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International Regulatory Enforcement (PHIRE)

Not a U.S.-Fits-All-Proposition: Four Key Considerations When Building the Compliance Framework to Go Global with Patient Support—Part I of II

April 11, 2019

Gary F. Giampetruzzi, S. Joy Dowdle, Jessica R. Montes & Aisling Murray

Within the U.S., patient support programs (“PSPs") have drawn increased regulator scrutiny, consistent with their growing importance in the healthcare sector, where it is increasingly being said, and quite appropriately so, that “the patient is the new healthcare provider." As such, many companies have begun developing compliance programs for PSPs structured entirely on practices, regulations, and enforcement in the U.S. Yet as global healthcare spend continues to increase, multi-national companies throughout the industry are likewise increasing investment in PSPs and other patient support, such as interactions with or funding of patient assistance organizations or other charitable organizations helping patients (together, “Patient Support") outside of the U.S. All too often, however, this increased global investment has not been met with a corresponding globalization of patient support compliance efforts—leaving many companies ill-prepared to mitigate risk or face global regulator scrutiny as they go global with Patient Support. This two Part series considers the growth of global patient support, and the global patient support compliance framework required to mitigate the corresponding compliance risks.

  • As companies invest in global patient support efforts, there should be a commensurate investment in a global compliance framework to mitigate risk.

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