PLoS Medicine
(Accessed 28 February 2015)
http://www.plosmedicine.org/

Humanitarian Access to Unapproved Interventions in Public Health Emergencies of International Concern
Jerome Amir Singh
Essay | published 24 Feb 2015 | PLOS Medicine 10.1371/journal.pmed.1001793
Summary Points
– Time-sensitive access to unapproved experimental interventions should be permitted on humanitarian grounds when patients or communities are facing death or irreversible disease progression and no other efficacious diagnostic, preventive, or therapeutic alternative exists.
– 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.
– United States regulatory mechanisms may provide useful guidance from a regulatory perspective to policy makers grappling with how to adequately prepare for, or respond to, potential or emerging public health emergencies.
– Access to unapproved experimental interventions should be underpinned by a robust monitoring and evaluation component that will inform product development and licensure.
– A global-level rapid-response governance framework for the employment of unapproved interventions in humanitarian contexts should be established as a matter of urgency.

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The Movement of Multidrug-Resistant Tuberculosis across Borders in East Africa Needs a Regional and Global Solution
Kevin P. Cain, Nina Marano, Maureen Kamene, Joseph Sitienei, Subroto Mukherjee, Aleksandar Galev, John Burton, Orkhan Nasibov, Jackson Kioko, Kevin M. De Cock
Policy Forum | published 24 Feb 2015 | PLOS Medicine 10.1371/journal.pmed.1001791
Summary Points
– Multidrug-resistant tuberculosis (MDR TB) and other deadly infectious diseases commonly occur in states suffering from political turmoil and armed conflict.
– The same conditions that promote MDR TB and other diseases often diminish the capacity of the public health system to address these needs, leading patients to seek care in other countries.
– In East Africa, a large number of patients from Somalia with MDR TB crossed the border to Kenya seeking treatment. While diagnostic capacity for MDR TB exists in Somalia, treatment capacity does not.
– Identification and management of such diseases need to be a priority for countries in the region both for humanitarian purposes and for the protection of their own residents. Often diseases will need to be diagnosed and treated outside of the country in which they are occurring.
– The solutions must be regional and global. Control of an infectious disease, such as MDR TB, must be focused at its source to be successful. Its control cannot depend on the existing capacity of the country in which it happens to occur.