SCALES OF PRODUCTION: the need to strengthen capacity

Various types of support are needed to improve the quality and the production capacity of antisera to meet worldwide needs. Some producers are likely to have ‘global’ market perspectives, i.e. a willingness to produce antivenoms for different regions of the world, based on demand, humanitarian needs and on agreements with national and regional health authorities.

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A strategy towards the consolidation of ‘regional’ laboratories should also be considered. These regional manufacturers should have reliable manufacturing processes and ability to ensure regional distribution of antisera of consistent quality and safety, in accordance with GMP standards. They should be encouraged and supported to increase production output and to demonstrate the effi cacy of the antivenoms against the species of snakes and scorpions of greatest medical importance in the regions of distribution.

Similar objectives prevail for the manufacture of safe and effective rabies immunoglobulins. Fostering ‘regional’ producers could be complemented by the strengthening of production laboratories, at national level, willing to improve product quality and to cover the national demand. This scenario, involving local, regional and global producers alike, and supported and coordinated by national and world health authorities, would guarantee an adequate and suffi cient supply of safe and effective antisera.

THE CRITICAL CASE OF AFRICA:

need for a multifaceted approach

The crisis in antiserum supply and correct use is most critical and urgent in sub-Saharan Africa. The number of antisera manufacturers supplying this region has decreased dramatically and the total amount of antiserum being offered is insuffi cient to cover even the most basic needs in this region. Moreover, the price of a vial of antivenom ranges between $50 and $150, which often represents a high portion of the yearly income of a rural worker.

Since an average adequate treatment usually involves the administration of at least 3 vials of antivenom, plus the use of ancillary therapeutic interventions, the cost of treating a single envenomed patient in Africa may reach around $200. In addition, some products imported to Africa are inappropriate and ineffective for the treatment of envenomings by African snakes. This situation, together with the poor development of health facilities and training of doctors, nurses and dispensers responsible for treating snakebites, have deterred many people suffering a snake bite from seeking medical treatment and driven them instead, to seek the help of traditional healers. A similar situation occurs regarding the procurement of rabies post-exposure prophylaxis. This combination of factors has created a self-perpetuating vicious cycle which needs to be urgently interrupted and corrected (47).

The solution to this disastrous situation should be multifaceted, involving simultaneously the various strategies discussed above. First, there is a need to involve a number of manufac-turers, both within Africa and in other regions, to commit themselves to a quota of antivenom production for Africa. An increase in overall antivenom supply to a level of 200,000 doses per year should be achieved by the year 2010. This effort should be combined with the transfer of manufacturing technologies to countries in Africa willing to start local production. The high cost of antivenoms for national health systems is another critical issue. Antivenom prices need to be affordable and international agencies and non-governmental organizations should commit to the purchase and donation of antivenoms. Achievement of these goals would break the vicious cycle by building up confi dence in the use and supply of antivenoms. Concomitantly, antivenom distribution should be optimized and guided by appropriate epidemiological information. The development of regional treatment guidelines and the continuous training of health workers in the correct use of antivenom should complete the multifaceted strategy.

Local community organizations should participate in all these efforts. The serious current crisis in antiserum supply and use in sub-Saharan Africa should involve global, regional and local manufacturers, public-private partnerships, local and regional health authorities and health workers in coordination with WHO.

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