Guidance for Patient Interactions June 2018 Beverly Harrison, Sr. Director and Head, Patient Support, GMO

Internal Guidance for Patient Interactions Overview “Patient” Definition Interactions with Patients Internal and External Compliance Preparation for Patient Interactions Patient Collaboration

“Patient” Definition A clear definition of the patient is critical to any internal guidelines for patient interaction Understanding who is considered a patient will ensure any interaction is compliant Example Patient definition: “Patients include both individuals and as represented by an external organization.”

Interactions with Patients Define when and where interactions with patients are acceptable Any interaction should be well-defined, with a stated purpose and clear rationale for interacting Transparency and documentation of any patient interaction is key Example settings for patient interactions: community health activities, educational meetings, and other similar venues

Internal and External Compliance Gain alignment with local Compliance Officers, Quality, and other relevant organizations within your company Interactions should not address personal information or health situations Personnel should be properly trained to interact with patients Interactions must be consistent with standards established by local compliance External Interactions must comply with applicable laws Relevant regulatory requirements must be met and maintained Company involvement with patients should be transparent and disclosed when appropriate

Preparing for Patient Interactions: Example Process Identify need for patient interaction Define a stated purpose, rationale, and scope Design interaction in accordance with internal guidance and applicable laws Review and approval of interaction by compliance and relevant internal partners

Patient Collaboration Working with patients on a project introduces additional complexity Written agreement: Detailed terms of the project between both parties is required Privacy permission: Must be obtained in advance to use the external group’s name, contact information, etc. Releases: Appropriate releases must be obtained prior to any publication Compliance and Governance: Must be consistent with internal compliance and relevant regulatory requirements