Orphan drugs are the drugs that are used for diagnosing, preventing and treating life-threatening diseases or disorders that are rare. These rare occurring diseases are called orphan disease. However, there is no standard definition for an orphan disease. Definition of Orphan disease as per the World Health Organisation, (WHO) is a frequency of occurrence of less than 6.5 – 10 in 10,000. As per the European, Community definition is less than 5 in 10,000.
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What is an example of an Orphan Drug?
Haem Arginate – used to treat intermittent porphyria, variegate porphyria, hereditary coproporphyria.
Why are they called Orphan Drugs?
Pharmaceutical companies are not keen on investing in R&D to develop medicines for rare diseases as it won’t help the company from a business perspective. The target market for such medicines will be very small. As a result, companies won’t be able to recover their costs. Hence these drugs are called Orphan Drugs.
Does India have Legislation on the Development of Orphan Drugs?
No, India is yet to have a legislation on the development of Orphan Drugs.
Governments across the globe provide incentives to pharmaceutical companies for developing orphan drugs. Legislations were enacted by various governments to tackle this problem. The USA enacted a law in 1983, Japan in 1985, Australia in 1997, and the European Union in 2000. The enacted laws help pharmaceutical companies in the following ways.
- Tax incentives
- Funds for research
- Simplification of marketing authorization procedures.
- Market exclusivity
Since the law enacted by the USA in 1983, more than 700 orphan drugs have been developed by pharmaceutical companies in the USA.