Chandani G S, BMS College of Law
ABSTRACT
Orphan drugs are those drugs which are used to treat rare diseases/orphan diseases. Rare diseases are those diseases which affect a relatively small population and generally of low prevalence. Most of the rare diseases are genetic in nature and persist throughout a person’s lifetime. The severity of rare diseases is acute even though they affect a small segment of people. Most of the pharmaceutical companies/drug manufacturers are extremely reluctant to come with up drugs to treat these rare diseases. This is because of low profits and low sales as it affects lesser number of people. As a result, orphan drugs are priced at high rates and are not accessible to the general public depriving them of their precious right to health. Under the Indian Patent law regime, compulsory licensing is recognized under Section 84 of the Patents Act, 1970 when the reasonable requirements of the public are not met or when the drugs are not easily affordable. This paper firstly discusses definition of rare diseases and orphan drugs. Secondly, it traces the various Indian Constitutional law and human rights provisions promoting right to health. Thirdly, it elaborates on the law channelizing compulsory licensing including the famous judgment of Bayer Corporation. Fourthly, it reviews the existing policy framework on rare diseases/orphan drugs primarily New Drugs and Clinical Trial Rules, 2019 and National Policy for Rare Diseases, 2021. Fifthly, it conducts a critical analysis keeping in mind the lacuna in affordability of orphan drugs, right to health and how compulsory licensing can provide a solution. Lastly, it concludes with making recommendations about orphan drugs including the necessity of having an Orphan Drugs Act (ODA) in India.
Keywords: Orphan Drugs, Rare Diseases, Right to Health, Compulsory Licensing, Patent Law.
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