CORPORATE COMPLIANCE Our Commitment to Corporate Compliance
Integrity is one of Millennium's most important core values, and is expressed in our Core Values statement and Core Values Handbook, our code of conduct. We ask and expect that our employees adhere to the highest ethical standards.
The Core Values Handbook includes Millennium's standards for behavior and emphasizes our commitment to compliance with these standards and with all applicable laws. In addition to making a personal commitment to living our Core Values in everything we do (see Millennium's Core Values statement on page 5 of the Core Values Handbook), including our relationships with patients, physicians, and shareholders, all Millennium employees must certify annually that they will comply with the Core Values Handbook. For information on corporate governance at Millennium generally please see our Commitment to Good Corporate Governance. Ethical relationships with healthcare professionals are an important part of living our Core Values. To further foster ethical and compliant relationships with healthcare professionals, Millennium has adopted the PhRMA Code on Interactions with Healthcare Professionals.
Our Compliance Program
We implemented a compliance program ("Program") based on the fundamental elements outlined in the Office of Inspector General ("OIG") Compliance Program Guidance for Pharmaceutical Manufacturers. This Program includes internal controls and procedures that promote adherence to federal and state statutes, regulations and requirements applicable to our business. We periodically reexamine the Program's policies and procedures to ensure that they are compliant with the most recent federal and state requirements.
Key elements of our Program are highlighted below:
1. Written Standards of Conduct, Policies and Procedures
Written materials include:
The Core Values Handbook provides guidance to Millennium employees regarding the ethical and legal compliance requirements of their jobs. It describes the internal policies we have implemented to ensure that we uphold our responsibilities and act with accountability. The Core Values Handbook provides a foundation for a wide range of important policies of the company, such as:
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Health and safety policies and practices
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Equal employment opportunity/affirmative action policies and practices
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Policy against workplace harassment
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Health regulatory compliance
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Ethics Standards and Guidelines adopted by our Sourcing Department
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Policies on humane animal care and use
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Intellectual property policies
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Recordkeeping policies
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The Compliance Guidance for Sales and Marketing Professionals provides more detailed guidance with respect to day-to-day activities including: presenting promotional materials, conducting promotional discussions; providing meals, gifts, and entertainment; supporting continuing medical education programs; providing grants and charitable donations; and obtaining consulting services.
The Handbook for Medical Science Liaisons provides guidance to those professionals on their interactions with healthcare professionals, including responding to unsolicited requests to provide medical and scientific information.
Conduct:
In addition to promoting compliance through education, compliance goals are integrated into and are an important component of our company goals. Compliance is an element of performance plans and reviews for our employees.
2. Our Compliance Officer and Compliance Committee
Millennium has a Compliance Officer (see page 52 of the Core Values Handbook) who coordinates and monitors legal compliance activities across the company. The Compliance Committee, comprised of leaders of key areas throughout the company, meets to discuss best practices, monitor compliance activities and coordinate advice-seeking.
3. Training
We require that all new hires complete training on the processes and policies relevant to their positions. For example, employees engaged in research are trained on the Guidelines for Good Laboratory Practices; those engaged in the clinical testing of products are trained on the Guidelines for Good Clinical Practices, human subject protection, and the PhRMA Principles on the Conduct of Clinical Trials and Communication of Clinical Trial Results; employees working in the manufacturing of pharmaceutical products are trained on the Guidelines for Good Manufacturing Practices.
New hires within our clinical and commercial organizations complete health regulatory compliance training within 90 days of employment. We also require employees in the commercial organization to attend annual health regulatory compliance training and to certify attendance at such training. The general and the specific training sessions focus on, among other issues, the Anti-kickback Statute and its relationship with sales and marketing in pharmaceutical companies, the False Claims Act, the PhRMA Code on Interactions with Healthcare Professionals, the ACCME's Standards for Commercial Support, and the OIG Compliance Guidance for Pharmaceutical Manufacturers.
Training on identified risk areas is also conducted at regular meetings of the sales and marketing organizations. The training is specifically tailored to respond to new compliance issues in sales and marketing and compliance problems of similarly situated companies. The training is updated to reflect the most current changes to the Federal healthcare program requirements and any emerging issues that the company must address. Additional training programs are implemented in response to needs that are identified through monitoring and auditing.
4. Communicating Concerns: Hotline, Email and Reporting
Millennium encourages all employees to express their concerns and provides several channels for communication (see page 11 of the Core Values Handbook). Millennium has established an anonymous hotline for employees to seek guidance on ethical or legal issues, or who want to report concerns regarding business-related conduct (see page 12 of the Core Values Handbook). Anonymity is preserved at the caller's option. Company policy protects the caller against retaliation for raising concerns, especially in circumstances when the caller does not wish to remain anonymous. In addition to the anonymous hotline, Millennium has a compliance electronic mail account dedicated for questions regarding compliance or other issues.
Millennium is committed to investigating and resolving any and all issues identified through the compliance hotline, email account, exit interviews, or by any other method.
5. Monitoring and Auditing
Millennium regularly monitors and/or audits its regulated activities, for example, its adherence to Good Laboratory Practices, Good Clinical Practices and Good Manufacturing Practices, and its OIG Guidance compliance. Routine audits allow for the evaluation of risk areas, so that appropriate policies may be implemented or adjusted if necessary to manage such risks. The Quality Assurance group, the Legal Department on behalf of the Compliance Officer, and the internal audit functions formulate corrective action plans, working with the Human Resources department as necessary, to address issues arising from the monitoring and auditing of our systems. These corrective action plans may include disciplinary action, education or development of new policies and procedures.
6. Disciplinary Guidelines
Millennium conducts regular performance reviews of its employees and takes compliance into consideration as an important component of performance. We take disciplinary action in response to violations of internal policies, and applicable laws or regulations relating to federal healthcare program requirements. Sanctions for the violation of Millennium's internal policies or federal or state laws range from oral warnings to suspension, termination or other sanctions, as appropriate. We do not employ individuals or entities excluded from participation in federal healthcare programs.
7. Corrective Action
We investigate problems we identify or that are reported through the anonymous hotline and other reporting systems. Remediation of such problems may include appropriate sanctioning of the employees involved in the inappropriate action, development and implementation of training programs to prevent future occurrences, and establishment of mechanisms for continued monitoring.
Rev. 1 June, 2008