Patient Advocacy: How Top Pharma Companies Partner with Advocacy Groups to Shape Policy, Improve Access, and Boost Patient Voice Outside of the United States

Industries Profiled:
Pharmaceutical; Manufacturing; Biotech; Consumer Products; Diagnostic; Medical Device; Clinical Research; Research; Health Care; Communications; Medical; Biopharmaceutical; Laboratories


Companies Profiled:
AbbVie; Astellas; Bayer; BioMarin; Bionical Emas; Bluebird Bio; Covance; Janssen; Lundbeck; Merck; MSD; NexGen Healthcare Communications; Novartis; Parkway Pantai; Sanofi; Servier; Shire; Spark Therapeutics; Takeda Pharmaceuticals; Teva Pharmaceutical Industries Ltd; Tillotts Pharma; UCB Pharma; The Mexican Organization for Rare Disorders (OMER)

Study Snapshot

Best Practices, LLC engaged 26 leaders supporting patient advocacy at 23 life sciences companies through a benchmarking survey. Benchmark partners represent groups that operate outside of the United States.


Key topics covered in this report include:

• Understanding the “advocacy” landscape outside of the United States
• Effective practices for working with potentially hostile patient advocacy groups
• Preferred advocacy structures
• Advocacy tools
• Core competencies of advocacy professionals
• Advocacy lessons learned from socially sensitive or stigmatized disease areas
• Profiling advocacy group experience & expertise

• Structuring high performance pharma advocacy groups: There is no one-size-fits-all approach to structure pharma patient advocacy groups. Nearly half of the benchmark class has adopted centralized structure followed by decentralized structure at 27% companies and hybrid structure at 23%.

• 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.

• New technologies for patient education: Video sites, social networks, professional networks, and podcasts have created new channels and opportunities for pharma and external advocacy groups to educate patients. This study reveals that around 80% of participants rated social network groups like Facebook and YouTube & other video sites as important.

I.	Overview	pgs. 3-11
	Research Overview	pg. 4
	Universe of Learning	pg. 5
	Pharmaceutical Advocacy	pg. 6
	Key Recommendations	pg. 7
	Key Findings	pgs. 8-11
II.	Patient Advocacy Functional Structure	pgs. 12-21
III.	Patient Advocacy Partner Coordination & Effectiveness	pgs. 22-25
IV.	Developing & Optimizing Patient Advocacy Partnerships	pgs. 26-30
V.	Managing Relationships Within Controversial Disease States	pgs. 31-39
VI.	Current Trends & Future Directions	pgs. 40-44
VII.	Regulatory Impact on Patient Advocacy	pgs. 45-51
VIII.	Use of Technology, Future Trends & Issues	pgs. 52-56
IX.	Ethics and Patient Advocacy Relations	pgs. 57-60
X.	Lessons Learned	pgs. 61-69
XI.	Participants’ Profile	pgs. 70-72
XII.	Appendix	pgs. 73-88
XIII.	About Best Practices, LLC	pg. 89

• Structure of company’s patient advocacy function
• Efficacy of current structure of patient advocacy function
• Optimal structure for an internal patient advocacy group with reasons
• Interview narrative around company-sponsored summits
• Ensuring that patient advocacy organizations may properly contact or communicate with your company’s patient advocacy functional personnel
• Interview narratives on using Medical Affairs as a contact point
• Estimated number of FTEs dedicated to patient advocacy activities
• Patient advocacy experience of benchmark partners
• Number of patient advocacy groups currently supported by benchmark companies and expected to support in the coming year

• Effective metrics for measuring the success of patient advocacy activities and relationships
• Effective approaches designed to build relationships with patient advocacy groups
• Effective methods for prioritizing objectives when a patient advocacy group maintains relationships with multiple brands or therapeutic areas

• Importance of patient advocacy collaborations at different lifecycle stages
• Most important forms of education, program support, and grants/sponsorships during each of the four key lifecycle stages
• Effective approaches to seed early advocacy relationships
• Effective strategies for gaining early-stage support with advocacy groups

• Interview narrative around demonstrating the benefits of a collaborative relationship to advocacy groups
• Most critical considerations when managing collaboration with an advocacy group regarding therapies that may trigger controversy or social stigma
• Interview narrative around education being a key element when working in areas with a social stigma
• Most effective approaches in educating the market on conditions that may be highly controversial or have a social stigma
• Special interest groups’ impact
• Interview narrative around transparency being key to collaborating on social stigma disease areas
• Most effective strategies and tactics in minimizing opposition from patient advocacy or other special interest groups against a therapy that could be considered controversial
• Interview narrative around listening to external partners for achieving success with advocacy groups

• Interview narrative around developing an advocacy approach depending upon the maturity level of a patient advocacy group
• Current factors in the marketplace that should receive the greatest consideration with respect to patient advocacy issues
• Interview narrative around working on the overall negative attitude toward pharma companies
• Interview narrative around taking inputs into development process from patient advocacy groups

• Interview narrative around patient groups’ involvement in drug development
• Interview narrative around engagement of patient groups in many aspects of clinical studies
• Funding of clinical trial studies by patient advocacy groups
• Impact of new regulations on patient advocacy strategies and tactics to address them
• Interview narrative around patient groups’ interaction with regulatory agencies
• Impact of patient involvement in government regulatory agencies, including the FDA and the Prescription Drug User Fee Act on advocacy initiatives within benchmark companies

• Importance of listed platforms in delivering education to patient groups
• Issues or opportunities foreseen as important for patient advocacy over the next 3 years
• Interview narrative around understanding external group’s perspective to create effective advocacy relationship
• Maintaining robust relationships with existing advocacy groups, while also expanding to regional groups and providing strong support to national policies

• Interview narrative around abiding to ethical boundaries when interacting with patient groups
• Ethical boundaries adhered to while working with patient advocacy groups
• Interview narrative on the do’s and don’ts for effective advocacy relationships

• Interview narrative: Not all patient advocacy groups are effective organizations
• Most “painful” lessons learned by benchmark partners about relationships with patient advocacy groups
• Interview narrative around one of the biggest concerns that external cancer advocacy groups have and one of the ways to mitigate it
• Top success stories about relationships with patient advocacy groups
• Interview narrative around working with competitors to advance patient welfare
• Interview narrative around building relations
• Interview narrative: Patient groups are not always effective in the policy-making process
• Additional insights in patient advocacy

• Demographics of benchmark partners
• Therapeutic area represented by benchmark partners

• Voices from the field: Optimal structure for an internal patient advocacy group along with reasons
• Voices from the field: Organization of patient advocacy in a formal structure and improving the structure
• Voices from the field: Organization of patient advocacy in an informal structure and improving the structure
• Voices from the field: Top collaboration issues when working with socially sensitive diseases
• Voices from the field: Best approaches to minimize opposition from special interest groups
• Voices from the field: Current issues challenging patient advocacy
• Voices from the field: Impact of new regulations and addressing them
• Voices from the field: Patient involvement in government regulatory agencies
• Voices from the field: Future patient advocacy issues and opportunities
• Voices from the field: Patient advocacy, religious or other special interest groups having a greater impact
• Voices from the field: Ethical boundaries while working with patient advocacy groups
• Voices from the field: Painful lessons learned about relationships with patient advocacy groups
• Voices from the field: Success stories about relationships with patient advocacy groups
• Voices from the field: Benchmark partners’ experience in working with patient advocacy groups