pfizer eli lilly case study
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Case study of accounting frauds at Pfizer Eli LillyTRANSCRIPT
PFIZER – FCPA ISSUES
(VARIOUS COUNTRIES)
IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA
U.S. SECURITIES AND EXCHANGE COMMISSION, 100 F Street, NE Washington, DC 20549,
Plaintiff,
-v-
PFIZER INC., 235 East 42nd Street New York, NY 10017,
Defendant.
COMPLAINT
Plaintiff, U.S. Securities and Exchange Commission (the “Commission”), alleges:
SUMMARY
1. This action arises from violations of the books and records and internal controls
provisions of the Foreign Corrupt Practices Act of 1977 (“the FCPA”) by Defendant Pfizer Inc.
(“Pfizer”), relating to improper payments made to foreign officials in numerous countries by the
employees and agents of Pfizer’s subsidiaries in order to assist Pfizer in obtaining or retaining
business.
2. At various times from at least 2001 through 2007, employees and agents of
subsidiaries of Pfizer, conducting business in Bulgaria, China, Croatia, Czech Republic, Italy,
Kazakhstan, Russia, and Serbia, engaged in transactions for the purpose of improperly
influencing foreign officials, including doctors and other healthcare professionals employed by
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foreign governments. These improper payments were variously made to influence regulatory
and formulary approvals, purchase decisions, prescription decisions, and to clear customs.
Employees in each of the involved subsidiaries attempted to conceal the true nature of the
transactions by improperly recording the transactions on the books and records of the respective
subsidiaries. Examples included falsely recording the payments as legitimate expenses for
promotional activities, marketing, training, travel and entertainment, clinical trials, freight,
conferences and advertising.
3. These improper payments were made without the knowledge or approval of
officers or employees of Pfizer, but the inaccurate books and records of Pfizer’s subsidiaries
were consolidated in the financial reports of Pfizer, and Pfizer failed to devise and maintain an
appropriate system of internal accounting controls.
4. As a result of this conduct, Pfizer violated Section 13(b)(2)(A) of the Securities
Exchange Act of 1934 (“Exchange Act”) by failing to make and keep books, records and
accounts, which, in reasonable detail, accurately and fairly reflect the transactions and
disposition of assets of the issuer. Additionally, by failing to ensure that it maintained adequate
internal controls to detect and prevent FCPA violations, Pfizer violated Section 13(b)(2)(B) of
the Exchange Act, as it failed to devise and maintain a system of internal accounting controls
sufficient to provide reasonable assurances that: (i) transactions are executed in accordance with
management’s general or specific authorization; (ii) transactions are recorded as necessary to
permit preparation of financial statements in conformity with generally accepted accounting
principles or any other criteria applicable to such statements; (iii) transactions are recorded as
necessary to maintain accountability for assets; and (iv) that access to assets is permitted only in
accordance with management’s general or specific authorization.
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5. Pfizer made an initial voluntary disclosure of certain of these issues to the
Commission and Department of Justice in October 2004, and thereafter diligently and thoroughly
undertook a global internal investigation of its operations in no less than 19 countries, which
identified additional potential violations, and regularly reported on the results of these
investigations and fully cooperated with the staff of the Commission. Pfizer also undertook a
comprehensive compliance review of its operations, enhanced its internal controls and
compliance functions, engaged in significant disciplinary measures, and developed and
implemented global FCPA compliance procedures, including the development and
implementation of innovative proactive procedures, and sophisticated supporting systems.
JURISDICTION AND VENUE
6. This Court has jurisdiction over this action pursuant to Sections 21(d), 21(e) and
27 of the Exchange Act [15 U.S.C. §§ 78u(d), 78u(e), and 78aa].
7. Venue in this District is proper pursuant to Section 27 of the Exchange Act [15
U.S.C. § 78aa] or 28 U.S.C. § 1391(d).
DEFENDANTS
8. Pfizer Inc. (“Pfizer”) is a global pharmaceutical company that discovers,
develops, manufactures and markets prescription medicines for humans and animals. Pfizer is
incorporated in the State of Delaware and is headquartered in New York, New York. Its
securities are registered with the Commission under Section 12(b) of the Exchange Act, and its
common stock trades on the New York Stock Exchange under the symbol “PFE.” Pfizer
conducts worldwide operations in over 180 countries, employing more than 100,000 people.
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OTHER RELEVANT ENTITIES
9. Pfizer Italia S.r.l. is an Italian limited liability company and indirect wholly-
owned subsidiary of Pfizer.
10. Pfizer Investment Co. LTD is a Chinese company and indirect majority-owned
subsidiary of Pfizer.
11. Pfizer spol. s.r.o. is a Czech company and indirect wholly-owned subsidiary of
Pfizer.
12. Pfizer H.C.P. Corporation (“Pfizer HCP”) is a New York Corporation and an
indirect wholly-owned subsidiary of Pfizer. During the relevant period, Pfizer HCP operated in
several international markets through representative offices, including offices in Bulgaria,
Croatia, Kazakhstan and Serbia, as well as through contracts with Russian distributors and
employees of its parent company who worked in a Pfizer representative office in Moscow.
13. Pharmacia Corporation (“Pharmacia”) was a multinational pharmaceutical
company acquired by Pfizer on April 16, 2003 in a stock-for-stock transaction. Its international
operations were combined with Pfizer’s, including operations in Russia, Kazakhstan, Bulgaria,
Serbia and Croatia, which were thereafter restructured and incorporated into Pfizer HCP.
FACTUAL ALLEGATIONS
14. The manufacture, registration, distribution, sale, and prescription of
pharmaceuticals are highly-regulated activities throughout the world. While there are
multinational regulatory schemes, it is typical that each country establishes its own regulatory
structure at a local, regional, and/or national level. These regulatory structures generally require
the registration of pharmaceuticals and regulate labeling and advertising. Additionally, in certain
countries the government establishes lists of pharmaceuticals that are approved for government
reimbursement or otherwise determines those pharmaceuticals that may be purchased by
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government institutions. Moreover, countries often regulate the interactions between
pharmaceutical companies and hospitals, pharmacies, and healthcare professionals.
15. In those countries with national healthcare systems, hospitals, clinics, pharmacies,
doctors, and other healthcare professionals and institutions are generally government officials or
instrumentalities within the meaning of the FCPA.
16. During the relevant period, for the purpose of improperly influencing foreign
officials in connection with regulatory and formulary approvals, purchase decisions, prescription
decisions, and customs clearance, employees of Pfizer’s subsidiaries made and authorized the
making of payments of cash and the provision of other things of value both directly and through
third parties. Funds for these payments were often generated by the subsidiaries’ employees
through the use of collusive vendors, such as travel agents or restaurants, to create fraudulent
invoices.
A. Pfizer HCP Bulgaria
17. During the relevant period, Pfizer products were marketed in the Republic of
Bulgaria through a representative office of Pfizer HCP (“Pfizer HCP Bulgaria”).
18. From 1999 and continuing into 2005, Pfizer HCP Bulgaria, through its employees
and agents in Bulgaria, paid for domestic and international travel and provided equipment to
government-employed doctors. These payments were intended to influence these government
officials to prescribe Pfizer products.
