The Pharmaceutical and MedTech industries are highly regulated. Society at large—patients and HealthCare Professionals (HCPs)* in particular—expect companies to act appropriately and to comply with existing laws, regulations, and industry codes. Those in Medical Affairs need to understand these requirements to manage their activities in a legal, compliant, and ethical manner. The objective of this White Paper is to guide Medical Affairs personnel on the key components of the legal, regulatory, and industry codes of practice requirements which are applicable to Medical Affairs in Pharma and Medical Devices industries, and how to identify and mitigate risks. This paper also includes company control frameworks for compliance with the requirements through policies, processes (usually captured in Standard Operating Procedures [SOPs]), systems, training, monitoring, and audit.

Medical Governance and Compliance are underpinned by ethical guidelines for interactions between these industries and HCPs.  These ensure that interactions and collaborations prioritise patient welfare, maintain professional integrity, and prevent undue influence or conflicts of interest. Government regulations and industry codes of practice provide the requirements, and Compliance functions use these to shape the advice they provide to staff in key areas such as:

Being aware of areas which can carry potential conflicts of interest, HCPs are thereby encouraged to transparently disclose these conflicts and maintain the integrity of their treatment decisions.