Fair Market Value for Working with Patients: An Oxymoron?
Lode Dewulf
Chief Patient Officer

Deborah Collyar
Founder and President

Patient Advocates In Research (PAIR)
Tony Hoos
Former Head of Medical

Amgen Europe

rom laboratory bench to regulatory/payer approval and real world use, medicine development has reached, perhaps even crossed, a tipping point. Today, the risk of not working with patients in the medicine lifecycle is higher than the risk of working with patients: A recent Economist Intelligence Unit report commissioned by PAREXEL found that trials using patient-centric designs were 19% more likely to be launched compared to trials that did not. Studies and product launches that failed because insights from patients were not sought remain lasting and powerful reminders of today’s new reality.

Even so, the need and commitment to work with patients and the broader patient community, including family and caregivers, also raises new questions and challenges. Among them, the question of fair compensation for such work is gaining increasing attention.

A first question: “Should patients be remunerated for their input?”

Whether indirectly through taxes, purely out-of-pocket, by paying their insurance, or a combination of all three, all patients pay for their own medical care. These combinations vary widely between countries, but the bill ultimately flows back to each of us. We often discuss and challenge these components and combinations, but the basic premise that one should be remunerated (financially and/or otherwise) for a service rendered has been with us since pre-agrarian times. It is no more than fair that a providing a service should yield a remuneration.

Customers (or consumers) in the travel, dining, or electronics industries are often (or should be) paid for sharing helpful feedback to providers in these industries. Shouldn’t patients (or healthcare consumers) who help hospitals, physicians, or researchers in academia, industry, care centers or other organizations deliver better outcomes (which may result in more organizational income) be remunerated as well? Research funders such as Cancer Research UK (CRUK) and the US Patient Centered Outcomes Research Institute (PCORI) have called for remuneration of patients who are involved and engaged in research.

Common counter-arguments

“Patients should not get paid because they can (or will, or do) benefit from the better product or service that results from their contribution.”

“Patients should not get paid because any payment induces a bias and thus renders invalid the patient’s contribution.”

Curiously, such arguments are often made by people who have no problem receiving a salary for their own contributions. Following this same logic: Tax consultants, legal counselors, and healthcare professionals should no longer be remunerated for their contributions because such remuneration would introduce biases that may make their work less valid if not invalid.

We can justify making “exceptions” for these experts but not for patients who are experts in their own disease?

Fortunately, the growing consensus is that, indeed, patients should be paid when they provide a service that allows other healthcare stakeholders to do their jobs better. It also remains interesting that stakeholders who are in fact already funded by patients via public taxes and financing still seem more reluctant to pay patients for their services than stakeholders who are privately funded (by, for example, pharmaceuticals companies). Publically funded stakeholders who receive less input from patients are limiting their ability to improve their products and services based on that input, thereby creating risk for all.

If they should be paid, how much?

Answering this question brings us to the concept of Fair Market Value (FMV) remuneration. The goal of FMV remuneration is to avoid bias and unfair treatment regardless of whether that bias comes through the advice received, through dependence, or through creating good will.

The concept was first introduced in the healthcare domain out of public concern for the independence (more accurately, for the lack thereof) of healthcare professionals who work in various capacities with the pharmaceutical industry. How truly independent can an academic researcher or clinical expert be if too much of their personal income (or the income of their business unit) comes from industry? How confident can I be that my doctor has prescribed the very best medicine for me, and not an inferior one produced by the company which “coincidentally” sponsors her/his attendance to six annual conferences? These and similar concerns led to implementation of FMV compensation for services rendered by healthcare professionals (HCPs) to industry and, more recently, an increased demand for transparency and disclosure of any/all such compensation.

HCP advice, ideally from multiple experts to cover different perspectives, remains a foundational cornerstone in developing better healthcare solutions, and this work needs to be remunerated. FMV remuneration for such advice (service) to the contributing HCP is based on the premise that the HCP is not unduly influenced in her/his independence (of decision making, of choice of what to work on, or of advice given). FMV remuneration for HCPs is therefore mainly based on the combination of time and effort spent providing that service (to replace income the HCP lost) with the expertise needed to provide that service, which is primarily derived from education, experience, or similar work. FMV standards for HCPs have been developed and refined over many years. These differ by the HCP’s specialty, experience, and location, and by the nature and complexity of the provided service (e.g., multivariate analysis of major dataset, or a clinical lecture to peers).

Patients are different types of partners

Patients can provide this service based on their own individual experience, whether part of a patient group or not; or based on experience beyond themselves (e.g., as the representative of a patient group, as a patient advocate, or even as a patient familiar with the R&D process). However, there are still no widely accepted FMV standards for services provided to industry, regulatory agencies, HTA bodies, or other healthcare stakeholders, by patients, the patient community, or by caregivers.

We cannot simply “copy” the FMV standards for HCPs and “paste” them over to patients for many reasons, including much more variance in parameters such as:

  • Income, from self-employed to dependent on social security, from CEO to carpenter, etc.
  • Type of experience/expertise
    • three months into a life-threatening cancer diagnosis versus living for twenty years with a chronic illness
    • no understanding of disease or medicine development versus certified graduate from the European Patients’ Academy (EUPATI)
  • Willingness versus non-willingness to accept remuneration.

This need for FMV principles and standards for patient services has engendered a plethora of FMV guidance projects. Many of these projects lack transparency into their co-creation process, sufficient representation of all involved stakeholders, or other essential development resources, and consequently have not gained broad adoption.

Today, several organizations and companies have by necessity created basic internal guidance. But how can we call these FMV standards when they do not represent, and are not shared throughout, the entire market? How can the public and other stakeholders consider self-developed guidelines fair instead of biased? Aren’t these simply another tool in marketing’s mix of creating brand and product advocacy?

Major patient FMV project launch

As previously reported (see December 2018 Global Forum), a major FMV co-creation project has been launched: the National Health Council (NHC, the US umbrella organization for most chronic disease associations), with support of its multi-stakeholder board, has launched an open call for collaboration and support to create FMV standards with the help of an independent third party. The Patient Focused Medicines Development coalition (PFMD, the only global coalition aimed at enhancing patient engagement in medicine development) has joined forces with the NHC to strengthen the project and to expand the scope to also include Europe and the thinking of the EPFIA Patient Think Tank.

What does this mean in practice? We all need FMV standards for working with patients. Ignoring or not using FMV for patient service remuneration carries huge risks. Standards cannot be created in isolation by a company or a patient group. Standards are not competitive know-how, but they can create certainty and advantages for all if co-created by all stakeholders. None of us can solve this puzzle alone, and so it is better to combine rather than fragment our efforts in a co-created solution and to then work with it and keep improving it.

If you want to contribute, please join the discussion via either organization. Get more information from the US National Health Council, from the Patient Focused Medicines Development coalition, or from the corresponding author.