COP Comprehensive Compliance Program
Sub-sections
1. Our Company
CONTENTS
Colgate Oral Pharmaceutical (COP) has been in the dental pharmaceutical
business for many years. It was formed in 1993 following a merger of three
other business acquisitions. It is headquartered in New York City. It has
helped in the advancement of dental science, increased the knowledge of
dental professionals, and improved the lives of many people through highly
innovative, better quality and safe oral care products.
2.

Produce and sell prescription,
in-office and specialty over-the-counter products

Detail Colgate professional and Colgate consumer products to the dental
profession

Be Colgate-Palmolive Company’s face to the dental profession
Our Mission
3.
Our Vision
Providing Lifelong Oral Health
4.
Our
Commitment
To Our
Consumers
COP has always strived to be a good corporate citizen, complying in good
faith with all laws and regulations governing its business. All through the
years of its operation, it has consistently dealt with its business partners, the
dental profession, the consumers, the government, and the society in
general, with integrity, openness and fairness. It stands on a solid reputation
for honesty and fair dealings with everybody.
5.
Introduction
This Compliance Program (“Program”) demonstrates COP’s continuing
commitment to conduct business ethically and lawfully and so preserve its
goodwill and further enhance its reputation as a truly responsible corporate
citizen. It operates in conjunction with the Colgate-Palmolive Company
Code of Conduct, and sets forth in a formal way the standards and principles
with which COP should deal with its stakeholders (e.g., business partners,
the dental healthcare profession, the consumers, its employees, stockholders,
and the government) and abide by laws and regulations affecting its
business. The Program will help ensure that COP remains true to its ideal of
doing business according to high standards of ethical corporate conduct.
The Program is designed to be consistent with the May 2003 publication
“Compliance Program Guidance for Pharmaceutical Manufacturers", which
was developed by the United States Department of Health and Human
Services Office of Inspector General ("OIG"). This Program also reflects the
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CONTENTS
guidelines laid out in the “Code on Interactions with Healthcare
Professionals” of the Pharmaceutical Research and Manufacturers of
America (“PhRMA”). This Program applies to everyone who works for
COP, including all officers, directors, and agents.
6.
By formally adopting this Program, COP will be able to continue to:
Program
Benefits
i)
demonstrate to its employees and all business stakeholders its
commitment to honest, fair and responsible corporate behavior
conducted in compliance with relevant state and federal laws;
ii)
identify and prevent possible unlawful and unethical conduct and
dealings;
iii)
take appropriate actions to correct improper conduct;
iv)
orient employees about the need to immediately report potential
problems and about the reporting mechanism therefore, allowing for a
timely investigation and remedial action; and avoid or minimize
financial loss to the company and the government.
7.
Commitment
of Company
Leadership
The COP Board of Directors and the Management of COP have
unanimously approved the Program, expressed their full support to the
purposes for which it was formally adopted, and commit to provide needed
direction and resources for its dissemination to and better understanding by
all employees and, where appropriate, its business partners, and for its
successful implementation and continuing improvement.
i)
Compliance
Officer
Monitoring of the implementation of the Program shall be done by the COP
Compliance Officer, who is a key Senior Manager, with direct access to the
President, the Compliance Officer of its parent company, Colgate-Palmolive
Company (“Colgate”), all other members of Senior Management, and the
COP Legal Advisor. The COP Compliance Officer is vested with authority
to review documents and other information relevant to the compliance
activities and to effectuate change within the organization subject only to
established approval procedures where necessary.
