At Merrimack, we are committed to building integrated cancer regimens to advance care for our patients. We aim to fulfill that purpose in responsible ways, earning the trust of co-workers, patients, partners, stockholders and the broader community. Transparency and a robust healthcare compliance program enable us to develop and foster that trust.
We have implemented a healthcare compliance program based on the fundamental elements outlined in the Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers. Our compliance program is designed to foster compliance with the laws, regulations and guidelines that apply to our business, to train our employees on these matters, and to prevent, detect and correct instances of non-compliance. We review our compliance program periodically to meet our evolving compliance needs.
Our Code of Business Conduct and Ethics helps to guide our daily operations and reflects the unique business and regulatory environment in which we operate. Our Code of Business Conduct and Ethics is supplemented by more detailed compliance policies and guidelines that address risk areas relevant to pharmaceutical manufacturers, including those identified in the OIG Compliance Program Guidance for Pharmaceutical Manufacturers and the updated Code on Interactions with Healthcare Professionals published by the Pharmaceutical Research and Manufacturers of America (PhRMA). The standards set forth in these policies apply to all of our employees.
Leadership and Structure
Our Head of Compliance has overall responsibility for oversight of our compliance program. In this role, our Head of Compliance has unrestricted access to our Chief Executive Officer and makes reports to the Board of Directors concerning operation of our compliance program. We have also appointed a compliance committee to advise and assist our Head of Compliance in the implementation and monitoring of our compliance program.
Education and Training
We are committed to effectively and timely training employees on the policies and guidelines relevant to their job function and responsibilities. Annual healthcare compliance training is required for all employees who support commercial activities. In addition, all new employees receive basic compliance training as part of their onboarding. We regularly review and update our training programs to ensure that they meet our educational needs.
Internal Lines of Communication
Our employees, officers and directors are expected to promptly report potential, suspected, planned or actual violations of our policies and guidelines and/or applicable laws that govern our activities. We encourage open communication. Reports of potential instances of inappropriate activity can be made to a supervisor, manager or directly to our Head of Compliance. We have also established a confidential and anonymous hotline that is available 24 hours a day, 7 days a week.
We also encourage our employees, officers and directors to ask questions about any activity that may represent a potential violation or seek advice about interpretation and best application of our compliance program.
Acts of retaliation or retribution against any person who in good faith reports a potential, suspected, planned or actual violation of our policies and guidelines and/or applicable laws is strictly prohibited.
Auditing and Monitoring
Our Head of Compliance, or a designee, monitors the implementation and administration of our compliance program, including monitoring the activities of field personnel for consistency with applicable laws, our policies and industry guidelines. The nature of our reviews, as well as the extent and frequency of our compliance monitoring and auditing, varies according to a variety of factors, including regulatory requirements, changes in business practices and other considerations. Potential or actual problem areas identified through the auditing and monitoring program are addressed through corrective measures in an effort to prevent the recurrence of non-compliance.
Responding to Potential Violations
Our Head of Compliance, or a designee, will promptly review all reports of possible violations in order to assess the need for an investigation. When deemed necessary, our Head of Compliance, or a designee, will conduct an investigation into potentially non-compliant activity to determine whether a violation of our compliance program has occurred. As necessary to evaluate a report, auditing or monitoring findings, or to undertake further investigation, our Head of Compliance may request the assistance of outside experts or legal counsel.
Corrective Action Procedures
We take corrective actions when it has been determined that a violation has occurred. Such corrective actions will be appropriate for the severity of the violation. Corrective actions may include appropriate disciplinary measures, up to and including termination, new and/or revised policies and procedures, new and/or revised monitoring and auditing protocols, and other internal controls and information systems to prevent future non-compliance.
State of California Compliance Program Declaration
In accordance with the requirements of California Health & Safety Code §§ 119400-119402, we have established an annual dollar limit of $2,000 for certain spending on individual medical or healthcare professionals licensed in California. We include in this dollar limit the value of educational items and meals provided to healthcare professionals in connection with business and educational discussions with those individuals. The annual spending limit set forth in this declaration does not include the value of:
- financial support for continuing medical education forums;
- financial support for health education scholarships; and
- payments made for legitimate professional services provided by a healthcare professional so long as the amount paid does not exceed the fair market value of the services provided.
This dollar limit represents a spending maximum and not an average or goal. We reserve the right to change this limit at any time.
We also adhere to global transparency laws and regulations, including Section 6002 of the Patient Protection and Affordable Care Act, which requires us to report payments and transfers of value made to certain healthcare professionals and teaching hospitals.
July 1, 2015 California Declaration of Compliance
To the best of our knowledge and based on our good faith understanding of the statutory requirements, we declare that we are in compliance with our compliance program and the requirements of California Health & Safety Code §§ 119400-119402 in all material respects.
This declaration is not intended and should not be construed to imply that we have not identified any individual instances in which an employee has or may have violated one or more provisions of our compliance program. In such situations, we take reasonable and appropriate remedial or corrective actions in a manner consistent with our compliance program.
Copies of this declaration and a description of our compliance program may be obtained by contacting our Corporate Compliance Department at firstname.lastname@example.org or our corporate headquarters at (617) 441-1000.