Katie Jensen

Rare disease patient advocacy organizations face ethical issues regarding their relationships with the pharmaceutical industry. While there are shared interests that make these relationships mutually beneficial, they can also fuel ethical concerns because of the funding biopharmaceutical companies provide, questions of patient access, and the inherent power imbalance between a multibillion dollar global company and a small nonprofit.

In March 2017, as part of my master’s research, I conducted a survey on behalf of the Foundation for Sarcoidosis Research. A total of 34 rare disease patient advocacy organizations participated in the survey, which was aimed at uncovering common practices and overall mission effect. Three key findings emerge:

  • Rare disease patient advocacy organizations partner with the pharmaceutical industry on funded and/or nonfunded activities aimed at educating the public and advancing research.
  • The goal of these relationships is to increase treatment options, obtain funding, and/or improve education.
  • These relationships lead nonprofit organizations toward mission fulfillment and have a positive effect on mission impact.

Good experiences
The good news is that despite these underlying concerns, most survey participants view the overall effect of these relationships as positive and characterize these relationships as ethical. The results suggest relationships with the pharmaceutical industry are beneficial to rare disease patient advocacy organizations’ missions. It is clear that rare disease patient advocacy organizations generally view relationships with the pharmaceutical industry as positive and ethical.

Similarly, the vast majority of organizations receiving pharmaceutical funding report mostly positive effects from pharmaceutical relationships. The ultimate goal in pharmaceutical relationships for most organizations is to bring more treatment options to market with the help of the pharmaceutical industry.

Some organizations indicate specific intentions for partnering with the pharmaceutical industry on this goal, including: medical research advancement, treatment safety and efficacy, faster development and access, market readiness, and help with the FDA approval process. Organizations that identified funding as the primary outcome noted the need for funding to carry out their missions through funding research and serving patients, and also the need for the pharmaceutical industry to better understand the patient community.

These relationships are beneficial for nonprofit organizations in multiple ways. Feedback from organizations’ key stakeholders is generally positive. Most stakeholders recognize these relationships as strengths, but are also aware of the need for independence and neutrality.

Negative stakeholder feedback is largely focused on a perceived lack of industry involvement. While organizations are cautious about the external appearance of pharmaceutical relationships, they do not appear to have concerns internally. To this end, the majority of participants have either a formal or informal conflict of interest policy in place.

Transparency important
Rare disease patient advocacy organizations are encouraged to continue expanding their relationships with the pharmaceutical industry. To ensure external transparency and maintain ethical standards, organizations should implement a formal corporate relations policy that is specific to the pharmaceutical industry.

Organizations may also consider creating a Board of Directors pharmaceutical relations subcommittee comprised of pharmaceutical industry personnel, patients, medical experts, and nonprofit personnel to guide these interactions. Another good step for organizations is to complete the National Health Council Standards of Excellence Certification Program. Patient organizations and pharmaceutical companies should work toward integrative, as opposed to transactional, relationships.

More research on the topic of patient advocacy and pharmaceutical industry relations is needed. Continued research on the effect on nonprofit management, non-funded joint activities, results of such partnerships, alternative methods for collaboration, and a focus on pharmaceutical industry motives and overall impact are all welcome.

Beyond money
The rare disease patient advocacy community welcomes pharmaceutical partnership, specifically regarding increased therapeutic options. Patient advocacy organizations should continue partnering the pharmaceutical industry, particularly as the industry continues to evolve and incorporate the patient voice in drug development. But the patient advocacy community and the pharmaceutical industry should think of these relationships beyond financial support, and make a deeper exploration of how they can achieve their mutual goals of helping patients through integrative collaboration.