The COP Compliance Officer is authorized to review all documents and
other information relevant to compliance activities, which should enable the
COP Compliance Officer to examine if COP’s interactions with government
programs, COP product purchasers, and dental healthcare professionals are
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in compliance with applicable federal and state laws and regulations and
relevant government health care program requirements. The COP
Compliance Officer is a member of the COP Compliance Committee and
has the following functions, among others:
i)
oversee and monitor the implementation of this Program;
ii)
report on a regular basis to COP’s President, the COP Compliance
Committee and the Colgate Compliance Officer on the progress of
implementation, and assist them in establishing methods to reduce
COP’s potential exposure to fraud and abuse;
iii)
periodically recommend and implement revisions to the Program and
COP policies and procedures, as appropriate, in light of changes in
COP’s needs and the requirements of applicable government laws and
regulations;
iv)
develop, coordinate and participate in a multi-faceted educational
seminar/training programs that focus on the elements of the Program;
v)
respond to questions concerning interpretation and implementation of
the Program;
vi)
coordinate with the Human Resources Department concerning the
conduct of compliance seminars/trainings, which should cover all
employees, and set the minimum number of additional educational
hours per year that marketing and sales employees must have as part of
their employment responsibilities;
vii) ensure that independent contractors and agents are aware of the
requirements of the Program with respect to sales and marketing
activities, among other things;
viii) coordinate personnel issues with the Human Resources to ensure that
COP does not hire or do business with individuals or entities that have
been excluded by the Office of Inspector General (OIG) from
participating in Federally-funded healthcare programs;
ix)
assist COP’s internal auditors in coordinating internal compliance
review and monitoring activities;
x)
review, and where appropriate, act in response to reports of
noncompliance received through COP’s Compliance Hotline, or
otherwise brought to the attention of the COP Compliance Officer;
xi)
independently investigate, along with the assistance of counsel or
outside consultants as needed, and act on matters related to
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compliance, and design and coordinate such investigation and the
resulting corrective action with other departments; and
xii)
participate with COP’s Legal Adviser in the appropriate reporting of
any self-discovered violations of federal healthcare program
requirements.
On a quarterly basis, and as often as necessary, the COP Compliance Officer
shall report to the COP Compliance Committee any implementation issue
relating to the Program and provide timely updates thereof.
ii)
Compliance
Committee
COP’s Senior Management team shall compose the COP Compliance
Committee, of which the COP Compliance Office is a member. The
Committee shall advise and assist the COP Compliance Officer in the
implementation of the Program. It shall meet quarterly to review reports and
updates on any implementation issue relating to the Program, set
compliance policies, and provide advice, direction and active support to the
COP Compliance Officer.
8.
Corporate
Business
Policies and
Practices
All of COP’s employees are mandated to faithfully comply with the
Program and with all laws and regulations governing the conduct of COP’s
business. Employee dealings on behalf of COP must always be conducted in
good faith and according to the dictates of high ethical standards.
i)
Code of
Conduct
COP adheres to and adopts as its own the Code of Conduct formulated by
Colgate. The Code of Conduct is provided to all employees of COP,
directors, officer, and agents. All personnel are required to read it and all
managers and key personnel must on a regular basis certify to their
compliance with it.
Any questions or doubts concerning the propriety of any act or application
of the Code should be referred to the COP Compliance Officer, a manager,
or the Hotline.
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CONTENTS
The Code of Conduct provides general principles on the following business
areas:
i)
Our Relationship with Each Other
ii)
Our Relationship with the Company
iii)
Our Relationship with the Board of Directors
iv)
Our Relationship with Outside Business Entities
v)
Our Relationship with Consumers
vi)
Our Relationship with Government and the Law
vii) Our Relationship with Society
viii) Our Relationship with the Environment
ix)
Our Relationship with Shareholders
x)
Responsibility for Compliance
The Colgate Code of Conduct may be found at ourColgate.com
ii)
Business
Practices
Guidelines
COP also strictly abides by and adopts as its own the Global Business
Practices Guidelines (“Guidelines”) of Colgate. The Guidelines is an
extension of the Code of Conduct and is intended to assist employees of
Colgate and those of its subsidiaries around the world in complying with
applicable laws and regulations affecting its business.
