Most marketers probably get more excited over the latest shiny new AI tool than a dusty old rule book. We’re attracted by opportunity, not by limitations. But the truth is that you’ll only be able to maximize your success if you also have an excellent handle on the regulatory environment you’re in. This is especially relevant in biopharmaceutical patient engagement, where regulatory infractions can have existential consequences. In this context, we shouldn’t just think of the Sacklers and Shkrelis and Holmeses of the world, who coupled regulatory noncompliance with lamentable ethical failures. We must also consider the many risks that linger around seemingly “minor” shortcomings and mishaps: The adverse event that wasn’t reported on time, the personal information that wasn’t handled in a HIPAA-compliant way, the missing fair balance disclaimer, the mishandled honorarium. A mistake in these areas can have far-reaching consequences, even if it won’t make the front page of the Wall Street Journal.
No training in the world can make up for a lack of the security and automation features that make regulatory compliance even possible.
The Unique Challenges of Patient/Pharma Interaction Patient engagement has become a critical component of medical marketing. With healthcare professionals becoming less accessible to biopharma reps, the emphasis has shifted toward patient empowerment. Patients today are knowledgeable and actively participate in deliberations about their healthcare, equipped with information from sources that may or may not be accurate and trustworthy. This shift calls for biopharma marketers to ensure patient access to reliable information as well as to listen and engage in a dialogue with the patient and caregiver community. Patient marketers are educators and facilitators as much as they are brand champions.
Most mistakes that are made in patient marketing stem from one thing: A failure to acknowledge that consumer engagement in healthcare needs a different approach to consumer engagement in other industries. It’s one thing to admire textbook-worthy marketing case studies from CPG brands and to learn new tactics as technology and the zeitgeist evolve. But it’s a terrible idea to carbon copy such campaigns without regard for the kinds of sensitivities that exist in our industry. Never mistake a Patient Ambassador® Program for a speaker bureau, a patient video for an online review, or a patient advisory board for just another market research effort. To an outsider, the difference may not be obvious, but a regulator will have no difficulty telling things apart and won’t hesitate to enforce rules that can make or break brands.
Stewards of a Brand
For this reason, marketers would do well to choose a patient engagement agency that acknowledges the idiosyncrasies of our industry and has a track record of working within this environment. First, all stewards of your brand must have a deep understanding of the regulatory landscape. They need to know what to do when it comes to adverse events, privacy laws like GDPR, and fair balance. This will only happen with thorough and consistently refreshed training throughout the organization. Second, compliance with regulations requires a technical infrastructure that allows the team to efficiently handle regulatory responsibilities. Ambiguity around processes and responsibilities is as much of a ticking time bomb as the reliance on general-purpose hardware and software. No training in the world can make up for a lack of the security and automation features that make regulatory compliance even possible.
Successful biopharma marketing is not just about avoiding pitfalls, but also about establishing a robust foundation in compliance and patient engagement.
The Human Angle
The third factor that can elevate or hurt biopharma brands is authenticity. Aspirational and exaggerated brand promises—the bread and butter in consumer goods marketing—are big no-nos in biopharma. Medications are no status symbols, and you don’t become a consumer of a drug because you would like to be a bit more like the sick person you saw in an ad. When you face a serious health condition, do you care if a model or an actor would like to motivate you to try a product? Likely not. Unless, of course, they also happen to be real patients who can share real, authentic perspectives.
Healthcare consumers place a premium on credibility, and regulators also keep a watchful eye on the kinds of promises biopharma brands make. Finally, beyond regulatory compliance, biopharma brand reputation also hinges on balancing the business angle of a patient engagement initiative with the human angle. For marketers accustomed to working with professional talent, it’s easy to lose sight of the healthcare context: Mobility, cognition, fatigue, dietary restrictions, vision, hearing, and emotional trauma are examples of patient-specific factors that wouldn’t normally come into play. Moreover, it’s a big ask to get someone to open up about their healthcare journey; this trust must be earned and rewarded with respect, patience, and accommodations for any limitations a patient may have. You don’t want to be barging into the patient and caregiver community with unreasonable demands based only on what you think your brand needs. Instead, remind yourself of your humanity, and let it show in your interactions.
Striking the Balance Marketers serve their brands by serving their customers. In biopharma, keeping the company safe becomes an added responsibility. By focusing on compliance and patient centricity, biopharma companies can protect their reputational and legal integrity, and patients stand to benefit along the way. There’s a balance to be struck between an assertive market presence and rigorous observance of pharma regulations and ethics. You can safely walk this tightrope when working with the right patient engagement agency.
Successful biopharma marketing is not just about avoiding pitfalls, but also about establishing a robust foundation in compliance and patient engagement. Companies that excel in these areas are not only avoiding scandal, they’re setting themselves apart as industry leaders in ethical and effective marketing.
