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Policy on Medical Affairs and Commercial Activities

Background

The ethical and compliant execution of medical and commercial activities relating to Astellas products and therapeutic areas is essential to meeting the needs of patients and the success of our global business. The purpose of this policy is to establish the principles governing appropriate commercial and medical activities and provide direction on certain of these activities, including the ethical and compliant collaboration between Commercial and Medical Affairs when conducting these activities.

Policy

Commercial is responsible for promoting the safe and effective use of Astellas products consistent with Astellas policies, applicable laws, rules, regulations, Codes and Guidelines and the product’s labeling and prescribing information approved by local regulatory authorities.

Medical Affairs is responsible for conducting medical activities that are intended to ultimately benefit patient care and experience. These activities advance the understanding and science behind compounds in development and the appropriate safe and effective use of Astellas products through medical leadership and excellence. Medical Affairs is also responsible for engaging in scientific exchanges that generate and result in the appropriate dissemination of relevant, scientifically accurate, objective, truthful and not misleading information about Astellas investigational compounds and marketed products.

The ethical and compliant collaboration and interaction between Medical Affairs and Commercial, both externally-focused and internal, are critical to the success of Astellas. Together, they will advance the science, understanding and appropriate use of Astellas products, help to meet the needs of patients and our other stakeholders, provided that the independence and integrity of the Medical Affairs and Commercial functions is maintained.

For these reasons, collaboration and interaction between Medical Affairs and Commercial must be conducted in a manner that is compliant with applicable local laws, rules, regulations, Codes and Guidelines. These activities should also maintain the independence and integrity of the Medical Affairs and Commercial functions. Specifically:

  • Commercial cannot direct or dictate medical activities or scientific exchange
  • Medical Affairs cannot direct or dictate the commercial activities or promotional activities of the Commercial organization.

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