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CONTENTS
The Guidelines discuss in detail the following business policies:
i)
Guidelines of the U.S. Foreign Corrupt Practices Act
ii)
International Business Activities Guidelines
iii)
Guidelines on Business Relationships With U.S. Government Entities
- Political Activity and Contributions
- Customer Service and Contract Compliance
- Prohibited Expenditures
- Lobbying Government Entities
- Anti-Kickback Statute
- False Statements
- Obtaining Confidential Data
- Hiring Former and Current Government Employees
- Relationships with Distributors and Brokers
iv)
Guidelines on Conflict of Interests and Related Issues
v)
Guidelines on Securities Trading and Confidentiality of Information
vi)
U.S. Antitrust and Trade Regulation Guidelines
vii) Environmental, Occupational Health and Safety Policy Statement
viii) Product Safety Research Statement
ix)
Advertising Guidelines
x)
Advertising Policy Statement
xi)
Product Integrity Guidelines
xii) Guidelines on Government Investigations and Civil Litigation
xiii) Guidelines on Preserving Company Proprietary Information and
Respecting the Proprietary Information of Others
The Business Practice Guidelines may be found at ourColgate.com.
6
Sub-sections
iii) Policies On
Dealings
With Dental
Health Care
Professionals
CONTENTS
Dental healthcare professionals trust, use and recommend - COP products
for their reliability, safety and superior performance. These products are
made available to them through ethical and lawful marketing and selling
practices. COP has adopted the following additional ethical standards of
behavior concerning interactions with dental healthcare professionals and
their staff. Any doubts or questions concerning the propriety of an act or
dealing with these individuals or organizations should be referred promptly
to the COP Compliance Officer.
COP supports and adheres to the Code on Interactions with Healthcare
Professionals enacted by the Pharmaceutical Research Employees on July 1,
2002 (“PhRMA Code”). Thus, COP employees, including agents retained
and authorized to act on behalf of COP, who interact with dental healthcare
professionals, and those in COP who are involved in the review, adoption or
approval of policies and procedures concerning interactions with dental
healthcare professionals, are mandated to observe and comply with the
following additions to the COP Code of Conduct:
Interactions in General: COP’s interactions with dental healthcare
professionals are mainly for the purpose of providing them with scientific,
technical and educational information about dental science and proper oral
health care, supporting medical research and education for the benefit of
their patients and the public in general, and gathering feedback or providing
information about oral care products, their risks and benefits. COP
employees shall avoid interactions that might be viewed as being improper
by patients or the public in general. Interactions with healthcare
professionals shall be done only in places conducive to communication and
the transfer of scientific or educational information.
Entertainment: Generally, no entertainment or recreational activities may be
provided to dental healthcare professionals, even if in connection with an
educational or scientific presentation or discussion, unless pre-approved by
the Vice President & General Manager of COP. A meal of modest value
may be provided so long as it is given in conjunction with a legitimate
informational presentation or discussion made in a location conducive to an
effective communication of educational or scientific information; however,
providing even modest meals on more than an occasional basis would not be
appropriate. No entertainment, recreation, travel, meals, or other benefits
maybe provided to dental health care professionals for the purpose of
influencing them to prescribe or promote COP products.
Continuing Dental Education/Trainings/Scholarships: Financial assistance
for independent, continuing dental education or other carefully selected
scientific, educational or professional conferences and trainings,
scholarships or other similar educational support efforts intended to benefit
dentists, fellows, dental students or other healthcare professionals may be
offered provided that the assistance is given directly to the sponsor or
7
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organizer of the conference/training, or in the case of scholarships or
educational funds to the academic or training institution. Colgate does not
provide support for programs of individual dental practices. The
responsibility for the selection of content, faculty, educational methods,
materials and venue shall belong to the sponsor or organizer. In the case of
scholarships or similar educational support funds, the academic or training
institution shall be responsible for the selection of individuals who will
receive the funds. None of the above activities or funds shall be used to
channel improper benefits or remunerations to dental healthcare
professionals.
Promotional Educational Programs
COP may develop and offer scientific and educational conferences and
training, including in-person speaker programs, on-line training, or selfstudy materials, regarding the use of COP products and other areas of
therapeutic interest to COP. COP is responsible for the content of these
programs, which shall comply with applicable FDA requirements and be
approved via the Approval Team. These programs must not promote any
unapproved use or “off-label” use for a COP product. The duration and
venue for any such program, including on-line or self-study activities, must
be consistent with their educational and scientific focus. Participants shall
receive no compensation for participation.
