Humanitarian access to unapproved interventions in public health emergencies of international concern.

Jerome Amir Singh

doi:10.1371/journal.pmed.1001793

Abstract

Jerome Singh considers how regulatory mechanisms can allow access to experimental interventions in humanitarian emergencies such as the Ebola epidemic.

Highlights

The rampant spread of the Ebola virus in West Africa has prompted the World Health Organization (WHO) to declare the outbreak there a public health emergency of international concern [1]
The United Nation’s Ebola Emergency Response Mission’s (UNMEER) announcement that it would miss its December 2014 deadline to contain the epidemic because of rising numbers of cases [2] illustrates that in the absence of a proven cure, efficacious treatment options or preventive vaccines for stemming Ebola’s spread in Africa and beyond will depend on several factors, including locating, isolating, and caring for those infected with Ebola, tracing their contacts, educating affected communities on safe burial practices, and strict adherence to infection control measures [1,3]
Most countries lack regulatory frameworks that permit the use of unapproved interventions on humans outside of systematic research conditions and lack reciprocal recognition agreements with major regulatory agencies, such as the US Federal Drug Administration (FDA) and the European Medicines Agency (EMA), both of which permit use of such interventions in prescribed circumstances. Such regulatory deficits could stymie time-sensitive efforts to contain public health threats when no efficacious curative, therapeutic, or preventive interventions exist to counter the threat in question

Summary

OPEN ACCESS

Most countries lack regulatory frameworks that permit the use of unapproved interventions on humans outside of systematic research conditions (including in “compassionate use” circumstances) and lack reciprocal recognition agreements with major regulatory agencies, such as the US FDA and the European Medicines Agency (EMA), both of which permit use of such interventions in prescribed circumstances Such regulatory deficits could stymie time-sensitive efforts to contain public health threats when no efficacious curative, therapeutic, or preventive interventions exist to counter the threat in question. The FDA has the discretion to partially lift a trial’s previously declared “hold” in prescribed circumstances Such a mechanism avoids an “all-or-nothing” approach and permits the clinical trial of an investigational agent to proceed under prescribed conditions, which is invaluable in the context of time-sensitive public health emergencies.

Addressing Governance Gaps

Ethics Considerations

Conclusions