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Pfizer Compliance

Pfizer Compliance

Pfizer's Compliance Program represents a shared undertaking on the part of colleagues ranging from the highest levels of management to the most junior employees. Our training programs and organizational structures have been developed to go beyond compliance. All colleagues are expected to take ownership of compliance and to perform all tasks with integrity. We continuously scrutinize our internal practices and have put into place procedures for taking immediate action when we identify potential violations. We offer a Compliance Helpline, an Open Door Policy and anti-retaliation protections. 

Colleagues at Pfizer have an additional resource for addressing and resolving work-related concerns – Pfizer’s Office of the Ombudsman.

Our Compliance Program incorporates the elements in accordance with the "Compliance Program Guidance for Pharmaceutical Manufacturers" ("OIG Guidance") developed by the United States Department of Health and Human Services, Office of Inspector General ("OIG"). Click below for a brief description of each element.

Written Policies and Procedures

In the United States, some of the policies that provide our colleagues with guidance around their conduct of day–to–day operations include the following:

Pfizer's Summary of Policies on Business Conduct "The Blue Book"
The Blue Book is Pfizer's code of business conduct for all colleagues.

The Orange Guide (The Field Guide)

Policies & Procedures: Health Care Law Compliance Guide (The White Guide).

Policies & Procedures: FCPA and Anti-Corruption

Pfizer has international anti-bribery and anti-corruption policies and procedures that cover, among other things, colleagues’ interactions with government officials and non-U.S. healthcare professionals, as well as third parties that provide goods or services to Pfizer. These policies and procedures are reinforced through anti-corruption training and tested through periodic auditing and monitoring. Where appropriate, third parties are required to undergo anti-corruption due diligence, monitoring and auditing, follow Pfizer’s internal anti-bribery and anti-corruption policies and procedures, receive anti-corruption training and/or abide by Pfizer’s International Anti-Bribery and Anti-Corruption Business Principles. Translations available here.

Chief Compliance and Risk Officer and Compliance Committees

Rady Johnson serves as the Company's Chief Compliance and Risk Officer and is responsible for overseeing Pfizer's global compliance program. In this capacity, Mr. Johnson reports directly to the CEO and makes regular reports to the Audit Committee and the Regulatory & Compliance Committee of the Board of Directors. Mr. Johnson heads the Compliance Division, which is responsible for administering all aspects of the Compliance Program, including training programs and monitoring systems, developing informational resources, and investigating potential violations of law or Company policy. Mr. Johnson also chairs the Corporate Compliance Committee, which is made up of senior leaders from across the Company and is a member of the Executive Compliance Committee, which oversees and supports Pfizer's efforts to ensure that its business is conducted appropriately in every country in which it operates around the world.

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Effective Training and Education

Pfizer is committed to providing effective training to employees, managers, officers, and directors on the Compliance Program. Training resources include online compliance education, as well as online access to policies, including the Blue Book, the Orange Guide and the White Guide.

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Effective Lines of Communication

Pfizer provides multiple channels for reporting general issues and raising compliance concerns. The Company has Open Door, anti–retaliation, and confidentiality policies to encourage and protect colleagues who raise a valid concern.

Open Door Policy
Pfizer adheres to an "Open Door Policy," and encourages colleagues to discuss all issues, concerns, problems and suggestions with their immediate supervisors or other managers without fear of retaliation and with the assurance that the matter will be kept as confidential as possible.

Compliance Direct
At Pfizer, colleagues can contact the Compliance Division directly in any of the following ways:

Compliance Helpline
Where available and permitted by law, Pfizer's Compliance Helpline allows colleagues to report a concern or to get information or advice anonymously. Where available, the Compliance Helpline can be reached by phone or online via the web–reporting tool. This resource is accessible 24 hours a day, 7 days a week, 365 days a year and is offered in 70 languages. The Compliance Helpline is operated by specially trained third–party representatives:

  • Compliance Helpline Number* (U.S. and Puerto Rico): 1.866.866.PFIZ (7349)

    *The Compliance Helpline numbers for Pfizer locations outside the U.S. and Puerto Rico can be provided upon request.

  • Compliance Helpline Web–Reporting Tool https://pfizer.alertline.com

Communication to Management About Compliance Issues
The Compliance Division communicates with management about compliance matters. The development and implementation of compliance policy benefit substantially when colleagues at all management levels are engaged.

Communication to the Audit Committee of the Board of Directors, the Regulatory and Compliance Committee of the Board of Directors, and the Full Board of Directors
Communication with the Audit Committee of the Board of Directors, the Regulatory and Compliance Committee of the Board of Directors, and the full Board is part of an effective compliance program. Members of the Board and its Audit and Regulatory and Compliance Committees are readily accessible to management and the Compliance Division.

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Internal Monitoring and Auditing

Internal monitoring and auditing are vital parts of the Compliance Program. Monitoring and auditing business processes does more than simply verify their thorough and efficient operation. Effective monitoring and auditing can provide an organization with the capacity to detect and prevent deviations that, in certain circumstances, can potentially engender compliance concerns. The Corporate Internal Audit team maintains responsibility for auditing the policies and procedures of the Compliance Program.

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Enforcement Through Discipline Pursuant to Published Guidelines

Our Compliance Guidance documents (e.g., Blue Book, Orange Guide and White Guide) educate colleagues about our company's commitment to compliance. The Guidance documents put all colleagues, including management, on notice that failure to adhere to our compliance standards may have disciplinary consequences, up to and including termination of employment. If an investigation suggests that discipline may be warranted, appropriate action is taken.

