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

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.

• pharmaceutical industry
• patient advisory group
• transparency
• compliance
• ethics
• reputation

Acknowledgements

This article was based on a lecture given by NH and CT in February 2016 entitled ‘Priorities and challenges: phase III advocacy activities’. The said lecture was given as part of the European Market Access University Diploma (EMAUD) run by the University of Marseille.

Lilian Anekwe assisted in the writing of the manuscript.