Humanitarian Access to Unapproved Interventions in Public Health Emergencies of International Concern

摘要

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]. The prioritised, accelerated provision of the unapproved investigational drug Z-Mapp to selected infected individuals and apparent cures in some instances as a result thereof highlight that arresting Ebola’s spread may, by necessity, also have to centre on the accelerated provision of experimental drugs, biological products (including vaccines and biological therapeutics), and devices (including in vitro diagnostics) to affected countries when no adequate, approved, and available alternative to the emergency use of the products in question exists. Such provision must be underpinned by a robust monitoring and evaluation component so that the provision can inform future use and policy on the issue. While this strategy has won WHO endorsement [4], many countries bar the use of unapproved interventions on humans outside of a clinical trial context and lack appropriate regulatory regimes to facilitate the fast-tracked provision of unapproved interventions to those who need them. Also currently lacking at a global level is a coordinating rapid response framework for the employment of unapproved interventions in humanitarian emergencies. In light of this shortcoming, crucial regulatory-related developments in the aftermath of the West African Ebola epidemic are welcomed. These include the US Federal Drug Administration’s (FDA) establishment of an Ebola task force with wide representation from across the FDA to coordinate its Ebola-related activities [5] and a cooperation pledge by members of an interim International Coalition of Medicines Regulatory Authorities in August 2014 [6]. Such initiatives must, however, result in comprehensive, harmonised regulatory mechanisms to ensure that a wide-range of potential Ebola-related interventions are permissible for use in clinical trial and post-trial contexts.