On the Importance and Challenges of Global Access to Proven Life-Saving Treatments for Ebolavirus

Effective outbreak preparedness and response requires products available in sufficient quantities and delivered where and when needed. Clearly, providing prompt diagnosis and health care is challenging in the Democratic Republic of the Congo and other Ebola virus disease-epidemic countries, as stated by Olivier Mbaya and colleagues; less than a third of the 181 people who had Ebola virus disease during 2020–22 had received mAb-114 or REGN-EB3.1Crozier I Britson KA Wolfe DN et al.The evolution of medical countermeasures for Ebola virus disease: lessons learned and next steps.Vaccines. 2022; 101213Crossref Scopus (4) Google Scholar But, despite the commitment of leading research organisations such as the Congolese Institut National de Recherche Biomédicale and the US National Institutes of Health, relying on remaining drugs from trial batches under expanded access use, without formal regulatory authorisation and with limited supply channels falls short of being a satisfactory, sustainable solution, for the Democratic Republic of the Congo and more broadly, patients with Ebola virus disease in all at-risk countries. Should a major outbreak happen tomorrow in Africa, there will be no readily available stocks of either products with regulatory approval by local or regional health authorities to roll out swiftly. There is also no clear pathway for local authorities or emergency first responders such as WHO and Médecins Sans Frontières to purchase and deliver these treatments where needed. As documented in our Personal View,2Torreele E Boum Y Adjaho I et al.Breakthrough treatments for Ebola virus disease, but no access-what went wrong, and how can we do better?.Lancet Infect Dis. 2023; (published online Jan 19.)https://doi.org/10.1016/S1473-3099(22)00810-6Summary Full Text Full Text PDF PubMed Scopus (4) Google Scholar safety and efficacy evidence obtained collectively through the PALM clinical trial3Mulangu S Dodd LE Davey Jr, RT et al.A randomized, controlled trial of Ebola virus disease therapeutics.N Engl J Med. 2019; 381: 2293-2303Crossref PubMed Scopus (973) Google Scholar was handed over to the pharmaceutical companies Ridgeback and Regeneron, which then registered these treatments with the US Food and Drug Administration in 2020, and also enjoyed a lucrative priority review voucher. However, these companies did not do their part to enable affordable access, nor did any of the organisations in charge of the PALM trial set in place the right conditions for these research and licencing collaborations to guarantee timely availability and access. Ridgeback is understood to have no capacity to produce mAb-114 before 2024 at the earliest, and Regeneron's REGN-EB3 is stockpiled by the US government.4RegeneronPress release July 2020: Barda procures Regeneron's REGN-EB3 investigational Ebola treatment for national preparedness.https://investor.regeneron.com/news-releases/news-release-details/barda-procures-regenerons-regn-eb3-investigational-ebolaDate: Feb 19, 2023Google Scholar This situation epitomises the limitations of relying on goodwill and charity approaches for epidemic preparedness, and the need for an enforceable end-to-end approach that includes access from start.2Torreele E Boum Y Adjaho I et al.Breakthrough treatments for Ebola virus disease, but no access-what went wrong, and how can we do better?.Lancet Infect Dis. 2023; (published online Jan 19.)https://doi.org/10.1016/S1473-3099(22)00810-6Summary Full Text Full Text PDF PubMed Scopus (4) Google Scholar When issuing its Ebola virus disease treatment guidelines in August, 2022, WHO expressed concerns that access to these therapeutics is challenging and pricing and future supply remain unknown, and even warned that this strong recommendation could exacerbate health inequity.5WHOTherapeutics for Ebola virus disease.https://www.who.int/publications/i/item/9789240055742Date: 19 August 2022Date accessed: March 6, 2023Google Scholar It is time for the international community and for national authorities of the affected countries to step up efforts to complete the unfinished agenda, and ensure equitable access to Ebola treatments where and when needed, reflecting the collective effort many organisations have put into their development, including setting up and conducting a very challenging clinical trial. Building on lessons learnt from COVID-19, these efforts should include exploring technology transfer and local production of these life-saving health technologies, for greater autonomy and resilience in the region. We declare no competing interests. On the importance and challenges of global access to proven life-saving treatments for EbolavirusAs noted by Els Torreele and colleagues,1 among the key ethical standards of medical research is the principle that communities who participate in research receive benefit from the results of that research.2 Providing breakthrough therapies to patients who can benefit from them is a crucial mandate, requiring global coordination to address logistical challenges of product access, distribution, and administration that often arise in low-resource settings. Full-Text PDF Breakthrough treatments for Ebola virus disease, but no access—what went wrong, and how can we do better?Three years since proving effective for Ebola virus disease in a clinical trial, two breakthrough treatments are registered and stockpiled in the USA but still not registered and generally available in the countries most affected by this deadly infection of epidemic potential. Analysing the reasons for this, we see a fragmentation of the research and development value chain, with different stakeholders taking on different steps of the research and development process, without the public health-focused leadership needed to ensure the end goal of equitable access in countries where Ebola virus disease is prevalent. Full-Text PDF