Compulsory Licensing of Vaccination: The Need of the hour
Authored By: Ayush Sharma
Covid-19, a pandemic crisis that began in 2019, spread like wildfire over the world in 2020. Economic and human life were in a state of limbo as rich and third-world countries throughout the world struggled to save the lives of their citizens while trade and economy suffered a severe setback. Since no medical facilities were on hand to combat, countries were eliminated and the world's trade was destroyed. There were also attempts by scientists to create a vaccination but only a few countries such as the USA and the United Kingdom were able to succeed in this endeavour. Every country kick-started its own strategy for jabbing its people with the hope of ascertaining herd immunity. India started the immunization process in different phases. Front line workers were among the firsts to get vaccination with utmost priority, and subsequently, the second vaccination drive began which turned out to be beleaguered since the people of 60 plus age group are more vulnerable to the virus.
After the second phase, the Government of India started to vaccinate the people of age group 45-60 in the third phase of the vaccination drive which started in April 2021.
After opening the third phase of vaccination, there was an initial demand of nearly 700 million doses to vaccinate the eligible people nonetheless situation blew out drastically when the vaccination of the age group 18-45 started. Now, the vaccination drive is open for the most populous bracket and India requires nearly 2.2 billion jabs to vaccinate all the eligible people. Accelerating the vaccination drive stemmed from the paucity of vaccines. The government strategized the policy to vaccinate 300 million people by August 2021 which appears insurmountable as the prerequisite is nearly 3.4 million doses per day to match out the decided aim which is unachievable at the present rate of production.
Pharmaceutical manufacturers such as Bharat Biotech and SII have ramped up their production to the fullest yet this dexterity cannot meet the exigency. Central Government affirmed that SII and Bharat Biotech are producing 85 million doses per month. Nearly 105 million doses are required per month to meet out the aim of vaccinating 300 million people by August 2021.
THE PATENT ACT AND INDIAN CONSTITUTION
The pandemic took a devastating turn in the form of a second wave which has broken all the precedents set by itself the last year and on the other hand experts have warned of the third wave which will be of greater magnitude and more malignant than the second one.
India is facing a scarcity of vaccines but it is the only elixir available against the coronavirus. Currently, only two manufacturers are producing the vaccine and other leading pharmaceutical manufacturers do not have a license to produce the vaccine, as they cover it under the trade secret and the other required ingredients like the ratio, production protocol, clinical trial details, and other information are clandestine. India is the second-most populous country in the world and has a population of about 1.38 billion, therefore only two manufacturers meeting the arising demand for vaccines is not convincible. The propaganda should shift to protect the social interest rather than individual interests.
Circumstances arising out of the pandemic qualify all the criteria to override the patent and grant a compulsory license under section 92 of the Patents Act, 1970 which will empower the other capable pharmaceutical manufacturers to produce the vaccine and lead to the acceleration of the drive. Government can also invoke section 100 which enables them to use the invention or to authorize manufacturers to produce and encounter the demand of vaccine. The compulsory license can be obtained under section 84 however the process is cumbersome and the exigency of the current situation is of granting a compulsory license under section 92 which will be feasible and act as an absolute measure.
In the landmark case of Natco Pharma Ltd. vs. Bayer Corporation, the compulsory license was granted for the very first time to ensure public health and to comply with the socialization policy of India in consonance with Article 21 of the Constitution which provides the right to life to everyone. Also, Under Article 47 and Article 12 of ICESCR, it is the duty of the state to promote public health by providing them all the medical facilities. Therefore, the essence of these articles needs to be squeezed out over the current situation of Covid-19 to abate the inevitable loss of mankind.
Also, the Supreme Court of India by the way of suo moto cognizance, highlighted the suppleness given in the patents act to grant the compulsory license. This course of action was negated by stating that government is antagonistic to adopt the available statutory provisions and working on a global level to find out the most effective solution. The government’s rationale is not reasonable enough since the people are losing their lives every minute and the primary duty of the government is to protect and promote public health. The essence of the patent act is to protect the rights of the inventors, but not at the cost of public health.
INDIAN SHREWDNESS OF COMPULSORY LICENSING
India has anticipated at the international level for the waiver of the Trips Agreement and initially, South Africa also buttressed the same. Afterward, the USA and other WTO members reinforced India in waiver but countries such as Japan and UK are still persistent in not waiving the Trips Agreement. The reason is to protect big pharma companies since the making of a drug requires a huge amount of investment in terms of research, analysis, innovation, and development, and waiving off the patent rights will cause paramount loss to them in the future as the industry flourishes on new innovations which require huge investments.
Chief of WTO probed member nations to come up with a proposal on an exigent basis so that the patent could be waived off and the request of India and South Africa could prosper. Meanwhile, International Monetary Fund propounded a plan to inoculate around 60% of the world population by early 2022 at a cost of 60 billion dollars.
Compulsory licensing can be granted in situations of national emergency or matters of extreme urgency or for public non-commercial use and the current pandemic is sufficing these criteria. The plausible solution accessible is a waiver of the Trips Agreement which will waive off the intellectual protection to the technologies obligatory for fighting with the covid-19 including the manufacturing of vaccines.
The commercial rights of few individuals are in no way imperative than human life. Keeping this in mind it is high time for the govt. to grant compulsory license by invoking the provisions given under the patents act, to the pharmaceutical companies, not only for the vaccine but also for all other medical needs such as diagnostic kits, remdesivir, etc., which are required to ensure the public health and to safeguard the people from the inevitable third wave of coronavirus which may hit in coming 6-8 weeks. Granting Compulsory license will not only help to fulfill the domestic requirement of the country but also enable to discharge its global duties by providing vaccine to the least developed countries. In order to effectively immunize the whole country and recover from the pandemic, approximately 70% of the population needs to be inoculated and then only protection could be affirmed against the mutating variants of coronavirus.