Opinion: Regulatory and Economic Turmoil Is More Familiar in Other Countries

I received a worried call from a partner’s senior executive one morning a few years ago. Overnight, the health minister had ousted the regulatory head in one of the key countries where we’ve filed, and the newly appointed successor had swiftly dismissed most senior civil servants in the regulatory agency. The executive’s concern was palpable; our critical marketing authorization application now seemed imperiled.

Sound familiar?

Under new Health and Human Services Secretary Robert F. Kennedy Jr., the FDA has experienced staffing changes, including layoffs and resignations at various levels, extending to senior leadership. Notably, Peter Marks, director of the Center for Biologics Evaluation and Research, has departed. These changes have prompted discussion within the biopharma industry about potential impacts on regulatory processes and repercussions for their business.

But while Western markets rarely experience significant, rapid changes, these are commonplace in many other parts of the world. In addition to major policy shifts, natural disasters, economic volatility and even war can greatly unsettle diverse industries. While such events may be a once-in-a-lifetime experience for those living in the West, recurring crises in other regions severely disrupt biopharma operations, impacting drug launches, jeopardizing patient access to vital medications and challenging commercial success.

As CEO of Er-Kim, a company with 45 years of experience in complex and volatile markets, I’ve seen firsthand how instability affects biopharmaceutical operations. But I’ve also learned that adaptability, foresight and the right strategic partners are key to success.

In response to the panicked call I received that morning, I reassured the company executive that we had foreseen this possibility—in fact, we had witnessed similar major policy changes in that very same country earlier in the year—and we were prepared.

By proactively adapting to changes, we can maintain our commitment to consistent medicine launches, even amidst near-daily challenges.

Drawing from my experience navigating biopharmaceutical launches in developing markets, I’ve identified four principles that can help biopharmaceutical companies navigate and thrive amidst volatility: adaptability, diversification, investment in human capital, and adherence to a strong ethical framework.

Transitioning from a stable environment to a dynamic paradigm is unsettling, especially because it will alter our plans. However, it should not alter our mission. Disruption, while challenging, also creates opportunities. Move beyond the pursuit of certainty and embrace a dynamic, strategic perspective. This mindset, similar to our probabilistic approach in biopharmaceutical development, should be implemented across all levels of the organization.

Drug launches in Western markets are typically long-term, predictable processes with minimal, easily anticipated disruptions. In the U.S. or EU, drug launch risks are essentially limited to FDA rejection or pricing disagreements, allowing for straightforward, predictable planning. In developing markets, on the other hand, the potential pitfalls extend far beyond the standard regulatory and pricing challenges. The dynamic landscape constantly reshapes possibilities in ways that defy prediction, demanding rapid and decisive action.

Instead of adhering to a standard, extended launch sequence, look to more unconventional models to make medications available as quickly and to as many patients as possible, while also limiting unnecessary work or financial obligations. In the case of rare disease treatments, the use of an Early Access Program as part of a business model in the initial commercial sales strategy can ensure that, regardless of any market disruptions, patients are able to receive treatment.

Finding individuals who can thrive in both stable and volatile settings necessitates different approaches to talent acquisition, training and HR management, moving beyond traditional models. In stable markets, the focus might be on specialized skills and linear career progression. However, volatile environments demand a more adaptable and resilient workforce.

Recruitment should prioritize not just technical skills, but also soft skills like adaptability, problem-solving and emotional intelligence. Those individuals who can demonstrate a capacity for ambiguity and a comfort with rapid change will prove to be the best performers when faced with uncertainty.

While the biopharmaceutical industry shares the moral goal of saving lives, recent events have highlighted the diverse and often conflicting ethical interpretations of “doing the right thing” among various stakeholders. Companies should prioritize a robust ethical foundation and adhere to it consistently. Even when faced with challenging choices, unwavering moral principles will yield long-term advantages for the organization and the patients it serves.

An example of this is when companies decide to distribute treatments in areas of political unrest and wars. Despite potential internal disagreements, biopharmaceutical companies are committed to ensuring patient access to life-altering treatments, even when difficult decisions must be made. While the decision may not be universally accepted, staying the course is a matter of moral commitment.

Instability is a long-term reality for developing countries. I like to look at this reality as a market trader. In these dynamic, often unpredictable environments, the concept of fixed outcomes simply doesn’t apply. Instead, we must operate within a framework of probabilities. Each new piece of data, whether it’s a political shift, a regulatory change or a sudden economic fluctuation, acts as a catalyst, subtly or dramatically shifting those probabilities.

Biopharmaceutical companies can embrace the inherent volatility of developing markets to allow them to gain a strategic advantage by identifying and seizing opportunities that others, blinded by the pursuit of certainty, cannot see.