Orphan drug legislation: lessons for neglected tropical diseases
Version of Record online: 24 APR 2008
Copyright © 2008 John Wiley & Sons, Ltd.
The International Journal of Health Planning and Management
Volume 24, Issue 1, pages 27–42, January/March 2009
How to Cite
Villa, S., Compagni, A. and Reich, M. R. (2009), Orphan drug legislation: lessons for neglected tropical diseases. Int. J. Health Plann. Mgmt., 24: 27–42. doi: 10.1002/hpm.930
- Issue online: 26 FEB 2009
- Version of Record online: 24 APR 2008
- orphan drug;
- orphan drug legislation;
- rare diseases;
- tropical diseases
In the last 20 years, orphan drug legislation (ODL) has been adopted in several countries around the world (USA, Japan, Australia, and the European Union) and has successfully promoted R&D investments to develop new pharmaceutical products for the treatment of rare diseases. Without these incentives, many life-saving new drugs would have not been developed and produced.
For economic reasons, the development of medicines for the treatment of diseases prevalent in the developing world (or tropical diseases) is lagging behind. Among several factors, the low average per-capita income makes pharmaceutical markets in developing countries appear relatively unprofitable and therefore unattractive for R&D-oriented companies.
The case of ODL may offer some useful insights and perspectives for the fight against neglected tropical diseases. First, the measures used in ODL may also be effective in boosting R&D for neglected tropical diseases, if appropriately adapted to this market. Second, small-sized companies, which have played a successful role in the development of orphan drugs for rare diseases, may also represent a good business strategy for the case of tropical diseases. Copyright © 2008 John Wiley & Sons, Ltd.