19. Between 1999 and 2003, Pfizer HCP Bulgaria organized “Incentive Trips” to
destinations in Greece that were attended by Pfizer HCP Bulgaria sales representatives and
Bulgarian healthcare providers. Incentive Trips typically lasted three days and included both
educational training and hospitality and entertainment. Pfizer HCP Bulgaria sales
representatives were instructed to reach agreements with doctors on the specific quantities of
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Pfizer pharmaceuticals they would prescribe in return for participation in these events. Pfizer
HCP Bulgaria employees also offered to support doctors’ travel to medical conferences in
exchange for promises to use Pfizer’s products.
20. Pfizer HCP Bulgaria employees took steps to conceal the true nature of these
transactions by inaccurately recording the transactions as payments for educational or charitable
support.
B. Pfizer China
21. During the relevant period, Pfizer’s pharmaceutical products were promoted in
the People’s Republic of China by Pfizer’s subsidiary based in Beijing, Pfizer Investment Co.
LTD (“Pfizer China”).
22. From at least 2003 through 2007, Pfizer China, through its employees and agents,
provided cash payments, hospitality, gifts, and support for international travel to doctors
employed by Chinese government healthcare institutions. The payments of cash and other things
of value were intended to influence these government officials to prescribe Pfizer products,
provide hospital formulary listing, and otherwise use their influence to grant Pfizer China an
unfair advantage.
23. Pfizer China employees provided these improper payments in recognition of past
product sales or prescriptions, as incentives to prescribe or purchase Pfizer products in the future,
or upon the basis of Pfizer China employees’ assessments of the doctors’ potential prescribing
levels.
24. To facilitate the payment of rewards and incentives, Pfizer China employees
organized meetings with Chinese government doctors that were marketed as “clubs” or “high-
prescribing doctors” programs. Invitations to such events were provided to doctors in
recognition of past product sales or prescriptions, or as incentives to prescribe or purchase Pfizer
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products in the future. In some cases, meeting agendas included only minimal professional
content and extensive recreational and entertainment activities.
25. Pfizer China also created various “point programs,” under which government
doctors could accumulate points based upon the number of Pfizer prescriptions they had written.
The points could be redeemed for various gifts, some of which were related to the practice of
medicine (e.g., medical books), but others that were gifts of a personal nature (e.g., cell phones,
tea sets, and reading glasses).
26. Pfizer China employees offered and provided financial and other support for
Chinese doctors to attend domestic and international conferences in return for explicit
agreements to prescribe, purchase, or recommend Pfizer products. For example, in March 2006,
a Pfizer China marketing manager explained to his regional sales manager that Pfizer China
would only offer to support travel to a conference in Australia for two doctors if they promised
to “use no less than 4,200 injections a year” and to prescribe a Pfizer product to “more than
80%” of their patients.
27. Pfizer China employees also offered and provided small cash payments in order to
influence doctors to prescribe Pfizer products. These payments were directly linked to the
volume of Pfizer products prescribed by those doctors.
28. Pfizer China employees took steps to conceal the true nature of the cash
payments, gifts, and travel support made to Chinese government doctors by failing to accurately
record the transactions.
C. Pfizer HCP Croatia
29. During the relevant period, Pfizer products were marketed in the Republic of
Croatia through a representative office of Pfizer HCP (“Pfizer HCP Croatia”). Prior to the 2003
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merger with Pfizer, Pharmacia also operated a representative office in Croatia (“Pharmacia
Croatia”).
30. From at least 1997 and continuing to late 2004, Pfizer HCP Croatia, Pharmacia
Croatia, and their employees and agents in Croatia made payments and provided benefits to
doctors employed by the Croatian government. The payments of cash and other things of value
were intended to influence these government officials to prescribe Pharmacia and Pfizer products
and to provide regulatory approvals for Pharmacia and Pfizer products.
31. From February 1997 until May 2003, Pharmacia Croatia made monthly payments
of approximately $1,200 per month to the Austrian bank account of a doctor who served as a
member of several Croatian government committees that oversaw the registration and
reimbursement of pharmaceutical products. A memorandum prepared in April 1997 by a senior
Pharmacia Croatia manager stated that the Croatian doctor was expected to ensure that all of
Pharmacia’s products were approved for registration and reimbursement by the relevant
committees and noted that “as he is a member of the Registration Committee regarding
pharmaceuticals, I do expect that all products which are to be registered, will pass the regular
procedure by his assistance. . . . He is a person of great influence in Croatia in the area of
pharmaceuticals, and his opinion is respected very much; that’s the reason he is so important to
us.”
32. Pharmacia Croatia continued to make the payments to the Croatian doctor until
the Pharmacia/Pfizer merger in early 2003. After the merger, Pfizer HCP Croatia made three
separate payments in or around April, May, and July 2003. During this period, the committees
on which the doctor served approved three Pfizer products. No further payments were made to
the doctor after July 2003.
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33. Pharmacia Croatia also made payments and provided benefits under a “Bonus
Program” to Croatian doctors who were employed in senior positions in Croatian government
healthcare institutions. Under the Bonus Program, once a doctor agreed to use Pharmacia’s
products, a percentage of the value of Pharmacia products purchased by a doctor’s institution
would be given back to the doctor in the form of cash payments, international travel support,
donations of durable goods, or free products.
34. Although Pfizer HCP Croatia ended the majority of the Bonus Program payments
after the 2003 merger, it permitted the program to continue with respect to one Pharmacia
product until 2005. For example, a Pfizer HCP Croatia sales representative wrote to her manager
in early 2004 recommending that Pfizer enter into bonus agreements “tied to specific sales” and
explaining that she had entered into a bonus agreement with a senior doctor in the past and that
“the increase in sales of [a Pharmacia product] was immediately evident.” Based on this
recommendation, Pfizer HCP Croatia authorized the employee to enter into an unwritten 12%
bonus agreement with the doctor, paid the expenses and hotel accommodations of the doctor and
his colleagues to attend a conference in Lisbon, and purchased a television that was to be used in
the doctor’s office.
35. Pfizer HCP Croatia employees took steps to conceal the true nature of these
transactions and failed to accurately record these transactions by falsely booking them as
“Conventions,” “Gifts,” and “Professional Services – Non Consultant” expenses, among other
false and misleading descriptions.
D. Pfizer Czech
36. During the relevant period, in the Czech Republic, Pfizer’s pharmaceutical
products were marketed and sold through Pfizer’s subsidiary, Pfizer spol. s.r.o. (“Pfizer Czech”).
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37. From at least 2003 and through 2004, Pfizer Czech, through its employees and
agents, provided support for international travel and recreational opportunities to doctors
employed by the Czech government with the intent to influence these government officials to
prescribe Pfizer products.
38. For example, in October 2004, Pfizer Czech paid for a group of Czech
government-employed doctors and pharmacists to visit a Pfizer manufacturing facility in Perth,
Australia. In connection with the site visit, Pfizer Czech provided sightseeing opportunities for
the government doctors, including layovers in Hong Kong, visits to Australian landmarks, and
additional free time in Australia at the end of the program. At least one of the attending doctors
participated in meetings of a committee that advises the Czech Ministry of Health on drug
reimbursement issues.
39. Similarly, from 2003 through 2004, Pfizer Czech organized and sponsored
approximately 10 “educational weekends” that approximately 920 healthcare professionals
attended, including doctors employed by the Czech government. The events were held at resort
destinations, including ski resorts in Austria and Slovakia, usually over a three-day period. The
events typically included skiing or other recreational activities for the majority of the weekend,
and had little legitimate promotional or educational content.
