry (Läkemedelsindustriföreningen) (LIF), Rules Governing Drug Information

Many industry codes prohibit inducements to prescribe, supply, sell or administer a medicinal product, for example:

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General Program Guidance From The Cases

• Focus on maintenance of controls by companies (and individuals?)• Development of clear FCPA policies and program elements

– Communication, regular training, and annual certifications– Reporting systems, and appropriate discipline when violations occur

• Development of FCPA procedures reasonably capable of preventing violations

– Should be a risk-based approach to controls / procedures– Due diligence and post-retention oversight of third-party relationships– Appropriate contractual language with third-party agreements setting forth anti-

corruption reps and warranties, compliance with anti-corruption laws, etc.– Controls to ensure that books, records and accounts are maintained accurately

• Senior management reporting on FCPA status to audit committee, etc.

• Regular audits to ensure that program has been implemented in an effective manner

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FCPA Policies? Start With Your FCPA Risk Areas

Direct Healthcare Regulators

•Product approval and registration•Product pricing•Product reimbursement•Placement on hospital formularies

Government-employed doctors

•Gifts and hospitality•Congresses and meetings•Consultant arrangements•Education and research grants

Other public officials

•Customs and importation officials•Charitable and political contributions, etc.•Third-party agreements (ex. wholesalers, distributors and other service providers)

Foreign Officials

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Global Policy on Interactions with Healthcare Professionals

Primacy of Patient And Healthcare Professional Relationship

Corporate Citizenship

Transparency

Core Global Policy Principles

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Dealing With Specific Areas Of RiskEx. Support for Third Party

Medical Meetings and Conferences

The main purpose of medical congresses, conferences, symposia and similar programs supported by Pfizer must be scientific exchange

and/or medical education. . . . In no instance will Pfizer provide financial

support as an inducement for a healthcare professional to

use, prescribe or recommend a Pfizer product or otherwise influence

the outcome of a clinical trial.

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Controls? A Global FCPA Procedure

• A comprehensive, corporate-developed global procedure– Real controls; not merely another statement of policy (ex. GPIHP)

• Implementation by local markets to enforce and implement corporate procedure

– Local market identification of public officials– Detailed written procedures govern gifts and hospitality, congresses, consultant

arrangements, research and other grants, third-party relationships, etc. with officials

– Local implementation reviewed by Legal, with annual certifications– Essentially becomes gap analysis with existing implementing SOPs

• Local systems, processes and controls subject to periodic auditing– Local trend analysis on interactions in consultation with Corporate Compliance

• Appropriate record retention and training, training and more training• Owned and operated by the business

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Fundamental Point: Policies Are Not Procedures

PolicyProcedure

• Directional guidance

• No specification of process

• Detailed guidance• Process steps and

controls outlined

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Example: Dealing With Third-Party Consultants

• Healthcare professionals may be hired as consultants to provide bona fide services, such as assisting in the development of medicines, participating in clinical trials, etc.

• In no instance will Pfizer retain any healthcare professional, regardless of qualification, as an inducement for such healthcare professional to use, prescribe, or recommend products.

• In some countries, many healthcare professionals are employed by government or regulatory authorities. Pfizer will ensure that all such relationships are appropriately reviewed to ensure compliance with Pfizer policies and applicable laws.

• Consider the subject market / territory• Identify relationships with gov’t officials• Determine the competence / integrity of

the third party (questionnaires, interviews, etc.)

• Reasonableness of compensation (vs. work to be performed, fair market value)

• Ensure compliance with local laws• Integrate standard FCPA language and

safeguards into the third-party agreement

• Maintain continuing oversight of third- party

• Maintain accurate books and records, including the due diligence file

GPIHP (Policy) FCPA Procedure

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Deep Dive: International Meeting Procedure (online tool)

• Covers Pfizer-organized meetings and support for 3rd party-organized meetings• Ensures that all international meetings attended by HCPs or GOs that Pfizer invites or supports,

comply with the laws of both the Meeting Jurisdiction (country in which the meeting takes place) and Home Jurisdiction = (country of the invited HCP or GO)

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FCPA Training (Along With More Communications)

• Prior training approach - The first 150 years– Mostly non-web based (ex. Compliance and Values Workshops)– New employee orientations, various corporate and divisional programs

• Since 2003 – Addition of web-based training– More than 100,000 colleagues trained in the U.S. and international markets– More than 80 countries worldwide, and approximately 30 languages– Pfizer Code of Conduct module, FCPA substantive and procedural modules– 92% liked the courses; 91% better understand rules; 94% intend to use

• Proactive collaborative market education and review– Business and compliance collaboration on risk assessments– Concentrated in-person compliance training in the markets

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Pfizer Compliance Education Center (PCEC)

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PCEC Global Training – Languages, Languages, Languages

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Utilizing the Resource - PCEC Online FCPA Certifications

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Auditing and Assessing An FCPA Program

• Legal Division survey• Global Colleague and

Values survey• Global compliance survey• Employee exit interviews• Corporate Compliance

website

PCEC feedback and statistics

Feedback and statistics from the Open Door and Compliance Hotline

Auditing and Monitoring functions (Healthcare, Manufacturing, R&D, etc.)

