Médecins Sans Frontières Access to Medicines Campaign
Executive Summary
Ebola virus disease (EVD) is a severe, often fatal, illness that is caused by the Ebola virus and transmitted between humans or to humans from animals. While there are six different species in the genus Ebolavirus, Zaire ebolavirus is the species responsible for most outbreaks of EVD. Named after Zaire (now Democratic Republic of the Congo [DRC]), the country where the first recorded outbreak of EVD occurred in 1976, Zaire ebolavirus also caused the largest EVD outbreak on record in West Africa in 2014-16 which killed more than 11,000 people.
As of 2023, the world has two effective treatments approved by the US Food and Drug Administration (FDA) for disease caused by Zaire ebolavirus. After nearly half a century without any treatments, this breakthrough was made possible thanks to an unprecedented global collaborative effort by a wide range of stakeholders, including public researchers, ministries of health in affected countries, the World Health Organization (WHO), pharmaceutical corporations and non-governmental organisations (NGOs). Médecins Sans Frontières (MSF) teams, the people in our care, and their communities were also a part of these efforts.
Public contributions to biomedical research and development (R&D) have always been integral to new medicines’ development, but the role, scale and breadth of public contributions were particularly noteworthy in the case of treatments for EVD. The culmination of this was the publicly funded and managed Pamoja Tulinde Maisha (PALM) clinical trial that demonstrated the superior efficacy of two EVD treatment candidates. A monoclonal antibody (mAb) cocktail of atoltivimab, maftivimab, and odesivimab, known as REGN-EB3 and marketed by Regeneron Pharmaceuticals (Regeneron) as Inmazeb, was approved by the FDA in October 2020. In December 2020, the FDA also granted approval to a second monoclonal antibody treatment, ansuvimab, known as mAb114 and marketed by Ridgeback Biotherapeutics (Ridgeback) as Ebanga. mAb114 was originally isolated from a blood sample taken from an EVD survivor in DRC.
In August 2022, the WHO made a strong recommendation for their separate use in the first ever therapeutic guidelines for EVD. The guidelines also included a conditional recommendation against the use of ZMapp and remdesivir, the two other treatment candidates in the PALM trial. Although the approval of these products was a great achievement, the process of ensuring that people who need them can access them is at a standstill. As crucial contributors to the R&D of these treatments, survivors, affected countries and NGOs should have a say in this process. However, we see that decisions related to access and affordability are currently left only to the private corporations holding legal rights and regulatory data, and to the goodwill of these corporations and national governments.
The US government has set up its own emergency stockpile of EVD treatments which contains nearly all currently available treatments. As a result, these treatments have not been adequately rolled out as lifesaving public health tools for people in countries where outbreaks occur and are instead retained primarily as biosecurity tools. Other actors such as the European Union (EU) have also shown interest in establishing their own stockpile as part of their pandemic preparedness efforts. More than two years since their approval and five outbreaks of EVD later, the recommended medicines are still far from being used to their full potential in outbreak response.
In addition, as of April 2023, the format, size, governance, and location of a UN/WHO global stockpile of EVD treatments were still under discussion. The offered price per treatment course has not been disclosed but is likely to be exorbitant based on the estimated price paid by the US for its stockpile. The ambitions for the size of the UN/WHO stockpile may have to be considerably scaled down due to price barriers and lack of supply. It is uncertain at this stage whether a global UN/WHO stockpile will be established in the near future, leaving people, countries and treatment providers like MSF without direct access to the two medicines whose development they contributed to for future outbreaks of this deadly disease.
