PREQUALIFICATION OF ANTISERA: the way to improve access to quality and safe products

WHO has developed a programme of prequalifi cation of essential medicines aimed at expanding patients’ access to drugs for the treatment of HIV/AIDS, tuberculosis and malaria. This programme ensures the quality, effi cacy and safety of medicines procured by United Nations agencies, such as UNICEF. The concept of prequalifi cation may be benefi cial in the fi eld of therapeutic antiserum as a means to assure the quality and safety of products distributed on the international market.

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Furthermore, it would stimulate antisera manufacturers, including those in developing countries, to improve their products.

The basic principles of the prequalifi cation programme of medicines are:

(a) it is voluntary, i.e. the manufacturers decide whether to participate or not;

(b) it is based on general procedures and standards approved through WHO Expert Committees involving WHO member states and WHO Governing bodies;

(c) it has been widely discussed and is supported by the International Conference of Drug Regulatory

Authorities (ICDRA);

(d) it is transparent, since all the information is available on the web site (48);

(e)

it is open to both products developers and manufacturers of generic products; (f) currently, it has no

costs for applicants;

(g) it involves a component of capacity building as a key issue in the process, which is particularly relevant in the fi eld of antiserum manufacture.

The expected outcomes of this programme of prequalifi cation, whether applied to essential medi-

cines or to antisera, include the publication of lists of products and manufacturers, which would help national, regional and large scale procurement agencies. This process will also promote capacity

building and harmonization among national drug regulatory authorities, manufacturers, WHO treatment

programmes, non-governmental organizations and procurement institutions. The programme includes continuous quality monitoring of production and control laboratories. In the long term, it is expected that such a process, applied to the fi eld of antiserum manufacturers and regulators, would result in widespread improvement in the capacity of the laboratories in developing countries, as well as in the quality and safety of available products. This will guarantee fulfi lling the needs of effective and safe rabies immunoglobulin and antivenoms procurement where they are most needed.

For the manufacturers, the prequalifi cation programme allows a free-of-charge independent review of the quality, safety and effi cacy of their antisera, together with free-of-charge training and technical assistance by international experts in the fi eld to assure production of high quality antisera. The programme will also be helpful in building up market confi dence in the quality of the products, and may contribute to the involvement of international procurement organizations in the purchase of antisera for regions whose governments are unable to obtain these life-saving products.

The processes in which the laboratories applying for prequalifi cation will be involved could also benefi t other laboratories, through transfer of technology and training workshops on manufacture, quality control and regulation, under the coordination of WHO. Therefore, if well structured, the capacity building of this initiative could have a great impact on antiserum producers worldwide.

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