40. Pfizer Czech employees took steps to conceal the true nature of these transactions,
and failed to accurately record these transactions by falsely booking them as “Conventions and
Trade Meeting,” among other false and misleading descriptions.
E. Pfizer Italy
41. During the relevant period, Pfizer products were marketed and sold in the
Republic of Italy through Pfizer’s subsidiary, Pfizer Italia S.r.l (“Pfizer Italy”).
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42. From at least 2001 and continuing through early 2004, Pfizer Italy provided,
directly or through vendors, cash payments, gifts, support for domestic and international travel,
and other benefits to doctors employed by Italian government healthcare institutions. The
payments of cash and other things of value were intended to influence these government officials
to prescribe Pfizer products.
43. For example, from at least 1996 through 2003, Pfizer Italy engaged third parties
to run observational studies conducted by doctors employed by Italian government healthcare
institutions, purportedly to obtain research and marketing information from Italian doctors. In
reality, many of the “observational studies” lacked scientific value and were instead designed to
improperly influence Italian government doctors to prescribe Pfizer products. Medical personnel
were not solely responsible for selecting the doctors to participate, but instead, Pfizer Italy sales
personnel selected doctors to participate based on the doctors’ agreement to prescribe Pfizer
products at specific levels. The Pfizer sales personnel directed cash payments, gifts and other
benefits to the doctors, and monitored the performance of the doctors to ensure that the agreed-
upon prescription levels were met.
44. From at least 2000 to 2003, Pfizer Italy employees also made direct cash
payments (ostensibly honoraria and lecture fees), provided goods (e.g., televisions, monitors,
mobile telephones, photocopiers, printers), and improper travel sponsorship (e.g., “weekend in
European capital,” “weekend in Gallipoli,” “weekend with companion,” “weekend in Rome”) in
return for promises by doctors to recommend or prescribe Pfizer’s products.
45. Pfizer Italy employees took steps to conceal the true nature of these transactions
and failed to accurately record these transactions by falsely booking them as “Marketing
Expenses,” “Professional Training,” and “Advertising in Scientific Journals,” among other false
and misleading descriptions.
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F. Pfizer HCP Kazakhstan
46. During the relevant period, Pfizer products were marketed in the Republic of
Kazakhstan through a representative office of Pfizer HCP (“Pfizer HCP Kazakhstan”).
47. In 2000, Pfizer HCP Kazakhstan applied to the Kazakh government for approval
of the registration of a Pfizer product for sale in Kazakhstan. At about the same time, two
representatives of Company A, a Kazakh company, approached Pfizer’s Regional Manager for
the Central Asia and Caucasus region at a pharmaceuticals conference in Tashkent, Uzbekistan
and requested an exclusive distributorship of the Pfizer product. When the Regional Manager
informed Company A’s representatives that Pfizer policy prohibited exclusive arrangements, the
representatives stated that if Company A did not receive the exclusive distributorship, Pfizer
HCP Kazakhstan would be unable to sell the Pfizer product in Kazakhstan.
48. Following this meeting, Pfizer HCP Kazakhstan experienced substantial difficulty
obtaining approval of its registration, including receiving numerous requests for additional
documentation and clinical trial data. Despite Pfizer HCP Kazakhstan’s compliance with these
requests, the Kazakh government did not grant approval. The Regional Manager explained the
situation to his supervisor and indicated in contemporaneous internal correspondence that he
believed that Company A was associated with senior Kazakh government officials.
49. Company A subsequently contacted the Regional Manager and again demanded
an exclusive distributorship. In May 2000, Pfizer HCP Kazakhstan executed a written
distribution agreement for the Pfizer product with Company A, and the Regional Manager
verbally agreed with Company A that this relationship would be exclusive. Pfizer HCP
Kazakhstan and Company A later entered into two other distribution agreements.
50. Pfizer HCP Kazakhstan granted Company A the distributorship in order to
improperly obtain approval for the registration of the Pfizer product in Kazakhstan. Soon after
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the May 2000 agreement was reached, the Kazakh government approved a three-year registration
for the Pfizer product.
51. During the period in which Company A had an exclusive arrangement for the
Pfizer product, sales were lower than projected. As a result, in early 2003, Pfizer HCP
Kazakhstan, without objection from Company A, terminated the exclusive relationship and
entered into agreements with two other distributors.
52. In September 2003, Pfizer HCP Kazakhstan was required to renew its registration
for the Pfizer product with the Kazakh government, and Pfizer HCP Kazakhstan again
encountered difficulties obtaining approval. Company A again offered to help and sought an
exclusive distributorship. Pfizer HCP Kazakhstan did not grant Company A an exclusive
distributorship in 2003, but did sign an additional contract and maintained a non-exclusive
distributor relationship through mid-2005 believing that some of the profits from Company A
would be provided to senior Kazakh government officials for their assistance in obtaining
registration.
53. The Kazakh government approved the renewal of the registration for the Pfizer
product for sale in Kazakhstan near in time to when Pfizer HCP Kazakhstan signed the
additional contract with Company A.
G. Pfizer Russia
54. During the relevant period, in the Russian Federation, Pfizer’s pharmaceutical
products were imported and distributed by Russian wholesalers who contracted directly with
Pfizer HCP, and were marketed by employees of a Pfizer representative office located in
Moscow (“Pfizer Russia”). Prior to its acquisition, Pharmacia also operated a representative
office in Russia (“Pharmacia Russia”).
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55. From at least 2000 and through 2005, Pfizer Russia, through its employees and
agents, provided cash payments, gifts, support for domestic and international travel, and
donations to doctors employed by the Russian government and other government officials. The
payments of cash and other benefits were intended to obtain regulatory approvals relating to
Pfizer products, to avoid delays and penalties associated with the importation of certain Pfizer
products, and to influence the doctors to prescribe Pfizer products.
“Hospital Program” Payments
56. From as early as the mid-1990s through 2005, Pfizer Russia engaged in a sales
initiative referred to as the “Hospital Program.” Under this program, Pfizer Russia employees
were permitted to provide payments to hospitals of 5% of the value of certain Pfizer products
purchased by the hospitals as price discounts or in-kind benefits to hospitals for their purchases.
In practice, some Hospital Program payments were made directly to or for the benefit of
individual Russian doctors to reward past purchases and prescriptions and induce future
purchases and prescriptions of Pfizer products.
57. In addition to direct payments, Pfizer Russia also made Hospital Program
payments through intermediary companies. In some cases the intermediary companies were
identified by the recipient doctors, and in other cases they were selected by Pfizer Russia
employees.
58. Employees of Pfizer Russia obtained cash for the Hospital Program payments
with the assistance of collusive vendors who provided the cash to Pfizer Russia employees after
receiving payment on the basis of false invoices. Pfizer Russia employees would then use the
cash to make payments to doctors to reward past purchases and prescriptions and induce future
purchases and prescriptions of Pfizer products.
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59. The then-finance director of Pfizer Russia established two account codes in the
company’s General Ledger and instructed employees to book all their Hospital Program
payments to this account, including improper payments. From in or around December 2003
through 2005, Pfizer Russia booked approximately $820,000 in transactions to the two Hospital
Program account codes.
Distributor Discount Payments
60. A number of Pfizer Russia’s distributors made cash payments, referred to as
“discounts,” to hospital administrators responsible for hospital purchasing decisions. These
payments were used to reward past purchases and induce future purchases.
