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What is an Orphan Drug?

Orphan drugs are medicines that are specifically developed to treat rare disorders and diseases. The medical conditions that are treated with the use of orphan drugs are known as orphan diseases. Orphan diseases are highly uncommon and are often genetic. These pharmaceutical agents are offered when the market for a specific medication is low, and there is no need to mass produce them.

  1. Orphan Drug Act

    • In January of 1983, the Orphan Drug Act was passed in the United States. This law encourages pharmaceutical companies to develop drugs to treat diseases that affect fewer than 200,000 individuals. Creating drugs for such a small market is unprofitable. In order to convince drug companies to produce these orphan drugs, the government gives benefits such as tax breaks to the company for a certain period of time, generally seven years.

    Reason

    • By encouraging the development of orphan drugs, governments aim to make it easy for individuals suffering from rare medical conditions to receive the proper medications that they need.

    Research

    • The exclusivity period for companies regarding orphan drugs is about seven years. During this period, continuing research that is conducted regarding a certain medication could bring upon additional, previously unknown uses for it (for ailments that are not orphan diseases). This could lead to the medicine becoming profitable enough for the company to promote it aggressively and earn it entry in the market.

    Benefits

    • Some of the benefits that are provided by the government to drug companies that manufacture orphan drugs include, apart from tax incentives: financial subsidization for clinical research, increased marketing rights and patient protection and the creation of an enterprise that is government-run for the ongoing development and research of the orphan drug.

    Information

    • Historically, companies have sought to educate individuals on the details of orphan drugs via educating medical professionals beforehand. However, due to the increasing strength and ubiquity of the Internet, manufacturers, health care providers and non-profit agencies aim to educate the public with information on orphan medications through informational pages, using language that is simple for people to understand.

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