Consultants: Dental health care consultants shall be engaged only for
legitimate and reasonable scientific or educational purposes and in the
appropriate, project-relevant number. Their services shall at all times be
covered by a written contract. They shall be compensated on the basis of
their expertise, their time and the value and type of their services, and not as
an inducement to prescribe or promote COP products. Payments to
consultants shall not exceed the fair market value of the services rendered.
The need for research services of consultants shall be determined by the
Research and Development Department. Consultants will be required to
adhere to the COP Code of Conduct while conducting business on behalf of
COP.
Educational and Dental Healthcare Practice Related-Items: COP employees
dealing with dental healthcare professionals must not in any way interfere
with the independent practice by the latter of their profession. Thus, it is
COP’s policy that no items tending to create that interference should be
given to dental healthcare professionals by any COP employee. COP may
provide items that benefit patients, but such items must be given only
occasionally, and must not be of substantial value (i.e., not exceeding US$
100). Items of minimal value may be offered provided they are primarily
related with the dental professional’s practice, such as pens, notepads, and
8
Sub-sections
CONTENTS
reminder items with the company logo. Gift, gratuities and other business
courtesies may not be given for the purpose of influencing dental health care
professionals to prescribe or promote COP products. All gifts, promotional
materials, and similar items must be part of an approved promotional
program or otherwise approved by the COP Compliance Officer or the COP
Legal Adviser.
Exhibits, Displays, and Event Sponsorship: Exhibits and displays at
hospital grand rounds, regional conferences and conventions, or meetings
are promotional activities. All general guidelines pertaining to promotion of
COP products also apply to the materials that may be distributed from an
exhibit or display and the type of promotional discussions that may occur.
Any fees used to pay for displays, exhibits, or event sponsorship must be
requested and approved per COP guidelines.
Samples Distribution/Management: Product samples are an important tool
of COP’s sales promotion program and are beneficial to patients. They shall
be clearly and conspicuously labeled not for sale. Sample recipients must be
informed in a meaningful manner that samples are not to be sold and are
solely for free use by their patients. They shall be distributed to as many
dental healthcare professionals as possible and only in reasonable quantities.
COP employees tasked with the distribution of COP samples, including
agents (if any) retained and authorized to act on behalf of COP, must be
familiar and strictly comply with the Prescription Drug Marketing Act of
1987 in the performance of their tasks. Any doubts concerning the propriety
of any act or dealing with the dental healthcare professionals relating to
distribution of COP samples should be referred to the Corporate Compliance
Officer.
A copy of the Prescription Drug Marketing Act of 1987 may be found at
www.access.gpo.gov/nara/cfr/waisdx_02/21cfr203_02.html
Product Promotion: All product promotion activities shall be undertaken in
a manner consistent with applicable state and federal laws. Personnel may
only use sales aids approved in accordance with COP standard operating
procedures, and must not directly or indirectly promote any unapproved or
off-label use of COP products.
State laws: Many states have implemented laws and regulations that further
regulate interactions with dental healthcare professionals and other persons
and organizations in a position to influence the use of COP products. Due
to the variability among states and the continual new developments in this
area, personnel should contact the COP Compliance Officer for the most
current information.
9
Sub-sections
iv) Spending
Limit
CONTENTS
COP has established a specific annual aggregate dollar limit of three
hundred US Dollars ($ 300) on gifts, promotional materials or items or
activities that COP may give or otherwise provide to an individual dental
healthcare professional in accordance with the Program. The annual
spending limit is not to be taken as an expense authorization for any COP
sales employee or agent. As with every COP cost incurrence, expenses
relating to healthcare professionals are subject to set approval policies and
procedures, and must also be consistent with this Program, the OIG’s
Guidance, and the PhRMA Code. Notwithstanding the above limit,
prescription drug samples given to dental healthcare professionals intended
for free distribution to patients, financial support for continuing medical
education forums, and financial support for health educational
scholarships, are exempt from the limit if provided in a manner conforming
to the OIG’s Guidance and the PhRMA Code. Payments made for legitimate
professional services provided by a healthcare professional, including
consulting, are likewise exempt from the limit provided such payments do
not exceed the fair market value of the services rendered and are given in
accordance with OIG’s Guidance and the PhRMA Code.
