The topic at hand touches upon the recent proposition presented by the CPI (Marxist) party to the government regarding the issuance of compulsory licenses for the production of a generic version of Remdesivir. With this medicine being increasingly utilized in the treatment of Covid-19 patients, the suggestion aims to address related challenges with accessibility and affordability. Notably, generic medications and vaccines are essentially identical copies of original drug formulas sold at significantly lower prices.
Understanding Compulsory Licensing
Compulsory Licensing (CL) is a provision that provides governments the authority to license third parties, i.e., parties other than the patent holder, to produce and market a patented product or process. This is possible without requiring the approval of the patent owners. Application for a compulsory license can be made any time after three years from the date of patent sealing provided certain conditions are met: the public’s reasonable requirements are not satisfied; the patented invention is not available to the public at a reasonably affordable price; and the patented inventions are not carried out in India.
The Indian Patent Act, 1970 moderates compulsory licensing under its provisions. The Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) does not explicitly mention the reasons that may justify compulsory licensing. However, the Doha Declaration on TRIPS and Public Health acknowledges that countries have the freedom to determine the grounds for granting compulsory licences and to define what constitutes a national emergency.
Remdesivir: Background and Current Issues
Developed initially to treat Ebola and related viruses, Remdesivir has found usage in preventing Covid-19 viral replication according to the World Health Organization (WHO). The drug demonstrates remarkable potential and can be administered in high doses without causing toxicities. Recent observations reveal that the USA has secured the entire stock of Remdesivir for the next three months, making it unavailable for the rest of the world. This act is an example of vaccine nationalism where a country secures vaccine doses for its citizens before global availability through pre-purchase agreements with a vaccine manufacturer.
Furthermore, the manufacturing company of Remdesivir holds a patent monopoly, which allows them to charge prices that are hundreds of times the original cost of production.
Recommendations and Proposals
Given the monopolization of all Remdesivir stocks by the USA and the escalated pricing due to the patent monopoly, a suggestion has been put forth to invoke Clause 92 of the Patent Act (1970) allowing the government to issue compulsory licences. As per the said clause, the Central Government can issue compulsory licenses for any enforced patent in cases of national emergency or extreme urgency. The notification for such issuance can be released at any time after the sealing of the patent through the Official Gazette. Implementing compulsory licenses would enable Indian manufacturers to produce a more affordable generic version of Remdesivir.
The Way Forward
The government should aim towards breaking the patent monopoly as access to medicine, especially during pandemic times, is a fundamental right (Right to Health under Article 21) of every individual in the nation. The proposed usage of compulsory licensing could prove to be a significant step towards ensuring equitable access to essential drugs during this global health crisis.