If your pre-commercial organization is planning or executing access programs for an investigational product, you’re taking a powerful, ethical, and respectful approach to demonstrating your commitment to patient communities.

But access programs for investigational products represent a classic philosophical challenge:  how do we balance the needs of an individual versus the needs of the population as a whole? Different people—and different cultures—have sought to solve this age-old question. If you are considering or have implemented an access program at your organization, you too, have not only joined this debate; you will be in the position to offer a real-world expression of your stance.

You are in business to bring lifesaving therapies to patients who desperately need them. Yet, there are substantial risks to making your therapy available ahead of full approval—to your company, to your clinical trials, and to your relationships with key stakeholders. One of these risks is simple misunderstanding of your company’s intent, with the potential to alienate those you most wish to help. In developing your communication approach it’s essential that you describe your program with compassion and clarity, based on an understanding of your corporate mission and goals, as well as the features and boundaries of the programs themselves.

Understanding Your Audience

Those people seeking access to your EAP likely have an advanced, life-threatening condition and are not eligible for clinical trials. He or she may have been living with the condition for years and have faced unimaginable hardships. Your EAP embodies hope—a powerful emotion—but one that can also result in bitter disappointment. To communicate effectively, compassion is imperative. But clarity is just as important. In your outreach, you must be driven by a singular principle:  Do Not Waste Their Time.  Your communications must use extreme efficiency of language, while also effectively navigating the complexity of these programs.

But how to communicate some of the arcane language and complex ethical challenges around your EAP?  As with all important conversations, it begins with the words you choose and the tone you employ.

Health Literacy vs. Technical Language

In the highly regulated legal and clinical environment around EAP, it can be tempting to fall back on more clinical language common to internal legal and regulatory discussions and decision-making. However, this language may not be comprehensible to a family without advanced degrees or experience navigating the healthcare system. The unintended consequences of this “conservative” approach is a disconnect with your audience—and worse, the potential to alienate them. In order to accurately frame your intentions, a health literate approach becomes more important than ever. But health literacy isn’t just “dumbing down” clinical and legal language; it’s “smarting up” this language to be truly democratic, understandable, and ultimately, more human. However, it isn’t easy “translating” this language. How do the words “investigational agent” become more understandable to a person with a high school education?  One approach is to create a glossary, but there are other solutions, too. Health literacy is more than reducing syllables and simplifying sentence structure. It’s also an organizing principle, arranging language in a read-friendly way, “chunking” text for easy scanning, and using simple graphics where possible.

Find a Voice. Establish a Tone.

The tone of your communication is also critical—and difficult to craft. You must express your humanity and commitment, while also communicating the business realities of the challenges of offering EAP. Through internal discussions, determine the principles that influence your decision-making around your access programs and their limitations—whether they are financial limitations, drug supply limitations, the limited availability of treating physicians, or any number of other challenges. While it may be difficult to broach these subjects and the content may not satisfy everyone, the reality of your challenges—and their truth—reflects your company’s integrity, honesty, and long-term vision.

But besides all of that, it is simply the right thing to do.

Like an EAP itself.


How We Can Help

We help pre-commercial organizations with EAP communications plans and work closely with key stakeholders within the organization to ask and answer important questions, including:

At Pre Commercial, we have deep experience in finding answers to these questions, as well as exploring unconventional lines of thinking that can lead to market moving insights regarding your product, disease environment, and corporate brand.

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