61. For example, in an email dated November 24, 2005, Pfizer Russia employees
discussed the calculation of a “basic discount” of approximately $1,652, which was reportedly
made by the distributor by providing cash in an envelope to a government doctor at the hospital
in order to reward past purchases and induce future purchases.
Improper Travel
62. Pfizer Russia employees sought to use conference attendance or travel to
influence the inclusion of Pfizer products in tenders or on formulary lists, and to induce
healthcare providers to prescribe or purchase Pfizer products.
63. For example, on or about November 19, 2003 in an invoice cover letter, a Pfizer
Russia employee requested “payment for the (motivational) trip of [the First Deputy Minister of
Health] for the inclusion of [a Pfizer product] into the list . . . of medications refundable by the
state” in order to influence the First Deputy Minister of Health to add the Pfizer product to the
regional formulary list.
64. Similarly, on or about December 2, 2004, a Pfizer Russia employee requested
sponsorship for a Moscow Department of Health employee who was assisting the chief
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pharmacologist of a regional pediatric hospital in compiling algorithms for antibiotic therapy,
and who wanted “to be financially compensated” for this work. The Pfizer Russia employee
noted that, “in return for this,” the pharmacologist “will include our products in the treatment
algorithms.” The treatment algorithms by the pharmacologist, a government official, constituted
the official government-recommended treatment.
65. Another example is an email dated June 27, 2005, in which a Pfizer Russia
employee noted that a government doctor “should be assigned the task of stretching the amount
of the purchases . . . to US $100 thousand” as an “obligation” in exchange for a trip to a
conference in the Netherlands or Germany. Subsequently, on or about September 14, 2005, a
Pfizer Russia employee emailed that an “agreement on cooperation” had been reached with the
government doctor, and that Pfizer Russia’s requirements were the “purchase quantities,” and the
doctor’s requirement was “a trip to a conference.”
66. On or about September 8, 2003, a Pfizer Russia employee emailed colleagues
regarding the request by a government doctor for sponsorship to attend a conference and noted
that he “has pledged to prescribe at least 20 packs of [a Pfizer product] per month, and 20 packs
[of another Pfizer product].”
Customs Related Payments
67. During the relevant period, Russian Federation customs officials would not clear
pharmaceutical products for importation unless the importer provided an official certification
indicating that the products conformed to the specific terms of the product registration and
packaging requirements filed by the manufacturer with the Ministry of Health. The Russian
government licensed a private certification company (the “Certification Center”) to perform this
governmental function, which performed inspections and furnished the necessary certificates.
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68. In the spring of 2005, Pfizer Russia began to experience increasing difficulty in
obtaining the necessary certificates because the Pfizer products did not conform to the precise
terms of the product registration and packaging requirements filed with the Ministry of Health.
69. On or about September or October 2005, a Certification Center employee
proposed that the Certification Center would overlook the non-compliance of Pfizer Russia’s
products in exchange for monthly payments of approximately $3,000. With the approval of the
then-Pfizer Russia Country Manager, between October and December 2005 Pfizer Russia made
payments of over $13,000 through an intermediary company, which then forwarded the
payments to a company Pfizer Russia employees believed to be controlled by the Certification
Center’s employees.
70. The customs clearing problems ceased after Pfizer Russia started making
payments, but they resumed when Pfizer Russia stopped the payments in 2006 after Pfizer began
a Corporate Compliance review in Russia.
Use of Intermediaries to Make Payments
71. Pfizer Russia also used third-party intermediaries to make improper payments
intended to increase the sales of pharmaceuticals. This practice was known to and approved by
senior leadership in Pfizer Russia, including the Country Manager and the Finance Director.
72. For example, on or about April 7, 2004, a Pfizer Russia employee requested that a
payment be made to a public official from Samara “who took an active part in getting [a Pfizer
product] into the bidding.” This request was supported by two invoice cover letters. The first
was dated March 9, 2004, for 100,000 rubles (approximately $3,800) for “payment for the
service of [an employee of the State Department of Samara Healthcare] for the purchase of [a
Pfizer product]” in the Samara Region. The second invoice cover letter was dated April 16,
2004, for a payment of approximately $4,500 for “hospital program for purchase of [a Pfizer
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product] . . . to civil servant [] of health service of Samara,” but was directed to an intermediary
company used by Pfizer Russia to make improper payments to public officials.
73. In or about October 2005, Pfizer Russia employees discussed how a regional
distributor would provide Pfizer Russia with companies that have “neutral names,” to which
Pfizer Russia could make improper payments that would be booked as conferences to provide
benefits to doctors.
Offshore Payments of Sales Discounts
74. Pfizer Russia, through its employees and agents, continued and expanded a
Pharmacia Russia practice of paying sales discounts owed to Russian distributors into offshore
bank accounts. At least as early as 1999, Pharmacia Russia had entered into arrangements with
one of its distributors by which sales discounts owed the distributor were paid into accounts of
the distributor’s shell companies located in Latvia and Cyprus.
75. Pfizer Russia continued the practice of making payments to the distributor’s
Cyprus shell company following the 2003 merger with Pharmacia. In 2003 and 2004, Pfizer
Russia management entered into similar arrangements for the benefit of two other Russian
distributors that had set up shell companies in Canada and Hungary for this purpose.
76. Pfizer Russia’s management attempted to hide the true nature of the relationship
with the Cyprus distributor from Pfizer HCP’s regional management located in Germany. In
2003 and 2004, when regional managers questioned the Cyprus payments, Pfizer Russia’s
Country Manager claimed that the shell companies actually were providing lobbying services
necessary to “gain access” to the Russian public sector tender market.
77. Pfizer HCP’s regional management did not verify that the Country Manager’s
explanation was accurate, nor did they follow up to understand how a third-party intermediary
being paid outside Russia could lawfully help Pfizer Russia “gain access” to Russian government
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tenders. The practice continued through early 2005, when it was ended unilaterally by Pfizer
Russia (prior to Pfizer’s commencement of an internal investigation in the market).
78. Pfizer Russia employees took steps to conceal the true nature of these various
improper transactions, and failed to accurately record these transactions by booking them as
“Travel and Entertainment,” “Convention and Trade Meetings,” “Conferences,” “Distribution
Freight,” and “Clinical Grants/Clinical Trials,” among other false and misleading descriptions.
H. Pfizer HCP Serbia
79. During the relevant period, Pfizer products were marketed in the Republic of
Serbia and Montenegro through a representative office of Pfizer HCP (“Pfizer HCP Serbia”).
80. Pfizer HCP Serbia, through one of its sales representatives, paid for a government
employed doctor to attend a conference in Chile in exchange for the doctor’s agreement to
increase his department’s purchases of Pfizer products. Although Pfizer HCP Serbia
management discovered the improper agreement and terminated the responsible sales
representative, it still provided the support after the doctor threatened to spread negative
information about Pfizer’s reputation as a company.
I. Accounting and Internal Controls
81. As described above, four Pfizer subsidiaries engaged in transactions in eight
countries which were intended to improperly influence foreign government officials in
connection with regulatory and formulary approvals, purchase decisions, prescription decisions,
and customs clearance. Through the four subsidiaries, Pfizer earned aggregate profits of
$16,032,676 as a result of these improper transactions.
