HEALTHCARE COMPLIANCE PROGRAM OVERVIEW
Agios is committed to doing business in an ethical manner and in compliance with all applicable laws, regulations and industry standards.
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. The 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 will assess our compliance program periodically to meet our evolving compliance needs and to ensure consistency with additional laws and guidance.
The program includes a Code of Business Conduct and Ethics that helps to guide our daily operations and is supplemented by more detailed compliance policies and guidelines that address risk areas relevant to pharmaceutical manufacturers and are consistent with the Pharmaceutical Research and Manufacturers of America Code on Interactions with Health Care Professionals (PhRMA Code).
Our Chief Compliance Officer has overall responsibility for oversight of our compliance program. In this role, our Chief Compliance Officer has direct 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 Chief Compliance Officer in the implementation and monitoring of our compliance program.
We are committed to effectively and timely training employees on the policies and guidelines relevant to their job function and responsibilities. All new employees receive basic compliance training as part of their onboarding and will receive additional annual healthcare compliance training on an annual basis. In addition, employees whose roles implicate potential risk areas, including the commercial function, receive more detailed training. We will regularly review and update our training programs to ensure that they meet our educational needs.
We encourage open communication. We encourage our employees to ask questions about any activity that may present risk or seek advice about interpretation and best application of our policies and other elements of our compliance program. Our employees, officers and directors are also expected to promptly report potential, suspected, planned or actual violations of our policies and guidelines or applicable laws that govern our activities. Reports of potential instances of inappropriate activity can be made to a manager, HR, Legal or directly to our Chief Compliance Officer. We have also established a confidential and anonymous compliance helpline that is available 24 hours a day, 7 days a week.
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.
Our Chief Compliance Officer, or a designee, will monitor the implementation and administration of our compliance program. 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 will be addressed through corrective measures in an effort to prevent the recurrence of non-compliance.
Our Chief Compliance Officer, or a designee, will promptly review all reports of possible violations in order to assess the need for an investigation. An investigations into potentially non-compliant activity will be conducted to determine whether a violation of our compliance program has occurred. 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 or revised policies and procedures, new or revised monitoring and auditing protocols, additional training 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 $1,500 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.
SEPTEMBER 1, 2021 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 Compliance Department at firstname.lastname@example.org or our corporate headquarters at (617) 649-8600.