|
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
For full text of this article contact the publisher on
info@kppub.com
|
The above content is an
abstract only. For the full Article please contact:
KONGPOSH Publications Pvt. Ltd.
ICS House, C-19, Commercial Complex, SDA, Opp. IIT Gate,
New Delhi, India -110016
Tel.: 26855839, 20057149, Fax: 91-11-26855876
Email:
info@kppub.com /
fpc@vsnl.com, Website:
http://www.kppub.com |