A copy of the PhRMA Code may be found at
http://www.phrma.org/code_on_interactions_with_healthcare_professionals/
v)
Policies on
Dealings
With
Government
relating to
Government
Healthcare
Programs
COP at times may transact with the government concerning reimbursements
to COP of purchases by patients who enjoy health benefits under certain
Federally-funded or State-funded healthcare programs. COP is committed to
comply fully with all applicable requirements of such Federal or State
healthcare programs in support of its claims and reported pricing data, and
shall take reasonable steps to ensure the completeness, accuracy, and
integrity of its generated data for government reimbursement purposes.
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Sub-sections
vi) Other Policies
and
Procedures
CONTENTS
From time to time, as the need arises, COP may adopt additional guidelines
for all personnel to follow in carrying out their respective functions. All
affected COP personnel will be furnished with a copy of such materials, to
which he/she must adhere to in good faith at all times.
9.
On at least an annual basis, the COP Compliance Officer shall evaluate the
compliance program and applicable policies and procedures. To the extent
necessary to improve the program as well as to ensure continuing
compliance by COP and its personnel with existing laws and regulations
affecting the business, the COP Compliance Officer shall recommend
appropriate revisions to the COP Compliance Committee. The COP
Compliance Committee shall make recommendations to the Colgate
Compliance Officer and the Colgate Compliance Officer in conjunction
with the Colgate Board of Directors is responsible for approving all changes
to the Program.
Conforming
Changes
10. Program
Dissemination
Key to a clear understanding by all concerned of the requirements of this
Program is their access to it. Thus, a printed copy of the Program shall be
provided to all COP employees and to persons or entities retained and
authorized by COP to act on its behalf in areas to which the Program is
applicable. It shall be made part of the detailing kit of every sales employee
dealing with dental healthcare professionals. A complete text of the Program
shall also be posted in bulletin boards within COP premises and will be
accessible on-line. A copy shall also be posted on Colgate’s website.
11. Training &
Education
COP shall provide to its employees ongoing training concerning this
Compliance Program, the laws and regulations that affect the company’s
business, and those policies and procedures the company has adopted to
ensure compliance.
All new employees of COP shall also be required to undergo appropriate
11
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compliance training.
The COP Compliance Officer shall coordinate with the Human Resources
Department on the scheduling of all compliance-related seminars/trainings
and shall document any such formal activities undertaken by COP. The
Human Resources Department shall retain adequate records of all
seminars/trainings of employees, including attendance logs, descriptions of
the seminar/training sessions, and copies of the materials distributed at
seminar/training sessions.
COP shall regularly review its compliance training program and where
appropriate, update the same to reflect issues identified through audits or
monitoring and any relevant changes in the government’s health care
program requirements.
12. Open-Door
Policy
COP has an open-door policy and encourages dialogue between
management and employees.
Employees are encouraged to raise questions concerning the Program, or
clarifications as to how it might apply to specific situations. Knowledge or
suspicion of any violation of the Program is required to be brought to the
attention of the Compliance Officer, or the employee’s supervisor, or the
Legal Department. Alternatively, employees should feel free to go to higher
levels of management. Questions or reports may be sent by e-mails, letters,
or discussed face-to-face, or the employee may also call directly the
Compliance Hotline. The COP Compliance Officer shall document such
questions and/or reports and the responses or results of investigations
conducted.
13. Compliance
Hotline
COP adopts as its own and available for use by its employees Colgate’s
Code of Conduct Hotline. It is a toll-free number which the employees can
use to report questions about the Program or the Code of Conduct or
violations thereof. The number is indicated in every employee’s copy of the
Code of Conduct, mentioned in the Colgate website, printed on wallet cards
and posted on bulletin boards. It is available 24 hours a day, 7 days a week
and can be accessed from all locations.
