As part of our ongoing commitment to uphold high scientific and ethical standards, Amgen has adopted the following policy to which all Amgen staff or their representatives in Amgen’s Global Research and Development (R&D) organization must comply when engaging in Research and Development activities with external parties.
All Amgen sponsored, funded, or otherwise supported research activities with external parties must be designed to fill a legitimate research need on the part of Amgen. Under no circumstances may a research opportunity be directly or indirectly offered or provided to influence or encourage the recipient to purchase, prescribe, refer, sell, arrange for the purchase or sale, or recommend formulary placement of any Amgen product.
Under this policy, Amgen may conduct legitimate research, the results of which may be used in discussions about sales and formulary placement by Amgen personnel who are authorized to conduct those discussions. Amgen’s payments to external parties for research activities must reflect fair market value compensation that reflects the services to be provided.
FUNDAMENTAL PRINCIPLES
Legitimate Research Need: There must be a legitimate research need for the proposed research. Research must be designed to further scientific, pharmacoeconomic, and/or epidemiological understanding of areas in which Amgen currently has a business interest or may have such interests in the future. The legitimate research need must be documented in advance.
Responsible Amgen Employee (“RAE”): There must be a Responsible Amgen Employee (“RAE”) for each research activity. The RAE must be a staff member in Amgen’s R&D organization. The RAE is responsible for ensuring compliance with this policy and any related procedures, business practices, guidelines and standards that may apply.
Evaluation of Proposed Research: All research must be evaluated by an appropriate R&D review committee prior to commencing or funding the research. The RAE must submit to the appropriate R&D review committee a detailed proposal for the planned research.
Discussions with Investigators: While preliminary discussions may be held with proposed investigators regarding the proposed scope of services, no verbal or written commitment regarding engagement, scope of services, or amount of payment may be made before the Law Department or relevant contracting group approves the proposed written arrangement.
Monitoring Performance: Amgen will monitor and document performance under each research agreement, and any significant failures will be brought to the attention of the Global R&D Compliance (GRDC) Department and/or the Law Department.