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Prompt Response and Corrective Action for Detected Problems

Our compliance program supports prompt response and corrective action for detected problems as appropriate under the circumstances. It is expected that compliance concerns referred through any of the many communication channels (personal contact, email, Compliance Helpline, etc.) will be carefully reviewed, thoroughly and thoughtfully investigated in a timely manner, and appropriately resolved.

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If you are a Health Care Professional with additional questions about Global Multi—Product Settlement with the U.S. Federal and State Governments Announced on September 2, 2009 or wish to report any instances in which you believe that a Pfizer representative inappropriately promoted a product or engaged in other questionable conduct, please call 866-490-2633.

Pfizer Policies on Interactions with Health Care Professionals In California and Declaration of Compliance

Policies that regulate Pfizer colleagues' interactions with health care professionals in the United States reflect our commitment to compliance with applicable federal and state laws and regulations. We review and revise our policies as we deem appropriate to meet the requirements of a highly regulated and complex health care environment. California SB 1765 (California Business & Professions Code 119400, 119402) requires pharmaceutical companies to set an annual aggregate limit on certain promotional expenditures provided to a medical or health care professional as defined under the statute.

The statute excludes from covered promotional expenditures such items as drug samples given to medical or health care professionals intended for free distribution to patients, financial support for continuing medical education forums, financial support for health educational scholarships, and payments made at fair market value for legitimate professional services provided by health care professionals.

In light of California SB 1765, Pfizer has modified certain policies and procedures that regulate interactions with covered medical and health care professionals in the State of California. Pfizer has set a specific annual dollar limit on gifts, promotional materials, and items or activities that we may give or otherwise provide to an individual medical or health care professional as defined under the statute.

Subject to this law, Pfizer has determined that the annual aggregate limit on covered promotional expenditures is set at $3,500 per covered medical or health care professional for annual periods commencing on May 1, 2008. This limit may be revised by Pfizer from time to time. The foregoing limit does not represent a usual, customary, average or typical amount for medical or health care professionals.

This annual aggregate limit is based on an estimate of the maximum value of gifts, promotional materials and other items or activities as defined herein that a medical or health care professional may receive in one year. In setting this limit, we have taken into account the size of the Company and the size of its product portfolio. Pfizer is the largest pharmaceutical company in the United States with the largest field force.

The Company markets more than 20 products, many of which are prescribed by the same base of primary care physicians. This often requires multiple interactions with the same physician to provide appropriate information on our products. Our sales force has been advised and will be reminded that this limit applies to covered medical or health care professionals in California. We do not believe it applies to medical or health care professionals practicing in other states. Each category of items or activities that are included in the annual aggregate limit — gifts, promotional materials, and other items or activities — is discussed separately below.

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Gifts

The PhRMA Code allows pharmaceutical companies to provide "items primarily for the education of patients or health care professionals if the items are not of substantial value ($100 or less) and do not have value to health care professionals outside of his or her professional responsibilities," as long as "they are not offered or provided in a manner or on conditions that would interfere with the independence of a health care professional's prescribing practices." Our annual aggregate limit on certain promotion-related expenditures excludes the provision of items permissible under the PhRMA Code as being of minimal value (less than a $25 retail value) and primarily for the education of patients or health care professionals.

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Promotional Materials

Neither California SB 1765, nor the PhRMA Code, nor the OIG Guidance defines "promotional materials." For purposes of this statute, Pfizer interprets that promotional materials are not materials that, under the PhRMA Code, form the basis of our interactions with medical and health care professionals. Accordingly, Pfizer does not include in its definition of "promotional materials," documents and information that inform medical or health care professionals about Pfizer products, provide scientific and educational data, or support medical research and education.

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Other Items or Activities

California SB 1765 also subjects to the per-medical or health care professional annual aggregate limit all other "items or activities that the pharmaceutical company may give or otherwise provide to an individual medical or health care professional in accordance with the OIG Guidance and with the PhRMA Code." We include, among other items in this category, the retail cost of meals provided to covered medical or health care professionals in connection with educational presentations. Historically, Pfizer has not limited attendance at these educational events. The per-medical or health care professional annual aggregate limit on certain promotional expenditures reflects Pfizer's commitment to responsible education and reasonable facilitation of attendance at educational programs in California. To comply with California SB 1765, Pfizer will monitor and limit, if necessary, the number of educational presentations that covered medical or health care professionals may attend during the reporting period to ensure compliance with the annual aggregate limit.

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Pfizer Declaration of Compliance

In May, 2008, Pfizer amended the annual aggregate limit on covered promotional expenditures to $3,500 per covered medical or health care professional. Pfizer declares, in good faith, that for the reporting period commencing on May 1, 2011 and ending April 30, 2012, it is in substantial compliance with its Comprehensive Compliance Program and the requirements of California SB 1765. Our declaration is based upon an analysis of information available during the twelve (12) month period from May 1, 2011 through April 30, 2012. The next declaration will be based upon information captured beginning May 1, 2013 through April 30, 2014.

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Conclusion

We have embedded in the structure of our Corporate Compliance Program, and established in our guidelines for interactions with health care professionals, the principles articulated in the OIG Guidance and PhRMA Code. As appropriate, and consistent with the law, we will amend and update our policies, and this statement, to ensure compliance with the law. A description of Pfizer's Corporate Compliance Program, including the Company's written declaration and certification of compliance with California SB 1765, can be requested by calling the Compliance Division directly via telephone at (212) 733-3026, via Pfizer's Compliance Helpline number at (866) 866-7349 (PFIZ), or by emailing us at corporate.compliance@pfizer.com.

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Note: All policies are subject to regular monitoring and evaluation.

 

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