The World Health Organisation (WHO) recently announced that the ongoing outbreak of Covid-19 is a pandemic. In a surprising move, the United States Food and Drug Administration (FDA) has classified Covid-19 as an orphan disease — a term generally reserved for rare health conditions.
FDA Grants Gilead Sciences Orphan Drug Status
On March 23, 2020, the FDA granted Gilead Sciences orphan drug status for its antiviral drug, Remdesivir, which was initially developed to treat Ebola. The medication is currently in Phase III clinical trials as a potential treatment for COVID-19.
Gilead Submits Request to Rescind Orphan Drug Designation
On March 25, however, Gilead revealed that it had submitted a request to the FDA to remove the orphan drug designation for Remdesivir. Advocates for global access to medicines had previously rejected Gilead’s claim to orphan status for Remdesivir, arguing against the company’s pricing. Gilead has faced criticism in the past due to its high pricing for drugs to treat Hepatitis C and HIV.
The Controversial Orphan Drug Act of 1983
In the United States, the Orphan Drug Act of 1983 provides incentives for companies to develop therapies, known as orphan drugs, for rare diseases. These incentives include seven years of market exclusivity and financial rewards for innovators. As a result, orphan drugs are often highly priced.
Issues Regarding Orphan Drug Status for COVID-19
The paradoxical situation arises from the FDA granting orphan drug status to Remdesivir, a proposed treatment for COVID-19, which is not a rare disease. As of now, there are over 800,049 confirmed cases across the globe.
Potential Impact on Global Health Care
Had Gilead not requested the FDA to rescind the orphan drug status, generic manufacturers would have been prohibited from marketing a drug to treat COVID-19 using the same active ingredient until seven years of market exclusivity had passed. This could have given Gilead unrestricted control over pricing and licensing, leading to potentially devastating effects on the healthcare system.
Patents and Access to Treatment in India
In India, Gilead Sciences holds patents and any patents are available for challenge. Indian law permits the government to issue a compulsory license in certain public health crises, which would allow third parties to manufacture a patented drug without the patent holder’s consent.
Rare Diseases: An Overview
Rare diseases are health conditions that affect a small number of people compared with more prevalent diseases. They impact a significant segment of the population when considered collectively and often disproportionately affect children due to their genetic origins. In India, between 56-72 million people are affected by rare diseases.
National Policy for Treatment of Rare Diseases, 2017
This policy outlines steps that need to be taken to comprehensively deal with rare diseases in both short and long-term scenarios. It includes the creation of an Inter-ministerial Consultative Committee to coordinate initiatives concerning rare diseases and the establishment of a patient registry with the Indian Council of Medical Research (ICMR). The policy also aims to create awareness among health professionals and the public about rare diseases.