Both patient advocacy groups (PAGs) and the healthcare industry are ultimately working toward the same goal: Better outcomes for patients. Each has its own way to get there, although sometimes their efforts do overlap. Depending on the circumstances, the overlap can present an opportunity for either partnership or peril.
Let’s dig a little deeper to find out which one it is.
Patient Advocacy Groups Defined
Patient advocacy groups educate, advocate for, and provide support services to patients and their caregivers. Their primary mission is to improve the life of patients and their caregivers. While most people are aware that patient advocacy groups work directly with patients and caregivers, few realize that some of their most impactful work can be with industry.
The healthcare industry works with patient advocacy groups to increase patient engagement across the entire patient life cycle with the aim of producing and delivering better treatments to patients.
There are partnership opportunities at every stage of the patient life cycle. – Source
Patient advocacy groups can be formal organizations like the American Heart Association, March of Dimes, and the National Organization for Rare Disorders. Or, patient advocacy groups can be informal cooperatives or consortiums of individual patient advocates and small organizations like the Diabetes Online Community which is organized around the hashtag #DOC.
Formal patient advocacy groups are often established as 501(c)3 tax-exempt organizations. Along with being recognized as tax-exempt, 501(c)3 organizations must operate within IRS-mandated restrictions and requirements. They are limited in the amount of lobbying or legislative activity they can engage in. And, 501(c)3s are required to disclose their financials annually, including a report of major donors, by filing a Form 990 with the IRS.
The various groups and individuals that make up an informally organized patient advocacy cooperative may or may not be 501(c)3s. Individual patient advocates who act as influencers and receive compensation from industry are subject to FTC disclosure guidelines. These advocates and influencers must disclose when they have received payment or some other consideration of value in exchange for promoting a product, brand, or message.
What Patient Advocacy Groups Offer the Healthcare Industry
Against the backdrop of patient-centered care, working with patient advocacy groups offers industry direct access to patients, caregivers, and health community opinion leaders. The insights and experiences that these patient advocates offer can have an impact on every aspect of industry, from medical research to regulatory processes to raising awareness and product launch campaigns.
Patient advocacy groups offer knowledge and services that help meet the healthcare industry’s need for patient and caregiver input, access, and data.
Patient-centric pharma and healthcare gain direct input, access, and data that informs their efforts when working directly with patient advocacy groups. – Source
Patient advocates can play an important role in medical research and clinical trials. Traditionally, industry has turned to patient advocacy groups for help in recruiting patients to participate in clinical trials. This is especially true for rare diseases that affect small populations. In today’s more patient-centered healthcare climate, pharma and industry are involving patients earlier in the product design and research planning processes. Involving patients early on in product development gives industry a proactive reality check on their efforts and helps them avoid putting precious resources toward unviable projects.
In the regulatory process, nothing has more impact than the testimony of a patient or caregiver. When patient advocates share their personal experiences and knowledge before the legislature or a regulatory agency, they offer authentic insights from their unique vantage point. Regulatory agencies understand how powerful the voice of the patient can be and are finding ways to integrate patient input into their regulatory process. One example of this is the FDA’s Patient Preference Initiative.
Additionally, patient advocacy groups can provide industry with direct access to patient communities and patient opinion leaders. By tapping into the networks and communities of these patient advocacy groups, industry’s direct-to-patient campaigns are more likely to succeed at raising awareness or helping patients make decisions about their care.
What the Healthcare Industry Offers to Patient Advocacy Groups
Industry offers patient advocacy groups opportunities to be directly involved in product development, medical research, educational events, and conferences. Through their participation, patient advocates have the opportunity to influence the development and delivery of new treatments. Patient advocates can also learn about new developments in the healthcare industry and medical science early on, adding to their knowledge.
By working with industry patient advocacy groups gain direct involvement in healthcare and pharma initiatives as respected partners. – Source
Educational campaigns offered by industry raise awareness about a particular health concern and its treatments or cure. Through these campaigns, the healthcare industry makes information available to patient advocacy groups. Sometimes this comes in the form of content to be shared with their communities. Other times it’s in the form of access to a medical or research professional to speak at a gathering or participate in a podcast. Cancer.com is an example of such an educational partnership. It was developed by Janssen Oncology in partnership with three patient advocacy groups; Cancer Support Community (CSC), CancerCare and the American Cancer Society (ACS).
