Patient Advocacy: Ethical Boundaries & Regulatory Impact on Patient Advocacy

Patient advocacy groups are an important partner for pharma in educating the marketplace about new medicines and treatments. Yet, the shifting regulatory landscape coupled with increased involvement of patient groups in key treatment and policy decisions is changing the advocacy relationship dynamics.

Best Practices, LLC undertook this benchmarking research to identify effective ways for biopharmaceutical organizations to collaborate with patient advocacy groups. In particular, this research establishes benchmarks around ethical boundaries and addressing regulatory impact for patient advocacy initiatives. The study also contains a chapter with qualitative data from respondents related to the regulatory environment, patient involvement in regulatory issues, and ethical boundaries.

KEY TOPICS

• Understanding the “advocacy” landscape
• Strategies to address regulatory impact
• Clinical trials funding
• Ethics and patient advocacy relationships

• Do patient advocacy groups that your organizations support/fund clinical trial studies?
• How much impact do you think initiatives such as the proposed 21st Century Cures Act could have on patient advocacy strategies at your company?
• What are the ethical boundaries that you adhere to while working with patient advocacy groups?

• Evolving regulatory environment is challenging patient advocacy: Changing regulations are also affecting the patient advocacy landscape. Groups are increasingly getting involved with FDA. Patient advocates are influencing the entire drug development lifecycle with the Affordable Care Act and proposed 21st Century Cures Act. In fact, 73% of partners believe the latest changes in regulation 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.

Best Practices, LLC engaged 74 leaders supporting patient advocacy at 61 biopharmaceutical companies through a benchmarking survey. More than 60% of participants are at the director/ senior director level. Nearly 65% of participants are from the United States.

If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.