Colgate Oral Pharmaceuticals (“COP”) is committed to conducting its business consistently with all applicable laws and the highest standards of business integrity. As required by California Health and Safety Code § 119402, COP has established a Compliance Program to ensure adherence with all applicable laws and guidance, including those that govern the sale and marketing of pharmaceutical products. The Compliance Program and related COP policies and procedures have been designed to be consistent with: (1) the “Compliance Program Guidance for Pharmaceutical Manufacturers” from the U.S. Department of Health and Human Services, Office of Inspector General, and (2) the Pharmaceutical Research and Manufacturers of America’s “Code on Interactions with Healthcare Professionals” (“PhRMA Code”).
The following is an overview of the Compliance Program and its key elements:
Leadership and Structure
The COP Compliance Officer has responsibility for development and execution of the Compliance Program. Specific oversight responsibilities include: ensuring appropriate and ongoing training and education; investigating reports of violations of the Compliance Program or applicable laws, and taking disciplinary when appropriate; and regularly reviewing the Compliance Program and its elements, and refining them when necessary, to support continuous improvement with the organization and compliance with the Compliance Program and applicable laws.
The COP Compliance Committee consists of members of the COP leadership team, and includes the COP Compliance Officer. The Compliance Committee advises and provides active support to the COP Compliance Officer. It has responsibilities including meeting quarterly, or as often as necessary, to review any updates or other relevant information related to the Compliance Program, and recommending any updates to the Compliance Program and related COP policies and procedures, as appropriate.
Written Policies and Procedures
COP has internal procedures in place to address all aspects of the Compliance Program. These procedures cover topics including: interactions generally with Healthcare Professionals; use of consultants; support to external organizations; use of product samples; and compliance with applicable state laws governing the marketing and sale of prescription drugs and devices.
To support its objectives under the Compliance Program, COP also follows the Colgate-Palmolive Company Code of Conduct, which summarizes additional compliance and ethics standards. Please see the Code of Conduct, which is available at https://www.colgatepalmolive.com/en-us/core-values/code-of-conduct.
COP is committed to providing ongoing and effective education and training to all COP employees on the Compliance Program as well as relevant COP policies and procedures. This training is implemented in a manner to promote: (1) awareness and understanding of applicable laws and internal policies and procedures and (2) compliant and ethical behaviors within the COP organization. It includes general Compliance Program training for all new COP employees, including specific training for any employees whose activities implicate any applicable state laws, as well as annual refresher training and other training programs as appropriate.
Monitoring and Auditing
Through its Compliance Program Coordinator, COP regularly engages in routine monitoring of COP activities to assess compliance with the Compliance Program. On at least an annual basis, the Colgate-Palmolive Corporate Audit team evaluates the Compliance Program activities and applicable policies and procedures. Through both routine monitoring and audit activities, the COP Compliance Officer, together with relevant functions, determines whether to propose any changes to the Compliance Program, as necessary, to improve the Compliance Program or to ensure compliance with applicable laws.
Discipline and Corrective Action
A COP employee who has knowledge or a good faith suspicion of any violation of the Compliance Program or applicable laws has an affirmative duty to report such information, and a failure to report a suspected or actual violation that has been brought to their attention may be subject to disciplinary action. There are several ways to report such information, including by contact the person’s manager, Human Resources, Legal Compliance, or Global Ethics & Compliance verbally via an Ethics line or through a dedicated e-mail address. All reported violations of the Compliance Program or applicable laws are documented and appropriately investigated to determine their veracity and the scope and cause of any underlying problem.
Violations of the Compliance Program or applicable laws shall be dealt with accordingly. Depending on the results of an appropriate investigation, sanctions could range from oral or written warning, to suspension or termination. Violations of the Compliance Program or applicable laws trigger an appropriate review by the Compliance Officer of the violated component of the Compliance Program to determine appropriate corrective measures or changes either in the Compliance Program or in COP’s other existing policies and procedures.
Annual Aggregate Limit
COP has established an annual dollar limit of $1,000.00 on spending for gifts, promotional materials, and items or activities provided to a Healthcare Professional in California, as required by California law. This limit represents a spending cap, not a goal or overage, and in many cases, the amount spent per Healthcare Professional may be significantly less than the cap amount.
Declaration of Compliance
Based on a good faith understanding of applicable California requirements, as of the date of this Declaration, COP declares that, to the best of its knowledge, its Compliance Program is in compliance with the requirements of California Health and Safety Code section 119402.
A copy of this California Comprehensive Compliance Program Summary and Declaration may be obtained by calling 1-800-226-5428.
Version: June 2018