Meda Pharmaceuticals Inc. Compliance Program
Meda Pharmaceuticals Inc. is committed to conducting its business in an ethical and lawful manner. We will engage only in sales and marketing practices that comply with applicable laws and regulations. The company will also comply with laws and regulations that ensure the integrity of data used in calculating and reporting government pricing and discounts.
To assure that our policy objective is achieved, we have established a comprehensive compliance program based on the Department of Health and Human Services Office of the Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers
. We have designated a Compliance Committee that will be responsible for overseeing and monitoring the compliance program to ensure compliance with our legal and regulatory obligations. The elements of our compliance program are set forth below:
Comprehensive Healthcare Compliance Program
Written Policies, Procedures, and Standards of Conduct
The company has adopted written policies, procedures, and standards of conduct to document the company's commitment to compliance and serve to guide Meda personnel in the ethical and compliant conduct of daily activities. The company's Business Conduct Guidelines reiterates our adherence to applicable U.S. laws, regulations, and industry guidance. Our pharmaceutical marketing and promotional activity complies with the principles incorporated in the PhRMA Code on Interactions with Healthcare Professionals
updated as of January 1, 2009. For compliance with California law, Section 119402(d)(1) of the California Health and Safety Code, we have adopted a specific annual limit of $1500.00 on gifts, promotional materials, medically relevant items, and other promotional items or activities (such as modest meals during informational presentations) provided to individual medical or health care professionals. This amount does not include the value of pharmaceutical drug samples, grants for medical education, professional service fees, patient education materials, printed prescription pads and approved scientific reprints. We are adopting additional policies and procedures concerning the integrity of data collection and reporting to ensure that our government pricing and rebating obligations are properly fulfilled.
Designation of a Compliance Committee
We have designated a Compliance Committee with responsibility for overseeing the compliance program including its training, auditing and monitoring components. Members of the Compliance Committee will also address employee concerns and will be responsible for enforcement of the compliance program within the company. The Compliance Committee is chaired by the Compliance Officer.
Training and Education
Employees are trained on corporate responsibilities, their legal and ethical obligations, and relevant policies and procedures. Meda will regularly review and update its training programs and identify additional areas of training on an as needed basis.
Effective Lines of Communication
Employees and external stakeholders should feel comfortable expressing any concerns they may have with our corporate activities. Any employee with concerns about whether a corporate activity is in compliance with law or any of our written policies and procedures is required to raise the matter through their supervisory chain of command, through another supervisor, or through the 24-hour business conduct hotline. If a satisfactory resolution is not achieved through the supervisory chain of command, other supervisor, or the business conduct hotline, the employee is urged to contact the Legal or Human Resources Departments. Anonymity (if desired) will be maintained to the maximum extent permitted by law and the circumstances of the matter. There will be absolutely no retaliation permitted for good faith reporting of such activities or concerns.
The company will respond promptly to all questions and issues, will determine whether cause exists for further investigation or corrective action, and will follow up to ensure that there is appropriate resolution of compliance matters and that resolutions are appropriately communicated.
Auditing and Monitoring
The Compliance Committee will be responsible for ensuring that periodic audits are scheduled and will oversee audits of our sales and marketing activities, our data collection and monitoring activities and any other activities that affect compliance with laws and regulations covered by this compliance program, and will assure that appropriate corrective action is undertaken.
All employees are required to comply with our policies and procedures. We will take appropriate disciplinary action against anyone who does not. Corporate disciplinary policies address illegal, unethical, or non-compliant behavior. Disciplinary actions, ranging from warnings up to and including termination, are determined on a case-by-case basis and applied consistently in light of the nature and severity of the violation.
Investigation and Corrective Action
The company will promptly investigate actual or suspected noncompliance or misconduct and institute corrective action and preventative measures whenever appropriate.
Annual Declaration of Compliance
In accordance with Section 119402 of the California Health and Safety Code, the company will post an Annual Declaration of Compliance on its website each year.