Access to antivenoms in the developing world: a multidisciplinary analysis

Dear Friends, 

 Even if the majority of us is probably not involved in procurement or management of antivenoms, I think the attached paper remains of great interest, for raising awareness of a very neglected access problem. It examines some of the most relevant barriers to access in resource-limited settings and discusses actions to overcome them. In short:  

Snakebite envenoming (SBE) may kill up to 137,880 persons annually, and only a small fraction of the estimated 2.7 million people envenomed after a snake bite each year have access to antivenom therapy. Antivenoms (or antivenins) are complex biological products, specific to a limited range of snake species; as such, they are produced from hyperimmune plasma obtained by immunizing donor animals, and they must be manufactured using immunoglobulins raised against venoms from snakes that occur in the countries and regions where the product will be deployed.

Barriers to access are situated upstream, midstream and downstream, including:

·       Production is far below the global need, and the supply crisis is particularly serious in sub-Saharan Africa. The small number of private manufacturers and the general lack of interest from multinational producers are indicative of the commercial realities of manufacturing nationally or regionally-specific products for unpredictable and unreliable markets (e.g. Sanofi ceased production in 2010).

·    Even if the WHO published Guidelines for the Production, Control and Regulation of Snake Antivenom Immunoglobulins, designed to assist both manufacturers and regulatory authorities and currently under revision, there remains considerable work to be done to improve the quality and safety of antivenom products, especially in weakly regulated markets such as sub-Saharan Africa.

·    There is a need to align research priorities on practical issues that must be overcome to improve production, quality control and regulation. One example is the emergence of lyophilization as a means of producing antivenoms that do not depend on cold-chain, while a wider range of innovations includes new adjuvants, improved immunizing mixtures, new generation SBE treatments based on small molecules or cocktails of neutralizing antibody cocktails etc.

·     The degree to which the registration process independently and robustly establishes the validity and reliability of manufacturer’s claims is, unfortunately, extremely variable.

·     The cost has a major impact on accessibility and affordability. While costs are generally lower in LMICs, antivenoms are often prohibitively expensive relative to the incomes of often impoverished snakebite victims.

·    Procurement processes can vary substantially depending on in-country supply. To ensure that products are fit-for-purpose, procurement agencies need to carefully define specifications based on expert consensus, but when there are no products registered, or in the absence of evidence-based recommendations, procurement of appropriate products may be especially challenging.

·    Finally, downstream challenges include adequate prescribing and dispensing/use; local availability and geographical accessibility; rational use of antivenom; and community perceptions of antivenom.

The authors conclude that with almost 140,000 deaths and hundreds of thousands of disabilities caused each year, SBE is a threat to the health and economic growth of LMIC communities in all parts of the world. Concerted action, led by WHO and strongly supported by governments, NGOs, donors and the pharmaceutical community is imperative. Please …spread the word!

Raffaella

PS A usual reminder that the second ITM short-course on Pharmaceutical Policies in Health Systems will take place in Antwerp, from 30th May to 17th June 2022. Those interested can apply until the end of January 2022, at https://edu.itg.be/courses/pharmaceutical-policies-in-health-systems

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