An Update on the NHC’s Tools to Support Sponsor-Patient Engagement: Fair-Market Value Calculator and Engagement Templates
By Silke Schoch, Manager, Research and Programs
In an effort to create sustainable, compliant, and patient-friendly agreements between stakeholders and the patient and caregiver community, the National Health Council (NHC) is completing a toolbox of fair-market value (FMV) materials. The Toolbox is expected to go live in early Summer 2020 and will include:
Fair-Market Value Tools
· The NHC’s FMV Calculator provides guidance on how companies can provide fair compensation and reimbursements to patients and patient representatives who are involved in patient-engagement activities. The FMV Calculator considers the various activities a patient might be asked to be involved in, their knowledge about the condition and other expertise they may have, travel time, preparation time, and other special considerations.
· The Compensation Principles provide general guidance regarding compensating patient-community representatives for their time and expertise when participating in patient-engagement activities. It addresses subjects such as logistics of compensation, travel and reimbursement considerations, declining compensation, and the time commitment of the participants.
· The Contracting Principles guide contracts between patients/patient advocates and industry. They were originally developed by Myeloma Patients Europe, WECAN, and Patient Focused Medicines Development, and adapted to a US setting by the NHC. The contracting principles address topics including; confidentiality, recording of meetings, data protection, indemnification, conflict resolution, adverse event reporting, and conflicts of interest.
· The Contracting Templates include plain-language legal agreements that can be used by companies when engaging with patients, caregivers, or patient advocates. It is intended to make contracting easier and more transparent.
· The Companion Guide to the Contracting Templates explains topics and terms that are included in the contracting templates, such as what is a scope of work, conflicts of interest, confidentiality, fees and expenses, intellectual property rights, liability, data privacy, and anti-bribery compliance. It also includes a section describing “Things to Know about Contract Negotiation” for patients, patient advocates, and companies.