What makes a compliant Phase III and pre-launch patient advocacy strategy?

J Mark Access Health Policy. 2016 Dec 13:4. doi: 10.3402/jmahp.v4.33177. eCollection 2016.

Abstract

Background: A key task for the pharmaceutical industry is to understand the compliance implications of engaging with a patient advocacy group (PAG). This presents challenges for the industry to negotiate the ethical and reputational issues that can arise when working with a PAG.

Objective: To gain the views of pharmaceutical industry executives on future compliance challenges when working with PAGs.

Study design: We conducted two surveys among two sets of industry executives: one group focussed on market access roles and the other focussed on non-market access roles.

Results: Transparency was identified as the biggest challenge, followed by project rationale and then by project ownership.

Conclusion: We explore how this can be overcome and make recommendations on how best to work compliantly with PAGs.

Keywords: compliance; ethics; patient advisory group; pharmaceutical industry; reputation; transparency.