The Code of Conduct is a statement of Takeda’s policies and procedures for conducting its business in accordance with applicable laws and the highest ethical standards.  The Code contains the business and ethical policies that Takeda expects its management, employees, and agents to follow.

The Compliance Guidelines set forth the ethically appropriate manner in which Takeda personnel will interact with healthcare professionals.  This document reflects the company’s commitment to the principles set out in the PhRMA Code on Interactions with Healthcare Professionals.

Takeda also has developed policies and procedures identifying appropriate conduct in the three primary risk areas for pharmaceutical companies identified in the OIG Guidance, including, (1) data integrity pertaining to government reimbursement practices; (2) kickbacks and other illegal remuneration; and (3) compliance with laws regulating drug samples.  These include the company’s Compliance Guidelines as well as Standard Operating Procedures (SOPs) pertaining to government price calculations and sample accountability.

We also have established a specific annual dollar limit of $3,000.00 on spending for gifts, promotional materials, and items or activities provided to healthcare professionals, as required by California law.  While we are committed to not exceeding this amount, the establishment of this limit does not mean that we spend this amount on all healthcare professionals.  To the contrary, the California law requires the establishment of a maximum dollar limit and, therefore, very few of the healthcare professionals with whom we interact approach this limit.

2. Leadership & Oversight

Takeda has established its Office of Ethics & Compliance (OEC) to lead the company’s compliance efforts.  The OEC is responsible for developing, implementing, and continuously improving Takeda’s Corporate Ethics & Compliance Program.  Takeda is committed to ensuring that the OEC has the ability to effectuate necessary and appropriate change within the company and to exercise independent judgment.  The director of the OEC reports to Takeda’s president.

The OEC works closely with Takeda’s Ethics & Compliance Committee in shaping the company’s Corporate Ethics & Compliance Program.  The mission of Takeda’s Ethics & Compliance Committee is to provide advice and oversight in the development, implementation, and continuous improvement of this Program.  The Ethics & Compliance Committee consists of a number of Takeda’s senior management personnel, including Takeda’s president and the heads of the Law, Marketing, Sales, and Medical & Scientific Affairs departments, which bring to the Committee a variety of skills and personality traits, as well as the authority to push compliance initiatives into their respective functions.

3. Training & Education

Training and education are critical features of Takeda’s Ethics & Compliance Program.  We firmly believe that when provided with the proper tools and information, Takeda employees will conduct their activities in a manner consistent with our culture and the law.  Takeda is committed to taking the necessary steps to effectively communicate our compliance policies and procedures to all employees. 

New employees in both the Home Office and the Field receive initial training and tenured employees receive annual refresher training on Takeda’s Code of Conduct and Compliance Guidelines.  We employ a mix of instructor-led and computer-based training that is example based to provide employees with real world scenarios to which to apply Takeda’s policies.  Takeda employees also receive training that is specific either to their particular roles—for example, sample accountability training for sales representatives involved with the distribution of samples—or to a particular topic area—for example, records retention.

4. Lines of Communication

Employees are encouraged to take advantage of Takeda’s open-door policy when it comes to raising compliance questions and discussing potential compliance concerns.  Managerial personnel are available to respond to these questions and concerns, as is the Office of Ethics & Compliance.  If an employee does not feel comfortable talking with their manager, they also may contact the Office of Ethics & Compliance, either directly or through the Takeda Compliance HelpLine.  Reports to the HelpLine may be made anonymously.  Upon receiving a report, the OEC, in conjunction with other relevant functions, will follow up to ensure appropriate resolution. 

Takeda is committed to its policy of not retaliating against personnel who make good faith reports of potential compliance issues.  This policy is expressed in Takeda’s Ethics & Compliance Policy, Code of Conduct, and Compliance Guidelines.

5. Monitoring & Auditing

The Office of Ethics & Compliance engages in ongoing monitoring and auditing to evaluate the existence of appropriate policies and procedures, the implementation and communication of such policies and procedures, and compliance with such policies and procedures.  In accordance with the OIG Guidance, the nature, extent, and frequency of the reviews Takeda conducts varies according to factors such as new regulatory requirements, changes to Takeda’s business practices, or identified high-risk areas.

In addition to the company’s auditing and monitoring activities—including activities involving the company’s fee-for-service engagement of physicians and provision of grant funds—Takeda employees at all levels are responsible for reporting potential compliance issues of which they become aware.  Both the Code of Conduct and the Compliance Guidelines expressly highlight this responsibility.

6. Disciplinary Policies

Takeda is committed to having clear disciplinary policies to address situations where employees engage in illegal or unethical conduct.  While conduct is evaluated on a case-by-case basis, the company will undertake disciplinary or corrective action in a consistent manner so as to ensure that such action is appropriate under the circumstances and has the intended deterrent effect.  Penalties for compliance violations may include termination, depending upon the seriousness of the violation.

7. Investigation & Corrective Action

Takeda’s Ethics & Compliance Program is designed to create a culture of compliance and to help prevent the likelihood of the occurrence of illegal or unethical behavior.  As recognized in the OIG Guidance, no compliance program can prevent all occurrences of misconduct by individuals.  However, Takeda’s Ethics & Compliance Program is reasonably designed to prevent and detect violations. 

The Code of Conduct and Compliance Guidelines both address the investigation of suspected violations of compliance policies.  Upon receipt of reports or discovering information about a suspected violation of the Code of Conduct, Compliance Guidelines, or related policies and procedures, Takeda shall respond promptly, including, where appropriate, conducting an investigation to determine if a violation has occurred.  If the company determines that a violation has occurred, it shall promptly take appropriate disciplinary and/or corrective action to help prevent similar violations in the future.

To further assist in preventing violations, the company screens individuals against the OIG exclusion list prior to making hiring decisions.

Takeda’s Compliance Mission

Takeda’s compliance mission boils down to one ideal—doing the right thing.  At Takeda, we want to maximize our business opportunities, but we must always strive to minimize the risks associated with noncompliance.  Takeda’s Corporate Ethics & Compliance Program is designed to help each and every one of us achieve this mission.

Accomplishing our Compliance Mission will ensure that we will continue to build Takeda’s reputation as a new kind of pharmaceutical company. To report a suspected violation please call 1-888-TAKEDA-0 or make an on-line report by clicking this link COMPLIANCE HELPLINE REPORT.

Version: July 2007