82. As described above, during the relevant period the Pfizer subsidiaries recorded
transactions associated with the improper payments in a manner that did not accurately reflect
their true nature and purpose. The false entries in the subsidiaries’ books and records were
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consolidated into the books and records of Pfizer, which reported the results of its subsidiaries’
operations in its consolidated financial statements.
83. As described above, during the relevant period Pfizer failed to devise and
maintain an effective system of internal controls sufficient to prevent or detect the above-
described conduct.
J. Remedial Efforts
84. Pfizer has taken extensive remedial actions including: undertaking a
comprehensive worldwide review of its compliance program; implementing enhanced anti-
corruption compliance policies and procedures on a worldwide basis; developing global systems
to support employee compliance with the enhanced procedures; adding FCPA-specific reviews
to its internal audits; performing innovative and proactive anti-corruption compliance reviews in
approximately 10 markets annually; and conducting comprehensive anti-corruption training
throughout the organization.
CLAIM FOR RELIEF
(Company Books and Records and Internal Controls)
85. Paragraphs 1 through 84 are realleged and incorporated herein by reference.
86. Section 13(b)(2)(A) of the Exchange Act requires issuers to make and keep
books, records, and accounts, which, in reasonable detail, accurately and fairly reflect the
transactions and dispositions of their assets.
87. Section 13(b)(2)(B) of the Exchange Act requires issuers to devise and maintain a
system of internal accounting controls sufficient to provide reasonable assurances that
transactions are executed in accordance with management’s general or specific authorization;
transactions are recorded as necessary to permit preparation of financial statements in conformity
ELI LILLY – FCPA ISSUES
(RUSSIA)
Lilly-Brazil negotiated the amount of the discount with the distributor based on the distributor's
anticipated sale. The discount to the distributors generally ranged between 6.5% and 15%, with
the majority of distributors in Brazil receiving a 1 0% discount.
23. In early 2007, at the request of one of Lilly-Brazil's sales and marketing
managers at the time, Lilly-Brazil granted a nationwide pharmaceutical distributor, unusually
large discounts of 17% and 19% for two of the distributor's purchases of a Lilly drug, which the
distributor then sold to the government of one of the Brazilian states. Lilly-Brazil's pricing
committee approved the discounts without further inquiry. The policies and procedures in place
to flag unusual distributor discounts were deficient. They relied on the representations of the
sales and marketing manager without adequate verification and analysis of the surrounding
circumstances of the transactions. In May 2007, Lilly sold 3,200 milligrams of the drug to the
distributor for resale to the Brazilian state; in August 2007, Lilly-Brazil sold 13,500 milligrams
of the drug to the distributor for resale to the Brazilian state. Together the sales were valued at
approximately $1.2 million.
24. The distributor used approximately 6% of the purchase price (approximately
$70,000) to bribe government officials from the Brazilian state so that the state would purchase
the Lilly product. The Lilly-Brazil sales and marketing manager who requested the discount
knew about this arrangement.
Russia
25. From 1994 through 2005, Lilly-Vostok, a wholly-owned subsidiary of Lilly, sold
pharmaceutical products either directly to government entities in the former Soviet Union or
through various distributors, often selected by the government, who would then resell the
products to the government entities. Along with the underlying purchase contract with the
9
Case 1:12-cv-02045 Document 1 Filed 12/20/12 Page 9 of 20
government entity or distributor, Lilly-Vostok sometimes entered into another agreement with a
third-party selected by a government official or by the government-chosen pharmaceutical
distributor. Generally, these third-parties, which had addresses and bank accounts located
outside of Russia, were paid a flat fee or a percentage of the sale. These agreements were
referred to as "marketing" or "service" agreements. In total, Lilly-Vostok entered into over 96
such agreements with over 42 third-party entities between 1994 and 2004.
26. Lilly-Vostok had little information about these third-party entities, beyond their
addresses and bank accounts. Rarely did Lilly-Vostok know who owned them or whether the
entities were actual businesses that could provide legitimate services. Senior management
employees in Lilly-Vostok's Moscow branch assisted in the negotiation of these agreements.
The contracts themselves were derived from a Lilly-Vostok-created template and enumerated
various broadly-defined services, such as ensuring "immediate customs clearance" or
"immediate delivery" of the products; or assisting Lilly-Vostok in "obtaining payment for the
sales transaction," "the promotion of the products," and "marketing research."
27. Contrary to what was recorded in the company's books and records, there is little
evidence that any services were actually provided under any of these third-party agreements.
Indeed, in many instances, the "services" identified in the contract were already being provided
by the distributor, a third-party handler (such as an international shipping handler) or Lilly itself.
To the extent services such as expedited customs clearance or other services requiring interaction
with government officials were provided, Lilly-Vostok did not know or inquire how the third
party intended to perform their services.
28. Contemporaneous documents reflect that Lilly-Vostok employees viewed the
payments as necessary to obtain the business from the distributor or government entity, and not
10
Case 1:12-cv-02045 Document 1 Filed 12/20/12 Page 10 of 20
as payment for legitimate services. For example, in November 1994, a senior manager at Lilly
Vostok emailed the commercial manager, the employee tasked with drafting and approving the
language of the agreements, that the "standard Marketing Agreement [is] where the [service
provider] delivers the service of getting this [purchase] contract for us .... " In August 1999, the
commercial manager emailed senior managers that "if real services are provided the marketing
agreement is not the appropriate form." In other documents, Lilly-Vostok employees referred to
the payments as "discounts" or "commissions" to the distributor or government purchaser.
29. In 1997, Lilly conducted a business review of Lilly-Vostok to identify business
risks and assess the subsidiary's policies and procedures which resulted in a report. The report,
which was sent to Lilly-Vostok offices in Geneva and to Lilly headquarters in Indianapolis,
noted that "[b]usiness ethics [in Russia] are low" and that "[a] large base of opportunistic
entrepreneurs, lacking national presence build the distribution network." The report concluded
that "[t]he nature and complexity of customers require that 'consultants' be used to 'support'
activities, leading to agreement signing" (quotation marks in the original). The report pointed
out that the services provided by these consultants were broadly defined and duplicated activities
usually performed by Lilly-Vostok's Russian staff, and that documentation of the services
received was not available. The report recommended that Lilly-Vostok modify its internal
controls to ensure that the services were documented and Lilly-Vostok was getting "value."
30. In 1999, Lilly again reviewed Lilly-Vostok's operations, including its use of
marketing agreements and concluded that they raised concerns. A second report, which was sent
to Geneva and Indianapolis headquarters and distributed to, among others, the individuals who at
that time were Lilly's Chief Financial Officer, President of Lilly International Operations and
General Auditor, stated that:
11
Case 1:12-cv-02045 Document 1 Filed 12/20/12 Page 11 of 20
Attention has been given to contain external unethical pressures through guidelines and training. The use of marketing agreements with thirdparties has been tightened; agreements substance and permanent education program continue to require effort and refinements.
31. Regarding the agreements, the second report concluded that the "[ n ]eed exists to
call on third-parties to create sales potential." It recommended that Lilly-Vostok modify its
internal controls to assure itself that the agreements accurately and fairly reflect the services to
be provided.
32. Lilly did not curtail the use of marketing agreements by its subsidiary or make
any meaningful efforts to ensure that the marketing agreements were not being used as a method
to funnel money to government officials, despite recognition that the marketing agreements were
being used to "create sales potential" or "to 'support' activities leading to agreement-signing"
with government entities. In fact, during the 2000-2004 period -- after the above-described
reports, but prior to the company ending use of the agreements-- Lilly-Vostok entered into the
three most expensive of these arrangements.
