December 2018

“Eyes on the Stars, Feet on the Ground”

ith these words, European Medicines Agency Executive Director Guido Rasi opened his keynote address at the DIA Japan Annual Meeting last month. This was no ordinary civil service speech.

The “stars” are the disruptive scientific innovations occurring all around us at accelerating speeds within the global healthcare landscape. They drive unprecedented opportunities to alleviate and cure diseases. Regulators know this, and they are paying attention. Today’s regulators see themselves as regulatory scientists and enablers – the bridge between science and better health. To the surprise of many (old-timers), most sophisticated regulators today work hard to remove roadblocks to applied innovation, not to create them.

The “ground” is the hard reality that not all patients who need medical products have access to them; this is not acceptable in the age of disruptive innovation. Guido Rasi and his peers in the International Coalition of Medicines Regulatory Authorities (ICMRA), which also met in Tokyo concurrently with the DIA Japan Annual Meeting, see collaboration across the widest possible range of stakeholders (from academic scientists to payers, and everyone in between) as the solution to the issue of ultimate patient access. Enabling tools like innovative clinical trial designs, real world evidence, and precision medicine are among the many new approaches that will be used to connect the ground to the stars.

Guido Rasi’s closing words “We will not rest until access is ensured“ is a reminder to all of us who operate in the global healthcare environment: As long as there is a patient somewhere who does not have access to the life-saving medicines they need, our work is not done.

All of us are enablers. Or we should be.