Teva Pharmaceuticals USA, Inc. (TUSA) and its divisions and affiliated U.S. companies are committed to conducting their business in compliance with all applicable federal and state statutes and regulations.
To help ensure this, TUSA has established and will maintain an effective Compliance Program in accordance with the OIG Compliance Program Guidance for Pharmaceutical Manufacturers ("OIG Guidance") issued by the Office of Inspector General, U.S. Department of Health and Human Services. Our Compliance Program is one of the key components of our commitment to fostering a culture of compliance where it is understood that integrity is the bottom line.
The OIG Guidance sets forth the federal government's views on the value and fundamental principles of compliance programs for pharmaceutical manufacturers and the specific elements that manufacturers should consider when developing and implementing an effective compliance program. The OIG Guidance is a major initiative in support of the federal government's efforts in preventing and reducing fraud and abuse in the sales and marketing of pharmaceutical products.
The purpose of TUSA's Compliance Program is to prevent and detect violations of law or company policy. As the OIG Guidance recognizes, the implementation of such a program cannot guarantee that improper employee conduct will be entirely eliminated. Nonetheless, it is TUSA's expectation that employees will comply with the policies and procedures established in support of our Compliance Program. In the event that TUSA becomes aware of violations of law or company policies and procedures, we will investigate the matter and, where appropriate, take disciplinary action and implement corrective measures to prevent future violations.
TUSA's relationships with healthcare professionals are intended to benefit patients and to enhance the practice of medicine. All TUSA interactions with healthcare professionals should be focused on informing the healthcare professionals about products, providing scientific and educational information, and supporting medical research and education.
TUSA recognizes the seriousness and critical need to establish and maintain a compliance program consistent with the OIG Guidance. As described below, TUSA has established a Compliance Program aligned with the philosophy and specific requirements of the OIG Guidance. Consistent with the OIG Guidance, we have tailored our Compliance Program to fit the unique environment of TUSA. We regularly review and enhance our Compliance Program to meet our evolving compliance needs.
1. Written Policies & Procedures
TUSA has in place various policies and procedures that are intended to:
- Help assure compliance with U.S. laws and regulations; and
- Assure consistency in the way that TUSA conducts its business.
These policies include the Teva Code of Conduct, the Teva Integrity Principles, and Teva's Anti-Kickback Statute Policy. The Code of Business Conduct sets forth our basic standards—standards which are based on Teva's fundamental values. The Code provides us with a common set of ethical standards, and a common language for describing what is, and what is not, within the realm of ethical conduct. The Teva Integrity Principles implement the PhRMA Code on Interactions with Healthcare Professionals and describe the principles to which we adhere when interacting with our customers, including healthcare professionals. Teva's Anti-Kickback Statute Policy requires compliance with the Federal Anti-Kickback Statute and provides information on the law to help ensure that Teva employees understand the law and their obligations to report potential violations.
Company procedures implement the concepts found in these two policies to provide employees with more specific instruction with respect to business practices that the OIG Guidance identified as falling within three risk areas, namely (1) data integrity pertaining to government reimbursement practices; (2) kickbacks and other illegal remuneration; and (3) compliance with laws regulating drug samples.
Pursuant to California law, TUSA has established an annual spending limit of $3000 on promotional items and activities directed toward healthcare professionals licensed in California. These items and activities consist of:
- Business meals provided in connection with informational presentations and discussions relating to a Teva product, and
- Educational items intended to advance disease or treatment education.
The annual limit is an estimate of the maximum amount spent on these promotional items and activities. Few California healthcare professionals will actually reach this limit and the limit is not a spending goal.
This limit does not include the value of written promotional and educational materials, including reprints of peer-reviewed journal articles, provided to healthcare professionals in connection with informational presentations and discussions about Teva products.
This limit is in effect until June 30, 2016. TUSA may periodically re-evaluate this limit and, if appropriate, make any necessary adjustments.
2. Compliance Officer & Compliance Committee
TUSA's Compliance Department is headed by the Compliance Officer. We are committed to ensuring that the Compliance Officer has the ability to effectuate change within the company as necessary and to exercise independent judgment. The Compliance Department is charged with the responsibility for establishing and maintaining the Compliance Program.
The Compliance Department works closely with and seeks the advice and counsel of the Compliance Committees in the implementation of the Compliance Program. The Compliance Committees are made up of senior-level leaders at TUSA.
3. Training & Education
Critical to the success of TUSA's Compliance Program is each individual employee's understanding of the Program and the policies and procedures established as part of that Program. TUSA is committed to effectively communicating company policies and procedures to its employees and other personnel to ensure they have an understanding and appreciation for how to conduct their business practices appropriately. The company also will regularly review and update its training programs to ensure their effectiveness and will work to identify additional areas of training.
4. Lines of Communication
TUSA is committed to fostering dialogue between management and employees about reporting concerns or questions about non-compliance. All Teva employees have a responsibility to report misconduct (either suspected or confirmed) and are encouraged to discuss these questions or concerns with their own manager or other members of the management team. Teva employees may also report non-compliance to the Teva Integrity Hotline, which is available toll free, 24 hours a day. Information on how to make a report can be found on the Global Compliance page of teva.net. Reports made to the hotline will be investigated by Teva's Office of Business Integrity (OBI). The company has a firm policy prohibiting retaliation against any individual who reports a concern in good faith. If you have any questions about the Teva Integrity Hotline or the OBI's investigative process, please contact the OBI at Office.BusinessIntegrity@tevapharm.com.
5. Auditing & Monitoring
TUSA utilizes auditing and monitoring to verify that the business practices engaged in by its employees follow the various policies and procedures that are in place to ensure compliance with the laws and regulations applicable to the company. The Compliance Department identifies potential risk areas on which to focus its auditing and monitoring activities. As recognized in the OIG Guidance, the extent and frequency of the company's auditing and monitoring activities varies according to a number of factors, including new regulatory requirements and changes in business practices.
6. Disciplinary Action
Failure to comply with our established policies, procedures and the overall TUSA Compliance Program will be treated as a breach of company policy and will result in appropriate disciplinary action, up to and including termination for Teva employees. Although each situation is considered on a case-by-case basis, we will consistently undertake appropriate disciplinary action to address non-compliance and deter future violations.
TUSA will investigate suspected non-compliance with its policies and procedures as well as all applicable laws and regulations in a manner designed to promptly and accurately ascertain the facts and to determine the underlying cause or causes of any substantiated, non-compliant conduct. The investigation will assess whether the non-compliance is due to gaps in policies or internal controls and take appropriate action to address any gaps so as to prevent future violations. The Compliance Department will direct investigations of suspected non-compliance and document the nature and results of such investigations. As mentioned above, reports of non-compliance made through the Teva Integrity Hotline will be investigated through Teva's Office of Business Integrity.