33. For example, in 2002, the Russian Ministry of Health announced that it would
engage in a "federal tender" in which it would purchase drugs for the treatment of diabetes to be
provided free of charge to patients by the government. Under the terms of the tender, the
ministry selected a large Russian pharmaceutical distributor from which to purchase the
products, and this distributor, in tum, negotiated with Lilly-Vostok for the purchase of diabetes
products for resale to the Ministry of Health.
34. The large Russian pharmaceutical distributor was owned and controlled by a
wealthy and prominent Russian businessman. The Russian pharmaceutical distributor required
Lilly-Vostok, as a condition of their agreement, to enter into a "Storage and Delivery
Agreement" with an entity incorporated in Cyprus. In July 2002, Lilly-Vostok executed the
12
Case 1:12-cv-02045 Document 1 Filed 12/20/12 Page 12 of 20
purchase agreement with the distributor, which was signed on the distributor's behalfby its
chairman, the promine~t Russian businessman. At approximately the same time, Lilly-Vostok
also entered into the "Storage and Delivery Agreement" with the entity in Cyprus.
35. Lilly's due diligence regarding the entity in Cyprus was limited to ordering a Dun
and Bradstreet report and conducting a search using an internet service to scan publicly available
information. Neither the Dun and Bradstreet report nor the internet search revealed the Cyprus
entity's beneficial owner or anything about its business. Nonetheless, pursuant to the terms of its
arrangement with the distributor, Lilly-Vostok paid the entity in Cyprus over $3.8 million in
early 2003.
36. The Cyprus entity was, in fact, owned by the Russian businessman who was the
owner of the distributor. There is no evidence of services provided to Lilly-Vostok by the
Cyprus entity in consideration for Lilly-Vostok's $3.8 million in payments. Lilly's books and
records improperly reflected these payments as payments for services.
37. In at least two instances, the arrangements involved foreign government officials.
Between 2000 and 2005, Lilly-Vostok sold significant amounts of pharmaceutical products to a
major Russian pharmaceutical distributor for resale to the Russian Ministry of Health. The
pharmaceutical distributor was owned and controlled by an individual who, at the beginning of
the distributor's relationship with Lilly-Vostok, was a close adviser to a member of Russia's
Parliament. In 2003, this official became a member of the upper house of Russia's Parliament.
Throughout the period, this official exercised considerable influence over government decisions
relating to the pharmaceutical industry in Russia.
38. As part of most of the sales arrangements with the distributor, the official
demanded that Lilly-Vostok enter into separate "marketing" agreements with entities with
13
Case 1:12-cv-02045 Document 1 Filed 12/20/12 Page 13 of 20
addresses and bank accounts in Cyprus. Under the arrangement, Lilly-Vostok paid the Cypriot
entities up to thirty percent of the sales price of the underlying sales contracts in return for the
Cypriot entities entering into an agreement "to offer all assistance necessary" in various areas
like storage, importation and payment.
39. In conjunction with outside counsel, Lilly-Vostok conducted limited due diligence
on these third-parties. However, the due diligence did not identify the beneficial owners of these
third-parties or determine whether the third-parties were able to provide the contracted-for
assistance. Nonetheless, Lilly-Vostok concluded that it could proceed with the transactions and
paid the Cypriot entities over $5.2 million. In fact, the Cypriot entities were owned by an
individual associated with the distributor controlled by the member of the upper house of Russia
Parliament. The Cypriot entity transferred the payments from Lilly-Vostok to other off-shore
entities.
40. In connection with another series of contracts, from 2000 through 2004, Lilly-
Vostok sold products to a distributor, headquartered in Moscow, which was wholly-owned by a
Russian government entity. The purchase agreements were signed on the government-owned
distributor's behalf by its General Director. As part of the arrangement, the government-owned
distributor selected a third-party entity with an address in the British Virgin Islands ("the BVI
entity") with which Lilly-Vostok entered into agreements for the broadly defined
"services" enumerated in the Lilly-Vostok template (see above). Under the terms of the
agreements between Lilly-Vostok and the BVI entity, Lilly-Vostok was to pay the BVI entity up
to 15% of the price of the product purchased by the government-owned distributor. Accordingly,
from 2000 through 2005, Lilly-Vostok made approximately 65 payments to the BVI entity
totaling approximately $2 million.
14
Case 1:12-cv-02045 Document 1 Filed 12/20/12 Page 14 of 20
41. There is no evidence that the BVI entity performed any of the services listed in its
agreement with Lilly-Vostok. There is also no evidence that Lilly-Vostok performed any due
diligence or inquiry as to whether the BVI entity was able or did perform the contracted-for
services. Lastly, there is no evidence that Lilly-Vostok performed any due diligence or inquiry
into the identity of the beneficial owner of the BVI entity. In fact, the beneficial owner of the
BVI entity was the General Director of the government-owned distributor, and he ulimately
received the payments from the BVI entity.
42. Lilly did not direct Lilly-Vostok to cease entering into these third-party
agreements until 2004. However, Lilly permitted the subsidiary to continue making payments
under already existing third-party contracts as late as 2005.
43. From 2005 through 2008, Lilly-Vostok made various proposals to government
officials in Russia regarding how Lilly-Vostok could donate to or otherwise support various
initiatives that were affiliated with public or private institutions headed by the government
officials or otherwise important to the government officials. Examples included their personal
participation or the participation of people from their institutions in clinical trials and
international and regional conferences and the support of charities and educational events
associated with the institutes. At times, these proposals to government officials were made in a
communication that also included a request for assistance in getting a product reimbursed or
purchased by the government. Generally, Lilly-Vostok personnel believed these proposals were
proper because of their relevance to public health issues and many of the proposals were
reviewed by counsel. Nonetheless, Lilly-Vostok did not have in place internal controls through
which such proposals were vetted to ascertain whether Lilly-Vostok was offering something of
15
Case 1:12-cv-02045 Document 1 Filed 12/20/12 Page 15 of 20
value to a government official for a purpose of influencing or inducing him or her to assist Lilly
Vostok in obtaining or retaining business.
Lilly's Books and Records
44. As detailed above, subsidiaries of Eli Lilly made numerous payments that were
incorrectly described in the company's books and records. In China, payments were falsely
described as reimbursement of expenses when, in fact, the money was used to provide gifts to
government-employed physicians. In Brazil, money that was described in company records as a
"discount" for a pharmaceutical distributor was, in actuality, a bribe for government officials. In
Poland, payments classified as charitable donations were not intended for a genuine charitable
purpose but rather to induce a government official to assent to the purchase of a Lilly product.
Finally, in Russia, millions of dollars in payments, described in the company's books and records
as for various services, were actually payments to assure that Lilly was able to conduct business
with certain pharmaceutical distributors.
Lilly's Internal Controls
45. During the relevant period, Lilly and its subsidiaries failed to devise and maintain
an adequate system of internal accounting sufficient to provide reasonable assurance that the
company maintained accountability for its assets and transactions were executed in accordance
with management's authorization. Particularly, Lilly did not adequately verify that
intermediaries with which the company was doing government-related business would not
provide a benefit to a government official on Lilly's behalf in order to obtain or retain business.
