Our company has implemented a comprehensive compliance program based on the fundamental elements outlined in the Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers (OIG Guidance). Our program includes internal controls, policies and procedures that foster compliance with federal and state laws, regulations, the PhRMA Code and other requirements applicable to our business.
Highlighted below are key elements of our program. Click each topic to read in full.
1. Written Standards of Conduct, Policies and Procedures
The Core Values Handbook provides guidance to employees regarding the ethical, legal and compliance requirements applicable to their employment. The handbook describes the internal policies that we have implemented to foster compliance with these requirements and to promote individual accountability. The Core Values Handbook provides a foundation for a wide range of important policies of the company. The general provisions of the Core Values Handbook are supplemented by more detailed compliance policies and procedures for individual business functions. These policies address risk areas relevant to pharmaceutical manufacturers, including those identified in the OIG Guidance and the PhRMA Code.
2. Our Compliance Officer and Compliance Committee
Takeda has a Global Compliance Officer who is responsible for overseeing compliance activities across the Company. We also have a Compliance Committee, comprised of leaders in key areas throughout the company that meets to discuss best practices, monitor compliance activities and coordinate advice-seeking. Concerns or reports of wrongdoing as well as corresponding corrective actions, as applicable, are also discussed with the Compliance Committee.
All new hires are required to complete basic orientation training within 90 days of employment on legal and compliance related topics, processes and policies relevant to their positions, and applicable quality guidelines and regulations.
Employees in the sales, marketing, medical affairs, and medical organizations are also required to complete training on general science and product-specific information in addition to annual training in health regulatory compliance. Compliance training topics include but are not limited to the Anti-Kickback Statute, False Claims Act, OIG Guidance, PhRMA Code, FDA regulatory standards, and ACCME's Standards for Commercial Support.
Training on identified risk areas are also conducted regularly at the sales and marketing organization meetings. This training is tailored specifically to respond to new compliance challenges faced by these organizations and additional training programs are implemented in response to needs identified through ongoing monitoring and auditing.
4. Communicating Concerns: Hotline, Email and Reporting
Takeda encourages all employees to ask questions, seek guidance on ethical or legal issues, and express any concerns regarding business-related conduct. We provide several channels for these types of communications, such as an external telephone hotline for reporting compliance concerns, where anonymity may be preserved at the caller's request. Employees also may address their questions or concerns to their manager, Human Resources, the Compliance Department, the Legal Department, or the Compliance Officer. Company policy is designed to protect employees from retaliation for raising concerns in good faith.
5. Monitoring and Auditing
Regulated activities are monitored and audited for compliance with applicable laws, regulations, guidelines, and Company policies and procedures. The Quality Assurance group, the Compliance Department, the Legal Department, the Compliance Officer, and the internal audit functions formulate corrective action plans, working with the Human Resources department as necessary, to address concerns that are identified through monitoring and auditing.
6. Disciplinary Guidelines
We conduct regular performance reviews of employees and take compliance into consideration as an important component of performance. Failure to comply with the law, regulations or Compliance policies will subject employees to disciplinary action, up to and including termination of employment. Our company also has processes in place to screen individuals or entities excluded from participation in the federal healthcare programs or debarred by FDA. It is our policy to not employ such excluded individuals or entities.
7. Corrective Action
We strive to address issues that are identified or that are reported to us. Remediation of such problems may include disciplinary action, training, review or development of policies and procedures, and/or mechanisms for monitoring or auditing.
California Health & Safety Code §§ 119400-119402
Per the requirements of California Health & Safety Code §§ 119400-119402, our company has established an annual dollar limit of $1500 for certain spending on individual medical or healthcare professionals licensed in California. The value of educational items and meals provided to healthcare professionals in connection with business and educational discussions with those individuals is included in this dollar limit. This dollar limit represents a spending maximum and not an average or goal and we reserve the right to change this limit at any time.
July 1, 2016 California Declaration of Compliance
To the best of its knowledge and based on its good faith understanding of the statutory requirements, Millennium Pharmaceuticals, Inc. (doing business as Takeda Pharmaceutical International Co.) declares that it is in compliance with its Program and the requirements of California Health & Safety Code §§ 119400-119402 in all material respects.
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