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.
More at Institute for Patient Access