Lilly and its subsidiaries primarily relied on assurances and information provided in the
paperwork by these intermediaries or by Lilly personnel rather than engaging in adequate
verification and analyzing the surrounding circumstances of the transaction. Lilly and its
16
Case 1:12-cv-02045 Document 1 Filed 12/20/12 Page 16 of 20
PFIZER – FCPA COMPLIANCE
PROGRAM IMPROVEMENTS
t
In order to address any deficiencies in its internal controls, policies, and procedures
regarding compliance with the Foreign Corrupt Practices Act ("FCPA"), 15 U.S.C. §§ 78dd-1, et
seq., and other applicable anti-corruption laws, Pfizer Inc. and its subsidiaries and operating
companies (collectively, "Pfizer") agree to continue to conduct appropriate reviews of its
existing internal controls, policies, and procedures.
Where necessary and appropriate, Pfizer agrees to adopt new or to modify existing
internal controls, policies, and procedures in order to ensure that it maintains: (a) a system of
internal accotulting controls designed to ensure that Pfizer makes and keeps fair and accurate
books, records, and accounts; and (b) rigorous anti-corruption compliance code, standards, and
procedures -designed to detect and deter violations of the FCPA and other applicable anti-
corruption laws. At a minimum, this should include, but not be Limited to, the following
elements:
A clearly articulated corporate policy against violations of the FCPA,
including its anti-bribery, books and records, and internal controls provisions, and other
applicable counterparts (collectively, the "anti-corruption laws");
2. Promulgation of compliance standards and procedures designed to reduce
the prospect of violations of the anti-corruption laws and Pfizer's compliance code. These
standards and procedures shall apply to all directors, officers, and employees and, where
necessary and appropriate, outside parties while acting on behalf of Pfizer in a foreign
jurisdiction, including but not limited to, agents, consultants, representatives, distributors,
teaming partners, and joint venture partners (collectively, "agents and business partners");
:~~
The assignii~ent of responsibility to one or more senior corporate
executives of Pfizer for the implementation and oversight of compliance with policies, standards,
and procedures regarding the anti-corruption laws. Such corporate officials) shall have the
authority to report matters directly to Pfizer's Board of Directors or any appropriate committee
of the Board of Directors;
4. Mechanisms designed to ensure that the policies, standards, and
procedures of Pfizer regarding the anti-corruption laws are effectively communicated to all
directors, officers, employees, and, where appropriate, agents and business partners. These
mechanisms shall include: (a) periodic training for all directors, officers, and employees, and,
where necessary and appropriate, agents and business partners; and (b) accompanying
certifications by all such directors, officers, and employees, and, where necessary and
appropriate, agents, and business partners, certifying compliance with the training requirements;
An effective system for reporting suspected crimuial conduct and/or
violations of the compliance policies, standards, and procedures regarding the anti-con-uption
laws for directors, officers, employees, and, where necessary and appropriate, agents and
business partners;
6. Appropriate disciplinary procedures to address,. among other things,
violations of the anti-corruption laws and Pfizer's compliance code by Pfizer's directors,
officers, and employees;
7. Appropriate due diligence requirements pertaining to the retention and
oversight of agents and business partners;
Standard provisions in agreements, contracts, and renewals thereof with
all agents and business partners that are reasonably calculated to prevent violations of the anti-
comtption laws, which may, depending upon the circumstances, include: (a) anti-corruption
C.1-2
representations and undertakings relating to compliance with the anti-corruption laws; (U) rights
to conduct audits of the books and records of the agent or business partner to ensiue complialice
with the foregoing; and (c) rights to terminate an agent or business partner as a result of ally
breach of anti-con~uption laws, and regulations or representations and undertakings related to
such matters; and
9. Periodic testing of the compliance code, standards, and procedures
designed to evaluate their effectiveness in detecting and reducing violations of anti-corruption
laws and Pfizer's compliance code.
C.1-3
ATT'r~CI-~l~~I~1~' C.2
In addition to and building upon the commitments enumerated in Attachment C.1, Pfizer
Inc. and its subsidiaries acid operating companies (collectively, "Pfizer") agree that they have
taken or will undertake the following, at a minimum, for the duration of the Deferred Prosecution
Agreement between the United States Department of Justice, Criminal Division, Fraud Section
(the "Department") and Pfizer H.C.P. Corporation dated ~'
General
Pfizer will:
a. Maintain the appointment of a senior corporate executive with significant
experience with compliance with the FCPA, including its anti-bribery, books and
records, and internal controls provisions, as well as other applicable anti-
corruption laws and regulations (hereinafter "anti-corruption laws and
regulations") to serve as Chief Compliance and Risk Officer. The Chief
Compliance and Risk Officer will have reporting obligations directly to the Chief
Executive Officer and periodic reporting obligations to the Audit Committee of
the Board of Directors.
b. Maintain the appointment of heads of compliance with responsibility for each of
its business units ("BU Compliance Leads") who have reporting obligations
through the Chief Compliance and Risk Officer or General Counsel.
c. Establish and maintain an "Executive Compliance Committee" to oversee Pfizer's
corporate compliance program with respect to both the laws and regulations
applicable to Pfizer's business and to Pfizer's Code of Conduct and related
C2-1
policies. The Executive Compliance Committee is chaired by the Chief Executive
Officer, and includes appropriate senior leaders, such as the Chief Financial
Officer, the General Counsel and senior leaders from compliance, finance, audit,
human resources and Pfizer's business units.
2. Pfizer has and will maintain gifts, hospitality, and travel policies and procedures in each
jurisdiction that are appropriately designed to prevent violations of the anti-corruption
laws and regulations. ,Specifically, Pfizer has implemented and will maintain the
following enhanced anti-con-uption policies and procedures:
a. A Global Anti-Bribery and Anti-Corruption Corporate Policy and an International
Anti-Bribery and Anti-Corruption Procedure (the "FCPA Procedure"), which are
supported by implementing standard operating procedures by market, region or
function as appropriate; and which provide detailed procedures for employees to
follow when interacting with foreign government officials and conducting FCPA
due diligence on consultants, technical advisors, researchers and grant recipients
and, where appropriate, in commercial transactions with "agents and business
partners" (as defined in Attachment C.1). The FCPA Procedure establishes
procedures and specific limi±s governing the provision by Pfizer's employees of
gifts, hospitality, international travel and site visits, meeting support, educational
grants, charitable donations, and consulting fees, speaker fees, honoraria, and the
like to foreign government officials. All of these procedures are in the local
language when appropriate.
b. A Global Policy on Interactions with Healthcare Professionals which is supported
by implementing standard operating procedures by market, region or function, as
appropriate, establishing ethical standards and procedures for Pfizer employees to
C.2-2
follow when interacting with physicians, nurses, and other such human healthcare
professionals, including standards related to product samples, support for
conferences, and practice-related items.
c. At a minimum, these policies and procedures shall contain the following
restrictions regarding foreign government officials, including but not limited to
public health care providers, administrators, and regulators:
Gifts must be modest in value, appropriate under the circumstances, and
given in accordance with anti-comtption laws and regulations, including
those of the government official's home country;
ii. Hospitality shall be limited to reasonably priced meals, accommodations,
and incidental expenses that are part of product education and gaining
programs, professional training, and conferences or business meetings;
iii. Travel shall be limited to product education and training programs,
professional training and education, and conferences or business meetings;
and
iv. Gifts, hospitality, and travel shall not include expenses for anyone other
than the relevant officials, unless different standards are required by local
law or regulation.
