By: Brian Kennedy, Executive Director, Global Alliance for Patient Access
This month’s World Health Organization Open Sessions with INN Stakeholders explored the value, and the future, of the biological qualifier system. The Global Alliance for Patient Access was pleased to present to WHO officials and an international group of fellow stakeholders.
While there, I conveyed three core ideas: Distinguishable names encourage strong pharmacovigilance. Physicians and patients alike welcome them. And the WHO’s biological qualifier system represents an important step forward.
These sentiments are exactly what GAfPA, the Alliance for Patient Access, and the physicians and advocates who comprise our membership have expressed in recent years:
- In 2014, AfPA chairman David Charles, MD, urged regulators to “Ensure Patient Safety When Naming Biological Medicines.”
- In 2015, AfPA’s educational video, “A Prescription for Safe Biologics,” encouraged distinct names.
- Later that year, the Institute for Patient Access appealed to U.S. regulators to address unresolved policy issues, including the question of naming.
- The issue has also come across in physician articles, blog posts and letters.
Meanwhile, the Global Alliance for Patient Access has extended the conversation about naming to an international audience. In addition to offering educational materials in translation, GAfPA has organized and attended workshops in Latin America and throughout Europe to discuss the value of distinguishable names. We’ve offered poster presentations for physicians and policymakers with the same message.
As we continue to move this educational message forward, the World Health Organization is working with regulatory authorities on the logistics of adopting the biologic qualifier system. The WHO must also coordinate with the U.S. Food and Drug Administration to determine how the U.S. naming system, once finalized, will co-exist with the WHO’s approach.
International regulators have a ways to go toward making the biological qualifier system a reality for patients and health care providers. But growing global consensus on why distinguishable names matter is a good omen, and a promising reminder that increasing options for patients doesn’t require us to throw caution to the wind.
It’s possible to have both a range of biological and biosimilar treatment options and a regulatory system that acknowledges variations among medications, encouraging pharmacovigilance across geographical borders. With continued advocacy, regulatory progress and the help of the WHO biological qualifier system, patients and health care providers can achieve both.