Campaigns that provide access to medication or medical devices are another way industry reaches out to patient advocacy groups and their communities. Through these campaigns, medication, medical supplies, or medical devices are provided to qualifying patients at no- or low-cost. Patient advocacy groups often spread the word about these campaigns among their communities.
Industry also provides patient advocacy groups with financial support. This financial support takes on many forms. Sometimes it is in the form of donations given by a charitable foundation that is associated with a company. Other times it’s project-specific funding given through the company’s community outreach department. Industry sometimes buys paid advertising in the patient advocacy group’s publications and on their websites, and industry provides travel and associated costs for patient advocates to attend meetings and conferences.
For patient advocacy groups, the healthcare industry is but one source of funding. Depending on the patient advocacy group, other sources of funding can include foundation grants, direct fundraising, fees for services, and/or membership dues. Granted, industry funding can be a substantial source of funding for many patient advocacy groups.
For those patient advocacy groups that are 501(c)3s, there are limits to the amount of funding they can receive from a single source. If these groups go beyond these limits, they risk losing their tax-exempt status. For individuals who receive payments from industry, they are subject to the FTC disclosure guidelines and risk FTC sanctions if they don’t comply with those guidelines.
The Perils of PAG-Industry Partnerships
Because of the large amount of money the healthcare industry has paid to patient advocacy groups, some people question whether there exists an inherent conflict of interest for patient advocacy groups who promote industry’s messages, engage in lobbying, or participate in the regulatory process.
There’s no denying industry has a strong financial presence among patient advocacy groups. One study estimated that between 30% and 71% of patient advocacy groups have financial ties to pharma. After it came to light that opioid makers had given advocacy groups a total of $10 million dollars over five years, Senator Claire McCaskill questioned whether opioid makers had undue influence over those advocacy groups who testified in support of painkillers.
The fear is that financial considerations are supplanting the primary mission of improving the lives of patients. This is leading some to question the trustworthiness of testimony and endorsements given by groups that receive payments from the healthcare industry.
The Best Ways to Manage the Perils of PAG-Industry Partnerships
Ethical standards and transparent practices help patient advocacy groups and industry avoid conflicts of interest and undue influence. – Source
It’s easy to glibly say, “Follow the money” and assume that any kind of monetary exchange naturally results in a conflict of interest or undue influence. However, by applying ethical standards and transparent practices to partnerships between patient advocacy groups and the healthcare industry, these perils can be avoided.
Industry has recognized the importance of having codes of conduct that apply to partnerships with patient advocacy groups.
For example, a consortium of international pharmaceutical associations has published a Consensus Framework for Ethical Collaboration between Patients’ Organizations, Healthcare Professionals, and the Pharmaceutical Industry. This framework puts forth four principles:
- Put patients first
- Support ethical research and innovation
- Ensure independence and ethical conduct
- Promote transparency and accountability
Every partnership needs to start from common ground interests. For patient advocacy groups and the healthcare industry, that means improving the lives of patients in some way.
Every organization has its principles. Neither partner should expect the other to take any action that is outside the bounds of, or in conflict with, its mission, values, and principles. Patient advocacy groups and the healthcare industry need to clearly state in writing and communicate their principles and boundaries to each other.
Both sides of the partnership need to understand and accept that there is no quid pro quo. With its financial support, industry is not buying a spokesperson in the form of a patient advocacy group. Likewise, the patient advocacy group cannot expect a guarantee of financial support from industry simply because they agree to work together on an initiative.
Policies and procedures should be put in place that support independent and ethical conduct. For the healthcare industry, this means clear organizational separation between charitable foundations and daily operations. Patient advocacy groups should look to their governing boards for clear guidance on what constitutes conflicts of interest and how to avoid them. Governing boards can also define acceptable parameters for certain activities like lobbying. Industry must respect any boundaries and restrictions defined by their PAG partners’ governing boards.
Disclosing partnerships publicly promotes transparency and accountability. Both sides should make a practice of disclosing partnerships, including financial arrangements. This should be conducted in a way that makes the information easy to find and understand. Don’t just include financial disclosures in IRS filings; go beyond that and share this information on organizational websites, in annual reports, and in any collateral produced as part of a funded initiative.
Together, the healthcare industry and patient advocacy groups can produce dramatic improvements in the lives of patients and caregivers. They just can’t lose sight of their mission and values while working for a better tomorrow.