C'omplaint~, I2epoa~ts, and C'o~apliance Issues
Pfizer has committed and will continue the commitment of significantly enhanced
resources for the international functions of the Compliance Division that have reporting
obligations through the Chief Compliance and Risk Officer or General Counsel,
including the following:
C.2-3
a. An international investigations group charged with responding to and
investigating anti-corruption compliance issues reported on a global basis acid
ensuring that appropriate remedial measures are undertaken after the completion
of an investigation;
b. An anti-corruption program office providing centralized assistance and guidance
regarding the implementation, updating and revising of the FCPA Procedure, the
establishment of systems to enhance compliance with the FCPA Procedure, and
the administration of corporate-level training and annual anti-corruption
certifications; and
c. A mergers and acquisitions compliance function designed to support early
identification of compliance risks associated with complex business transactions
and to ensure the integration of Pfizer's compliance procedures into newly
acquired entities.
4. Pfizer shall maintain its mechanisms for making and handling reports and complaints
related to potential violations of anti-corruption laws and regulations, including, when
appropriate, referral for review and response by internal audit, finance, legal, compliance
and other personnel as appropriate, and will ensure that reasonable access is provided to
an anonymous, toll-free hotline as well as to an anonymous electronic complaint form,
where anonymous reporting is legally permissible.
5. Pfizer, through its Executive Compliance Committee, ~~ill ensure that the Compliance
and Legal Divisions review and respond to FCPA and corruption issues promptly and
consistently.
C.2 - 4
disk 14ssess~a~erzt~ and ~r oactive Reviews
6. Pfizer has conducted and will continue to conduct arisk-based program of amlual
proactive anti-corruption reviews of high-risk markets. These FCPA proactive reviews
are designed to identify anti-corruption con7pliance issues, examine compliance
procedures and controls as implemented in the field and identify best practices to be
implemented in additional markets. On the basis of those assessments, as needed, Pfizer
will modify compliance implementation to minimize risks observed through the FCPA
proactive review process.
7. Specifically, Pfizer will identify markets which are at high risk for con-uption because of
their business and location, and will select at least five of those markets to receive FCPA
proactive reviews during that year. High risk markets shall be identified based on
Pfizer's risk assessment process in consultation with the Chief Compliance and Risk
Officer, taking into account multiple risk factors including, but not limited to: a high
degree of interaction with foreign government officials; the existence of internal reports
of potential corruption risk; a high corruption risk based on certain corruption indexes;
and financial audit results. Each FCPA proactive review shall include, at a minimum:
a. On-site visits by an FCPA review team comprised of qualified personnel from the
Compliance and, when appropriate, Legal Divisions who have received FCPA
and anti-corruption training;
b. Where appropriate, participation in the on-site visits by qualified auditors;
c. Review of a representative sample, appropriately adjusted for the risks of the
market, of contracts with and payments to individual foreign government officials
or health care providers, as well as other high-risk transactions in the market;
C.2-5
d. Creation of action plans resulting from issues identified during FCPA proactive
reviews; these action plans will be shared with appropriate senior management,
including when appropriate the Chief Compliance and Risk Officer, and will
contain mandatory remedial steps designed to enhance anti-corruption
compliance, repair process weaknesses, and deter violations; and
e. Where appropriate, feasible, and permissible under local law, review of the books
and records of a sample of distributors which, in the view of the FCPA proactive
review team, may present corruption risk.
8. Pfizer has implemented and will continue to implement an FCPA trend analysis that
requires various operational functions to track and review certain categories of
interactions with foreign government officials and due diligence on agents and business
partners.
~4cquisitions
Pfizer has ensured and will continue to ensure that, when practicable and appropriate on
the basis of a FCPA risk assessment, new business entities are only acquired after
thorough risk-based FCPA and anti-corruption due diligence was conducted by a suitable
combination of legal, accounting, and compliance personnel. When such anti-corruption
due diligence is appropriate but not practicable prior to acquisition of a new business for
reasons beyond Pfizer's control, or due to any applicable law, rule, or regulation, Pfizer
has conducted and will conduct anti-corruption due diligence subsequent to the
acquisition and report to the Department any corrupt payments or falsified books and
records as required by Attachment C.3.
C.2-6
I0. Pfizer will ensure that Pfizer's policies, standards and procedures regarding anti-
con~uption laws and regulations apply as quickly as is practicable, but in any event no
more than one year post-closing, to newly-acquired businesses, and will promptly:
a. Train directors, officers, and senior managers, and those employees working in
positions involving activities covered by Pfizer's policies regarding
anti-corruption and compliance with the FCPA, and, where necessary and
appropriate, agents and business partners; and
b. Include all newly-acquired businesses in Pfizer's regular anti-corruption auditing
schedule.
I~elatioreshzps with 7'Izird Pa~Pies
11. When appropriate on the basis of a FCPA risk assessment, Pfizer will conduct risk-based
due diligence of sales intermediaries, including agents, consultants, representatives,
dis~-ibutors, and joint venture partners. Such due diligence will be conducted prior to the
retention of any new agent, consultant, representative, distributor, or joint venture partner
and.for all such sales intermediaries will be updated no less than once every three years.
At a minimum, such due diligence shall include:
a. A review of the qualifications and business reputation of the sales intermediaries;
b. A rationale for the use of the sales intermediary; and
A review of relevant FCPA risk areas.
12. Where due diligence of a sales intermediary raises a serious red flag, the relevant
information shall be reviewed by personnel from the compliance or legal divisions who
have received FCPA and anti-corruption training.
13. Where necessary and appropriate and where permitted by applicable law, Pfizer has
included and will include standard provisions designed to prevent vialations of the FCPA
C.2-7
and other applicable anti-corruption laws and regulations in agreements, contacts, and
renewals thereof with.agents and business partners, including:
a. Anti-corruption representations and undertakings relating to compliance with the
anti-corruption laws and regulations;
b. Rights to conduct audits of the books and records of the agent or business partner
that are related to their business with Pfizer; and
c. Rights to terminate the agent or business partner as a result of any breach of anti-
corruption laws and regulations or representations and undertakings related to
such anti-corruption laws and regulations.
T`Yainin~
14. Pfizer has provided and shall provide:
a. Biennial training on anti-corruption laws and regulations to directors, officers,
executives, and employees working in positions involving activities covered by
Pfizer's policies regarding anti-corruption and compliance with the FCPA;
b. Enhanced FCPA training for all internal audit, financial, compliance and legal
personnel involved in FCPA proactive reviews or anti-corruption due diligence
related to the potential acquisition of new businesses, if not already qualified and
experienced; and
c. When appropriate on the basis of a FCPA risk assessment, provide FCPA and
anti-corruption training to relevant agents and business partners, at least once
every three years.
15. Pfizer has implemented and shall maintain a system of annual certifications from senior
managers in each of Pfizer's Business Units, Divisions, and operational functions (at the
market or regional level, or the reasonable equivalent) as appropriate, confirming that
C.2-8
their standard operating procedures adequately iinplenlent Pfizer's anti-corruption
policies, procedures and controls, including training requirements, that they have
reviewed and followed up on any issues identified in FCPA trend analyses, and that they
are not aware of any FCFA or other con-uption issues that have not already been reported
to the Compliance Division or the Legal Division.
C.2 - 9