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THE PHARMA REVIEW (MARCH 2009)

Orphan Drugs: Issues and Perspectives

Sachdev Yadav

Abstract: Rare diseases are characterized by their low prevalence (less than 1/2000). They are severe, life-threatening and chronically debilitating. About 80% of these rare diseases are of genetic origin and 20% are caused by viruses, bacteria and other environmental factors like chemicals, food, etc. Orphan drugs are medicinal products intended for diagnosis, prevention or treatment of life-threatening or very serious diseases or disorders that are rare. Governments and rare disease patient organizations have emphasized the need for economic incentives to encourage drug companies to develop and market medicines for the "orphaned" rare disease patients. The status of orphan drugs and expedite review provisions in selected ten countries are assessed.

Rare Diseases
Rare diseases are characterized by their low prevalence (less than 1/2000). They are severe, life-threatening and chronically debilitating. They are heterogeneous. 80% of these rare diseases are of genetic origin and 20% are caused by viruses, bacteria and other environmental factors like chemicals, food, etc. This category includes diseases such as mental deficiency, cerebral palsy, autism, psychosis, etc. At present, some four to five thousand rare diseases have been described in the world.

Orphan Drugs
Orphan drugs are medicinal products intended for diagnosis, prevention or treatment of life-threatening or very serious diseases or disorders that are rare, as mentioned above. These drugs are called "orphan" because the pharmaceutical industry has little interest under normal market conditions in developing and marketing products intended for only a small number of patients suffering from rare conditions. For the drug companies, the cost of bringing a rare disease medicinal product to the market would not be recovered by the expected sales of the product. For this reason, governments and rare disease patient organizations have emphasized the need for economic incentives to encourage drug companies to develop and market medicines for the "orphaned" rare disease patients.1

 

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