Patient Advocacy: Regulatory Impact, Technology Utilization and Lessons Learned Outside of the United States

STUDY OVERVIEW

Around the world, patient advocacy groups play an important role in educating patients on disease state advances and new therapies and treatment options. The pharma function that works with patient advocacy groups likewise plays a vital role - it serves as the bridge between the pharma industry and patient groups. The regulatory environment and emerging technologies are two forces that are continually affecting this partnership dynamic. This is especially true outside the United States because of tighter regulations.

Best Practices, LLC conducted this benchmarking research to present current regulatory and technology trends for pharma organizations that deal with advocacy groups outside the United States. More extensively, this study provides respondents’ lessons learned on topics affecting patient advocacy, including structure, relationship management, and current trends.

This study has been segmented so that all respondents represent groups that operate outside of the United States.

KEY TOPICS

• Understanding the advocacy landscape
• Regulatory Impact on Patient Advocacy
• Use of Technology, Future Trends & Issues
• Ethics and Patient Advocacy Relations
• Lessons Learned
• Voices from the Field

• Do patient advocacy groups that your organizations support fund clinical trial studies?
• How much impact do you think upcoming regulatory initiatives could have on patient advocacy strategies at your company? Please state the impact and how you plan to address them.
• How is patient involvement in government regulatory agencies impacting patient advocacy at your company?
• Please rate the importance of the following technology platforms in delivering education to patient groups.
• What are the ethical boundaries that you adhere to while working with patient advocacy groups?
• What would you describe as an optimal structure for an internal patient advocacy group and why?
• If you have informal structure, please elaborate how your patient advocacy group is organized and how would you improve the structure.
• What considerations are most critical when managing collaboration with an advocacy group regarding therapies that may trigger controversy or social stigma?
• What strategy or tactics do you find most effective in minimizing opposition from Patient Advocacy or other Special Interest Groups against a therapy that could be considered controversial?
• What current factors in the marketplace do you feel should receive the greatest consideration with respect to patient advocacy issues?

• Evolving regulatory environment is challenging patient advocacy: Changing regulations are also affecting the patient advocacy landscape. Groups are increasingly getting involved with the FDA. In fact, 76% of partners believe the latest changes in regulations will have high-to-medium impact on patient advocacy strategies. Increasing patient centricity, enabling ease of access, collaborating, and preparing clinical teams will help companies address these regulatory changes.

This study engaged 26 leaders supporting patient advocacy at 23 life sciences companies and organizations. All the respondents represent groups that operate outside of the United States.

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