(2002; 166 pages)
Drugs for neglected diseases: challenges for regulators
Dr Krisantha Weerasuriya, WHO, South-East Asia Region
Neglected diseases are generally tropical diseases, for which there is a lack of effective drugs. There is often a high disease burden in particular areas and sometimes a fatal outcome. The most neglected diseases include visceral leishmaniasis, African trypanosomiasis and Chagas disease.
In the past 25 years, 1393 new chemical entities have been granted market authorization. Among these, there were only 16 drugs for neglected diseases, all of which were included in the WHO Model List of Essential Drugs. Of the other 1377, only 21 were considered important enough to be included in the WHO List.
At present, there are no significant projects to develop drugs for the neglected diseases initiated by the pharmaceutical industry. A few products are in the pipeline but the industry is involved as partners with non-industry institutions; this situation is unlikely to change in the future. Therefore, a major challenge for regulators is to play a role in encouraging the development of these drugs. This is most pertinent for regulators in the developing world, who might consider fast-track registration, limited-release schemes for specific products, and joint evaluation of new products of public health importance.