Amgen

Lucia Cuadros

Building Trust, Enabling Access

One lesson has stood out in the journey toward improving patient access to medicines: trust is not just a virtue—it’s a strategy. Trust is not something to be assumed; it must be intentionally built, especially when what’s at stake is systemic change with collective impact.

In Colombia’s evolving regulatory landscape, fostering mutual trust between health authorities, industry leaders and policymakers has laid the groundwork for meaningful conversations about regulatory reliance. This trust has allowed us to move beyond transactional relationships and engage in strategic dialogue—discussions rooted not only in safety and efficiency but also in shared values and long-term vision.

In this piece, I share personal reflections on what it has meant to build trust in Colombia’s regulatory environment—and how that foundation allowed us to bring reliance out of the shadows, from being a “forbidden term” to a viable tool for transformation. I also explore the essential role of leadership, public policy evolution and public-private collaboration's power in ensuring faster, fairer access to healthcare solutions.

Trust Was the Missing Word

Regulatory reliance has followed a slow and hesitant path in Colombia. The most significant barrier wasn’t technical or legal—it was emotional—distrust.

From the regulatory authority’s perspective, there were fears of losing autonomy. Some evaluators expressed anxiety about job security and relevance in a rapidly changing landscape. On the other hand, parts of the pharmaceutical industry—especially companies not operating in reference countries—felt that reliance could be “unfair,” offering shortcuts to some and not others.

This wasn’t about regulatory loopholes or policy gaps. It was about how we, as humans, respond to change: with resistance, caution and sometimes fear. So, we quietly placed the term reliance in a drawer. We avoided using it. We left it untouched.

That silence lasted for years—until crisis made it unavoidable.

In recent years, Colombia’s regulatory authority faced unimaginable delays in decision-making, compounded by budget cuts and chronic underfunding. Something had to change. And so, we did something brave: we brought reliance back into the conversation. But not before returning to a deeper, more human conversation about trust.

Human First, Policy Second

Distrust isn’t born from the law. It’s born from uncertainty, fear and the unknown. And while these are natural reactions, public policy—especially at the intersection of public and private collaboration—has to be more ambitious than our reflexes.

Before discussing regulatory reliance, we had to consult each other, the people behind the institutions and the shared mission we often lose sight of: We are all part of an ecosystem that serves patients.

That common purpose became our foundation. It wasn’t about reaching a consensus on every technical detail or writing perfect definitions. It was about agreeing on something more basic and more powerful: that we all belong to the same system and that this system exists to protect health and life.

With that foundation in place, we dared dust off the term reliance and give it a new meaning rooted in mutual understanding.

The Power and Purpose of Reliance

Today, regulatory reliance is finding its place in Colombia—not as an imported trend but as a locally adapted strategy. It is being understood as a practical tool to optimize limited institutional resources, accelerate access to medicines and strengthen regulatory standards through shared practices and transparent data exchange.

Reliance does not mean giving up control. It means trusting peer systems, leveraging proven evaluations and focusing the limited attention of national agencies where it matters most.

We are not there yet—but reliance is no longer taboo. It is now part of our vocabulary and our vision. And from that place, we can build forward.

Leadership in Motion

Progress has not come from policy alone. It came from leadership— quiet, persistent, sometimes uncomfortable leadership. The kind that opens space for dialogue instead of defensiveness. The kind that doesn’t posture from expertise but shows up from shared humanity.

We didn’t lead this time by trying to “win the argument.” We led by listening. We chose to understand the resistance, not fight it. That shift changed everything. Real transformation demands trust in people, trust in process and a shared belief that timely access to medicines is a right. Trust may not be written into law, but it is the condition for progress.