Global Compliance Liaisons(eyes and ears on the ground)

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In The Weeds: Red Flags During FCPA Auditing

• High commissions• Payments into offshore

accounts• Inadequate, generic or

otherwise questionable descriptions

• Missing or incomplete support• Repetitive payments of same

amount• Homemade or self generated

invoices• Consecutive numbered

invoices• Duplicate invoices (payees?)

• Round dollar transactions• Substantial activity for new

vendor• Invoices paid unusually quickly• Large individual or aggregate

payments/benefits to one payee

• Repetitive entertainment/dinner/travel

• Increased payments at period end

• Employee (or unknown third parties) bonuses or loans without explanation

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Identifying Issues: A Viable Open Door Policy

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Referable Compliance Issues (RCIs)

• Definition– Significant violations of applicable law or company policy or procedure– “Significance” determined by severity of action or consequence and nature of law

(i.e. intentional, criminal, or repeated behavior; participation of a manager; serious financial, operational, investor relations, health, or safety consequences)

• Points of process1. Handled exclusively at the direction of Corporate Compliance and GI

2. Reported to the Corporate Compliance Officer; Audit and Compliance Committees

• Response to changed environment– Need to ensure corporate awareness of significant compliance issues (ex.

Sarbanes)– Provides ability to investigate and decide whether to disclose

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Identifying Issues: Hotlines in Every Country and Region

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Global Compliance Liaisons / Regional Compliance Directors

• Liaison Partnership between Corporate Compliance and leadership of local markets

– Designated Compliance Liaisons in every market around the world– Liaise between market and Corporate Compliance– Ensures that Corporate Compliance Officer (CEO, CFO, Board and Audit

Committee of Board) up-to-date on compliance issues at every Pfizer location around the world

• Report Referable Compliance Issues to Corporate Compliance Group

– Act as chief point of contact between business and Compliance Group

• Be an on-site source of compliance information for colleagues– Spreads compliance knowledge and empowers colleagues– Drives compliance into the business

• Regional Compliance Directors– Newest addition to corporate compliance structure

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Don’t Be Afraid To Ask: A Global Compliance Survey

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Conduct an Investigation? Is There Really Any Choice?

• It’s a small market, located far, far away – “Nobody will ever find out”• Revised U.S. Sentencing Guidelines

– Once criminal conduct has been detected, the company shall take certain “reasonable steps” to respond appropriately to such criminal conduct

• Dep’t of HHS, Office of the Inspector General Model Guidance– Upon receipt of indications of suspected noncompliance, company must

“immediately investigate” the issues to determine whether a material violation of law has occurred

• Other practical consequences from failing to conduct an internal investigation

– Bad actors remain with company– No ability to control public relations issues– Company remains in legally defensive position– Raise government concerns regarding commitment to compliance

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Determining the Scope of an FCPA Investigation

• The typical FCPA investigation: “the more you look, the more you find”

– Most FCPA investigations go beyond the initial market at issue

• A comprehensive plan should be developed at the outset of the investigation

– Are there other concerns in the market at issue?– Are there other markets that present similar issues?– What are the riskier markets? Prior audit findings? Prior compliance issues?

• DOJ and SEC will look at scope to determine whether investigation effective

• Strength of company’s FCPA compliance program bears on scope– If FCPA controls are more robust, more limited investigation may be ok– If FCPA controls are weak (or even non existent), more broad review will be

required

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Who Should Conduct The Investigation? In- House?

• Pros of in-house counsel– May be familiar with the employees to be interviewed– Less likely to cause disruption– Greater latitude with employees– Less expensive

• Cons of in-house counsel– May not be adequate time and resource– May be influenced by management– Possibly not viewed as independent by the government

• Conclusion– With smaller scope and less significant exposures, inside counsel might be best– Will still need to collaborate with local and U.S. counsel

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Who Should Conduct The Investigation? Outside Counsel?