14. Investigation
and Corrective
Action
Any violation of the Code of Conduct, the Guidelines and this Program is
harmful to COP’s reputation and will be handled seriously. All reported
matters suggesting material violations of compliance policies or applicable
federal or state laws or regulations shall be documented and appropriately
investigated to determine their veracity and the scope and cause of any
underlying problem. Matters identified through routine audits also shall be
similarly evaluated and investigated. The COP Compliance Officer may
12
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work with appropriate internal departments as well as outside counsel and
consultants. Appropriate corrective action shall be taken in a timely
manner, which may include imposition of appropriate disciplinary measures
consistent with COP’s existing rules and regulations. The COP Compliance
Officer shall maintain a detailed log that records such reports, including the
nature of any investigation, its results, and any remedial or disciplinary
action taken. Such information, redacted of individual identifiers, shall be
summarized and included in reports to the Board of Directors, the President
and the Compliance Committee.
15. Confidentiality Employees may choose to submit information on an anonymous basis. All
and Nonreported violations shall be treated confidentially to the extent possible.
Retaliation
COP shall endeavor to keep the information confidential, but may need at
some point to disclose some or all of that information in order to conduct an
effective investigation and take appropriate action.
No retaliation or reprisal shall be made against any individual who in good
faith reports information concerning potential violations, or who participates
in any investigation or proceeding by COP or the government. Any
employee who retaliates against such individual, or harasses or threatens
him/her, shall himself/herself be subject to appropriate disciplinary action.
16. Compliance
Audit
The COP Compliance Officer shall be responsible for monitoring the
implementation of the Program and periodically reviewing existing COP
policies and procedures to determine their consistency with any changes in
existing government healthcare policies and requirements and industry
standards. Necessary monitoring and review tools shall be COP’s periodic
internal and external audits. The COP Compliance Officer shall see to it that
such audits incorporate audit procedures that will test or verify adequate
communication of the Program to all concerned individuals and their
faithful compliance with its requirements. The focus of such compliance
audits shall be those departments or groups that have substantial
involvement with or impact Federal or State healthcare programs (e.g.,
sales, marketing).
17. Audit
Documentatio
n and
Reporting
The COP Compliance Officer shall appropriately document Program
monitoring and review activities and ensure that both the internal and
external compliance audits are conducted periodically. The Colgate
Compliance Officer, COP Senior Management, and the COP Compliance
Committee shall be furnished copies of the COP Compliance Officer’s
report of his monitoring/review efforts and the internal and external audit
reports.
18. Sanctions for
Violations
Violations of the Program or of existing government rules and regulations
governing COP’s business shall be dealt with accordingly. Depending on
the results of appropriate investigation, sanctions could range from oral or
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written warning, to suspension or termination. The violator may even be
subject to penal prosecution.
19. Mandatory
Review
Every violation of the Program shall trigger an appropriate review by the
COP Compliance Officer of the violated component of the Program to
determine appropriate corrective measures or changes either in the Program
or in COP’s other existing policies and procedures.
COP’s Compliance Program may be viewed by its employees through the
Colgate intranet, or by outside parties through Colgate’s website,
www.colgateprofessional.com. Interested parties who would like to request
a hard copy of COP’s Compliance Program, or of its Annual Declaration of
Compliance may write to the address below or call this toll-free number: In
the US: 1-800-778-6080. Outside the US please call collect 212-310-2330.
COLGATE ORAL PHARMACEUTICAL
COP Compliance Officer
Office Address: 300 Park Avenue, New York, New York 10022
Phone: 212-310-2000
Fax: 212-310-2317
COP declares that, to the best of its knowledge, and based on a good faith understanding of the
statutory requirements of California Health and Safety Code sections 119400 and 119402, COP
has adopted a Comprehensive Compliance Program as mandated by this California law that is
applicable to COP’s operations and dealings with California dental health professionals. As of
the date of this declaration, COP believes it is in compliance with its COP Compliance Program
and California Health & Safety Code section 119400 and 119402 in all material respects, and is
not aware of any of any violations that have not been addressed or corrective action taken. COP
has made this declaration, in good faith, in the absence of clarifying regulations or guidance from
the State of California.
Copies of this declaration and the COP Comprehensive Compliance Program may be obtained
by calling in the US: 1-800-778-6080. Outside the US please call collect 212-310-2330.
Dated: June 30, 2006.
SF1 1434207v.2
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