PT - JOURNAL ARTICLE AU - Mercuri, Mathew AU - Hackett, Kristy AU - Upshur, Ross AU - Emerson, Claudia Isabel TI - Expediting approval for medical countermeasures to address high burden disease: an ethical justification to move beyond emergency use authorisation AID - 10.1136/bmjgh-2023-013480 DP - 2023 Nov 01 TA - BMJ Global Health PG - e013480 VI - 8 IP - 11 4099 - http://gh.bmj.com/content/8/11/e013480.short 4100 - http://gh.bmj.com/content/8/11/e013480.full SO - BMJ Global Health2023 Nov 01; 8 AB - Addressing global health crises requires a receptive and expedient policy environment to minimise delays in making available potentially life-saving technologies. Over time, the policy environment has adapted to ensure that communities have expedited access to promising technologies, such as vaccines, that can mitigate morbidity and mortality. Emergency authorisations are one such policy mechanism. While these have been employed successfully for several diseases, such as influenza, Ebola and COVID-19, the policy mechanism is tied to contexts where key bodies have designated the disease an ‘emergency’, whereas no equivalent mechanism exists for those failing to acquire the designation (eg, malaria and tuberculosis). In this paper, we examine ethical issues associated with emergency authorisations. We argue that there is no moral difference between those diseases considered emergencies and many that fail to be designated as such with respect to impact on affected communities. Thus, tying access to an expedient policy mechanism for approval to an emergency designation is ethically unjustified—it should be based on considerations of risks and benefits, the disease burden and the values of the communities that carry those risks and not contingent on if the disease is designated an emergency. We suggest the need to further enhance the policy environment to ensure access to similar expedited approval programmes irrespective of if a disease is an emergency. Levelling the field for access to expedited approval programmes across diseases can help in moving towards achieving global health equity but is not a panacea.There are no data in this work.