• Pros of outside counsel– Appearance of independence– Greater resources available, and quicker investigation– Likely more collective experience with investigations– Greater ability to protect legal privileges

• Cons of outside counsel– Certainly much more expensive– Depending on other cases, may not have adequate resources– Not likely to have familiarity with business operations, employees, etc.

• Conclusion– With broader scope or more significant exposures, outside counsel likely best– Will still need to collaborate with inside and local counsel

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Securing Documents and Electronic Evidence• Once a party has been placed on notice of actual or anticipated

litigation, a duty to preserve evidence arises, and a timely document hold must be initiated

– Existence of government investigation requires hold– In the context of a voluntary disclosure, must consider the integrity of the internal

review, and extent to which an issue appears to be problematic and will be disclosed

• A document hold means (1) suspension of routine document retention and destruction; and (2) implementation of measures to preserve potentially relevant documents

• An effective litigation hold protocol should do the following: (1) describe the circumstances that trigger the hold; (2) identify key players and responsibilities; (3) set forth the coverage and terms of the holds; (4) describe the procedures to implement the holds; and (5) have a methodology for documenting the activities undertaken

• Tension between “anticipation” for document holds and work product protection

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Collecting The Electronic Evidence

• Critical for international / FCPA investigations– Experience shows most evidence of bribery found in email and electronic

documents

• E-discovery is not paper discovery– Estimates that 93 percent of information generated today in electronic format– Estimates that 70 percent of corporate records now in electronic format

• Attributes which distinguish electronic discovery from traditional paper discovery

1. Volume and duplicability2. Persistence (ex. “delete” means “not used”)3. Metadata (ex. Authorship, creation and edit dates, etc.)4. Dispersion (ex. hard drives, laptops, network servers, floppy disks, backup tapes,

etc.) and searchability (ex. software programs mean no need to read everything)

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Some Issues With The Collection of Electronic Data

• Where can this electronic evidence be found?– Central email servers, backup tapes for those servers, laptop hard drives, etc.– Mobile phones? Other sources?

• Evidence of “deletions” may also be very probative• Need to employ expert forensic resources (ex. Deloitte,

PriceWaterhouse, etc.)– Or bring the expertise in-house– Either way, the costs can be significant

• Data privacy issues– A minefield in the EU and possibly elsewhere– Criminal penalties may apply to violations of employee privacy rights– Work with experts, including local counsel

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Conducting On-Site Employee Interviews

• In the FCPA context, usually preferable to conduct interviews in local market

– May even be more cost effective when planned well

• Better ability to gain sense of business and cultural environment at issue

• Employee witnesses may be more forthcoming on their home turf• Avoidance of automatic submission to jurisdiction in the United

States• Increases credibility of investigation overall, and for the DOJ and

SEC• Despite presence of U.S. counsel in the market, local counsel

should be retained– Local counsel can flag any local legal issues, investigative or substantive– Can assist with determinations of credibility, and language / translation issues

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Some Issues With Employee Interviews

• Never (almost) conduct witness interviews alone• Creating right setting particularly important in the international

context• At the beginning of each interview

– You represent the company; not the employee (reiterate w/ business card writing)– Emphasize “two-way street” of confidentiality – Emphasize no retaliation for participation in the interview

• Employee requests for presence of attorney or representative– Specific rules differ across international markets

• Counsel for employees?• Computer Associates risks

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Communication, Communication, Communication

• Effective internal and external communications are critical to minimizing disruptions

• Some of the necessary internal communications– The business (including human resources, finance, etc.)– Business lawyers– Compliance-related functions– Colleagues involved in the matter under investigation

• Some of the potentially necessary external communications– Outside auditors– Audit Committee– U.S. and local press and public– U.S. and local regulators, prosecutors, etc.

• What else?

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What To Do With The Findings? Voluntary Disclosure?

• U.S. Department of Justice (Holder and Thompson Memos)– In determining whether to charge, prosecutors should consider the corporation’s:

(1) timely and voluntary disclosure of wrongdoing; and (2) willingness to cooperate (ex. identify wrongdoers; make witnesses available, and disclose results of investigation)

– With McNulty Memo, privileged materials only to be sought in “rare circumstances”

• Dep’t of HHS, Office of the Inspector General Model Guidance– Where the company believes any law has been broken, the conduct should be

“promptly” reported to state and federal authorities (and no later than 60 days later)

• SEC / 2001 Seaboard Report• When should the disclosure be made?

– Want to understand the situation (accurate and complete disclosure)– But still want to get credit for timeliness

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