Drug and Vaccine Development and Access

Ml, Berman; Parasidis, Efthimios; Pj, Zettler

doi:10.2139/ssrn.3685135

Cited by 1 publication

(1 citation statement)

References 30 publications

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“…Emergency approvals offer more flexibility in the evidentiary requirements but with more conditions compared with other expedited approval programmes. 3 To qualify for an EUA/EUL the technology must target a disease that is considered an 'emergency'. In practice, that means technology for some diseases can benefit from an approval mechanism, whereas others cannot, BMJ Global Health which may be concerning if the latter carry an equal or even greater burden of morbidity and mortality.…”

Section: Introductionunclassified

Expediting approval for medical countermeasures to address high burden disease: an ethical justification to move beyond emergency use authorisation

Mercuri,

Hackett,

Upshur

et al. 2023

BMJ Glob Health

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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.

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Section: Introductionunclassified